Batina Tinidazole Tablets

BATINA®
Tinidazole Tablets B.P. 500mg

 

DRUG DESCRIPTION

Each tablet contain 500mg of tinidazole.

Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole.

 

INDICATIONS

1. Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomoras vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

2. Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age.

3. Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.

4. Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

DOSAGE AND ADMINISTRATION

Dosing Instructions

It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.

Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards.

Trichomoniasis

The recommended dose in both females and males is a single 2 g oral dose taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.

Giardiasis

The recommended dose in adults is a single 2 g dose taken with food. In pediatric patients older than three years of age, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food.

Amebiasis

Intestinal: The recommended dose in adults is a 2 g dose per day for 3 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days with food.

Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days.

Bacterial Vaginosis

The recommended dose in non-pregnant females is a 2 g oral dose once daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis.

As directed by physician.

 

CONTRAINDICATIONS

The use of tinidazole is contraindicated:

1. In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome.

2. During first trimester of pregnancy.

3. In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.

 

SIDE EFFECTS

Bitter/metallic taste in the mouth, nausea, vomiting, upset stomach, stomach cramps/pain, loss of appetite, constipation, diarrhea, dizziness, or drowsiness may occur.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This drug may cause your tongue or urine to darken. This is harmless.

 

PHARMACOLOGY

Mechanism of action

The mode of action is thought to involve reduction by bacterial ‘nitroreductases’ to an unstable intermediate which interacts with DNA, effectively preventing further replication.

Antibacterial Spectrum

Tinidazole has well established bactericidal activity against obligate anaerobic in vitro, including the Gram-negative organisms. Bacteroides fragilis and other bacteroides spp., fusobacterium spp., and veillonella spp., and the grain positive organisms clostridium difficile, C1 perfringens, and other clostridium spp., Eubacterium spp., peptococcus spp., and peptostraptococcus spp., propionibacterium and Actinomyces spp. It is also active on H. pylori.

Pharmacokinetics

Tinidazole is almost completely absorbed following administration by mouth and typically, a peak plasma concentration of about 40µg per ml is achieved 2 hours after a single 2 g dose, falling to about 10µg/ml at 24 hours and 2.5 g per ml at 48 hours; concentrations above 8µg per ml are maintained by daily maintenance dose of 1 g. Comparable concentrations are achieved with equivalent intravenous dose. The plasma elimination half life of Tinidazole is 12 to 14 hours. Tinidazole is widely distributed and concentrations similar to those in plasma have been achieved in bile, breast milk, cerebrospinal fluid, saliva, and a variety of body tissues, it crosses the placenta readily. Only 12% is reported to be bound to plasma proteins. An active hydroxyl metabolite has been identified. Unchanged drug and metabolites are excreted in the urine and to lesser extent in the faeces.

 

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects.

 

STORAGE

Store in an airtight container, protected from heat and light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

 

Manufactured by

GREENFIELD PHARMACEUTICAL (JIANG SU) CO., LTD.

NO.38, TAI JIU ROAD, TAI ZHOU, JIANG SU PROVINCE, P.R.CHINA

 

Marketed by

BAKAN GIZO NIG. LTD.

(PHARMACEUTICAL DIVIDION)

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