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DESCRIPTION
RONCIP-TZ is a fixed dose combination of ciprofloxacin hydrochloride and Tinidazole. Ciprofloxacin is a fluorinated 4-quinolone antibacterial agent with a broad spectrum of activity.
Tinidazole is a nitroimidazole which has antimicrobial action against microaerophilic Protozoa, Giardia lamblia, Entamoeba histolytica and Trichomonas vaginalis and against obligate anaerobic bacteria.
Thus, the overall benefits of the combination of ciprofloxacin and tinidazole include:
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Broad spectrum coverage of both aerobic and anaerobic organisms in a variety of infections. A possible synergistic effect against some species of anaerobic bacteria such as B. fragilis Empiric therapy in patients in whom it is difficult to identify the organism. Combination of one of the most potent fluoroquinolones against gram-negative organisms and gram-positive aerobic organisms and a highly potent agent against anaerobes. Sequential therapy in surgery and other cases, where ciprofloxacin and tinidazole can be given initially I.V. followed by the oral formulation.
Since the combination is in a fixed dose, it ensures that the patient gets both the drugs against aerobes and anaerobes. Significant improvement in compliance since the number of pills to be taken by the patient is reduced by half. There are no interactions between the two drugs. Both the drugs are well tolerated and have been used for several years.
PHARMACOLOGY
Ciprofloxacin exerts its bactericidal effect by inhibiting the A subunit of DNA gyrase, an essential enzyme involved in DNA replication.
Tinidazole acts by damage of DNA strands or inhibition of their synthesis
INDICATIONS
RONCIP-TZ is indicated for the treatment of a wide variety of infections caused by susceptible Gram-positive and Gram-negative organisms along with anaerobes and protozoa. ,
Surgical Prophylaxis and Surgical Wound Infections, Gynaecological Infections including prophylaxis in gynaecological surgeries. Respiratory Tract Infections like lung abscess, aspiration pneumonia, empyema and bronchiectasis ENT Infections like chronic sinusitis, chronic suppurative otitis media, cholesteatoma and mastoiditis. Orofacial and Dental Infections Dermatological Infections like cellulitis, breast and other cutaneous abscesses, gangrene, diabetic and decubitus ulcers. Intra-Abdominal Infections and diarrhoeas of mixed bacterial and protozoal origin
DOSAGE AND ADMINISTRATION
RONCIP-TZ should be taken one hour before or two hours after meals with a glass of water
Adults : One tablet twice a day
In Impaired Renal Clearance
If creatinine clearance is less than 20 mL/min, half the recommended dosage may be administered.
CONTRAINDICATIONS
Hypersensitivity to the quinolone group or the nitroimidazole group of compounds and those patients with a history of blood dyscrasias.
WARNINGS AND PRECAUTIONS
Drug Interactions
Theophylline : Serum concentration and elimination half-life of theophylline may be increased when it is used concurrently with ciprofloxacin.
Antacids : Antacids containing magnesium hydroxide and/or aluminium hydroxide may interfere with the absorption of ciprofloxacin, resulting in lower serum and urine levels.
Anticoagulants : Prolongation of bleeding time has been reported during concomitant administration of ciprofloxacin and anticoagulants.
Cyclosporine : Transient increases in serum creatinine have been seen following concomitant administration of cyclosporine and ciprofloxacin.
Caffeine : Ciprofloxacin may interfere with the metabolism of caffeine resulting in reduced clearance of caffeine
Alcohol : Disulfiram-like antabuse reaction may occur due to tinidazole.
Pregnancy
RONCIP-TZis not recommended for use in pregnancy.
Lactation
RONCIP-TZis not recommended for use in nursing mothers.
Paediatric Use
As with other drugs of this class of quinolones, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Hence the drug is usually not recommended for use in children.
UNDESIRABLE EFFECTS
CNS Stimulation : Ciprofloxacin should be used with caution in patients with CNS disorders such as severe cerebral arteriosclerosis or epilepsy.
Crystalluria : Inadequate intake of water, when on ciprofloxacin, can cause crystalluria.
Phototoxicity : Moderate to severe phototoxicity has been observed in patients who are exposed to direct sunlight with some members of the quinolone class of drugs.
OVERDOSAGE
For acute overdosage, the stomach should be emptied by inducing vomiting or gastric lavage. Haemodialysis or peritoneal dialysis may aid the removal of ciprofloxacin from the body, particularly if renal function is compromised.
Presentation
2 X 7 tablets in ALU/PVC blister pack.
Metallic taste, mild nausea, headache, vomiting, anorexia, abdominal pain, furry tongue, pruritus, photosensitivity, vasculitis, skin rash, dizziness, vertigo, incoordination, insomnia, tremor, convulsion, paraesthesia, blurred vision, eosinophilia, leucopenia, myalgia, tendonitis and exacerbation of myasthenia gravis are also observed.
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