Klaribact tablets

Klaribact

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

The active ingredient of Klaribact 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

Klaribact 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 Klaribact include: loss of appetite; lower back or side pain; fast, slow, pounding, or irregular heartbeat or pulse; unusual bleeding or bruising; unpleasant breath odor.

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3. Who can and can't take Klaribact

Klaribact can be taken by adults and children.

Klaribact isn't suitable for some people.

To make sure Klaribact is safe for you, tell your doctor if you have:

  • had an allergic reaction to Klaribact or any other medicines in the past
  • had diarrhoea when you have taken antibiotics before
  • fast, pounding or irregular heartbeats
  • abnormally low levels of potassium in your blood
  • liver or kidney problems
  • porphyria (a rare, inherited blood disorder)
  • myasthenia gravis - Klaribact can make the symptoms of this muscle-weakening illness worse
  • an illness called phenylketonuria - people with phenylketonuria have to avoid the sweetener aspartame and some brands of liquid Klaribact contain aspartame

Also tell your doctor if you're pregnant, trying to get pregnant, or breastfeeding.

Klaribact isn't generally recommended during pregnancy and while breastfeeding.

What should I tell my health care provider before taking Klaribact?

Before taking Klaribact, tell your health care provider:

  • If you are allergic to Klaribact or any other medicines.
  • About any medical conditions you have or have had.
  • About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills. A liquid form of Klaribact is available for people who have difficulty swallowing pills.
  • If you are pregnant or plan to become pregnant. Klaribact should not be used during pregnancy except when there are no other treatment options. Talk to your health care provider about the risks of taking Klaribact during pregnancy.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Klaribact may affect the way other medicines or products work, and other medicines or products may affect how Klaribact works. Ask your health care provider if there are interactions between Klaribact and the other medicines you take.

Ask your health care provider about possible side effects from Klaribact. Your health care provider will tell you what to do if you have side effects.

How does Klaribact 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.

  • Chlamydophila pneumoniae
  • Helicobacter pylori
  • Mycobacterium avium complex (MAC) consisting of M. avium and M. intracellulare
  • Mycoplasma pneumoniae

At least 90 percent of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the Klaribact susceptible MIC breakpoint for organisms of similar type to those shown in Table 11. However, the efficacy of Klaribact in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.

Dosage Modifications

Coadministration with atazanavir: Decrease Klaribact dose by 50%

How should Klaribact be stored?

  • Store Klaribact tablets at room temperature, 68°F to 77°F (20°C to 25°C). Protect the tablets from light.
  • Store Klaribact granules for oral suspension below 77ºF ( 25ºC). After mixing Klaribact granules with water as instructed by your health care provider or pharmacist, do not refrigerate the mixture (also called an oral suspension). Store the oral suspension between 59ºF and 86ºF (15ºC to 30ºC) and use within 14 days.
  • Keep Klaribact in the container that it came in and keep the container tightly closed.
  • Do not use Klaribact if the original seal over the container opening is broken or missing.
  • Throw away Klaribact that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Klaribact and all medicines out of reach of children.

What is Klaribact, and how does it work (mechanism of action)?

Klaribact is a semi-synthetic macrolide antibiotic chemically related to erythromycin and azithromycin (Zithromax). It is effective against a wide variety of bacteria, such as Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Staphylococcus aureus, and mycobacterium avium, and many others. Like all macrolide antibiotics, Klaribact prevents bacteria from growing by interfering with their ability to make proteins. Due to the differences in the way proteins are made in bacteria and humans, the macrolide antibiotics do not interfere with production of proteins in humans. The FDA approved Klaribact in October 1991.

Klaribact has been shown to be active against most of the isolates of the following microorganisms both in vitro and in clinical infections .

Precautions

Before taking Klaribact, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (such as erythromycin, azithromycin); 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: liver disease (including liver problems with past Klaribact use), kidney disease, heart disease (coronary artery disease, heart attack), a certain type of muscle disease (myasthenia gravis).

Klaribact may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Klaribact, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Klaribact safely.

Klaribact may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

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

Older adults may be more sensitive to the side effects of this drug, especially hearing loss and QT prolongation (see above).

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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

The following in vitro mutagenicity tests have been conducted with Klaribact:

  • Salmonella/Mammalian Microsomes Test
  • Bacterial Induced Mutation Frequency Test
  • In Vitro Chromosome Aberration Test
  • Rat Hepatocyte DNA Synthesis Assay
  • Mouse Lymphoma Assay
  • Mouse Dominant Lethal Study
  • Mouse Micronucleus Test

All tests had negative results except the in vitro chromosome aberration test which was positive in one test and negative in another. In addition, a bacterial reverse-mutation test (Ames test) has been performed on Klaribact metabolites with negative results.

Dictionary Entries near Klaribact

Cite this Entry

“Klaribact.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Klaribact. Accessed 27 December 2019.

Comments on Klaribact

What made you want to look up Klaribact? Please tell us where you read or heard it (including the quote, if possible).

Generic Name: Klaribact (kla RITH roe MYE sin)Brand Names: Biaxin, Biaxin XL

Medically reviewed by Sanjai Sinha, MD Last updated on Nov 4, 2019.

Michael Stewart, Reviewed by Sid Dajani | Last edited 31 May 2017 | Certified by The Information Standard

Klaribact is a macrolide antibiotic. It can be taken by people who are allergic to penicillin.

It is important to complete the prescribed course (unless you are told to stop). Otherwise your infection could come back.

Any side-effects are usually mild. The most common are diarrhoea, feeling sick (nausea), tummy (abdominal) discomfort, and unusual tastes.

Life-threatening and fatal drug interactions have been reported in patients treated with BIAXIN and colchicine. Klaribact is a strong CYP3A4 inhibitor and this interaction may occur while using both drugs at their recommended doses. If co-administration of BIAXIN and colchicine is necessary in patients with normal renal and hepatic function, reduce the dose of colchicine. Monitor patients for clinical symptoms of colchicine toxicity. Concomitant administration of BIAXIN and colchicine is contraindicated in patients with renal or hepatic impairment .


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