Lenzetto^® (Spray) Instructions for Use

ATC Code

G03CA03 (Estradiol)

Active Substance

Estradiol

Clinical-Pharmacological Group

Estrogen. An analogue of endogenous 17β-estradiol

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system; estrogens

Pharmacological Action

Estrogen. A follicular hormone necessary for the development of the female body and the reproductive system.

Exogenous Estradiol exerts the same physiological action as natural hormones: it stimulates the development of the uterus, fallopian tubes, the development of secondary sexual characteristics in cases of their underdevelopment, causes proliferative changes in the endometrium, increases the excitability of the uterus, and in large doses suppresses lactation.

Estradiol regulates nitrogen metabolism, reduces the level of lipids and cholesterol in the blood, and has a weak anabolic effect.

It helps maintain the balance between osteoblasts and osteoclasts, reduces bone resorption and promotes its formation.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract.

It undergoes the “first-pass” effect through the liver.

It is metabolized to less active metabolites – estriol and estrone.

The metabolites are excreted by the kidneys, a small part – through the intestines.

Indications

Primary and secondary amenorrhea; hypoplasia of the reproductive system and secondary sexual characteristics; hormone replacement therapy for disorders observed during natural or surgically induced menopause (including vasomotor disturbances, hot flashes, increased sweating, sleep disorders, atrophic processes of the vagina and lower urinary tract), the cause of which is a deficiency in the production of endogenous estrogens; prevention of recurrent infectious and inflammatory diseases of the vagina and lower urinary tract; prevention and treatment of postmenopausal osteoporosis.

ICD codes

Dosage Regimen

Apply the spray to a clean, dry, intact, and non-irritated area of skin on the inner forearm. Avoid application to the breasts, face, or other areas with high fat content. Do not spray the medication onto mucous membranes.

Prime the pump before first use by pressing the actuator three times while pointing away from yourself and others. If the spray has not been used for more than three days, re-prime with one spray.

Hold the bottle upright approximately 10-15 cm from the skin. Press the actuator firmly and fully once to deliver one dose. Do not rub the application site. Allow the spray to dry completely for at least two minutes before covering the area with clothing.

Rotate the application site daily to minimize the risk of skin irritation. Avoid washing the application site for at least one hour after administration.

The dosage must be individualized based on the clinical indication, patient response, and therapeutic goal. The usual starting dose for menopausal hormone replacement therapy is one spray per day.

Adjust the dose based on the severity of symptoms and clinical response. Do not exceed the prescribed number of sprays. Regularly re-evaluate the dosage to ensure the lowest effective dose is used for the shortest duration consistent with treatment goals.

For women with an intact uterus, concomitant progestogen therapy is mandatory for at least 10-14 days per calendar month to counteract the estrogenic effects on the endometrium and reduce the risk of hyperplasia. Adhere strictly to the prescribed cyclic or continuous combined regimen.

Adverse Reactions

From the central nervous system: headache, dizziness, depression are possible.

From the digestive system: nausea, vomiting, cholestatic jaundice, impaired liver function, gallstone formation are possible.

From the endocrine system: uterine and vaginal bleeding, breast tension and enlargement, changes in libido, endometrial proliferation, development of endometrial carcinoma (in women with an intact uterus after menopause), edema, weight gain are possible.

Allergic reactions: urticaria, skin rash are possible.

Dermatological reactions: erythema multiforme, chloasma, melanoderma are possible.

Contraindications

Breast cancer and endometrial cancer, uterine fibroids, endometriosis, uterine bleeding of unknown etiology; severe liver damage, severe cardiovascular diseases, collagenoses, porphyria, pituitary tumors, otosclerosis, thrombophlebitis, thromboembolism; history of hepatitis, jaundice, prolonged itching, herpes during previous pregnancy; pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver damage, history of hepatitis, jaundice.

Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Special Precautions

Before starting treatment, a gynecological examination is necessary; with long-term therapy, it should be performed at least once a year.

Treatment with estradiol is advisable to combine with progestogenic drugs.

Should be used with caution in patients with coronary artery disease, circulatory failure, migraine, bronchial asthma, epilepsy, severe arterial hypertension, impaired liver and/or kidney function.

Estradiol may cause an increase in existing uterine fibroids.

During the use of estradiol, liver function, blood pressure parameters should be systematically monitored; in patients with diabetes mellitus, blood glucose concentration should be monitored.

Drug Interactions

With simultaneous use, estrogens may reduce the effects of anticoagulants, antihypertensive and hypoglycemic drugs.

With simultaneous use of estradiol and drugs that induce liver enzymes (barbiturates, carbamazepine, griseofulvin and rifampicin), a decrease in the level of estradiol in blood plasma is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.