Product Details

SOLOSEC PKT 2 GM

Manufacturer: Lupin Pharmaceuticals, Inc.

MFG#: 27437-0051-01

NDC: 27437-0051-01

PID: 234364

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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category S
Drug Type Code 1
FDA Approval Date 09/15/2017
FDA Therap Equiv NR
HCPCS -
Market Entry Date 04/15/2018
Medical Coverage -
Termination Date -
Unit GM
Units Per Pkg 1
Active Ingredients 5775 secnidazole 3366958
AHFS Class 8309200 ANTIPROTOZOALS, MISCELLANEOUS
DEA Class NC
Dose Form GRANULES, DELAYED RELEASE, IN PACKET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 77738 secnidazole ORAL GRANDR PKT 2 G
Inactive Ingredients 2537 povidone 9003398; 2598 sucrose 57501
OMP Family -
Product Category RX Pharmaceuticals
Strength -
Common Brand Name COMMON BRAND NAME(S): Solosec
Drug Interaction DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Case Quantity 72
Drug Form Pack Size 2
Form PACKET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 2
How to Use HOW TO USE: Read the Patient Information Leaflet and the Instructions for Use if available from your pharmacist before you start taking secnidazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor. This medication is taken as a single dose. Open the packet and pour its contents onto applesauce, yogurt, or pudding. Eat all of the mixture within 30 minutes without chewing or crunching the granules. Do not prepare a supply in advance. You may drink a glass of water afterward to help with swallowing the medication. Avoid drinking alcoholic beverages and preparations that contain ethanol or propylene glycol during treatment and for at least 2 days after completing treatment. Doing so may make side effects worse. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: Not applicable. This medication is taken as a single dose.
Notes NOTES: Do not share this medication with others unless directed by your doctor. If this medication is used to treat trichomoniasis, all sex partners should be treated at the same time to avoid getting infected again.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (sek-NID-a-zole)
Precautions PRECAUTIONS: Before taking secnidazole, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics (such as tinidazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain rare genetic disorder (Cockayne syndrome). If you are taking this medication to treat trichomoniasis, avoid having sex until you and your sex partner(s) have completed treatment and do not have any symptoms (such as vaginal discharge, pain when urinating). Many people with trichomoniasis do not have any symptoms, so it is important to treat all sex partners at the same time to avoid getting infected again. Secnidazole may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using secnidazole before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 4 days after taking this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Headache, nausea, diarrhea, or abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, vaginal discomfort/itching/discharge may occur or worsen. These symptoms may be due to a new vaginal infection (such as a yeast/fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new vaginal symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women. Secnidazole is also used to treat a certain common sexually transmitted infection (trichomoniasis). If you are taking this medication for trichomoniasis, your sexual partner(s) should be treated at the same time. Secnidazole is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Frequently Asked Questions (FAQs)

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SOLOSEC PKT 2 GM is manufactured by Lupin Pharmaceuticals, Inc..

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