Allynol 5 mg

Description

Indications

Allynol is prescribed for the management of conditions related to pregnancy, including:

• Intrauterine Growth Retardation (IUGR)
• Threatened abortion
• Recurrent (habitual) miscarriage
• Risk of premature labor

Use under the supervision of a registered physician.

Description

Allynol is an oral gestagen that plays a crucial role in maintaining pregnancy. It has been shown to support pregnancy without causing hormonal side effects, particularly avoiding masculinization of female fetuses. Clinical research indicates that Allynol enhances the endocrine activity of the trophoblast. In vitro studies demonstrate that it stimulates the placenta to produce increased levels of progesterone.

For patients at risk of pregnancy complications, Allynol has been observed to normalize abnormally low levels of placental hormones such as human chorionic gonadotropin (HCG), human placental lactogen (HPL), estrogen, and progesterone. It also increases the levels of specific enzymes like oxytocinase and CAP. Most patients with high-risk pregnancies who received Allynol treatment successfully carried their pregnancies to full term without complications. The medication is well tolerated, with no significant side effects reported.

Pharmacology

Allylestrenol, the active ingredient in Allynol, exhibits a relatively mild progestational effect on the endometrium. Higher doses than those recommended for preventing abortion are required to achieve a full secretory endometrium in estrogen-primed castrated women or to delay menstruation when combined with estrogen.

Laboratory studies have shown that allylestrenol enhances progesterone synthesis in the placenta. It significantly boosts the production of key placental enzymes, such as cystine aminopeptidase and heat-stable alkaline phosphatase.

Histological and biochemical analyses have demonstrated increased placental activity in patients treated with allylestrenol. This stimulatory effect is supported by the rise in placental hormone levels, including pregnanediol, estriol, HCG, and HPL, as well as key enzymes in maternal urine and plasma.

A study on full-term pregnant women indicated that high doses of allylestrenol (up to 100 mg daily) reduced the intensity of spontaneous uterine contractions without affecting uterine sensitivity to oxytocin or interfering with normal labor progression.

Further research in non-pregnant women with or without hormonal disorders has confirmed that allylestrenol does not exhibit estrogenic or androgenic effects and does not impair adrenal function. Additionally, no abnormalities in liver function, water retention, or electrolyte balance were observed in healthy female volunteers administered allylestrenol.

Dosage & Administration

• Intrauterine Growth Retardation (IUGR): 1 tablet three times daily for at least two months. The dosage may be reduced if symptoms improve.
• Threatened abortion: 1 tablet three times daily until symptoms resolve.
• Habitual abortion: 1–2 tablets daily starting from pregnancy confirmation, continued for at least one month after the critical period.
• Threatened premature labor: Dosage should be individualized, with higher doses (up to 40 mg daily) used as needed.

If a dose is missed, it should be taken as soon as remembered. However, double dosing is not recommended.

Use under the supervision of a registered physician.

Contraindications

Allynol should not be used in patients with:

• Breast cancer or a history of breast-related conditions such as nodules, abnormal mammograms, or fibrocystic disease
• Severe liver disorders, including cholestatic jaundice, hepatitis, hepatic cell tumors, Rotor syndrome, or Dubin-Johnson syndrome
• Unexplained vaginal bleeding
• Pregnancy-related toxemia
• A history of seizures, migraines, or other neurological conditions

Side Effects

Long-term use of Allynol may lead to mild gastrointestinal symptoms, including:

• Nausea
• Vomiting
• Occasional epigastric discomfort

Pregnancy & Lactation

Allylestrenol is specifically designed for use during pregnancy. However, it should be discontinued after childbirth, as it may have a slight but noticeable effect on a breastfeeding infant.

Precautions & Warnings

Caution is advised for patients with:

• Cardiovascular conditions (heart disease, congestive heart failure, coronary artery disease)
• Sinus node dysfunction (sick sinus syndrome)
• Seizures or epilepsy
• Kidney disorders
• Migraine headaches
• Respiratory conditions such as asthma, emphysema, chronic bronchitis, or COPD
• Breastfeeding mothers

Use in Special Populations

Allynol is not recommended for use in individuals under 16 years of age.

Overdose Effects

Symptoms of an overdose may include:

• Unusual drowsiness
• Rapid heartbeat
• Fainting
• Muscle rigidity or abnormal movements in the face, neck, or limbs
• Seizures
• Loss of consciousness

Therapeutic Class

Female sex hormones

Storage Conditions

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