Description

COMPOSITION of Safe Abort Kit

Each Safe Abort Kit contains

Mifepristone Tablet I.P-IN

Each uncoated tablet contains

Mifepristone IP                200 mcg

Excipients                             q.s

B) Misoprostol Tablet IP-4N

Each uncoated tablet contains

Misoprostol IP…………………2oomg

(As 1% HPMC Dispersion)

Excipients…………………q.s

DOSAGE FORM

Mifepristone tablet for oral use and misoprostol tablets for vaginal Use

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SAFE ABORT KIT contains 1 tablet of mifepristone 200 mg to be given orality and 4 tablets of misoprostol 200 mcg to be given vaginally for the medical termination of pregnancy up to 9 weeks

Mifepristone has anti-progestational activity As mifepristone inhibits the activity of progesterone it results in termination of pregnancy Mifepristone also exhibit ant glucocorticoid and weak and-androgenic activity

Misoprostol is a synthetic prostaglandin E1. Misoprostol causes the cervix to soften and the uterus to contract, and also inhibits gastric acid secretion in humans.

PHARMACOLOGY

Safe Abort Kit The and-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptors Based on studies with various oral doses in several animal species (mouse, rat, rabbit, and monkey), the compound inhibits the activity of endogenous or exogenous progesterone and results in the termination of pregnancy Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women During pregnancy.

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The compound senses the myometrium to the contraction-inducing activity prostaglandins, Mifepristone also exhibits ant glucocorticoid and weak antiandrogenic activity Doses of 45 mcg greater in human beings resulted in a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol. The antiandrogenic activity was observed in rats following repeat administration of doses from 10 to 100 mg/kg

Misoprostol

Prostaglandin El causes myometrial contractions by interacting with specific receptors on the myometrial cell.  This interaction result in a change in calcium concentration  thereby initiating muscle contraction by interacting with prostaglandins receptors cores the cervix to soften and  the uterus  to contract resulting in the expulsion of the uterine contents

Pharmacokinetics

Mifepristone 

Absorption

Following  oral administration of a single dose of 600 mg mifepristone rapidly absorbed with a peak plasma concentration of 1.98 mg/l occurring Approximately 90 minutes after ingestion The absolute bioavailability of a 20 mg oral dose in 69%

Metabolism

Metabolism of mifepristone is primarily via  pathways involving N-demethylation  and terminal hydroxylation of the 17-property dain in vitro studies have shown that CYp450 3A4 is primarily responsible  for the metabolism The three major metabolites  identified in humans (1) RU 42 633, most widely found in plasma is  the N monomethylated imitation (2) AU 42 848, which results from the loss of two  methyl groups from the 4-dimethylaminophenyl position 11B, and (3) RU 42 698  which result for terminal  hydroxylation of the 17 propynyl chain

Excretion

By 11 days after a 600 mg dose of titrated compound 83% of  drug  has been accounted for by the faces and 9% by the urine Serum levels are undetectable by 11 days

Misoprostol

Misoprostol extensively absorbed, and undergoes rapid de-esterification to its free acid  and which is responsible for its clinical activity and Unlike the parent compound is detectable in plasma, the alpha side chain undergoes bet ration and the beta side chain undergoes  beta  oxidation followed by reduction of the ketone to give prostaglandin analogues The compound is a lipophilic methyl ester pro drug and is readily to  metabolized to the free sold, which is biologically active form Following oral administration, the plasma misoprostol levels increased rapidly, with a peak at 30 declined rapidly by 120 minutes and remained low theater

in contrast, in her vaginal administration, the plasma concentration gradually increased reaching maximum levels after 70-80 minutes and slowly declined with delectable levels’ presenter fi hours Vaginal misoprostol was present in the circulation longer than oral misoprostol and hence its duration of stimulation of the cans exceeds that of oral misoprostol Vaginal application of misoprostol results in slower increases and lower peak plasma concentrations of misoprostol acid than does

oral administration, but overall exposure to the drug is increased.

INDICATIONS

Safe Abort Kit, indicated for early medical abortion up to 9 weeks (63days) of gestation

DOSAGE AND ADMINISTRATION

Sale Abort Kit is indicated for the medical termination of intrauterine pregnancy up to 63 days of Gestation. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 days cycle with ovulation occurring at mid-cycle The duration of pregnancy may be determined from menstrual history an by clinical examination, Ultrasonographical scan should be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected. Any intrauterine contraceptive device [UD] should be removed before treatment with mifepristone and misoprostol begins. Pregnancy termination by surgery is recommended in cases when Safe Abort Kit fails to cause termination of intrauterine pregnancy.

Mifepristone may be administered by or under the supervision of a gynecologists’, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The gynecologists’ must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure the patient’s access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

The dosage is mifepristone 200 mg orally, followed 1-3 days later by misoprostol 800 mcg (4 tablets of 200 mcg)vaginally. The misoprostol may be administered by a physician or self administered by women. For at 49-63 days of gestation, if abortion has not occurred hours after administration of misoprostol, a second dose of misoprostol 400 mcg (2 tablets of 200 mcg) may be administered vaginally or orally depending upon preference and amount of bleeding).

The patient should return for a follow-up visit approximately 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographical scan that a complete termination of pregnancy has occurred Patients who have an ongoing pregnancy at this visit have a risk of a fetus malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failure.

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