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Oraf
Hallmark Pharmaceuticals Ltd.
Generic: Fluconazole
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Oraf. Please consult your doctor.
CONSULT YOUR DOCTOR
Oraf is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.
SAFE IF PRESCRIBED
Oraf is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
UNSAFE
Oraf may cause side effects which could affect your ability to drive.
Oraf may cause dizziness or seizures. This may affect your ability to drive.
UNSAFE
Oraf is probably unsafe to use in patients with kidney disease and should be avoided. Please consult your doctor.
Caution to be advised in patients with impaired renal function.
CAUTION
Oraf should be used with caution in patients with liver disease. Dose adjustment of Oraf may be needed. Please consult your doctor.
Medicine Overview of Oraf 50mg/5ml Powder for Suspension
Introduction
Oraf belongs to a group of medicines called antifungals. It works by stopping the growth of fungus and is used to treat infections of the mouth, throat, vagina and other parts of the body including fingernails and toenails. It kills fungi by destroying the fungal cell membrane. Oraf should be taken in the dose and duration as prescribed by your doctor. It should be swallowed whole and can be taken with or without food. The dosage and length of treatment will depend on the condition you are being treated for. Sometimes this will be in cycles of use and non-use....
... Show moreUses of Oraf
- Fungal infections
Side effects of Oraf
Common
- Headache
- Nausea
- Rash
- Vomiting
How to use Oraf
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. Oraf may be taken with or without food, but it is better to take it at a fixed time.
How Oraf works
Oraf is an antifungal medication. It kills and stops the growth of the fungi by destroying its cell membrane, thereby treating your skin infection.
What if you forget to take Oraf?
If you miss a dose of Oraf, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- Your doctor has prescribed Oraf to cure your infection and improve symptoms.
- Do not skip any doses and finish the full course of treatment even if you feel better.
- Use a reliable method of contraception to prevent pregnancy while taking this medicine.
- Your doctor may check your liver function before starting treatment and regularly thereafter. Inform your doctor if you notice yellowing of eyes or skin, dark urine, or stomach pain.
- Inform your doctor if you develop severe skin rash like blistering of the skin along with fever.
Brief Description
Indication
Cryptococcal meningitis, Candidiasis, Tinea pedis, Tinea cruris, Tinea corporis, Vaginal candidiasis, Onychomycosis, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Mucosal candidiasis, Candidal balanitis, Dermatophytosis
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...
... Show moreChild 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 Usual dose.
Contraindication
Hypersensitivity.
Mode of Action
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.
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
Side Effect
>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.
Pregnancy Category Note
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...
... Show moreInteraction
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.
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