Valena-001
Generic Name
Clotrimazole Vaginal Cream
Manufacturer
MediLife Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| valena 001 vaginal cream | ৳ 425.00 | N/A |
Description
Overview of the medicine
Valena-001 Vaginal Cream contains Clotrimazole, an antifungal medication used to treat vaginal yeast infections. It works by stopping the growth of yeast that causes the infection.
Uses & Indications
Dosage
Adults
One applicator full (approximately 5g of cream containing 50mg Clotrimazole) intravaginally, preferably at bedtime, for 3 to 7 consecutive days, depending on the severity of the infection and specific product instructions.
Elderly
No specific dose adjustment is generally required for elderly patients.
Renal_impairment
No dose adjustment needed due to minimal systemic absorption.
How to Take
For intravaginal use only. Insert one applicator full of cream deep into the vagina, preferably at bedtime. Read and follow the instructions provided with the applicator.
Mechanism of Action
Clotrimazole inhibits the biosynthesis of ergosterol, a primary component of fungal cell membranes. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death.
Pharmacokinetics
Onset
Symptom relief may begin within a few days; complete clearance of infection may take 3-7 days.
Excretion
Excreted in feces and urine as inactive metabolites.
Half life
Not well-defined for topical application due to minimal systemic absorption.
Absorption
Minimal systemic absorption (approximately 3-10%) occurs after vaginal administration. Peak plasma concentrations are very low.
Metabolism
Metabolized in the liver to inactive metabolites when absorbed systemically.
Side Effects
Contraindications
- Hypersensitivity to Clotrimazole or any other ingredient of the cream.
- Known allergy to other azole antifungals.
Drug Interactions
Vaginal contraceptive products
Clotrimazole vaginal cream may damage latex contraceptives (condoms, diaphragms), reducing their effectiveness.
Tacrolimus and Sirolimus (oral)
May increase plasma concentrations of these immunosuppressants due to inhibition of CYP3A4, although systemic absorption of topical Clotrimazole is minimal. Monitor levels if co-administered.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overdose is unlikely with topical vaginal application. In case of accidental ingestion, seek medical attention. Symptoms of accidental oral overdose might include nausea, vomiting, or abdominal discomfort.
Pregnancy & Lactation
Pregnancy Category B. Consult your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding. Generally considered safe in the second and third trimesters. Avoid use in the first trimester unless absolutely necessary. Small amounts may be excreted in breast milk, but risk to the infant is low due to poor absorption.
Side Effects
Contraindications
- Hypersensitivity to Clotrimazole or any other ingredient of the cream.
- Known allergy to other azole antifungals.
Drug Interactions
Vaginal contraceptive products
Clotrimazole vaginal cream may damage latex contraceptives (condoms, diaphragms), reducing their effectiveness.
Tacrolimus and Sirolimus (oral)
May increase plasma concentrations of these immunosuppressants due to inhibition of CYP3A4, although systemic absorption of topical Clotrimazole is minimal. Monitor levels if co-administered.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overdose is unlikely with topical vaginal application. In case of accidental ingestion, seek medical attention. Symptoms of accidental oral overdose might include nausea, vomiting, or abdominal discomfort.
Pregnancy & Lactation
Pregnancy Category B. Consult your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding. Generally considered safe in the second and third trimesters. Avoid use in the first trimester unless absolutely necessary. Small amounts may be excreted in breast milk, but risk to the infant is low due to poor absorption.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, when stored as recommended.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Clotrimazole has been extensively studied in numerous clinical trials and is a well-established and effective treatment for vaginal candidiasis. Studies demonstrate high cure rates and good tolerability.
Lab Monitoring
- No specific lab monitoring is typically required for topical Clotrimazole.
Doctor Notes
- Ensure patients understand the importance of completing the full course of treatment.
- Advise patients on proper application technique using the provided applicator.
- Counsel patients on avoiding potential re-infection or recurrence factors, such as tight clothing and unprotected intercourse during treatment.
Patient Guidelines
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
- Avoid sexual intercourse during treatment to prevent re-infection of partner and ensure treatment effectiveness.
- Do not use tampons, douches, spermicides, or other vaginal products during treatment.
Missed Dose Advice
If a dose is missed, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double dose to make up for a missed one.
Driving Precautions
Valena-001 Vaginal Cream is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Wear loose-fitting cotton underwear to allow air circulation and keep the area dry.
- Avoid tight clothing and synthetic fabrics.
- Practice good personal hygiene.
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Global Brand Names
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