Uses, Side Effects, Interactions & Pill Images

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Chlorthalidone is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to reduce extra salt and water in the body caused by conditions such as heart failure, liver disease, and kidney disease. Decreasing extra salt and water in the body helps to decrease swelling (edema) and breathing problems caused by fluid in the lungs. Chlorthalidone is a “water pill” (diuretic). It increases the amount of urine you make, especially when you first start the medication. It also helps to relax the blood vessels so that blood can flow more easily.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used for a condition known as “water diabetes” (diabetes insipidus). It may also be used to reduce the risk of calcium kidney stones in people with increased calcium in their urine (hypercalciuria).

Take this medication by mouth with food as directed by your doctor, usually once daily in the morning. It is best to avoid taking this medication within 4 hours of your bedtime to avoid having to get up to urinate. Consult your doctor or pharmacist if you have questions about your dosing schedule. The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after these medications.Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).

Dizziness, lightheadedness, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.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.This medication may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps, weakness, fast/irregular heartbeat, confusion.Tell your doctor right away if you have any serious side effects, including: fainting, toe/joint pain, signs of kidney problems (such as change in the amount of urine).Get medical help right away if you have any very serious side effects, including: decrease in vision, eye pain.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.

Before taking chlorthalidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, gout, lupus, untreated mineral imbalance (such as low potassium).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of dizziness or lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you have diabetes, this product may affect your 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 medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. A potassium supplement may be prescribed by your doctor.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Older adults may be more sensitive to the side effects of this product, especially dizziness.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.Some products that may interact with this drug include: cisapride, dofetilide, lithium. Some products have ingredients that could raise your blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

Do not share this medication with others.Lifestyle changes that may help this medication work better include stress reduction programs, exercise, and dietary changes. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.Laboratory and/or medical tests (including kidney function, blood mineral levels such as potassium) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2020. Copyright(c) 2021 First Databank, Inc.

Hygroton 25 Tablets – NPS MedicineWise

What is in this leaflet

This leaflet answers some common questions about Hygroton 25 tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Hygroton 25 against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Hygroton 25 is used for

This medicine contains chlortalidone. It is used to treat high blood pressure (also called hypertension) and fluid build-up.

Everyone has blood pressure. This pressure helps to move your blood around your body. Your blood pressure may be different at various times of the day, and can be affected by how busy you are.

You have high blood pressure (hypertension) when your blood pressure stays higher than is needed even when you are calm and relaxed. There may be no symptoms of high blood pressure so you need to have it checked regularly. If high blood pressure is not treated, it can lead to serious health problems. Hygroton 25 helps to lower your blood pressure.

Hygroton 25 is also used to treat fluid build-up caused by heart or liver problems.

This medicine belongs to a group of medicines called diuretics (commonly called fluid or water tablets). These medicines help to reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine.

Hygroton 25 can be used alone or in combination with other medicines to treat your condition.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor’s prescription.

Before you take Hygroton 25

When you must not take it

Do not take Hygroton 25 if you have an allergy to:

• any medicine containing chlortalidone
• any of the ingredients listed at the end of this leaflet
• any other medicines with a similar structure (e.g. thiazide diuretics or sulfur drugs).

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take Hygroton 25 if you have any of the following health conditions:

• severe kidney or liver failure
• too little potassium or sodium in your blood
• too much calcium in your blood
• gout or if you have had gout in the past
• high blood pressure during pregnancy
• adrenal glands not working properly.

If you are not sure whether any of the above medical conditions apply to you, ask your doctor or pharmacist.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• any form of kidney or liver trouble
• a problem with your heart
• unusual amount of salt in your body
• diabetes
• high cholesterol.

Your doctor may want to take special precautions if you have any of the above conditions.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Hygroton 25 may affect your baby during pregnancy and at birth.

The active ingredient in Hygroton 25 passes into breast milk and there is a possibility that your baby could be affected.

Your doctor can discuss the risks and benefits involved.

Tell your doctor if you are lactose intolerant.

This medicine contains lactose.

If you have not told your doctor about any of the above, tell him/her before you start taking Hygroton 25.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Hygroton 25 may interfere with each other. These include:

• some medicines used to treat high blood pressure or heart problems (e.g. ACE inhibitors, digitalis)
• medicines used to relax muscles
• insulin or other medicines for diabetes
• medicines for arthritis, pain or inflammation, such as non- steroidal anti-inflammatory drugs (called NSAIDs)
• asthma relievers
• amphotericin B, a medicine used to treat fungal infections
• carbenoxolone, a medicine for stomach ulcer
• ACTH, a medicine for increasing steroid levels in the body
• steroid medicines, such as cortisone or prednisone
• lithium, a medicine used for mood swings and some types of depression
• colestyramine, a medicine used to lower high cholesterol
• allopurinol, a medicine for gout
• vitamin D or calcium supplements
• ciclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
• medicines for Parkinson’s disease (e. g. amantadine, biperiden)
• atropine, a medicine used in some eye drops or products to manage diarrhoea
• some medicines used to treat cancer or to treat joint pain and swelling (e.g. cyclophosphamide monohydrate, methotrexate).

These medicines may be affected by Hygroton 25 or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Hygroton 25

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

You will usually be started on a low dose of Hygroton 25 and, if necessary, your doctor will increase the dose gradually.

For an adult, the usual dose ranges from 12.5 mg to 50 mg (half a tablet to two tablets), taken each day or sometimes every other day. For a child, the dose needed will depend on how much the child weighs.

How to take it

Take the tablets during a meal with a full glass of water.

If you take only one dose of Hygroton 25 each day, take it in the morning unless your doctor tells you otherwise.

If you take more than one dose each day, take the last dose no later than 6 pm if possible.

Diuretic medicines tend to increase the amount of urine you pass. It is best to take the last dose of medicine no later than 6 pm so that you will not have to get up during the night to urinate.

How long to take it

Continue taking your medicine for as long as your doctor tells you to.

This medicine helps to control your condition, but it does not cure it. It is important to keep taking your medicine even if you feel well. Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Hygroton 25. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Some of the symptoms of an overdose may include nausea (feeling sick), dizziness, sleepiness, muscle spasms, low blood pressure and irregular heartbeat.

While you are taking Hygroton 25

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Hygroton 25.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell your surgeon or anaesthetist that you are taking Hygroton 25.

This will help to prevent unwanted side effects such as a sudden drop in blood pressure. Hygroton 25 may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor will want to check your heart and blood pressure and do regular blood tests to make sure the treatment is working and to prevent unwanted side effects.

Follow any instructions that your doctor gives you to maintain the correct level of a salt (called potassium) in your blood.

Hygroton 25 may sometimes cause your body to lose too much potassium. To help prevent this from happening, your doctor may ask you to:

• eat foods that have high potassium content (such as vegetables, fruit, fresh fruit juices, nuts, legumes and wholegrain cereals)
• take a potassium supplement
• take another medicine to help prevent the loss of potassium.

It is important not to add potassium to your diet without your doctor’s advice. Extra potassium may not be needed and, in some cases, could be harmful.

If you are sick and have severe or continuing vomiting or diarrhoea, tell your doctor.

Vomiting and diarrhoea may cause your body to lose too much salt and water, causing unwanted side effects.

If you are being treated for diabetes, monitor your blood sugar carefully and report any problems to your doctor.

Hygroton 25 may increase your blood sugar levels and affect how well your diabetes is controlled. The dose of your medicines for diabetes may have to be changed.

Things you must not do

Do not take Hygroton 25 to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you or if their condition seems similar to yours.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Hygroton 25 affects you.

This medicine may cause dizziness, light-headedness or blurred vision in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, it can cause a sudden drop in your blood pressure and dizziness or light-headedness may be worse.

If you feel light-headed, dizzy or faint when getting up from a sitting or lying position, get up slowly.

These symptoms may be due to a sudden fall in your blood pressure. If this problem gets worse or doesn’t go away, talk to your doctor.

To avoid symptoms of low blood pressure, here are some hints that may help:

• stand up slowly to help your body get used to the change in position and blood pressure
• if you feel dizzy, sit or lie down until you feel better
• if you feel faint, breathe deeply, sit down, bend forward and put your head between your knees
• avoid alcohol or medicines to help you sleep as they may make your blood pressure fall even more
• take extra care when exercising, driving or standing for long periods, especially in hot weather. Drink plenty of fluids, especially if you sweat a lot.

Be careful to stay out of direct sunlight as much as possible until you find out if your skin is more sensitive to the sun than usual. Wear protective clothing and use a sunscreen. Do not use a sunlamp.

In rare cases, this medicine can make the skin more sensitive to sunlight than usual.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Hygroton 25.

This medicine helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and they worry you:

• dizziness or light-headedness, especially on standing up
• loss of appetite, stomach upset, nausea (feeling sick) or vomiting
• diarrhoea or constipation
• headache
• skin rash
• problems with sexual function.

Tell your doctor as soon as possible if you notice any of the following:

• unusual tiredness, lack of energy or weakness, sometimes with nausea and a feeling of disorientation
• difficulty breathing
• constant “flu-like” symptoms (chills, fever, sore throat, aching joints, swollen glands)
• unusual bleeding or bruising, reddish or purplish blotches under the skin
• pain in the abdomen with nausea, vomiting and fever
• yellowing of the skin or eyes
• irregular heart beat
• burning, numbness or pain in arms and legs
• symptoms of gout such as pain and swelling of the joints, often in the big toe
• difficulty urinating, sometimes with pain or fever
• blurred or changed vision
• symptoms of sunburn (redness, itching, swelling, blistering) that happen much more quickly than normal.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice:

• serious allergic reaction (shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin).

This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some people.

Some of these side effects (e.g. raised cholesterol levels) can only be found when your doctor does tests from time to time to check your progress.

After taking Hygroton 25

Storage

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store Hygroton 25 or any other medicine in the bathroom, near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Hygroton 25 or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Hygroton 25 tablets are pale orange, speckled, round flat tablets with bevelled edges. One side bears the imprint “CW” with a score line and there is nothing on the other side. Each bottle contains 50 tablets.

Ingredients

Hygroton 25 contains 25 mg of chlortalidone as the active ingredient.

It also contains:

• colloidal anhydrous silica
• lactose monohydrate
• magnesium stearate
• maize starch
• purified talc
• iron oxide yellow
• iron oxide red

This medicine does not contain sucrose, gluten, preservatives, tartrazine or any other azo dyes.

Sponsor

Distributed in Australia by:

Amdipharm Mercury (Australia) Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060

Date of preparation:
31 January 2017

Australian Registration Number:
AUST R 11035

Amdipharm Mercury (Australia) Pty Ltd is licensed to use the trademark Hygroton.

Hygroton (chlortalidone)

What is it used for?

• High blood pressure (hypertension).
• Mild to moderate chronic, stable heart failure.
• Fluid retention (ascites and oedema) in liver cirrhosis.
• Fluid retention due to kidney disease (nephrotic syndrome).
• Reducing urine production in a rare disease where there is a problem with the kidneys that causes large amounts of dilute urine to be produced (diabetes insipidus).

How does it work?

Hygroton tablets contain the active ingredient chlortalidone, which is a type of medicine known as a thiazide-related diuretic.

Diuretics are sometimes referred to as ‘water tablets’. They remove excess fluid from the body by increasing the production of urine. (However, when chlortalidone is used to treat a condition called diabetes insipidus, it has the opposite effect and actually reduces urine production.)

Diuretics act in the kidneys. Their usual effect is to cause the kidneys to increase the amount of salts, such as potassium and sodium, that are filtered out of the blood and into the urine. When these salts are filtered out of the blood by the kidneys, they draw water alongside them. As diuretics increase the removal of salts from the blood, they also cause more water to be drawn out of the blood and into the urine.

Removing water from the blood decreases the volume of fluid circulating through the blood vessels. This subsequently decreases the pressure within the blood vessels. Diuretics such as chlortalidone can therefore be used to lower high blood pressure.

Chlortalidone is also used to treat conditions where excess fluid has been retained in the body (oedema). For example, in heart failure, the pumping mechanism of the heart is less effective. This can cause fluid to build up in the ankles and the lungs (pulmonary oedema), which makes it difficult to breathe. Chlortalidone helps the body to remove this excess fluid. Removing fluid from the blood vessels also decreases the pressure within the blood vessels. This makes it easier for a weak heart to pump blood around the body.

Chlortalidone can also be used to remove excess fluid that accumulates in the body in people with kidney disease or cirrhosis of the liver. In liver cirrhosis this fluid may accumulate in the abdomen (ascites) or in the legs (oedema).

How do I take it?

• Hygroton tablets should preferably be taken in the morning with food.
• The number of tablets to be taken daily will vary depending on your symptoms. The tablets are usually taken once daily, although for diabetes insipidus you may start treatment by taking the tablets twice a day. For the treatment of oedema you may be asked to take the tablets on alternate days. Follow the instructions given by your doctor.
• As diuretics cause your kidneys to produce more urine, you may find that if you take a dose too late in the day that you need to get up in the night to visit the toilet. For this reason, it is recommended that you take this medicine in the morning. (This doesn’t apply to people with diabetes insipidus because the medicine doesn’t increase urine production in this condition.) Seek further advice from your doctor or pharmacist.

Warning!

• This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activities, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
• Alcohol may enhance the blood pressure lowering effect of this medicine, which could cause dizziness or fainting. Take extra care if you drink alcohol while you are taking this medicine.
• While taking this medicine you may need to have regular blood tests to monitor your kidney function and the levels of salts such as potassium and sodium in your blood.
• If you experience any of the following symptoms while taking this medicine you should inform your doctor promptly, so that the amount of fluids and salts in your body can be checked: thirst, lethargy, confusion, weakness, drowsiness, muscle cramps, scanty production of urine, abnormal heart rhythm, seizures, nausea and vomiting.
• Chlortalidone can sometimes cause the level of sodium in your blood to fall too low and for this reason, following a very strict low salt (sodium) diet should be avoided while you are taking this medicine.

Use with caution in

• Elderly people.
• Decreased liver function.
• Decreased kidney function.
• Diabetes mellitus.
• People with a history of gout or high levels of uric acid in their blood.
• An inflammatory disease of connective tissue (systemic lupus erythematosus).
• People with high levels of fats (lipids) such as cholesterol and triglycerides in the blood (hyperlipidaemia).
• People on a low salt (sodium) diet.
• People who are malnourished.

Not to be used in

• Severe liver disease.
• Severe kidney failure.
• People whose kidneys are not producing urine.
• People allergic to thiazide diuretics.
• People allergic to medicines from the sulphonamide group, eg the antibiotic sulfamethoxazole.
• People with a high level of calcium in their blood (hypercalcaemia).
• People with a low level of potassium or sodium in their blood (hypokalaemia or hyponatraemia).
• Gout.
• People with inadequate production of natural steroid hormones by the adrenal glands (Addison’s disease).
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not normally be used during pregnancy. Thiazide diuretics can reduce placental blood flow to the baby and, if used in the second or third trimester, can cause problems such as jaundice, low platelet count and disturbances in the baby’s electrolyte levels. This medicine should not be used to treat high blood pressure in pregnancy or fluid retention in otherwise healthy pregnant women. It should only be used in other situations if considered essential by your doctor. The expected benefit to the mother must be greater than the possible risks to the developing baby. Seek further medical advice from your doctor.
• Chlortalidone passes into breast milk and could have unwanted effects on a nursing infant. Women who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people, but mainly at higher doses)

• Decreased level of potassium in the blood (hypokalaemia).
• Increased level of uric acid in the blood (hyperuricaemia).
• Increases in the level of cholesterol or triglycerides in the blood.

Common (affect between 1 in 10 and 1 in 100 people)

• Dizziness.
• A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
• Decreased level of sodium in the blood (hyponatraemia).
• Increased blood glucose level (hyperglycaemia).
• Skin rash.
• Loss of appetite.
• Erectile dysfunction (impotence)

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Headache.
• Sensation of pins and needles.
• Increased level of calcium in the blood (hypercalcaemia).
• Increased sensitivity of the skin to sunlight (photosensitivity).
• Yellowing of the skin or whites of the eyes (jaundice).
• Abnormal heart beats (arrhythmias).
• Disturbance in the normal numbers of blood cells in the blood.

Very rare (affect less than 1 in 10,000 people)

• Inflammation of the pancreas (pancreatitis).

The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

This medicine is likely to have an additive effect with other medicines that decrease blood pressure, particularly medicines that are used to treat high blood pressure (antihypertensives). This may cause dizziness, which can usually be relieved by lying down until the symptoms pass. If you feel dizzy while taking this medicine in combination with other medicines that can lower blood pressure you should let your doctor know, as your doses may need adjusting. Other medicines that decrease blood pressure include the following:

• ACE inhibitors, eg enalapril
• aldesleukin
• alpha-blockers such as prazosin
• alprostadil
• angiotensin II receptor antagonists such as losartan
• antipsychotics such as chlorpromazine
• benzodiazepines, eg temazepam, diazepam
• baclofen
• beta-blockers such as propranolol
• calcium-channel blockers such as verapamil, nifedipine
• clonidine
• diazoxide
• other diuretics, eg furosemide
• dopamine agonists, eg bromocriptine, apomorphine
• hydralazine
• levodopa
• MAOI antidepressants, eg phenelzine
• methyldopa
• minoxidil
• moxisylyte
• moxonidine
• nicorandil
• nitrates, eg glyceryl trinitrate
• tizanidine.

This medicine reduces the ability of the body to remove the medicine lithium. As this can increase the blood level of lithium and the risk of its side effects, this medicine should not be taken by people taking lithium.

Chlortalidone can decrease the amount of potassium in the blood. If it is used in combination with any of the following medicines, which can also lower potassium in the blood, the risk of a low blood potassium level (hypokalaemia) is increased:

• acetazolamide
• amphotericin
• corticosteroids, such as hydrocortisone and prednisolone
• beta ₂ agonists, eg salbutamol, terbutaline
• other diuretics, eg furosemide
• theophylline.

If the level of potassium in your blood falls during treatment, this can increase the risk of side effects on the heart from various other medicines, including digoxin, certain antipsychotics and medicines for abnormal heart rhythms (anti-arrhythmics), eg amiodarone.

Diuretics can sometimes increase blood glucose levels and people with diabetes may therefore need increases in their dose of insulin or antidiabetic tablets while taking this medicine. If you have diabetes you should talk to your doctor about this. You may need to monitor your blood sugar levels more frequently.

Chlortalidone can increase the amount of calcium in your blood. If you are taking calcium or vitamin D supplements, or regularly take large amounts of calcium-containing antacids, your doctor may want to monitor the level of calcium in your blood to make sure it doesn’t rise too high. Taking occasional antacids should not cause any problems.

Colestyramine and colestipol can reduce the absorption of chlortalidone from the gut. If you have been prescribed either of these medicines you should not take them within four hours of taking Hygroton.

There may be an increased risk of allergic reactions to allopurinol in people taking thiazide diuretics such as chlortalidone, particularly if they also have any kidney problems.

The following medicines may reduce the blood pressure lowering effect of this medicine:

• corticosteroids, such as dexamethasone or prednisolone
• oestrogens, such as those in the contraceptive pill
• regular use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or indomethacin (occasional painkilling doses are unlikely to have a significant effect).

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain chlortalidone as the active ingredient.

Last updated 11.12.2011

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Buy Hygroton (chlorthalidone) Online | Blink Health

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

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, gout, lupus, untreated mineral imbalance (such as low potassium).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of dizziness or lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have diabetes, this product may affect your 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 medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. A potassium supplement may be prescribed by your doctor.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Older adults may be more sensitive to the side effects of this product, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Chlorthalidone Linked to Higher Risk of Electrolyte, Kidney Problems

Chlorthalidone — known by the brand name Thalitone — is the American College of Cardiology and American Heart Association’s preferred first-line treatment for high blood pressure, but a recent study found that the drug may cause more serious side effects than similar drugs. 

The February 2020 cohort study by Drs. George Hripcsak, Marc A. Suchard and Steven Shea published in JAMA Internal Medicine looked at medical data from 730,255 people. Researchers compared the safety and effectiveness of chlorthalidone and a similar drug, hydrochlorothiazide.

Chlorthalidone and hydrochlorothiazide are both diuretics — also called “water pills” — and belong to the thiazide-like and thiazide drug classes, respectively. They work to lower blood pressure by causing the kidneys to remove excess water and salt from the body through urine. 

According to the JAMA study, both drugs are just as effective and chlorthalidone doesn’t protect the heart any better than hydrochlorothiazide. But chlorthalidone was associated with a “significantly higher risk” of side effects. 

Chlorthalidone increased the risk of the following side effects when compared to hydrochlorothiazide:

• Low potassium levels (hypokalemia), nearly three times greater risk
• Low sodium levels (hyponatremia), 31 percent greater risk
• Acute kidney failure, 37 percent greater risk
• Chronic kidney disease, 24 percent greater risk
• Type 2 diabetes, 21 percent greater risk

“The difference in the occurrence of side effects was striking,” Dr. Hripcsak told Columbia University. “Hypokalemia, hyponatremia, chronic and acute kidney problems, along with other electrolyte imbalances, are all potentially dangerous side effects.”

Researchers say their findings don’t support chlorthalidone as the preferred treatment, but more studies are needed before regulators change guidelines. 

Chlorthalidone Is One of the Oldest Blood Pressure Drugs

Thiazide and thiazide-like drugs have been around since the late 1950s, and health care providers have prescribed them to lower blood pressure for decades. This makes them the oldest type of blood pressure drug on the market. 

About 103 million Americans have high blood pressure, according to the American Heart Association. High blood pressure is a serious condition that can lead to heart attack, stroke, heart failure and other serious diseases. 

Health care providers in the Unites States write about 49 million prescriptions a year for hydrochlorothiazide alone, according to Consumer Reports.   

Thiazide and thiazide-like drugs are also less expensive than other blood pressure medications such as valsartan, losartan and lisinopril — many of these other blood pressure drugs were included in N-nitrosodimethylamine (NDMA) contamination recalls in 2018.

Electrolyte Imbalance and Other Side Effects

The 2020 JAMA study isn’t the first study to find side effects with chlorthalidone, according to Columbia University. Previous studies found that the drug was associated with more electrolyte imbalances than hydrochlorothiazide. 

Electrolyte balance refers to the balance between sodium, calcium, potassium, chloride, phosphate and magnesium in the body. Too little or too much water in the body can cause these levels to become imbalanced and lead to several side effects.

According to the Thalitone drug label, all patients taking chlorthalidone should be observed for clinical signs of electrolyte imbalance, including:

• Drowsiness
• Dryness of mouth
• Gastrointestinal disturbances, such as nausea and vomiting 
• Lethargy
• Low blood pressure (hypotension)
• Low urine output (oliguria)
• Muscle pains or cramps
• Muscular fatigue
• Palpitations
• Restlessness
• Tachycardia
• Thirst
• Weakness

The label also warns that people with liver problems who take chlorthalidone should use caution. Electrolyte imbalance is particularly dangerous for people with liver problems, because minor electrolyte imbalance can cause hepatic coma — a loss of brain function that happens when the liver doesn’t remove toxins from the blood. 

Other side effects have been reported with chlorthalidone use, but there isn’t enough data for researchers to determine their frequency, according to the drug label. 

Other side effects include:

• Blood cell irregularities
• Color vision deficiency (xanthopsia)
• Cramping
• Diarrhea
• Dizziness
• Frequent urination
• Gastric irritation
• Headache
• Hypoglycemia
• Impotence
• Jaundice
• Low blood pressure aggravated by alcohol, barbiturates or narcotics
• Muscle spasm
• Pancreatitis
• Pins and needles (paresthesia)
• Rash
• Restlessness
• Vertigo
• Vomiting
• Weakness

People with moderate or severe side effects may need to adjust their dose or discontinue chlorthalidone, according to the drug label. Patients who experience side effects should speak to their health care providers.

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Can You Get a Hygroton Prescription Online?

If you have high blood pressure or edema (water retention) due to heart, liver, or kidney problems, a doctor may have recommended that you start taking Hygroton. What is Hygroton? How does it work? What are the risks and benefits? Can you get a Hygroton prescription online?

We’ll answer these questions and cover all the information you should know about Hygroton, including, its side effects, and if you can buy a Hygroton prescription online.

What is Hygroton?

Hygroton is one brand name for the drug Chlorthalidone, which is a diuretic (water pill) that helps your body get rid of excess water and salt. This can help lower high blood pressure and reduce swelling caused by water retention that may be the result of congestive heart failure, liver cirrhosis, or kidney problems.

How does Hygroton work?

Hygroton is a “water pill” which relaxes blood vessels and increases urination to help lower blood pressure and remove extra water and salt from your body. This helps reduce swelling caused by water retention that can result from certain liver, kidney, or heart problems.

Hygroton dosage and treatment

The Hygroton dosage will vary based on your age, medical condition, and what it is being used to treat. The typical dosage ranges from 25-100 mg per day, although doses may be as low as 12.5 mg per day or as high as 200 mg per day. Sometimes doses may be taken multiple times per day or only every other day.

Always follow your doctor’s instructions about how you should take this medication to avoid an overdose.

Benefits of Hygroton

Hygroton can reduce swelling caused by water retention related to kidney, liver, or heart problems. This swelling can cause pain or difficulty breathing. Hygroton can also lower high blood pressure. High blood pressure can lead to problems like stroke, kidney problems, or heart attack.

Side Effects of Hygroton

Like any medication, Hygroton can cause a variety of potential side effects ranging from mild to severe. You should always talk to a doctor or seek medical attention if you experience serious side effects as they may be life-threatening. Some side effects of Hygroton include:

• Lightheadedness
• Restlessness
• Dizziness
• Stomach upset
• Headache
• Sun sensitivity
• Dehydration
• Weakness
• Muscle cramps
• Extremely dry mouth
• Intense thirst
• Confusion
• Fast or irregular heartbeat
• High blood sugar
• Excess uric acid in the blood
• Joint or toe pain
• Fainting
• Kidney problems
• Eye pain
• Pancreatitis
• Decreased vision
• Impotence
• Involuntary muscle movement or stiffness
• Trouble breathing
• Swelling
• Rash
• Itching
• Low blood pressure

Considerations and Precautions of Hygroton

Hygroton is generally considered safe, but it isn’t appropriate for everybody. Always tell your doctor about every medication, supplement, or vitamin that you take as well as all medical conditions you may have to prevent potentially deadly complications.

Hygroton Interactions

Hygroton can interact with a wide variety of medication: it has moderate interactions with at least 154 medications and minor interactions with at least 147 drugs. That’s why you should always tell your doctor about all your medications. Hygroton can also have serious interactions with the following medications:

Other Hygroton Considerations

Always tell your doctor about any health conditions you have, especially:

• Gout
• Asthma
• Low potassium
• Excess cholesterol
• Lupus
• Liver disease
• Low blood pressure
• Diabetes
• Kidney disease
• Allergy to sulfa drugs

Can You Buy Hygroton Online?

Since federal law requires everybody to speak to a doctor before receiving any prescription medication, there is no legal way to buy Hygroton online without getting a prescription from a doctor first. Be wary of sites that claim they can provide you with a Hygroton prescription without speaking to a doctor, this is not legal and there is no way to ensure the quality of the medication you are getting.

Luckily, there is a way to get a Hygroton prescription online. With PlushCare, you can speak to a doctor with a video or phone call, and if they feel that Hygroton would be appropriate for you, they can send a prescription to your local pharmacy, where you can pick it up as soon as it’s ready.

With PlushCare, appointments are easy. Any time of day, any day of the year, you can call (888) 819-5017 or click here to schedule an appointment for a phone or video call with a top doctor.

Before your appointment, you will input all of your medications and health conditions into our proprietary software, which will check for any drug interactions or health precautions to help prevent a negative medication interactions. This helps make PlushCare one of the safest and convenient ways to get prescriptions online.

If you think that you might benefit from Hygroton, or if you’re currently taking it, but you need prescription refills, make an appointment today to buy a Hygroton prescription online.

PlushCare takes content accuracy seriously so we can be your trusted source of medical information. Most articles are reviewed by M.D.s, Ph.D.s, NPs, or NDs. Click here to meet the healthcare professionals behind the blog.

Read More About Getting a Hygroton Prescription Online

Chlortalidone | Health Navigator NZ

Easy-to-read medicine information about chlortalidone – what it is, how to take chlortalidone safely and possible side effects. Chlortalidone is commonly called Hygroton.










Type of medicine	Also called
Diuretic (causes you to pass more urine) Thiazide diuretic ‘Water’ tablet or ‘water pill’	Hygroton® Chlorthalidone

What is chlortalidone?

Chlortalidone is a diuretic, which means it helps your body get rid of extra salt (sodium) and water. It works by increasing the amount of urine (pee) you make. Chlortalidone is used to treat high blood pressure (hypertension), and is also used to lessen extra fluid in the body (called oedema) caused by conditions such as heart failure, liver disease, or kidney disease. This can reduce symptoms such as swelling in your ankles or feet, or shortness of breath. In New Zealand, chlortalidone is available as tablets (25 mg). 

Dose

• High blood pressure: the usual dose is half to one tablet (12.5 mg to 25 mg) a day.
• Oedema (excess fluid): the usual dose is 25 mg once a day. Some people may need higher doses.
• Your doctor will advise you how long to take chlortalidone for.
• Always take your chlortalidone exactly as your doctor has told you. The pharmacy label on your medicine will tell you how much chlortalidone to take, how often to take it, and any special instructions.

How to take chlortalidone

• Take chlortalidone once a day, in the morning.  
• It is best taken in the morning, so it works during the day and your sleep is not disturbed by you needing to get up to go to the toilet during the night.
• You can take chlortalidone with or without food.
• Limit or avoid drinking alcohol while you are taking chlortalidone. Alcohol may increase your chances of getting side effects such as dizziness.
• If you forget to take your dose, take it as soon as you remember. But, if it is late in the afternoon, skip the missed dose and continue as usual the next day. Do not take double the dose.







Be careful when taking some pain relief medicines
Taking diuretics together with pain relief medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs), such as ibuprofen and diclofenac and medicines called ACE inhibitors or ARBs can be harmful to your kidneys. Read more about NSAIDs and blood pressure medicines.

Precautions – before starting chlortalidone

• Are you pregnant or breastfeeding?
• Do you have difficulty peeing, or do you have prostate problems?
• Do you have problems with your liver or kidneys?
• Do you have gout or diabetes? These conditions can be made worse by bendroflumethiazide.
• Are taking any other medicines? This includes any medicines you are taking which you can buy without a prescription, as well as herbal and complementary medicines and medicines you can buy for pain relief.

If so, it’s important that you tell your doctor or pharmacist before you start chlortalidone. Sometimes a medicine isn’t suitable for a person with certain conditions, or it can only be used with extra care.

Side effects

Like all medicines chlortalidone can cause side effects, although not everyone gets them. Often side effects improve as your body gets used to the new medicine.



















Side effects	What should I do?
Feeling sick (nausea) Stomach upset	These are quite common when you first start taking chlorthalidone, and usually go away after the first few days Tell your doctor if troublesome
Dizziness Feeling lightheaded Feeling faint when you stand up	Be careful when getting up from either lying down or sitting to avoid falls. These effects put you at risk of falls and injuries, especially if you are elderly Be careful when driving or using tools until you know how this medicine affects you
Signs and symptoms of gout Chlortalidone may raise serum uric acid levels and cause an acute attack of gout in some people
Signs of dehydration (losing too much salt and water) such as muscle cramps, weakness, dry mouth, thirst or passing unusually reduced amounts of urine
Signs of an allergic reaction such as skin rashes, itching, blisters, peeling skin, swelling of the face, lips, mouth or have problems breathing	Tell your doctor immediately or ring HealthLine 0800 611 116

Interactions




Diuretics can interact with a number of other medicines and herbal supplements so check with your doctor or pharmacist before starting diuretics or before starting any new medicines.

Be careful when taking some pain relief medicines

Taking the group of pain relief medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs) can be harmful to your kidneys. Examples include: 

Taking NSAIDs together with diuretics and medicines called ACE inhibitors or ARBs can be harmful to your kidneys (this combination of medicines is called the triple whammy). If you are taking ACE inhibitors or ARBs and diuretics, tell your doctor or pharmacist before starting NSAIDs.

• Examples of ACE inhibitors are captopril, cilazapril, enalapril, lisinopril, perindopril and quinapril.
• Examples of ARBs are candesartan, irbesartan, valsartan and losartan.

Before buying NSAIDs for pain relief, check with your pharmacist whether these are safe for you.

Read more about NSAIDs, ACE inhibitors, ARBs and The triple whammy SafeRx

Learn more

The following links have more information on chlortalidone.

Medsafe Consumer Information Sheets: Hygroton 
New Zealand Formulary Patient Information: Chlortalidone

References

1. Chlortalidone New Zealand Formulary

Gordox instructions for use: indications, contraindications, side effects – description Gordox solution for intravenous injection 100,000 KIE / 10 ml: amp. 5 or 25 pcs. (203)

When using aprotinin, especially with repeated use of the drug, allergic / anaphylactic reactions may develop. Therefore, before using the drug, it is necessary to carefully assess the benefit / risk ratio. 10 minutes before the administration of the main dose of the drug Gordox ^® , a trial dose of 1 ml (10 thous.KIE). 15 minutes before the administration of a therapeutic dose of the drug Gordox ^® , it is possible to use blockers of histamine H ₁ – and H ₂ – receptors. However, allergic / anaphylactic reactions can also develop with the introduction of a therapeutic dose of the drug, even if no adverse reactions were noted during the administration of the test dose.

In case of hypersensitivity reactions when using aprotinin, the drug should be discontinued immediately and the standard emergency measures aimed at treating allergic / anaphylactic reactions should be ensured.

Patients in whom antibodies (IgG) to aprotinin are detected have a high risk of developing anaphylactic reactions when using aprotinin. In this regard, the use of the drug Gordox ^® in such patients is contraindicated. Before prescribing the drug Gordox ^® , each patient is recommended to perform a test for the presence of antibodies (IgG) to aprotinin. If the determination of antibodies (IgG) to aprotinin is not possible, then in patients in whom the use of aprotinin during the previous 12 months cannot be excluded, the use of the drug Gordox ^® is contraindicated.

Despite the fact that anaphylactic reactions most often develop with repeated administration of aprotinin within 12 months, there are reports of the development of anaphylactic shock at a later date (when the repeated administration was performed later than 12 months after the first administration).

When performing an operation on the thoracic aorta using AIK and using deep cold cardioplegia, Gordox ^® should be used with extreme caution against the background of adequate heparin therapy.

The determination of the activated clotting time is not a standardized test for determining the coagulation capacity of blood, and the use of aprotinin may affect various test methods. The Coagulation Measurement Test (ACT) is influenced by various dilution and temperature effects. The ACT kaolin test does not increase as much with aprotinin as the ACT test with celite. Due to the difference in protocols, it is recommended to take the minimum values ​​of the ACT test – 750 sec and the ACT test with kaolin – 480 sec in the presence of aprotinin, regardless of the effects of hemodilution and hypothermia.

The standard dose of heparin administered before the canalization of the heart and the amount of heparin added to the primary volume in the AIC should be at least 350 IU / kg. The additional dose of heparin is determined by the patient’s body weight and the duration of the extracorporeal circulation period.

The protamine titration method is not influenced by aprotinin. Heparin supplements are determined based on the heparin concentration calculated by this method. The concentration of heparin during bypass surgery should not fall below 2.7 U / ml (0.2 mg / kg) or below the level determined before the use of aprotinin.

In patients treated with Gordox ^® , heparin neutralization with protamine should be carried out only after interruption of extracorporeal circulation, based on a fixed amount of heparin administered or under the control of protamine titration.

The total amount of injected aprotinin during the treatment cycle should not exceed 7 million KIE.

Aprotinin is not a substitute for heparin.

Preparations for parenteral administration should be visually inspected immediately before use. Do not use the remains of the solution for subsequent use.

Excipients

Gordox ^® contains benzyl alcohol. The daily dose of benzyl alcohol should not exceed 90 mg / kg of body weight. Benzyl alcohol can cause anaphylactoid reactions.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of Gordox ^® on the ability to drive vehicles and work with mechanisms.

90,000 2 reviews, instructions, analogs, price 0 rubles.

Active ingredient : Chlorthalidone check compatibility

☠ Attention! Dummy medicines – how Russians are bred or what you can’t spend money on!

Names
Russian name: Gigroton.
English name: Hygroton.

ATX code
C03BA04 Chlorthalidone.

Components of the preparation
1 tablet contains chlorthalidone 50 mg; in the package 20 pcs.

Dosage and administration
Inside. Adults – 25-200 mg / day (depending on the disease), children – 2 mg / kg / day.

Storage conditions
Keep out of reach of children.

Components Contraindications
Chlortalidone Contraindications. Hypersensitivity, hypokalemia, acute renal failure (anuria), hepatic coma, acute hepatitis, diabetes mellitus (severe), Gout.Use of Chlortalidone when breastfeeding. In experiments on rats and rabbits receiving chlorthalidone in doses up to 420 times higher than the human dose, no adverse effect of chlorthalidone on the fetus was found.
During pregnancy – only according to indications (possible adverse effects – jaundice of the fetus or newborn, thrombocytopenia, hypokalemia in infants).
FDA Fetal Activity Category. B.
Chlorthalidone passes into breast milk, in this regard, it is necessary to decide whether to stop breastfeeding, or to take chlorthalidone (given the importance of the drug for the mother). Side effects of the ingredients
Side effects of Chlortalidone.
From the nervous system and sensory organs. Dizziness, vertigo, headache, paresthesia, xanthopsia.
From the cardiovascular system and blood (hematopoiesis. Hemostasis): orthostatic hypotension (may increase under the influence of ethanol. Barbiturates and anesthetics). Arrhythmia (due to hypokalemia). Thrombocytopenia. Leukopenia. Agranulocytosis. Eosinophilia. Aplastic anemia.
From the digestive tract. Anorexia, nausea, vomiting, gastrospasm, constipation / diarrhea, intrahepatic cholestasis, jaundice, pancreatitis.
Allergic reactions. Purpura, photosensitivity, rash, urticaria, cutaneous vasculitis / Lyell’s syndrome (toxic epidermal necrolysis).
Others. Salt imbalance. Such as hyponatremia (including accompanied by neurological symptoms – confusion. Spasms and convulsions. Weakening of thinking processes.Fatigue. Irritability). Hypochloremic alkalosis and hypokalemia (including dry mouth. Increased thirst. Irregular heartbeat. Mood changes or mental changes. Muscle cramps or pain. Nausea or vomiting. Unusual tiredness or weakness. Pulse weak). Hypomagnesemia. Hypercalcemia. Hyperuricemia (gout). Hyperglycemia. Glucosuria. Hyperlipidemia. Decreased potency.

Manufacturers of the drug
Ciba-Geigy

contraindications, side effects, dosages, composition – solution for injections in the drug reference

Recent observational studies confirm that treatment with aprotinin can be accompanied by impaired renal function, in particular in patients who already have kidney damage.When analyzing the results of placebo-controlled studies carried out in patients who underwent coronary artery bypass grafting, it was shown that in the group receiving aprotinin, there was an increase in serum creatinine by 0.5 mg / dL compared to the normal value. Accordingly, before prescribing aprotinin to patients with impaired renal function or at risk of kidney damage (for example, with simultaneous treatment with aminoglycosides), a careful assessment of the benefit-risk ratio is necessary.

During pregnancy, aprotinin should only be prescribed if the potential benefits outweigh the expected risks.

This medicine contains benzyl alcohol. According to European guidelines, the daily dose of benzyl alcohol should not exceed 90 mg / kg body weight. Thus, during the treatment cycle, the maximum dose of aprotinin cannot exceed 6 million KIE.

When using aprotinin, a careful assessment of the balance of benefits and risks is necessary, especially in patients who have previously used aprotinin (incl.including fibrin filling material containing aprotinin), since they may develop an allergic reaction. Although most cases of anaphylaxis develop after a clearance dose for 12 months, there are isolated reports of cases where an anaphylactic reaction has occurred with repeated exposure after 12 months. When carrying out therapy with aprotinin, it is necessary to have an emergency aid available for the treatment of allergic and anaphylactic reactions.

All patients receiving treatment with aprotinin should first be given a test dose in order to assess whether they are prone to allergic reactions.The test dose should be administered to the patient in the operating room.

H ₁ – and H ₂ – histamine receptor blockers can be administered 15 minutes before the aprotinin test.

The test dose of aprotinin in all patients should be 1 ml (10,000 KIE), after which it is necessary to observe the patient for at least 10 minutes before administering the loading dose.

However, even despite the absence of complications in the period after the introduction of the initial dose of 1 ml, a therapeutic dose of aprotinin can cause anaphylactic reaction.If an anaphylactic reaction develops, the aprotinin infusion should be discontinued and the necessary emergency measures should be taken.

In connection with the possibility of developing hypersensitivity reactions, before starting the use of Gordox, it is necessary to carefully assess the balance of benefits and risks in each patient who has already received treatment with aprotinin.

In case it is known that the patient has already received or could receive repeated treatment with aprotinin, it is recommended to observe the following precautions.As indicated in the Dosing Regimen section, all patients should receive a test dose of Gordox in a volume of 1 ml (10,000 KIE) at least 10 minutes before the initial dose is administered. In addition, an H ₁ histamine receptor blocker (eg clemastine) and an H ₂ histamine receptor blocker (eg cimetidine) can be administered 15 minutes before the test dose of Gordox is administered. Standard emergency measures should be used to treat an allergic (anaphylactic) reaction if necessary.

It should not be forgotten, however, that the therapeutic dose can cause an allergic reaction, even if the patient tolerated the administration of the initial test dose of 1 ml well, without experiencing any undesirable symptoms. If this happens, the aprotinin infusion should be stopped immediately and the standard emergency measures for the treatment of anaphylactic reactions should be started.

In patients treated with Gordox, there was an increase in the incidence of renal failure and mortality, compared with an age-comparable control group, which had a similar medical history and in which operations were also performed on the thoracic aorta under cardiopulmonary bypass with circulatory arrest against a background of deep hypothermia.In such cases, Gordox can be prescribed only with extreme caution. Appropriate anticoagulant treatment with heparin is necessary.

Influence on the ability to drive vehicles and mechanisms

Given the scope of the drug, the consideration of these effects is irrelevant.

Additional notes on the use of the drug in cardiopulmonary bypass

To maintain adequate anticoagulant activity against the background of cardiopulmonary bypass while using Gordox, it is recommended to use any of the following methods:

1.Activated Clotting Time (ABC) :

• ABC cannot be considered a standard coagulation test;
• The interpretation of the results of this test depends on the presence of aprotinin. In addition, the test results are influenced by differences in dilution and the temperature used in the cardiopulmonary bypass setting. It was shown that the effect of aprotinin is less pronounced in relation to kaolin ABC, in comparison with ABC using diatomaceous earth (celite).Despite the variety of protocols, a 750-second ABC test using diatomaceous earth or a 480-second ABC test using kaolin in the presence of aprotinin is recommended, regardless of the degree of hemodilution and hypothermia. Consult the ABC reagent manufacturer for advice on the interpretation of the results of the assay in the presence of Gordox.

2. Constant dose heparin: the standard loading dose of heparin, which is administered before cardiac catheterization, and the amount of heparin added to the primary filling solution of the heart-lung machine, must be at least 350 IU / kg.The additional dose of heparin is determined taking into account the patient’s body weight and the duration of the intervention under cardiopulmonary bypass.

3. Heparin / protamine titration: This method is unaffected by the presence of aprotinin and is therefore suitable for measuring heparin levels. The relationship between the dose of heparin and the response to it should be assessed by titration of protamine before administration of aprotinin (to determine the loading dose of heparin).

Additional heparin can be administered based on the heparin concentration as measured by protamine titration. The concentration of heparin under the conditions of cardiopulmonary bypass should not decrease below 2.7 U / ml (2.0 mg / kg) or below the dose, which was determined by testing the dependence of the response on the dose of heparin, carried out before the administration of aprotinin.

After the end of cardiopulmonary bypass, if the patient received Gordox injections, heparin should be neutralized by the introduction of protamine.The amount of protamine should be calculated on the basis of a fixed ratio, which is determined by the amount of heparin administered or calculated using the protamine titration method.

Important: the use of Gordox does not mean that the need for heparin decreases.

Results of preclinical safety studies

Acute toxicity

In rats, guinea pigs, rabbits and dogs, the rapid administration of a large amount (over 150,000 KIU / kg body weight) of the active substance was accompanied by the development of arterial hypotension of varying severity, which quickly resolved.

Approximate values ​​of 50% of the lethal dose (LD ₅₀ ) with intravenous administration were:

Mice:

• from 2.5 to 6.5 million CIU per kg of body weight.

Rats:

• from 2.5 to 5.0 million CIU per kg of body weight.

Dogs:

• over 1.36 million KIE per kg of body weight.

Rabbits:

• over 0.5 million KIE per kg of body weight.

In a study designed to simulate intended use in humans, dogs received a daily dose of 340,000 CIU / kg bw as a 4-hour infusion or 1,360,000 CIU / kg bw daily at the form of an 8-hour infusion.These doses are 3-10 times the recommended doses for humans. The following deviations from the norm were observed:

• pseudo-allergic reactions and mild or moderate hyaline changes in the cytoplasm of the epithelial cells of the renal tubules. The morphological changes observed in the kidneys did not affect the glomeruli, but were not completely reversible at the end of the 10-day period without treatment.

In rats, guinea pigs, rabbits and dogs, the rapid administration of a large amount (over 150,000 KIE / kg body weight) of the active substance was accompanied by the development of rapidly resolving hypotension of varying severity.

Chronic toxicity

Rats received aprotinin at a daily dose of 10,000 to 300,000 CIU / kg body weight for 13 weeks intraperitoneally. When administered in high doses, a slowdown in the rate of weight gain was observed, not accompanied by a deterioration in renal function. Autopsy revealed an increase in the relative weight of the kidneys, and histological examination revealed hyaline drops and casts in the renal tubules in the renal tubules, especially in the two groups receiving the highest doses of the drug (150,000 and 300,000 KIE per kg of body weight).Changes in the tubules were not permanent and were not accompanied by damage to the glomeruli.

In another study on rats, pathological changes (including abnormalities in biochemical parameters, macro- and microscopic changes) in the kidneys were absent at the end of the 35-day recovery period. The only exception was the relative weight of the kidneys, which was slightly higher in males and females who received the maximum dose of the drug. Subsequently, all morphological and functional changes that occurred in the renal tubules were completely reversible within 35 days after the end of treatment.

Numerous studies have been carried out on dogs; in this case, doses of 5,000 to 500,000 KIU / kg body weight were used, which were administered intravenously or intraperitoneally for a maximum period of 16 weeks. As in rats, the most significant target of toxic effects in dogs was also the epithelium of the renal tubules. In separate studies, which included a period without treatment, it was shown that these morphological and functional abnormalities are reversible.

Reproductive toxicity

In rats, intravenous administration of aprotinin at a daily dose of 80,000 CIU per kg / body weight did not have a toxic effect on the mother and was not accompanied by embryotoxicity or fetotoxicity.Daily administration of the drug at a dose of up to 100,000 KIE / kg body weight was not accompanied by an effect on the growth and development of offspring; IV injection at a dose of 200,000 KIE / kg / day had no teratogenic effect. In rabbits, intravenous administration of aprotinin in a daily dose of up to 100,000 KIE / kg body weight did not have a toxic effect on the mother and was not accompanied by embryotoxicity, fetotoxicity and teratogenic effects.

Mutagenicity

Aprotinin was not mutagenic in Salmonella / microsomal test (Ames) and DNA damage test B.subtilis.

Gigroton

2. Pharmacological action.

(Pharmacological action)

Suppresses the active reabsorption of Na, mainly in the peripheral renal tubules of the cortical segment of Henle’s loop by increasing the excretion of Na, Cl -. and urinary K and Mg 2 through the kidneys increases, while Ca 2 excretion decreases. causes a slight decrease in blood pressure, the severity of the hypotensive effect gradually increases and is fully manifested 2-4 weeks after the start of therapy.At the beginning of therapy, it causes a significant decrease in the volume of extracellular fluid, BCC and MBC, however, after several weeks of use, these indicators return to a level close to the initial one. as a thiazide diuretic, causes a decrease in polyuria in patients with renal diabetes insipidus. the action ended 2-4 hours after ingestion, the maximum effect was 12 hours, the duration was 2-3 days.

Indications: chronic heart failure II article, arterial hypertension, liver cirrhosis with portal hypertension, nephrosis, diabetes mellitus, nephritis, late gestosis, fluid retention on the background of premenstrual syndrome, insipidus, dysproteinemias edema, obesity.long-term use, and with its simultaneous use with cardiac glycosides, corticosteroids, ACTH prevention of hypokalemia, it is recommended to prescribe potassium preparations is contraindicated when taking ACE inhibitors or potassium-sparing diuretics half dose Veroshpiron 12.5 instead of 25 while using ACE inhibitors and chlorthalidone.

Contraindications: Hypersensitivity to including sulfonamide derivatives, which include thiazide diuretics, hypokalemia, acute renal failure, diabetes, anuria, hepatic coma, acute hepatitis, severe sugar, gout, lactation.With caution in renal and / or hepatic failure, allergic reactions, bronchial asthma, systemic lupus erythematosus. side effects: from the digestive system: nausea, vomiting, gastrospasm, constipation or diarrhea, intrahepatic cholestasis, jaundice, pancreatitis. from the nervous system: dizziness, paresthesia, asthenia, excessive fatigue or weakness, disorientation, apathy, from the sense organs: xanthopsia, blurred vision. on the part of the hematopoietic organs: thrombocytopenia, leukopenia, agranulocytosis, eosinophilia, aplastic anemia.on the part of the cardiovascular system: orthostatic hypotension may increase under the influence of ethanol, anesthetics and sedatives, arrhythmia due to hypokalemia conclusions. laboratory: hypokalemia, hyponatremia, including accompanied by neurological symptoms – nausea, hypomagnesemia, hypochloremic alkalosis, hypercalcemia, hyperuricemia, gout, hyperglycemia, glucosuria, hyperlipidemia. allergic reactions: urticaria, photosensitivity. others: muscle spasm, decreased potency.overdose symptoms: dizziness, nausea, drowsiness, hypovolemia, excessive decrease in blood pressure, arrhythmia, seizures. treatment: gastric lavage, the appointment of activated charcoal inside, symptomatic therapy, including intravenous administration of a saline solution to restore the electrolyte balance of the blood.

Method of administration and dosage: Inside. with long-term therapy, it is recommended to prescribe the lowest effective dose sufficient to maintain the optimal effect, especially in elderly patients.mild arterial hypertension – 25 mg once a day or 50 mg 3 times a week, if necessary, it is possible to increase the dose to 50 mg / day. with edematous syndrome, an initial dose of 100-120 mg / day in severe cases, 100-120 mg / day for the first few days, a dose above 120 mg usually does not cause an increase in the diuretic effect, and then proceed to a maintenance dose of 100-50-25 mg / d 3 times a week. renal diabetes insipidus in adults: an initial dose of 100 mg 2 times a day, a maintenance dose of 50 mg a day.the average daily dose for children is 2 mg / kg

Special instructions: during the treatment period, it is necessary to periodically determine blood electrolytes, especially in patients taking digitalis preparations. a very strict salt-free diet is not recommended. if signs of hypokalemia, myasthenia gravis, cardiac arrhythmia or the presence of additional patients appear, replacement therapy with drugs is indicated.while taking thiazide diuretics, an exacerbation of SLE was noted. Although no such events have been reported with chlorthalidone, caution should be exercised in the management of patients with SLE.

Interaction: increases the concentration of Li in the blood and, therefore, increases the risk of drug intoxication. enhances the effect of curariform muscle relaxants and antihypertensive drugs. while taking cardiac glycosides can aggravate heart rhythm disturbances caused by digitalisnaya intoxication. the hypokalemic effect of the drug is enhanced with the simultaneous use of corticosteroids and amphotericin carbenoxolone.non-steroidal anti-inflammatory drugs weaken the diuretic and hypotensive effect of the drug. patients with diabetes mellitus may need correction to increase or decrease the dose of insulin and increase the dose of oral hypoglycemic drugs.

instructions for use, analogs, composition, indications

Safety Profile Summary
The safety of aprotinin has been evaluated in more than forty-five phase II and III studies involving more than 3800 patients treated with aprotinin.In total, adverse reactions developed in 11% of patients treated with aprotinin. The most serious adverse reaction was myocardial infarction. Adverse reactions should be assessed in the context of the surgical situation.
List of adverse reactions
Adverse drug reactions (ADRs) recorded during placebo-controlled clinical trials of aprotinin were grouped by frequency in accordance with the requirements of the Council for International Organizations of Medical Sciences III (CIOMS) (aprotinin n = 3817 and placebo n = 2682; information as of April 2005).NLRs are presented in the table below.
The frequency was determined as follows:
Often: ≥1 / 100 –
Uncommon: ≥ 1/1000 –
Rarely: ≥1 / 10000 –
Very rare:
Frequency unknown: cannot be determined from the available data.

Class of organ systems according to MedDRA	Uncommon	Rarely	Very rare
Immune system disorders		Allergic reactions Anaphylactic / anaphylactoid reactions	Anaphylactic shock (potentially life-threatening)
Disorders of the blood and lymphatic system			Disseminated intravascular coagulation syndrome Coagulopathy
Heart disorders	Myocardial ischemia Coronary artery occlusion / thrombosis Myocardial infarction Exudate in the pericardial cavity
Vascular disorders	Thrombosis	Arterial thrombosis (and its specific manifestations on the part of organs, for example, such vital ones as the kidneys, lungs, or the brain)	Pulmonary embolism
Renal and urinary tract disorders	Oliguria Acute renal failure Tubular necrosis
General disorders and disorders at the injection site			Injection or infusion site reactions (thrombophlebitis)

• NLRs, information about which was obtained from reports of post-marketing applications, are represented by in bold .
Description of selected adverse reactions.
Allergic / anaphylactic reactions rarely develop in patients who have not previously received aprotinin. In the case of repeated use of aprotinin, the incidence of allergic / anaphylactic reactions can reach 5%. In a retrospective analysis of allergic / anaphylactic reactions, it was found that their frequency increases if repeated administration is carried out within 6 months after the first use (frequency is 5% for repeated administration within 6 months and 0.9% for repeated administration after 6 months).In addition, a retrospective analysis revealed that the frequency of severe anaphylactic reactions may still increase in patients who received aprotinin more than twice within 6 months. Even if the patient tolerated the second administration of aprotinin well (without any symptoms), the subsequent administration can cause a severe allergic reaction or anaphylactic shock, in extremely rare cases, death is possible.
Symptoms of allergic / anaphylactic reactions may include the following:
Respiratory system: bronchial asthma (bronchospasm).
From the cardiovascular system: arterial hypotension.
Skin and subcutaneous tissue disorders: itching, rash, urticaria.
From the digestive system: nausea.
If allergic reactions develop during the injection or infusion period, the drug should be discontinued immediately. Standard emergency procedures such as epinephrine / epinephrine, corticosteroids, and fluid replacement therapy may be required.
Cardiovascular system
A pooled analysis of all placebo-controlled clinical trials showed that the incidence of myocardial infarction (MI) in patients treated with aprotinin was 5.8% compared with 4.8% in the placebo group, the difference between the groups was 0.98% (aprotinin n = 3817 and placebo n = 2682; information as of April 2005). In some studies, there was a trend towards an increase in the incidence of MI with the use of aprotinin, while in other studies there was a decrease in the incidence of MI compared with the placebo group.
Lethality
Information on the risk of death when using aprotinin is presented in the section “Precautions”.
Suspected Adverse Reactions Report
Reports of suspected adverse reactions following registration of a medicinal product are important. They allow continuous monitoring of the benefit / risk ratio of the use of a medicinal product.
In the event of any adverse reactions, both specified in the instructions for medical use and not specified, patients should seek the advice of a doctor.
Health care professionals should report any suspected adverse reaction to the Republican Unitary Enterprise “Republican Center for Expertise and Testing in Health Care”, website rceth.by.

instructions for use, analogs, composition, indications

Aprotinin inhibits the action of thrombolytic drugs, including streptokinase, urokinase and alteplase (p-TAP = recombinant tissue plasiminogen activator), and the inhibitory effect is dose-dependent.

special instructions

Recent observational studies confirm that treatment with aprotinin may be associated with impaired renal function, especially in patients who already have renal impairment. When analyzing the results of placebo-controlled studies carried out in patients who underwent coronary artery bypass grafting, it was shown that in the group receiving aprotinin, there was an increase in serum creatinine by 0.5 mg / dL in comparison with the normal value.Accordingly, before prescribing aprotinin to patients with impaired renal function or at risk of kidney damage (for example, with concomitant treatment with aminoglycosides), a careful assessment of the benefit-risk ratio is required.

This medicine contains benzyl alcohol. According to European guidelines, the daily dosage of benzyl alcohol should not exceed 90 mg per kilogram of body weight. Thus, during the treatment cycle, the maximum dosage of aprotinin cannot exceed 6 million CIU.

When using aprotinin, a careful assessment of the balance of benefits and risks is necessary, especially in patients who have previously used aprotinin (including fibrin filling materials containing aprotinin), since they may develop an allergic reaction. Although most cases of anaphylaxis develop after a clearance dose for 12 months, there are isolated reports of cases where an anaphylactic reaction has occurred with repeated exposure after 12 months.When carrying out therapy with aprotinin, it is necessary to have an emergency aid available for the treatment of allergic and anaphylactic reactions.

All patients receiving treatment with aprotinin should first be given a test dose in order to assess whether they are prone to allergic reactions. The test dose must be administered to the patient in the operating room.

The h2 and h3 antagonists can be administered 15 minutes before the aprotinin test.

The test dose of aprotinin in all patients should be one milliliter (10,000 CIE), after which it is necessary to observe the patient for at least 10 minutes before administering the loading dose.However, even despite the absence of complications in the period after the introduction of the initial dose of 1 ml, a therapeutic dose of aprotinin can cause anaphylactic reaction. If an anaphylactic reaction develops, the aprotinin infusion should be discontinued and the necessary emergency measures should be taken.

In connection with the possibility of developing hypersensitivity reactions, before starting the use of Gordox®, it is necessary to carefully assess the ratio of benefits and risks in each patient who has already received treatment with aprotinin.

If it is known that the patient has already received or could receive repeated treatment with aprotinin, it is recommended to observe the following precautions. All patients should receive a test dose of Gordox® in a volume of 1 milliliter (10,000 CIU) at least 10 minutes before the initial dose. In addition, an h2 antagonist (eg clemastine) and an h3 antagonist (eg cimetidine) can be administered 15 minutes before the administration of the test dose of Gordox®. Standard emergency measures should be used to treat an allergic (anaphylactic) reaction if necessary.

It should not be forgotten, however, that the therapeutic dose can cause an allergic reaction even if the patient has tolerated the initial 1 ml test dose well without experiencing any undesirable symptoms. If this happens, the aprotinin infusion should be stopped immediately and the standard emergency measures for the treatment of anaphylactic reactions should be started.

In patients treated with Gordox®, there was an increase in the incidence of renal failure and mortality, compared with an age-matched control group, which had a similar medical history and in which operations on the thoracic aorta were also performed under cardiopulmonary bypass with circulatory arrest against a background of deep hypothermia.In such cases, Gordox® can be prescribed only with extreme caution. Appropriate anticoagulant treatment with heparin is necessary.

Additional notes on the use of the drug in cardiopulmonary bypass

To maintain adequate anticoagulant activity against the background of cardiopulmonary bypass while using Gordox®, it is recommended to use any of the following methods:

one.activated clotting time (ABC): ABC cannot be considered a standard coagulation test; the interpretation of the results of this test depends on the presence of aprotinin. In addition, the test results are influenced by differences in dilution and the temperature used in the cardiopulmonary bypass setting. It was shown that the effect of aprotinin is less pronounced in relation to kaolin ABC, in comparison with ABC using diatomaceous earth (celite). Despite the variety of protocols, a 750-second ABC test using diatomaceous earth or a 480-second ABC test using kaolin in the presence of aprotinin is recommended, regardless of the degree of hemodilution and hypothermia.For advice on the interpretation of test results in the presence of Gordox®, contact the manufacturer of the reagents for the ABC test.

2. administration of constant dosages of heparin: the standard loading dose of heparin, which is administered before cardiac catheterization, as well as the amount of heparin that is added to the primary filling solution of the heart-lung machine, should be at least 350 IU / kg. The additional dose of heparin is determined taking into account the patient’s body weight and the duration of the intervention under cardiopulmonary bypass.

3. titration of heparin / protamine: the results of this method are not influenced by the presence of aprotinin, therefore it is acceptable for measuring heparin levels. The relationship between the dose of heparin and the response to it should be assessed by titration of protamine before administration of aprotinin (to determine the loading dose of heparin).

Additional heparin can be administered based on the heparin concentration as measured by protamine titration.The concentration of heparin under the conditions of cardiopulmonary bypass should not decrease below the level of 2.7 U / ml (2.0 mg / kg) or below the dose, which was determined when testing the dependence of the response on the dose of heparin, carried out before the administration of aprotinin.

After the end of cardiopulmonary bypass, if the patient received Gordox® injections, heparin should be neutralized by the introduction of protamine. The amount of protamine should be calculated on the basis of a fixed ratio, which is determined by the amount of heparin administered or calculated using the protamine titration method.

Important: the use of Gordox® does not mean that the need for heparin decreases.

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women.

Aprotinin should not be used during pregnancy unless the potential benefit outweighs the expected risk. If serious adverse reactions develop (such as anaphylactic reaction, cardiac arrest, etc.)and during their treatment, the potential risk of harm to the fetus should be taken into account when assessing the risk and benefit.

The ability of aprotinin to be excreted in human breast milk has not been studied.

There is no information on the use of Gordox® injections during breastfeeding. Given that aprotinin is not absorbed when taken orally, no amount of it present in breast milk can harm a nursing baby.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Given the scope of the drug, consideration of these effects is irrelevant.

Gordox solution for intravenous administration 10,000 cues / 1 ml 10 ml N1 amp

Composition

Aprotinin.

Form of issue

Solution for intravenous administration 10000 KIE / ML 10 ml No. 1.

Pharmacological action

Antifibrinolytic, antiprotease.

Indication for use

Pancreatitis (acute, chronic exacerbation, prevention of postoperative), pancreatonecrosis, hyperfibrinolytic bleeding – post-traumatic, postoperative (especially during operations on the prostate gland, lungs), before, during and after childbirth, complications of thrombolytic therapy, open heart surgery using devices artificial circulation, etc., treatment and prevention of various forms of shock (endotoxic, traumatic, hemolytic), postoperative parotitis.

Methods of administration and doses

V / V (slow), jet or drip. The dose is selected individually, depending on the patient’s condition.

In pancreatitis: in acute pancreatitis – 300,000-1,000,000 KIE / day for 2-6 days, exacerbation of chronic – 25,000-50,000 KIE / day for 3-6 days, for the prevention of traumatic pancreatitis – 200,000 KIE before surgery and 100,000 KIE each 6 hours after the intervention.