Klarmin tablets

Klarmin

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

The active ingredient of Klarmin 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

Klarmin 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 Klarmin include: unusual tiredness or weakness; light-colored stools; passing gas; watery and severe diarrhea, which may also be bloody; feeling of constant movement of self or surroundings; hives; nightmares.

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

Life-threatening and fatal drug interactions have been reported in patients treated with BIAXIN and colchicine. Klarmin 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 .

Mechanism Of Action

Klarmin is a macrolide antimicrobial drug .

How is Klarmin used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV include recommendations on the uses of Klarmin in people with HIV to:

  • Disseminated MAC infection and certain bacterial respiratory diseases (such as community-acquired pneumonia)
  • Infections of the bloodstream and bone caused by Bartonella bacteria (also called bartonellosis )

Klarmin and the 14-OH Klarmin 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 Klarmin

What is Klarmin used for?

Klarmin is used to treat infections caused bacteria, including the following:

▪️ Chest infections such as bronchitis, pneumonia.

▪️ Infections of the nasal passages, sinuses or throat such as sinusitis, pharyngitis

▪️ Skin or soft tissue infections, such as cellulitis, folliculitis or erysipelas.

▪️ Eradicating Helicobacter pylori bacteria from the gut.

▪️ to prevent whooping cough in people who haven't been vaccinated against whooping cough and who are in close contact with someone who has it.

How to take Klarmin

  • Before you start taking the antibiotic, read the manufacturer's printed information leaflet from ins >

1. About Klarmin

Klarmin is an antibiotic.

It's used to treat chest infections, such as pneumonia, skin problems such as cellulitis, and ear infections.

It's also used to get rid of Helicobacter pylori, a bacteria that can cause stomach ulcers.

Klarmin is sometimes used by people who have an allergy to penicillin and antibiotics similar to penicillin, like amoxicillin.

Klarmin is only available on prescription.

It comes as tablets, granules, or a liquid that you drink.

It can also be given by injection, but this is usually only done in hospital.

Geriatric Use

In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of BIAXIN every 12 hours, the maximum serum concentrations and area under the curves of Klarmin and 14-OH Klarmin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. Consider dosage adjustment in elderly patients with severe renal impairment. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients .

Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older .

Especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of Klarmin and colchicine, some of which occurred in patients with renal insufficiency. Deaths have been reported in some patients .

Introduction

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

Contraindications

  • Documented hypersensitivity
  • Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine
  • History of cholestatic jaundice or hepatic dysfunction associated with previous use of Klarmin
  • Coadministration with colchicine in patients with kidney (renal) or liver (hepatic) impairment
  • Coadministration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin, simvastatin), due to the increased risk of muscle disease (myopathy), including destruction of muscle tissue (rhabdomyolysis)

Effects of Drug Abuse

  • No information available

  • See "What Are Side Effects Associated with Using Klarmin?"

  • See "What Are Side Effects Associated with Using Klarmin?"

  • Severe kidney (renal) impairment
  • Oral solution must not be refrigerated
  • Not for use in pregnancy, except when there is no alternative therapy; apprise patient about potential hazard to fetus if pregnancy occurs while in therapy
  • Use for endocarditis prophylaxis is appropriate only for high-risk patients, per American Heart Association (AHA) guidelines
  • Associated with heart rhythm disorder (QT interval prolongation) and infrequent cases of arrhythmias, including torsade de pointes; avoid using with ongoing proarrhythmic conditions (uncorrected low blood levels of potassium or low blood levels of magnesium), clinically significant slow heart rate; do not coadminister with class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmics
  • Elderly patients may be more susceptible to drug-associated hear rate disorder (QT prolongation)
  • Use caution in patients with coronary artery disease; postmarketing trials suggest increased risk of cardiovascularmortality
  • Discontinue immediately if severe hypersensitivity reactions occur (severe allergic reaction (anaphylaxis), Stevens-Johnson syndrome, TEN, drug reaction with eosinophilia and systemic symptoms syndrome, Henoch-Schonlein purpura)
  • Clostridium difficile associated diarrhea reported with use of nearly all antibacterial agents, including Klarmin
  • May cause kidney injury when administered concomitantly with calcium channel blockers metabolized by CYP3A4
  • Do not coadminister with ranitidine/bismuth citrate with history of acute porphyria or if Creatinine Clearance under 25 mL/min
  • Coadministration with quetiapine may result in quetiapine related toxicities including neurolepticmalignant syndrome, heart rhythm disorder (QT prolongation), sleepiness, dizziness upon standing, altered state of consciousness
  • Exacerbation of myasthenia gravis or new onset of symptoms reported
  • Hepatic dysfunction
  • Increased liver enzyme activity and hepatocellular or cholestatic hepatitis, with or without jaundice, have been reported; this may be severe and is usually reversible
  • In some instances, hepatic failure with fatal outcome has been reported, generally in association with serious underlying diseases or concomitant medications
  • Discontinue Klarmin immediately if signs and symptoms of hepatitis occur (anorexia, jaundice, dark urine, pruritus, or tender abdomen)

  • Use Klarmin during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
  • Klarmin is excreted in breast milk; use with caution if breastfeeding. Consult your doctor

Rated Klarmin for Streptococcus Pneumoniae Report

I wish I had read other reviews before having taken Klarmin. I took it 8 1/2 years ago and stuck it out for about half of my 14 day prescription. I had severe anxiety, hallucinations, severe claustrophobia, noise intolerance, raw skin under my eyes, racing heartbeat, peripheral bounding pulse, and severe insomnia. 8 1/2 years later, I still have anxiety, peripheral bounding pulse, and insomnia. Do not take this drug. I do not usually write reviews like this, but this drug has changed my life. I wish I could go back and take something different. I am finally finding treatment that looks hopeful in helping combat these side effects.

BIAXIN Filmtab Immediate-Release Tablets

The absolute bioavailability of 250 mg Klarmin tablets was approximately 50%. For a single 500 mg dose of Klarmin, food slightly delays the onset of Klarmin absorption, increasing the peak time from approximately 2 to 2.5 hours. Food also increases the Klarmin peak plasma concentration by about 24%, but does not affect the extent of Klarmin bioavailability. Food does not affect the onset of formation of the active metabolite, 14-OH Klarmin or its peak plasma concentration but does slightly decrease the extent of metabolite formation, indicated by an 11% decrease in area under the plasma concentration-time curve (AUC). Therefore, BIAXIN Filmtab may be given without regard to food. In non-fasting healthy human subjects (males and females), peak plasma concentrations were attained within 2 to 3 hours after oral dosing.

BIAXIN XL Filmtab Extended-Release Tablets

Klarmin extended-release tablets provide extended absorption of Klarmin from the gastrointestinal tract after oral administration. Relative to an equal total daily dose of immediate-release Klarmin tablets, Klarmin extended-release tablets provide lower and later steady-state peak plasma concentrations but equivalent 24-hour AUCs for both Klarmin and its microbiologically-active metabolite, 14-OH Klarmin. While the extent of formation of 14-OH Klarmin following administration of BIAXIN XL Filmtab (2 x 500 mg tablets once daily) is not affected by food, administration under fasting conditions is associated with approximately 30% lower Klarmin AUC relative to administration with food. Therefore, BIAXIN XL Filmtab should be taken with food.

Figure 2: Steady-State Klarmin Plasma Concentration-Time Profiles

BIAXIN Granules For Oral Suspension

When 250 mg doses of Klarmin as BIAXIN as an oral suspension were administered to fasting healthy adult subjects, peak plasma concentrations were attained around 3 hours after dosing.

For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively.

In adults given 250 mg Klarmin as suspension (n = 22), food appeared to decrease mean peak plasma Klarmin concentrations from 1.2 (± 0.4) mcg/mL to 1.0 (± 0.4) mcg/mL and the extent of absorption from 7.2 (± 2.5) hr•mcg/mL to 6.5 (± 3.7) hr•mcg/mL.

Cholestatic Jaundice/Hepatic Dysfunction

BIAXIN is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of Klarmin.


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