Solosec

Vulvo-Vaginal Candidiasis

The use of Solosec may result in vulvo-vaginal candidiasis. In controlled clinical trials of non-pregnant women with bacterial vaginosis, vulvo-vaginal candidiasis developed in 19/197 (9.6%) of subjects who received 2 g Solosec and 4/136 (2.9%) subjects who received placebo [see Adverse Reactions (6.1)]. Symptomatic vulvo-vaginal candidiasis may require treatment with an antifungal agent.

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 of these nitroimidazoles indicate a risk to patients taking a single dose of Solosec to treat bacterial vaginosis. Avoid chronic use of Solosec [see Nonclinical Toxicology (13.1)]

Drug Resistance

Prescribing Solosec in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Mechanism of Action

Solosec is a nitroimidazole antimicrobial drug [See Microbiology (12.4)].

Pharmacodynamics

Secnidazole exposure-response relationships and the time course of pharmacodynamic response are unknown.

Cardiac Electrophysiology

The effect of secnidazole on the QTc interval was evaluated in a Phase 1 randomized, double blind, placebo- and positive-controlled four-period crossover thorough QTc study in 52 healthy adult subjects following single oral granule doses of 2 g and 6 g (3-times the recommended dose). Although there was a positive relationship of the QTc interval with secnidazole concentrations, there was no clinically relevant increase in the QTc interval following either dose.

Pharmacokinetics

A single oral dose of 2 g of Solosec in healthy adult female subjects, following an overnight fast and admixed with (4 oz) of applesauce, resulted in a mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg•hr/mL. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours. Following administration of the 2-g dose, mean secnidazole plasma concentrations decreased to 22.1 mcg/mL at 24 hours, 9.2 mcg/mL at 48 hours, 3.8 mcg/mL at 72 hours, and 1.4 mcg/mL at 96 hours.

Absorption

Effect of Food

Administration of 2 g of Solosec admixed with applesauce followed by ingestion of a high-fat meal (approximately 150 protein calories, 250 carbohydrate calories, and 500-600 fat calories) resulted in no significant change in the rate (Cmax) and extent (AUC) of secnidazole exposure as compared to administration when admixed with applesauce and taken under fasted conditions. There was no effect of admixing Solosec with pudding and yogurt as compared to admixing with applesauce (Table 2). [see Dosage and Administration (2.2)]

Distribution

The apparent volume of distribution of secnidazole is approximately 42 L. The plasma protein binding of secnidazole is <5%.

Elimination

The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min.

The plasma elimination half-life for secnidazole is approximately 17 hours.

Metabolism

Secnidazole is metabolized in vitro via oxidation by human hepatic CYP450 enzyme system with ≤ 1% conversion to metabolites.

Excretion

Approximately 15% of a 2-g oral dose of Solosec is excreted as unchanged secnidazole in the urine.

Drug Interactions

Oral Contraceptives

Concomitant administration of 2 g of Solosec with the combination oral contraceptive (OC), ethinyl estradiol (EE) plus norethindrone (NE), to healthy adult female subjects resulted in a decrease in mean Cmax of EE of 29%, and no significant effect on the mean AUC of EE. Administration of 2g of Solosec 1 day before combination OC administration resulted in no significant effect on mean Cmax or AUC of EE.

Concomitant administration of 2 g of Solosec with the combination OC resulted in no significant effect on mean Cmax and AUC of NE (increases of 13% and 16%, respectively). Administration of 2g of Solosec 1 day before combination OC administration also resulted in no significant effect on mean Cmax and AUC of NE. [see Drug Interactions (7.1)]

Ethanol Metabolism

In vitro studies showed that secnidazole had no effect on aldehyde dehydrogenase activity.

Microbiology

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.

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.

Antibacterial Activity

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Indications and Usage (1.2)]; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis or Mobiluncus spp. has not been defined.

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:

Bacteroides spp.

Gardnerella vaginalis

Prevotella spp.

Mobiluncus spp.

Megasphaera-like type I/II

Solosec (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. Solosec is supplied in unit-of-use packages containing one packet of granules in an individual carton. Each packet contains 4.8 g of granules containing 2 g secnidazole. Solosec is supplied as follows:

NDC 71000-102-01 carton containing one unit-of-use 2 g packet

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].

Solosec is a prescription medicine used to treat bacterial vaginal infections in adult women.

It is not known if this medicine 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 active and inactive ingredients.

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.

• Store the granules at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Keep all medicines out of the reach of children and pets.

Secnidazole is a nitroimidazole antimicrobial.1

General

Secnidazole is available in the following dosage form(s) and strength(s):

Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Administer a single packet of granules (containing 2 g of secnidazole) once orally, without regard to the timing of meals.1

• 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 secnidazole to aid in swallowing.1

• Secnidazole is not intended to be dissolved in any liquid.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

Secnidazole is an antibiotic that fights bacteria.

Secnidazole is used in women to treat bacterial vaginal infections.

This medicine will not treat a fungal (yeast) infection.

Secnidazole may also be used for purposes not listed in this medication guide.

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

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.BasicDescription Back to TopSolosec Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may develop a vaginal yeast infection while taking secnidazole. Call your doctor at once if you have:

• vaginal itching or burning;
• redness or swelling; or
• white or yellow vaginal discharge (may be odorless).

Common side effects may include:

• nausea, vomiting, diarrhea, stomach pain;
• headache; or
• a bitter or metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.