Exomax Injection
Fluconazole 0.2% IV
200mg
Claris Lifesciences Ltd
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Indications
Exomax Injection is used for:
Systemic fungal infections, Cryptococcal meningitis, Disseminated candidiasis, Fungal UTIs, Oral or vaginal thrush
Adult Dose
Intravenous
The daily dose of Fluconazole Injection, for the treatment of infections should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis:
The recommended dosage 200 mg on the first day, followed by 100 mg once daily. Treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis:
The recommended dosage is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic candidiasis; Cryptococcal infections
The recommended dosage is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy.
The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative.
The recommended dosage of Fluconazole Injection, USP for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once 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
Intravenous
Oropharyngeal candidiasis:
The recommended dosage of Fluconazole Injection, in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis:
The recommended dosage is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms.
Systemic Candida infections:
The daily doses of 6-12 mg/kg/day have been used in children.
Cryptococcal meningitis:
The recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily.
A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative.
For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of Fluconazole Injection, USP is 6 mg/kg once daily.
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.
Administration
Contra Indications
- Known hypersensitivity
- Advanced liver disease
Precautions
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
Pregnancy-Lactation
Interactions
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.
Adverse Effects
Side effects of Fluconazole 0.2% IV :
>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.
Mechanism 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.
Note
Exomax 200mg Injection manufactured by Claris Lifesciences Ltd. Its generic name is Fluconazole 0.2% IV. Exomax is availble in Nepal.
Farmaco Nepal drug index information on Exomax Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.