SOLOSEC secnidazole

Get an overview of SOLOSEC (secnidazole granule), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in SOLOSEC can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as SOLOSEC.

Drug Basics

Brand Name: SOLOSEC

Generic Name: SECNIDAZOLE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: GRANULE

Packager: Lupin Pharmaceuticals, Inc.

Data Current As Of: 2021-02-11

Indications & Usage

SOLOSEC® is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in adult women. (1)

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.

bacterial vaginosis

SOLOSEC is indicated for the treatment of bacterial vaginosis in adult women [see Use in Specific Populations (8.1) and Clinical Studies (14)].

usage

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Drug Interactions

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).

Patient Counseling Information

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.

Lactation

Advise women not to breastfeed during treatment with SOLOSEC and to discontinue breastfeeding for 96 hours following the administration of SOLOSEC. Also, advise a nursing mother that she may choose to pump and discard her milk for 96 hours after administration of SOLOSEC and feed her infant stored human milk or formula [see Use in Specific Populations (8.2)].

Vulvo-Vaginal Candidiasis

Advise the patient that use of SOLOSEC may result in vulvo-vaginal candidiasis that may require treatment with an antifungal agent.

Drug Resistance

Patients should be counseled that antibacterial drugs including SOLOSEC should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When SOLOSEC is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by SOLOSEC or other antibacterial drugs in the future.

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc

Baltimore, MD 21202

© 2019 Symbiomix Therapeutics, LLC (A Lupin Company). All Rights Reserved

Solosec® is a registered trademark of Symbiomix Therapeutics, LLC (A Lupin Company)

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Patient Information

SOLOSEC (SO-lo-sec)

(secnidazole) oral granules

What is SOLOSEC?

  • SOLOSEC is a prescription medicine used to treat bacterial vaginal infections in adult women.
  • It is not known if SOLOSEC is safe and effective in children under 18 years of age.

Do not take SOLOSEC if you:

  • are allergic to secnidazole or other nitroimidazole medicines. See the end of this leaflet for a complete list of ingredients in SOLOSEC.

Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if SOLOSEC will harm your unborn baby. Tell your healthcare provider if you learn that you were pregnant when you took SOLOSEC.
  • are breastfeeding or plan to breastfeed. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC. SOLOSEC may pass into breast milk. Talk with your healthcare provider about the best way to feed your baby while taking SOLOSEC.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take SOLOSEC?

  • See "Instructions for Use" at the end of this leaflet for instructions on how to take SOLOSEC.
  • Take SOLOSEC exactly as your healthcare provider tells you to. Do not take SOLOSEC more often than it is prescribed. Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve.

What are the possible side effects of SOLOSEC?

SOLOSEC can cause side effects including vaginal yeast infections. Symptoms of a vaginal yeast infection include white or yellowish discharge (discharge may be lumpy or look like cottage cheese) and vaginal itching.

The most common side effects of SOLOSEC include headache, nausea, vomiting, diarrhea, abdominal pain, and vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia).

These are not all of the side effects of SOLOSEC. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of SOLOSEC.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOLOSEC for a condition for which it was not prescribed. Do not give SOLOSEC to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SOLOSEC that is written for health professionals.

What are the ingredients in SOLOSEC?

Active ingredient: secnidazole

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).

For more information visit www.solosec.com or contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732).

INSTRUCTIONS FOR USE

SOLOSEC

(secnidazole) oral granules

For oral use (by mouth) only.

How to take SOLOSEC?

  • Open the SOLOSEC packet by folding over the corner marked by an arrow (see diagram) and tearing across the top.
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2. Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve. Take within 30 minutes without chewing or crunching the granules.

3. You can drink a glass of water after taking SOLOSEC to help with swallowing. You should not try to dissolve the medicine in water or any other liquid.

Even though you only take 1 packet of SOLOSEC, the medicine stays in your body and continues working for 4 days.

Important Information

  • 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.

How should I store SOLOSEC?

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

This Patient Information and Instructions for Use have been approved by the US Food and Drug Administration. Revised: 06/2019

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

© 2019 Symbiomix Therapeutics, LLC (A Lupin Company). All Rights Reserved Solosec® is a registered trademark of Symbiomix Therapeutics, LLC (A Lupin Company)

226679

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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