Orogurd 2% w/w (Oral Gel)
15 gm tube: ৳ 60.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Miconazole nitrate |
| Company | Eskayef pharmaceuticals ltd |
Categories
- Derivatives
- Antifungal Medication
- Oral Gel
- Topical Cream
Age Group
- Infants (4-24 months)
- Children (2 years and older)
- Adults
Dosage Form
- Oral Gel
- Cream
Indications
- Treatment of oral and gastrointestinal candidiasis
- Eradication of fungal colonization
- Treatment of super infections due to gram-positive bacteria
- Dermatomycoses such as tinea pedis, tinea corporis, tinea manuum, tinea cruris, candidial infections, tinea versicolor, skin infections, perianal infections, stomatitis angularis, balanoposthitis, otitis externa
Pharmacodynamics
- Antifungal activity against dermatophytes and yeasts
- Antibacterial activity against certain gram-positive bacilli and cocci
- Inhibition of demethylation step in ergosterol biosynthesis
- Disruption of fungal cell membrane leading to cell death
Pharmacokinetics
- Low oral bioavailability (25-30%)
- Systemic absorption after oral gel administration
- Binding to plasma proteins (88.2%)
- Metabolism of absorbed portion
- Excretion in urine (less than 1%)
- Terminal plasma half-life (20-25 hours)
Administration
- Application 2-4 times a day directly to affected area
- Removal of dental prosthesis at night and brushing with the gel
- Continued treatment for at least a week after symptoms disappear
Interactions
- Avoidance of concomitant treatment with Terfenadine, Astemizole, or Cisapride
- Potential delay of Phenytoin and Cyclosporine metabolism
Contraindications
- Known hypersensitivity to the active ingredient
Side Effects
- Occasional nausea and vomiting
- Diarrhea with long term use
- Rare allergic reactions
Pregnancy & Lactation
- No safety information during pregnancy
- Caution in nursing women
Precautions & Warnings
- Monitoring of anti-coagulant effect and phenytoin plasma levels
- Caution in infants and young children to prevent throat obstruction
Overdose Effects
- Symptomatic and supportive treatment
- Vomiting and diarrhea
Therapeutic Class
- Aural Anti-fungal preparations
Storage Conditions
- Dry place away from light and heat
- Keep out of the reach of children
Usability
- Relief of symptoms in 2-3 days
- Clinical improvement soon after treatment begins
- Lesions usually disappear after 2-5 weeks
Preventive Treatment Duration
- 10 days to prevent relapse
- Two weeks for Candida infections, tinea cruris and corporis
- One month for tinea pedis
Absorption in Gastrointestinal Tract Candidosis
- Low absorption from intestinal tract
- 20 mg per kg body weight per day
- Daily dose not to exceed 250 mg (10 ml gel)
Missed Dose
- Apply missed dose as soon as remembered
- Omit missed dose if close to next dosing time
Application of Miconazole Cream
- Twice daily for tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis
- Once daily for tinea versicolor
- Sparingly in intertriginous areas
Rapid Alleviating Effect
- On pruritus which often accompanies infections
Reduction of Possibility of Recurrence
- Two weeks for Candida infections, tinea cruris and corporis
- One month for tinea pedis
Efficacy in Candidiasis
- Very rapid alleviating effect on pruritis
Antidote for Overdose
- Not available
Avoidance of Anticoagulant Interaction
- Monitor and titrate anti-coagulant effect
Caution in Drug Excretion via Breast Milk
- Exercise caution in nursing women
Effect on Fungal Cell Membrane
- Disruption leading to cell death
Caution in Infants and Young Children
- To ensure gel does not obstruct the throat
Immune Response
- Rare allergic reactions
Drug Excretion
- Less than 1% excreted unchanged in urine
Potential Toxicity
- Potential toxicity of Phenytoin and Cyclosporine when metabolism is delayed
Application Frequency
- 2-4 times a day for localized lesions of the mouth
Duration of Treatment for Recurrence Prevention
- 10 days to prevent relapse
- Two weeks for Candida infections, tinea cruris and corporis
- One month for tinea pedis
Binding to Plasma Proteins
- Primary binding to serum albumin and red blood cells
Metabolism of Absorbed Miconazole
- Largely metabolized after systemic absorption
Elimination Half-life
- Similar in any renal-impaired patient
Effect on Ergosterol Biosynthesis
- Inhibition of a demethylation step
Disruption of Fungal Cell Membrane
- Causing holes to appear and cell death
Storage Precaution
- Keep away from light and heat
Child-Safe Storage
- Keep out of the reach of children