Ulipristal 5mg tablet | ULIPSTALL 5
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Composition ulipristal 5mg tablet
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Description:
Ulipristal 5mg tablet is a prescription-only medication in the selective progesterone receptor modulator (SPRM) class, used for the pre-operative treatment of moderate-to-severe uterine fibroids in women of reproductive age. It works by blocking progesterone's effect on fibroid tissue, helping control heavy bleeding and shrink fibroid size before surgery. It's important to note that ulipristal acetate also exists in a separate 30mg single-dose formulation used as emergency contraception — the two strengths serve entirely different purposes and are not interchangeable. Ulipristal 5mg also carries a rare but serious risk of liver injury, which is why it's used only under close medical supervision.
What Is Ulipristal 5mg Tablet?
Ulipristal acetate is a synthetic selective progesterone receptor modulator (SPRM) available in two distinct strengths:
- Ulipristal 5mg — taken once daily over a defined treatment course for uterine fibroids (the focus of this article)
- Ulipristal 30mg — a single dose used as emergency contraception, taken within 120 hours of unprotected intercourse
Uterine fibroids (leiomyomas) are non-cancerous growths in the uterus that can cause heavy menstrual bleeding, pelvic pressure, pain, and reduced quality of life. Ulipristal 5mg is used specifically to manage these symptoms and shrink fibroid size, typically as preparation before a planned surgical procedure or in patients for whom surgery is not currently suitable.
How Ulipristal Works
- Progesterone receptor blockade — Ulipristal binds to progesterone receptors in fibroid tissue and the uterine lining, blocking progesterone's growth-promoting signals.
- Antiproliferative effect — This interrupts the signals that drive proliferation of the smooth muscle cells making up fibroid tissue.
- Apoptotic effect — Ulipristal also promotes programmed cell death within fibroid cells, contributing to reduced fibroid volume over the treatment course.
- Bleeding control — These combined effects help control abnormal uterine bleeding, often producing amenorrhea (absence of periods) during treatment.
- Pre-surgical optimization — Reduced fibroid size and improved blood counts (from less heavy bleeding) can make subsequent surgery technically easier and lower-risk.
Clinical Indications
| Condition | How Ulipristal 5mg Helps |
|---|---|
| Moderate-to-severe uterine fibroid symptoms | Reduces heavy menstrual bleeding and pelvic pressure before planned surgery |
| Pre-operative fibroid size reduction | Shrinks fibroid volume, potentially enabling a less invasive surgical approach |
| Fibroid-related anemia | Helps normalize heavy bleeding, supporting recovery of hemoglobin levels prior to surgery |
| Patients unsuitable for immediate surgery | May be used, under close monitoring, in premenopausal women for whom surgery is not currently appropriate or has not worked |
Dosage Guidelines
| Parameter | Typical Guidance |
|---|---|
| Standard dose | One 5mg tablet taken once daily, as prescribed |
| Course duration | Typically up to three months per treatment course, as directed by the treating gynecologist |
| Administration | Taken orally, with or without food, at the same time each day |
| Missed dose | Follow your doctor's specific instructions; do not double up without medical advice |
| Monitoring requirement | Liver function tests are typically required before starting treatment and periodically during the course |
Dosing and treatment duration must be individualized by a gynecologist based on fibroid characteristics, symptom severity, and liver health monitoring. This is strictly a doctor-prescribed and doctor-monitored medication.
Key Benefits
- Effectively reduces heavy menstrual bleeding caused by uterine fibroids, often leading to amenorrhea during treatment
- Shrinks fibroid size, which can simplify subsequent surgical procedures or reduce their invasiveness
- Non-surgical option for symptom control in appropriately selected patients
- Clinical trial data (PEARL I and PEARL II studies) demonstrated efficacy comparable to GnRH agonist therapy, with fewer menopause-like side effects such as hot flushes
- Oral, once-daily dosing offers a more convenient regimen compared to injectable hormonal alternatives
Precautions
- Serious liver injury warning: Rare but serious cases of liver injury, including liver failure requiring transplantation, have been reported with ulipristal acetate 5mg use. Liver function must be assessed before starting treatment and monitored throughout, as directed by your doctor.
- Current regulatory guidance restricts use to women for whom surgery is not appropriate or has been unsuccessful.
- Not for use in women who are pregnant, planning pregnancy, or breastfeeding.
- Not recommended for patients under 18 years of age.
- Inform your doctor of any history of liver disease before starting this medication.
- Report signs of liver problems immediately — yellowing of the skin or eyes (jaundice), unusual fatigue, dark urine, pale stools, nausea, or right upper abdominal pain.
- Do not confuse this 5mg formulation with the 30mg emergency contraceptive formulation — they serve entirely different purposes and dosing schedules.
- Regular follow-up with your prescribing gynecologist is essential throughout treatment.
Side Effects
Common side effects:
- Absence of periods (amenorrhea) or irregular bleeding patterns
- Hot flushes
- Headache
- Nausea
- Abdominal pain
- Fatigue or weakness
- Dizziness
Serious side effects
- Signs of liver injury: yellowing of skin/eyes, dark urine, pale stools, unusual tiredness, right upper abdominal pain, unexplained nausea/vomiting
- Severe or persistent abdominal pain
- Signs of an allergic reaction: swelling of the face, lips, or throat; difficulty breathing; hives
Comparison with Alternatives
| Feature | Ulipristal Acetate 5mg | GnRH Agonists (e.g., Leuprolide) |
|---|---|---|
| Mechanism | Selective progesterone receptor modulator | Suppresses ovarian hormone production |
| Administration | Oral, once daily | Typically injectable, monthly |
| Menopause-like side effects | Fewer hot flushes reported in clinical trials | Hot flushes and bone density loss are common |
| Key safety concern | Rare risk of serious liver injury; requires liver monitoring | Bone mineral density loss with prolonged use |
| Typical use context | Pre-operative fibroid management, selected patients | Pre-operative fibroid shrinkage, symptom control |
Frequently Asked Questions
1. What is ulipristal 5mg used for?
Ulipristal 5mg tablet is used for the pre-operative treatment of moderate-to-severe uterine fibroids, helping control heavy bleeding and shrink fibroid size in women of reproductive age, under a gynecologist's supervision.
2. What is ulipristal used for?
Ulipristal acetate is used for two distinct purposes depending on strength: the 5mg daily tablet treats uterine fibroids before surgery, while the separate 30mg single dose is used as emergency contraception after unprotected intercourse.
3. What is the time period for ulipristal tablets?
Ulipristal 5mg is typically prescribed in defined treatment courses of up to three months for fibroids, with liver monitoring throughout. Ulipristal 30mg, by contrast, is a single one-time dose for emergency contraception, not a course.
4. What is the cost of ulipristal tablets?
Pricing varies by brand, dosage strength, and region. Please check with your pharmacist, doctor, or Steris Healthcare directly for current, accurate pricing rather than relying on unverified online figures.
5. Who should not take ulipristal?
Ulipristal should not be taken by women who are pregnant or suspect pregnancy, those with a known allergy to the medicine, and those with significant liver disease. It's also not recommended for patients under 18. Always disclose your full medical history to your doctor before starting treatment.
6. What is the price of ulipristal 5mg tablet?
The price of ulipristal 5mg tablet depends on the brand, pack size, and pharmacy or region. Contact your doctor or Steris Healthcare for the most current, verified pricing.
7. What is the 7-day rule for the pill?
The "7-day rule" is a guideline associated with combined oral contraceptive pills (not ulipristal), referring to needing 7 consecutive days of active pill-taking to ensure reliable ovulation suppression after a missed dose or a pill-free interval. It does not apply to ulipristal 5mg, which follows its own doctor-directed dosing schedule for fibroid treatment.
8. What are the side effects of ulipristal?
Common side effects include amenorrhea or irregular bleeding, hot flushes, headache, nausea, abdominal pain, fatigue, and dizziness. More seriously, rare cases of liver injury have been reported, so any signs of jaundice, dark urine, or unusual fatigue should be reported to a doctor immediately.
9. How many times can you take ulipristal?
For fibroid treatment, ulipristal 5mg is taken once daily for the course length your doctor prescribes. The separate 30mg emergency contraceptive dose is intended as a one-time dose per instance of unprotected intercourse; it is not recommended for repeated use within the same cycle without your doctor's guidance.
10. How does ulipristal prevent pregnancy?
In its 30mg emergency contraceptive form, ulipristal works by preventing or delaying ovulation, even after the hormonal surge that normally triggers egg release has begun — this is separate from the 5mg fibroid tablet, which is not used for contraception.
Conclusion
Ulipristal 5mg tablet offers a valuable, non-invasive option for managing uterine fibroid symptoms before surgery, effectively controlling heavy bleeding and reducing fibroid size through its action on progesterone receptors. Clinical trial data has shown it performs comparably to established therapies like GnRH agonists, with the added benefit of fewer menopause-like side effects. This benefit must be weighed against a rare but serious risk of liver injury, which is why regulatory guidance limits its use to specific clinical situations and requires close liver function monitoring throughout treatment. It's also worth remembering that ulipristal acetate exists in a separate 30mg formulation for emergency contraception — a different product, with a different purpose and dosing schedule, from the 5mg fibroid tablet discussed here. As a Schedule H prescription medicine, ulipristal 5mg should only be started, adjusted, or stopped under the direct supervision of a qualified gynecologist.
Disclaimer: This content is for informational purposes only and is not a substitute for professional medical advice. Ulipristal 5mg tablet is a prescription-only medicine and must be used strictly under the supervision of a qualified gynecologist, with appropriate liver function monitoring.
Brand name: ULIPSTALL 5 (STERIS HEALTHCARE PVT LTD)
Composition Name: Ulipristal Acetate 5 mg
Formulation: Tablet
Pack size: 6 × 1 × 10 Tablets (60 Tablets)
Marketed By: Steris Healthcare Pvt Ltd
Regulatory standard: WHO-GMP Certified
Schedule: Valid Prescription Required (Prescription Only)
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