solosec

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. ( 2.1 ) 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. ( 2.2 ) 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. ( 2.3 ) SOLOSEC is not intended to be dissolved in any liquid. ( 2.3 ) 2.1 Recommended Dosage for Bacterial Vaginosis The recommended dosage of SOLOSEC for the treatment of bacterial vaginosis in female patients 12 years of age and older is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3) ] . 2.2 Recommended Dosage for Trichomoniasis The recommended dosage of SOLOSEC for the treatment of trichomoniasis in patients 12 years of age and older is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3) ] . Since trichomoniasis is a sexually transmitted disease, treat sexual partners with the same dose and…

The following important adverse reactions are discussed in greater detail in other sections of labeling: Vulvovaginal Candidiasis [Warnings and Precautions (5.1)] 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. ( 6.1 ). Trichomoniasis : Most common adverse reaction observed in the clinical trial of trichomoniasis (incidence ≥ 2%) was vulvovaginal candidiasis. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free-phone 1-833-EVFMBIO (1-833-383-6246) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 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…

SOLOSEC is contraindicated: In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives. In patients with Cockayne syndrome: Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to secnidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2) ] . History of hypersensitivity to secnidazole, or other nitroimidazole derivatives. ( 4 ) Patients with Cockayne syndrome. ( 4 , 6.2 )

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 (12.3) ] . SOLOSEC can be co-administered with combination oral contraceptives (e.g., ethinyl estradiol plus norethindrone). 7.2 Alcohol Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during SOLOSEC therapy and for 2 days after treatment is stopped. Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol [see Dosage and Administration (2.3) , Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ] .