Uliroid 5mg

Tablet
Ulipristal Acetate [For uterine fibroids]
Ziska Pharmaceuticals Limited

Other Strength:

Alternative:
- Fibropress 5mg
- Utal 5mg
- Preroid 5mg



Uliroid
Presentation
Uliroid 5 mg tablet: Each tablet contains Ulipristal Acetate INN 5 mg

Description
Uliroid (Ulipristal Acetate) is an orally-active synthetic Selective Progesterone Receptor Modulator (SPRM) characterized by a progesterone antagonist effect. Ulipristal Acetate exerts a direct effect on the endometrium. When administrated daily during a menstrual cycle, most women will complete their first menstruation but will not menstruate again until the treatment is stopped. Menstrual cycles generally resume within 4 weeks. Ulipristal Acetate reduces the fibroid size through inhibition of cell proliferation and induction of apoptosis

Indications
Uliroid (Ulipristal Acetate) is indicated for pre-operative & intermittent treatment of moderate to severe symptoms of uterine fibroids

Dosage & Administration
Treatment with Uliroid should be started during the first week of menstruation. One tablet should be taken once daily for up to three months. This 3 months treatment course can be repeated once. Retreatment should be started within 1 st week of 2 nd menstrual cycle after previous course. If a patient missed a dose, the patient should take Uliroid as soon as possible. If the dose was missed by more than 12 hours, the
patient should not take the missed dose and simply resume the usual dosing schedule

Side Effects
The majority of the adverse reactions are mild to moderate & do not lead to discontinuation of the drug & usually resolves spontaneously. Among them the most common side-effects are- headache, vertigo, abdominal pain, excessive sweating, hot flushes, acne, muscle or bone pain, breast tenderness, excessive bleeding from the uterus, fatigue, ovarian cyst etc

Precautions


Ulipristal Acetate should only be prescribed after careful diagnosis.
Contraception:Concomitant use of progesterone-only pills, progesterone-releasing intrauterine device or combined oral contraceptive pills is not recommended, a non hormonal contraceptive method is recommended during treatment.Endometrial changes: Changes in the histology of the endometrium may be observed in patients treated with Ulipristal Acetate. These changes are reversible after treatment cessation and should not be mistaken for endometrial hyperplasia. Bleeding pattern: Ulipristal Acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. If an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions. Asthma patients: Use in women with severe asthma insufficiently controlled by oral Glucocorticoids is not recommended

Pediatric use
There is no relevant use of Ulipristal Acetate in the pediatric population

Renal impairment
No dose adjustment is recommended in patients with mild or moderate renal impairment. In the absence of specific studies, Ulipristal Acetate is not recommended in patients with severe renal impairment unless the patient is closely monitored

Hepatic impairment
No dose adjustment is recommended for patients with mild hepatic impairment. In the absence of specific studies, Ulipristal Acetate is not recommended in patients with moderate or severe hepatic impairment unless the patient is closely monitored

Contraindications


Ulipristal Acetate is contraindicated in the following cases-

Hypersensitivity to Ulipristal Acetate
Women with abnormal vaginal bleeding of unknown cause
Women with uterine, cervical, ovarian or breast cancer
Pregnancy
Breastfeedin

Use in Pregnancy & Lactation
Ulipristal Acetate is contraindicated during pregnancy.Ulipristal Acetate is excreted in human milk. The effect on newborn/infants has not been studied. Thus, Ulipristal Acetate is contraindicated during breastfeeding

Commercial Packaging
Each box contains 2x10's tablets in blister strip

Drug Interaction
Ulipristal Acetate interacts with the following drugs- Erythromycin, Rifampicin, Rifabutin, Verapamil, Ketoconazole, Ritonavir, Nefazodone, Itraconazole, Telithromycin, Clarithromycin, Carbamazepine, Oxcarbazepine, Phenytoin, Fosphenytoin, Phenobarbital and Primidone

Overdose
Experience with Ulipristal Acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported

Storage
Store at 250 C. Protect from moisture and light.


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