products-page-bottom-left-box

Joclar

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Joclar

Manufacturer

Joswe Medicals, Na'ur Jordan

Therapeutic Class

Antibacterial, Macrolides

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Caplet 250 mg (NRN:04-8549): Clarithromycin 250 mg; film-coated caplet.

Pack size: 14's in HDPE jar.

Caplet 500 mg (NRN:04-8550): Clarithromycin 500 mg; film-coated caplet.

Pack size: 14's; 20's in HDPE jar

Pharmacology

Clarithromycin is a semi-synthetic macrolide antibiotic. Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.

Joclar has been shown to be active in vitro against the following microorganisms: Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Neisseria gonorrhoea, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Campylobacter pylori, Campylobacter jejuni, Chlamydia trachomatis, Branhamella catarrhalis, Bordertella pertussis, Staphylococcus aureus, Propionibacterium acnes.

Peak plasma concentrations of clarithromycin were attained after two hours from administration of a single oral dose of 100 mg of Clarithromycin with the values 0.35 mcg/mL, and 3.97 mcg/mL after an oral dose of 1200 mg. Clarithromycin half-life is dose dependent.

Food does not have a significant effect over drug bioavailability in this pharmaceutical form.

Clarithromycin is rapidly absorbed and diffused to the majority of tissues without significant differences in concentration with the exception of CNS. Clarithromycin is metabolised by the liver, the principal metabolite is 14-hydroxy-N-desmethyl-Clarithromycin, which attains peak plasma concentration at 0.5 mcg/mL and 1.2 mcg/mL after 2-4 hours from administration of 250 and 1200 mg respectively.

Low plasma levels of descladinosyl-Clarithromycin have been identified only after administration of 1200 mg. Metabolic process tends towards saturation with higher doses. Within 5 days from oral or I.V. administration of radiolabelled C14-Clarithromycin, 36% of the dose is excreted in the urine and 52% in the stool.

Indications

Joclar is indicated for the treatment of infections caused by susceptible microorganisms.

Infections of nasopharyngeal tract (tonsilitis, pharyngitis), and of paranasal sinuses.

Infections of the lower respiratory tract: bronchitis, bacterial pneumonia and atypical pneumonia.

Skin infections: impetigo, erysipelas, folliculitis, furunculosis and septic wounds.

Contra-indications

Hypersensitivity to macrolide antibiotics, pregnancy, breast feeding and severe liver insufficiency.

Precautions/Warnings

Clarithromycin is mainly metabolised and excreted by the liver, so caution should be taken when administering it to patients with liver impairment, to patients with severe renal insufficiency and to elderly patients >65 years.

Clarithromycin use in patients who are receiving Carbamazepine can be associated with a significant increase in Carbamazepine plasma levels so patients taking this combination should be clinically monitored and, if necessary, relevant posology modifications must be made. Concomitant administration of clarithromycin and theophylline can cause an increase of theophylline plasma concentration, slight enough not to justify a modification of theophylline usual posology. As with other macrolides, interactions with Warfarin and Cyclosporines are possible.

Interactions

A number of drugs have been known to interact with clarithromycin. It is therefore advisable to consult your healthcare provider if you are using other drugs and placed on Clarithromycin.

Adverse Effects

After oral administration of Clarithromycin, some cases of GI disturbances have been reported (nausea, hearburns, abdominal pain, diarrhoea), headache, and skin rashes. Using macrolides, transient increases of SGOT-SGPT are possible, normally reversible after therapy withdrawal. While during clinical studies with clarithromycin more severe problems relevant to the liver have not been experienced, it should be taken into account that with antibiotics of this family, episodes of cholestatic hepatitis can exceptionally happen.

Like with other antibiotics, during therapy with clarithromycin superinfections by resistant bacteria or fungi can rarely arise, needing drug withdrawal and adoption of suitable therapies.

Dosage & Administration

The recommended adult dosage is 250 mg tablet every 12 hours. In severe infections dose can be increased up to 500 mg every 12 hours. According to the severity of the infection the administration should be continued up to 6-14 days.

The dosage should be reduced by one half in patients with renal impairment with creatinine clearance less than 30 mL/minute. Dosage should not be continued beyound 14 days in these patients.

Overdosage:

Symptoms of overdosages include: GI disturbances, a systemic reaction can also follow, which need to be treated immediately by means of gastric lavage and supportive measures.

Clarithromycin cannot be removed by haemodialysis or peritoneal dialysis so a rapid action should be done to eliminate the amount of drug not yet absorbed, and a suitable symptomatic therapy should be given at the same time.

Storage/Handling Recommendations

Keep in a cool dry place and away from the reach of children.

Review Date

2015-08-19 10:17:32