Peuli Tablet 30 mg

Indications

Ulipristal Acetate is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Description

Ulipristal Acetate 30 mg tablet is an Emergency Contraceptive (EC) pill that prevents unwanted pregnancy. This is a Selective Progesterone Receptor Modulator (SPRM). Ulipristal Acetate tablet is supplied for oral administration. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.

Pharmacology

Ulipristal Acetate is an orally-active synthetic SPRM that acts via high-affinity binding to the human progesterone receptor. The primary mechanism of action is inhibition or delay of ovulation. Data shows that even when taken immediately before ovulation is scheduled to occur, Ulipristal Acetate is able to postpone follicular rupture in some women.

Dosage & Administration

One 30 mg tablet must be taken as soon as possible but no later than 120 hours of unprotected intercourse or contraceptive failure, with or without food. If vomiting occurs within 3 hours of intake, then another tablet needed to be taken. Ulipristal Acetate can be taken at any time of menstrual cycle.

Interaction

Ulipristal Acetate interacts with the following drugs: Barbiturates, Carbamazepine, Phenobarbital, Rifampicin, Itraconazole, Ketoconazole etc.

Contraindications

Ulipristal Acetate is contraindicated in case of hypersensitivity to active substances and in pregnancy.

Side Effects

Most common side-effects are headache, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness, breast tenderness etc.

Pregnancy & Lactation

Contraindicated in suspected or existing pregnancy. Ulipristal Acetate excretes in breast milk. So breastfeeding is not recommended for one week after intake. Extremely limited data are available on the health of the fetus/newborn exposed to Ulipristal acetate.

Precautions & Warnings

Existing Pregnancy: Ulipristal Acetate is not indicated for termination of an existing pregnancy.

Ectopic Pregnancy: A history of ectopic pregnancy is not a contraindication to the use of this emergency contraceptive method.

Repeated Use: Ulipristal Acetate is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of Ulipristal Acetate within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated.

Fertility Following Use: A rapid return of fertility is likely following treatment with Ulipristal Acetate for emergency contraception. So, to prevent pregnancy on a later episode of sexual intercourse one should use the barrier method (ex. Condom).

Effect on Menstrual Cycle: After Ulipristal Acetate intake, menses sometimes occur earlier or later than expected by a few days. In clinical trials, cycle length was increased by a mean of 2.5 days but returned to normal in the subsequent cycle. 7% of subjects reported menses occurring more than 7 days earlier than expected, and 19% reported a delay of more than 7 days. If there is a delay in the onset of expected menses beyond 1 week, a pregnancy test should be performed. 9% of women studied reported intermenstrual bleeding after the use of Ulipristal Acetate.

Use in Special Populations

Children and Adolescents: Limited safety and efficacy data available on women under 18 years old.

Hepatic Impairment: No studies have been conducted to evaluate the effect of hepatic disease on the disposition of Ulipristal Acetate.

Renal Impairment: No studies have been conducted to evaluate the effect of renal disease on the disposition of Ulipristal Acetate.

Overdose Effects

Experience with Ulipristal Acetate overdose is limited, in a clinical study, a single dose equivalent to four times Ulipristal Acetate was administered to a limited number of subjects without any adverse reactions.

Therapeutic Class

Drugs acting on the Uterus, Emergency Contraceptive Pill

Storage Conditions

Store in a dry and cool place, protected from sunlight. Do not freeze. Keep out of reach of children.