LUTENYL

Indications

• Hormonal contraceptive
• Management of endometriosis
• Treatment of abnormal uterine bleeding
• Management of menopausal symptoms

Dosage

Children: For paediatric use, refer to the BNF for Children for appropriate dosing guidelines.

Adults: The usual dosage for hormonal contraception is one tablet taken orally once daily. For other indications, refer to specific guidelines and clinical recommendations.

Mechanism of action

Nomegestrol acts primarily by binding to progesterone receptors in target tissues, leading to changes in gene expression that affect the menstrual cycle and pregnancy. This action results in the inhibition of ovulation, alteration of the endometrium to prevent implantation, and thickening of cervical mucus, which reduces sperm passage.

Pharmacodynamics

As a progestogen, nomegestrol has effects that include the regulation of the menstrual cycle, prevention of ovulation, and alteration of the endometrium. These effects are crucial in contraceptive methods and in the treatment of conditions like endometriosis and abnormal uterine bleeding.

Pharmacokinetics

Nomegestrol is well absorbed after oral administration. It undergoes hepatic metabolism, primarily by cytochrome P450 enzymes. The elimination half-life is approximately 30-40 hours, allowing for once-daily dosing in contraceptive use. Its metabolites are primarily excreted in urine and feces.

Contra-indications

• Hypersensitivity to nomegestrol or any of its excipients
• Severe liver disease
• Active or previous venous thromboembolism
• Known or suspected breast cancer or other hormone-sensitive cancers
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• Migraines with aura
• Pancreatitis
• Undiagnosed vaginal bleeding

Adverse effects

• Headache
• Nausea
• Breast tenderness
• Weight gain
• Mood changes
• Decreased libido
• Acne
• Gastrointestinal disturbances

Interactions

• Anticonvulsants (e.g., phenytoin, carbamazepine) may reduce efficacy
• Rifampicin may decrease the effectiveness of nomegestrol
• St. John's Wort may reduce plasma concentrations
• Antibiotics may potentially alter the metabolism of nomegestrol, although effect is variable

Precautions

• Monitor for signs of thromboembolic disorders
• Consider alternative contraceptive methods in women with a history of thrombosis
• Use with caution in women with hypertension
• Regular breast examinations and mammograms should be performed in women using hormonal contraceptives
• Evaluate risks vs benefits in women with a history of migraines

Pregnancy

Nomegestrol is contraindicated during pregnancy due to potential risks to the fetus.

Breast-feeding

Nomegestrol is excreted in breast milk; caution is advised when used during breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

• Tablets containing nomegestrol 2.5 mg