Orcipol (Ciprofloxacin/Ornidazole)
Pharmaceutical Form
Film - coated tablets for oral use.
COMPOSITION
Each film - coated tablet contains ciprofloxacin
hydrochloride equivalent to 500 mg of ciprofloxacin and 500 mg of ornidazole.
THERAPEUTIC INDICATIONS
Orcipol is indicated for treatment of the
following infections caused by strains sensitive to the combination of
ciprofloxacin and ornidazole:
- Infectious and inflammatory diseases of pelvis
minor organs including post- operating and post-abortion prophylaxis;
- Infections of urogenital system: chronic and
acute pyelonephritis, cystitis, urethritis, prostatitis, epididymitis,
including complicated and recurrent;
- Sexually transmitted infections: chlamidiosis,
mycoplasmosis, gonorrhea, trichomoniasis, mixed infections;
- Infections of respiratory tracts – acute
bronchitis, chronic bronchitis exacerbation, pneumonia, infected
bronchiectasis, lung abscess, pleural empyema;
- Infections of ENT organs: sinusitis, external
otitis and otitis media, mastoiditis.
- Skin, soft tissues, joint and bone infections.
- Infections of abdominal cavity: diarrhea,
caused by bacterial or protozoal microorganisms
CONTRAINDICATIONS
- Hypersensitivity to ciprofloxacin or
ornidazole.
- Pregnancy and lactation;
- Infancy and adolescence younger 15 years.
- Central nerve system diseases, acute
neurological diseases.
ADVERSE EFFECTS
Nausea, vomiting, diarrhea, abdominal pains,
headaches, vertigo, sleep disturbances, cosinophilia, leucopenia, granulopenia,
change of thrombocyte numbers, allergic reactions may be reported. Seldom -
photosensitization
PRECAUTIONS
The dosage adjustment is required for patients
with renal dysfunction. Orcipol is cautiously administered in elder patients,
in case of cerebral atherosclerosis, cerebral circulation disorder, epilepsy,
and spastic syndrome of unknown etiology.
DRUG INTERACTOINS
Theophylline: the co-administration of
ciprofloxacin with theophylline results in increasing of theophylline plasma
concentrations, owing to competitive inhibition in binding site of cytochrome
P450, results in increasing of theophylline half-time and
increasing of toxic action, associated with theophylline.
Anticoagulants: ornidazole potentiates
indirect anticoagulants effect and increases the duration of vecuronium
bromide effect.
Warfarin: the co-administration of
ciprofloxacin with warfarin increases the risk of bleeding.
The co-administration with antacids and drugs
containing ions of Al, Zn, Fe and Mg; may cause decreasing of ciprofloxacin
absorption that is why the dosage interval between these drugs should be not
less than 4 hours.
DOSAGE AND ADMINISTRATION
1 tablet of Orcipol should be orally
administered 2 times/daily.
Tablets should be administered without chewing
and with the sufficient quantity of liquid. Orcipol may be used before meal
or 2 hours after it.
STORAGE CONDITIONS
Keep in a dry place at a temperature not
exceeding 250C.
Keep out of reach of children.
MANUFACTURED FORM
Box containing 10 tablets.
SALES TERMS
Sold under prescription.
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