SOLOSEC- secnidazole granule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SECNIDAZOLE (UNII: R3459K699K) (SECNIDAZOLE - UNII:R3459K699K)

Available from:

Ropack Inc.

INN (International Name):

SECNIDAZOLE

Composition:

SECNIDAZOLE 2 g in 4.8 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SOLOSEC is indicated for the treatment of bacterial vaginosis in adult women [see Use in Specific Populations ( 8.1) and Clinical Studies ( 14)]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Hypersensitivity SOLOSEC is contraindicated in patients who have shown hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives. 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 reproducti

Product summary:

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 an individual carton. Each packet contains 4.8 g of granules containing 2 g secnidazole. SOLOSEC is supplied as follows: NDC 27437-051-01 carton containing one unit-of-use 2 g packet 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].

Authorization status:

New Drug Application

Summary of Product characteristics

SOLOSEC- SECNIDAZOLE GRANULE
ROPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLOSEC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SOLOSEC.
SOLOSEC (SECNIDAZOLE) ORAL GRANULES
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
SOLOSEC
is a nitroimidazole antimicrobial indicated for the treatment of
bacterial vaginosis in adult women. ( 1)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of SOLOSEC and other antibacterial
drugs, SOLOSEC should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by
bacte ria.
DOSAGE AND ADMINISTRATION
Administer a single 2-gram packet of granules once orally, without
regard to the timing of meals. ( 2.1)
Sprinkle entire contents of packet onto applesauce, yogurt or pudding
and consume all of the mixture within 30 minutes
without chewing or crunching the granules. A glass of water may be
taken after the administration of SOLOSEC to aid in
swallowing. ( 2.2)
SOLOSEC is not intended to be dissolved in any liquid. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil
packet. ( 3)
CONTRAINDICATIONS
History of hypersensitivity to secnidazole, other ingredients of the
formulation, or other nitroimidazole derivatives. ( 4)
WARNINGS AND PRECAUTIONS
Vulvo-vaginal candidiasis may develop with SOLOSEC and require
treatment with an antifungal agent ( 5.1)
Potential Risk for Carcinogenicity: Carcinogenicity has been seen in
mice and rats treated chronically with
nitroimidazole derivatives, which are structurally related to
secnidazole. It is unclear if the positive tumor findings in
lifetime rodent studies indicate a risk to patients taking a single
dose of SOLOSEC to treat bacterial vaginosis. Avoid
chronic use ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions observed in clinical trials (incidence
≥ 2%) were vulvo-vaginal candidiasis, headache,
nausea, dysgeusia, vomiti