Secnidazole

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 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 bacteria. ( 1.3 ) 1.1 Bacterial Vaginosis SOLOSEC is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older [see Use in Specific Populations (8.1) and Clinical Studies (14) ]. …

• 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
• 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
• 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
• SOLOSEC is not intended to be dissolved in any liquid
• 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 ]
• 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 ]
• Since trichomoniasis is a sexually transmitted disease, treat sexual partners with the same dose and at the same time [see Indications and Usage ] . …

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. Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet. ( 3 )

• The safety and effectiveness of SOLOSEC
• For the treatment of bacterial vaginosis have been established
• In pediatric patients aged 12 to 17 years old
• Use of SOLOSEC in this age group is supported by evidence from a multicenter, open-label safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse Reactions ] and evidence from adequate and well-controlled studies in adult women [see Clinical Studies ]
• The safety and effectiveness of SOLOSEC
• For the treatment of trichomoniasis have been established
• In pediatric patients aged 12 to 17 years old. …

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

• 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 of SOLOSEC onto applesauce, yogurt or pudding and take all the mixture within 30 minutes without chewing or crunching the granules
• That after consuming the mixture, they may take a glass of water to aid in swallowing
• That SOLOSEC is not intended to be dissolved in any liquid
• Advise the patient that SOLOSEC may be taken without regard to the timing of meals. …

• CONTRAINDICATIONS 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 ] . …

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. …

Vulvovaginal Candidiasis: This 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 ) 5.1 Vulvovaginal Candidiasis The use of SOLOSEC may result in vulvovaginal candidiasis. …

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 ). …

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 adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose (see Data ). …

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].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.