Dosing & Uses
AdultPediatric
Dosage Forms & Strengths
vaginal cream
- 0.4%
- 0.8%
suppository
- 80mg
Candidal Vulvovaginitis
0.4% vaginal cream: 1 full applicator intravaginally qHS x7 days OR
0.8% cream: 1 full applicator intravaginally qHS x3 days
Suppository: Insert 1 suppository (80mg) intravaginally qHS x3 days
Safety & efficacy not established
Adverse Effects
>10%
Headache
1-10%
Abdominal pain
Chills
Fever
Dysmenorrhea
Vulvar/vaginal burning
Dysmenorrhea
1% (limited to important or life-threatening)
Vulvar itching, soreness, edema, or discharge
Polyuria
Burning or itching of penis of sexual partner
Flu-like syndrome
Postmarketing Reports
General: Asthenia, Influenza-like illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise
Immune: Hypersensitivity, anaphylaxis, face edema
Nervous: Dizziness
Respiratory: Bronchospasm
Skin: Rash, toxic epidermal necrolysis, rrticaria
Warnings
Contraindications
Hypersensitivity
Cautions
Discontinue if irritation or sensitization occurs
Perform/repeat microbiological studies (KOH smear and/or cultures) in patients not responding to terconazole to rule out other pathogens
Anaphylaxis and toxic epidermal necrolysis (TENs) reported; discontinued if anaphylaxis or TENs develops
Product is petroleum-based, which may damage latex or rubber condoms or diaphragms (separate use by 3 days)
Discontinue use if toxic epidermal necrolysis occurs; institute supportive therapy and monitoring; do not reinstitute therapy
If flu-like symptoms or chills, fever occur, discontinue therapy and do not reinitiate
Pregnancy & Lactation
Pregnancy Category: C
Lactation: unknown
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.
Pharmacology
Mechanism of Action
Unknown; may alter fungal cell membrane permeability
Pharmacokinetics
Absorption: Systemic absorption after vaginal administration may depend on presence of a uterus; 5-8% absorption in women who had a hysterectomy versus 12-16% in nonhysterectomy women
Excretion: Feces & urine
Images
No images available for this drug.
Patient Handout
A Patient Handout is not currently available for this monograph.
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.
View explanations for tiers and restrictions
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. |
Non-Medicare Plans Medicare Plans
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.