Prelab 5 mg

INDICATIONS

Allylestrenol is indicated in:

Intra Uterine Growth Retardation (IUGR)
Threatened abortion
Habitual abortion
Threatened premature delivery

PHARMACOLOGY

Allylestrenol has been found to have a relatively weak progestational effect on the human endometrium. To obtain a full secretory endometrium in oestrogen-primed castrated women or to postpone menstruation (with an oestrogen added) in normal ovulating women, doses of allylestrenol were required which were higher than those recommended for the treatment/prevention of abortion.In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.

DOSAGE & ADMINISTRATION

Intra Uterine Growth Retardation: 1 tablet three times a day at least two months. Dose to be reduced if symptoms improve. Threatened abortion: 1 tablet three times daily until symptoms disappear.Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.

SIDE EFFECTS

Treatment with Allylestrenol (especially a long term treatment) is known to cause some gastrointestinal complaints such as vomiting, nausea, and sometimes epigastric discomfort.

PREGNANCY & LACTATION

Allylestrenol is specifically designed to be taken during pregnancy. It should be discontinued after delivery as it may affect a nursing infant to a small but noticeable degree.

PRECAUTIONS & WARNINGS

Patients with the following conditions should be cautious: Heart disease, congestive heart failure, sick sinus syndrome, coronary artery disease, seizures, epilepsy, renal dysfunction, migraine headaches, or breathing diseases including asthma, emphysema, chronic bronchitis, or COPD, breast-feeding.

USE IN SPECIAL POPULATIONS

It should not be used for children younger than 16 years old.

THERAPEUTIC CLASS

Female Sex hormones

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.