TERCONAZOLE Vaginal cream (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
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1. Description
Terconazole vaginal cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, <em>cis</em>1[<em>p</em>[[2(2,4-Dichlorophenyl) ...
2. Clinical Pharmacology
Absorption Following a single intravaginal application of a suppository containing 240 mg <sup>14</sup>C-terconazole to healthy women, approximately 70% (range: 64 to 76%) of terconazole remains in the ...
3. 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 ...
4. Contraindications
Patients known to be hypersensitive to terconazole or to any of the components of the cream.
5. Warnings
Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
6.1. General
For vaginal use only. Terconazole Vaginal Cream 0.4% is not for ophthalmic or oral use. Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms ...
6.3. Laboratory Tests
If there is a lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
6.4. Drug Interactions
The therapeutic effect of terconazole is not affected by oral contraceptive usage.
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Studies to determine the carcinogenic potential of terconazole have not been performed. Mutagenicity Terconazole was not mutagenic when tested <em>in vitro</em> for induction of microbial ...
6.7. Pregnancy
Teratogenic Effects Pregnancy Category C. There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (100x the intravaginal human dose of the 0.4% vaginal cream ...
6.9. Nursing Mothers
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first ...
6.10. Pediatric Use
Safety and efficacy in children have not been established.
6.11. Geriatric Use
Clinical studies of terconazole vaginal cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical ...
7. 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 ...
9. Overdosage
In the rat, the oral LD<sub>50</sub> values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD<sub>50</sub> values for the male and female dog were ≅1280 and ≥640 mg/kg, ...
10. 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 ...
11. How Supplied
Terconazole Vaginal Cream 0.4% is available in: NDC 0168-0346-46 45 gram tube, with a measured dose applicator. E. FOUGERA & CO. A division of Fougera, PHARMACEUTICALS INC., Melville, New York 11747
12. Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].