Klaram tablets

Klaram

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

The active ingredient of Klaram 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

Klaram 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 Klaram include: black, tarry stools; confusion about identity, place, and time; sore mouth or tongue; hives; feeling, seeing, or hearing things that are not there; continuing ringing or buzzing or other unexplained noise in the ears; stomach pain; clay-colored stools.

How to Buy Klaram tablets online?

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What if I take too much?

Taking an extra dose of Klaram by accident is unlikely to harm you or your child.

It may give you temporary side effects, like stomach pain, feeling and being sick, and diarrhoea.

Talk to your pharmacist or doctor if you're worried or get severe side effects, or if you or your child accidentally take more than 1 extra dose.

Like all medicines, Klaram can cause side effects, although not everyone gets them.

What are the side effects of Klaram?

Klaram generally is well tolerated, and side effects usually are mild and transient. Common side effects of Klaram are:

Other important side effects which are rare, but serious include:

Klaram should be avoided by patients known to be allergic to Klaram or other chemically-related macrolide antibiotics, such as erythromycin. Treatment with Klaram and other antibiotics can alter the normal bacteria flora of the colon and permit overgrowth of C. difficile, a bacterium responsible for pseudomembranous colitis. Patients who develop pseudomembranous colitis as a result of antibiotics treatment may experience diarrhea, abdominal pain, fever, and sometimes even shock.

More common side effects

The more common side effects of Klaram oral tablet can include:

  • stomach pain
  • diarrhea
  • nausea
  • vomiting
  • abnormal taste in your mouth

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist

Hypersensitivity

BIAXIN is contraindicated in patients with a known hypersensitivity to Klaram, erythromycin, or any of the macrolide antibacterial drugs .

Hepatotoxicity

Klaram, like other macrolide antibiotics, has been linked to a low rate of acute, transient and usually asymptomatic elevations in serum aminotransferase levels which occur in 1% to 2% of patients treated for short periods and a somewhat higher proportion of patients given Klaram long term. Asymptomatic elevations in serum enzymes are particularly common among elderly patients given higher doses of Klaram.

Klaram can also cause acute, clinically apparent liver injury with jaundice, which is estimated to occur in 3.8 per 100,000 prescriptions. The liver injury usually appears within the first 1 to 3 weeks after initiation of treatment and can arise after Klaram is stopped. The pattern of liver enzyme elevations varies, but the resulting hepatitis is often cholestatic and can be prolonged (Case 1). Allergic signs and symptoms have not been consistently reported. While cholestatic hepatitis is most typical of Klaram induced liver injury, rare cases with hepatocellular injury and abrupt onset have been described. These hepatocellular cases are more likely to be severe and can result in acute liver failure. However, in most instances, recovery occurs within 4 to 8 weeks of withdrawal of the medication. The typical latency, clinical pattern and course of the cholestatic hepatitis due to Klaram resembles that of the other macrolide antibiotics.

Likelihood score: B (highly likely cause of clinically apparent liver injury).

Contraindications

  • Documented hypersensitivity
  • Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine
  • History of cholestatic jaundice or hepatic dysfunction associated with previous use of Klaram
  • 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 Klaram?"

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

  • 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 Klaram
  • 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 Klaram immediately if signs and symptoms of hepatitis occur (anorexia, jaundice, dark urine, pruritus, or tender abdomen)

  • Use Klaram 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
  • Klaram is excreted in breast milk; use with caution if breastfeeding. Consult your doctor

Changes in laboratory values with possible clinical significance in patients taking BIAXIN and omeprazole in four randomized double-blind trials in 945 patients are as follows:

Hepatic: elevated direct bilirubin 1 A numerically higher number of primary outcome events in patients randomized to receive Klaram was observed with a hazard ratio of 1.06 (95% confidence interval 0.98 to 1.14). However, at follow-up 10 years post-treatment, there were 866 (40%) deaths in the Klaram group and 815 (37%) deaths in the placebo group that represented a hazard ratio for all-cause mortality of 1.10 (95% confidence interval 1.00 to 1.21). The difference in the number of deaths emerged after one year or more after the end of treatment.

The cause of the difference in all-cause mortality has not been established. Other epidemiologic studies evaluating this risk have shown variable results .

Median survival time from trial entry (trial 1) was 249 days at the 500 mg twice daily dose compared to 215 days with the 1000 mg twice daily dose. However, during the first 12 weeks of therapy, there were 2 deaths in 53 patients in the 500 mg twice daily group versus 13 deaths in 51 patients in the 1000 mg twice daily group. The reason for this apparent mortality difference is not known. Survival in the two groups was similar beyond 12 weeks. The median survival times for these dosages were similar to recent historical controls with MAC when treated with combination therapies. 2

Median survival time from entry in trial 2 was 199 days for the 500 mg twice a day dose and 179 days for the 1000 mg twice a day dose. During the first four weeks of therapy, while patients were maintained on their originally assigned dose, there were 11 deaths in 255 patients taking 500 mg twice daily and 18 deaths in 214 patients taking 1000 mg twice daily.

Dosage-Ranging Monotherapy Trials In Pediatric AIDS Patients With MAC

Trial 4 was a pediatric trial of 3.75 mg/kg, 7.5 mg/kg, and 15 mg/kg of BIAXIN twice daily in patients with CDC-defined AIDS and CD4 counts less than 100 cells/mcL. The trial enrolled 25 patients between the ages of 1 to 20. The trial evaluated the same endpoints as in the adult trials 1 and 2. Results with the 7.5 mg/kg twice daily dose in the pediatric trial were comparable to those for the 500 mg twice daily regimen in the adult trials.

Combination Therapy In AIDS Patients With Disseminated MAC

Trial 5 compared the safety and efficacy of BIAXIN in combination with ethambutol versus BIAXIN in combination with ethambutol and clofazimine for the treatment of disseminated MAC (dMAC) infection. This 24-week trial enrolled 106 patients with AIDS and dMAC, with 55 patients randomized to receive BIAXIN and ethambutol, and 51 patients randomized to receive Klaram, ethambutol, and clofazime. Baseline characteristics between treatment arms were similar with the exception of median CFU counts being at least 1 log higher in the BIAXIN, ethambutol, and clofazime arm.

Compared to prior experience with Klaram monotherapy, the two-drug regimen of Klaram and ethambutol extended the time to microbiologic relapse, largely through suppressing the emergence of Klaram resistant strains. However, the addition of clofazimine to the regimen added no additional microbiologic or clinical benefit. Tolerability of both multidrug regimens was comparable with the most common adverse events being gastrointestinal in nature. Patients receiving the clofazimine-containing regimen had reduced survival rates; however, their baseline mycobacterial colony counts were higher. The results of this trial support the addition of ethambutol to Klaram for the treatment of initial dMAC infections but do not support adding clofazimine as a third agent.

Other uses for this medicine

Klaram 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.

Rated Klaram for Upper Respiratory Tract Infection Report

The first two nights I took this drug, I had insomnia. not usually a condition I suffer from. Horrible taste in my mouth from the first dose. Then four days in, I suddenly developed tremors and shaking in one of my hands. I stopped taking the drug immediately. Four days post-drug, and the shaking and jerky movements went into my arms and hands along with experiencing the odd bout of anxiety. Six days post-drug, and I am still mildly shaking with occasional anxiety. I will not take this drug again.

COMMON BRAND(S): Biaxin

GENERIC NAME(S): Klaram

Klaram is used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. It may also be used to prevent certain bacterial infections. Klaram is known as a macrolide antibiotic. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Interactions

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.

Many drugs besides Klaram may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, pimozide, procainamide, quinidine, sotalol, among others.

Other medications can affect the removal of Klaram from your body, which may affect how Klaram works. Examples include rifamycins (such as rifabutin), efavirenz, nevirapine, saquinavir, among others.

Klaram can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include colchicine, digoxin, some drugs used to treat erectile dysfunction-ED/pulmonary hypertension (such as sildenafil, tadalafil), ergot alkaloids (such as ergotamine, dihydroergotamine), some statin drugs (such as lovastatin, simvastatin), tamsulosin, tolvaptan, ticagrelor, among others.

Although most antibiotics are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details.

Before taking Klaram

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Klaram it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have any problems with the way your liver works or the way your k >


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