Secnidazole

Secnidazole (SOLOSEC) is a nitroimidazole antimicrobial.

What are the uses of this medicine?

This medicine is used to treat:

• bacterial vaginal infections in adult women.
• trichomoniasis, a common sexually transmitted infection (STI), in adults. Sexual partners should be treated at the same time. People should avoid having sex until they and their sex partners are treated (for example, when therapy has been completed and any symptoms have resolved) to help prevent reinfection.

How does this medicine work?

SOLOSEC is a nitroimidazole antimicrobial drug. Secnidazole, like other 5‑nitroimidazoles, enters the bacterial and Trichomonas cells where the nitro group is reduced by nitroreductase enzyme(s) leading to the production of radical anions and a series of intermediates, depletion of thiols, DNA damage, and death of susceptible isolates of Gram positive bacteria, Gram negative bacteria and T.vaginalis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• are allergic to secnidazole or other nitroimidazole medicines.

What drug interactions can this medicine cause?

• SOLOSEC can be co-administered with combination oral contraceptives (e.g., ethinyl estradiol plus norethindrone).
• 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage for Bacterial Vaginosisː

• The recommended dosage of SOLOSEC for the treatment of bacterial vaginosis in adult women is a single 2-gram packet of granules taken once orally, without regard to the timing of meals

Recommended Dosage for Trichomoniasisː

• The recommended dosage of SOLOSEC for the treatment of trichomoniasis in adults is a single 2-gram packet of granules taken once orally, without regard to the timing of meals.
• Since trichomoniasis is a sexually transmitted disease, treat sexual partners with the same dose and at the same time.

Administration

• Take SOLOSEC exactly as your healthcare provider tells you to.
• Do not take SOLOSEC more often than it is prescribed.
• Open the SOLOSEC packet by folding over the corner (marked by an arrow) and tearing across the top.
• Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding.
• 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.
• SOLOSEC may be taken before or after or during a meal.
• Take 1 entire packet of SOLOSEC at one time. Do not take only part of the medicine and save a portion for later.
• Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet.

This medicine is available in fallowing brand namesː

• SOLOSEC

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• vomiting
• diarrhea
• abdominal pain
• vaginal itching
• a bad, bitter or metallic taste in your mouth (dysgeusia).

What special precautions should I follow?

• The use of SOLOSEC may result in vulvovaginal candidiasis. This may develop with SOLOSEC and require treatment with an antifungal agent.
• 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.
• Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC because the following side effects may happen:
• Nausea
• Vomiting
• Diarrhea
• stomach (abdominal pain) cramps
• dizziness
• headache

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: secnidazole
• Inactive ingredients: Eudragit NE30D (ethyl acrylate methyl methacrylate copolymer), polyethylene glycol 4000, povidone, sugar spheres, and talc.

Who manufactures and distributes this medicine?

• Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202

What should I know about storage and disposal of this medication?

• Store SOLOSEC at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep SOLOSEC and all medicines out of the reach of children.

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