Levonorgestrel USP 1.50 mg
Setfree Th Tablet: Each tablet contains Levonorgestrel USP 1.50 mg.
DESCRIPTION Setfree Mis a synthetic Progesterone hormone taken as an emergency oral contraceptive pill to prevent pregnancy after unprotected sex (if a contraceptive fails or if no contraception was used). It should not be taken as regular birth control pill. It is also known as morning after pill. Setfree TM does not protect against HIV or any other sexually transmitted disease. CLINICAL PHARMACOLOGY PHARMACODYNAMICS The mechanism of action of SetfreeTM in an individual case can not be certain as it depends on the time in the menstrual cycle when the intercourse has occurred and when Setfree This taken. The various postulated mechanisms depending on the phase of cycle are:
- Inhibition or delay of ovulation when used prior to ovulation
- Thickening of cervical mucus resulting in trapping of sperms
- Direct inhibition of fertilization, alteration in the transport of egg, sperm or embryo,
interference with corpus luteum function and luteolysis
- Histological and biochemical alterations in the endometrium leading to impaired inhibition or delay of ovulation when used prior to ovulation endometrial receptivity to implantation of a fertilized egg PHARMACOKINETICS Absorption No specific investigation of the absolute bioavailability of Levonorgestrel in humans has been conducted. However, Levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism. Distribution Levonorgestrel in serum is approximately 50% is bound to Albumin and 47.5% is bound to sex hormone binding Globulin. Metabolism Following a single oral dosage, Levonorgestrel does not appear to be extensively metabolized by the liver. Excretion About 45% of Levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as Glucuronide conjugates. INDICATIONS SetfreeTM is used as soon as possible, preferably within 12 hours and not later 72 hours (3 days) after the unprotected sexual intercourse under prescription or as OTC drug or in following conditions:
- If the partner’s condom has broken, slipped or been improperly removed or if he has forgotten
to use it
- If there is a fear of intrauterine device has been expelled
- If there is a vaginal diaphragm or contraceptive cap that has moved or removed too easily
- If there is a chance of coitus interruptus failure and had sexual intercourse during the period
when there is a possibility to be fertile while using the rhythm method
- In the event of rape HOW TO TAKE Setfree? The treatment necessitates the intake of one tablet. One Setfree. TM tablet must be taken as soon as possible preferably within 12 hours after unprotected intercourse and no longer than
within 72 hours (3 days) after the intercourse.
Setfreem can be taken at any moment during the menstrual cycle. After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide and cervical cap) until the next menstrual period resume. The use of Setfree does not contraindicate the continuation of regular hormonal contraception. Use of Setfree, while taking an oral contraceptive pill, one should carry on taking the usual tablets till the end of the treatment. In case of no menstrual period occurs in the next pill free period following the use of Setfree, a pregnancy test should be performed to rule out a pregnancy.
DOSAGE AND ADMINISTRATION Setfree should be taken orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. SetfreeTM can be used at anytime during the menstrual cycle. If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.
CONTRAINDICATIONS SetfreeTM is not recommended for known or suspected pregnancy, hypersensitivity to any component of the product.
SIDE EFFECTS The common side effects are abdominal or stomach pain, dizziness, headache, nausea, tenderness of the breasts, unusual tiredness or weakness, vomiting, diarrhea (In rare cases).
OVER DOSAGE There are no data on over dosage of SetfreeTM, although the common adverse event of nausea and associated vomiting may be anticipated.
WHEN SHOULD SEEK ATTENTION FROM HEALTHCARE PROFESSIONAL?
Immediate consultation with healthcare professional is necessary if absent or irregular menstrual periods, dysmenorrhea, menorrhagia, hypomenorrhea, oligomenorrhea etc occurs.
PRECAUTIONS AND WARNINGS SetfreeTM must be used exceptionally; since it does not allow to prevent a pregnancy in every instance, the associated hormonal overdosing is not advisable in case of regular intake, it can not replace a regular contraception. After taking Setfreemenstrual period usually occurs at the expected date nevertheless, it can occur earlier or later by a few days. After taking this tablet, it is therefore mandatory to check the absence of pregnancy by performing a pregnancy test in case of abnormal bleeding at the date of expected period or in case of menstrual delay of more than 5 days.
USE IN PREGNANCY AND LACTATION Setfree T is not indicated in case of pre-existing pregnancy and can not interrupt it in case of failure of this contraceptive mean with persisting pregnancy. Epidemiological studies indicates no adverse effects of Progestogen on malformation of a fetus. Lactation is possible. However, since Setfreem is secreted into breast milk it is suggested that to breast feed immediately before taking each tablet and to skip nursing following each Levonorgestrel tablet administration.
DRUG INTERACTIONS Simultaneous administration of certain anticonvulsants (e.g. Phenobarbitone, Phenytoin, Primidone, Carbamazepin etc.), also other medicine such as antituberculosis drug Rifampicin and antifungal drug Griseofulvin can reduce or suppress the effectiveness of Setfree, .
STORAGE CONDITION Store in a cool & dry place, protected from light. Keep out of reach of children.
COMMERCIAL PACK Setfreem Tablet: Each box contains 1 tablet in 1×1’s Alu-PVC blister pack.
Manufactured by: Nuvista Pharma Limited
Tongi – Gazipur