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Solosec is a brand name for Secnidazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) Treatment of trichomoniasis in patients 12 years of age and older. ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Bacterial Vaginosis (female patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. 1 ) Trichomoniasis (patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals.
Treat sexual partners with the same dose and at the same time. 2 ) 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.
3 ) SOLOSEC is not intended to be dissolved in any liquid. 3) ] . 3) ] . 2) ] . 3 Instructions for the Preparation and Administration of SOLOSEC Open the SOLOSEC packet by folding over the corner (marked by an arrow) and tearing across the top.
3) ] . The granules will not dissolve. 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. The granules are not intended to be dissolved in any liquid.
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1)] Bacterial Vaginosis : Most common adverse reactions observed in clinical trials of bacterial vaginosis (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
1 ).
Trichomoniasis :
Most common adverse reaction observed in the clinical trial of trichomoniasis (incidence ≥ 2%) was vulvovaginal candidiasis. 1 ). gov/medwatch. 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 drug and may not reflect the rates observed in practice.
Bacterial Vaginosis The safety data described below reflect exposure to 629 patients, of whom 558 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in four clinical trials of female patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and two uncontrolled safety trials (Trial 3 n=321, Trial 4 n=40).
Most Common Adverse Reactions in Trials 1 and 2 All patients in Trial 1 and Trial 2 received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC in patients aged 18 to 54 years.
Trial 2 evaluated a 2 g dose (n=125) in patients aged 18 to 54 years. Patients in the placebo-controlled trials were primarily Black or African American (54%) or Caucasian (41%). Among 197 patients treated with a single 2 g dose of SOLOSEC in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients.
Table 1 displays the most common adverse reactions (≥ 2% in SOLOSEC-treated patients) in these two trials. There were no deaths in the trials. 5) Most Common Adverse Reactions in Trial 3 Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients.
5 WARNINGS AND PRECAUTIONS Vulvovaginal Candidiasis: This may develop with SOLOSEC and require treatment with an antifungal agent. 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. 1 Vulvovaginal Candidiasis The use of SOLOSEC may result in vulvovaginal candidiasis.
9%) subjects who received placebo. 1) ] . Symptomatic vulvovaginal candidiasis may require treatment with an antifungal agent. 2 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 of these nitroimidazoles indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis. 3 Risk of Development of Drug Resistance Prescribing SOLOSEC in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
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CONTRAINDICATIONS SOLOSEC is contraindicated:
In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives. 2) ] . History of hypersensitivity to secnidazole, or other nitroimidazole derivatives. ( 4 ) Patients with Cockayne syndrome. 2 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4%) were the most common adverse reactions reported in this trial. Two SOLOSEC-treated patients in Trial 3 discontinued due to vulvovaginal candidiasis. Most Common Adverse Reactions in Trial 4 In Trial 4, the safety of SOLOSEC was evaluated in a multicenter, uncontrolled, open-label study evaluating the safety and tolerability of SOLOSEC in 40 pediatric patients between the ages of 12 and less than 18 years old all of whom were treated with a 2 g single dose of SOLOSEC.
The overall safety findings of a SOLOSEC 2 g dose in patients aged 12 to 17 years are consistent with findings in adult patients aged 18 to 65 years old. There were no deaths, severe adverse reactions, or discontinuations due to adverse reactions.
Adverse reactions occurring in at least one SOLOSEC-treated pediatric patient included: nausea and abdominal pain. 3%) patients completed the 'Test of Cure' (TOC) visit. In this trial, 74 patients received a single 2-gram oral dose of SOLOSEC, and 73 patients received placebo.
7 years, with a range of 15 to 65 years. 2%). , baseline to TOC visit, one SOLOSEC-treated patient was discontinued from the study due to nausea and productive cough. 9%) in the placebo group reported adverse reactions, respectively. 7%) in the SOLOSEC-treated group and in none of the patients in the placebo group.
2 Postmarketing Experience The following adverse reactions have been reported during use of SOLOSEC and other 2 g formulations of secnidazole outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse Reactions with SOLOSEC Nervous System Disorders:
Dysgeusia Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. 3) ] . Metronidazole, Another Nitroimidazole Agent, Structurally Related to Secnidazole Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, another nitroimidazole agent structurally related to secnidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) [ see Contraindications (4) ].