Generic Name:Tinidazole/Ofloxacin 200/600mg
Brand Name: Tinidazole/Ofloxacin (OZO-O/T)
Ofloxacin has in vitroactivity against a broad spectrum of gram-positive and gram-negative aerobic and
anaerobic bacteria. Ofloxacin is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible microorganisms by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
The antimicrobial activity of Tinidazole & Ornidazole is due to the reduction of the nitro group to a more reactive amine that attacks microbial DNA, brings about loss of helical structure of DNA and subsequent DNA breakage thus inhibiting further synthesis and causing degradation of existing DNA.
Generic Name:Tinidazole/Ofloxacin 200/600mg
Brand Name: Tinidazole/Ofloxacin
Ofloxacin has in vitroactivity against a broad spectrum of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible microorganisms by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
The antimicrobial activity of Tinidazole & Ornidazole is due to the reduction of the nitro group to a more reactive amine that attacks microbial DNA, brings about loss of helical structure of DNA and subsequent DNA breakage thus inhibiting further synthesis and causing degradation of existing DNA.
Rationality: Tinidazole/Ofloxacin (OZO-O/T)
The pharmacokinetic behaviour of the two drugs should be similar to support the use of the two agents in fixed-dose-combination.
Both the drugs in Co-trimoxazole, which is an established combination of sulphamethoxazole and trimethoprim, have their pharmacokinetic parameters like t 1/2 (about 10 hrs for both the drugs) matching with that of each other.
Similarly, the half-lives of Ofloxacin & Ornidazole/Tinidazole fall in the same range and hence, the time course of
action of the three drugs might be similar which is an important criterion for the possibility of a rational fixed-dose-combination.
It can be said that Ofloxacin & Ornidazole/Tinidazole show synergistic potential which is one of the most important factor in deciding the feasibility of a FDC.
Ornidazole/Tinidazole is metabolised in the liver and is excreted in the urine, mainly as conjugates and metabolites, and to a lesser extent in the faeces; 85% of a single oral dose has been reported to be eliminated within 5 days, 63% in the urine and 22% in the faeces. Biliary excretion may be important in the elimination of ornidazole/tinidazole and its metabolites.
Indications of Tinidazole/Ofloxacin (OZO-O/T):
Tinidazole/Ofloxacin (OZO-O/T) may be used in the treatment of mixed polymicrobial infections like :
· Lower Respiratory Tract (Acute bacterial exacerbations of chronic bronchitis & Community-acquired Pneumonia)
· Skin and skin structure infections
· Sexually Transmitted Diseases
· Acute, complicated urethral and cervical gonorrhea.
· Nongonococcal urethritis and cervicitis
· Mixed infections of the urethra and cervix
· Urinary Tract Infections (cystitis)
· Prostatitis due to Escherichia coli.
· Hepatic and intestinal amoebiasis, giardiasis, trichomoniasis of urogenital tract
· Bacterial vaginosis.
· ENT Infections
· All the above infections and other mixed infections in Children
Tinidazole/Ofloxacin (OZO-O/T)is also used in the treatment and prophylaxis of susceptible aerobic and anaerobic infections in dental and gastrointestinal surgery & in other mixed aerobic – anaerobic infections. OZO-T is also advocated in the management of H. pylori duodenal ulcer in combination with other drugs.
Contraindications of Tinidazole/Ofloxacin (OZO-O/T):
* Tinidazole/Ofloxacin (OZO-O/T) is contraindicated in persons with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication and in patients hypersensitive to ornidazole/tinidazole and other imidazoles. There is no evidence of accumulation when used in pregnant women. Therefore dosage regimen requires no adjustment during pregnancy.
Adverse Reactions of Tinidazole/Ofloxacin (OZO-O/T):
* The most frequently encountered side effect is dizziness, alone or in combination with other adverse reactions.
The other side effects occuring to a lesser extent are nausea, pyrosis, intestinal spasms and metallic taste. Vertigo, fatigue and other discomforts such as loose stools, insomnia, skin rash and headache have also been reported.
Dosage and Administration of Tinidazole/Ofloxacin (OZO-O/T)
* The usual dose of Tinidazole/Ofloxacin (OZO-O/T) are 1 tablet orally every 12 h. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 ml/min).
-- Mixed Amoebiasis
Adults : 1 tab twice daily for 5-7 days
Children: ½ tab once daily for 5 to 10 days
-- Mixed Amoebic dysentery
Adults : 3 tablets once daily for 3 days
Children : 1 tablet once daily for 3 days
-- Mixed Giardiasis :
Adults : 3 tablets once daily for 1-2 days
Children: 1 tablet for 2 days
-- Trichomoniasis:
Adults : 3 tablets once or 1 tablet twice daily for 5 days. Sexual partner should be simultaneously treated.
-- Bacterial vaginosis and STD
Adults : 3 tablets once or 1 tablet once daily for 5-7 days
-- Mixed bacterial infections in Lower Respiratory Tract, Gynaecology, ENT, Surgical Infections and dental Infections:Initiate oral therapy as soon as possible after I.V. infusion in surgical conditions.
Adults : 1 tablet twice daily for 5 to 10 days
Children : ½ tablet twice daily
Dosage of OZO-O Suspensionn:
* The usual dose of OZO-O suspension are 5-10ml twice daily.
* These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 ml/min).No data is available on overdosage toxicity. In the event of an overdosage the stomach may be emptied and symptomatic treatment should be given.
Storage instructions of Tinidazole/Ofloxacin (OZO-O/T)
* Store at a temperature below 25°C, protect from light and moisture.
Presentation of Tinidazole/Ofloxacin (OZO-O/T):
* Available in blister strips of 10 x 10's tablets' (OZO-T).
& 30 ml Suspension (OZO-O)
