Product Dossier

MICROLUT

Product Dossier for MICROLUT (levonorgestrel, Bayer). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

MICROLUT is a levonorgestrel 30 microgram tablet . Levonorgestrel is used in gynaecology as the progestogenic component in combined oral contraceptives and for contraception in progestogen-only pills . Levonorgestrel is a potent progestin of the 19-nortestosterone class which possesses characteristic gestagenic properties such as endometrial transformation, antigonadotropic action and antiestrogenic effects .

Approved indications

— Contraception in progestogen-only pills .

Dosing overview

MICROLUT is supplied as tablets of 30 micrograms . The product information provided does not contain specific dosing instructions for the tablet formulation; dosing should be determined according to standard contraceptive protocols for progestogen-only pills.

Key safety warnings

MICROLUT does not protect against HIV infection (AIDS) and other sexually transmitted infections . The woman should be advised that additional measures, for example condoms, are needed to prevent the transmission of sexually transmitted infections . Interactions can occur with drugs that induce or inhibit microsomal enzymes. Substances increasing the clearance of levonorgestrel include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort . Low-dose levonorgestrel may affect glucose tolerance and the blood glucose concentration should be monitored in diabetic users .

Contraindications

MICROLUT is not to be used during an existing or suspected pregnancy .

PBS listing

MICROLUT 30 micrograms tablets are listed on the PBS in a pack of 28, with unrestricted access at an ex-manufacturer price of A$7.16 .

Regulatory history

MICROLUT was first listed on the ARTG on 19 August 1991 . In March 2019, the PBAC recommended listing of MICROLUT for contraception on a cost minimisation basis against a currently listed form of levonorgestrel .