OUR PRODUCTS
Each 5 ml of suspension after preparation contains 125 mg or 250 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).
Oral clarithromycin and midazolam is contraindicated
- 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.
- Lower respiratory tract infections (such as bronchitis and pneumonia)
- Upper respiratory tract infections (eg, pharyngitis, sinusitis).
- Skin and skin structure infections (eg folliculitis, cellulitis, erysipelas)
- Acute otitis media.
Dosage: The recommended daily dose of clarithromycin 250 mg/5 mL oral suspension for children is given in the following table and is based on an approximate dosage regimen of 7.5 mg/kg twice daily. Doses of up to 500 mg twice daily have been used to treat severe infections. The prepared suspension can be taken with or without meals and can be taken with milk.
After children, the dose is given according to body weight, as shown in the following table:
|
The dose is estimated in ml twice daily of the suspension (250 mg/5 ml). |
The dose is estimated in ml twice daily of the suspension (125 mg/5 ml). |
Age |
Weight (kg) |
|
1.25 |
2.5 |
1-2 |
8-11 |
|
2.5 |
5 |
3-6 |
12-19 |
|
3.75 |
7.5 |
7-9 |
20-29 |
|
5 |
10 |
10-12 |
30-40 |
- Patients with renal and hepatic insufficiency: Clarithromycin should not be given to pediatric patients with severe hepatic or renal impairment. Caution should be exercised when clarithromycin is administered to children with lower degrees of renal or hepatic impairment.
- In children with a creatinine clearance of less than 30 mL/min/1.73 m2, the dose of clarithromycin should be reduced by half to 7.5 mg/kg per day.
- Dosage should not last more than 14 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 125 mg granules for oral suspension .............( 667 /2019)
KALTOP 250 mg granules for oral suspension .............( 668 /2019)
A carton box containing an opaque glass bottle containing 60 ml of the suspension after preparation.