Lutenyl

Lutenyl®
Nomegestrol acetate
Hormone

Composition
Each caplet contains Nomegestrol Acetate 5 mg

Mode of actions
Hormones - progestogens

• Synthesis progestogen derived from 19-norprogesterone
  1. True pseudogestagen, compensates for progesterone deficiency Lutenyl's affinity for the progesterone receptor is 2.5 times greater than that of the natural hormone.
  2. Devoid of any androgenic, anabolizing, estrogenic, corticoadrenal and anti-inflammatory effect. It does not interfere with glucide metabolism nor with water and electrolyte metabolism. It does not affect BSP clearance.
• Administered from the 5th to 25th day at the usual dose of 5 mg per day, Lutenyl suppresses the ovulatory peak of the gonadotrophins, reduces the level of circulating oestrogens and prevents progesterone secretion.
• Clinical and biological studies show Lutenyl has good general and digestive tolerance without parallel adverse effects (hormonal, vascular, hepatic or metabolic).

Indications

• Symptoms linked to progesterone deficiency, particularly in the perimenopausal period (menstrual irregularities, premenstrual syndrome, mastodynia)
• Functional uterine bleedings and menorrhagia of fibromas
• Endometriosis
• Dysmenorrhoea
• Hormone replacement therapy combination with estrogens

Dosage and administration
The average daily dose is 5 mg. Usual treatment length is 10 days per cycle, from the 16th to the 25th day
inclusive.
Nevertheless, both the dose and duration of treatment can be adjusted according on the type of indication and the patients response.

Warning and precautions
Women who are breast-feeding because of the passage of steroids into breast milk.
In some indications, particularly dysmenorrhoea, uterine haemorrhage and amenorrhoea. it is essential to ensure the disorder is functional in nature before treatment is started.
Before starting treatment, the doctor should ascertain no adenocarcinoma of the breast or endometrium exists.
Although no cases have been reported with Lutenyl, thromboembolic and metabolic risk cannot be completely discounted. Consequently, the administration of the product must be stopped should any of the following signs occur ; ocular disorders such as unilateral loss of vision, diplopia, vascular lesions of the retina, thrombotic or venous thromboembolic incidents, severe headaches.
As with all steroid hormones, care must be taken with patients with a history of myocardial infarction or
cerebrovascular disease, arterial hypertension or diabetes.

Side Effects

• Menstrual disorders, amenorrhoea, breakthrough bleeding
• Exceptionally: weight gain, insomnia, pilosis, gastrointestinal disorders
• Although these have never yet been reported with Lutenyl:
  • Aggravation of venous insufficiency in the legs
  • Possibility of cholestatic icterus and pruritus

Contraindications
These are common to all synthetic progestogens:

• History of thrombophlebitis
• Serious liver dysfunction
• Non-diagnosed genital haemorrhage
• Pregnancy

Drug Interactions
Association requiring precautions for use
Anti diabetic drugs because of the diabetogenic effect of high doses of progestogens. The patient should be
warned and urine and glycaemia monitoring must be more frequent.
If needed, the anti diabetic posology can be adjusted during and after treatment with progestogens.

inadvisable associations
Anti-convulsants (carbamazepine, phenobarbitone, phenytoin, primidone), barbiturates, griseofulvin,
rifampicin.These drugs reduce the efficacy of progestogens through enzyme induction..

Pregnancy and lactation
The risks concerning the sexual differentiation of the foetus (particularly female), previously described for the
older extremely androgenomimetic progestogens, do not extend to the more recent progestogens which are
much less or not at all androgenomimetic (as it the case for the one used in this preparation).
The passage of steroids into breast milk should betaken into consideration.

Presentation
Box of 3 x 10 caplets in blister

Storage
Store below 25°C

On medical prescription only
"Harus dengan resep dokter"

Manufactured by
Theramex, Monaco Cedex
Imported by
PT. Merck Tbk., Jakarta
Reg.No.: DKI0272600104A1

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