Clarithromycin STELLA 250 mg

Rx

Indications

Clarithromycin is indicated for treatment of infections caused by susceptible organisms in adults and children 12 years and older.

• Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.
• Upper respiratory tract infections for example, sinusitis and pharyngitis.
• Initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens.
• Skin and soft tissue infections of mild to moderate severity.
• Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of Helicobacter pylori in patients with duodenal ulcers. The activity of clarithromycin against Helicobacter pylori greater at neutral pH than at acid pH.

Dosage

Respiratory tract/skin and soft tissue infections

• Adults and children older than 12 years: The usual dose is 250 mg twice daily although this may be increased to 500 mg twice daily in severe infections.
• The usual duration of treatment is 14 days.
• Use of Clarithromycin STELLA 250 mg is not recommended for children younger than 12 years.

Eradication of Helicobacter Pylori in patients with duodenal ulcers (adults and elderly)

• The usual duration of treatment is 14 days.
• Triple therapy: Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with amoxycillin 1000 mg twice daily.
• Triple therapy: Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with metronidazole 400 mg twice daily.
• Triple therapy: Clarithromycin (500 mg) twice daily and omeprazole 20 mg twice daily should be given with amoxycillin 1000 mg twice daily or metronidazole 400 mg twice daily.
• Triple therapy: Clarithromycin (500 mg) twice daily should be given with amoxycillin 1000 mg twice daily and omeprazole 20 mg twice daily.

Renal impairment

• Creatinine clearance < 30 ml/min, the dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections.
• Treatment should not be continued beyond 14 days in these patients.

Usage

• Clarithromycin STELLA 250 mg is administered orally and may be given without regard to meals.

• Patients with known hypersensitivity to clarithromycin, erythromycin, or any other macrolide antibiotic or to any of the other ingredients in the tablets.
• Concomitant use of clarithromycin with certain drugs, including terfenadine, astemizole, cisapride and pimozide is contraindicated because such use is likely to produce substantially increased plasma concentrations of the drugs and possibly cause serious and/or life-threatening cardiotoxicity.
• Concomitant use with ergot alkaloids (ergotamine, dihydroergotamine) also is contraindicated because of potentially serious toxicity.
• Clarithromycin should not be given to patient with history of QT prolongation or ventricular cardiac arrhythmia, including torsade de points.
• Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to increased risk of myopathy, including rhabdomyolysis. Treatment with these agents should be discontinued during clarithromycin treatment.
• Clarithromycin should not to be given to patients with hypokalemia (risk of prolongation of QT-time).
• Clarithromycin should not be sued in patients who suffer from severs hepatic failure.

Common

• Gastro-intestinal disturbances which have been seen particularly in young men, at a frequency of 5%.
• Allergic reaction of different degrees, from urticaria to anaphylaxis and Stevens-Johnson syndrome has been reported.
• Case of pseudomembraneous colitis has been report and it can vary in severity, from mild to life-threatening.
• Hypersensitivity reactions as pruritus, urticarial, skin rash, irritation.

• Prescribing clarithromycin when having a proven or strongly suspected bacterial infection or a prophylactic indication.
• No dosage adjustment is required for patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
• Concomitant use of clarithromycin and ranitidine bismuth citrate is not recommended in patients with creatinine clearance < 25 ml/minute, and should not be used in patients with a history of acute porphyria.
• As with other anti-infective agents, use of clarithromycin may result in overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, appropriate therapy should be instituted.
• Hepatic effects have been reported e.g. elevation in serum ALT (SGPT), AST (SGOT), γ-glutamyltransferase (γ-glutamyl transpeptidase, GGT, GGTP), alkaline phosphatase, LDH, and/or total bilirubin concentration; hepatomegaly and hepatic dysfunction. This hepatic dysfunction may be severe but usually is reversible. However, hepatic failure leading to death has been report rarely, generally in patients with serious underlying diseases and/or receiving concomitant drug therapy.
• Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when clarithromycin is administered to a nursing woman.
• Dizziness, vertigo, confusion and disorientation may occur. It should be taken into account before patients drive or use machines.Patients should be aware of how they react to drug before driving or operating machinery.