Clarigen Tablet

Clarigen is a macrolide antibiotic. It acts by inhibiting microsomal protein synthesis by binding to the 50S subunit of the bacterial ribosome. Clarigen is active against most gram-positive bacteria, Chlamydia, some gram-negative bacteria and Mycoplasmas.

Uses

  • LRTIs for example, acute and chronic bronchitis and pneumonia.
  • URTIs for example, sinusitis and pharyngitis.
  • Community-acquired pneumonia, atypical pneumonia
  • Skin and soft tissue infection
  • Adjunct in the treatment of duodenal ulcers to eradicate of H. pylori

Clarigen is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute maxillary sinusitis, Bacterial Infections, Bartonellosis, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Infective Endocarditis, Lyme Disease, Mycobacterial Infections, Otitis Media (OM), Pertussis, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated skin and subcutaneous tissue bacterial infections

Trade Name Clarigen
Generic Clarithromycin
Other Names 6-O-methyl erythromycin, 6-O-methylerythromycin, 6-O-methylerythromycin A, Clarithromycin, Clarithromycina, Clarithromycine, Clarithromycinum, Claritromicina
Weight 250mg, 5mg
Type Tablet
Formula C38H69NO13
Weight Average: 747.9534
Monoisotopic: 747.476891299
Protein binding

~ 70% protein bound

Therapeutic Class Macrolides
Manufacturer Genix, Genera Pharmaceuticals, Drug International Ltd
Available Country India, Pakistan, Bangladesh
Last Updated: June 23, 2021 at 9:00 am

Dosage

Clarigen dosage

Clarigen may be given with or without meals.

Adults (12 years or above):

250 mg twice daily for 7 days. Dose may be increased to 500 mg twice daily for up to 14 days in pneumonia or severe infections.

Combination therapy for H. pylori infection:

Clarigen 500 mg (two 250 mg tablets or one 500 mg tablet) twice daily in combination with Amoxicillin 1000 mg twice daily and Omeprazole 20 mg twice daily should be continued for 10 days.

Children:

The usual recommended daily dosage is 15 mg/kg in 2 divided doses for 10 days.

 

Approximate Calculation of dose:

1. For 9kg body weight 2.5ml 12 hourly for 10 days

2. For 17kg body weight 5ml 12 hourly for 10 days

3. For 25kg body weight 7.5ml 12 hourly for 10 days

4. For 33kg body weight 10ml 12 hourly for 10 days

 

Direction for reconstitution of suspension:

Shake the bottle to loosen granules. Add 35 ml of boiled and cooled water with the help of the supplied cup, to the dry granules of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the granules is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator.

This may be given with or without meals.

The usual duration of treatment is 6 to 14 days. 

Children older than 12 years: As for adults. 

Eradication of H. pylori in patients with duodenal ulcers: Adults: The usual duration of treatment is 6 to 14 days.

45 ml of water is to be added to the granules in the bottle and shaken to yield 70 ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125 mg per 5 ml.

Side Effects

The most frequently reported events in adults taking Clarigen were diarrhoea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), headache (2%) and oral monilia.

Precaution

Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarigen may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, Clarigen should be discontinued.

Pharmaceutical precaution

Clarigen tablet should be stored in a cool and dry place and away from sunlight.

Interaction

Concomitant use of Clarigen who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Clarigen may alter the metabolism of Terfenadine. The effects of digoxin may be potentiated with concomitant administration of Clarigen. Clarigen resulted in decrease in serum levels of Rifabutin, followed by an increased risk of uveitis.

Food Interaction

  • Take with food. Food increases absorption.

Half Life

3-4 hours

Pregnancy & Breastfeeding use

Clarigen is not recommended for pregnant women. Breast milk from mothers receiving Clarigen should not be given to infants until treatment is completed. Clarigen may be used in neonates and children in appropriate doses.

Contraindication

Hypersensitive to Clarigen, Erythromycin or any of the macrolide antibiotics. Patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Special Warning

Clarigen may be used in neonates and children in appropriate doses.

Acute Overdose

Signs & Symptoms : Ingestion of large amounts of Clarigen can be expected to produce gastrointestinal symptoms. Symptoms of overdose may largely correspond to the profile of side effects.

Management: There is no specific antidote on overdose. Serum levels of Clarigen can not be reduced by haemodialysis or peritoneal dialysis.

Storage Condition

Store in a cool and dry place, protected from light.

Clarigen contains Clarithromycin see full prescribing information from innovator Monograph