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Flugal dzKvbvRj BDGmwc


Fluconazole USP

COMPOSITION Dcv`vb
Flugal 50 Capsule : Each capsule contains Fluconazole USP 50 mg. dzMvj 50 Kvcmyj: cwZwU Kvcmyj AvQ dzKvbvRj BDGmwc 50 wg.Mv.|

Flugal 150 Capsule: Each capsule contains Fluconazole USP 150 mg. dzMvj 150 Kvcmyj: cwZwU Kvcmyj AvQ dzKvbvRj BDGmwc 150 wg.Mv.|

Flugal 200 Capsule: Each capsule contains Fluconazole USP 200 mg.

dzMvj 200 Kvcmyj: cwZwU Kvcmyj AvQ dzKvbvRj BDGmwc 200 wg.Mv.|
Flugal Oral suspension: Each 5 ml reconstituted suspension contains Fluconazole USP 50 mg.

dzMvj Iivj mvmcbkb: mvmcbkb cZi ci cwZ 5 wg.wj.-G AvQ dzKvbvRj BDGmwc 50 wg.Mv.|
PHARMACOLOGY dvgvKvjwR
Fluconazole is a triazole antifungal drug which acts by inhibition of the ergosterol component of the fungal cell membrane. It is
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active against a broad spectrum of fungal pathogens and is available for oral use. Following oral administration, absorption is
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rapid and extensive (>90%). Bioavailability is the same in the fasting and fed states. The bioavailability of Fluconazole is
unaffected by gastric pH. The plasma half life is approximately 30h. The plasma portein binding of Fluconazole is low, at 11%
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and the drug is widely distributed throughout the body. Most of the dose of Fluconazole is excreted unchanged in the urine, the (Plasma half-life) cvq 30 NUv| gv 11% cvRgv cvwUb hy _vK Ges kixii me Qwoq co| dzKvbvRj-Gi gvvi ewki
reminder of the dose being eliminated in the urine as metabolites. fvMB g~i mv_ AcwiewZZ Aevq wbtmwiZ nq Ges evwK Ask gUvevjvBU wnmve wbtmwiZ nq|

INDICATION wb`kbv
Fluconazole is indicated in the treatment of acute or recurrent vaginal candidiasis, mucosal candidiasis (as oropharyngeal dzMvj Zxe A_ev cybivgYRwbZ (recurrent) fRvBbvj KvbwWwWqvwmm, wgDKvmvj KvbwWwWqvwmm (hgb-IivdvwibwRqvj
candidiasis, oesophagitis, candiduria), systemic candidiasis and cryptococcal infections (including meningitis). KvbwWwWqvwmm, BmvdMvBwUm, KvbwWWywiqv), wmwgK KvbwWwWqvwmm Ges wcUvKvm msgY (gwbbRvBwUm mn) wb`wkZ|

DOSAGE AND ADMINISTRATION gvv I eenviwewa


Adults cv eq`i Rb:
Since oral absorption is rapid and almost complete, the daily dose of Fluconazole is the same for oral and intravenous gyLi gvag MnY Kiv dzKvbvRj Gi kvlY Lye `Z Ges cvq m~Y nIqvq gyL LvIqvi Rb A_ev AvBwfi gvag MnYi
administration. dzKvbvRj Gi WvR GKB iKg wb`wkZ|
Oropharyngeal Candidiasis:The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day,
IivdvwibwRqvj KvbwWqvwmm: 1g w`b 200 wg.Mv. nvi i Ki cieZxZ 100 wg.Mv. nvi `wbK GK evi Ki 7-14 w`b MnY KiZ
followed by 100 mg once daily for 7-14 days.
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Esophageal Candidiasis:The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day,
followed by 100 mg once daily for 2-3 weeks.
BmvdvwRqvj KvbwWqvwmm: 1g w`b 200 wg.Mv. nvi i Ki cieZxZ 100 wg.Mv. nvi `wbK GK evi Ki 2-3 mvn MnY KiZ ne|
Systemic Candidiasis and Cryptococcal Meningitis: 400 mg daily followed by 200 mg once daily. The recommended duration of wmwgK KvbwWqvwmm Ges wcUvKvj gvwbbRvBwUm: cv_wgKfve 400 wg.Mv. nvi i Ki cieZxZ 200 wg.Mv. `wbK 1 evi 2-3
treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks. mvni Rb MnY KiZ ne| wcUvKvj gvwbbRvBwUm Gi cv_wgK Aevq 10-12 mvn ch wPwKrmv Pvwjq hZ ne| AvwKDU
Acute or recurrent vaginal candidiasis: Single dose of 150 mg. I wiKviU fvRvBbvj KvbwWwWqvwmm: 150 wg.Mv. GKK gvvq MnY KiZ ne| g~bvjxi msgY Ges cwiUvbvBwUm: 50-200 wg.Mv.
Urinary Tract Infections and Peritonitis: 50 to 200 mg once daily. `wbK 1 evi|
Prophylaxis in Patients Undergoing Bone Marrow Transplantation: 400 mg once daily. Aw gv cwZvcbi c~et h mKj ivMxi Aw gv cwZvcb cqvRb Zv`i wPwKrmvi AvM 400 wg.Mv. `wbK 1 evi|
wk`i Rb:
Children IivdvwibwRqvj KvbwWqvwmm: wk`i Rb wb`wkZ eenvi gvv 1g w`b 6 wg.Mv./KwR IRb wnme, cieZxZ 3 wg.Mv./KwR gvvq
Oropharyngeal Candidiasis:The recommended dosage of Fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on Pvwjq hZ ne| cvq 2 mvn ch Gfve wPwKrmv Pvwjq hZ ne|
the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of BmvdvwRqvj KvbwWqvwmm: wk`i Rb wb`wkZ eenvi gvv 1g w`b 6 wg.Mv./KwR IRb wnme, cieZxZ `wbK 3 wg.Mv./KwR gvvq
relapse. IRb wnme Pvwjq hZ ne|
Esophageal Candidiasis: Recommended dosage of Fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once wcUvKvj gvwbbRvBwUm: : wk`i Rb wb`wkZ eenvi gvv 1g w`b 6 wg.Mv./KwR IRb wnme cv_wgK wPwKrmv i KiZ ne|
daily.
`wbK mevP 12 wg.Mv./KwR gvvq 3 mvn ch MnY Kiv hZ cvi Ges Gfve wPwKrmv 10-12 mvn ch Pvwjq hZ ne|
Cryptococcal meningitis: Initial therapy should be started with 6 to 12 mg/kg daily. Doses up to 12 mg/kg/day may be used for
three weeks and treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks.
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CONTRAINDICATION dzKvbvRj Gi cwZ AwZ mse`bkxj ivMx`i Ges hKZi AmyZvq GB Ilya eenvi Kiv hve bv|
Fluconazole is contraindicated to patients hypersensitive to this drug and in advanced liver disease.
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PRECAUTION ei AgZvq, Mfvevq, b`vbKvj Ges wjfvi GbRvBgi ewZ mveavbZv MnY Kiv DwPZ| b`vbKvix gvq`i dzKvbvRj
Caution should be taken in renal impairment, pregnancy and breast feeding and in raised liver enzymes. The use of Fluconazole wb`wkZ bq|
in lactating mothers is not recommended.
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SIDE EFFECTS ewg ewg fve, cvKjxi A^vQ`Zv, Wvqwiqv, cvKjxZ evZvm Rgv, gvS gvS wjfvi GbRvBgi A^vfvweKZv, Lye Kg dzmKzwo,
Nausea, abdominal discomfort, diarrhoea and flatulence, occasionally abnormalities of liver enzymes; rarely rash; angioedema GbwRIBwWgv Ges GbvdvBjwm `Lv w`Z cvi|
and anaphylaxis reported.
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DRUG INTERACTION
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Rifampicin reduces plasma concentration of Fluconazole. Effects of nicoumalone, phenytoin and warfarin are enhanced. Plasma
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concentrations of sulphonylureas & theophyline are possibly increased.

STORAGE msiY
Avjv I Av`Zv _K `~i, 30 m. Zvcgvvi wbP msiY Kib| AeenZ mvmcbkb 7 w`bi ewk eenvi Kiv DwPr bq| iwdRviUi
Store below 30C. Protect from light & moisture. Remaining reconstituted suspension should not be used after 7 days. If it is
(2m. - 8m.) msiY Kij 14 w`b ch mswgwkZ mvmcbkb eenvi Kiv hZ cvi| mKj Ilya wk`i bvMvji evBi ivLyb|
kept under freezing temperature (2C - 8C) , it can be used for 14 days. Keep out of the reach of children.
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HOW SUPPLIED
dzMvj 50 Kvcmyj: cwZwU ev AvQ 30 wU Kvcmyj wevi cvK-G|
Flugal 50 Capsule: Box containing 30 capsules in blister pack.

dzMvj 150 Kvcmyj: cwZwU ev AvQ 20 wU Kvcmyj wevi cvK-G|


Flugal 150 Capsule: Box containing 20 capsules in blister pack.

Flugal 200 Capsule : Box containing 12 capsules in blister pack.


dzMvj 200 Kvcmyj: cwZwU ev AvQ 12 wU Kvcmyj wevi cvK-G|
Flugal Oral suspension : Bottle of dry powder for reconstitution to 35 ml suspension.
dzMvj Iivj mvmcbkb: cwZwU evZj AvQ 35 wg.wj. mvmcbkb cZi Rb
cqvRbxq cwigvY cvDWvi|
4000006374