Allylestrenol is indicated for:

• Intrauterine growth restriction (IUGR)
• Threatened abortion
• Recurrent (habitual) abortion
• Risk of premature delivery

Allylestrenol is an orally active progestogen that helps maintain pregnancy without causing significant hormonal side effects, such as masculinization of female fetuses. It enhances the endocrine function of the trophoblast and stimulates the placenta to produce more progesterone. In high-risk pregnancies, where placental hormone levels (such as HCG, HPL, estrogens, and progesterone) and certain enzymes may be abnormally low, treatment with Allylestrenol helps restore these levels toward normal. Clinical evidence suggests that it can reduce the risk of miscarriage and support the continuation of pregnancy to term. It is generally well tolerated, with minimal significant side effects reported.

Allylestrenol exhibits a relatively mild progestational effect on the endometrium. Higher doses may be required to achieve a fully secretory endometrium or to delay menstruation in certain conditions.

Laboratory studies have shown that allylestrenol enhances progesterone production in the placenta and increases the activity of specific placental enzymes. It also promotes functional activity in the placenta, particularly within the syncytiotrophoblast, in both normal and high-risk pregnancies. This is reflected by increased levels of placental hormones such as pregnanediol, estriol, HCG, and HPL, as well as enzymes like oxytocinase and CAP in maternal blood and urine during treatment.

In full-term pregnancies, high doses of allylestrenol (up to 100 mg daily) have been shown to reduce spontaneous uterine contractions without affecting uterine sensitivity to oxytocin or interfering with normal labor progression.

Studies in non-pregnant women have demonstrated that allylestrenol does not possess estrogenic or androgenic effects and does not adversely affect adrenal function. Additionally, no abnormalities in liver function or fluid and electrolyte balance have been observed in healthy individuals taking the drug.

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.

Allylestrenol should not be used in patients with:

• Breast cancer or breast-related disorders such as nodules, abnormal mammogram findings, or fibrocystic disease
• Severe liver conditions including cholestatic jaundice, hepatitis, hepatic tumors, Rotor syndrome, or Dubin-Johnson syndrome
• Unexplained vaginal bleeding
• Toxemia of pregnancy
• Seizure disorders or severe migraine

Prolonged use of allylestrenol may lead to gastrointestinal disturbances such as nausea, vomiting, and occasional upper abdominal discomfort.

Allylestrenol is intended for use during pregnancy. It should be discontinued after delivery, as small amounts may pass into breast milk and could affect the nursing infant.

Caution is advised in patients with heart disease, congestive heart failure, sick sinus syndrome, coronary artery disease, epilepsy, migraine, or respiratory disorders such as asthma, emphysema, chronic bronchitis, or COPD. Use cautiously during breastfeeding.

Not recommended for children under 16 years of age.

Overdose symptoms may include excessive drowsiness, rapid heartbeat, fainting, abnormal muscle movements or stiffness, seizures, and possible loss of consciousness.

Female sex hormones.

Store below 30°C, away from light and moisture. Keep out of reach of children.