INFORMATION FOR HEALTH PROFESSIONALS
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Ampoules of a sterile straw-coloured solution of Progesterone BP 25 or 50mg per ml in ethyl oleate for injection containing 10% v/v benzyl alcohol.
Gestone 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 repeated miscarriages due to luteal phase defect and in selected cases as an adjunct to successful treatment of infertility with techniques such as In-Vitro Ferilisation (IVF) or Gamete Intra-Fallopian Transfer (GIFT) in order to facilitate uterine implantation of the fertilised ovum.
Gestone is given by intra-muscular 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.
Daily dosage can be increased to 200mg at the discretion of the physician.
As the indications for Gestone are restricted to women of childbearing age, dosage recommendations for children and the elderly are not appropriate.
Hypersensitivity to progestins, undiagnosed vaginal bleeding, missed or incomplete abortion, history of thrombo-embolism, mammary or genital tract carcinoma, thrombo-phlebitis, cerebral haemorrhage, marked hepatic dysfunction. Contra-indicated as a diagnostic test for pregnancy.
Gestone may interfere with the effects of bromocriptine. Gestone may affect the results of laboratory tests of hepatic and/or endocrine functions.
Gestone may affect the results of laboratory tests of hepatic and/or endocrine functions.
Gestone may raise the plasma concentration of cyclosporin.
No known effect.
Breakthrough bleeding, change in menstrual flow, amenorrhoea, changes in cervical erosion and secretions, breast changes, oedema, weight gain, catabolism, cholestatic jaundice, allergic reactions and rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism, local reactions at site of injection.
Gestone 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 Gestone once there is adequate secretion of placental progesterone. Gestone contains progesterone itself, the same as the naturally secreted hormone, and is not associated with masculinization 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 Gestone during lactation is not recommended.
Gestone should be used cautiously in patients with conditions that might be aggravated by fluid retention (eg 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 loss 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.
This is unlikely and is not expected to produce any adverse effects. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
Store in a cool place protected from light. On storage, solid matter may separate and this should be redissolved by warming before use.
Prescription medicine
Ampoules containing:
25mg in 1 ml
50mg in 1ml
100mg in 2ml
Boxes of 10
Nil
New Zealand Medical and Scientific Ltd,
PO Box 24-138,
Royal Oak,
Auckland.
20 January 1999