Solosec

What is Solosec?

Solosec is a prescription medicine that is used to treat vaginal infections.

Description

The active ingredient in SOLOSEC Oral Granules is secnidazole (also named 1-(2- hydroxypropyl)-2-methyl-5-nitroimidazole and 1-(2-methyl-5-nitro-1H-imidazol-1-yl) propan-2- ol), a nitroimidazole antimicrobial.

The molecular formula of secnidazole is C7H11N3O3, the molecular weight is 185.18 and the chemical structure is:

Structure of Secnidazole

Each packet of SOLOSEC contains 4.8 g of off-white to slightly yellowish granules, which contain 2 g of secnidazole and the following inactive ingredients: Eudragit NE30D (ethyl acrylate methyl methacrylate copolymer), polyethylene glycol 4000, povidone, sugar spheres, and talc. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Before taking Solosec, tell your doctor:

• If you are allergic to Solosec; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed for at least 4 days after using Solosec.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Solosec with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Solosec?

• Tell all of your health care providers that you take Solosec. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take Solosec for longer than you were told by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Solosec while you are pregnant.

How is Solosec best taken?

Use Solosec as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Sprinkle the contents of the packet on applesauce, yogurt, or pudding. Granules will not dissolve. Take your dose within 30 minutes of mixing. Do not chew or crush the granules. You may drink a glass of water after taking your dose to help you swallow Solosec.
• Do not mix with any liquid.

What do I do if I miss a dose?

• Only 1 dose of Solosec is needed. If you miss your dose, take it as soon as you think about it.

What are the side effects of Solosec that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Vaginal itching or discharge.

What are some other side effects of Solosec?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.
• Diarrhea.
• Stomach pain.
• Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Solosec?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

• Principal Display Panel – Individual Carton
• SOLOSEC® 2g
• secnidazole
• NDC 27437-051-01
• Oral Granules
• 1 Unit-of-Use Packet
• Rx Only
• LUPIN PHARMACEUTICALS, INC.

SRC: NLM .