TERCONAZOLE Vaginal suppository (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Taro Pharmaceuticals U.S.A., Inc.
Λέξεις κλειδιά
51672-1330
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Storage and Handling
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
1. Description
Terconazole Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg 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 Suppositories, 80 mg is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus <em>Candida ...
4. Contraindications
Patients known to be hypersensitive to terconazole or to any of the components of the suppositories.
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 vulvovaginal use only. Terconazole is not for ophthalmic or oral use. Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported ...
6.3. Laboratory Tests
If there is 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 this product 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 (25× the recommended intravaginal human dose of the suppository ...
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 suppositories did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported ...
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 Terconazole Vaginal Suppository (80 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis ...
11. How Supplied
Terconazole Vaginal Suppositories 80 mg are available as 2.5 g, elliptically-shaped white to off-white suppositories in packages of three with a vaginal applicator. NDC 51672-1330-3 Mfd. by: Taro Pharmaceuticals ...