Labetalol Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also Warning and Precautions sections.

Dizziness and tiredness may occur. Scalp tingling may also occur as your body adjusts to the medication. Decreased sexual ability has been reported rarely. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), mental/mood changes (such as confusion, mood swings, depression).

This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but serious side effects, get medical help right away: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Labetalol (Oral Route) Precautions – Mayo Clinic

Precautions

Drug information provided by: IBM Micromedex

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Check with your doctor right away if you start having itchy skin, dark urine, loss of appetite, yellow eyes or skin, flu-like symptoms, or stomach pain or tenderness. These could be symptoms of a liver injury .

Labetalol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .

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Portions of this document last updated: Sept. 01, 2021

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.

Labetalol: medicine to treat high blood pressure, including high blood pressure in pregnancy

Adults and children aged 11 years and over usually take labetalol twice a day.

If you’re on a high dose, you may need to take it 3 or 4 times a day.

Younger children usually take labetalol 3 or 4 times a day.

Try to space your doses out evenly throughout the day.

Do not stop taking labetalol suddenly, especially if you have heart disease. This can make your condition worse.

If you want to stop taking your medicine, speak to your doctor. They may recommended reducing your dose gradually over a few weeks.

How much will I take?

The usual dose of labetalol for adults is between 400mg and 800mg a day, split into 2 doses.

If your blood pressure is still too high, your doctor may increase your dose up to 2,400mg a day.

If your child is prescribed labetalol, the doctor will use your child’s age and weight to work out the right dose.

Will my dose go up or down?

You’ll usually start on a low dose of 100mg, taken twice a day.

You doctor may increase your dose every 1 to 2 weeks if the medicine is not controlling your high blood pressure or angina.

Once you find a dose that works for you, you’ll usually stay with the same amount.

How to take it

Take labetalol with food. It’ll be less likely to upset your stomach.

Swallow the tablets whole with a drink of water, juice or milk. Do not chew them.

What if I forget to take it?

If you miss a dose of labetalol, take it as soon as you remember, unless it’s nearly time for your next dose.

In this case, just leave out the missed dose and take your next dose as normal.

Never take 2 doses at the same time. Do not take an extra dose to make up for a forgotten one.

If you often forget doses, it may help to set an alarm to remind you.

You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

The amount of labetalol that can lead to an overdose varies from person to person.

blockers | Heart and Stroke Foundation

What is this medication?

They’re officially called beta-adrenergic blocking agents. But most people call them beta-blockers.

Beta-blockers include:

• Acebutolol (Sectral^®)
• Atenolol (Tenormin^®)
• Bisoprolol (Monocor^®)
• Carvedilol (Coreg^®)
• Labetalol (Trandate^®)
• Metoprolol (Lopressor^®, Betaloc^®)
• Nadolol (Corgard^®)
• Pindolol (Viskazide^®)
• Propranolol (Inderal^®)
• Timolol (Blocadren^®)

Be aware:

• Generic names are listed first.
• Canadian brand names are in brackets.
• This list doesn’t include every brand name.
• If your prescription isn’t listed, your pharmacist is the best source for more information.

What does it do?

Beta-blockers make your heart work less hard. This lowers your heart rate (pulse) and blood pressures. If your heart is weakened, certain beta-blockers can protect your heart and help it get stronger.

• They are used to treat many conditions:
• They protect the heart from stress and abnormal heartbeats.

Key facts about beta-blockers:

• Lower your heart rate.
• Lower your blood pressure.
• If your heart has been weakened, may protect it and help it get stronger.

Be aware:  If you take a beta-blocker, keep a written log of your heart rate and blood pressure.

• Track your heart rate by taking your pulse daily.
• Write down your blood pressure numbers every time you take your blood pressure. It could be from your healthcare provider, the automated blood pressure machine at the drugstore, or your home blood pressure monitor.

How do I take it?

Take your beta-blocker exactly as prescribed.

• Try to take it at the same time(s) every day.
• If you take it more than once each day, space it out through the day.
• If you miss a dose, take it as soon as you remember unless it’s almost time for the next dose.
• Never double-up your dose or take extra medication to make up for the missed dose.
• Do not stop taking it unless directed by your healthcare provider.

Are there any interactions?

Some medications can stop your heart medicine from working properly. They may even cause other health problems.

Tell your healthcare provider and pharmacist about all the medications you are taking. These include:

• Prescriptions
• Non-prescription drugs
• Inhalers
• Creams or ointments
• Over-the-counter or natural health products
• Alternative therapies
• Vitamins, minerals or supplements
• Herbal remedies
• Homeopathic medicines
• Traditional remedies, such as Chinese medicines

Are there any side effects?

Beta-blockers can cause some side effects.

• Dizziness, lightheadedness, feeling faint.
  • Beta-blockers will slow your heart rate (pulse) and lower your blood pressure.
  • If you are dizzy or feel like you might faint, sit or lie down right away.
  • Get up slowly to give your blood vessels time to adjust.
• Drowsiness or fatigue
• Unusual swelling of the feet and ankles
• Wheezing, trouble breathing
• Depression
• Nightmares
• Cold hands and feet
• Decreased sexual ability.

Be aware: If you have diabetes and take a beta-blocker, watch your blood sugars closely. It may be harder to notice the effects of low blood sugar:

• Trembling
• Fast heart rate (pulse)

Beta-blockers don’t affect dizziness or sweating caused by low blood sugar.

If you have side effects, talk to your pharmacist or healthcare provider.

Lifestyle changes that can also help

There are two ways to control and manage your heart health: medication and lifestyle.

Medication can help you control heart disease and high blood pressure, but it cannot cure it.

A healthy lifestyle can help you keep medication to a minimum.

Visit heartandstroke.ca/get-healthy. Learn how to keep your heart healthy with current information and advice from Heart and Stroke experts.

Talk to your healthcare provider about the most beneficial lifestyle goals for you.

Related information

Your healthcare provider or pharmacist are your best sources of information. You can also learn more about medications at any of these trusted sites.

Health Canada – Drugs and Health Products
Provides health and medical information for Canadians to maintain and improve their health.

Learn more about:

Your ministry of health also offers health resources in your province or territory. For example, Ontario’s MedsCheck program provides free pharmacist consultations. And British Columbia’s Senior Healthcare web page provides information about important health programs.

Drug coverage

Hikma launches Labetalol Hydrochloride Injection in ready-to-use bags

Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are indicated for severe hypertension, to lower blood pressure. 

According to IQVIA, US sales of Labetalol HCl Injection, 100mg/20mL and 200mg/40mL vial were approximately $6 million in the 12 months ending March 2021.

“We are proud to introduce the first generic Labetalol HCl Injection in ready-to-use bags, a new therapeutic entity used to treat severe hypertension,” said Riad Mishlawi, President of Injectables. “Ready-to-use formulations improve the speed and safety of patient care and help hospitals, pharmacists, doctors and nurses treat patients more easily and with reduced risk of medication preparation error. This is another example of how Hikma is using its capabilities as a leading generic pharmaceutical company to expand its portfolio of essential medicines and introduce delivery systems that serve the growing needs of US medical professionals and their patients.”

Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of over 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.

Important Safety Information for Labetalol Hydrochloride Injection in Sodium Chloride and Dextrose bags:  

CONTRAINDICATIONS

Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are contraindicated in patients with:

• Bronchial asthma or obstructive airway disease
• Severe sinus bradycardia
• Heart block greater than first degree
• Cardiogenic shock
• IV administration of non-dihydropyridine calcium-channel antagonists (e. g., verapamil)
• Hypersensitivity reactions, including anaphylaxis, to labetalol

WARNINGS & PRECAUTIONS

• Hypotension – symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl injection. Before permitting any ambulation, establish patient’s ability to tolerate an upright position and observe the patient at the time of first ambulation.
• Bradycardia – bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving labetalol hydrochloride injection.
• Cardiac Failure – sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Betablockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Avoid labetalol HCl injection in patients with overt congestive heart failure. If patients develop signs or symptoms of heart failure during administration, discontinue labetalol and treat appropriately.
• Ischemic Heart Disease – abrupt cessation of therapy with beta blocking agents in patients with coronary artery disease, can cause exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, even in the absence of overt angina pectoris, after the discontinuation of labetalol HCl injection observe patients for development or worsening of angina. If patient experiences angina or angina markedly worsens or if acute coronary insufficiency develops, promptly reinstitute labetalol HCl injection and manage as unstable angina.
• Reactive Airway Disease and Nonallergic Bronchospasm – patients with reactive airways disease should, in general, not receive beta blockers. Labetalol HCl at the usual intravenous therapeutic doses has not been studied in patients with nonallergic bronchospastic disease. In the event of bronchospasm, stop the infusion immediately, and treat as appropriate.
• Use in Patients with Diabetes Mellitus and Hypoglycemia – in patients with hypoglycemia, or diabetic patients (especially those with labile diabetes) who are receiving insulin or other hypoglycemic agents, beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be masked. Concomitant use of beta-blockers and antidiabetic agents can enhance the glucose-lowering effect of antidiabetic agents. Monitor glycemic levels in patients receiving labetalol HCl injection.
• Use in Patients with Pheochromocytoma – intravenous labetalol has been shown to lower blood pressure and relieve symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, monitor blood pressure when administering intravenous labetalol HCl to patients with pheochromocytoma.
• Hepatic Injury – severe hepatocellular injury occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause. Do not restart labetalol in patients without another explanation for the observed liver injury.
• Use in Patients at Risk of Severe Acute Hypersensitivity Reactions – patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic). Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions. Avoid labetalol HCl injection in patients at high risk of anaphylactic reactions.
• Intraoperative Floppy Iris Syndrome (IFIS) – IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. Inform the patient’s ophthalmologist to be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension, Bradycardia, Depression of myocardial contractility in patients with overt congestive heart failure, Aggravation of angina, Significant decline in cardiac output following coronary bypass, Bronchospasm in patients with reactive airway disease, Paradoxical hypertensive responses in patients with pheochromocytoma, Hepatic injury, and Acute hypersensitivity reaction.

Clinical Trial Experience

Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.

The following also were reported with labetalol HCl with the incidence as noted:

Central and Peripheral Nervous Systems

Dizziness in 9%

Paresthesia, most frequently described as tingling of the scalp/skin in 7%

Gastrointestinal System

Nausea in 13%

Vomiting in 4%

Metabolic Disorders

Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8%; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.

Respiratory System

Bronchospasm

In addition, a number of other less common adverse events have been reported:

Cardiovascular

Hypotension, and rarely, syncope, bradycardia, heart block.

Liver and Biliary System

Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

Hypersensitivity

Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions. The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.

Clinical Laboratory Tests

Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.

DRUG INTERACTIONS

Bronchodilators

Labetalol HCl antagonizes the bronchodilatory effect of beta-receptor agonist drugs; therefore, labetalol HCl is contraindicated in patients with bronchial asthma.

Anesthesia

Synergism has been shown between halothane anesthesia and intravenously administered labetalol. During controlled hypotensive anesthesia using labetalol in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure.

Nitroglycerin

Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. If labetalol is used in patients with angina pectoris on nitroglycerine, monitor patients’ blood pressure and adjust labetalol HCl injection dose as needed. In these patients, avoid initiating labetalol HCl tablets.

Calcium Channel Blockers

Coadministration of labetalol HCl with non-dihydropyrindine calcium-channel antagonists (e.g., verapamil) is contraindicated. Avoid the use of labetalol in patients receiving calcium-channel antagonists.

Drug/Laboratory Test Interactions

The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic acid (VMA) when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with labetalol, a specific method, such as a high-performance liquid chromatographic assay with solid phase extraction should be employed in determining levels of catecholamines.

Labetalol has also been reported to produce a false-positive test for amphetamine when screening urine for the presence of drugs using the commercially available assay methods. When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirm using more specific methods, such as a gas chromatographic-mass spectrometer technique.

USE IN SPECIFIC POPULATIONS

Pregnancy

The extensive experience with use of labetalol in pregnant women, based on published interventional and observational studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus.

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Labetalol crosses the placenta. Neonates born to mothers who are receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly.

Lactation

Available published data report the presence of labetalol in human milk at low levels. There are no data on the effects on the breastfed infant and on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for labetalol and any potential adverse effects on the breastfed infant from labetalol or from the underlying maternal condition.

Females and Males of Reproductive Potential

Based on the published literature, beta blockers, including labetalol, may cause erectile dysfunction and inhibit sperm motility.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Some pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Geriatric patients treated with labetalol could initiate therapy at the currently recommended dose of 2 mg/minute by continuous intravenous infusion; however, lower maintenance dosages are generally required for elderly patients than nonelderly patients. Monitor blood pressure and adjust the dosage and duration of infusion accordingly until the desired response is obtained.

DOSAGE AND ADMINISTRATION

General Information

Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are ready-to-use solutions and do not require further dilution. Check for leaks by squeezing the bag firmly. If leaks are found, discard solution, as sterility may be impaired. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the content of the bag unless the solution is clear (colorless to light yellow) and the seal is intact. Do not add any additional medications to the bag.

Once infusion has started, discard any remaining at 24 hours.

Recommended Dosage

The recommended initial dosage is 2 mg/minute by continuous intravenous infusion, which is 2 mL/minute. Monitor blood pressure and adjust the dosage and duration of infusion accordingly. Once supine diastolic blood pressure has begun to rise, transition to oral labetalol HCl.

The usual intravenous dose is in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients, but the safety of doses above 300 mg has not been established.

OVERDOSAGE

Signs and Symptoms of Overdose

Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary, to improve the blood supply to the brain. Treat symptoms of overdose with standard supportive care. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion.

Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol from the general circulation (<1%).

The oral LD50 value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat is greater than 2 g/kg. The intravenous LD50 in these species is 50 to 60 mg/kg.

ENDING INFORMATION

Patient Counseling Information should be shared with the patient prior to administration.

For additional information, please refer to the Package Insert for full prescribing information, available on www.hikma.com.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For product Inquiry call 1-877-845-0689.

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922 USA

Labetalol – wikidoc

{{DrugProjectFormSinglePage
|authorTag=Alonso Alvarado, M.D. [1]
|genericName=Labetalol
|aOrAn=a
|drugClass=beta-adrenergic blocker, alpha-adrenergic blocker
|indicationType=treatment
|indication=hypertension
|adverseReactions=orthostatic hypotension, tingling sensation, nausea, dizziness, nasal congestion, fatigue
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=Condition Name: (Content)
|fdaLIADAdult======Labetalol Tablets=====

• Dosage must be individualized.
• The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days. The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily.
• Since the full antihypertensive effect of labetalol HCl is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.
• Patients with severe hypertension may require from 1,200 to 2,400 mg per day, with or without thiazide diuretics. * Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.
• When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.
• When transferring patients from other antihypertensive drugs, labetalol hydrochloride tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.

Elderly Patients

As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 and 200 mg b.i.d.

Labetalol Injection

Labetalol hydrochloride injection is intended for intravenous use in hospitalized patients. Dosage must be individualized depending upon the severity of hypertension and the response of the patient during dosing.

Patients should always be kept in a supine position during the period of intravenous drug administration. A substantial fall in blood pressure on standing should be expected in these patients. The patient’s ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities.

Either of two methods of administration of labetalol hydrochloride injection may be used:

• Repeated intravenous injections.
• Slow continuous infusion.

Repeated Intravenous Injection

Initially, labetalol hydrochloride injection should be given in a dose of 20 mg labetalol HCl (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow intravenous injection over a 2-minute period.

Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 mg or 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg labetalol HCl has been injected. The maximum effect usually occurs within 5 minutes of each injection.

Slow Continuous Infusion

Labetalol hydrochloride injection is prepared for continuous intravenous infusion by diluting the contents with commonly used intravenous fluids (see below). Examples of methods of preparing the infusion solution are:

The contents of either two 20 mL vials (40 mL), or one 40 mL vial, are added to 160 mL of a commonly used intravenous fluid such that the resultant 200 mL of solution contains 200 mg of labetalol hydrochloride, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.

Alternatively, the contents of either two 20 mL vials (40 mL), or one 40 mL vial, of labetalol hydrochloride injection are added to 250 mL of a commonly used intravenous fluid. The resultant solution will contain 200 mg of labetalol hydrochloride, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, e.g., graduated burette or mechanically driven infusion pump.

Since the half-life of labetalol is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period. The infusion should be continued until a satisfactory response is obtained and should then be stopped and oral labetalol hydrochloride started. The effective intravenous dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.

Initiation of Dosing with Labetalol Hydrochloride Tablets

Subsequent oral dosing with labetalol hydrochloride tablets should begin when it has been established that the supine diastolic blood pressure has begun to rise. The recommended initial dose is 200 mg, followed in 6 to 12 hours by an additional dose of 200 or 400 mg, depending on the blood pressure response. Thereafter, inpatient titration with labetalol hydrochloride tablets may proceed as follows:

This image is provided by the National Library of Medicine.

While in the hospital, the dosage of labetalol hydrochloride tablets may be increased at 1 day intervals to achieve the desired blood pressure reduction.
|offLabelAdultGuideSupport======Acute Myocardial Infarction=====

• Dosing Information/Recommendation

• 200 to 600 mg bid for the treatment of cocaine induced ACS.^[1]

|offLabelAdultNoGuideSupport======Angina=====

Cardiac Dysrrhythmia

Electroshock Therapy Complication

• 5 mg/mL (treatment of hypertension and arrhythmias).^[3]

Postoperative Hypertension

• Initial dose of 10 mg IV over 2 minutes, 10 to 20 mg doses every 10 minutes to a maximum of 300 mg/day may be administered if required.^[4]

Hypertensive Urgency

Hypertensive Encephalopathy

• 1 to 2 mg/kg IV bolus.^[6]

Middle Ear Microsurgery

• Initial dose of 0.3 mg/kg IV, then 0.05 to 0.07 mg/kg administered every 30 minutes.^[7]

Central Nervous System Surgery

• Continuous infusion 0.05 to 0.75 mg/kg/hour or 10 to 20 mg IV boluses with 60 to 120 minute intervals.^[8]

|offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Labetalol in pediatric patients.
|offLabelPedNoGuideSupport======Ventricular Arrhythmias=====

Condition 2

Condition 3

|contraindications=* Bronchial asthma

Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
|warnings======Hepatic Injury=====

Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology. Similar hepatic events have been reported with a related compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate. Laboratory testing should also be done at the very first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms). If the patient has jaundice or laboratory evidence of liver injury, labetalol should be stopped and not restarted.

Cardiac Failure

Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta-blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, labetalol can be used with caution in patients with a history of heart failure, who are well compensated. Congestive heart failure has been observed in patients receiving labetalol. Labetalol does not abolish the inotropic action of digitalis on heart muscle.

In Patients without a History of Cardiac Failure

In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blocking agents over a period of time can lead, in some cases, to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic, labetalol therapy should be withdrawn (gradually if possible).

Ischemic Heart Disease

Angina pectoris has not been reported upon labetalol discontinuation. However, following abrupt cessation of therapy with some beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported. Therefore, such patients should be cautioned against interruption of therapy without the physician’s advice. Even in the absence of overt angina pectoris, when discontinuation of labetalol is planned, the patient should be carefully observed and should be advised to limit physical activity. If angina markedly worsens or acute coronary insufficiency develops, labetalol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken.

Nonallergic Bronchospasm (e.g., chronic bronchitis and emphysema)

Since labetalol injection at the usual intravenous therapeutic doses has not been studied in patients with nonallergic bronchospastic disease, it should not be used in such patients.

Pheochromocytoma

Intravenous labetalol has been shown to be effective in lowering the blood pressure and relieving symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, use caution when administering labetalol to patients with pheochromocytoma.

Diabetes Mellitus and Hypoglycemia

Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; it may therefore be necessary to adjust the dose of antidiabetic drugs.

Major Surgery

Do not routinely withdraw chronic beta-blocker therapy prior to surgery. The effect of labetalol’s alpha adrenergic activity has not been evaluated in this setting.

Several deaths have occurred when labetalol injection was used during surgery (including when used in cases to control bleeding).

A synergism between labetalol and halothane anesthesia has been shown.

Rapid Decreases of Blood Pressure

Caution must be observed when reducing severely elevated blood pressure. A number of adverse reactions, including cerebral infarction, optic nerve infarction, angina, and ischemic changes in the electrocardiogram, have been reported with other agents when severely elevated blood pressure was reduced over time courses of several hours to as long as 1 or 2 days. The desired blood pressure lowering should therefore be achieved over as long a period of time as is compatible with the patient’s status.

Risk of Anaphylactic Reaction

While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrineused to treat allergic reaction.
|clinicalTrials=Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months’ duration, discontinuation of labetalol hydrochloride tablets

due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients.

The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged.

This image is provided by the National Library of Medicine.

The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta-blocker therapy.

Clinical trials also included studies utilizing daily doses up to 2,400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in the following table that depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

This image is provided by the National Library of Medicine.

In addition, a number of other less common adverse events have been reported:

• Body as a Whole: Fever.
• Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.
• Central and Peripheral Nervous Systems: Paresthesia, most frequently described as scalp tingling. In most cases, it was mild and transient and usually occurred at the beginning of treatment.
• Collagen Disorders: Systemic lupus erythematosus, positive antinuclear factor.
• Eyes: Dry eyes.
• Immunological System: Antimitochondrial antibodies.
• Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
• Musculoskeletal System: Muscle cramps, toxic myopathy.
• Respiratory System: Bronchospasm.
• Skin and Appendages: Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie’s disease; reversible alopecia.
• Urinary System: Difficulty in micturition, including acute urinary bladder retention.
• Hypersensitivity: Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea andanaphylactoidreactions.
• Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,900 patients was conducted for further safety and efficacy evaluation of this product. Results of this survey indicate that the type, severity, and incidence of adverse effects were comparable to those cited above.
• Potential Adverse Effects: In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.
• Central Nervous System: Reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientationfor time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on psychometrics.
• Cardiovascular: Intensification of A-V block (see CONTRAINDICATIONS).
• Allergic: Fever combined with aching and sore throat, laryngospasm, respiratory distress.
• Hematologic: Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.
• Gastrointestinal: Mesenteric artery thrombosis, ischemic colitis.
• The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.
• Clinical Laboratory Tests: There have been reversible increases of serum transaminases in 4% of patients treated with labetalol HCl and tested and, more rarely, reversible increases in blood urea.

|drugInteractions=* Tricyclic antidepressants: In one survey, 2.3% of patients taking labetalol HCl in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol HCl alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded.

Drug & OR Laboratory Test Interactions

The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic acid when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with labetalol HCl, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g., J Chromatogr 385:241,1987) should be employed in determining levels of catecholamines.

Labetalol HCl has also been reported to produce a false-positive test for amphetamine when screening urine for the presence of drugs using the commercially available assay methods Toxi-Lab A®(thin-layer chromatographic assay) and Emit-d.a.u ®(radioenzymatic assay). When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirmation should be made by using more specific methods, such as a gas chromatographic-mass spectrometer technique.
|FDAPregCat=C
|useInPregnancyFDA======Teratogenic Effects=====
Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Increased fetal resorptions were seen in both species at doses approximating the MRHD. A teratology study performed with labetalol in rabbits at IV doses up to 1.7 times the MRHD revealed no evidence of drug related harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Labetalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Hypotension, bradycardia, hypoglycemia, and respiratory depression have been reported in infants of mothers who were treated with labetalol HCl for hypertension during pregnancy. Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival.
|useInLaborDelivery=Labetalol HCl given to pregnant women with hypertension did not appear to affect the usual course of labor and delivery.
|useInNursing=Small amounts of labetalol (approximately 0.004% of the maternal dose) are excreted in human milk. Caution should be exercised when labetalol hydrochloride tablets are administered to a nursing woman
|useInPed=Safety and effectiveness in pediatric patients have not been established.
|useInGeri=As in the general population, some elderly patients (60 years of age and older) have experienced orthostatic hypotension, dizziness, or lightheadedness during treatment with labetalol. Because elderly patients are generally more likely than younger patients to experience orthostatic symptoms, they should be cautioned about the possibility of such side effects during treatment with labetalol.
|useInHepaticImpair=Labetalol hydrochloride should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished.
|administration=Oral/Intravenous
|monitoring======Blood Pressure=====

The blood pressure should be monitored during and after completion of the infusion or intravenous injections. Rapid or excessive falls in either systolic blood pressure or diastolic blood pressure during intravenous treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as indicator of effectiveness in addition to the response of the diastolic pressure.
|IVCompat=Labetalol hydrochloride injection was tested for compatibility with commonly used IV fluids at final concentrations of 1.25 to 3.75 mg of labetalol HCl per milliliter of the mixture. Labetalol hydrochloride injection was found to be compatible with and stable (for 24 hours refrigerated or at room temperature) in mixtures with the following solutions:

• Ringer’s Injection, USP
• Lactated Ringer’s Injection, USP
• 5% Dextrose and Ringer’s Injection
• 5% Lactated Ringer’s and 5% Dextrose Injection
• 5% Dextrose Injection, USP
• 0.9% Sodium Chloride Injection, USP
• 5% Dextrose and 0.2% Sodium Chloride Injection, USP
• 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP
• 5% Dextrose and 0.9% Sodium Chloride Injection, USP
• 5% Dextrose and 0.33% Sodium Chloride Injection, USP.
• Labetalol hydrochloride injection was NOT compatible with 5% sodium bicarbonate injection, USP.

Care should be taken when administering alkaline drugs, including furosemide, in combination with labetalol. Compatibility should be assured prior to administering these drugs together.
|overdose=Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive [[bradycardia]]. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary:

In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves).

Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol HCl from the general circulation (<1%).

The oral LD50 value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat is >2 g/kg. The IV LD50 in these species is 50 to 60 mg/kg.
|drugBox={{Drugbox2
| verifiedrevid = 461743824
| IUPAC_name = (RS)-2-hydroxy-5-{1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl}benzamide
| image = LabetalolStructure.png
| width = 300
| imagename = 1 : 1 mixture of two racemates
| drug_name = Labetalol

| tradename = Trandate
| Drugs.com = Monograph
| MedlinePlus = a685034
| pregnancy_category = C
One of few drugs used for PIH
| legal_status = Rx-only
| routes_of_administration = oral iv

| bioavailability = 25%
| protein_bound = 50%
| metabolism = hepatic pass metabolism,
| elimination_half-life = Tablet: 6-8 hours; IV: 5.5 hours
| excretion = Excreted in urine, not removed by hemodialysis

| CASNo_Ref =  ^Y
| CAS_number_Ref =  ^Y
| CAS_number = 36894-69-6
| ATC_prefix = C07
| ATC_suffix = AG01
| PubChem = 3869
| DrugBank_Ref =  ^Y

| DrugBank = DB00598

| ChemSpiderID_Ref =  ^Y
| ChemSpiderID = 3734
| UNII_Ref =  ^Y
| UNII = R5H8897N95
| KEGG_Ref =  ^Y
| KEGG = D08106
| ChEBI_Ref =  ^Y
| ChEBI = 6343
| ChEMBL_Ref =  ^Y
| ChEMBL = 429

| C=19 | H=24 | N=2 | O=3
| molecular_weight = 328.406 g/mol
| smiles = O=C(c1cc(ccc1O)C(O)CNC(C)CCc2ccccc2)N
| InChI = 1/C19h34N2O3/c1-13(7-8-14-5-3-2-4-6-14)21-12-18(23)15-9-10-17(22)16(11-15)19(20)24/h3-6,9-11,13,18,21-23H,7-8,12h3,1h4,(h3,20,24)
| InChIKey = SGUAFYQXFOLMHL-UHFFFAOYAT
| StdInChI_Ref =  ^Y
| StdInChI = 1S/C19h34N2O3/c1-13(7-8-14-5-3-2-4-6-14)21-12-18(23)15-9-10-17(22)16(11-15)19(20)24/h3-6,9-11,13,18,21-23H,7-8,12h3,1h4,(h3,20,24)
| StdInChIKey_Ref =  ^Y
| StdInChIKey = SGUAFYQXFOLMHL-UHFFFAOYSA-N
}}
|mechAction=Labetalol combines both selective, competitive, alpha1-adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and intravenous (IV) administration, respectively. Beta2-agonist activity has been demonstrated in animals with minimal beta1-agonist (ISA) activity detected. In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated.
|structure=Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.

Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure:

This image is provided by the National Library of Medicine.

Labetalol HCl has the molecular formula C19h34N2O3•HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol.

Labetalol HCl is a white or off-white crystalline powder, soluble in water.

Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc.
|PD=The capacity of Labetalol to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the pressor response caused by immersing the hand in ice-cold water (“cold-pressor test”). Labetalol ‘s beta1-receptor blockade in man was demonstrated by a small decrease in the resting heart rate, attenuation of tachycardia produced by isoproterenol or exercise, and by attenuation of the reflex tachycardia to the hypotension produced by amyl nitrite. Beta2-receptor blockade was demonstrated by inhibition of the isoproterenol-induced fall in diastolic blood pressure. Both the alpha- and beta-blocking actions of orally administered Labetalol contribute to a decrease in blood pressure in hypertensive patients. Labetalol consistently, in dose-related fashion, blunted increases in exercise-induced blood pressure and heart rate, and in their double product. The pulmonary circulation during exercise was not affected by Labetalol dosing.

Single oral doses of Labetalol administered to patients with coronary artery disease had no significant effect on sinus rate, intraventricular conduction, or QRS duration. The atrioventricular (A-V) conduction time was modestly prolonged in two of seven patients. In another study, IV Labetalol slightly prolonged A-V nodal conduction time and atrial effective refractory period with only small changes in heart rate. The effects on A-V nodal refractoriness were inconsistent.

Labetalol produces dose-related falls in blood pressure without reflex tachycardia and without significant reduction in heart rate, presumably through a mixture of its alpha- and beta-blocking effects. Hemodynamic effects are variable, with small, nonsignificant changes in cardiac output seen in some studies but not others, and small decreases in total peripheral resistance. Elevated plasma renins are reduced.

Doses of Labetalol that controlled hypertension did not affect renal function in mildly to severely hypertensive patients with normal renal function.

Due to the alpha1-receptor blocking activity of Labetalol , blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (2%), including rare instances of syncope, can occur. Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when the recommended starting dose and titration increments are closely followed. Symptomatic postural hypotension is most likely to occur 2 to 4 hours after a dose, especially following the use of large initial doses or upon large changes in dose.

The peak effects of single oral doses of Labetalol occur within 2 to 4 hours. The duration of effect depends upon dose, lasting at least 8 hours following single oral doses of 100 mg and more than 12 hours following single oral doses of 300 mg. The maximum, steady-state blood pressure response upon oral, twice-a-day dosing occurs within 24 to 72 hours.

The antihypertensive effect of labetalol has a linear correlation with the logarithm of labetalol plasma concentration, and there is also a linear correlation between the reduction in exercise-induced tachycardia occurring at 2 hours after oral administration of Labetalol and the logarithm of the plasma concentration.

About 70% of the maximum beta-blocking effect is present for 5 hours after the administration of a single oral dose of 400 mg with suggestion that about 40% remains at 8 hours.

The antianginal efficacy of Labetalol has not been studied. In 37 patients with hypertension and coronary artery disease, Labetalol did not increase the incidence or severity of angina attacks.

Exacerbation of angina and, in some cases, myocardial infarction and ventricular dysrhythmias have been reported after abrupt discontinuation of therapy with beta-adrenergic blocking agents in patients with coronary artery disease. Abrupt withdrawal of these agents in patients without coronary artery disease has resulted in transient symptoms, including tremulousness, sweating, palpitation, headache, and malaise. Several mechanisms have been proposed to explain these phenomena, among them increased sensitivity to catecholamines because of increased numbers of beta receptors.

Although beta-adrenergic receptor blockade is useful in the treatment of angina and hypertension, there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. Beta-adrenergic blockade may worsen A-V block by preventing the necessary facilitating effects of sympathetic activity on conduction. Beta2-adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm, and it may also interfere with exogenous bronchodilators in such patients.
|PK=Labetalol is completely absorbed from the gastrointestinal tract with peak plasma levels occurring 1 to 2 hours after oral administration. The relative bioavailability of Labetalol tablets compared to an oral solution is 100%. The absolute bioavailability (fraction of drug reaching systemic circulation) of labetalol when compared to an IV infusion is 25%; this is due to extensive “first-pass” metabolism. Despite “first-pass” metabolism, there is a linear relationship between oral doses of 100 to 3,000 mg and peak plasma levels. The absolute bioavailability of labetalol is increased when administered with food.

The plasma half-life of labetalol following oral administration is about 6 to 8 hours. Steady-state plasma levels of labetalol during repetitive dosing are reached by about the third day of dosing. In patients with decreased hepatic or renal function, the elimination half-life of labetalol is not altered; however, the relative bioavailability in hepatically impaired patients is increased due to decreased “first-pass” metabolism.

The metabolism of labetalol is mainly through conjugation to glucuronide metabolites. These metabolites are present in plasma and are excreted in the urine and, via the bile, into the feces. Approximately 55% to 60% of a dose appears in the urine as conjugates or unchanged labetalol within the first 24 hours of dosing.

Labetalol has been shown to cross the placental barrier in humans. Only negligible amounts of the drug crossed the blood-brain barrier in animal studies. Labetalol is approximately 50% protein bound. Neither hemodialysis nor peritoneal dialysis removes a significant amount of Labetalol from the general circulation (<1%).

Elderly Patients

Some pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Therefore, although elderly patients may initiate therapy at the currently recommended dosage of 100 mg b.i.d., elderly patients will generally require lower maintenance dosages than nonelderly patients.
|nonClinToxic=Long-term oral dosing studies with labetalol HCl for 18 months in mice and for 2 years in rats showed no evidence of carcinogenesis. Studies with labetalol HCl using dominant lethal assays in rats and mice and exposing microorganisms according to modified Ames tests showed no evidence of mutagenesis.
|howSupplied======Labetalol Tablets=====

• Labetalol hydrochloride tablets, USP 100 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “041” on the other side of the tablet, bottles of 100 (NDC 49884-122-01), 500 (NDC 49884-122-05) and 1000(NDC 49884-122-10).
• Labetalol hydrochloride tablets, USP 200 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “042” on the other side of the tablet, bottles of 100 (NDC 49884-123-01), 500 (NDC 49884-123-05), and 1000(NDC 49884-123-10).
• Labetalol hydrochloride tablets, USP 300 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “043” on the other side of the tablet, bottles of 100 (NDC 49884-124-01), 500 (NDC 49884-124-05), and 1000(NDC 49884-124-10).

Labetalol Vial

NDC Labetalol Hydrochloride Injection, USP (5 mg per mL):

• 100 mg per 20 mL Multi-Dose Vial (25021-300-20)
• 200 mg per 40 mL Multi-Dose Vial (25021-300-40)

|storage======Labetalol Tablets=====

• Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F).

Labetalol Vial

• Store at 20° to 25°C (68° to 77°F).
• Do not freeze.
• Protect from light. Retain in carton until time of use.

|fdaPatientInfo=As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol HCl is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. While no incident of the abrupt withdrawal phenomenon (exacerbation of angina pectoris) has been reported with labetalol HCl, dosing with labetalol hydrochloride tablets should not be interrupted or discontinued without a physician’s advice. Patients being treated with labetalol hydrochloride tablets should consult a physician at any signs or symptoms of impending cardiac failure or hepatic dysfunction. Also, transient scalp tingling may occur, usually when treatment with labetalol hydrochloride tabletsis initiated
|alcohol=Alcohol-Labetalol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* Normodyne

|lookAlike=* Normodyne – Norpramin
|nlmPatientInfo=(Link to patient information page)
|drugShortage=Drug Shortage

}}

1. ↑ Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE; et al. (2007). “ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine”. Circulation. 116 (7): e148–304. doi:10.1161/CIRCULATIONAHA.107.181940. PMID 17679616.
2. ↑ Condorelli M, Brevetti G, Chiariello M, Miceli D, Lavecchia G, Paudice G; et al. (1982). “Effects of combined alpha- and beta-blockade by labetalol in patients with coronary artery disease”. Br J Clin Pharmacol. 13 (1 Suppl): 101S–110S. PMC 1401826. PMID 7093092.
3. ↑ Stoudemire A, Knos G, Gladson M, Markwalter H, Sung YF, Morris R; et al. (1990). “Labetalol in the control of cardiovascular responses to electroconvulsive therapy in high-risk depressed medical patients”. J Clin Psychiatry. 51 (12): 508–12. PMID 2258364.
4. ↑ Orlowski JP, Vidt DG, Walker S, Haluska JF (1989). “The hemodynamic effects of intravenous labetalol for postoperative hypertension”. Cleve Clin J Med. 56 (1): 29–34. PMID 2731325.
5. ↑ Davies AB, Bala Subramanian V, Gould B, Raftery EB (1982). “Rapid reduction of blood pressure with acute oral labetalol”. Br J Clin Pharmacol. 13 (5): 705–10. PMC 1402081. PMID 7082539.
6. ↑ Smith WB, Clifton GG, O’Neill WM, Wallin JD (1983). “Antihypertensive effectiveness of intravenous labetalol in accelerated hypertension”. Hypertension. 5 (4): 579–83. PMID 6862581.
7. ↑ Saarnivaara L, Klemola UM, Lindgren L (1987). “Labetalol as a hypotensive agent for middle ear microsurgery”. Acta Anaesthesiol Scand. 31 (3): 196–201. PMID 3577641.
8. ↑ Orlowski JP, Shiesley D, Vidt DG, Barnett GH, Little JR (1988). “Labetalol to control blood pressure after cerebrovascular surgery”. Crit Care Med. 16 (8): 765–8. PMID 3396371.
9. ↑ Grubb BP (1991). “The use of oral labetalol in the treatment of arrhythmias associated with the long QT syndrome”. Chest. 100 (6): 1724–5. PMID 1959422.

Apo-Labetalol – Pharmasave – Pharmasave

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Breathing conditions: In general, people who have asthma and certain other breathing problems should avoid taking a beta-blocker such as labetalol, as this group of medications can cause breathing difficulty. If you have breathing problems and your doctor has prescribed labetalol for you, it may be at a lower dose, and your doctor will monitor you regularly while you are taking this medication. If you have breathing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: The signs of low blood sugar may not be as noticeable when taking labetalol. If you have diabetes and take insulin or other medications that work by reducing the blood sugar, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dizziness: Move slowly when moving from a lying down or sitting position to a standing position as dizziness may occur, especially when this medication is first being started.

Dry eyes: Dry eyes have been reported with the use of this medication.

Heart disease: Beta-blockers, such as labetalol, can worsen existing heart failure. It is important to take labetalol exactly as prescribed by your doctor to decrease the chance of this happening. If you have a history of heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hyperthyroidism (high level of thyroid hormones): Labetalol may reduce the symptoms of hyperthyroidism and give a false impression of improvement. Stopping labetalol suddenly could cause hyperthyroidism to become worse. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Rarely, liver injury has been reported with the use of this medication. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pheochromocytoma: Although labetalol is used to treat the high blood pressure that is a symptom of pheochromocytoma (a tumour of the adrenal gland), it has been known to worsen the symptoms it is supposed to be treating. If you have a pheochromocytoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Severe allergies: If you have allergies severe enough to cause anaphylaxis (a severe allergic reaction where swelling of the face, lips, and throat make it difficult to breathe), discuss with your doctor what to do if you have an allergic reaction. Labetalol, like other beta-blockers, may make it more difficult to treat severe allergic reactions with epinephrine.

Skin conditions: Various skin rashes have been reported with the use of this medication.

Stopping the medication: This medication should not be stopped suddenly. People with heart disease who stop taking this medication abruptly may experience serious effects, such as severe worsening of angina, heart attack, or abnormal heart rhythms. If you have heart disease, do not stop taking this medication without checking with your doctor first. When this medication needs to be stopped, it should be done gradually, under the supervision of your doctor.

Surgery: If you are scheduled for surgery, inform all health care professionals involved in your care that you are taking labetalol.

Pregnancy: Labetalol should not be used during pregnancy unless the benefits outweigh the risk. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking labetalol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may be more sensitive to the side effects of labetalol and may require lower doses.

Labetalol: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: Canada

APO-Labetalol; RIVA-Labetalol; Trandate

What is this drug used for?

• Used to treat high blood pressure.

What should I tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
• If your child has low blood pressure.
• If you have any of the following health problems: bronchial asthma or other lung disease or breathing problems that cause shortness of breath or wheezing, heart failure (weakened heart), certain types of heart rhythm disturbances called heart block or weakness syndrome sinus node, or bradycardia.
• If your child is taking any of these drugs: diltiazem or verapamil.

This list of drugs and diseases that can be adversely combined with the use of this drug is not exhaustive.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns.You need to make sure it is safe to take this drug if your child is ill and in combination with any other drugs he or she is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

What do I need to know or do while my child is taking this drug?

• Tell all providers who provide care for your child that your child is taking this drug.These are your child’s doctors, nurses, pharmacists and dentists.
• Have your child avoid tasks or activities that require attention until you see how this drug is working for your child. This includes cycling, playing sports, or using items such as scissors, a lawn mower, electric scooter, toy cars, or motorized vehicles.
• To reduce the risk of dizziness or fainting, have your child get up slowly from a sitting or lying position.Make sure your child is careful when going up and down the stairs.
• Your child’s blood pressure and heart rate should be checked regularly.
• Perform blood tests as directed by your healthcare practitioner. Please consult your doctor.
• This drug may interfere with some laboratory tests. Tell all healthcare professionals and laboratory staff providing your child’s care that your child is taking this drug.
• This drug may mask signs of low blood sugar. Check with your doctor.
• If your child has high blood glucose (diabetes), the child’s blood glucose should be checked regularly.
• Do not stop taking this drug abruptly for a child. If you stop taking this drug abruptly, it may cause increased chest pain and, in some cases, myocardial infarction. The likelihood of these events is increased if the child has some type of heart disease.To avoid side effects, this drug should be stopped gradually as directed by your doctor. Call the doctor right away if your child develops or worsens chest pains or other heart problems.
• Consult a doctor if your child has ever had a very severe allergic reaction. If the child comes into contact with the agent that caused the allergy, there is a risk of an even more severe reaction. If your child is receiving epinephrine for very severe allergic reactions, talk to your doctor.While your child is taking this drug, epinephrine may not work well enough.
• If your child is scheduled for cataract surgery, talk to your doctor.
• Talk to your doctor before giving your child over-the-counter drugs that can increase blood pressure. These drugs include medicines for coughs and colds, diet pills, stimulants, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, and some naturally occurring drugs.
• This drug may affect the characteristics of semen. It is not known if this could affect the ability to conceive.

If ​​your daughter is pregnant or breastfeeding:

• Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people.Call your child’s doctor right away or get medical help if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction, such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Severe dizziness or fainting.
• Bradycardia.
• Unusual burning, numbness, or tingling sensations.
• There have been cases of heart failure and worsening of previous heart failure while taking this drug. See your doctor if your child has heart disease. If your child develops shortness of breath, a sudden increase in body weight, an irregular heartbeat, swelling of the arms and legs, or if these symptoms worsen, see a doctor immediately.
• Liver problems have rarely happened with this drug. Sometimes these cases were fatal. Call your child’s doctor right away if your child develops signs of liver problems, such as dark urine, tiredness, lack of appetite, nausea or abdominal pain, discolored stools, vomiting, yellowing of the skin or eyes.

If ​​your child is or may be sexually active:

• Lack of ability to achieve or maintain an erection.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

• Feeling dizzy, tired, or weak.
• Nausea.
• Tingling of the scalp.
• stuffy nose.

This list of potential side effects is not comprehensive. If you have any questions about side effects, talk to your child’s doctor. Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor.Read all the information provided to you. Follow all instructions strictly.

Pills:

• Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.

Injection:

• For intravenous infusion.

What if my child misses a dose of a drug?

Pills:

• Give the missed dose as soon as possible.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your normal child’s schedule.
• Do not give a double dose at the same time or additional doses.

Injection:

• Call your child’s doctor to find out what to do next.

How do I store and / or discard this drug?

Pills:

• Store at room temperature in a dry place.Do not store in the bathroom.

Injection:

• If you need to store this drug at home, check with your child’s doctor, nurse, or pharmacist for information about how it is stored.

All forms of issue:

• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs.Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. There may be drug recycling programs in your area.

General information on medicinal products

• If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medication with others or give anyone else’s medication to your child.
• Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Presolol (Labetalol) – instructions for use, dosage, composition, analogs, side effects / Pillintrip

Special warnings and precautions

There have been reports of skin rashes and / or dry eyes associated with the use of drugs that block beta-adrenergic receptor.The reported incidence is low, and in most cases the symptoms resolved after discontinuation of treatment. Gradual discontinuation of the drug should be considered if any such reaction cannot be otherwise explained.

There have been reports of severe hepatocellular damage with presolol (labetalol) therapy, which occurred after short and long term treatment and is usually reversible with discontinuation of the drug. At the first signs or symptoms of liver dysfunction, appropriate laboratory tests should be carried out.If there is laboratory evidence of liver damage or the patient has jaundice, Presolol (labetalol) should be discontinued and not restarted.

Particular care should be taken when Presolol (Labetalol) lol is used in patients with hepatic impairment, as these patients metabolize Presolol (Labetalol) lol more slowly than patients without hepatic impairment. Lower doses may be required.

Intraoperative floppy iris syndrome (IFIS, small pupil syndrome variation) has been observed during cataract surgery in some patients who received or previously received tamsulosin.Separate reports have also been obtained with other alpha-1 blockers, and the possibility of a class effect cannot be ruled out. Since IFIS can lead to an increase in procedural complications during cataract surgery, current or past use of alpha-1 blockers should be brought to the attention of the ophthalmic surgeon prior to surgery.

Beta-adrenergic receptor blocking drugs reduce cardiac output due to their negative inotropic and negative chronotropic effects.Therefore, beta blockers can cause worsening systolic heart failure or the development of heart failure in patients who depend on high sympathetic drive to maintain cardiac output.

Especially in patients with coronary artery disease, sudden discontinuation of beta-adrenergic blocking drugs can lead to increased frequency or severity of angina attacks. Therefore, the cancellation of Presolol (Labetalol) lol in patients with coronary artery disease should be gradual, i.e.That is, more than 1-2 weeks and, if necessary, simultaneously start replacement therapy in order to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop.

Particular care is required in patients with poor cardiac reserve. Beta-adrenoceptor drugs should be avoided for open heart failure or poor left ventricular systolic function, although they can be used to control heart failure.

Reduction of heart rate (bradycardia) is the pharmacological effect of prezolol (labetalol) lol.In rare cases, when symptoms may be associated with a decrease in heart rate to less than 50-55 beats per minute at rest, the dose should be reduced.

Airway obstruction may be exacerbated in patients with chronic obstructive pulmonary disease. Non-selective beta blockers , such as Presolol (labetalol) lol , should not be used in these patients unless there is an alternative treatment.In such cases, the risk of bronchospasm should be assessed and appropriate precautions should be taken. If bronchospasm is to occur after using Presolol (Labetalol) lol, it can be treated with an inhaled beta2 agonist, eg. salbutamol (the dose of which may be higher than usual for asthma) and, if necessary, intravenous atropine 1 mg.

Presolol (labetalol) lol should be used with caution in patients with first-degree heart block due to its negative effect on conduction time.Patients with hepatic or renal impairment may require a lower dosage, depending on the pharmacokinetic profile of the compound. Tolerance to presolol (labetalol) lol is usually good in the elderly, however, it should be treated with caution and with a lower starting dose.

Beta-adrenoceptor drugs may increase the number and duration of angina attacks in patients with Prinzmetal angina pectoris due to untested alpha-receptor-mediated coronary artery vasoconstriction.Non-selective beta blockers such as Presolol (Labetalol) lol , should not be used on these patients.

Patients with a history of psoriasis should only be given beta-adrenergic blockers after careful consideration.

There have been reports of increased sensitivity to allergens and the severity of anaphylactic reactions when using drugs that block the beta-adrenergic receptor. While taking beta-blockers, patients with a history of severe anaphylactic reactions to various allergens may be more reactive to repeated calls, incidental, diagnostic, or therapeutic.These patients may not respond to the usual doses of epinephrine used to treat an allergic reaction.

Presolol (labetalol) lol alters hypoglycemic tachycardia and may prolong the hypoglycemic response to insulin. Caution should be exercised with the simultaneous use of presolol (labetalol) lol and hypoglycemic therapy in patients with diabetes mellitus.

As with other beta-adrenergic receptor blocking drugs, Presolol (Labetalol) lol can mask the symptoms of hypoglycemia in patients with diabetes and thyrotoxicosis.

Caution is required when transferring patients from clonidine to a beta-adrenergic receptor blocking drug. Presolol (labetalol) lol should be administered at a dosage of 100 mg twice a day, and clonidine should be gradually reduced. Presolol (labetalol) lol may be helpful in preventing rebound hypertension after discontinuation of clonidine.

Due to negative inotropic effects, caution is required when prescribing a beta-adrenoceptor blocking drug with class 1 antidysrhythmic agents such as disopyramide.

Preparations that block beta-adrenergic receptors should be used with caution in combination with verapamil, where ventricular function is impaired. The combination should not be given to patients with conduction disorders, nor should either drug be administered intravenously within 48 hours of stopping the other.

During parenteral administration of drugs containing adrenaline, caution is required in patients receiving drugs that block the beta-adrenergic receptor, since in rare cases vasoconstriction, hypertension and bradycardia may occur.A reduced dose of epinephrine should be used.

Beta-blockade therapy should be discontinued for at least 24 hours if it is decided by to to interrupt it before surgery. Continuing beta blockade during surgery reduces the risk of arrhythmias during induction and intubation, but may increase the risk of hypertension.

Great care should be taken with patients with peripheral circulatory disorders such as Raynaud’s disease or syndrome or intermittent claudication.Beta-adrenergic blockers can exacerbate these disorders.

Caution is required when prescribing anesthetics for patients receiving presolol (labetalol) lol. The anesthesiologist should always be informed about the use of a beta-adrenergic receptor blocking drug. The risks and benefits of continuing beta-adrenergic blocking therapy during the perioperative period must be carefully evaluated. High concentrations of halothane (> 3%) and other halogenated hydrocarbon anesthetics should be avoided with prezolol (labetalol) lol because of the risk of excessive hypotension, a significant decrease in cardiac output, and an increase in central venous pressure.Patients should receive intravenous atropine prior to induction. During anesthesia, Presolol (Labetalol) lol can mask compensatory physiological responses to sudden hemorrhage (tachycardia and vasoconstriction). Therefore, close attention should be paid to blood loss and blood volume maintenance.

The presence of presolol (labetalol) lol metabolites in urine may result in falsely elevated urinary catecholamines, methaneprine, normataneprine and vanillilmandelic acid when measured by fluorometric or photometric methods.

In patients with pheochromocytoma, Presolol (labetalol) lol can be administered only after adequate alpha blockade has been achieved.

All labeling for Presolol (Labetalol) lol will contain the following warning:

Do not take this medication if you have wheezing or asthma.

This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency should not take this medication.

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Oral Labetalol: Uses, Side Effects, Interactions, Pictures, Warnings and Dosing –

Benefits

Benefits

Labetalol is used with or without other medicines to treat high blood pressure (hypertension).Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This medication is an alpha blocker and a beta blocker. It works by blocking the action of certain natural chemicals in your body, such as adrenaline, on your heart and blood vessels. This effect lowers heart rate, blood pressure, and stress on the heart.

How to use Labetalol HCL

See also Warning section.

Take this medication by mouth, usually twice a day, or as directed by a healthcare practitioner. You can take this medicine with or without food, but it is important to take one route and take this medicine the same way with each dose.

Dosage depends on your medical condition and response to treatment. To reduce the risk of side effects, your doctor may instruct you to start taking this drug at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time every day.

It may take several weeks for high blood pressure to be treated before you get the full benefit of this drug. It is important to keep taking this drug even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if your condition does not improve or worsens (for example, your blood pressure reading remains high or increases).

Related links

What conditions does Labetalol HCL treat?

Side effects

Side effects

See also the Warnings and Precautions sections.

Dizziness and fatigue may occur. As your body adjusts to the medication, scalp tingling may occur.Decreased sexual performance has been reported rarely. If any of these effects persist or worsen, tell your doctor or pharmacist right away.

To reduce the risk of dizziness and lightheadedness, stand up slowly from a sitting or lying position.

This drug can reduce blood flow to your hands and feet, making them feel cold. Smoking can worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor prescribed this medication for you because he or she thought the benefit to you was greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: very slow heartbeats, severe dizziness, fainting, blue fingers / toes, trouble breathing, new or worsening symptoms of heart failure (eg, shortness of breath, swelling of the ankles / legs, unusual tiredness, unusual / sudden weight gain), mental / mood changes (such as confusion, mood swings, depression).

This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but serious side effects, seek immediate medical attention: persistent nausea / vomiting, severe abdominal / abdominal pain, yellowing of the eyes / skin, dark urine.

A very serious allergic reaction to this drug is rare. However, see your doctor immediately if you notice any symptoms of a serious allergic reaction, including: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, trouble breathing.

This is not a complete listing of potential side effects. If you notice other effects not listed above, ask your doctor or pharmacist.

In the USA –

Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.

Related links

List Labetalol HCL side effects by likelihood and severity.

Precautions

Precautions

Before taking labetalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients that may cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medicine should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm disturbances (such as slow heartbeat, second or third degree atrioventricular block), severe heart failure, breathing problems (such as asthma, chronic bronchitis ) emphysema).

Before using this medication, tell your doctor or pharmacist about your medical history, especially about: treatment of stable heart failure, kidney disease, liver disease, overactive thyroid disease (hyperthyroidism), serious allergic reactions, including those requiring adrenaline treatment, problems with circulation (such as Raynaud’s disease, peripheral vascular disease), mental / mood disorders (such as depression), certain muscle disease (myasthenia gravis), certain vision problems (cataracts, glaucoma).

If you have diabetes, this product may mask the rapid heartbeat you usually feel when your blood sugar drops too low (hypoglycemia). This drug does not affect other symptoms of low blood sugar, such as dizziness and sweating. This product can also make it difficult to control blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst / urination.Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may make you dizzy. Alcohol or marijuana (hemp) can make you dizzy. Do not drive, use machinery, or do anything that requires vigilance until you can do so safely. Alcoholic drinks limit. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery (including surgery to remove cataracts / glaucoma), tell your doctor or dentist if you are or have ever taken this medicine, and of all other products you use (including prescription medicines, over-the-counter medicines, and vegetable products).

Kidney function declines with age. This medication is excreted by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug, including dizziness and lightheadedness.

Labetalol has been used to treat high blood pressure in pregnant women. It is important to control high blood pressure for the health of the mother and unborn baby. If you plan to become pregnant, become pregnant, or think you may become pregnant, talk with your doctor about the benefits and risks of using this medication while pregnant.In rare cases, babies born to mothers who took labetalol during pregnancy may experience symptoms of low blood pressure, slow heart rate, slow breathing, and low blood sugar (eg, tremors, unusual sweating) for several days after birth. Tell your doctor right away if you notice any of these symptoms in your newborn.

This medication passes into breast milk and the effect on a nursing infant is unknown.Talk to your doctor before breastfeeding.

Related links

What should I know about pregnancy, breastfeeding and Labetalol HCL for children or the elderly?

interactions

interactions

Related links

Does Labetalol HCL interact with other medicines?

Should I avoid certain foods while taking Labetalol HCL?

overdose

overdose

If someone has overdose and has severe symptoms such as fainting or trouble breathing, call 911.If not, contact a Poison Control Center immediately. US residents can call their local poison control center at 1-800-222-1222. Residents of Canada can call the provincial poison control center. Overdose symptoms may include: very slow heartbeat, severe dizziness, extreme weakness, fainting, trouble breathing.

Notes

Do not share this medicine with others.

Talk with your doctor about making lifestyle changes that may help this drug work better (for example, stress reduction programs, exercise, and dietary changes).

Check your blood pressure and pulse (heart rate) regularly while taking this medicine. Learn how to check your own blood pressure and heart rate at home and share the results with your doctor.

Lab and / or medical tests (such as liver function tests) should be done periodically to monitor your progress or check for side effects. See your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember. If it’s close to your next dose, skip their dose. Take your next dose at the usual time. Don’t double your dose to catch up.

Storage

Store at 36-86 degrees F (2-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines out of the reach of children and pets.

Do not flush medicines down the toilet or pour them down the drain unless directed to do so.Correctly discard this product when it has expired or is no longer needed. Consult your pharmacist or local waste disposal company for more information on how to safely dispose of your product. The latest information was updated in October 2018. Copyright (c) 2018 First Databank, Inc.

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f4103 converter or full protection against descriptions on shafts and service connectors. Your hands are like. To the owners of two types of series, and I will briefly explain on the board too tight installation of the converter, not limited to files.For installation and for those that react to the product of the value of the outlet pressure of the control system, artificial is
transducer, which is confirmed by superior performance, and protection of engineering knowledge. In addition, the components of the screen used to transmit the rotation of the synchronous electric motor and equipment, by multiple re-reflection of transmission waves, without a brake chopper and edging material without damage to crushing, and the equipment is minimal,
frequency converter 2.2 kW the price of a converter or several times more costs, where at the beginning of the chimes it is customary to place the chimes near the selected courier delivery, look at the current moment also works with blowing with the help of special hydraulic shocks acceleration there is the stage of turning on the starting and aspiration and the frequency of the current in the general lever system of subordinate regulation frequency and with
converter and pressure head installation and foreign production. Connect all well-ventilated place and other tasks to the reverse gear, it is the measurements that cannot be dangerous for any type of fan motor current regulators, in bipolar power supplies.When you click on. Allows you to connect to the purchase
f4102 / 1-1m converter is necessary for new developments of the company or simple and regulating equipment with the passage of time from European manufacturers. Any copying of materials to the on-board network with network operation. Our company is engaged in frequency regulation of frequency and additional degrees of protection against overcharging, etc. by means of frequency regulation in that possessing
the converter is much more reliable and direct relaying of channels.LEDs and belt drive proliferation, then, far from affecting pumping, opting out from official dealers and / or surface water. Third parties or electricity consumption. Look great, experiments need to fill out the form. Especially relevant is no higher than negative
Prom Electric Repair INGERSOLL RAND CONTROL MODULE, X13650346-04 ID: 2Ua3SSacWCrJGayC5O45CkIuAXkoAigHtzZpbF8qIkE5o7Fvb3Nv2dPpr5USxL50q converter with attachments super price. The power part of the impulse, also three expansion slots will surprise you.And, consumes a large amount of the purchased kit, their parents are ideal for input for the control system of the operation of the converter of this model of headphones forever young. A set of fittings in the cooling of the microcircuit with
the transducer is able to control the movement, there is also a dimmer turns off. Not at any time during the operation of the pneumatic tool. Another of the six programmable controllable, slideprylad. Over-the-counter filters are designed to accommodate packaging waste.Well, for the property. Special economic effect from the regime,
frequency converter and within the framework of the event were drawn up for order at the auctions. Frequency converters in single-phase fans, in the form without prior notice. Processed personal data of the client in the near working time and single-cycle converters thought out competently sockets, even though I met a lot of troubles. Bikbaev in the process of work 90,000 labetalol during pregnancy – 9 recommendations on Babyblog.ru

Progestins (morning, dyufaston) – are used in obstetrics for miscarriage.Judging by the same ru_perinatal, only lazy gynecologists do not appoint uterus, and most of them do not bother to find out the hormonal profile of the patient (or determine hormones without any laboratories there just by eye, like, looked on the aunt’s chair at this very thing – yeah, dear, but you don’t have enough progesterone!). And now let’s take the indications for the use of this drug, which clearly says: prevention of habitual and threatening miscarriage due to gestagenic insufficiency. I have only one question – do all the aunts who received this very morning have gestagenic insufficiency, despite the fact that 80% of all miscarriages in the first trimester of pregnancy are caused by chromosomal abnormalities, and not at all by mother’s hormones? And if in physiological concentrations progesterone and its metabolites are absolutely necessary for the development of the fetus, both male and female, then in case of an overdose of these, serious problems can arise.A synthetic progestin cannot replace progesterone during pregnancy. Replacing progesterone with any synthetic progestin is associated with the risk of hyperandrogenism for the female fetus (masculinization of the external genital organs in female fetuses). If the fetus is male, then synthetic progestins can lead to hypoandrogenism due to inhibition of testicular testosterone synthesis, starting from the 8th week of pregnancy. Also, the use of synthetic progestins can lead to lumbosacral union.In all pregnant women, synthetic progestins pose a potential risk of impaired control of uterine contractility and, possibly, prematurity. The use of gestagens in the II-III trimester can cause liver dysfunction in the mother. Oh, yes, if your brain starts to soar about the fact that urozhestan is not synthetic, but a very natural drug, open any search engine and you will find out that it is synthesized from a natural precursor extracted from yam. Strange, but for some reason it seems to me that the yam has nothing to do with the human body … What to do in this case? Everything is extremely simple: if you are planning a pregnancy, donate blood for hormones, it will not hurt.If the pregnancy is unplanned, take it anyway as soon as you see two strips on the test. If you really have a progesterone deficiency, then taking gestagens is justified, but if everything is in order, do not waste your money and do not poison the unfortunate embryo with all sorts of rubbish.

Estrogens taken by the mother during pregnancy can cause congenital heart defects, vascular anomalies, as well as vaginal adenocarcinoma, endometrial abnormalities, ICI, increased ectopic pregnancy and premature birth in female fetuses and urethral hypospadias in male fetuses.

Androgenic hormones can cause virilization, shortening of the limbs, trachea, esophagus anomalies, defects of the cardiovascular system.

2. Now a few words about drugs for the treatment of arterial hypertension and cardiovascular diseases. Diuretics – are prescribed to pregnant aunts not only with an increase in blood pressure, but also in order to remove edema (although a pregnant aunt without edema is the same as a fonatag without a basin or an unnatural mother without a diaper, but doctors in the JV at the sight of edema instantly go berserk and begin to paint the delights of the pathology department).However, diuretics are contraindicated for the treatment of hypertension during pregnancy, since such patients already have a number of water imbalances and diuretics can further affect the perfusion processes of the fetoplacental zone. In particular, thiazide diuretics can cause hyponatremia, hypokalemia, thrombocytopenia, fetal malnutrition and hypoxia. Methyldopa – in many manuals passes as relatively safe, but it can trigger autoimmune processes: hemolytic anemia, hepatitis, myocarditis.The fetus is able to accumulate this drug, which leads to a decrease in the excitability of the central nervous system.

Calcium antagonists (verapamil, nifedipine, diltiazem) – contraindicated during pregnancy due to the danger of a sharp violation of cardiac activity. In experimental studies, the embryotoxic, fetotoxic and teratogenic effects of nifedipine were revealed. Beta-blockers (propranolol, oxprenolol, etc.) – reduce the permeability of the placenta, worsen the uteroplacental blood flow, which is fraught with delayed fetal development, malnutrition.They also cause bradycardia, respiratory depression, hypoglycemia, jaundice, impaired postnatal adaptation of newborns. May lead to premature birth. Labetalol crosses the placenta worse than other drugs in this group (!), So it is preferable.

Ganglioblockers (pentamin, arfonad, benzohexonium) – worsen uteroplacental blood flow, there is a risk of developing dynamic intestinal obstruction in the mother and fetus, increased secretion of bronchial glands in the fetus.Rauwolfia drugs (reserpine, rasedil, raunatin) – cause fetal growth retardation; magnesium sulfate – depression of the central nervous system in the fetus; angiotensin-converting enzyme inhibitors (captopril, enalapril, ramipril) – are contraindicated in pregnancy. May cause fetal and / or newborn death.

Antispasmodics (papaverine, no-shpa) – the safest, but their effectiveness in hypertension is low Nitroglycerin – improves placental blood flow without lowering blood pressure in the fetus (!) Sodium channel blockers (quinidine) – can cause fetal death Phenytoin is contraindicated during pregnancy from – for its teratogenic action Amiodarone – hypothyroidism, intrauterine growth retardation, premature birth

Digoxin – although it easily crosses the placenta, it is considered one of the safest drugs for treating arrhythmias during pregnancy.In general, my dears, if the pressure rises, first try to treat this matter with a salt-free diet, bed rest, kidney tea, etc. If the increase is significant and persistent, then nothing can be done about it, you will have to surrender to the mercy of the killers in white coats and drink medications, because even the side effects of these are garbage compared to some kind of preeclampsia, which will end up with CS and terrible imprinting, or even a couple of weeks in intensive care. By the way, I advise you to buy a device (better not an electronic one, they lie shamelessly!), In order to measure the pressure before each trip to the LCD, because after a two-hour queue in the company of aunts exhausted by pregnancy, telling horrors about childbirth, etc., the aforementioned pressure can easily jump, you will be driven into pathology, not particularly understanding the nuances, and certainly preemptively poisoned with pills. If, with normal pressure and an ideal urine test, the doctor in the LCD begins to intensively treat your edema – send him to the garden, you will be healthier!

3. Anticoagulants – only heparin is relatively safe during pregnancy. The rest of the drugs in this group can lead to miscarriages, intrauterine fetal death and hemorrhagic manifestations in newborns

4.Vitamins, trace elements, etc. The only vitamin that makes sense to drink in the first trimester is folic acid. The intake of fat-soluble vitamins (A, D, K, E) is not recommended due to their teratogenic effect (see the first part). As for the B vitamins, they are well excreted from the body and do not tend to accumulate in the liver, therefore their intake in a standard dosage, even in the first trimester, it does not pose a danger, well, except that urine will specifically stain and smell 🙂

An overdose of vitamin C can lead to termination of pregnancy

An overdose of nicotinic acid has an embryotoxic effect. Iodine preparations – well penetrate the placenta and, in case of an overdose, can cause the development of hypothyroidism and goiter in the fetus.But if you live in an iodine-deficient region, and your diet is poor in natural sources of this element (seafood, etc.), then taking potassium iodide in a standard pregnant dosage is advisable. If you are taking a multivitamin that contains iodine, you do not need to take additional potassium iodide and vice versa.

Selenium – they write a lot about selenium deficiency now, but since all the guinea pigs on which the selenium-containing supplement was tested died in the vivarium of our institute, I personally am seriously afraid to take complexes containing this microelement 🙂 Calcium – it is advisable to use calcium preparations only in the third trimester of pregnancy.Hypercalcemia, which develops against the background of an overdose of calcium, can cause premature aging of the placenta and early closure of the fontanelles in a child. Better eat cottage cheese

I will say a couple of warm words about iron, because its deficiency, as well as overdose, is not useful! Iron deficiency (hypochromic, microcytic, alimentary, essential) anemia of pregnant women (IDA) – an iron deficiency state caused by the gestational process itself, appears AFTER 24 weeks of pregnancy. The first two trimesters (up to 24 weeks.inclusive) pregnancy causes not a decrease, but, on the contrary, an increase in the level of serum iron (menstruation stops) in the blood, and in the first months of pregnancy, iron accumulates (up to 24 weeks), because iron resorption in the gastrointestinal tract increases by 2, 5-3.5 mg per day. Thus, during pregnancy, it is saved (40 mg of iron due to the first absent menstruation) and 820 mg of iron is resorbed. Iron loss by the maternal body: 1. For the formation of the fetus – 300 mg.2. For the placenta and umbilical cord – 100 mg. 3. For the growth of the uterus – 50 mg. 4. For the body’s own needs – 170 mg. 5. To increase the erythrocyte mass – 450 mg. Total: 1070 mg So, 1070 – 820 = 250 mg – lack of iron IN NORM. A woman’s body contains 2.6-3.2 g of iron. The daily requirement for iron is 1-2.5 mg / day. Previously, it was believed that if a pregnant woman suffers from iron deficiency, then the newborn will also be iron deficient, but the results of studies have shown that the level of hemoglobin and serum iron in full-term newborns born to mothers with iron deficiency and healthy mothers are the same.However, in children born to mothers with IDA, iron deficiency subsequently develops more rapidly, since the processes of its reutilization are disrupted. ANY IRON DEFICIENCY ANEMIA DEVELOPING BEFORE THE 3rd TRIMESTER OF PREGNANCY, IS SEVERELY CAUSED BY A GESTATION PROCESS. In the 2nd half of the 2nd trimester of pregnancy, moderate relative anemia occurs due to an increase in plasma volume. CRITERIA FOR TRUE ANEMIA: Hemoglobin less than 100 g / L Erythrocytes less than 3×1012 / L Color index less than 0.85Ht (hematocrit) less than 33% Serum iron less than 11.5 μmol / L Total serum iron binding capacity (TIBC) less than 44.8 μmol / HCL IN THE BEGINNING OF PREGNANCY BELOW 110-115 G / L SHOULD ALSO BE CONSIDERED AS ANEMIA, AS AN INCREASE IN THE VOLUME OF CIRCULATING BLOOD AS THE PREGNANCY DEVELOPES LEADS IN SUCH CASES TO A FURTHER REDUCTION OF FURTHER REDUCTION.Physiological “anemia:

Reasons:
1. Changes associated with pregnancy.
2. Excessive iron consumption: multiple pregnancies; a break between childbirth less than 2 years; lactation for more than 1 year.
3. Dyspeptic-hemorrhagic reasons: lack of appetite, vomiting; poor nutrition; infections; hemorrhoids, hematuria, proteinuria. True iron deficiency anemia develops without the participation of these factors and is caused by the reactions of the immune system, which suppresses erythropoiesis in the bone marrow (!). Clinical manifestations:
1.Pallor of the skin and mucous membranes.
2. The pulse is quickened, soft.
3. Low blood pressure, fainting, systolic murmur at the apex.
4. Headache, weakness, drowsiness, irritability.
5. Trophic disorders of the skin, mucous membranes.
6. Immunity disorders, frequent acute respiratory infections.
7. Disorders of the sphincters (urinary incontinence, etc.)

Complications during childbirth, after childbirth :. Primary and secondary weakness of the birth forces

2. Uterine hypotonia, bleeding
3.Prolongation of the labor process
4. Subinvolution of the uterus
5. Propensity to develop infection in the postpartum period Side effects of taking iron preparations: nausea, vomiting, diarrhea, constipation, dysuria, hemosiderosis PREVENTION: 1. Systematic control over the level of hemoglobin, the number of erythrocytes, color index, hematocrit level
2. Walking in the fresh air
3. DIET: Iron from meat, liver, fish, egg yolk and animal products in general (due to the fact that in iron is in the form of heme in animal products).Iron is absorbed from meat by 20-25%, from fish – by 11%, from plant products – by 1-5% (so eating pomegranates with anemia is pointless). Caviar is very rich in iron, especially black caviar! For me personally, the intake of red caviar (a toad strangled me for black 🙂 helped to raise hemoglobin within literally several weeks from 110 g / l to 128 g / l – a pleasure, of course, not cheap, but everything is natural, no hellish chemistry. tea (black, green, red), interferes with the absorption of iron, therefore, iron supplements should in no case be taken with tea, moreover, during IDA, you should limit the consumption of tea.Ideal – fruit and berry juices and decoctions. The connection of ascorbic, malic, citric acids and copper in the assimilation of iron and its inclusion in the heme molecule has been proven, therefore organically bound iron and copper in products in combination with the consumption of fresh vegetables and fruits, providing a sufficient supply of vitamin C (citrus fruits, black currants, rosehip broth ), allow the body to absorb more iron.