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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