OUR PRODUCTS
Each film-coated extended-release tablet contains 500 mg clarithromycin.
- Hypersensitivity to clarithromycin or any of the excipients used.
- Concomitant use of clarithromycin with any of the following active substances: astemizole, cisapride, pimozide, terfenadine, lometabide.
- Concomitant use with ticagrelor or ranolazine.
- Concomitant use of clarithromycin and ergotamine or dihydroergotamine should not be done, as this may lead to ergot toxicity.
- Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to an increased risk of myopathy.
- Clarithromycin should not be given to patients with electrolyte disturbances (hypokalemia or hypomagnesemia, due to the risk of QT prolongation).
- Clarithromycin should not be used in patients with severe hepatic impairment concurrent with renal impairment.
- Cisapride, pimozide, astemizole and terfenadine: increased serum concentrations of each of the following medicines:
Ergotamine/Dihydroergotamine: Acute ergot toxicity occurs characterized by vasospasm and ischemia of the extremities and other tissues, including the central nervous system.
- Simvastatin (statins): Increased serum concentrations and thus increased risk of myopathy.
- Rifampicin: reduced the therapeutic effect of clarithromycin.
- Dabigatran, rivaroxaban, apixaban: possible increased risk of bleeding.
- Sildenafil, vardenafil: Increased plasma concentrations of these drugs and therefore the dose used should be reduced.
- Theophylline, carbamazepine: increased levels of both drugs and therefore the dose used should be reduced.
-Alprazolam, midazolam: concomitant administration with clarithromycin should be avoided.
- Colchicine and digoxin: concomitant use increases plasma concentrations of both drugs.
- Calcium channel blockers: increased risk of hypotension, bradycardia and lactic acidosis.
- Itraconazole: a bidirectional drug interaction may occur. Careful monitoring should be exercised with concomitant use.
- bacterial pharyngitis, Mild to moderate acquired pneumonia, Acute bacterial sinusitis, Acute exacerbation of chronic bronchitis, Skin infections and soft tissue infections of mild to moderate severity.
- In appropriate combination with antibacterial regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with ulcers associated with Helicobacter pylori.
Dosage :
The dose of clarithromycin film-coated tablets depends on the type and severity of the infection:
- Adults and Teens (12 years and over)
• The usual dose: The usual dose is 250 mg twice daily (morning and evening).
• Treatment with high doses (severe infections): the usual dose may be increased to 500 mg twice daily in severe infections.
- Children under 12 years of age:
Clarithromycin film-coated tablets are not recommended for use in children under 12 years of age who have a body weight of less than 30 kg.
- Renal impairment: In patients with renal impairment with creatinine clearance less than 30 ml/min, the dose of clarithromycin should be reduced by half, i.e. 250 mg once daily, or 250 mg twice daily in severe infections. Treatment should not be continued for more than 14 days in these patients.
- Patients with hepatic insufficiency: Caution should be exercised when clarithromycin is administered to patients with impaired hepatic function.
- Resection of Helicobacter pylori in peptic ulcer disease: Clarithromycin is usually given in combination with another antibiotic and a proton pump inhibitor for one week.
- Treatment may be repeated if the patient still has H. pylori
Duration of treatment:
• The usual duration of treatment is 7 to 14 days.
• Treatment should be continued for at least two days after the symptoms disappear.
• In Streptococcus pyogenes infection (Group A beta-hemolytic streptococcus), the duration of treatment should be at least 10 days.
• The combined treatment for H. pylori infection should be continued for 7 days.
Insomnia, anxiety, headache, dysgeusia, vasodilatation, diarrhea, nausea, vomiting, indigestion and abdominal pain, abnormal liver function tests, skin rashes, hyperhidrosis, candidiasis, vaginal infection, leukopenia, thrombocytosis, loss of Appetite, tremor, nosebleed, pseudomembranous colitis, flatulence...
KALTOP 500 mg ex.r film coted tablets ...........( 287 / 2020 ).
A carton box containing 2 blisters, each one contains 7 ex.r film coated tablets.