Fungifix 50 mg
Fluconazole
Category: Capsule
Manufacturer: Doctor Tims Pharmaceuticals Ltd.
Doctor Tims Pharmaceuticals Ltd.
Allopathic
MFG. Licence No. Biological
199
MFG. Licence No. Non-Biological
436
Address
Plot No. S-60 & 136 (Part), BSCIC I/A, Konabari
Medicine Selling service is not available yet.
Uses of Fungifix:
- Fungal infections
Cryptococcal meningitis, Candidiasis, Tinea pedis, Tinea cruris, Tinea corporis, Vaginal candidiasis, Onychomycosis, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Mucosal candidiasis, Candidal balanitis, Dermatophytosis
Hypersensitivity.
Drugs for subcutaneous and mycoses
Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.
How to use
Fluconazole:
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it.
Fluconazole may be taken with or without food, but it is better to take it at a fixed time.
Administration:
May be taken with or without food
Reconstitution: Powd for oral susp: Add 24 mL of distilled or purified water to the container labeled as containing 0.35 g or 1.4 g of fluconazole to provide a susp containing 50 mg or 200 mg per 5 mL, respectively. Shake vigorously to suspend the powd.
Adult Dose:
Oral
Oropharyngeal Candidiasis
200 mg PO on Day 1, THEN 100 mg qDay
Treatment should be continued for at least 2 weeks to decrease likelihood of relapse
Esophageal Candidiasis
200 mg PO on Day 1, THEN 100 mg qDay; doses up to 400 mg/day may be used based on patient’s response
Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms
Vaginal candidiasis; Candidal balanitis
Uncomplicated: 150 mg PO as a single dose
Complicated: 150 mg PO q72hr for 3 doses
Recurrent: 150 mg PO qDay for 10-14 days followed by 150 mg once weekly for 6 months
Cutaneous candidiasis; Dermatophytosis; Pityriasis versicolor
Adult: 50 mg once daily for up to 6 wk.
Systemic candidiasis ; Cryptococcal infections
Adult: Initially, 400 mg, followed by 200-400 mg once daily. Treatment duration is based on clinical and mycological response, but is usually at least 6-8 wk in cryptococcal meningitis. To prevent relapse after a primary course of treatment for acute cryptococcal meningitis in AIDS patients: 100-200 mg daily.
Prophylaxis of fungal infections in immunocompromised patients
Adult: 50-400 mg daily.
Prophylaxis in patients undergoing bone marrow transplantation:
The recommended daily dosage is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start Fluconazole Injection, USP prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Child Dose:
Child: PO 3–12 mg/kg/day, max 600 mg/day q24h
Max 800–1,000 mg/day may be used for some CNS fungal infections
Age Average Weight Dose/Day
1 year: 9 kg - ½ spoonful
1-2 years: 12 kg- 1 spoonful
2-3 years: 14 kg- 1½ spoonful
3-4 years: 16 kg- 2 spoonful
Renal Dose:
Renal impairment: Haemodialysis patients: Usual dose given after each session.
CrCl (ml/min) Dosage Recommendation
<50 and not receiving dialysis 50% of the usual dose.
>50 Usual dose.
May increase plasma concentrations of oral hypoglycaemics (e.g. tolbutamide, glyburide, glipizide), phenytoin, theophylline, tofacitinib, rifabutin. May increase prothrombin time w/ anticoagulants. May cause significant increase in ciclosporin levels in renal transplant patients w/ or w/o renal impairment. Rifampicin reduces fluconazole levels. May increase risk of nephrotoxicity w/ tacrolimus. May increase the effect of short-acting benzodiazepines (e.g. midazolam).
Potentially Fatal: Increased risk of cardiac arrhythmias or QT prolongation w/ terfenadine, cisapride, astemizole, pimozide, quinidine, halofantrine and erythromycin.
Hypersensitivity.
Common
- Headache
- Nausea
- Rash
- Vomiting
>10%
Headache (2-13%)
1-10%
Nausea (2-7%),Abdominal pain (2-6%),Diarrhea (2-3%),Rash (2%),Vomiting (2-5%)
Frequency Not Defined
QT prolongation,Torsades de pointes,Alopecia,Anaphylactic reactions,Angioedema,Cholestasis,Dizziness,Dyspnea,Hepatic failure,Hepatitis,Hypertriglyceridemia,Hypokalemia,Increased alkaline phosphatase,Increased ALT/AST,Jaundice,Leukopenia,Pallor,Seizures,Stevens-Johnson syndrome,Taste perversion,Thrombocytopenia,Toxic epidermal necrolysis
Potentially Fatal: Hepatotoxicity; rarely anaphylaxis; Stevens-Johnson syndrome.
US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Precaution:
Renal or hepatic impairment. May prolong QT interval. Pregnancy, lactation. CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.
Lactation
Enters breast milk; use caution
In the event of overdosage, supportive measures and symptomatic treatment with gastric lavage if necessary may be adequate. As fuconazole is excreted largely in the urine, forced volume diuresis would probably increase the elimination rate. A three hour session of haemodialysis decreases plasma levels by approximately 50%
Keep in a dry place away from light and heat. Keep out of the reach of children.
Drugs for subcutaneous and mycoses
Fluconazole decreases ergosterol synthesis by interfering w/ cytochrome P450 activity, thus inhibiting cell membrane formation of susceptible fungi including B. dermatitidis, Candida spp., C. immitis, C. neoformans, Epidermophyton spp., H. capsulatum, Micosporum spp., Trichophyton spp.
Pregnancy
Single maternal PO dose of 150 mg for vaginal candidiasis
Results of a Danish study concludes there is a possible increased risk of miscarriage; women who are pregnant or actively trying to get pregnant should ask their physician about alternative treatments
Spontaneous abortion between 7 and 22 weeks' gestation occurred significantly more often in women exposed to oral fluconazole than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); fluconazole was also compared with intravaginal azole antifungals to account for confounding by candidiasis, again, the oral drug was associated with significantly increased risk for spontaneous abortion - JAMA. 2016;315(1):58-67
CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur
All other indications
Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus
A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester
Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with 400-800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose
Reported anomalies are similar to those seen in animal studies and consist of brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease
Lactation
Secreted in human milk at concentrations similar to maternal plasma concentrations; use caution (AAP Committee states "compatible with nursing")
Samm Care