SOLOSEC Oral granules (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Lupin Pharmaceuticals, Inc.

Λέξεις κλειδιά

27437-051

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

1. Indications and Usage

1.1 Bacterial Vaginosis SOLOSEC is indicated for the treatment of bacterial vaginosis in adult women [see Use in Specific Populations (8.1) and Clinical Studies (14)]. 1.2 Usage To reduce the ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended dosage of SOLOSEC is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3)]. Sections ...

3. Dosage Forms and Strengths

Oral Granules: 2 g, of off-white to slightly yellowish granules with 4.8 g net weight, packed in a unit-of-use child-resistant foil packet.

4. Contraindications

Hypersensitivity SOLOSEC is contraindicated in patients who have shown hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.

5. Warnings and Precautions

5.1 Vulvo-Vaginal Candidiasis The use of SOLOSEC may result in vulvo-vaginal candidiasis. In controlled clinical trials of nonpregnant women with bacterial vaginosis, vulvo-vaginal candidiasis developed ...

6.1. Clinical Trials Experience

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been reported during use of other formulations of secnidazole 2 g outside of the United States. Because these reactions are reported voluntarily from a population of ...

7. Drug Interactions

7.1 Oral Contraceptives There was no clinically significant drug interaction between secnidazole and the combination oral contraceptive, ethinyl estradiol plus norethindrone [see Clinical Pharmacology ...

8.1. Pregnancy

Risk Summary Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, there were no ...

8.2. Lactation

Risk Summary There is no information on the presence of secnidazole in human milk, the effects on the breast- fed child, or the effects on milk production. Other nitroimidazole derivatives are present ...

8.4. Pediatric Use

The safety and effectiveness of SOLOSEC in pediatric patients below the age of 18 years have not been established.

8.5. Geriatric Use

Clinical studies with secnidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11. Description

The active ingredient in SOLOSEC Oral Granules is secnidazole (also named 1-(2- hydroxypropyl)-2-methyl-5-nitroimidazole and 1-(2-methyl-5-nitro-1H-imidazol-1-yl) propan-2- ol), a nitroimidazole ...

12.1. Mechanism of Action

SOLOSEC is a nitroimidazole antimicrobial drug [See Microbiology (12.4)].

12.2. Pharmacodynamics

Secnidazole exposure-response relationships and the time course of pharmacodynamic response are unknown. Cardiac Electrophysiology The effect of secnidazole on the QTc interval was evaluated in a Phase ...

12.3. Pharmacokinetics

A single oral dose of 2 g of SOLOSEC in healthy adult female subjects, following an overnight fast and admixed with (4 oz) of applesauce, resulted in a mean (SD) secnidazole peak plasma concentration (C ...

12.4. Microbiology

Mechanism of Action Secnidazole is a 5-nitroimidazole antimicrobial. 5-nitroimidazoles enter the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Nitroimidazoles, which have similar chemical structures to secnidazole, have been associated with tumors affecting the liver, lungs, mammary, and lymphatic tissues in animals after lifetime exposures. ...

14. Clinical Studies

Two randomized placebo-controlled clinical trials (Trial 1 and Trial 2) with similar designs were conducted to evaluate the efficacy of SOLOSEC 2 gram for the treatment of bacterial vaginosis. A diagnosis ...

16.1. How Supplied

SOLOSEC (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. SOLOSEC is supplied in a unit-of-use package containing one packet of granules in ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Instruct the patient: To sprinkle the entire contents of the packet ...