Composition :
Each film coated tablet contains:
Ciprofloxacin Hydrochloride USP to Ciprofloxacin 500 mg
Ornidazole: 500 mg
Excipients: Q.S.
Colour: Titanium Dioxide & Yellow oxide of Iron
About Ornidazole & Ciprofloxacin
Ornidazole: A nitro imidazole derivative, Antiprotozoal antibiotic, Antimicrobial.
Ciprofloxacin: It is a broad-spectrum fluoroquinolone with activity against Pseudomonas aeruginosa.
Mechanism of Action of Ornidazole & Ciprofloxacin
Ornidazole: Ornidazole is a nitro imidazole which has broad spectrum cidal activity against Protozoa and some anaerobic bacteria. Its selective toxicity to anaerobic microbes involves 1. Drug enters the cell by diffusion, 2. Nitro group of drug is reduced by redox proteins present only in anaerobic organisms to reactive nitro radical which excerts cytotoxic action by damaging DNA and other critical biomolecules. 3. DNA helix destabilization &strand breakage has been observed.
Ciprofloxacin
Ciprofloxacin is a bacteriostatic at low concentration and bactericidal at high concentration. It act by inhibiting the enzyme DNA gyrase (Topoisomerase 2) and Topoisomerase 4.DNA gyrase helps in the formation of a highly condensed three dimensional structure of the DNA by its nicking and closing activity and also by introducing negative supercoil in to the DNA double helix. Ciprofloxacin inhibits DNA gyrase which results in abnormal linkage between opened DNA and gyrase and negative supercoiling is also impaired. This will inhibits transcription of DNA in to RNA and subsequent protein synthesis.
Pharmacokinetics of Ornidazole & Ciprofloxacin
Ornidazole:
Absorption: Well absorbed orally, Distribution: Widely distributed,
Metabolism: Metabolized in liver by conjugation, Excretion: Excreted in urine and small portion is excreted in bile
Ciprofloxacin:
Absorption: They are adequately absorbed after oral administration. Distribution: It is distributed widely in the body. Metabolism: It undergoes hepatic metabolism. Excretion: Drug is excreted mainly through urine.
Side Effects of Ornidazole & Ciprofloxacin
1. Abdominal pain
2. Vertigo
3. Nausea
4. Vomiting
5. Fatigue
6. Dry mouth
7. Headache
8. Rash
9. Urticaria
10. Abdominal distress
11. Dizziness
12. Vertigo
13. Diarrhoea
14. Restlessness
15. Drowsiness
16. Arthralgia
17. Confusion
18. Insomnia
19. Anorexia
20. Bad taste
21. Photosensitivity
Contra-indications of Ornidazole & Ciprofloxacin.
Hypersensitivity to the drug or other imidazoles & Hypersensitivity to Ciprofloxacin and other Fluoroquinolones
Special Precautions while taking Ornidazole & Ciprofloxacin
1. Vertigo
2. Mental confusion
3. Ataxia
4. Hepatic impairment
5. Renal impairment
6. Epilepsy
7. Dehydration
Pregnancy Related Information
Use with caution
Indications for Ornidazole & Ciprofloxacin
1. Amoebiasis
2. Giardiasis
3.Trichomonas vaginitis
4. Anaerobic bacterial infections
5.Bacterial vaginosis
6. Respiratory tract infection
7. Bone and joint infections,
8. Infectious diarrhoea
9. Gonorrhoea
10. ENT infections
11. Skin and soft tissue infections
12. Typhoid fever
13. Intra-abdominal infections
14. Prostatitis
15. Sinusitis
16. Chancroid
13. Gynaecological infections
14. Tularemia
Antacids (aluminium/magnesium hydroxide), Iron salts, Zinc salts.: Absorption of ciprofloxacin is decreased.
Antineoplastic drugs: Decrease serum levels of ciprofloxacin.
Caffeine: Enhanced efficacy of caffeine.
Oral anti-coagulants: Enhanced efficacy of anti-coagulants.
Cyclosporine: Nephrotoxicity increased by ciprofloxacin.
Theophylline: Increased plasma levels of theophylline resulting in toxicity.
NSAIDs: CNS excitation may occur.
Rifampicin: Decreases serum concentration of ciprofloxacin.
Chloramphenicol: Antagonises effects of ciprofloxacin.
Typical Dosage for Ornidazole
Amoebiasis:
Adults: 1gm daily in 2 divided doses for 7 to 10 days
Children: 10 to 25mg/kg once daily for 3days
Amoebic dysentery:
Adults: 1.5gm once daily for 3 days
Children: 40mg/kg once daily for 3 days
Trichomoniasis
Adults: 1.5gm single daily dose or 0.5gm 12hourly for 5 days,
Male partner should be concurrently treated.
Children: 25mg/kg as a single dose
Giardiasis:
Adults: 1 to 1.5gm once daily for 2days
Children: 40mg/kg for 2 days
Bacterial vaginosis: 1.5gm once or 500mg once daily for 5 to7 days
Typical Dosage for Ciprofloxacin
Adults: Dose is determined on the basis of severity of the infection, type of infecting organism, age, weight and renal function of the patient.
UTI: 0.5 – 1 g / day in 2 divided doses.
Respiratory tract infection, Bone and joint infections, Infectious diarrhoea, ENT infections, .Skin and soft tissue infections, Enteric fever: 1 – 1.5 g / day in 2 divided doses
Typhoid fever, Intra-abdominal infections, Gynaecological infection: 1 g / day in 2 divided doses
Uncomplicated gonorrhea: 250 mg / day
Storage:
Store below 30°C. Protect from light and moisture.
KEEP THE MEDICINE OUT OF REACH OF CHILDREN.
Presentation :
10 Tablets in a pack