TOP-3 KIT Tablet

For the syndromic management of vaginal discharge. Clinical manifestations range from asymptomatic carriage to severe inflammatory signs and symptoms. Approximately one third or asymptomatic female carriers become symptomatic within 6 months. Typical symptoms include vaginal or introital itch plus discharge. The classical clinical feature-bright red vaginal mucosa and a yellow or green frothy, malodorous discharge are often evident but some cases merely present as a mildly inflamed vagina of nonspecific appearance, or even without any abnormalities.

Direction for use: For oral use only.

Take Azithromycin 1 tablet on empty stomach, 1 hour before lunch.

Fluconazole 1 tablet to be taken after lunch.

Secnidazole 2 tablets to be taken as a single dose after dinner at bed time.

TOP-3 KIT is meant for one day’s treatment as single dose of Azithromycin, Fluconazole and Secnidazole.

Dosage and administration

Azithromycin 1g tablet as a single oral dose under supervision. Fluconazole 150mg orally as a single dose. Secnidazole 2g single dose (administration of 2 Secnidazole 1g tablets).

Administration

The absorption of Azithromycin is hampered by presence of food in the stomach. Hence Azithromycin to be administered 1 hour before meals. Fluconazole administration is not hampered by presence of food. 1 tablet of Fluconazole to be administered after lunch. 2 tablets of Secnidazole to be administered after the food preferably at the bed time. This shall avoid the unwanted G.I disturbances.

Azithromycin: in patients with known hypersensitivity to Azithromycin, Erythromycin, or any macrolide antibiotic.

Fluconazole: in patients with known hypersensitivity to Fluconazole or to any excipients in the product. There is no information regarding cross hypersensitivity between Fluconazole and other azole antifungal agents, use with caution in patients with hypersensitivity to other azoles.

Secnidazole: As in case of other Nitroimidazole derivative, the drug should not be administered during the first trimester of pregnancy, or lactation or in individual hypersensitive to Nitroimidazole derivatives.

Secnidazole:

The clinical studies have been shown that Secnidazole is characterized by very good tolerance and no serious adverse reactions have been reported to date. The following side-effects may be observed with Secnidazole as with all nitroimidazole derivatives & are rarely serious Most frequent side-effects: Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, and stomatitis. Occasional side-effects: Vertigo, ataxia and motor incoordination, paresthesia, and peripheral neuropathy. With Secnidazole, gastrointestinal disorders e.g. nausea, vomiting, epigastric pain, etc. have been reported in very rare cases.

Azithromycin:

Adults: Cardiovascular: Palpitations, chest pain, G.I: Dyspepsia, gastritis, constipation, flatulence, anorexia, vomiting, cholestatic jaundice. Genitourinary: Monilia, vaginitis, nephritis. Nervous System: Dizziness, hyperkinesias, headache, vertigo, agitation, nervousness, somnolence. General: Fever, fatigue, malaise. Allergic: Rash, photosensitivity, angioedema. Skin & appendages: Pruritus, urticaria. Special Senses: Conjunctivitis.

Fluconazole:

Fluconazole is usually live well tolerated. The commonly reported side effects are abdominal pain, headache, skin eruption and diarrhea, nausea, vomiting. Clinical adverse events were more frequently reported in patients with HIV infection in patients infected with non-HIV. However, the model was similar. In rare vans, anaphylaxis has been reported.

Secnidazole: Administration of Secnidazole with disulfiram is not recommended: confusional state & paranoid reaction may occur. Use of Secnidazole simultaneously with warfarin requires close monitoring: increased effect of oral anticoagulants and of the hemorrhagic risk is likely.

Azithromycin: Aluminium & Magnesium containing antacids reduce Cmax by 24% but not AUC. No effect on absorption with 800mg Cimetidine 2 hours prior to AZITROCIN. No effect on plasma levels or pharmacokinetics of single I.V. dose theophylline. No effect on prothrombin time response to a single dose warfarin. Elevated digoxin levels. Ergotamine or dihydroergatamine: Acute ergot toxicity with severe peripheral vasospasm & dysesthesia, decreases clearance of triazolam. Elevations of serum carbamazepine, terfenadine, cyclosporine, hexobarbital, and phenytoin levels.

Fluconazole: Anticoagulants: Fluconazole prolongs prothrombin time of coumarin drugs therefore requires careful monitoring. Cyclosporine: Concomitant administration of cyclosporine and Fluconazole may result in the increase of cyclosporine. Phenytoin: Fluconazole significantly increases the rate and AUC phenytoin resulting toxicity of phenytoin. Oral hypoglycemic agents: Concomitant administration of oral hypoglycemic and Fluconazole such as sulphonylurea, diabetic patients results in the highest concentration in plasma and metabolism reduced antidiabetic agents. Rifampicin: Concomitant administration of fluconazole and rifampicin decreases the AUC of Fluconazole 20%.. Theophylline: Fluconazole may increase serum concentrations of theophylline. Careful monitoring is recommended when both drugs are co-administered.

Secnidazole: Secnidazole may be prescribed in pregnancy after the first trimester. As with other similar drugs, Secnidazole should not be administered during the first trimester of pregnancy or during lactation because Secnidazole is found in placenta and breast milk.

Azithromycin: Use during pregnancy only if clearly needed. Exercise caution in nursing mothers.

Fluconazole: Pregnancy: There are no adequate and well-controlled studies in pregnant women. Fluconazole should be used during pregnancy only if the benefits outweigh the risks.

Breastfeeding: Since the drug is secreted in breast milk, it should not be used in nursing women.

This kit treats vaginal discharge. This treatment is recommended on the principle of “Syndromic Management of Sexually Transmitted Diseases”. The syndromic approach has identified 7 common presenting symptoms. Vaginal discharge is one of the commonest presenting symptoms in women.

Microbiology:

Causative Organisms: The three most common cause of vaginitis are:

Bacteria-N. gonorrhoea, C.trachomatis, Gardnerella vaginalis.

Fungus-Candida albicans (Monilia)

Parasite-Trichomonas vaginalis

Anti-infective action:

Based on causative infective organisms of vaginal discharge the TOP-3 KIT contains:

Antibacterial- Azithromycin

Antifungal- Fluconazole

Antitrichomonal- Secnidazole

Azithromycin eradicated N.gonorrhoea and C.trachomatis

Fluconazole eradicated Candida albicans.

Secnidazole is effective against Trichomonas vaginalis and bacteria causing Bacterial vaginosis

(Gardnerella vaginalis and anaerobes).