Mackrol

Ciprofloxacin 500 mg & Ornidazole 500 mg Tablets

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