Protogyn (Tinidazole): Your Comprehensive Guide to Treating Bacterial and Parasitic Infections

Tinidazole

Properties:

Protogyn (Tinidazole) is an antiprotozoal and anaerobic antibacterial drug. It exerts its effect by penetrating the microbial cell and then damaging the DNA strands or inhibiting their synthesis.

Protogyn is effective against:

• Protozoa: Trichomonas vaginalis, Entamoeba histolytica, and Giardia lamblia.
• Anaerobic bacteria: Bacteroides fragilis, other Bacteroides species, Fusobacterium species, Peptococcus, Clostridium, Eubacterium, Veillonella, and Gardnerella vaginalis.

Indications:

Protogyn is used for the treatment of the following infections:

Anaerobic Bacterial Infections:

• Bacterial septicemia
• Chronic sinusitis, pneumonia, and lung abscess.
• Post-operative abdominal infections
• Gynecological infections.
• Bacterial vaginosis.
• Peritonitis.
• Cellulitis.
• Osteomyelitis caused by Bacteroides.

Protozoal Infections:

• Urogenital trichomoniasis in both males and females.
• Giardiasis.
• Intestinal amoebiasis.
• Hepatic amoebiasis.
• Acute ulcerative gingivitis.

Prophylaxis:

For the prevention of post-operative infections caused by anaerobic bacteria, especially those associated with colonic, gastrointestinal, and gynecological surgery.

Dosage and Method of Administration:

Protogyn is recommended to be taken during or after meals.

• Anaerobic Bacterial Infections: Initial dose is 2 g on the first day, followed by 1 g daily as a single dose or 500 mg twice daily. Duration of treatment is 5-6 days, but clinical assessment should determine the treatment period.
  • Data are not available to allow dosage recommendations for children under 12 years of age for the treatment or prophylaxis of anaerobic bacterial infections.
• Bacterial vaginosis: A single dose of 2 g.
• Acute ulcerative gingivitis: A single dose of 2 g.
• Urogenital trichomoniasis: Adults: A single dose of 2 g. Children: A single dose of 50-75 mg/kg. In some cases, the dose should be repeated once.
• Giardiasis: Adults: A single dose of 2 g. Children: A single dose of 50-75 mg/kg. In some cases, the dose should be repeated once.
• Intestinal amoebiasis: Adults: 2 g daily for 2-3 days. The treatment period can be extended to 6 days if the 3-day course is ineffective. Children: A dose of 50-60 mg/kg daily for 3 days.
• Hepatic amoebiasis: Adults: 1.5-2 g daily for 3-6 days. Children: A dose of 50-60 mg/kg daily for 5 days.
• Prophylaxis in abdominal surgery: A single dose of 2 g taken approximately 12 hours before surgery.

Contraindications:

• Patients with a prior history of or current blood dyscrasia.
• Patients with organic neurological disorders.
• Patients with known hypersensitivity to the drug.
• During the first trimester of pregnancy, and during lactation.

Side Effects:

• Mild gastrointestinal side effects, including: loss of appetite, metallic taste, diarrhea, nausea, and vomiting.
• Hypersensitivity reactions may occur rarely, including skin rash, pruritus (itching), urticaria, and angioedema.
• Other effects: Dizziness, vertigo, ataxia, headache, fatigue, and dark urine. A transient decrease in white blood cell count may also occur.

Overdose:

There is no specific antidote for tinidazole overdose. Treatment is symptomatic and supportive. Gastric lavage may be useful. Tinidazole is easily removed by dialysis.

Precautions:

• During tinidazole use, neurological disturbances such as dizziness, vertigo, ataxia, and peripheral neuropathy have been observed. Therefore, if any abnormal neurological signs occur during therapy, treatment should be discontinued.
• Concomitant use of tinidazole with alcoholic beverages may lead to abdominal cramps, flushing, and vomiting due to a disulfiram-like reaction.
• Vaginal Candidiasis Tinidazole use may lead to vaginal candidiasis. In a clinical study of 235 women receiving tinidazole for bacterial vaginosis, 11 women (4.7%) developed vaginal fungal infection.
• Drug Resistance Prescribing Protogyn in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions:

• Alcohol: Alcoholic beverages should be avoided during tinidazole therapy because a disulfiram-like reaction may occur.
• Coumarin-type anticoagulants: Tinidazole may potentiate the effect of coumarin-type anticoagulants.

Storage Conditions:

Store at a temperature up to 30°C.

Pharmaceutical Forms:

Protogyn film-coated tablets: Each film-coated tablet contains Tinidazole B.P. 500 mg in packs of 4 tablets.

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(This is a medicine – Do not leave medicines within reach of children)

• The medicine is a product that affects your health, and its consumption contrary to instructions exposes you to danger.
• Follow strictly the doctor’s prescription, the method of use advised, and the instructions of the pharmacist who dispensed it.
• The doctor and the pharmacist are the experts on medicine, its benefits, and its risks.
• Do not interrupt the period of treatment prescribed for you on your own.
• Do not repeat dispensing the medicine without a medical prescription.

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Al Hayat Pharmaceutical Industries Co. Ltd. P.O. Box 1564 Amman 11118 Jordan