JAYDESS INTRAUTERINE SYSTEM 13.5MG

Levonorgestrel

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one | (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one | 13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one | 13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one | 13-Ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one | 17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one | 17-alpha-Ethynyl-13-ethyl-19-nortestosterone | 17-Ethynyl-18-methyl-19-nortestosterone | 17alpha-Ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol | 17alpha-Ethynyl-17-hydroxy-18-methylestr-4-en-3-one | 17alpha-Ethynyl-18-homo-19-nortestosterone | 18-Methyl-17-alpha-ethynyl-19-nortestosterone | 18-Methylnorethisterone | d(-)-Norgestrel | Jadelle | Levonelle | Levonorgestrel | Lévonorgestrel | Levonorgestrelum | Levonova | Microlut | Microluton | Microval | NorLevo | Postinor | Levonorgestrel |

Description

A synthetic progestational hormone with actions similar to those of progesterone and about twice as potent as its racemic or (+-)-isomer (norgestrel). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. It is usually supplied in a racemic mixture (Norgestrel, 6533-00-2). Only the levonorgestrel isomer is active. Levonorgestrel is marketed mostly as a combination oral contraceptive under several brand names such as Alesse, Triphasil, and Min-Ovral.

Indication

For the treatment of menopausal and postmenopausal disorders and alone or in combination with other hormones as an oral contraceptive.

Mechanism of Action

Binds to the progesterone and estrogen receptors. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like levonorgestrel will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge.

Pharmacodynamics

Levonorgestrel is a progestin or a synthetic form of the naturally occurring female sex hormone, progesterone. In a woman's normal menstrual cycle, an egg matures and is released from the ovaries (ovulation). The ovary then produces progesterone, preventing the release of further eggs and priming the lining of the womb for a possible pregnancy. If pregnancy occurs, progesterone levels in the body remain high, maintaining the womb lining. If pregnancy does not occur, progesterone levels in the body fall, resulting in a menstrual period. Levonorgestrel tricks the body processes into thinking that ovulation has already occurred, by maintaining high levels of the synthetic progesterone. This prevents the release of eggs from the ovaries.

Pharmacokinetics

Absorption:

Levonorgestrel is not subjected to a "first-pass" effect and is virtually 100% bioavailable.

Distribution:

* 260 L [Healthy Female Volunteers under Fasting Conditions] * 1.8 L/kg

Metabolism:

Hepatic

Elimination:

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.

Half-life

Not Available

Clearance

* 7.7 +/- 2.7 L/h [Healthy Female Volunteers under Fasting Conditions]

Toxicity

LD50 >5000 mg/kg (orally in rats)

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

JAYDESS INTRAUTERINE SYSTEM 13.5MG was registered with Health Science Authority of Singapore by BAYER (SOUTH EAST ASIA) PTE LTD. It is marketed with the registration number of SIN15024P with effective from 2016-06-01.

This product contains 13.5mg of Levonorgestrel in the form of INTRAUTERINE DEVICE.

The medicine was manufactured by Bayer Oy in FINLAND, and Sterigenics Belgium SA (Petit-Rechain) in BELGIUM

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: G02BA

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407TRIMAXAZOLE TABLETSulfamethoxazole|TrimethoprimPOMBEACONS PHARMACEUTICALS PTE LTDActive
435APO-SULFATRIM TABLETSulfamethoxazole|TrimethoprimPOMPHARMAFORTE SINGAPORE PTE LTDActive
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678BANEOCIN POWDERBacitracin|NeomycinPOMNOVARTIS (SINGAPORE) PTE LTDActive