What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Osphena (Ospemifene)
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Product Details
Description
Osphena is an oral medication that is used to treat different symptoms of menopause, including severe dyspareunia (painful vaginal intercourse) and vaginal dryness due to menopause.
Osphena is used for the treatment of symptoms of menopause but can increase your risk for other diseases. Talk with your doctor carefully before starting this drug.
Fact Table
Formula
C24H23ClO2
License
EU EMA, US FDA
Bioavailability
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Legal status
Rx Only
Chemical Name
Ospemifene
Elimination half-life
22hr
Dosage (Strength)
60mg
Pregnancy
Consult Doctor
Brands
Osphena, Senshio
Protein binding
99%
PubChem CID
3036505
MedlinePlus
a613039
ChEBI
73275
ATC code
G03XC05
DrugBank
DB04938
KEGG
D08958
Routes of administration
By mouth
Directions
Take Osphena exactly as directed by your doctor. The standard dosage is 60 mg by mouth once daily.
Ingredients
The active ingredient in Osphena is ospemifene.
Ospemifene has two mechanisms, it activates certain estrogen receptors and shuts off other receptors. By doing so, it regulates the amount of estrogen activation in different tissues of the body.
Interactions
Common drug-drug interactions with Osphena can include:
- Abametapir
- Apalutamide
- Fexinidazole
- Fluconazole
- Fusidic Acid (Systemic)
- Selective Estrogen Receptor Modulators
- Atazanavir
- Ceritinib
- Clarithromycin
- Cobicistat and cobicistat-containing coformulations
- Darunavir
- Fluoroestradiol F18
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Mifepristone
- Nefazodone
- Nelfinavir
- Ombitasvir-paritaprevir-ritonavir
- Ombitasvir-paritaprevir-ritonavir plus dasabuvir
- Posaconazole
- Ritonavir and ritonavir-containing formulations
- Saquinavir
- Telithromycin
- Tucatinib
- Voriconazole
Cautions
Do not take Osphena if you have a history of endometrial cancer or uterine cancer. You should be regularly screened for cancer risk if you are taking Osphena.
Tell your doctor if you have a history of clotting disorders like deep vein thrombosis, pulmonary embolism, or heart attack.
Side Effects
When taking Osphena, some of the more common side effects can include:
- Angioedema
- Cerebrovascular accident
- Cysts
- Deep vein thrombosis
- Endometrial carcinoma
- Endometrial hyperplasia
- Endometrial polyps
- Erythematous rash
- Headache
- Hot flash
- Hyperhidrosis
- Hypersensitivity reaction
- Malignant neoplasm
- Myocardial infarction
- Night Sweats
- Pruritus
- Pulmonary embolism
- Vaginal discharge
- Vaginal hemorrhage
Let your healthcare team know if you are experiencing any of the above side effects. You may need to stop the medication if symptoms are severe.
References
Osphena. Florham Park, NJ: Shionogi Inc; 1/2019.
Frequently Asked Questions about Osphena
What is Osphena?
Osphena is a prescription medication that contains ospemifene as its active ingredient. It is used to treat moderate to severe painful intercourse (dyspareunia) that occurs due to changes in the vaginal tissue often associated with menopause.
How does Osphena work?
Osphena is a selective estrogen receptor modulator (SERM). It works by acting like estrogen in some tissues in the body, including the vaginal tissue. This can help improve vaginal health and reduce pain during intercourse.
Who can benefit from using Osphena?
Osphena is primarily prescribed for postmenopausal women who experience painful intercourse as a result of vaginal changes, such as dryness and thinning of vaginal walls.
Are there any common side effects of Osphena?
Common side effects of Osphena may include hot flashes, vaginal discharge, muscle spasms, and increased sweating. It's important to discuss potential side effects with your healthcare provider.
How should I take Osphena?
Osphena is typically taken as a tablet by mouth, usually once daily with food. It's essential to follow your healthcare provider's dosing instructions carefully.
Can Osphena be taken with other medications?
Inform your healthcare provider about all the medications you are currently taking, including over-the-counter drugs and supplements. Some medications may interact with Osphena, so it's important to discuss potential drug interactions.
Is Osphena a hormone replacement therapy (HRT)?
No, Osphena is not a hormone replacement therapy. While it may have estrogen-like effects on vaginal tissue, it is not a systemic hormone therapy and does not provide the same benefits or risks associated with traditional HRT.
Is Osphena safe for long-term use?
Your healthcare provider will determine the appropriate duration of treatment with Osphena based on your individual condition and needs. It is not intended for long-term use.
Can I stop taking Osphena if my symptoms improve?
It's important not to discontinue Osphena without consulting your healthcare provider. They will guide you on the appropriate course of treatment and whether it should be continued or adjusted.
Is Osphena available over the counter (OTC)?
No, Osphena is a prescription medication and is not available over the counter. It should only be used under the supervision and guidance of a healthcare provider.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13585
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