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Cosmos focussing on new product development & continual improvement of existing products & processes, this facility is  equipped with small scale manufacturing equipment for all dosage forms except parenterals.

Diconazol Tablets 50mg

PRESENTATION:

  • Diconazol® - 150 Capsules: White fine powder filled in Blue/Blue hard gelatin capsule printed 'COSMOS COSMOS' on body and cap. Each capsule contains: Fluconazole 150mg.
  • Diconazol® - 50 Tablets: Blue, circular, biconvex film coated tablet plain on both sides. Each film coated tablet contains: Fluconazole 50mg.
  • Diconazol® - 150 Tablets: Blue, oval-shaped, biconvex, film coated tablet plain on both sides. Each film coated tablet contains: Fluconazole 150mg.
  • Diconazol® - 200 Tablets: Blue, circular, biconvex film coated tablet embossed 'C' on one side and a breakline on the other side. Each film coated tablet contains: Fluconazole 200mg.

CLINICAL  PHARMACOLOGY:

Fluconazole is a triazole antifungal agent which inhibits fungal cytochrome P450- dependent enzymes resulting in impairment of ergosterol synthesis in fungal cell membranes. Fluconazole is active against Blastomyces dermatitidis, Candida spp., Coccidioides immitis, Cryptococcus neoformans, Epidermophyton spp., Histoplasma capsulatum, Microsporum spp., and Trichophyton spp.

Pharmacokinetics:

Fluconazole is well absorbed following oral administration achieving a bioavailability of 90% or more. Mean peak plasma concentrations of 6.72mg per mL have been reported in healthy subjects following a 400mg oral dose. Peak concentrations are reached within 1 to 2 hours of oral administration. Multiple dosing leads to increases in peak plasma concentrations; steady-state concentrations are reached in 5 to 10 days but may be attained on day 2 if a loading dose is given. Fluconazole is widely distributed and the apparent volume of distribution is close to that of total body water. Concentrations in breast milk, joint fluid, saliva, sputum, vaginal fluids, and peritoneal fluid are similar to those achieved in plasma. Concentrations in the CSF range from 50 to 90% of plasma concentrations, even in the absence of meningeal inflammation. Protein binding is only about 12%.
About 80% of a dose is excreted unchanged in the urine and about 11% as metabolites. The elimination half-life of fluconazole is about 30 hours and is increased in patients with renal impairment. Fluconazole is removed by dialysis.

USES:

Diconazol® is used for superficial mucosal candidiasis (oropharyngeal, oesophageal, or vaginal)  and for fungal skin infections. It is also given for systemic infections including systemic candidiasis, coccidioidomycosis and cryptococcosis. Its use in the treatment of acute cryptococcosis meningitis has gained a lot of importance in the management of opportunistic infections in HIV/AIDS patients.

DOSAGE AND ADMINISTRATION:

  • Superficial mucosal candidiasis:
  • Oropharyngeal candidiasis:50 - 100mg daily treatment for 7 to 14 days.
  • Atrophic oral candidiasis associated with dentures:50 - 100mg daily treatment 14 days.
  • Other mucosal candidiasis: e.g. oesophagitis 50 - 100mg daily treatment for 14  to 30 days.

DICONAZOL®
Vaginal candidiasis or candidal balanitis                150mg oral single dose
Dermatophytosis, pityriasis  versicolor and Candida skin and infections.                    50mg daily for 6 weeks
Cryptococcal meningitis and                           Initial 400mg then 200mg to
other cryptococcal infections                         400mg daily for 6 to 8 weeks
Prevention of relapse following acute cryptococcal meningitis in AIDS patients                    100 - 200mg daily
Prophylaxis against fungal infections in immunocompromised patients                    50 - 400mg daily

Children:
Age: over 4 weeks: 
Superficial Infections: 3mg per kg body weight daily (6mg per kg  loading dose if necessary).
Systemic Infections: 6 - 12mg per kg body weight daily.
Prophylaxis in immunocompromised children: 3 - 12mg per kg bodyweight daily.
Infants under 2 weeks: Above doses every 72 hours.
2 and 4 weeks: Above doses every 48 hours.
Do not exceed a maximum of 400mg daily or 12mg per kg bodyweight at appropriate intervals.

CONTRA-INDICATIONS AND  WARNINGS:
Precautions:
Fluconazole should be used with caution in patients with impaired renal or hepatic functions.
Use in Pregnancy: Its use is not recommended in pregnancy however benefits should be weighed against the risks.
Adverse Effects: Adverse effects reported with Fluconazole most commonly affects the gastro-intestinal tract and include abdominal pain, diarrhoea, flatulence, nausea, and vomiting. Other adverse effects include headache, dizziness, leucopenia, thrombocytopenia, and raised liver enzyme values. Serious hepatotoxicity has been reported in patients with severe underlying disease. Anaphylaxis and angioedema have been reported rarely. Skin reactions are rare but exfoliative cutaneous reactions such as toxic epidermal necrolysis and Stevens-Johnson Sydrome have occured, more commonly in patients with AIDS.
Interactions: Concomitant administration of rifampicin with fluconazole results in reduced plasma concentrations of fluconazole. Increases in terfenadine concentrations following high doses of fluconazole have been associated with ECG abnormalities. Fluconazole may also reduce the clearance of theophylline.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 25ºC. Protect from light. Keep all medicines out of the reach of children.

LEGAL CATEGORY:
Prescription Only Medicine (POM)
®Regd.TM  Ref. No.: INS217/03.08

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