SANOXOL 

PATIENT  INFORMATION LEAFLET

SANOXOL

TRADE NAME
Sanoxol

INTERNATIONAL  NONPROPRIETARY  NAME
Ciprofloxacin + Оrnidazole

PHARMACEUTICAL FORM
Film-coated tablets.
Description: oval film-coated tablets, pale yellow, one side “ORCP” printed other side bisect.

COMPOSITION
Film-coated tablet contains
Active ingredients: ciprofloxacin (as ciprofloxacin hydrochloride)                   500 mg ornidazole          500 mg
Excipients: sodium starch glycolate, сroscarmellose sodium, povidone, magnesium stearate, silica colloidal anhydrous, talc, maize starch.
Composition of film coating: Opadry yellow 85F220095 (polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow, tartrazine aluminum lake, sunset yellow aluminum lake).

АТС  CODE   J01

PHARMACOTHERAPEUTIC   GROUP
Antimicrobials and antiprotozoals for systemic use.

PHARMACOLOGIC PROPERTIES PHARMACODYNAMICS
Sanoxol is a combined antimicrobial and antiprotozoal drug, the pharmacological action of which is conditioned by the properties of comprising its active components: ciprofloxacin (derivative of II generation fluoroquinolones) and ornidazole (derivative of 5-nitroimidazole).
Ciprofloxacin inhibits bacterial DNA gyrase and synthesis of bacterial DNA; it evokes morphological changes in membrane and bacterial cell wall that leads to fast cell death. It influences on microorganisms in the growth and quiescent states. Ciprofloxacin has a broad-spectrum antimicrobial activity and is active in relation to a number of gram-positive and gram-negative aerobic bacteria: Staphylococcus spp. (including strains producing and not producing penicillinase, methicillin-resistant strains), Streptococcus spp. (including the following strains S.pneumoniae and S. pyogenes), Enterococcus spp., Listeria monocytogenes, Enterobacter spp., Haemophilus influenzae, Klebsiella spp., Legionella spp., Moraxella catarrhalis, Morganella morganii, Neisseria spp., Proteus spp., Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Vibrio cholerae, Campylobacter spp., Citrobacter spp., Yersinia enterocolitica, E.coli; and others Mycobacterium tuberculosis, Chlamydia trachomatis and Mycoplasma hominis. The following bacteria are resistant to ciprofloxacin: Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroidеs. The action of the drug against Treponema pallidum is insufficiently studied.
The mechanism of action of ornidazole is related with DNAstructure damage of sensitive microorganisms. It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, and also against some anaerobic bacteria (including Bacteroides spp., Clostridium spp., Fusobacterium spp. and anaerobic cocci).
PHARMACOKINETICS
Ciprofloxacin is quickly absorbed in gastrointestinal tract. Bioavailability is 70-80%. Ornidazole is quickly absorbed after oral administration. Bioavailability is 90%.

THERAPEUTIC  INDICATIONS
Sanoxol is indicated for treatment of the following infections caused by strains sensitive to the combination of ciprofloxacin and ornidazole:

  1. infectious and inflammatory diseases of pelvic organs including post- operative and post-abortion prophylaxis;
  2. kidney and/or urinary tract infections: chronic and acute pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, including complicated and recurrent;
  3. sexually transmitted infections: clamidiosis, mycoplasmosis, gonorrhea, trichomoniasis, mixed infections (concurrent infections);
  4. infections of respiratory tracts: acute bronchitis, aggravation of chronic bronchitis, pneumonia, (Sanoxol is recommended for prescription in case of pneumonias induced by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, Branhamella, Legionella, Staphylococcus), infected bronchiectasis, lung abscess, pleural empyema;
  5. infections of ENT organs: sinusitis, external and otitis media, mastoiditis;
  6. infections of eyes;
  7. infections of skin and soft tissues;
  8. infections of bones and joints;
  9. infections of abdominal cavity, bacterial infections of gastrointestinal tract and bile-excreting ducts, peritonitis;
  10. amebiasis (intestinal infections induced by Entamoeba histolytica, including amoebic dysentery, and all the extraintestinal forms of amebiasis, especially amoebic abscess of liver);
  11. lambliasis;
  12. sepsis;
  13. infections or infection prophylaxis in immune-suppressed patients (for example, in patients receiving immunosuppressants

or in patients with neutropenia);

  1. selective intestinal decontamination in immune-suppressed  patients;
  2. prophylaxis of anaerobic infections after operations on large intestine and after gynecological interventions;
  3. prophylaxis and treatment of the pulmonary form of the Siberian ulcer (infection by Bacillus anthracis);
  4. treatment of the complications induced by Pseudomonas aeruginosa at children with mucoviscidosis of lungs from 5 to 17 years old.

DOSAGE AND ADMINISTRATION
Sanoxol is administered orally before meal or in 2 hours after meal, not chewing.
The course of treatment at acute infections makes 5-7 days, and in case of treatment of chronic recurrent infections - 10-14 days in a dosage of 1 tablet 2 times daily.
It is necessary to continue administration of the drug during 2 days after elimination of illness symptoms.
Patients with creatinine clearance 20 ml/min and less, elderly patients and patients with small body weight are prescribed one-half of a standard dose.

CONTRAINDICATIONS
- hypersensitivity to ciprofloxacin or ornidazole.

SIDE EFFECTS
Symptoms are usually mild or moderate and are rapidly disappearing. In rare cases they can require the canceling of treatment.
Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pains.
Central nervous system: headaches, dizziness, sleep disorders.
Hematopoietic system: eosinophilia, leukopenia, neutropenia, change of platelet quantity.
Immune system and skin: allergic reactions, photosensivity.

PARTICULAR  INDICATIONS
Patients with impaired renal function need the correction of dosage regimen. It should be carefully applied to elderly patients, at cerebral atherosclerosis, cerebrovascular disease, epilepsy and convulsive syndrome of unclear etiology.
It is necessary to avoid alcohol during treatment.

INFLUENCE ON ABILITY TO DRIVE AND OPERATE  MECHANISMS
The ability to concentrate the attention and psychomotor reaction rate can be reduced at the administration of Sanoxol. It should be considered if necessary to administer the drug in persons which activity is connected with driving, machine- tending and mechanisms maintenance and with works execution in unstable position.

PREGNANCY AND LACTATION
Administration of Sanoxol during pregnancy and lactation is recommended only if the expected benefit to the mother significantly exceeds the possible risk to the fetus. It is recommended to stop breastfeeding if there is a necessity of drug administration during lactation.

PEDIATRIC USE
Prescribe with caution under special indications.

DRUG INTERACTIONS
Co-application of ciprofloxacin and theophylline can lead to the increase of theophylline concentration in blood plasma due to the competitive inhibition in the binding sites of cytochrome P450. This can result in an increase of theophylline elimination half-life and the occurrence of theophylline induced side effects.
Ornidazole potentiates the action of oral coumarin type anticoagulants that requires the corresponding correction of their dose.
Ornidazole lengthens the myorelaxing action of vecuronium bromide.
Co-administration of ciprofloxacin and warfarin can strengthen the action of the last one.
Co-administration of antacids as well as the drugs containing aluminum, zinc, iron or magnesium ions can lead to the lowering of ciprofloxacin absorption, therefore the interval between applications of these drugs should be not less than 4 hours.

OVERDOSE
Symptoms: dizziness, impairment of consciousness and cramps attacks, nausea, mucous membrane lesions.
Treatment: to carry out symptomatic therapy. There is no any specific antidote.

PACKAGING
Film-coated tablets. 10 tablets in a blister.
1 or 2 blisters with the enclosed leaflet in a carton box.

STORAGE CONDITIONS
Store at temperature not exceeding 25°С. Keep out of reach of children!

SHELF LIFE
3 years from the manufacturing date. Do not use after expiry date.

SALES TERMS
Sold under prescription.

MANUFACTURER
SANOXOL is a product and a trade mark of "Sanolife", Great Britain.
Manufactured by
"WORLD MEDICINE İLAÇ SAN. VE TİC. А.Ş.", TURKEY
(Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No:50 K. 1B Zemin 4-5-6, İstanbul).