Indications
5X Tablet is used for:
Emergency contraception, For pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Adult Dose
Oral
Emergency Contraception:
One tablet taken orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
If vomiting occurs within 3 hours of Ulipristal Acetate intake, consideration should be given to repeating the dose.
Uterine Fibroids:
The treatment consists of 1 tablet of 5 mg to be taken orally once daily for up to 3 months.
This 3-month treatment course can be repeated once.
Re-treatment should start at the earliest during the second menstruation following the 1st treatment course completion.
Treatments should always be started during the 1st week of menstruation.
If a patient misses a dose, the patient should take ulipristal acetate as soon as possible.
If the dose was missed by >12 hrs, the patient should not take the missed dose and simply resume the usual dosing schedule.
Child Dose
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Ulipristal Acetate is contraindicated for use in the case of known or suspected pregnancy.
Hypersensitivity to ulipristal acetate or to any of the excipients.
Genital bleedng or unknown aetiology or for reasons other than uterine fibroids.
Uterine, cervical, ovarian or breast cancer.
Breastfeeding.
Precautions
Existing Pregnancy
Not indicated for termination of an existing pregnancy. Pregnancy should be excluded before prescribing Ulipristal Acetate.
Ectopic Pregnancy
A history of ectopic pregnancy is not a contraindication to 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; therefore, routine contraception should be continued or initiated as soon as possible following use of Ulipristal Acetate to ensure ongoing prevention of pregnancy.
Effect on Menstrual Cycle
After Ulipristal Acetate intake, menses sometimes occur earlier or later than expected by a few days.
Contraception
Concomitant use of progestagen only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended (see Interactions). Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment.
Sexually Transmitted Infections/HIV
This does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
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. These histological changes should not be mistaken for endometrial hyperplasia .
Pregnancy-Lactation
Pregnancy
Contraindicated for use during an existing or suspected pregnancy; no signal of concern regarding pregnancy complications was found in postmarketing studies; isolated cases of major malformations in ella-exposed pregnancies were identified; however, data are not sufficient to determine risk for birth defects with inadvertent use of therapy during pregnancy
Pregnancy exposure data to therapy was collected in the U.S. and Europe from 1999 to 2015 and analyzed post-marketing using data from interventional clinical trials, observational studies and pharmacovigilance reports; therapy-exposed pregnancies were not associated with a pattern of increased risk of adverse outcomes
Lactation
The drug and its active metabolite, monodemethyl-ulipristal acetate, are present in human milk in small amounts; based on levels of drug and active metabolite measured in breastmilk, a fully breastfed child would receive a weight-adjusted dosage of approximately 0.8% of ulipristal acetate and monodemethyl-ulipristal acetate on Day 1 of drug administration and an approximate total of 1% of maternal dose over a 5-day period after drug administration; there is no information on effects on breastfed child or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Concomitant administration of medicinal products containing progestagen is not recommended.
Also concomitant use of ulipristal acetate and potent CYP3A4 inducers (eg, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efzvirenz, nevirapine, long term use of ritonavir) is not recommended.
Side Effects
Side effects of Ulipristal Acetate :
Mood disorders; headache, dizziness; nausea, abdominal pain/discomfort, vomiting; myalgia, back pain; dysmenorrhea, pelvic pain, breast tenderness; fatigue.
Mode of Action
Selective progesterone receptor modulator with antagonistic and partial agonistic effects.
When taken immediately before ovulation, postpones follicular rupture.
It is thought that the primary mechanism of action for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also occur.
Note
5X 30mg Tablet generic name is Ulipristal Acetate. 5X 30mg Tablet is manufactured by Renata Limited5X is availble in all over Bangladesh.
Mes BD drug index information on 5X Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.