Clarithromycin

Brand names of Clarithromycin in Kenya

Acem, Emcure Pharmaceuticals Ltd
Aziclar, Flamingo
Cipclar, Cipla Ltd
Claranta, Ajanta Pharma Limited
Claricor, Coral
Claricos, Cosmos Limited
Claridar, Dar
Clarie, Indswift Limited
Claritek, Getz Pharma (Pvt) Limited
Clarimet, Metro
Claranta, Ajanta
Clarifred, Fredun Pharmaceutical Ltd
Clarimin , Kopran Limited
Clarithro, Alembic
Clarithromycin, Metro
Claritron, Strides Arcolab Limited
Clariwin, Micro Labs Ltd.
Clarized , Zawadi Healthcare Ltd
Clarizide, Agio
Clarix, Pharma
Cleron, Delorbis Pharmaceuticals Limited
Clith, Universal Corporation Limited
Deklarit , Pharmaco Healthcare Limited
Klacid, Abbott Laboratories S.A. (Pty) Ltd
Klerimed, Medochemie Ltd
Megamac, Indchemie
Niclar, Gracure Pharmaceuticals Ltd
Neklitro ,Nestor Pharmaceuticals Limited
Neo-Klar, CCL Pharmaceuticals (Pvt.) Ltd.
Neuclar, Sarabhai
Pharmathrocin, Pharmaniaga
Remac, Square Pharmaceuticals Ltd.
Rivaclarithin, Riva Pharma S.A.E
Zynclar, Lords Healthcare Limited

Clarithromycin in Kenya : Price, Brand names, Uses
Clarithromycin Chemical Structure

CLARITHROMYCIN MODE OF ACTION

Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppresses protein synthesis. It is highly potent against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms.

INDICATIONS

Clarithromycin film-coated tablets are indicated for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria.

  • Bacterial pharyngitis
  • Mild to moderate community acquired pneumonia
  • Acute bacterial sinusitis (adequately diagnosed)
  • Acute exacerbation of chronic bronchitis
  • Skin infections and soft tissue infections of mild to moderate severity

In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

DOSAGE AND ADMINISTRATION

Posology

The dosage of Clarithromycin depends on the type and severity of the infection and has to be defined in any case by the physician.

Adults and adolescents (12 years and older)

  • Standard dosage: The usual dose is 250 mg twice daily (in the morning and in the evening)
  • High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections.

Children younger than 12 years:

Children under 12 years of age should use clarithromycin paediatric suspension.

For children with a body weight of more than 30kg, the dose for adults apply.

Dosage in renal functional impairment:

In patients with renal impairment with creatinine clearance less than 30 mL/min, the dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.

Patients with hepatic impairment:

Caution should be exercised when administrating clarithromycin in patients with hepatic impairment

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

Usually clarithromycin is administered in combination with another antibiotic and a proton-pump inhibitor for one week.

The therapy may be repeated if the patient is still H. pylori-positive

Duration of therapy:

  • The duration of therapy with depends on the type and severity of the infection and has to be defined in any case by the physician.
  • The usual duration of treatment is 7 to 14 days.
  • Therapy should be continued at least for 2 days after symptoms have subsided.
  • In Streptococcus pyogenes (group A beta-haemolytic streptococcus) infections the duration of therapy should be at least 10 days.
  • Combination therapy for the eradication of H. pylori infection should be continued for 7 days.

CONTRAINDICATIONS

  • Clarithromycin is contraindicated in patients with known hypersensitivity to the active substance clarithromycin, to other macrolides or to any of the excipients.
  • Concomitant administration of clarithromycin and any of the following active substances is contraindicated: astemizole, cisapride, pimozide and terfenadine as this may result in QT prolongation (congenital or documented acquired QT prolongation) and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and Torsade de Pointes .
  • Concomitant administration with ticagrelor or renolazine is contraindicated.
  • Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity.
  • Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointe.
  • Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolosed by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
  • Clarithromycin should not be given to patients with hypokalaemia (risk of prolongation of QT-time).
  • Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.
  • As with other strong CYP3A4 inhibitors, Clarithromycin should not be used in patients taking colchicine.

DRUG INTERACTIONS

Elevated cisapride levels have been reported in patients receiving clarithromycin and cisapride concomitantly.

Macrolides have been reported to alter the metabolism of terfenadine resulting in increased levels of terfenadine which has occasionally been associated with cardiac arrhythmias such as QT prolongation, ventricular tachycardia, ventricular fibrillation and torsades de pointes

Co-administration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm, and ischemia of the extremities and other tissues including the central nervous system. Concomitant administration of clarithromycin and these medicinal products is contraindicated.

Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated as these statins are extensively metabolized by CYP3A4 and concomitant treatment with clarithromycin increases their plasma concentration, which increases the risk of myopathy, including rhabdomyolysis.

Drugs that are inducers of CYP3A (e.g. rifampicin, phenytoin, carabamazepin, phenobarbital, St. Johns wort) may induce the metabolism of clarithromycin. This may result in sub-therapeutic levels of clarithromycin leading to a reduced efficacy.

Strong inducers of the cytochrome P450 metabolism system such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine may accelerate the metabolism of clarithromycin and thus lower the plasma levels of clarithromycin, while increasing those of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Since the microbiological activities of clarithromycin and 14-OH-clarithromycin are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of clarithromycin and enzyme inducers.

Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased. Because 14-OH-clarithromycin has reduced activity against Mycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC.

Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g. carbamazepine) and/or the substrate is extensively metabolized by this enzyme.

Blood glucose levels should be monitored during concomitant administration of clarithromycin and disopyramide.

With certain hypoglycemic drugs such as nateglinide, and repaglinide, inhibition of CYP3A enzyme by clarithromycin may be involved and could cause hypolgycemia when used concomitantly. Careful monitoring of glucose is recommended.

Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil would likely result in increased phosphodiesterase inhibitor exposure.

Concomitant administration of oral midazolam and clarithromycin should be avoided. If intravenous midazolam is co-administered with clarithromycin, the patient must be closely monitored to allow dose adjustment.

Caution is advised regarding concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides.

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine

When clarithromycin and digoxin are administered together, inhibition of Pgp by clarithromycin may lead to increased exposure to digoxin.

Caution is advised regarding the concomitant administration of clarithromycin and calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) due to the risk of hypotension.

Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effect.

ADVERSE EFFECTS

Infections and infestations

Uncommon: Candidiasis, infection, vaginal infection

Not known: Pseudomembranous colitis, erysipelas

Blood and lymphatic system disorders

Uncommon: Leucopenia, thrombocythemia

Not known: Agranulocytosis, thrombocytopenia

Immune system disorders

Uncommon: Hypersensitivity

Not known: Anaphylactic reaction, angioedema

Metabolism and nutrition disorders

Uncommon: Anorexia, decreased appetite

Psychiatric disorders

Common: Insomnia

Uncommon: Anxiety, nervousness

Not known: Psychotic disorder, confusional state, depersonalisation, depression, disorientation, hallucinations, abnormal dreams

Nervous system disorders

Common: Dysgeusia, headache, taste perversion

Uncommon: Dizziness, somnolence, tremor

Not known: Convulsion, ageusia, parosmia, anosmia, paraesthesia

Eye disorders

Not known: Visual impairment, blurred vision

Ear and labyrinth disorders

Uncommon: Vertigo, hearing impaired, tinnitus

Not known: Deafness

Cardiac disorders

Uncommon: Electrocardiogram QT prolonged, palpitations

Not known: Torsades de Pointes, ventricular tachycardia, ventricular fibrillation

Vascular disorders

Not known: Haemorrhage

Gastrointestinal disorders

Common: Diarrhoea, vomiting, dyspepsia, nausea, abdominal pain

Uncommon: Gastritis, stomatitis, glossitis, constipation, dry mouth, eructation, flatulence

Not known: Pancreatitis, reversible tooth and tongue discoloration.

Hepatobiliary disorders

Common: Liver function test abnormal

Uncommon:Alanine aminotransferase increased, aspartate aminotransferase increased

Not known: Hepatic failure, jaundice hepatocellular

Skin and subcutaneous tissue disorders

Common: Rash, hyperhidrosis

Uncommon: Pruritus, urticaria, rash maculo-papular

Not known: Stevens-Johnson syndrome and toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS), acne, acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal, connective tissue and bone disorders

Uncommon: Muscle spasms

Not known: Myopathy

Renal and urinary disorders

Not known: Renal failure, interstitial nephritis

General disorders and administration site conditions

Uncommon: Pyrexia, asthenia

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:

Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya
Clarithromycin in Kenya

Clinical | Pharmacokinetic data

Pregnancy Category: C
Routes of Administration: By mouth, intravenous
Bioavailability: 50%
Protein Binding: low binding
Metabolosim: hepatic
Onset of Action: Not Available
Elimination Half life: 3–4 h
Excretion: Not Available

Legal Status | Dosage forms & Strengths

Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:

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References/ Citation:

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