Product Information
Composition:
Claryl 250: Each film coated tablet contains 250 mg clarithromycine USP.
Claryl 500: Each film coated tablet contains 500 mg clarithromycine USP.
Claryl 125 mg / 5 ml: Each 5 ml of suspension contains 125 mg clarithromycine USP.
Claryl 250 mg / 5 ml: Each 5 ml of suspension contains 250 mg clarithromycine USP.
Mechanism of Action:
Clarithromycin is a macrolide antimicrobial drug; it exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria resulting in inhibition of protein synthesis.
INDICATIONS:
Acute Bacterial Exacerbation of Chronic Bronchitis: it is indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute Maxillary Sinusitis: it is indicated in adults for the treatment of mild to moderate infections caused bysusceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumonia.
Community-Acquired Pneumonia: it is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to: Haemophilus influenzae (in adults) Haemophilus parainfluenzae (Extended-Release Tablets in adults) Moraxella catarrhalis (Extended-Release Tablets in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae (Extended-Release Tablets in adults, Tablets, and granules for Oral Suspension in adults and pediatric patients).
Pharyngitis /Tonsillitis: (Tablets, and granules for Oral Suspension) it is indicated for thetreatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes asan alternative in individuals who cannot use first line therapy.
Uncomplicated Skin and Skin Structure Infections:(Tablets and granules for Oral Suspension) it is indicated for thetreatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, orStreptococcus pyogenes.
Acute Otitis Media:(Tablets and granules for Oral Suspension) it is indicated in pediatricpatients for the treatment of mild to moderate infections caused by susceptible isolates due toHaemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumonia.
Treatment and Prophylaxis of Disseminated Mycobacterial Infections:(Tablets and granules for Oral Suspension) it is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium orMycobacterium intracellulare in patients with advanced HIV infection.
Helicobacter pylori Infection and Duodenal Ulcer Disease:the Tablets are given in combination with other drugs in adults as described below toeradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenalulcer recurrence.
Clarithromycin Tablets in combination with amoxicillin and lansoprazole or omeprazole Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.
Clarithromycin Tablets in combination with omeprazole capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection.
Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting.
DOSAGE AND ADMINISTRATION:
Clarithromycin Tablets and granules for Oral Suspension may be given with or without food.
Clarithromycin Extended-Release Tablets should be taken with food. Swallow Clarithromycin
Extended-Release Tablets whole; it should not be chewed, broken or crushed.
Adult Dosage: for the treatment of mild to moderate infections in adults
| Tablets | Extended-Release
Tablets |
|||
| infection | Dosage
(every 12 hours ) |
Duration ( days) | Dosage
(every 24 hours ) |
Duration ( days) |
| Acute bacterial exacerbation of chronic bronchitis | 250 to 500 mg
(For M. catarrhalis and S. pneumoniae use 250 mg, For H. influenzae and H. parainfluenzae, use 500 mg) |
7-14
(For H parainfluenzae, the duration of therapy is 7 days) |
1 g | 7 |
| Acute maxillary sinusitis
|
500 mg | 14 | 1 g | 14 |
| Community-acquired pneumonia
|
250 mg
For H. parainfluenzae and M. catarrhalis use the Extended-Release Tablets only |
7-14 For H. influenzae, the duration of therapy is 7 days | 1 g
For H. parainfluenzae and M. catarrhalis use Clarithromycin Extended-Release Tablets only |
7 |
| Pharyngitis/Tonsillitis
|
250 mg | 10 | – | – |
| Uncomplicated skin and skin structure
infections
|
250 mg | 7-14 | – | – |
| Treatment and prophylaxis of disseminated
Mycobacterium avium disease |
500 mg
Clarithromycin therapy should continue if clinical response is observed. It can be discontinued when the patient is considered at low risk of disseminated infection |
– | – | – |
| H.pylori eradication to reduce the risk of
duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole |
500 mg | 10-14 | – | – |
| H.pylori eradication to reduce the risk of
duodenal ulcer recurrence with omeprazole |
500 mg every
8 hours |
14 | – | – |
Combination Dosing Regimens for H. pylori Infection:
- Triple therapy: Clarithromycin Tablets/lansoprazole/amoxicillin: The recommended adult dosage is 500 mg Clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days.
- Triple therapy: Clarithromycin Tablets/omeprazole/amoxicillin:The recommended adult dosage is 500 mg Clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
- Dual therapy: Clarithromycin Tablets/omeprazole: The recommended adult dosage is 500 mg Clarithromycin given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Pediatric Dosage: The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information.
Storage conditions:
Claryl film coated tablets and powder for reconstitution store below 30o C.
Claryl suspension store between 5o – 30o C.
How supplied:
Claryl 250: Pack of 14 film coated tablets.
Claryl 500: Pack of 14 film coated tablets.
Claryl 125 mg / 5 ml (60 ml): Bottle of powder for reconstitution in 60 ml water.
Claryl 250 mg / 5 ml (60 ml): Bottle of powder for reconstitution in 60 ml water.
