Doramicin (spiramycin) coated tablets 3 000 000 IU №10


Manufacturer: Macedonia

Treatment of infections caused by microorganisms sensitive to spiramycin: confirmed tonsilopharyngitis caused by beta-hemolytic group A streptococci (as an alternative to treatment with beta-lactam antibiotics, especially if they can not be used); acute sinusitis (taking into account the microbiological characteristics of the infection, the use of macrolides is indicated when treatment with beta-lactam antibiotics is not possible); superinfection in acute bronchitis; exacerbation of chronic bronchitis; non-hospital pneumonia in patients who do not have risk factors, severe clinical symptoms, or clinical factors that indicate a pneumococcal etiology of the disease.



Doramicin Composition
Active substance: spiramycin;

1 coated tablet contains spiramycin 3,000,000 IU;

Doramicin Excipients: corn starch, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, colloidal silicon dioxide, microcrystalline cellulose, shell Opadry® II White 85F18422 (polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171) macrogol)

Doramicin Contraindications
Allergy to spiramycin.
Breastfeeding period.
Application to patients at risk of increasing the duration of the QT interval:
known hereditary long QT interval syndrome or a family history of hereditary long QT interval syndrome (if the electrocardiogram did not give other results);
or a known drug-induced lengthening of the QT interval.
In combination with drugs that cause ventricular tachycardia such as pirouette:

class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide)
class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide)
sultropride (benzamide neuroleptic);
other medicines: bepridil, cisapride, diphemanil, mizolastine, vincamine, erythromycin;
certain antipsychotics of the phenothiazine group (thioridazine, chlorpromazine, levomepromazine, cyamemazine), antipsychotics of the benzamide group (amisulpride, sulpiride, tiapride), neuroleptics of the butyrophenone group (haloperidol, droperidol) and other neuroleptics (pimozide)
halofantrine, pentamidine, moxifloxacin.
Application features

If necessary, spiramycin can be prescribed during pregnancy.

Spiramycin tablets containing 3,000,000 IU should not be used in children.

Does not affect.

Mode of application
The tablets should be swallowed whole with a glass of water.

The toxic dose of spiramycin is unknown.

After taking high doses, signs of gastrointestinal upset may occur, in particular, nausea, vomiting and diarrhea.

Cases of QT interval prolongation have been observed in newborns who were treated with high doses of spiramycin, as well as after spiramycin administration in patients at risk of QT interval prolongation. In case of an overdose of spiramycin, it is recommended to check the duration of the QT interval by ECG, especially if other risk factors also exist (hypokalemia, hereditary prolongation of the QTc interval, concomitant use of drugs leading to prolongation of the QT interval and / or bidirectional ventricular tachycardia).

There is no specific antidote.

In case of overdose, symptomatic treatment is recommended.

Adverse Reactions
Gastrointestinal tract

Dyspepsia, particularly stomach pain, nausea, vomiting, diarrhea, and very rare cases of pseudomembranous colitis.
Allergic reactions, including

skin rashes, hives, itching, redness of the skin.
Very rarely – angioedema or Quincke’s edema, anaphylactic shock, acute generalized exentematous pustulosis.

Central and peripheral nervous system

In rare cases – transient paresthesia, headache, dizziness, general weakness.

Symptoms of liver dysfunction

Very rarely, deviations from the norm in the indicators of liver function tests.
The cardiovascular system

Very rare cases of lengthening of the QT interval.