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Acem

Fidson Healthcare
268, Ikorodu Road, Obanikoro P.O. Box 7210, Shomolu, Lagos. Km 38, Lagos-Abeokuta Exp, Sango Otta.
Website: http://fidson.com

Brand Name

Acem

Manufacturer

Emcure Pharma. Ltd, C-10 (12), MIDC, Bhosari, Pune-411 026, India.

Therapeutic Class

Antibacterial, Macrolides

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-): Each film coated tablet contains: Clarithromycin USP 250 mg. Colours: Titanium dioxide & Lake of Quinoline yellow.

Pack size: 1 Blister strip of 10 tablets.

 

Tablet (NRN: 04-): Each film coated tablet contains: Clarithromycin USP 500 mg. Colours: Titanium dioxide & Lake of Quinoline yellow.

Pack size: 1 Blister strip of 10 tablets.

Pharmacology

Clarithromycin, a semi-synthetic macrolide antibiotic, is a derivativ of Erythromycin, with a similar spectrum of activity and clinical uses, but more consistent absorption and a longer half life. It interferes with the bacterial protein synthesis at the ribosomes. 

Clarithromycin binds to the donor site, and by competing with this site for attachment, prevents translocation of the peptide chain from the acceptor to the donor site. It has been suggested that macrolide antibiotics stimulate dislocation of peptidy t-RNA from the ribosomes during the elongation phase, leading to inhibition of protein synthesis. It is the most effective macrolide against Haemophilus influenzaem chlamydia trachomatic and chlamydia pneumonia.

Pharmacokinetics:

Clarithromycin is acid stable and is well tolerated on oral administration. On absorption, approximately half of the absorbed dose is converted to the active metabolite 14-hydroxy-clarithromycin. After a single 250 mg & 500 mg dose, a peak serum level of 0.78 mcg/mL & 2.12 mcg/mL respectively are achieved in 2-3 hours. It is 80% bound to plasma protein.

Clarithromycin is widely distributed throughout the body with prolonged high concentrations in lung, tonsil and nasal tissue. It is eliminated both by renal excretion and hepatic metabolism.

Indications

Pharyngitis, Tonsilitis, Sinusitis, Chronic bronchitis, Skin and soft tissue infections, Urinary tract infections, Disseminated or localized mycobacterial infections, Legionella & Chlamydial infections.

Contra-indications

Hypersensitivity to clarithromycin or any other macrolide antibiotic.

Precautions/Warnings

To be used with catuion in pregnancy, lactation, elderly and in renal impairment.

Interactions

Concomitant use with terfenadine may cause cardiac arrhythmia.

Concurrent use with Carbamazepine and Theophylline causes increase in serum levels of these drugs.

Clarithromycin may also increase the efficacy of drugs which are metabolised by thte cytochrome P450 system.

Adverse Effects

Nausea, vomiting, dyspepsia, diarrhoea, abdominal pain, headache and taste disturbance.

Transient CNS symptoms like anxiety, dizziness, insomnia, confusion and bad dreams.

Dosage & Administration

Adults: 250-500 mg to be taken twice daily for 7-14 days depending on the severity of the infection.

Storage/Handling Recommendations

Store in a dry place below 25oC.

Protect from light.

Review Date

2016-09-02 07:46:55