Lutenyl

Lutenyl

Manufacturer:

PT. Merck Tbk
Full Prescribing Info
Contents
Nomegestrol acetate.
Action
Pharmacotherapeutic Group: Progestogen. ATC Code: G: Genitourinary system and sex hormones.
Pharmacology: Pharmacodynamics: Compensates for progesterone deficiency. The affinity of Lutenyl for progesterone receptors is 2.5 higher than the natural hormone.
Lutenyl has no androgenic, anabolic, estrogenic, corticoadrenal or anti-inflammatory activity and therefore does not interfere with glucose metabolism, nor with water or electrolyte balance, and does not affect bromo-sulfophthalein (BSP) clearance.
When administered from the 5th-25th day at the usual dose of 5 mg daily, Lutenyl suppresses the ovulatory peak of gonadotropins, lowers circulating estrogen concentration and prevents secretion of progesterone. Pharmacoclinical studies have not shown a complete antigonadotropic effect in all patients.
Pharmacokinetics: The pharmacokinetic study conducted after administration of a single dose shows that: Absorption into the digestive tract is rapid, with peak plasma level being reached within 2 hrs, half-life is about 40 hrs. Nomegestrol acetate binds at a high rate (96.8±0.8%) as does progesterone (97.2-97.6%), to plasma albumin. It does not bind to sex hormone-binding globulin (SHBG) nor to corticosteroid-binding globulin (CBG).
As with other progesterone derivatives, the principal metabolites are hydroxylated. They are partially (glucurono- and sulpho-) conjugated and eliminated mainly by the intestinal route, and partly in the urine.
No accumulation of nomegestrol acetate occurred after daily administration of a tablet containing 5 mg.
A single daily dose of Lutenyl is justified by its good bioavailability after oral administration and by its long half-life.
Indications/Uses
In Premenopausal Women: Menstrual disorders associated with a deficient or absent progesterone secretion, in particular: Disorders of Cycle Duration: Oligomenorrhoea, polymenorrhoea, spaniomenorrhoea, amenorrhoea (after investigation of the cause).
Functional Uterine Bleedings: Metrorrhagia, menorrhagia.
Functional Signs and Symptoms Preceding or Accompanying Periods: Essential dysmenorrhoea, premenstrual syndrome, cyclical mastodynia.
In Postmenopausal Women: Artificial cycles in combination with an estrogen.
Dosage/Direction for Use
Usual Daily Dose: 5 mg (1 tab daily).
In Premenopausal Women: The usual treatment regimen is 10 days/cycle, from the 15th day up to and including 24th day.
In Postmenopausal Women: The treatment regimen will depend on the estrogen replacement therapy given. In sequential regimens, the progestin is prescribed for 12 days/month.
However, the dose and duration of treatment may be modified depending on the type of indication and the patient's response.
Overdosage
No case of overdosage has been reported.
Contraindications
Hypersensitivity to nomegestrol acetate or to any of the excipients of Lutenyl.
Active or past history of arterial thromboembolism (in particular, myocardial infarction, cerebrovascular stroke), and venous thromboembolism (in particular, phlebitis, pulmonary embolism).
Serious disturbances of liver function.
Undiagnosed genital bleeding.
Use in pregnancy: Lutenyl is not indicated during pregnancy. The results of a number of epidemiological studies have ruled out the risk of malformation (urogenital or other) resulting from the administration of progestins in early pregnancy. The risks associated with sexual differentiation of the foetus (particularly female), which have been described with older, highly androgenmimetic progestins, have not been extrapolated to recent progestins, which are not or are much less, androgen-mimetic (including the progestin used in Lutenyl).
Special Precautions
Pharmacoclinical studies have not shown a complete antigonadotropic effect in all patients.
In some indications eg, uterine bleeding, amenorrhoea and dysmenorrhoea, it is essential to investigate the cause before starting treatment in order to ensure that the disorders are functional.
A clinical examination and if appropriate, additional tests should be done before starting treatment to confirm that there is no breast or uterine cancer (cervix, endometrium).
Administration of Lutenyl should be discontinued if any of the following occur: Ocular disorder (diplopia, acute visual impairment, retinal vascular lesions); clinical signs of arterial or venous thromboembolism; severe and unexplained headaches.
Medical follow-up is particularly advised in patients suffering from or having suffered from cardiovascular disease, unstable hypertension, diabetes or porphyria.
Effects on the Ability to Drive or Operate Machinery: No effects on ability to drive and use machines have been observed.
Use in lactation: Administration of Lutenyl is not advised during lactation due to the passage of steroids into breast milk.
Use In Pregnancy & Lactation
Use in pregnancy: Lutenyl is not indicated during pregnancy. The results of a number of epidemiological studies have ruled out the risk of malformation (urogenital or other) resulting from the administration of progestins in early pregnancy. The risks associated with sexual differentiation of the foetus (particularly female), which have been described with older, highly androgenmimetic progestins, have not been extrapolated to recent progestins, which are not or are much less, androgen-mimetic (including the progestin used in Lutenyl).
Use in lactation: Administration of Lutenyl is not advised during lactation due to the passage of steroids into breast milk.
Side Effects
Disturbances of menstruation periods, amenorrhoea and breakthrough bleeding.
Worsening of venous insufficiency in lower limbs.
Exceptionally: Allergic skin reactions and fever.
Visual disorders.
Venous thromboembolic occurrence.
Weight gain, insomnia, pilopity, gastrointestinal disorder may also occur.
Drug Interactions
Enzyme Inducers: Anticonvulsants (carbamazepine, phenobarbital, phenytoin, primidone); barbiturates, griseofulvin, rifabutin, rifampicin. These medicinal products reduce the efficacy of the progestin by enzymatic induction.
Storage
Store below 25°C.
ATC Classification
G03DB04 - nomegestrol ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Caplet 5 mg x 3 x 10's.
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