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Intrarosa 6.5 Mg Vaginal Ins 28

  • Manufacturer Name : Prasco Laboratories
  • MFG # : 72495040128
  • NDC : 72495040128
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description S
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category USES: This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids. It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).
Drug Category S
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Intrarosa
FDA Approval Date 11/16/2016
FDA Therap Equiv NR
HCPCS 1
HCPCS -
Market Entry Date 07/17/2017
Medical Coverage -
Medical Coverage -
Termination Date (PRAS-ter-one)
Termination Date -
Unit SUP
Units Per Pkg 28
Active Ingredients 4609 prasterone (DHEA) 53430
Active Ingredients 4609 prasterone (DHEA) 53430
AHFS Class 68040000 ADRENALS
AHFS Class 68040000 ADRENALS
DEA Class NC
DEA Class NC
Dose Form INSERT
Dose Form INSERT
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 76858 prasterone (DHEA) VAGINAL INSERT 6.5 MG
Gen Code and Des 76858 prasterone (DHEA) VAGINAL INSERT 6.5 MG
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 6.5MG
Strength 6.5MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Intrarosa
Drug Interaction DRUG INTERACTIONS: 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.
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 36
Case Quantity 36
Drug Form Pack Size 28
Drug Form Pack Size 28
Form INSERT
Form INSERT
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 28
Unit Size 28
How to Use HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using prasterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is for vaginal use only. Empty your bladder and wash your hands before handling the vaginal insert and applicator. Unwrap one vaginal insert and follow the instructions to use the applicator to insert this medication into the vagina as directed by your doctor, usually once daily at bedtime. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Tell your doctor if your condition does not get better or if it gets worse.
How to Use -
Missed Dose 28
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as Pap smear) may be done while you are using this medication. Keep all medical and lab appointments.
Notes SUP
Overdose NR
Overdose OVERDOSE: This medicine may be harmful if swallowed. 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 -
Phonetic Pronunciation (PRAS-ter-one)
Precautions -
Precautions PRECAUTIONS: Before using prasterone, tell your doctor or pharmacist if you are allergic to it; 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: breast cancer, vaginal bleeding. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is not usually used by women of childbearing age. Tell your doctor if you are planning pregnancy, become pregnant, or think you may be pregnant. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Vaginal discharge may occur. If this effect lasts or gets 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. You may have an abnormal Pap smear test result after using this medication. Your doctor will monitor your results and tell you if more tests are needed. 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.
Side Effects -
Storage 11/16/2016
Storage STORAGE: Store in the refrigerator or at room temperature away from light and moisture. Do not freeze. 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 USES: This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids. It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).

Frequently Asked Questions(FAQs)

The cost of Intrarosa 6.5 Mg Vaginal Ins 28 is available for registerd members only .
Intrarosa 6.5 Mg Vaginal Ins 28 is manufactured by Prasco Laboratories.
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