Synoestrol (Solution) Instructions for Use

ATC Code

G03CA (Natural and semi-synthetic estrogens)

Active Substance

Hexestrol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Estrogenic drug

Pharmacotherapeutic Group

Non-steroidal structural analog of estrogen

Pharmacological Action

Synthetic estrogen. It helps to normalize the menstrual cycle in women of childbearing age.

It alleviates and stops the manifestations of menopausal syndrome.

It prevents the development of osteoporosis.

Indications

Use as a component of hormone replacement therapy for the management of hypoestrogenic conditions.

• Primary and secondary amenorrhea.
• Menopausal syndrome and associated vasomotor symptoms.
• Post-castration disorders to alleviate estrogen deficiency symptoms.
• Prevention of osteoporosis in postmenopausal women at risk.

ICD codes

Dosage Regimen

Administer the solution orally. The typical dosage is 2 mg taken one to two times per day.

Strictly adhere to the maximum single dose of 2 mg and the maximum daily dose of 4 mg. Adjust the regimen based on individual patient response and therapeutic goals under medical supervision.

Adverse Reactions

Monitor for gastrointestinal disturbances such as nausea and vomiting. Neurological effects like dizziness may occur.

Be aware of potential hepatotoxicity and impaired liver function. There is an increased risk of thromboembolic events, including thrombophlebitis and pulmonary embolism.

Drug Interactions

Concomitant use with hepatic enzyme inducers (e.g., barbiturates, rifampicin) may accelerate metabolism and reduce efficacy.

Exercise caution with anticoagulants, as estrogens can alter their effect. Monitor for potential interactions with drugs metabolized by cytochrome P450 enzymes.

Contraindications

Do not use under the following conditions.

• Known or suspected pregnancy and during lactation.
• Personal history of or active thromboembolic disease or acute thrombophlebitis.
• Estrogen-dependent neoplasms, including known or suspected cancer of the breast, uterus, or ovaries.
• Severe hepatic or renal dysfunction.
• Unexplained uterine bleeding and diabetes mellitus with vascular complications.

Overdose

Symptoms of overdose may include severe nausea and vomiting, with a potential for withdrawal uterine bleeding in women.

No specific antidote exists; manage with symptomatic and supportive care. Gastric lavage may be considered if ingestion is recent. Monitor vital signs and provide appropriate clinical support.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Use in Renal Impairment

Contraindicated in impaired kidney function.

Pediatric Use

Not applicable.

Geriatric Use

No restrictions for use are indicated.

Special Precautions

Before use, it is necessary to conduct laboratory and instrumental studies, taking into account the above contraindications.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.