Secnidazole

This is not a complete list of Secnidazoledrug interactions. Ask your doctor or pharmacist for more information.

Bacterial vaginosis: Treatment of bacterial vaginosis in adult women

Bacterial vaginosis: Oral: 2 g single dose

Adverse events were not observed in animal reproduction studies. Information related to the use of secnidazole in pregnancy is limited (Camargo 2015).

Secnidazole has the following uses:

Secnidazole 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 secnidazole and other antibacterial drugs, secnidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.1

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.1

Mechanism of Action

Secnidazole is a 5-nitroimidazole antimicrobial. 5-nitroimidazoles enter the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. It is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates.1

Spectrum

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis or Mobiluncus spp. has not been defined.1

The following in vitro data are available but their clinical significance is unknown. Secnidazole is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: 1

• Bacteroides spp.1

• Gardnerella vaginalis1

• Prevotella spp.1

• Mobiluncus spp.1

• Megasphaera-like type I/II1

Resistance

The development of resistance to secnidazole by bacteria associated with bacterial vaginosis was not examined. Bacterial isolates exhibiting reduced in vitro susceptibility to metronidazole also show reduced susceptibility to secnidazole. The clinical significance of such an effect is unknown.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In the U.S.

• Solosec

Available Dosage Forms:

• Tablet
• Granule

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Itching of the vagina or genitals
• thick, white vaginal discharge with mild or no odor

• Pain in the vagina or genital area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in taste
• diarrhea
• headache
• loss of taste
• nausea
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to secnidazole or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed for at least 4 days after using secnidazole.

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

You should not use this medicine if you are allergic to secnidazole or similar medicines such as benznidazole, metronidazole (Flagyl), or tinidazole (Tindamax).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine and for at least 4 days after your last dose.

Secnidazole is not approved for use by anyone younger than 18 years old.

Usual Adult Dose for Bacterial Vaginosis:

2 g orally once

Applies to secnidazole: oral granule, oral tablet

Along with its needed effects, secnidazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking secnidazole:

• Itching of the vagina or genitals
• thick, white vaginal discharge with mild or no odor

• Pain in the vagina or genital area

Some side effects of secnidazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in taste
• diarrhea
• headache
• loss of taste
• nausea
• stomach pain

For Healthcare Professionals

Applies to secnidazole: oral granule for reconstitution

Genitourinary

Common (1% to 10%): Vulvovaginal candidiasis, vulvovaginal pruritus[Ref]

Gastrointestinal

Nausea, abdominal pain, and vomiting have also been reported during postmarketing experience with other 2 g formulations outside the US.[Ref]

Common (1% to 10%): Nausea, diarrhea, abdominal pain, vomiting[Ref]

Nervous system

Dysgeusia and headache have also been reported during postmarketing experience with other 2 g formulations outside the US.[Ref]

Common (1% to 10%): Headache, dysgeusia[Ref]