Flamyd Gel Vaginal Gel
Metronidazole 0.75% Vag prep
.75%
Incepta Pharmaceuticals Ltd.
| Pack size | 30gm tube |
|---|---|
| Unite Price | 50.00 BDT |
Indications
Flamyd Gel Vaginal Gel is used for:
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or gardnerella vaginitis).
Adult Dose
Topical/Cutaneous
Bacterial vaginosis
Adult: As 0.75% gel: Apply to affected area intravaginally one applicatorful once daily or bid for 5 days.
Child Dose
Renal Dose
Administration
Contra Indications
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
Precautions
Metronidazole should be given with caution in the following conditions- anaemia or other blood disorders, liver disease, disease of the nervous system, seizures etc.
Lactation: Excreted in human milk; caution advised
Pregnancy-Lactation
Pregnancy
There are no data on the use of metronidazole intravaginal in pregnant women
Human systemic data
Blood levels following vaginal administration are lower than those achieved with oral metronidazole; Cmax and AUC of intravaginally administered metronidazole is 2% and 4%, respectively, of those following oral administration
There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole systemically during pregnancy
Many studies included first trimester exposures
One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in-utero; however, these findings were not confirmed
In addition, >10 randomized, placebo-controlled clinical trials enrolled >5000 pregnant women to assess the use of systemic antibiotic treatment (including metronidazole) for bacterial vaginosis on the incidence of preterm delivery; most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy
Three studies conducted to assess the risk of infant cancer following systemic metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited
Lactation
There is no information on the presence of metronidazole in human milk, or the effects on the breast-fed child, or the effects on milk production following intravaginal administration
Following PO administration, concentrations in human milk are similar to concentrations in plasma; since some metronidazole is systemically absorbed following vaginal administration, excretion in human milk is possible
Because of the potential for tumorigenicity shown in animal studies, breastfeeding is not recommended during treatment with metronidazole intravaginal and for 2 days after therapy ends
Breastfeeding women may choose to pump and discard milk for the duration of therapy, and for 24 hr after therapy ends and feed her infant stored human milk or formula
Interactions
Concurrent use w/ disulfiram may produce psychotic reactions. May potentiate the effect of oral anticoagulants. May increase risk of lithium toxicity. May reduce the renal clearance resulting to increased toxicity of 5-fluorouracil. May increase serum levels of ciclosporin. May increase plasma levels of busulfan resulting to severe busulfan toxicity. Enhanced metabolism w/ phenobarbital and phenytoin resulting to decreased serum concentrations.
Side Effects
Side effects of Metronidazole 0.75% Vag prep :
>10%
Bacterial infection (12%)
1-10%
Headache (7%), Pruritus (6%), Abdominal pain (5%), Nausea (3%), Dysmenorrhea (3%), Pharyngitis (2%), Rash (1%), Diarrhea (1%), Breast pain (1%), Metrorrhagia (1%)
Mode of Action
Metronidazole is converted to reduction products that interact w/ DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.
Note
Flamyd Gel .75% Vaginal Gel generic name is Metronidazole 0.75% Vag prep. Flamyd Gel .75% Vaginal Gel is manufactured by Incepta Pharmaceuticals Ltd.Flamyd Gel is availble in all over Bangladesh.
Mes BD drug index information on Flamyd Gel Vaginal Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.