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Please review Product Information before prescribing. The Product Information can be accessed at besins-healthcare.com.au/healthcare-professionals/ or telephone 1800 BESINS (237 467).
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Estrogel Pro PBS Information: This product is not available on the PBS.
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Estrogel PBS Information: This product is not available on the PBS.
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Minimum Product Information Estrogel® (estradiol hemihydrate) gel Indications: Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The lowest effective dose should be used for the shortest duration. Contraindications: Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism); Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency); Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; Known or suspected pregnancy; Lactation; Known hypersensitivity to the active substances or to any of the excipients; Porphyria. Precautions: Appraisal of the risks and benefits should be undertaken at least annually. Refer to full Product information (PI) for conditions which require supervision during treatment with Estrogel. Treatment should be withdrawn if the following occur, jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine type headache; pregnancy. Caution: endometrial hyperplasia and carcinoma, breast cancer, ovarian cancer, venous thromboembolism, coronary artery disease (CAD), ischaemic stroke, thyroid function, elderly, paediatric use (see full PI). Interactions: use of concomitant skin medications, surface active agents or strong skin cleansers and detergents should be avoided at site of application, metabolism of estrogens may be increased by concomitant use of inducers of hepatic enzymes such as anticonvulsants (phenobarbital, phenytoin, carbamezapine) and anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir) and some herbal preparations (St John’s wort) reducing the effectiveness of estrogen, Estrogel as a transdermal administration might be less affected than other oral hormones by enzyme inducers. Pregnancy Category B3; not for use in lactation. Adverse Effects: headache, nausea, abdominal pain, breast swelling/pain, breast enlargement, dysmenorrhea, menorrhagia, metrorraghia, leucorrhooea, endometrial hyperplasia, weight gain (increase or decrease), water retention with peripheral edema (see full PI). Dosage and Administration: Estrogel should be used daily on a continuous basis. Estrogel as an estrogen only product is indicated only for women without a uterus. In women with an intact uterus it is recommended to add a progestogen for at least 12 days of each month. Although some women will respond to 1.25 g daily (1 pump), the usual starting dose is 2.5 g per day (2 pumps). If after one month of treatment, effective relief of menopausal symptoms is not obtained the dosage may be increased to a maximum of 5 g (4 pumps) (see full PI). The lowest effective dose should be used for maintenance therapy. The optimal daily maintenance dose needs to be reevaluated regularly (e.g. annually). Estrogel should only be continued for as long as the benefit outweighs the risk. The correct dose of gel should be dispensed and applied to clean, dry, intact areas of skin e.g. on the arms and shoulders, and/or inner thighs. The area of application should be as large as possible. Refer to Full Product Information before prescribing.
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Prometrium PBS Information: This product is not available on the PBS.
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Minimum Product Information Prometrium (oral, micronised progesterone) Indications: menstrual irregularities; adjunctive use with an estrogen in postmenopausal women with an intact uterus. Contraindications: known allergy/hypersensitivity to progesterone or excipients; severe hepatic dysfunction; undiagnosed vaginal bleeding; known missed abortion/ectopic pregnancy; mammary/genital tract carcinoma; thromboembolic disorders; thrombophlebitis; cerebral haemorrhage; porphyria. Clinically Significant Precautions: not a treatment for premature labour; not a contraceptive; discontinue if unexplained visual loss/changes, proptosis, diplopia, papilloedema, retina vascular lesions or migraine; use caution in conditions affected by fluid retention and history of depression, diabetes, hepatic dysfunction, migraine, photosensitivity and during lactation; increased risk of breast cancer and venous thromboembolism with estrogen concomitant therapy (refer estrogen PI); may cause drowsiness; may affect laboratory test results. Clinically Significant Interactions: caution with P450 enzyme inducers and inhibitors; may increase antidiabetic medication; bioavailability may be reduced by smoking and increased by alcohol abuse. Very Common and Common Adverse Effects: menstrual disturbances; headache. Dosage and Use: take capsules (100mg/200mg) orally, OD at bedtime without food. Hormone Replacement Therapy: 200 mg/d for 12d (d15–d26) of the cycle; or 100mg can be given from d1–d25. Secondary amenorrhoea: 400mg/d for 10d. Ovulation disorders/anovulation: 200–300mg for 10d (d17–d26, inclusive).
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Utrogestan PBS Information: Authority required (STREAMLINED) for Assisted Reproductive Technology. Refer to PBS Schedule for full authority.
This product is not listed on the PBS for the prevention of preterm birth.
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Utrogestan 200 (vaginal use – micronised progesterone) Indication: luteal phase support during assisted reproduction; prevention of preterm birth in women with singleton pregnancy who have a short cervix (midtrimester sonographic cervix ≤25 mm) and/or a history of spontaneous preterm birth. Dosage and Use: during luteal phase support in controlled ovarian cycles 600 mg/day as 3 divided doses from day of embryo transfer until 7th week of pregnancy and not later than the 12th week. For prevention of preterm birth, usual dose is 200 mg/day, recommended at bedtime. Treatment can be initiated during the 2nd trimester (16-24 gestational weeks) and is to be continued to the end of the 36th week of gestation or until delivery. 200 mg capsules must be inserted deep into vagina. Contraindications: known allergy/hypersensitivity to progesterone/excipients; severe hepatic dysfunction; undiagnosed vaginal bleeding; known missed abortion/ectopic pregnancy; mammary/genital tract carcinoma; thromboembolic disorders; thrombophlebitis; cerebral haemorrhage; porphyria. Special Warnings and Precautions: should be used by vaginal route for the recommended timeframes for each indicated use (pregnancy Cat A); cytolytic liver damage/gravidic cholestasis exceptionally reported during 2nd and 3rd trimesters of pregnancy; not a contraceptive; uterine bleeding cause must be established before use; discontinue use upon diagnosis of missed abortion; use caution in conditions affected by fluid retention and history of depression, diabetes, hepatic dysfunction, migraine, venous thrombosis, photosensitivity and hypersensitivity to soya lecithin; not to be used during lactation; may cause drowsiness; may effect laboratory test results. Interactions: caution with P450 enzyme inducers and inhibitors; bioavailability may be reduced by smoking and increased by alcohol abuse. Very Common and Common Adverse Effects: none noted with vaginal administration in clinical trials.
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Testogel PBS Information: Authority required.
Refer to PBS Schedule for full information.
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Testogel® (Minimum Product Information) Testogel is 1% testosterone gel. Indications: Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Contraindications: known or suspected prostatic cancer/ breast carcinoma; known hypersensitivity to testosterone or any other ingredient, use in women or children. Precautions: Regular monitoring of the prostate gland and breast, hypercalcaemia, severe cardiac, hepatic or renal insufficiency, ischaemic heart disease, hypertension, diabetes, epilepsy and migraine. Risk of sleep apnoea. Effect on doping tests. Must not be used in women. Testosterone transfer to others via skin contact. Must not be used in pregnant women. Must not be used in breastfeeding women. Interactions with other medicines: Oral anticoagulants, ACTH or corticosteroids, oxyphenbutazone, insulin requirements, buproprion, cyclosporine. In general, any substance which affects liver function should not be taken with testosterone. Adverse effects: Reaction at the application site, erythema, acne, dry skin, changes in laboratory tests, headache, prostatic disorders, gynaecomastia, mastodynia, dizziness, paraethesia, amnesia, hyperaesthesia, mood disorders, hypertension, diarrhoea, alopecia, urticaria. Dosage and administration: Adult Men: 5g of gel applied once daily at about the same time, preferably in the morning. Depending on clinical/laboratory response, the dose may be adjusted by 2.5g steps to a maximum 10g of gel per day.
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