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butoconazole (Rx, OTC)Brand and Other Names:Femstat 3, Gynazole 1, more...Mycelex-3

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal cream

  • 2%
more...

Candidiasis

Gynazole: 1 applicatorful of cream (approximately 5 g of the cream) intravaginally as single dose

Mycelex 3: 1 applicator full of cream into the vagina qHS for 3 consecutive days; may need to extend treatment for up to 6 days in pregnant women (2nd or 3rd trimester only)

Safety & efficacy not established

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Adverse Effects

Frequency Not Defined

Pelvic/abd pain

Vulvar/vaginal irritation

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Warnings

Contraindications

Hypersensitivity to drug

1st trimester of pregnancy

Cautions

Hypersensitivity to other azoles

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known if excreted in breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Peak Plasma Time: 12-24 hr

Absorption: systemic (1.7%)

Mechanism of Action

Imidazole; alters fungal cell membrane permeability

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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