Prontogest is indicated for the treatment of dysfunctional uterine bleeding.
It is also indicated for the maintenance of early pregnancy in cases of documented history of 3 or more prior consecutive unexplained miscarriages and in selected cases as an adjunct to successful treatment of infertility with techniques such as in-vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT) in order to facilitate uterine implantation of the fertilised ovum.
Dosage and Administration
Dysfunctional uterine bleeding:
5 - 10mg daily for 5 - 10 days until 2 days before anticipated onset of menstruation.
Maintenance of pregnancy:
Twice weekly or more frequent (maximum: daily) injections of 25-100 mg from approximately day 15, or day of transfer of embryo or gametes usually until 8 - 16 weeks of pregnancy when secretion of progesterone from the placenta should be established.
Daily dosage can be increased to 200mg at the discretion of the physician.
As the indications for Prontogest are restricted to women of child-bearing age, dosage recommendations for children
and the elderly are not appropriate.
Prontogest is given by intramuscular injection. It should be injected deep into the buttock, rather than the thigh or deltoid, using a 1.5 inch (3.8 cm) needle. This site has ample fat cells where a depot of progesterone can be formed for slow release.
Hypersensitivity to progestins.
Undiagnosed vaginal bleeding.
Missed or incomplete abortion.
Mammary or genital tract carcinoma.
Marked hepatic dysfunction.
Contraindicated as a diagnostic test for pregnancy.
Breakthrough bleeding, Change in menstrual flow, Amenorrhoea, Changes in cervical erosion and secretions.
Breast changes, Oedema, Weight gain, Catabolism.
Allergic reactions and rashes, Acne, Local reactions at site of injection.
Mental depression, pyrexia, insomnia, somnolence.
Prontogest may interfere with the effects of bromocriptine. Prontogest may affect the results of laboratory tests of hepatic and/or endocrine functions.
Prontogest may raise the plasma concentration of cyclosporin.
Pregnancy and Lactation
Prontogest may be used to maintain pregnancy where there is deficient production of endogenous progesterone from the corpus luteum. It should not be necessary to administer Prontogest once there is adequate secretion of placental progesterone. Prontogest contains progesterone itself, the same as the naturally secreted hormone, and is not associated with masculinisation of a female foetus as are synthetic progestins.
Detectable amounts of progesterone enter the breast milk. As the effect on the suckling infant has not been determined, the use of Prontogest during lactation is not recommended.
Warning and Precaution
Prontogest should be used cautiously in patients with conditions that might be aggravated by fluid retention (e.g. hypertension, cardiac disease, renal disease, epilepsy), with a history of mental depression, diabetes, mild to moderate hepatic dysfunction, acute intermittent porphyria, migraine or photosensitivity.
If unexplained, sudden or gradual, partial or complete losses of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.
Package and Storage
Carton box 5 or 10 ampoules (transparent glass type I), each of 2 ml and insert leaflet.
Store at temperature not exceeding 30⁰C
, Under licence from Marcyrl