Neovera
Generic Name
Ulipristal Acetate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| neovera 6 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Ulipristal acetate is a selective progesterone receptor modulator (SPRM) used primarily for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. It helps reduce fibroid size and controls bleeding.
Uses & Indications
Dosage
Adults
6 mg orally once daily for up to 3-6 months.
Elderly
No specific dose adjustment generally needed, but use with caution.
Renal_impairment
No dose adjustment needed for mild to moderate impairment. Not recommended for severe impairment.
How to Take
Take orally, with or without food.
Mechanism of Action
Ulipristal acetate selectively binds to progesterone receptors, acting as a tissue-specific mixed agonist/antagonist. This action directly reduces the size of uterine fibroids and controls uterine bleeding. It can also inhibit or delay ovulation.
Pharmacokinetics
Onset
Symptomatic improvement for fibroids can be seen within weeks.
Excretion
Primarily excreted via feces, to a lesser extent via urine.
Half life
Approximately 32-38 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations reached in about 1 hour.
Metabolism
Primarily metabolized by CYP3A4, and to a lesser extent by CYP1A2 and CYP2A6. Main metabolite is active.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Undiagnosed vaginal bleeding
- Uterine, cervical, ovarian cancer
- Severe liver impairment
- Hypersensitivity to the active substance or any excipients
Drug Interactions
Hormonal contraceptives
May reduce efficacy of both ulipristal and the contraceptive.
Strong CYP3A4 inhibitors (e.g., ketoconazole)
May increase ulipristal exposure.
Gastric pH altering agents (e.g., antacids, PPIs)
May reduce absorption.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's Wort)
May decrease ulipristal exposure and efficacy.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited data available on overdose. Symptomatic and supportive treatment is recommended in case of overdose.
Pregnancy & Lactation
Contraindicated in pregnancy due to potential harm to the fetus. Not recommended during breastfeeding as ulipristal is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 years
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of ulipristal acetate in reducing fibroid volume, controlling bleeding, and improving quality of life for women with uterine fibroids.
Lab Monitoring
- Liver function tests (LFTs) should be performed before starting treatment and periodically during treatment (e.g., monthly).
- Pregnancy test before starting each course of treatment.
Doctor Notes
- Confirm absence of pregnancy before initiating treatment and before each new treatment course.
- Monitor liver function tests (LFTs) periodically, especially before and during each treatment course, and immediately if symptoms of liver injury occur.
- Emphasize the importance of using non-hormonal contraception during treatment due to potential interaction with hormonal methods.
- Educate patients on symptoms of liver injury and the need for immediate reporting.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, usually for a specific duration.
- Inform your doctor about all other medications you are taking, including herbal supplements.
- Report any symptoms of liver problems (e.g., yellow skin/eyes, dark urine, severe nausea, vomiting) immediately to your doctor.
- Use a reliable barrier method of contraception during treatment, as hormonal contraceptives may not be effective.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.
Driving Precautions
This medicine may cause dizziness in some patients. If you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Maintain regular follow-up appointments with your doctor to monitor your condition and treatment response.
- Discuss any concerns or side effects with your healthcare provider.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.