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August, 2010
25th Annual Report 2009-10 |
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May 31, 2010
Audited Financial Result For March 2010 Qtr |
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January 27, 2010
Unaudited Financial Result For December 2009 Qtr |
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| GVFLUC Suspension |
| Description |
GVFLUC contains as its
active ingredient Fluconazole 150mg as capsules, as 50mg per 5ml as
powder for oral
suspension on reconstitution with water. |
| Pharmacokinetics |
Fluconazole, a number of the triazole class
of antifungal agents, is a potent and selective inhibitor of
fungal enzymes necessary for the synthesis
of ergosterol.
After oral administration fluconazole is
well absorbed. Oral absorption is not affected by concomitant
food intake. Peak
plasma concentrations occur between 0.5 and 1.5 hours post dose with plasma
elimination half-life of approximately 30
hours. Plasma concentrations are proportional to dose. 90%
steady state levels
are reached by day 4-5 with multiple once daily dosing,
Fluconazole achieves
good penetration in all body fluids studied. The levels of fluconazole In
saliva
and septum are similar
to plasma levels In patients with fungal meningitis, fluconazole levels in the
CSF are approximately
80% of the corresponding plasma levels. High skin concentrations of
fluconazole, above
serum concentrations, are achieved in the stratum corneum, epidermis dermis
and eccrine sweat.
The major route of excretion is renal, with approximately 80% of the administered
dose appearing in the
urine as unchanged drug. Fluconazole clearance is proportional to the
creatinine clearance.
There is no evidence of circulating metabolites. The long plasma elimination
half-life provides the
basis tor single dose therapy for genital candidiasis and once daily dosing for
other indications. |
| Indications |
Therapeutic
Indications:
GVFLUC is indicated for
the treatment of the following conditions:
- Genital Candidiasis, Vaginal
Candidiasis: Acute or recurrent. Candidal balanitis. The treatment of
partners who present
with symptomatic genital Candidiasis should be considered.
- Mucosal
Candidiasis: It includes oropharyngeal, oesophageal, non-invassiv broncho
pulmonary
infections,
candiduria, mucocutaneous and chronic oral atrophic Candidiasis.
- Tinea pedis, tinea
corporis, tinea cruris, tinea versicolor and dermal candila infections.
- Systemic Candidiasis: It includes
candidaemia, disseminated Candidiasis. other forms of invasive
Candidal infectio, infections of the
peritoneum, endccardium and pulmonary and urinary tracts.
- Crytococcosis:
It includes Cryptococcal meningitis, pulmonary & cutaneous infections.
- Prevention of
fungal infection in patients with malignancy, AIDS, in intensive care units and
patients
on immunosuppressive
drugs.
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| Contra Indications |
| GVFLUC should not be
used in patients with known hypersensitivity to Fluconazole, Co-
administration of
terfenadine or cisapride is contra-indicated in patients receiving GVFLUC. |
| Dosage and Adminstration |
The daily dose of
GVFLUC should be based on the nature and severity of the fungal infection. IN ADULTS:
- Candidal Vaginitis or
balanitis: 150mg single dose
- Mucosal Candidiasis:
50mg once
daily for 7-14 days (oropharyngeal candidiasis) 50mg once daily for 14 days
(atrophic oral candidiasis) 50mg once daily for 14-30 days (oesophagitis)
- Tinea pedis corporis:
50 mg daily for 2 to 4 weeks.
- Candidaemia: 400mg on first day fallowed by
200mg daily based on clinical response.
- Cryptococcal
meningitis. 400mg on first day followed by 200mg daily at least for 6-8 weeks.
- AIDS 100mg - 200mg
daily
- Fungal Infection 50 to
400mg once daily based on developing fungal infection.
- Bone marrow transplantation: 400mg daily
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| USE IN CHILDREN |
| As with similar infections in adults, the
duration of treatment is based on the clinical and mycological
response. |
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