Terconazole 4 mg/g
terconazole · CREAM · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Terconazole is a cream containing terconazole at 4 mg/g, taken vaginal. Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Terconazole
- Generic Name
- terconazole
- NDC Code (Product)
0168-0346- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Strength
- 4 mg/g
- Dosage Form
- CREAM
- Route
- VAGINAL
- Marketing Status
- Application #
- ANDA076712
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 02/18/2005
Recall History
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
Dosage & Administration
DOSAGE AND ADMINISTRATION One full applicator (5 g) of terconazole vaginal cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal cream 0.4% is not affected by menstruation.
Warnings
WARNINGS Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
Contraindications
CONTRAINDICATIONS Patients known to be hypersensitive to terconazole or to any of the components of the cream.
Drug Interactions
Drug Interactions The therapeutic effect of terconazole is not affected by oral contraceptive usage.
Adverse Reactions
ADVERSE REACTIONS Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching. Post-marketing Experience The following adverse drug reactions have been first identified during post-marketing experience with terconazole vaginal cream 0.4%. Because these reactions are reported voluntarily from a population of uncertain…
Frequently Asked Questions
What is Terconazole used for?
Terconazole contains terconazole. It is a cream taken vaginal. Consult your doctor for specific uses.
Is Terconazole a controlled substance?
Terconazole is not classified as a controlled substance by the DEA.
What is the generic name for Terconazole?
The generic name for Terconazole is terconazole. There are 2 other brand versions of terconazole.
What is the NDC code for Terconazole 4 mg/g?
The NDC (National Drug Code) for Terconazole 4 mg/g is 0168-0346, listed by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC.