This package insert provides additional information about Gestone.
Leaflet informs about Gestone composition, usage, dosage, side effects, interactions, indications, contraindications, overdosage instructions, adverse reactions, pharmacological properties, procedure for use, dependence possibility.
This Gestone patient brochure is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
Consult your doctor or pharmacist before using Gestone.
Presentation: Ampoules of a sterile straw-coloured solution of Progesterone BP 50 mg per 1 ml and 100 mg per 2 ml in ethyl oleate for injection containing 10% v/v benzyl alcohol.
Uses: Gestone is indicated for the Gestone treatment of dysfunctional uterine bleeding. In selected cases as an adjunct to successful treatment of infertility with techniques such as in-vitro fertilization (IVF) or gamete intra-fallopian transfer (GIFT) in order to facilitate uterine implantation of the fertilized ovum.
Gestone dosage and administration: Gestone 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) needle. This site has ample fat cells where a depot of progesterone can be formed for slow release.
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 200 mg at the discretion of the physician.
As the indications for Gestone are restricted to women of child-bearing age, dosage recommendations for children and the elderly are not appropriate.
Contra-indications, Warnings, etc. Contra-indications: Hypersensitivity to progestins, undiagnosed vaginal bleeding, missed or incomplete abortion, history of thromboembolism, mammary or genital tract carcinoma, thrombo-phlebitis, cerebral haemorrhage, marked hepatic dysfunction. Contraindicated as a diagnostic test for pregnancy.
Gestone precautions: There is no absolute proof that progesterone treatment is effective in the maintenance of pregnancy. No clearcut evidence was shown proving the existence of a relation between the use of the preparation and the appearance of defections above the normal rate found in the population.
Interactions: Gestone may interfere with the effects of bromocriptine. Gestone may affect the result of laboratory tests of hepatic and/or endocrine functions. Gestone may raise the plasma concentration of cyclosporine.
Effects on ability to drive and use machinery: No known effect.
Other undesirable effects: 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.
Use in pregnancy and lactation: 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. 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.
Other special warning and precautions: Gestone 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 loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and therapeutic measures instituted.
Overdosage: 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.
Pharmaceutical precautions: Store in a cool place protected from light. On storage, solid matter may separate and this should be redissolved by warming before use.
Legal category: POM
Package quantities: Ampoules containing: 50 mg in 1 ml: 100 mg in 2 ml. Boxes of 10.
Manufacturer: Celltech Pharmaceuticals Ltd., for Nordic Pharma Ltd., UK.
Agencies: A. Lapidot Pharmaceuticals Ltd., 8 Hashita st., Industrial Park, Caesarea 38900.