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

See also Warning section.

Dizziness, lightheadedness, tiredness, headache, stomach upset, or diarrhea may occur. If any of these effects last or get worse, 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.

Triamterene can cause dehydration and electrolytes imbalance. Tell your doctor right away if you have any symptoms of dehydration or electrolytes imbalance, such as confusion, unusual dry mouth/thirst, fast/irregular heartbeat, severe dizziness/lightheadedness, or seizures.

Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn’t stop, stomach/abdominal pain, yellowing eyes/skin, dark urine, signs of infection (such as sore throat that doesn’t go away, fever, chills, cough), signs of kidney problems (such as pain in the side/back/abdomen, painful urination, blood in the urine, change in the amount of urine), joint pain (such as big toe pain), easy bruising/bleeding.

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.

List of Common Diuretics + Uses & Side Effects

Diuretics (also called water pills or fluid pills) are medicines that increase the amount of urine you produce. Urination is the body’s way of removing excess salt and water.  Not only does this relieve symptoms such as ankle swelling, it also helps to lower blood pressure.

There are several different classes of diuretics, including carbonic anhydrase inhibitors, loop diuretics, potassium-sparing diuretics, and thiazide diuretics. Each type works in a distinct way and in different parts of the kidney cell (called a nephron).

What are diuretics used for?

Diuretics are used to treat conditions that have fluid retention (also called edema) as a symptom, such as heart failure, kidney failure and cirrhosis of the liver.

They are also effective at reducing blood pressure and some (such as thiazides and loop diuretics) are used in the treatment of high blood pressure (hypertension). Carbonic anhydrase inhibitors are mainly used in the treatment of glaucoma and are sometimes used off-label for altitude sickness.

What are the differences between diuretics?

Each class of diuretic works in a different way to remove salt and water from the kidney, which means they have different potencies and different side effects. Below, we have grouped the most common diuretics into their respective classes.

Thiazide diuretics

Thiazide diuretics inhibit the sodium/chloride cotransporter located in the distal convoluted tubule of a kidney cell. This decreases the amount of sodium reabsorbed back into the body, which results in more fluid being passed as urine. Thiazides are relatively weak diuretics.

Loop diuretics

Loop diuretics work by inhibiting the sodium-potassium-chloride (Na+/K+/2Cl) cotransporter in the thick ascending loop of Henle, a distinct area in the kidney cell. They are potent diuretics.

Potassium-Sparing Diuretics

Potassium-sparing diuretics interfere with the sodium-potassium exchange in the distal convoluted tubule of a kidney cell. Some block the aldosterone receptor. Aldosterone is a hormone that promotes the retention of sodium and water. They are relatively weak diuretics; however, they do not cause hypokalemia (low potassium levels) but may cause hyperkalemia (high potassium levels), especially if they are used with other agents that also retain potassium, such as ACE inhibitors.

Carbonic anhydrase inhibitors

Carbonic anhydrase inhibitors act by increasing the amount of bicarbonate, sodium, potassium, and water excreted from the kidney. They are relatively weak diuretics. They also reduce fluid levels in the eye and may be used to treat glaucoma and are sometimes used off-label to treat altitude sickness.

Are diuretics safe?

When taken at the recommended dosage, diuretics are considered safe. However, they have been associated with several serious adverse effects including:

• Stevens-Johnson syndrome, erythema multiforme and other severe reactions in people with a sulphonamide allergy who have taken a sulphonamide-containing diuretic (includes acetazolamide, thiazides, or loop diuretics)
• Severe neurological changes have occurred in people with liver disease given loop diuretics who are already electrolyte depleted
• Tinnitus or hearing impairment have been reported with loop diuretics, mainly after intravenous administration, or in people with kidney disease, low protein levels, or administered another medicine that may also affect hearing
• Excessive urination can occur which may cause dehydration with the potential for adverse cardiovascular events such as a stroke or blood clots.

What are the side effects of diuretics?

Side effects vary depending on the type of diuretic taken: however, the more common side effects of diuretics include:

• Changes in electrolyte levels (such as potassium, sodium, calcium or magnesium levels), depending on the type of diuretic
• Constipation
• Dizziness
• Dry mouth
• Gout
• A headache
• An increase in blood sugar levels
• Muscle cramps
• Stomach upset
• Tiredness.

For a complete list of side effects, please refer to the individual drug monographs.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Furosemide: medicine to treat high blood pressure (hypertension) and oedema

When will I take it?

It’s usual to take furosemide once a day in the morning.

Sometimes you take it twice a day – once in the morning and again at lunchtime. Occasionally, you take it every other day.

You don’t need to take furosemide at the same time every day. You can occasionally take it at a different time if it’s more convenient for you, for example if you need to go out for a few hours in the morning and you won’t be near a toilet.

But do not take furosemide too late in the day (after 4pm) or at night, otherwise you may have to wake up to go to the toilet. Your doctor or pharmacist will tell you the best times for you to take your medicine.

How much will I take?

Doses are usually lower for people over 65 years as they may be more prone to side effects.

For babies and children, your doctor will use your child’s weight or age to work out the right dose.

How to take it

Furosemide doesn’t usually upset your tummy so you can take it whether or not you’ve eaten recently.

Swallow the tablets whole with a drink of water.

If you’re taking furosemide as a liquid, it will come with a plastic spoon or syringe to help you measure out the correct dose. If you don’t have one, ask your pharmacist for one. Do not measure the liquid with a kitchen teaspoon as it won’t give the right amount.

Some people take furosemide mixed with other diuretics or potassium:

• with amiloride (also called co-amilofruse, Frumil or Frumil LS)
• with spironolactone (also called Lasilactone)
• with triamterene (also called Frusene)
• with potassium (also called Diumide-K Continus)

What if I forget to take it?

Take your forgotten dose as soon as you remember, unless it is after 4pm in the afternoon. In this case, leave out the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicines.

What if I take too much?

Too much furosemide can cause headaches, dizziness, a pounding or irregular heartbeat and fainting. You may also pee more than normal and feel thirsty.

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

Diuretics | Heart and Stroke Foundation

What is this medication?

Diuretics are also called “water pills.” They are usually taken with other medications.

Diuretics include:

• Chlorthalidone
• Ethacrynic acid (Edecrin^®)
• Furosemide (Lasix^®)
• Hydrochlorothiazide
• Indapamide (Lozide^®)
• Metolazone (Zaroxolyn^®)

Be aware:

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

What does it do?

These drugs treat high blood pressure and heart failure. They do it by helping your kidneys produce more urine.

• The more you pee, the more excess salt and water you flush out of your body.
• Without the extra fluid, it’s easier for your heart to pump.

Key facts about diuretics:

• Lower your blood pressure.
• Can relieve shortness of breath.
• Reduce swelling and bloating.
• Make you pee more often.
• Reduce the time you spend in hospital.
• Help you to live longer with heart failure.

How do I take it?

Take your diuretic exactly as prescribed.

• Take it at least six hours before bedtime to help avoid getting up in the night.

Are there any interactions?

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

Water pills can affect your routine. If you take a diuretic:

• Your kidneys will make more urine (pee). You will need to use the bathroom more often.
  • To avoid getting up at night, take your medication at least six hours before bedtime.
• Limit your salt.
• Do not use salt substitutes without first talking to your healthcare provider or pharmacist.
  • Ask if you should restrict your fluids.
• Some diuretics can cause you to lose potassium.
  • Ask your pharmacist if you should eat foods rich in potassium or take a potassium supplement.
  • If you are on other medications that retain potassium, you may not need extra potassium.
• You may be asked to weigh yourself every day or two.
  • Rapid weight gain can be a sign of water retention.

Be aware: Furosemide may cause your skin to be more sensitive to sunlight. Protect yourself from sunburn.

Always tell your healthcare provider or pharmacist about any other medications you are taking. These include:

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

Are there any side effects?

Most people have no problem with diuretics.

Call your healthcare provider or pharmacist if you experience:

• Dehydration
  • Not enough pee
  •  Dry mouth
  • Decreased skin “springiness”
  • Muscle cramps
  • Weakness
  • Fever, sore throat or skin rash
• Dizziness
  • If you feel dizzy or faint, limit how much alcohol you drink.
• Upset stomach

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

Lifestyle changes that can also help

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

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

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

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

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

Related information

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

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

Learn more about:

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

Drug coverage

Tips for taking diuretic medications

Often called water pills, these drugs help lower blood pressure and are a mainstay for treating heart failure.

Diuretics, commonly called “water pills,” are the oldest and some of the least expensive class of drugs used to treat high blood pressure. They help the kidneys eliminate sodium and water from the body. This process decreases blood volume, so the heart has less to pump with each beat, which in turn lowers blood pressure. People with heart failure, who often gain weight because their bodies hold onto excess fluid (a condition called edema), are often prescribed diuretic medications.

Not surprisingly, one of the most common side effects of taking water pills is frequent urination. Other possible side effects include lightheadedness, fatigue, bowel changes, and muscle cramps. Men may occasionally experience erectile dysfunction.

In addition to getting rid of extra salt in your body, diuretic medications also affect levels of potassium. This mineral plays a key role in controlling blood pressure, as well as nerve and muscle function. In general, your kidneys help regulate potassium levels in your blood. But age, diabetes, heart failure, and certain other conditions may impair kidney function. And while some water pills tend to lower potassium levels, others have the opposite effect.

Thiazide diuretics, such as chlorothiazide (Diuril), chlorthalidone (Hygroton), and hydrochlorothiazide (Esidrix, HydroDiuril, Microzide) tend to deplete potassium levels. So do loop diuretics, such as bumetanide (Bumex) and furosemide (Lasix). If you take these medications, your doctor will likely encourage you to eat more potassium rich foods and beverages and limit salt intake.

Potassium-sparing diuretics, which include amiloride (Midamor), spironolactone (Aldactone), and eplerenone (Inspra), avoid the potential problem of potassium loss. But the opposite problem can occur. If potassium levels become too high, it can cause dangerous heart rhythm problems and even cardiac arrest.

People with high blood pressure or heart failure are often advised to limit how much salt or sodium they consume. One way to do that is to use salt substitutes, but these products are high in potassium—a quarter teaspoon of one brand contains about 800 mg of potassium. So, people who take potassium-sparing diuretics should avoid these products.

If you take any diuretic medication, ask your doctor whether you need periodic testing of your potassium and kidney function.

To learn more about managing hypertension, buy “Controlling Your Blood Pressure: What to do when your doctor says you have hypertension.“

– By Julie Corliss
Executive Editor, Harvard Heart Letter

As a service to our readers, Harvard Health Publishing provides access to our library of archived content.
Please note the date of last review or update on all articles. No content on this site, regardless of date,
should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

Heart Disease Drug Therapy | Cedars-Sinai

Anticoagulants do not actually make the blood thinner. These drugs prevent the blood from forming clots, which can block arteries, veins or the valves of the heart. Common anticoagulants are aspirin, warfarin and heparin.

Anticoagulants help reduce the risk for heart attack, stroke and blockages in veins and arteries, such as ones caused by phlebitis. While these types of drugs can prevent a clot from forming, they do not have an impact on a clot that already exists.

Blood-thinning drugs are given to people who have had a heart valve replaced or who have atrial fibrillation or congestive heart failure. These may be given to a person who is at risk of having a heart attack to prevent blood clots in the arteries of the heart or to people who are at risk of a clot forming in the heart’s chambers.

Certain types of drugs (including some over-the-counter pain relievers, such as aspirin) can combine with anticoagulants to cause an even greater anti-clotting effect. If anticoagulants are prescribed, the doctor should be made aware of any other drug, vitamin, mineral or herbal supplement the patient is taking, especially:

• Antacids
• Antiarrhythmics
• Antibiotics
• Anticonvulsive drugs
• Antidepressants
• Antihistamines
• Aspirin, acetaminophen (Tylenol®, Excedrin®), ibuprofen (Motrin®, Advil®) or naproxen (Aleve®)
• Calcium or vitamin K supplements
• Corticosteroids, such as prednisone or cortisone-like medications
• Medicines for treating an overactive thyroid
• Sleeping pills
• Some antifungal medicines

Smoking and drinking alcohol can also make the effect of blood-thinning drugs more powerful. Be aware that vitamin K (which is found in fish, liver, spinach, cabbage, cauliflower and Brussels sprouts) can make blood-thinning drugs less effective. Patients who eat these foods must be careful not to eat too much.

Conditions that put the patient at risk of bleeding or bruising require particular caution and should be discussed with the doctor. These include:

• Aneurysms
• Cancer
• Diabetes
• Heavy menstrual periods
• Hemophilia or other bleeding conditions
• Kidney or liver disease
• Sports
• Stomach ulcers or other problems
• Stroke or transient ischemic attack
• Surgery (including dental surgery)

Diuretics | Texas Heart Institute

Thiazides, potassium-sparing, loop-acting

Why do I need to take a diuretic?

Diuretics are sometimes called “water pills.” They are used to treat congestive heart failure (CHF), high blood pressure (hypertension), or edema (water retention). Diuretics are also prescribed for certain kinds of kidney or liver diseases.

How do diuretics work?

There are 3 types of diuretic medicines. Each type works a little differently, but they all lower the amount of salt and water in your body, which helps to lower your blood pressure.

1. Thiazide diuretics are used to treat high blood pressure by reducing the amount of sodium and water in the body. Thiazides are the only type of diuretic that dilates (widens) the blood vessels, which also helps to lower blood pressure.

2. Potassium-sparing diuretics are used to reduce the amount of water in the body. Unlike the other diuretic medicines, these medicines do not cause your body to lose potassium.

3. Loop-acting diuretics cause the kidneys to increase the flow of urine. This helps reduce the amount of water in your body and lower your blood pressure.

How much do I take?

There are many different kinds of diuretics. The amount of medicine that you need to take may vary. Talk to your doctor or pharmacist for more information about how and when to take this medicine.

What if I am taking other medicines?

Other medicines that you may be taking can increase or decrease the effect of diuretics. These effects are called an interaction. Be sure to tell your doctor about every medicine and vitamin or herbal supplement that you are taking, so he or she can make you aware of any interactions.

The following are some of the medicines that can interact with diuretics. Because there are so many kinds of medicines within each category, not every type of medicine is listed by name. Tell your doctor about every medicine that you are taking, even if it is not listed below.

• Digitalis and digoxin, especially if your potassium level is low
• Certain antidepressants, especially when taking thiazide or loop-acting diuretics
• Other medicines for high blood pressure
• Lithium
• Cyclosporine, especially when taking a potassium-sparing diuretic

What else should I tell my doctor?

Talk to your doctor about your medical history before you start taking a diuretic. The risks of taking the medicine need to be weighed against its benefits. Here are some things to consider if you and your doctor are deciding whether you should take a diuretic.

• You have allergies to other medicines.
• You are thinking of becoming pregnant, you are pregnant, or you are breast feeding your baby.
• You have diabetes. Thiazide and loop-acting diuretics can increase your blood sugar levels.
• You become dehydrated easily.
• You have pancreatitis. Loop-acting diuretics can make this condition worse.
• You have kidney problems.
• You have lupus or a history of lupus. Thiazide diuretics can make this condition worse.
• You have gout or are at high risk for developing gout, especially if your doctor is going to prescribe a thiazide diuretic.
• You have menstrual problems. Potassium-sparing diuretics can make these problems worse.

What are the side effects?

Sometimes a medicine causes unwanted effects. These are called side effects. Not all of the side effects for diuretics are listed here. If you feel these or any other effects, you should check with your doctor.

Common side effects:

• Weakness
• Muscle cramps
• Skin rash
• Increased sensitivity to sunlight (with thiazide diuretics)
• Throwing up
• Diarrhea
• Cramps
• Dizziness or lightheadedness
• Joint pain

Less common side effects:

• Impotence or decreased sexual desire

Rare side effects:

Again, tell your doctor right away if you have any of these side effects. Do not stop taking your medicine unless your doctor tells you to. If you stop taking your medicine without checking with your doctor, it can make your condition worse.

Safemedication.com
A consumer-based site by the American Society of Health-System Pharmacists that provides information about all types of medicines as well as safety tips for their proper use. The site’s search feature lets users search medicines by the brand or generic name.

OFS.1.4.1.0001.15 Dosage forms | Pharmacopeia.rf

Table of Contents

This General Pharmacopoeia Monograph considers a list of dosage forms, provides general requirements for their production, manufacture, indicators and methods for assessing quality.

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

GENERAL PHARMACOPY CLAUSE

Dosage forms of the OFS.1.4.1.0001.15

Introduced for the first time

This General Pharmacopoeia Monograph considers a list of dosage forms, provides general requirements for their production, manufacture, indicators and methods for assessing quality.

BASIC TERMS AND DEFINITIONS

Medicines – substances or their combinations that come into contact with the human or animal body, penetrate the organs, tissues of the human or animal body, used for prophylaxis, diagnostics (except for substances or their combinations that are not in contact with the human or animal body ), treatment of disease, rehabilitation, for the preservation, prevention or termination of pregnancy and obtained from blood, blood plasma, organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies.Medicines include pharmaceutical substances and medicinal products.

Dosage form – the state of a medicinal product corresponding to the methods of its administration and use and ensuring the achievement of the required therapeutic effect.

Medicines – medicines in the form of dosage forms used for the prevention, diagnosis, treatment of diseases, rehabilitation, for the preservation, prevention or termination of pregnancy.

Pharmaceutical substance is a drug in the form of one or more active substances with pharmacological activity, regardless of the nature of the origin, which is intended for the production, manufacture of drugs and determines their effectiveness.

Excipients – substances of inorganic or organic origin used in the production process, manufacture of medicinal products to give them the necessary physical and chemical properties.

Production of medicinal products – activity on the production of medicinal products by organizations-manufacturers of medicinal products at one stage, several or all stages of the technological process, as well as on the storage and sale of manufactured medicinal products.

Manufacturing – activities for the manufacture of medicinal products carried out by pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, according to prescriptions for medicinal products, at the request of medical organizations, veterinary organizations, in accordance with the rules for the manufacture and dispensing of medicinal drugs approved by the authorized federal executive body.

Stability – the ability of a medicinal product to maintain chemical, physical, microbiological, biopharmaceutical and pharmacological properties within certain limits during the shelf life.

Route of administration – a method of drug delivery to a human or animal body.

CLASSIFICATION AND LIST OF DOSAGE FORMS

All dosage forms can be hierarchically classified: by state of aggregation, type of disperse system, route of administration and type of release (table).

Table – Classification of dosage forms

Solid dosage forms include tablets, capsules, powders, granules, dragees, lozenges, lyophilisates, implants, pencils, tampons, collections, films, etc.

Liquid dosage forms – solutions, drops, syrups, suspensions, emulsions, liquid extracts, tinctures, elixirs, concentrates, shampoos, infusions, decoctions, etc.

Soft dosage forms include ointments, creams, gels, liniments, pastes, suppositories, patches, chewing gums, etc.

Gaseous dosage forms – medical gases, aerosols, sprays, inhalation dosage forms, etc.

By the type of dispersed system, dosage forms can be homogeneous, heterogeneous and combined.

By route of administration, there are dosage forms for oral administration, external use, topical use and parenteral dosage forms.

By the type of release, dosage forms can have normal and modified release. Modified (non-standard) release can be delayed, continuous, intermittent (pulsating), delayed and accelerated.

The assignment of a dosage form to a particular classification subgroup determines the approaches to assessing its quality.

Depending on the route of administration and purpose of the dosage form, the list of tests of its quality includes tests that reflect, if necessary, the features of this dosage form.

GENERAL REQUIREMENTS FOR THE MANUFACTURE AND MANUFACTURE OF MEDICINAL FORMS

The production of medicinal products in various dosage forms must be carried out in accordance with the Rules for the organization of production and quality control of medicinal products (GMP). GMP rules apply to all types of medicines and establish general requirements for the organization of their production and quality control, as well as special requirements for the organization of production of certain types of medicines.

The manufacture of medicinal products in various dosage forms should be carried out in accordance with the current requirements for the manufacture of medicinal products in pharmacy organizations.

Non-sterile dosage forms are produced and manufactured using materials and methods that prevent contamination and growth of microorganisms and ensure their compliance with the requirements of the General Pharmacopoeia Monograph “Microbiological Purity”.

Sterile dosage forms (parenteral, ophthalmic dosage forms, as well as dosage forms intended for application to damaged skin and mucous membranes, dosage forms for newborns) are produced and manufactured using materials and methods that prevent contamination and ensure their sterility in accordance with the requirements of the General Pharmacopoeia Monograph “Sterility”.

QUALITY ASSESSMENT OF DOSAGE FORMS

Assessment of the quality of medicinal products in various dosage forms is carried out, as a rule, according to quality indicators characterizing a specific dosage form, as well as quality indicators of the active substance / substances and, if necessary, the excipient / substances of the given medicinal product (“Authenticity”, ” Quantitative determination “, etc.).

The indicators that are mandatory for assessing the quality of a medicinal product regardless of the dosage form include “Description”, “Authenticity”, “Quantification”, “Microbiological purity” (for non-sterile dosage forms) and “Sterility” (for sterile dosage forms ).

Description. Provides information that most fully characterizes the requirements for the appearance and organoleptic characteristics (color, odor) of a medicinal product in a given dosage form.

Authenticity. The tests carried out are determined by the composition of the medicinal product: active, less often auxiliary substances (antimicrobial preservatives, antioxidants, stabilizers, etc.) included in the composition of the medicinal product.To assess the authenticity, a combination of physicochemical (HPLC, GC, TLC, etc.) and chemical methods of analysis is recommended.

Quantification. This test, like the identification of authenticity, depends on the composition of the medicinal product: active and auxiliary substances. For quantitative determination, it is recommended to use physicochemical (HPLC, spectrophotometry) and chemical methods of analysis (titrimetry), it is allowed to use other pharmacopoeial methods of analysis.

Unless otherwise specified in the Pharmacopoeia Monograph or regulatory documents, the content of the determined substances is expressed in mg or ED in one dose for dosage forms or in 1 g (ml) of the drug for non-dosed forms.

When introducing antimicrobial preservatives into medicinal preparations, the method for their determination and criteria for assessing their effectiveness must comply with the requirements of the General Pharmacopoeia Monograph “Determination of the effectiveness of antimicrobial preservatives”.

Microbiological purity. Controlled in all non-sterile dosage forms in accordance with the requirements of the General Pharmacopoeia Monograph “Microbiological purity”.

Sterility. Medicines intended for use on open wounds or damaged skin, dosage forms for newborns, as well as parenteral and ophthalmic dosage forms must be sterile and tested in accordance with the requirements of the General Pharmacopoeia Monograph “Sterility”.

The quality indicators of a medicinal product can be determined by the method of its production (for example, the use of organic solvents) and the properties of the active substance (the ability to form isomers, decomposition products, etc.).

The content of residual organic solvents in the medicinal product is assessed in accordance with the requirements of the General Pharmacopoeia Monograph “Residual organic solvents”.

In case of possible presence of impurities in the composition of the medicinal product (for example, as a result of accumulation of impurities (destruction products) during storage of the medicinal product), it is necessary to control their content according to the indicator “Related impurities”.

For individual dosage forms, characteristic quality indicators can be distinguished.

For solid dosage forms, transdermal patches, suppositories on a lipophilic basis, as a rule, a “dissolution” test is carried out.

For tablets, capsules, suppositories and vaginal tablets, disintegration assessment may be provided.

Powders are evaluated according to the parameters “Particle size”, “Loss in mass on drying”.

Dosage forms for parenteral administration must meet the requirements for the content of bacterial endotoxins and / or pyrogens, visible and invisible mechanical impurities.

Eye drops must meet the requirements for the content of visible mechanical impurities.

For a number of dosage forms, the quality is assessed according to indicators that are controlled in production. For example, for tablets – “Abrasion of tablets” and “Strength of tablets for crushing”, for sterile ointments – “Tightness of packaging”, for powders determine flowability, angle of repose, bulk volume, etc.

For liquid dosage forms represented by solutions, in some cases, assess the transparency, color, pH and osmolality.

Aerosols and sprays are evaluated according to such indicators as “Leak tightness of the package”, “Output of the contents of the package” (for non-metered aerosols and sprays), “Uniformity of the dose mass” (for metered aerosols and sprays), etc. For aerosols for inhalation, the aerodynamic distribution is assessed fine particles, respirable fraction, etc.

Mass uniformity. Dosage forms, including single-dose individual packaging, must withstand the uniformity of mass test for the unit dosage form.The test is carried out in accordance with the General Pharmacopoeia Monograph “Uniformity of the mass of dosage forms”. If the determination of uniformity of dosage is provided, the determination of uniformity of the mass is not required.

Uniformity of dosing. Dosage forms, including those in single-dose individual packaging, must withstand the dosing uniformity test in accordance with the General Pharmacopoeia Monograph “Dosage Uniformity”, unless otherwise indicated in the Pharmacopoeia Monograph or regulatory documentation.

Weight (volume) of the contents of the package. Tests are carried out for non-dosed dosage forms in accordance with the General Pharmacopoeia Monograph “Mass (volume) of package contents”, with the exception of liquid dosage forms for parenteral use and oral administration.

Recoverable volume. The test is carried out for liquid dosage forms for oral administration in accordance with the requirements of the General Pharmacopoeia Monograph “Extractable volume”. Tests are not carried out for dosage forms in single-dose packages if the uniformity of dosage test is included in the pharmacopoeial monograph or regulatory documentation.

Extractable volume of dosage forms for parenteral administration. Dosage forms for parenteral use are tested in accordance with the requirements of the General Pharmacopoeia Monograph “Extractable volume of dosage forms for parenteral use”.

PACKAGING

Packaging must ensure the quality of the medicinal product during the established shelf life under the stated storage conditions. Materials of primary and secondary packaging should be allowed for the production of this type of packaging, taking into account the route of administration of the dosage form.

MARKING

For dosage forms, the names of the active substances and their quantities in one dose of the drug are given, unless there are other indications in the monograph or regulatory documentation. For non-dosed dosage forms, the names of the active substances and their quantities in a certain volume (mass) of the drug are given. For parenteral dosage forms, dosage forms for inhalation, dosage forms for external and (or) local use, ophthalmic dosage forms, indicate the names of active substances, their quantities and a list of names of all excipients.For dosage forms for infusions, the names of active and auxiliary substances and their quantities are given.

STORAGE

In accordance with the requirements of the General Pharmacopoeia Monograph “Storage of Medicines”. Storage conditions should ensure the stability of the medicinal product during the entire established shelf life in the declared form of packaging.

SHELF LIFE

The shelf life of medicines in various dosage forms is set in accordance with the requirements of the General Pharmacopoeia Monograph “Shelf life of medicines”.

Download in PDF OFS.1.4.1.0001.15 Dosage forms

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Oral pain relievers available over the counter for acute pain

Acute pain is often felt after injury and is usually short-lived. Most people experience moderate to severe pain after surgery. Pain relievers (analgesics) are prescribed for people with pain after wisdom teeth extraction. Participants in the study should have pain of at least moderate intensity, and pain for which oral pain relievers are usually prescribed [by mouth].This review is useful mainly for acute pain lasting only a few days or weeks rather than chronic pain lasting for many months. We did not include information from reviews on migraines, tension headaches, or recurrent pain in this review.

In May 2015, we reviewed pharmaceutical websites for a range of oral [oral] pain relievers that are available in the UK without a prescription. We also reviewed websites in Australia, Canada and the United States.We then searched for Cochrane Reviews reporting how well these pain relievers work and any side effects. We used high quality evidence from 10 Cochrane Reviews, supplemented with information from one non-Cochrane analysis.

We considered the outcome of successful treatment to be at least 50% of the maximum pain relief possible, after about 6 hours, in people with moderate to severe pain. This is the outcome that people with acute and chronic pain and headache find beneficial.

Combinations of ibuprofen with paracetamol were effective in 7 out of 10 (70%) people, and fast-acting ibuprofen 200 mg and 400 mg, ibuprofen 200 mg with caffeine 100 mg, and diclofenac potassium 50 mg were effective in more than 5 out of 10 (50%) people. Dipyrone 500 mg, which is available over the counter in many parts of the world, has also been effective in about 5 in 10 people. Paracetamol with aspirin in different doses was effective [“worked”] in 1 in 10 (11%) to 4 in 10 (43%) people.An important result was that low doses of certain drugs in fast acting dosage forms were among the best. We could not find information on many of the widely available combinations containing low doses of codeine. Taking pain relievers with food can reduce their effectiveness.

There were fewer side effects in people taking ibuprofen with paracetamol than those taking placebo (sham treatment). Side effect results may vary if pain relievers are taken for more than a few days.

Codelac Neo – designed to eliminate dry cough in children from 2 months

KODELAK® NEO – powerful remedy for dry cough in adults and children antitussive agent of central action .

Benefits of the drug / molecule

• helps to suppress dry cough, selectively affecting the cough center;
• helps to reduce the frequency, strength and intensity of cough shocks with dry cough;
• has an antitussive, moderate bronchodilating and anti-inflammatory effect, improves the respiratory function of the lungs;
• begins to act within 30 minutes after the first dose ^{* 1.2} ;
• has a long-term antitussive effect after a single dose:
  • up to 6 hours – for liquid forms ³
  • up to 12 hours – for tablet forms ⁴

• retains an antitussive effect with prolonged use ⁵ ;
• has a favorable safety profile:
  • does not depress breathing;
  • contains no addictive ingredients;
  • approved for admission to children from 2 months of age ^** ;
  • the possibility of using in pregnant women from the 2nd trimester ^*** ;
  • Possibility of use in persons with diabetes mellitus – does not contain sucrose or glucose as a sweetener

Advantages of the release forms

• 3 release forms provide the possibility of using the drug in persons of different age groups:
  • drops – for babies from 2 months of age;
  • syrup – for children from 3 years old and adults;
  • tablets – for persons over 18 years old.
• each of the dosage forms provides the maximum convenience of using the drug:
• drops:
  • the bottle is equipped with a cap with first opening control
  • dosing accuracy in babies thanks to a convenient dropper bottle
  • doses the bottle is designed for 440 drops (1 ml = 22 drops)
• syrup:
  • each bottle is equipped with a polyethylene two-component cap with first opening control, which provides protection against independent use of the drug by children;
  • Convenience of a liquid dosage form that provides parents with a comfortable use of the drug, and ease of swallowing for babies;
  • Convenience and ease of intake – sweetish taste and pleasant vanilla aroma greatly facilitate the process of taking the drug by children;
  • Convenience and accuracy of dosing – the packaging of the drug is completed with a convenient two-sided measuring spoon, for 2.5 and 5 ml, respectively;
  • two packaging options – 100 and 200 ml in a bottle:
    • 100 ml – the optimal volume for the treatment of dry cough in a child 3-6 years old;
    • 200 ml – a rational volume for the treatment of dry cough in an older child (6-12 or 12-18 years old), as well as in adults who prefer liquid dosage forms of drugs for the treatment of cough; ideal for families with a frequently ill child or several children.
• tablets :
  • small tablet size, facilitating the process of swallowing the drug;
  • tablets, film-coated, preventing the appearance of unpleasant taste sensations in the process of taking the drug;
  • modified release tablets provide stable, even maintenance of the active substance concentrations and the possibility of reducing the frequency of drug intake up to 2 times a day.

Indications for use

• dry cough of any origin, with:
  • “colds” diseases;
  • influenza;
  • whooping cough;
  • other states.