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Estrogel® Pro

Estrogel Pro Medicine Co-Pack (1x Estrogel 80g pump plus 1x Prometrium 100mg x 30 capsules)

Resources

Estrogel Pro Patient Information
Estrogel Product Information
Prometrium Product Information
Estrogel Consumer Medicine Information
Prometrium Consumer Medicine Information

 

Therapeutic Indications

Estrogel transdermal gel is indicated for:

  • 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.

Prometrium oral capsules are indicated for:

  • Hormone replacement therapy – adjunctive use with an oestrogen in postmenopausal women with an intact uterus
  • In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see dosage and administration)

Description

Estrogel Pro is a TGA-approved medicine co-pack containing one pack of Estrogel (estradiol hemihydrate) plus one pack of Prometrium (micronised progesterone) for women with an intact uterus requiring menopausal hormone therapy (MHT).1

References

  1. Estrogel Pro ARTG Public Summary Document, effective 23 October 2019. Available at www.tga.gov.au; Accessed January 2020.

Estrogel®

Estrogel (0.06% estradiol transdermal gel)

Resources

Patient Information
Product Information
Consumer Medicine Information

Therapeutic 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.

Description

Estrogel is a transdermal gel delivered via a metered-dose pump containing estradiol that is chemically and biologically identical to endogenous estradiol. Estrogel is TGA-approved as menopausal hormone therapy (MHT) for postmenopausal women and for the prevention of osteoporosis.1

References

  1. Estrogel (estradiol hemihydrate) Product Information, updated 08 May 2019.

Prometrium®

Prometrium (micronised progesterone) 100mg oral capsules

Resources

Patient Information
Product Information
Consumer Medicine Information

Therapeutic Indications

Prometrium oral capsules are indicated for:

  • Hormone replacement therapy – adjunctive use with an oestrogen in postmenopausal women with an intact uterus
  • In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see dosage and administration)

Description

Prometrium is TGA-approved for adjunctive use with estrogen in post-menopausal women with an intact uterus.1 Prometrium is micronised progesterone, providing endometrial protection for post-menopausal women with an intact uterus receiving estrogen therapy.1

Prometrium can be added to any estrogen therapy.1 The usual dose is 100 mg (one capsule) taken at bedtime, from days 1 to 25 of each cycle. Alternatively, 200 mg/day (two capsules) can be taken at bedtime on days 15 to 26 of each cycle.1

References

  1. Prometrium (micronised progesterone) Product Information, updated 20 June 2016.

Utrogestan®

Utrogestan (micronised progesterone) 200mg vaginal capsule

Resources

Patient Information – In Vitro Fertilisation (IVF)
Patient Information – Prevention of Preterm Birth
Product Information
Consumer Medicine Information
PBS Criteria

Therapeutic Indications

Utrogestan 200mg, soft vaginal capsules are indicated for:

  • Luteal Support of Assisted Reproductive Technology (ART) cycles
  • 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.

Description

Luteal Phase Support

Utrogestan is indicated for use in luteal phase support during ART cycles and is reimbursed for the first two weeks following embryo transfer.1,2 Utrogestan is available as 200mg soft vaginal capsules in packs of 42 capsules (two weeks supply).1

Dosage is three times daily, administered vaginally, from the day of embryo transfer until at least the 7th week of pregnancy and no later than the 12th week of pregnancy.1

Preterm Birth Prevention

Utrogestan is TGA-approved for 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.1 Utrogestan vaginal capsules are administered once-daily, are easy to insert and readily absorbed.1

References

  1. Utrogestan (micronised progesterone) Product Information, updated 13 November 2019.
  2. Pharmaceutical Benefits Scheme. Available at https://www.pbs.gov.au/pbs/search?term=utrogestan&analyse=false&search-type=medicines Accessed April 2020.

Testogel®

Testogel (1% testosterone gel)

Resources

Patient Information
Product Information
Consumer Medicine Information
PBS Criteria

Therapeutic Indications

Testogel is indicated for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Description

Testogel is a clear, colourless 1% testosterone gel. Testogel is available as 2 x 60 actuation pump bottles, or 30 x 5mg sachets1. The usual starting dose is 50 mg of testosterone per day, given as 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.1

References

  1. Testogel Product Information, updated Oct 2014.

Estrogel®, Prometrium®, Utrogestan® and Testogel® are registered trademarks of Besins Healthcare.
Besins Healthcare Australia Pty Ltd. ABN 68 164 882 062. Suite 3, Level 2, Tower 1, 495 Victoria Ave, Chatswood, NSW 2067. Office phone (02) 9904 7473.
For medical information call 1800 BESINS (237 467). www.besins-healthcare.com.au MHT0027 Prepared Apr20.

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).

Estrogel Pro PBS Information: This product is not available on the PBS.

Estrogel PBS Information: This product is not available on the PBS.

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.

Prometrium PBS Information: This product is not available on the PBS.

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).

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.

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.

Testogel PBS Information: Authority required. Refer to PBS Schedule for full information.

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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