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Vikrol (Clarithromycin)

Active Ingredient: Clarithromycin
Dosage: 400 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 10, 20, 30 per pack

Why is Vikrol not used in the USA?

Vikrol is not used in the USA possibly because Clarithromycin is available under different brand names, such as Biaxin. The pharmaceutical market in the U.S. often prefers certain brands due to factors like marketing, distribution agreements, and consumer recognition.

Similar Drugs Available in the USA

Here are medications similar to Vikrol (Clarithromycin) available in the USA for treating bacterial infections:

Macrolide Antibiotics

Penicillin Antibiotics

Fluoroquinolone Antibiotics

Cephalosporin Antibiotics

Tetracycline Antibiotics

What is Vikrol?

Vikrol is prescribed for the treatment of certain bacterial infections, such as pneumonia, bronchitis, and infections of the ears, sinuses, skin, and throat. It also is applied to treat and prevent disseminated Mycobacterium avium complex (MAC) infection. This medication can be used as combined therapy to kill H. pylori, a bacterium that causes ulcers. Clarithromycin belongs to the class of medications known as macrolide antibiotics.

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Indications

Vikrol is used to treat upper and lower respiratory tract infections:

  • Upper respiratory infections (tonsillitis, pharyngitis, sinusitis, otitis);
  • Lower respiratory infections: (bronchitis, pneumonia);
  • Skin and soft tissue infections (folliculitis, cellulitis, erysipelas, impetigo);
  • Disseminated or localized infections, caused by Mycobacterium avium or M. intracellulare.

It is indicated for the prevention of the spread of MAC infection in HIV-infected patients, with CD4 counts

Dosage and administration

The drug is taken orally. Take 1 tablet every 12 or 24 hours, with or without food. The usual duration of treatment is 6 to 14 days, depending on the pathogen involved and the severity of the pathology. You can double the dose. Adults and children over 12 years: The recommended average dose is 500 mg orally every 12 hours in more severe infections. The recommended starting dose in patients with MAC infections is 500 mg every 12 hours, if there is no clinical or bacteriological response, change to 1,000 mg every 12 hours. Based on the current data, the duration of treatment is variable and should be continued until improvement continues. Vikrol should be used together with other antimicrobial agents. The dose for MAC prophylaxis in adults is 500 mg every 12 hours. Dosage in renal impairment: Dose adjustment or dosage interval should be considered in all subjects with renal impairment. In those with a creatinine clearance

Additional information: Helicobacter pylori is strongly associated with ulcero-peptic disease. From 90% to 100% of patients with duodenal ulcers are infected with that pathogen. Eradication of H. pylori has been shown to reduce the frequency of recurrence of duodenal ulcer; therefore, it reduces the need to maintain the antisecretory treatment.

Popularity and Use in Countries Other Than the USA

Vikrol is popular in several countries outside the United States, such as in Mexico and other parts of Latin America. It is commonly used due to its effectiveness against respiratory and skin infections, which are prevalent in these areas. Additionally, it may be favored due to its cost-effectiveness and availability in these regions.

Contraindications

Vikrol is contraindicated in patients with known hypersensitivity to clarithromycin, erythromycin or any other macrolide antibiotics. Concomitant administration of clarithromycin tablets and any of the following medications is contraindicated: cisapride, pimozide, rifabutin and terfenadine.

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Side effects

The drug can cause disorders of a mild and transient nature, a low number of patients require discontinuation of treatment. The most frequently reported side effects are nausea, vomiting, dyspepsia, abdominal pain and diarrhea. Other adverse events include headache, taste disturbance and elevated liver enzymes. Rare cases of liver dysfunction have been reported, including elevations of liver enzymes and hepatocellular hepatitis, cholestatic or both, with or without jaundice. These liver decreases can become severe, but they are usually reversible. Rarely, liver failure with fatal outcome has been reported and has generally been associated with serious underlying diseases or concomitant medication. Likewise, isolated cases of increase in serum creatinine levels have been reported, although no association has been established. Allergic reactions range from urticaria and mild skin rashes, to anaphylaxis and Stevens-Johnson syndrome. Transient CNS side effects included anxiety, dizziness, vertigo, tinnitus, disorientation, depersonalization, insomnia, hallucinations and confusion, even when the cause-effect relationship has not been established. They have rarely been associated with ventricular arrhythmias including ventricular tachycardia and Torsades de pointes in patients with prolonged QT intervals. There have been reports of hearing loss with clarithromycin, which is usually reversible upon discontinuation of treatment. Likewise, glossitis, stomatitis, oral moniliasis and discoloration of the tongue has been reported. There is no antibiotic that has no risks. In patients with AIDS or immunocompromised patients receiving high doses, serious adverse events have been reported that have been difficult to distinguish from the underlying signs of HIV or intercurrent diseases. The most frequently reported adverse events in adult patients treated with a daily dose of 1,000 to 2,000 mg of clarithromycin were: nausea, vomiting, abdominal pain, bad taste in the mouth, diarrhea, rash, flatulence, headache, constipation, elevations of SGOT and SGPT . With low incidence: dyspnea, insomnia and dry mouth. Laboratory analysis values ​​rose. The white blood cells and platelet count were abnormally low. In patients who received 4000 mg daily, a low percentage also had elevated levels of urea nitrogen. Rarely, hypoglycemia has been reported. Alterations in the sense of smell have been reported, usually along with changes in taste; also discoloration of the teeth can occur, which is usually reversible through professional cleaning.

Overdose

After ingestion of significant amounts of clarithromycin side effects can be intensified. An overdose of Vikrol can cause alterations in mental status, paranoid behavior, hypokalemia and hypoxemia. The immediate elimination of non-absorbed medication should be attempted by doing gastric lavage. Appropriate measures should also be taken for each case. If allergic reactions occur, the administration of antihistamines is recommended. An important decrease in serum clarithromycin levels with peritoneal hemodialysis is not expected.

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Interaction

Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolides such as lincomycin and clindamycin. Theophylline or carbamazepine levels are increased by approximately 20%, when these are administered concomitantly; therefore, in such circumstances, the need to monitor serum levels of theophylline or carbamazepine should be considered. Elevated levels of cisapride have been reported in patients receiving concomitantly clarithromycin and cisapride, resulting in prolongation of the QT segment, cardiac arrhythmias including tachycardia and ventricular fibrillation and Torsades de pointes. Similar effects have been observed with the concomitant use of pimozide. It has been reported that macrolides alter the metabolism of terfenadine, resulting in elevated levels of terfenadine, which has occasionally been associated with cardiac arrhythmias such as prolongation of the QT interval, tachycardia and ventricular fibrillation and Torsades de pointes. In a study in which clarithromycin and terfenadine were used concomitantly in 14 healthy volunteers, serum levels of the terfenadine acid metabolite increased two to three times. Similar effects have been observed with the concomitant use of astemizole and other macrolides. The use of clarithromycin in patients taking drugs that are biotransformed by the CYP3A isoenzyme (warfarin, ergot alkaloids, triazolam, midazolam, lovastatin, disopyramide, cyclosporine, rifabutin and phenytoin) may be associated with elevations of the serum levels. Rarely, rhabdomyolysis has been reported after co-administration of clarithromycin and lovastatin and simvastatin, HMG-COA reductase inhibitors. As an increase in serum digoxin levels has been reported in patients receiving clarithromycin together, consider monitoring digoxin levels. In patients infected with HIV, clarithromycin tablets interfere with the simultaneous administration of oral zidovudine, decreasing its concentration in the stable state since clarithromycin seems to interfere with the absorption of zidovudine, this interaction can be avoided mostly by spacing the doses of clarithromycin and zidovudine. This interaction does not occur in pediatric patients taking clarithromycin. A pharmacokinetic study showed that concomitant administration of ritonavir 200 mg every 8 hours and clarithromycin 500 mg every 12 hours resulted in marked inhibition of clarithromycin metabolism, increasing its Cmax 31%, Cmin 182% and ABC 77%, observing a complete inhibition of the formation of 14-OH-clarithromycin. Due to the wide therapeutic “window” of clarithromycin, it is not necessary to reduce the dose if the patient has a normal renal function. Doses of clarithromycin greater than 1 g / day should not be co-administered with ritonavir.