Klabid 500 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Clarithromycin |
| Company | Unimed unihealth pharmaceuticals ltd |
| Also available as |
Indications
- Acute bacterial exacerbation of chronic bronchitis in adults
- Acute maxillary sinusitis
- Community-acquired pneumonia
- Pharyngitis or tonsillitis
- Uncomplicated skin and skin structure infections
- Acute otitis media in pediatric patients
- Treatment and prophylaxis of disseminated mycobacterial infections
- Helicobacter pylori infection and duodenal ulcer disease in adults
Pharmacology
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.
Dosage & Administration
- Adults: Acute bacterial exacerbation of chronic bronchitis: 250 mg to 500 mg every 12 hours for 7 to 14 days.
- Triple therapy: Clarithromycin/lansoprazole/amoxicillin: The recommended adult dosage is 500 mg clarithromycin, 30 mg lansoprazole and 1 g amoxicillin, all given every 12 hours for 10 or 14 days.
- Renal and hepatic impairment: Clarithromycin is principally excreted via the liver and kidney. Clarithromycin may be administered without dosage adjustment to 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.
Interaction
Klabid is contraindicated when co-administered with certain medications such as HMG-CoA reductase inhibitors, gastroprokinetic agents, ergot alkaloids, antipsychotics, anti-gout agents, and antiarrhythmics drugs.
Contraindications
Clarithromycin is contraindicated in patients with known hypersensitivity to clarithromycin, erythromycin, any of the macrolide antibacterial drugs or any other components of this product. It is also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.
Side Effects
- Nausea
- Vomiting
- Diarrhoea
- Abdominal pain
- Stomatitis and glossitis
- Headache
- Allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis
- Taste perversion
- Transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.
Pregnancy & Lactation
The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.
Precautions & Warnings
Klabid should be discontinued if severe acute hypersensitivity reactions occur. It should be avoided in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia, hypokalemia or hypomagnesemia, significant bradycardia or taking Class IA or III antiarrhythmics. It should be discontinued if signs and symptoms of hepatitis occur. There is an increased risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease. Balancing this potential risk with the treatment benefits should be considered when prescribing Klabid in these patients.
Use in Special Populations
- Use in children and adolescents: The safety and effectiveness of Klabid have been established for the treatment of pharyngitis or tonsillitis, community-acquired pneumonia, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections in pediatric patients 6 months and older.
- The safety and effectiveness of Klabid have been established for the prevention of disseminated Mycobacterium avium complex (MAC) disease in pediatric patients 20 months and older with advanced HIV infection.
Overdose Effects
Reports indicate that the ingestion of large amounts of Klabid can be expected to produce gastro-intestinal symptoms. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, Klabid serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
Therapeutic Class
Macrolides
Storage Conditions
Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.