Doramycin
(Spiramycin)




COMPOSITION

Each film coated tablet contains spiramycin 1.5 mln/3 mln IU.

THERAPEUTIC INDICATIONS

- Acute community-aquired pneumonia, including atypical form (caused by Legionella pneumophila, Mycoplasma pneumoniae, Chlamydia spp.);
- Exacerbation of chronic bronchitis, acute bronchitis.
- Diseases of ENT-organs: sinusitis, tonsillitis, otitis.
- Osteomyelites and arthritises.
- Infections of skin: erysipelas; secondary infected dermatoses; abscesses and phlegmons, including stomatology.
-Non-gonococcal infections of the genital and urinary tracts: prostatitis; urethritis.
- Diseases which are genital tract transmissible: genital and extragenital chlamidiosis; syphilis, gonorrhea (in case of allergy to penicillin preparations).
- Toxoplasmosis (including toxoplasmosis in pregnant women).
- Preventive measures for meningococcosis meningitis in people, who had contact with the patient not more than 10 days before the establishment of the diagnosis.
- Preventive measures for acute articular rheumatism.

CONTRAINDICATIONS

Hypersensitivity to spiramycin and other preparation components, evident hepatic dysfunction.

ADVERSE EFFECTS

Sometimes there is a possibility of nausea, vomiting, diarrhea, allergic skin reactions.

DOSAGE AND ADMINISTRATION

For adults: the daily dose of Doramycin is 6-9 mln IU divided into 2 or 3 doses.
With acute bronchopulmonary disease: 1.5 mln IU every 8 hours (the daily dose is 4.5 mln IU), for severe cases the 2-fold increase of the dose is possible.
For meningococcal meningitis prevention: adults are prescribed the dose of 3 mln IU every 12 hours during 5 days, children with body weight below 20 kg are prescribed 0.75 mln IU per 1 kg every 12 hours during 5 days.
For patients with compromised renal function the dosage adjustment is not required due to poor renal excretion.
For children: with body weight below 10 kg Doramycin is administered in the dose of 3.75 mln IU daily; with body weight below 10-20 kg the daily dose of Doramycin is 1.5-3 mln IU divided into 2-4 doses; with body weight below 20 kg Doramycin is administered in the daily dose of 1.5 mln IU per 10 kg of body weight divided into 2 or 3 doses.

DRUG INTERACTIONS

Simultaneous application of spiramycin with medicines causing ventricular flutter and fibrillation as antiarrhythmic drugs (chinidin, hydrochinidin, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), sultopride (neuroleptic of the benzamide group) and other medicines (bepridil, cisapride, diphemanil, mizolastine, vincamine, erythromycin) is contraindicated. During simultaneous administration with medicines containing the combination of levodopa and carbidopa the decrease of levodopa plasma level was observed.

PREGNANCY AND LACTATION

Application of Doramycin is possible in pregnancy under indications. If the drug is administered during lactation period breast-feeding should be stopped as spiramycin penetrates into breast milk.

MANUFACTURED FORM

Doramycin 1.5 mln IU: film-coated tablets in a blister. 8 tablets in a blister. 2 blisters in a carton box together with instruction.
Doramycin 3 mln IU: film-coated tablets in a blister. 5 tablets in a blister. 2 blisters in a carton box together with instruction.

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