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ADEC 198th meeting resolutions, 6-7 August 1998

Australian Drug Evaluation Committee

6 August 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 198th (1998/4) Meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 August 1998) resolved to advise the Parliamentary Secretary to the Minister for Health and Family Services, and the Secretary, Department of Health and Family Services, that the following drugs should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

FAMCICLOVIR Famvir tablets 500 mg
SmithKline & Beecham Pty Limited
Indications: For the treatment of uncomplicated herpes zoster in immunocompromised patients at a dose of 500 mg three times daily for 10 days; for the treatment of recurrent herpes simplex in immunocompromised patients at a dose of 500 mg twice daily for seven days; and for suppression of recurrent herpes simplex in immunocompromised patients.

RAMIPRIL WITH FELODIPINE Unimax/Tazko fixed combination tablets 2.5 mg and 5 mg
Astra Pharmaceuticals/Hoechst Marion Roussel Pty Limited
Indications: For the treatment of mild to moderate hypertension. This combination should not be used as first line treatment.

SILDENAFIL CITRATE Viagra tablets 25 mg, 50 mg and 100 mg
Pfizer Pty Limited
Indications: For the treatment of erectile dysfunction. There should be a boxed warning which should read: "The use of Viagra in men with cardiac disease has been associated with sudden death. The concomitant use of nitrates and Viagra is contraindicated."

TRIAMCINOLONE ACETONIDE Nasacort AQ nasal spray 55 mg per actuation
Rhone-Poulec Rorer Pty Ltd
Indications: For the treatment of the symptoms of seasonal and perennial allergic rhinitis.

EPOETIN ALFA Eprex for injection in prefilled syringes 1000 IU/0.5 mL, 2000 IU/0.5 mL, 3000 IU/0.3 mL, 4000 IU/0.4 mL and 10000 IU/1 mL
Janssen-Cilag Pty Ltd
New formulation and additional strength.

SOMATROPIN Genotropin dry powder for injection 4 IU /mL with or without preservative
SOMATROPIN Genotropin dry powder for injection 16 IU/mL with preservative
Pharmacia & Upjohn Pty Ltd
Extension of Indications: For the treatment of growth disturbances associated with gonadal dysgenesis (Turner's Syndrome).

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ROCURONIUM BROMIDE Esmeron solution for injection vials (10 mg/mL & 1 mg/mL) and ampoules (10 mg/mL)
IBAH for Organon Teknika Pty Ltd
Indication: Esmeron can also be used as part of rapid sequence induction when suxamethonium is contraindicated.

RALOXIFENE HYDROCHLORIDE Evista tablets 60 mg
Eli Lilly Pty Ltd
Indications: For the prevention of bone mineral density loss in post-menopausal women.

GOSERELIN ACETATE Zoladex implant formulation 3.6 mg
ICI Australia Pty Ltd
Extension of Indications: For use as an endometrial thinning agent to facilitate endometrial ablation.

ALENDRONATE SODIUM Fosamax tablets (40 mg & 10 mg)
Merck Sharpe & Dohme Pty Ltd
Extension of Indications: For the treatment of osteoporosis, which must be defined by the finding of low bone mass (at least 2 standard deviations below the gender-specific mean for young adults) or by the presence or history of osteoporotic fracture; and for the treatment of Paget's disease of bone.

NICOTINE Nicorette inhaler 10 mg per cartridge
Pharmacia & Upjohn Pty Ltd
Indications: As a treatment-aid to smoking cessation for the relief of tobacco withdrawal symptoms.

OESTRADIOL Menorest transdermal patch with delivery rates of 50, 75 and 100 mg per day
Rhone-Poulenc Rorer Pty Ltd
Extension of Indications: To include the prevention of bone mineral density loss in menopausal women.

The ADEC also made the following safety related recommendations:

RESOLUTION NO 7501

THE FOLLOWING STATEMENT SHOULD BE ADDED TO THE PRECAUTIONS SECTION OF THE PRODUCT INFORMATION OF ALL PROTEASE INHIBITORS:

BODY FAT CHANGES:

REDISTRIBUTION OR ACCUMULATION OF BODY FAT INCLUDING CENTRAL OBESITY, DORSOCERVICAL FAT ENLARGEMENT AND BREAST ENLARGEMENT AND LOSS OF BODY FAT FROM THE FACE, LIMBS AND UPPER TRUNK (PERIPHERAL LIPODYSTROPHY) HAVE BEEN REPORTED IN HIV POSITIVE PATIENTS TAKING PROTEASE INHIBITORS. SOME OF THESE PATIENTS HAD HYPERTRIGLYCERIDAEMIA AND INSULIN RESISTANCE ALSO. THE LONG-TERM IMPLICATIONS OF THESE CHANGES ARE NOT KNOWN.

RESOLUTION NO 7502

THE CURRENT PRECAUTION STATEMENT RELATING TO HYPERGLYCAEMIA IN THE PRODUCT INFORMATION OF PROTEASE INHIBITORS SHOULD BE MODIFIED BY REQUESTING DELETION OF THE SENTENCE: "A CAUSAL RELATIONSHIP BETWEEN PROTEASE INHIBITOR THERAPY AND THESE EVENTS HAS NOT BEEN ESTABLISHED."

The ADEC also varied the following recommendation for approval (see Commonwealth of Australia Gazette No GN 26, 1 July 1998):

PRAVASTATIN SODIUM Pravachol 5 mg, 10 mg, 20 mg and 40 mg tablets
Bristol-Myers Squibb Pharmaceuticals Pty Ltd
Indications: Pravachol is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

4 September 1998

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