Solosec secnidazole 2 g/4.8g Granule — NDC 69751-400-01 (Billing 69751-0400-01)
This is a package of Solosec secnidazole 2 g/4.8g Granule from Evofem Inc., marketed since May 2018 and currently FDA-listed; retail pharmacies pay about $281.96 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 69751-400-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69751 labeler · 400 product · 01 package
- Package marketed since
- May 31, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0369751400010
- Medicaid fills, this package
- 565 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 077738
- GCN: 43866
- GPI-14 (Medi-Span): 14000080003020
- HICL (First Databank): 011210
- AHFS class code: 08:30.16.00
- RxCUI (RxNorm): 1946692
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Secnidazole is used to treat bacterial vaginosis (an infection caused by an overgrowth of harmful bacteria in the vagina) and trichomoniasis (a sexually transmitted disease that can affect both men and women). Secnidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Solosec comes as a small packet of granules — think of it like a powder. You just tear open the packet and sprinkle everything onto a soft food like applesauce, yogurt, or pudding....
- How do I actually take this medication? It looks different from a regular pill.
- Yes — Solosec is a single-dose treatment. You take one packet one time, and that's the full course. It's designed that way on purpose, which makes it much easier to complete than a...
- Do I really only take it once? That seems too simple.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Secnidazole — tap one for details:
Secnidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $281.957 | $281.96 / 1 packet |
| Medicaid paysCMS SDUD · 12 mo | $209.26 | $209.26 / 1 packet |
| Medicare drug plans payPart D · Q2 2026 | $281.61 | $281.61 / 1 packet |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69751-0400-01 You're viewing this Main listing | 1 PACKET in 1 CARTON / 2 g in 1 PACKET | 2018-05-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Solosec 2 g/4.8gthis 69751-0400-01 | Evofem | 1 packet | $281.957 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10335390 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 12280037 ↗ | Method of use | U-3302 | Dec 11, 2041 |
| US 11000507 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| US 11000507 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 11020377 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| US 11020377 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 11000508 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| US 11000508 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 10682338 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 10849884 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 10849884 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| US 10335390 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 10857133 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 11602522 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 11602522 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| US 10849884 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 11000507 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 11020377 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 11000508 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 10849884 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 10857133 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 10682338 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 11000508 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 11000507 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 11020377 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 11684607 ↗ | Method of use | U-2583 | Sep 16, 2035 |
| US 11684607 ↗ | Method of use | U-3169 | Sep 16, 2035 |
| US 11684607 ↗ | Method of use | U-3270 | Sep 16, 2035 |
| US 11684607 ↗ | Method of use | U-3302 | Sep 16, 2035 |
| US 11324721 ↗ | Method of use | U-2583 | Sep 4, 2035 |
| US 11324721 ↗ | Method of use | U-3169 | Sep 4, 2035 |
| US 11324721 ↗ | Method of use | U-3270 | Sep 4, 2035 |
| US 11324721 ↗ | Method of use | U-3302 | Sep 4, 2035 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Sep 15, 2022 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Sep 15, 2027 |
Is there a generic version of SOLOSEC 2 GM GRANULE PACKET?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Secnidazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII P2OM2Q86BI
A synthetic polymer made from two types of plastic-like chemicals bonded together. It forms a protective coating on tablets or capsules to control how quickly the medicine dissolves and releases in your digestive system.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Evofem Inc. labeler code 69751
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) Treatment of trichomoniasis in patients 12 years of age and older. ( 1.2 ) 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.
( 1.3 )
1.1Bacterial Vaginosis SOLOSEC is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older [see Use in Specific Populations (8.1) and Clinical Studies (14) ].
1.2Trichomoniasis SOLOSEC is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis in patients 12 years of age and older. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, treat partners of infected patients simultaneously in order to prevent reinfection [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .
1.3Usage 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Bacterial Vaginosis (female patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. ( 2.1 ) Trichomoniasis (patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. Treat sexual partners with the same dose and at the same time.
( 2.2 ) 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 SOLOSEC to aid in swallowing. ( 2.3 ) SOLOSEC is not intended to be dissolved in any liquid.
( 2.3 )
2.1Recommended Dosage for Bacterial Vaginosis The recommended dosage of SOLOSEC for the treatment of bacterial vaginosis in female patients 12 years of age and older is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3) ] .
2.2Recommended Dosage for Trichomoniasis The recommended dosage of SOLOSEC for the treatment of trichomoniasis in patients 12 years of age and older is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3) ] . Since trichomoniasis is a sexually transmitted disease, treat sexual partners with the same dose and at the same time [see Indications and Usage (1.2) ] .
2.3Instructions for the Preparation and Administration of SOLOSEC 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 [see Clinical Pharmacology (12.3) ] . 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.
Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy [see Adverse Reactions (6.2) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ].
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS Oral Granules: 2 g, of off-white to slightly yellowish granules with 4.8 g net weight, packed in a unit-of-use child-resistant foil packet. Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet. ( 3 )
⛔ Contraindications ▾
4. CONTRAINDICATIONS SOLOSEC is contraindicated: In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives. In patients with Cockayne syndrome: Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to secnidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2) ] .
History of hypersensitivity to secnidazole, or other nitroimidazole derivatives. ( 4 ) Patients with Cockayne syndrome. ( 4 , 6.2 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Vulvovaginal Candidiasis: This may develop with SOLOSEC and require treatment with an antifungal agent. ( 5.1 ) 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 indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis.
Avoid chronic use. ( 5.2 )
5.1Vulvovaginal Candidiasis The use of SOLOSEC may result in vulvovaginal candidiasis. In controlled clinical trials of non-pregnant women with bacterial vaginosis, vulvovaginal candidiasis developed in 19/197 (9.6%) of patients who received 2 g SOLOSEC and 4/136 (2.9%) subjects who received placebo. In a controlled clinical trial of non-pregnant female patients with trichomoniasis, vulvovaginal candidiasis developed in 2/74 (2.7%) of patients who received 2 g SOLOSEC and 0/73 (0%) subjects who received placebo [see Adverse Reactions (6.1) ] .
Symptomatic vulvovaginal candidiasis may require treatment with an antifungal agent.
5.2Potential 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) ]
5.3Risk of Development of 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are discussed in greater detail in other sections of labeling: Vulvovaginal Candidiasis [Warnings and Precautions (5.1)] Bacterial Vaginosis : Most common adverse reactions observed in clinical trials of bacterial vaginosis (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus. ( 6.1 ). Trichomoniasis : Most common adverse reaction observed in the clinical trial of trichomoniasis (incidence ≥ 2%) was vulvovaginal candidiasis.
( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free-phone 1-833-EVFMBIO (1-833-383-6246) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Bacterial Vaginosis The safety data described below reflect exposure to 629 patients, of whom 558 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in four clinical trials of female patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and two uncontrolled safety trials (Trial 3 n=321, Trial 4 n=40).
Most Common Adverse Reactions in Trials 1 and 2 All patients in Trial 1 and Trial 2 received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC in patients aged 18 to 54 years. Trial 2 evaluated a 2 g dose (n=125) in patients aged 18 to 54 years.
Patients in the placebo-controlled trials were primarily Black or African American (54%) or Caucasian (41%). Among 197 patients treated with a single 2 g dose of SOLOSEC in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients. Table 1 displays the most common adverse reactions (≥ 2% in SOLOSEC-treated patients) in these two trials.
There were no deaths in the trials. Table 1: Adverse Reactions Occurring (≥ 2 % SOLOSEC-Treated Patients) in the Pooled Placebo-Controlled Trials 1 and 2 in Adult Women with Bacterial Vaginosis Adverse Reaction SOLOSEC N=197 n (%) Placebo N=136 n (%) Vulvovaginal candidiasis 19 (9.6) 4 (2.9) Headache 7 (3.6) 2 (1.5) Nausea 7 (3.6) 1 (0.7) Diarrhea 5 (2.5) 1 (0.7) Abdominal pain 4 (2.0) 2 (1.5) Vulvovaginal pruritus 4 (2.0) 2 (1.5) Most Common Adverse Reactions in Trial 3 Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients.
Vulvovaginal candidiasis (8.4%), nausea (5.3%), vomiting (2.5%) and dysgeusia (3.4%) were the most common adverse reactions reported in this trial. Two SOLOSEC-treated patients in Trial 3 discontinued due to vulvovaginal candidiasis. Most Common Adverse Reactions in Trial 4 In Trial 4, the safety of SOLOSEC was evaluated in a multicenter, uncontrolled, open-label study evaluating the safety and tolerability of SOLOSEC in 40 pediatric patients between the ages of 12 and less than 18 years old all of whom were treated with a 2 g single dose of SOLOSEC.
Most patients in this study were either White (60%) or Black/African-American (38%).The overall safety findings of a SOLOSEC 2 g dose in patients aged 12 to 17 years are consistent with findings in adult patients aged 18 to 65 years old. There were no deaths, severe adverse reactions, or discontinuations due to adverse reactions. Adverse reactions occurring in at least one SOLOSEC-treated pediatric patient included: nausea and abdominal pain.
Trichomoniasis The safety of SOLOSEC was evaluated in 147 female patients with trichomoniasis who participated in Trial 5, a placebo controlled, double blind trial, of whom 143 (97.3%) patients completed the 'Test of Cure' (TOC) visit. In this trial, 74 patients received a sin… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Oral 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).
7.2Alcohol 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 [see Dosage and Administration (2.3) , Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. Discontinue breastfeeding for 96 hours after administration of SOLOSEC. ( 8.2 )
8.1Pregnancy Risk Summary Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes . In animal reproduction studies, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, pregnant rats were dosed orally with secnidazole during organogenesis (gestational days 6-17) at 100, 300 and 1000 mg/kg/day, up to 4 times the clinical dose based on AUC comparisons.
Animals showed no evidence of adverse developmental outcomes, but maternal toxicity (including reduced body weight gain) was observed at and above 300 mg/kg/day. In rabbits, no evidence of adverse developmental outcomes was observed when oral doses of secnidazole were administered to dams during organogenesis (gestational days 7-20) at doses up to 100 mg/kg/day (about 0.1 times the clinical dose, based on AUC comparisons). Secnidazole was associated with maternal toxicity (reduced food consumption and markedly reduced body weight gain) in dams at 100 mg/kg/day.
In a peri- and post-natal development study in rats, secnidazole was administered at 30, 100 and 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation. Secnidazole was not associated with any adverse effects on gestation, parturition, lactation or on subsequent development of first generation (F1) and second generation (F2) offspring at these doses, equivalent to up to 1.4 times the clinical dose based on AUC comparisons. Maternal toxicity (reduced gestational body weight gain) was evident at doses of 100 mg/kg and above (about 0.3 times the clinical dose based on AUC comparisons).
8.2Lactation Risk Summary There is no information on the presence of secnidazole in human milk, the effects on the breast-fed child, or the effects on milk production. Other nitroimidazole derivatives are present in human milk. Because of the potential for serious adverse reactions, including tumorigenicity, advise patients that breastfeeding is not recommended during treatment with SOLOSEC and for 96 hours (based on half-life) after administration of SOLOSEC.
Clinical Considerations A nursing mother may choose to pump and discard her milk during treatment with SOLOSEC and for 96 hours after administration of SOLOSEC and feed her infant stored human milk or formula.
8.4Pediatric Use The safety and effectiveness of SOLOSEC for the treatment of bacterial vaginosis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this age group is supported by evidence from a multicenter, open-label safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) ] and evidence from adequate and well-controlled studies in adult women [see Clinical Studies (14.1) ] . The safety and effectiveness of SOLOSEC for the treatment of trichomoniasis have been established in pediatric patients aged 12 to 17 years old.
Use of SOLOSEC in this group is based on the extrapolation of clinical trial data from adult women with trichomoniasis, four open-label trials in males with trichomoniasis, and an open-label safety study in pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .The safety and effectiveness of SOLOSEC in pediatric patients below the… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes . In animal reproduction studies, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, pregnant rats were dosed orally with secnidazole during organogenesis (gestational days 6-17) at 100, 300 and 1000 mg/kg/day, up to 4 times the clinical dose based on AUC comparisons.
Animals showed no evidence of adverse developmental outcomes, but maternal toxicity (including reduced body weight gain) was observed at and above 300 mg/kg/day. In rabbits, no evidence of adverse developmental outcomes was observed when oral doses of secnidazole were administered to dams during organogenesis (gestational days 7-20) at doses up to 100 mg/kg/day (about 0.1 times the clinical dose, based on AUC comparisons). Secnidazole was associated with maternal toxicity (reduced food consumption and markedly reduced body weight gain) in dams at 100 mg/kg/day.
In a peri- and post-natal development study in rats, secnidazole was administered at 30, 100 and 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation. Secnidazole was not associated with any adverse effects on gestation, parturition, lactation or on subsequent development of first generation (F1) and second generation (F2) offspring at these doses, equivalent to up to 1.4 times the clinical dose based on AUC comparisons. Maternal toxicity (reduced gestational body weight gain) was evident at doses of 100 mg/kg and above (about 0.3 times the clinical dose based on AUC comparisons).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SOLOSEC for the treatment of bacterial vaginosis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this age group is supported by evidence from a multicenter, open-label safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) ] and evidence from adequate and well-controlled studies in adult women [see Clinical Studies (14.1) ] . The safety and effectiveness of SOLOSEC for the treatment of trichomoniasis have been established in pediatric patients aged 12 to 17 years old.
Use of SOLOSEC in this group is based on the extrapolation of clinical trial data from adult women with trichomoniasis, four open-label trials in males with trichomoniasis, and an open-label safety study in pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .The safety and effectiveness of SOLOSEC in pediatric patients below the age of 12 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with secnidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action SOLOSEC is a nitroimidazole antimicrobial drug [see Microbiology (12.4) ].
12.2Pharmacodynamics 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.
12.3Pharmacokinetics 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 (C max ) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC 0-inf ) of 1331.6 (230.16) mcg∙hr/mL. Median (range) time to peak concentration (T max ) 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 (C max ) 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) ] Table 2: Pharmacokinetic Parameters Following Single Dose Administration of SOLOSEC 2 g Given Orally C max (mcg/mL) T max (hr) Median (range) AUC (mcg*hr/mL) Fasted Admixed with applesauce (N=23) Mean (SD) 41.2 (5.5) 4.0 (3.0 – 6.0) 1261.5 (236.5) Range 32.7 – 56.2 874.3 – 1750.4 High fat meal (N=23) Mean (SD) 40.1 (4.9) 6.0 (4.0 – 8.0) 1248.2 (291.6) Range 31.0 – 47.7 762.0 – 1769.4 Mixed with applesauce (N=24) Mean (SD) 44.1 (4.6) 4.0 (3.0 – 6.1) 1523 (372.2) Range 37.4 – 55.6 1040 – 2350 Mixed with pudding (N=23) Mean (SD) 45.6 (5.1) 4.0 (4.0 – 6.0) 1447 (331.0) Range 38.6 – 60.4 997 – 2130 Mixed with yogurt (N=24) Mean (SD) 43.4 (5.4) 4.0 (4.0 – 8.0) 1478 (335.0) Range 36.3 – 59.3 965 – 2240 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 Interaction Studies 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 C max of EE of 29%, and no significant effect on the mean AUC of EE. Administration of 2 g of SOLOSEC 1 day before combination OC administration resulted in no significant effect on mean C max or AUC of EE. Concomitant administration of 2 g of SOLOSEC with the combination OC resulted in no significant effect on mean C max and AUC of NE (increases of 13% and 16%, respectively).
Administration of 2 g of SOLOSEC 1 day before combination OC administration also resulted in no significant effect on mean C max and AUC of NE. [see Drug Interactio… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action SOLOSEC is a nitroimidazole antimicrobial drug [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED / STORAGE AND HANDLING SOLOSEC (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. SOLOSEC is supplied in one unit-of-use child-resistant foil 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 69751-400-01 carton containing one unit-of-use child-resistant 2 g foil 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].
📦 Storage and Handling ▾
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].
📋 Description ▾
11 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-1 H -imidazol-1-yl) propan-2-ol), a nitroimidazole antimicrobial. The molecular formula of secnidazole is C 7 H 11 N 3 O 3 , the molecular weight is 185.18 and the chemical structure is: Figure 1: 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). Chemical Structure
💬 Information for Patients ▾
17 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. Vulvovaginal Candidiasis Advise the patient that use of SOLOSEC may result in vulvovaginal candidiasis that may require treatment with an antifungal agent. [see Warnings and Precautions (5.1) ] Alcohol Advise patients to avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during SOLOSEC therapy and for 2 days afterward because nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache may occur [see Dosage and Administration (2.3) , Adverse Reactions (6.2) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ] .
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) ]. 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.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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 (C max ) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC 0-inf ) of 1331.6 (230.16) mcg∙hr/mL. Median (range) time to peak concentration (T max ) 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 (C max ) 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) ] Table 2: Pharmacokinetic Parameters Following Single Dose Administration of SOLOSEC 2 g Given Orally C max (mcg/mL) T max (hr) Median (range) AUC (mcg*hr/mL) Fasted Admixed with applesauce (N=23) Mean (SD) 41.2 (5.5) 4.0 (3.0 – 6.0) 1261.5 (236.5) Range 32.7 – 56.2 874.3 – 1750.4 High fat meal (N=23) Mean (SD) 40.1 (4.9) 6.0 (4.0 – 8.0) 1248.2 (291.6) Range 31.0 – 47.7 762.0 – 1769.4 Mixed with applesauce (N=24) Mean (SD) 44.1 (4.6) 4.0 (3.0 – 6.1) 1523 (372.2) Range 37.4 – 55.6 1040 – 2350 Mixed with pudding (N=23) Mean (SD) 45.6 (5.1) 4.0 (4.0 – 6.0) 1447 (331.0) Range 38.6 – 60.4 997 – 2130 Mixed with yogurt (N=24) Mean (SD) 43.4 (5.4) 4.0 (4.0 – 8.0) 1478 (335.0) Range 36.3 – 59.3 965 – 2240 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 Interaction Studies 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 C max of EE of 29%, and no significant effect on the mean AUC of EE. Administration of 2 g of SOLOSEC 1 day before combination OC administration resulted in no significant effect on mean C max or AUC of EE. Concomitant administration of 2 g of SOLOSEC with the combination OC resulted in no significant effect on mean C max and AUC of NE (increases of 13% and 16%, respectively).
Administration of 2 g of SOLOSEC 1 day before combination OC administration also resulted in no significant effect on mean C max and AUC of NE. [see Drug Interactions (7.1) ] Ethanol Metabolism In vitro studies showed that secnidazole had no effect on aldehyde dehydrogenase activity. However, postmarketing observations of adverse reactions of nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache with concomitant use of SOLOSEC and alcohol have been reported [see, Dosage and Administration (2.3) , Adverse Reactions (6.2) , and Drug Interactions (7.2) ] .
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics 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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Bacterial Vaginosis Two randomized placebo-controlled clinical trials (Trial 1 and Trial 2) with similar designs were conducted to evaluate the efficacy of SOLOSEC 2 gram for the treatment of bacterial vaginosis. A diagnosis of bacterial vaginosis was defined as all of (a) the presence of an off-white (milky or gray), thin, homogeneous vaginal discharge; (b) a vaginal pH ≥ 4.7; (c) the presence of Clue cells ≥ 20% of the total epithelial cells on a microscopic examination of the vaginal saline wet mount; (d) a positive "whiff" test (detection of amine odor on addition of 10% KOH solution to a sample of the vaginal discharge); and (e) a Nugent score ≥ 4.
Trial 1 enrolled 144 non-pregnant female patients aged 19 to 54 years and Trial 2 enrolled 189 non-pregnant females aged 18 to 54 years. Black or African American subjects in both trials were 54%. Efficacy was assessed by clinical outcome evaluated 21 to 30 days following a single dose of SOLOSEC.
A clinical responder was defined as "normal" vaginal discharge, negative "whiff" test, and clue cells <20%. Additional endpoints included Nugent score cure (Nugent score of 0-3) and therapeutic outcome. A therapeutic responder was defined as a clinical responder with a Nugent score cure.
In Trial 2, the endpoints were also assessed at Day 7-14. In both trials, a statistically significantly greater percentage of patients experienced clinical response, Nugent score cure, and therapeutic response at 21 to 30 days following a single dose of SOLOSEC compared to placebo. Statistically significant results for the endpoints were also achieved at Day 7-14 in Trial 2.
The percentage of patients with clinical response was also consistently higher in both trials in the SOLOSEC arm compared to placebo among all subsets of patients: number of prior episodes of bacterial vaginosis (≤ 3 episodes and ≥ 4 episodes) in past 12 months, baseline Nugent score (score 4-6 and score 7-10), and race (Black/African American and White). Tables 3 and 4 describe the efficacy of SOLOSEC in the treatment of bacterial vaginosis. Table 3.
Efficacy of SOLOSEC for Treatment of Bacterial Vaginosis in Two Randomized, Double-Blind, Placebo-Controlled Trials in Modified-Intent-to-Treat Population at 21-30 Days Trial 1 Trial 2 SOLOSEC (N=62) N=number of patients in treatment group (modified intent-to-treat population defined as all patients randomized who had a baseline Nugent score ≥4 and were negative for other sexually transmitted infections at baseline). n (%) Placebo (N=62) n (%) SOLOSEC (N=107) n (%) Placebo (N=57) n (%) Clinical Responder Patients missing one or more of the clinical assessments were considered as non-responders/not cured.
42 (67.7) 11 (17.7) 57 (53.3) 11 (19.3) 50.0 (33.4, 66.7) Difference in response (SOLOSEC – placebo) and 95% confidence interval 34.0 (18.7, 49.3) p<0.001 p<0.001 Nugent Score Cure Patients with missing Nugent scores were considered Nugent score failures. 25 (40.3) 4 (6.5) 47 (43.9) 3 (5.3) 33.8 (18.5, 49.1) 38.6 (26.2, 51.0) p<0.001 p<0.001 Therapeutic Responder 25 (40.3) 4 (6.5) 37 (34.6) 2 (3.5) 33.8 (18.5, 49.1) 31.1 (19.6, 42.6) p<0.001 p<0.001 Table 4. Efficacy of SOLOSEC for Treatment of Bacterial Vaginosis in Trial 2 in Modified-Intent-to-Treat Population at 7-14 Days Trial 2 SOLOSEC (N=107) N=number of patients in treatment group (modified intent-to-treat population defined as all patients randomized who had a baseline Nugent score ≥4 and were negative for other sexually transmitted infections at baseline). n (%) Placebo (N=57) n (%) Clinical Responder Patients missing one or more of the clinical assessments were considered as non-responders/not cured.
62 (57.9) 14 (24.6) 33.3 (17.4, 49.2) Difference in response (SOLOSEC – placebo) and 95% confidence interval p<0.001 Nugent Score Cure Patients with missing Nugent scores were considered Nugent score failures. 49 (45.8) 2 (3.5) 42.3 (30.4, 54.2) p<0.001 Therapeutic Responder 37 (34.6) 2 (3.5) 31.1 (19.… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Nitroimidazoles, which have similar chemical structures to secnidazole, have been associated with tumors affecting the liver, lungs, mammary, and lymphatic tissues in animals after lifetime exposures. It is unclear if these positive tumor findings in lifetime rodent studies of these nitroimidazoles indicate a risk to patients taking a single dose of secnidazole to treat bacterial vaginosis or trichomoniasis. Mutagenesis Secnidazole was positive in the Bacterial Reverse Mutation Assay but was negative for the rat micronucleus test and mouse lymphoma test.
Impairment of Fertility In a rat fertility study, females were dosed for two weeks prior to mating until Day 7 of gestation with males that were dosed for a minimum of 28 days before cohabitation. No parental toxicity or adverse effects on mating performance, estrous cycles, fertility or conception was observed at doses of up to the maximum tolerated dose (300 mg/kg/day, approximately 1.4 times the recommended dose based on AUC comparisons).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Nitroimidazoles, which have similar chemical structures to secnidazole, have been associated with tumors affecting the liver, lungs, mammary, and lymphatic tissues in animals after lifetime exposures. It is unclear if these positive tumor findings in lifetime rodent studies of these nitroimidazoles indicate a risk to patients taking a single dose of secnidazole to treat bacterial vaginosis or trichomoniasis. Mutagenesis Secnidazole was positive in the Bacterial Reverse Mutation Assay but was negative for the rat micronucleus test and mouse lymphoma test.
Impairment of Fertility In a rat fertility study, females were dosed for two weeks prior to mating until Day 7 of gestation with males that were dosed for a minimum of 28 days before cohabitation. No parental toxicity or adverse effects on mating performance, estrous cycles, fertility or conception was observed at doses of up to the maximum tolerated dose (300 mg/kg/day, approximately 1.4 times the recommended dose based on AUC comparisons).
📚 References ▾
15 REFERENCES Özbilgin A, Özbel Y, Alkan MZ et al. Trichomoniasis in non-gonococcic urethritis among male patients. J Egypt Soc Parasitol.
1994; 24(3):621-625. Dyudyun AD, Polyon NM, Gorbuntsov VV. Secnidazole in complex treatment of patients with urogenital trichomoniasis.
Dermatovenerology Cosmetology Sexopathology. 2016;1(4): 287-292. Siboulet A, Catalan F, Videau D, Niel G.
Urogenital trichomoniasis. Trials with a long half-life imidazole: secnidazole. Med Mal Infect.
1977;7(9):400-409. Videau D, Niel G, Siboulet A, Catalan F. Secnidazole: A 5-nitroimidazole derivative with a long half-life.
Br J Vener Dis. 1978;54(2):77-80. Krieger JN, Verdon M, Siegel N, Holmes KK.
Natural history of urogenital trichomoniasis in men. J Urol. 1993 Jun;149(6):1455-8.
📄 Patient Package Insert ▾
PATIENT INFORMATION SOLOSEC ® (SO-lo-sec) (secnidazole) oral granules What is SOLOSEC? SOLOSEC is a prescription medicine used to treat: bacterial vaginal infections in females 12 years of age and older. trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. 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. It is not known if SOLOSEC is safe and effective in children under 12 years of age. Do not take SOLOSEC if you: are allergic to secnidazole or other nitroimidazole medicines. have Cockayne syndrome.
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 become pregnant during treatment with 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 the Instructions for Use at the end of this Patient Information 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. What should I avoid while taking SOLOSEC?
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 dizziness headache 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, vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia). These are not all of the possible side effects of SOLOSEC. Call your doctor for medical advice about side effects.
You may report side effects to 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 Evofem at 1-833-EVFMBIO (1-833-383-6246).
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE SOLOSEC ® (SO-lo-sec) (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.
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.
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. Important Information SOLOSEC may be taken before, 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.
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 medicines out of the reach of children.
This Patient Information and Instructions for Use have been approved by the US Food and Drug Administration. Issued: 10/2024 Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc. San Diego, CA 92130 © 2024 Evofem, Inc.
All Rights Reserved. PN-5055 R02 Image
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 2 g Packet Carton NDC 69751-400-01 Rx Only solosec ® 2g secnidazole Oral Granules 1 Unit-of-Use Packet EVOFEM BIOSCIENCES ® PRINCIPAL DISPLAY PANEL - 2 g Packet Carton