Klarmyn tablets

Klarmyn

  • Active Ingredient: Clarithromycin
  • 500 mg, 250 mg
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What is Klarmyn?

The active ingredient of Klarmyn brand is clarithromycin. Clarithromycin is a macrolide antibiotic. Clarithromycin fights bacteria in your body. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are intended for oral administration and contain 250 mg or 500 mg of Clarithromycin, USP. In addition, each Clarithromycin tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, and titanium dioxide.

Used for

Klarmyn is used to treat diseases such as: Bacterial Endocarditis Prevention, Bronchitis, Dental Abscess, Follicular Lymphoma, Helicobacter Pylori Infection, Legionella Pneumonia, Mycobacterium avium-intracellulare, Prophylaxis, Mycobacterium avium-intracellulare, Treatment, Mycoplasma Pneumonia, Nongonococcal Urethritis, Otitis Media, Pertussis, Pertussis Prophylaxis, Pharyngitis, Pneumonia, Sinusitis, Skin and Structure Infection, Skin or Soft Tissue Infection, Strep Throat, Tonsillitis/Pharyngitis, Toxoplasmosis, Upper Respiratory Tract Infection.

Side Effect

Possible side effects of Klarmyn include: severe stomach cramps and pain; slurred speech; unusual bleeding or bruising; depression; sudden death.

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Introduction

Klarmyn is a semisynthetic macrolide antibiotic used for a wide variety of mild-to-moderate bacterial infections. Klarmyn has been linked to rare instances of acute liver injury that can be severe and even fatal.

How to use Klarmyn

Take this medication by mouth with or without food as directed by your doctor, usually every 12 hours. If stomach upset occurs, you may take it with food or milk.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage may also be based on weight.

If you are using this medication to treat an infection, continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition persists or worsens.

If you are taking this medication to prevent certain bacterial infections, take it exactly as directed by your doctor. Do not stop taking the medication without your doctor's approval. Tell your doctor if you develop signs of infection such as fever or night sweats.

What Is Klarmyn (Biaxin)?

Klarmyn is the generic form of the brand-name prescription drug Biaxin, an antibiotic used to treat bacterial infections.

Klarmyn is often used for pneumonia, bronchitis, and infections of the ears, sinuses, skin and throat. It is also used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection, which is a type of lung infection that often occurs in patients with HIV.

The drug may also be used in combination with other medicines to eliminate H. pylori - a bacterium that causes ulcers. It is sometimes used to treat other types of infections including Lyme disease, cryptosporidiosis, cat scratch disease, Legionnaires' disease, and pertussis (whooping cough). It is occasionally used to prevent heart infections in people having dental or other procedures.

Klarmyn is in a class of medications known as macrolide antibiotics. It works by stopping the growth of bacteria. Like all antibiotics, it cannot kill viruses that cause colds, flu or other viral infections.

Researchers from the Japanese drug company Taisho Pharmaceutical developed Klarmyn in the 1970s. In 1985, Taisho partnered with the American company Abbott Laboratories for the international rights, and Abbott gained FDA approval for Biaxin in October, 1991. The drug went generic in the United States in 2005.

You should continue to take Klarmyn until your prescription is finished, even if you feel better. Stopping this medication too soon or skipping doses can prevent your infection from being treated completely, and the bacteria may become resistant to antibiotics.

What Happens if I Miss a Dose of Klarmyn or Don't Take It as Prescribed?

If you miss a dose of Klarmyn, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue on your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Klarmyn and the 14-OH Klarmyn metabolite distribute readily into body tissues and fluids. There are no data available on cerebrospinal fluid penetration. Because of high intracellular concentrations, tissue concentrations are higher than serum concentrations. Examples of tissue and serum concentrations are presented below.

Table 9: Tissue and Serum Concentrations of Klarmyn

Prevent:
  • Disseminated MAC infection

The recommended uses may not always be consistent with FDA-approved uses of Klarmyn. See the guidelines for complete information on recommended uses of Klarmyn in adults and adolescents with HIV. Some recommended uses, such as uses in certain rare circumstances, may have been omitted above.

How does Klarmyn work?

It works by preventing bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers. The bacteria eventually die or are destroyed by the immune system. This clears up the infection.

Other uses for this medicine

Klarmyn also is used sometimes to treat other types of infections including Lyme disease (an infection that may develop after a person is bitten by a tick), cryptosporidiosis (an infection that causes diarrhea), cat scratch disease (an infection that may develop after a person is bitten or scratched by a cat), Legionnaires' disease, (type of lung infection), and pertussis (whooping cough; a serious infection that can cause severe coughing). It is also sometimes used to prevent heart infection in patients having dental or other procedures. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking this medicine

You should not use this medicine if you are allergic to Klarmyn or similar medicines such as azithromycin (Zithromax, Z-Pak, Zmax), erythromycin, or telithromycin, or if:

you have had jaundice or liver problems caused by taking Klarmyn; or

you have liver or kidney disease and you also take a medicine called colchicine.

Some medicines can cause unwanted or dangerous effects when used with Klarmyn. Your doctor may need to change your treatment plan if you use any of the following drugs:

To make sure this medicine is safe for you, tell your doctor if you have ever had:

long QT syndrome (in you or a family member);

an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Klarmyn may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant.

In animal studies, Klarmyn caused birth defects. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

Klarmyn can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

This medicine is not approved for use by anyone younger than 6 months old.

How should I take Klarmyn?

Take Klarmyn exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medicine to treat any condition that has not been checked by your doctor. Do not share this medicine with another person, even if they have the same symptoms you have.

You may take the regular tablets and oral suspension (liquid) with or without food.

Klarmyn extended-release tablets (Biaxin XL) should be taken with food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Shake the oral liquid well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Klarmyn is usually given for 7 to 14 days. Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Klarmyn will not treat a viral infection such as the flu or a common cold.

Store this medicine in the original container at room temperature, away from moisture, heat, and light.

Do not keep the oral liquid in a refrigerator. Throw away any liquid that has not been used within 14 days.

If your infection is treated with a combination of drugs, use all medications as directed by your doctor. Read the instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Dosage Modifications

Coadministration with atazanavir: Decrease Klarmyn dose by 50%

Klarmyn 500 mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult subjects. The steady-state plasma concentrations of omeprazole were increased (Cmax, AUC0-24, and t½ increases of 30%, 89%, and 34%, respectively), by the concomitant administration of Klarmyn.

The plasma levels of Klarmyn and 14–OH Klarmyn were increased by the concomitant administration of omeprazole. For Klarmyn, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when Klarmyn was administered with omeprazole than when Klarmyn was administered alone. Similar results were seen for 14–OH Klarmyn, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. Klarmyn concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.

Klarmyn Tissue Concentrations 2 hours after Dose (mcg/mL)/(mcg/g)

In two studies in which theophylline was administered with Klarmyn (a theophylline sustained-release formulation was dosed at either 6.5 mg/kg or 12 mg/kg together with 250 or 500 mg q12h Klarmyn), the steady-state levels of Cmax, Cmin, and the area under the serum concentration time curve (AUC) of theophylline increased about 20%.

When a single dose of midazolam was co-administered with Klarmyn tablets (500 mg twice daily for 7 days), midazolam AUC increased 174% after intravenous administration of midazolam and 600% after oral administration.

For information about other drugs indicated in combination with BIAXIN, refer to their full prescribing information, CLINICAL PHARMACOLOGY section.


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