D-PENAMINE

What it is

D-PENAMINE is a film coated tablet containing penicillamine as the active ingredient, available in strengths of 125 mg or 250 mg. The product contains sulfites.

Approved indications

— Severe, active rheumatoid arthritis. — Wilson's disease (as a chelating agent). — Lead poisoning (as a chelating agent). — Cystinuria in cases where high-fluid regimens are not adequate, or in conjunction with them.

Dosing overview

D-PENAMINE must be given on an empty stomach, at least one hour before meals or two hours after meals, and at least one hour apart from any other medicine, food or milk.

Key safety warnings

The use of D-penicillamine has been associated with fatalities due to aplastic anaemia, agranulocytosis, thrombocytopenia, Goodpasture's Syndrome and myasthenia gravis. Because of the potential for serious haematological and renal adverse reactions to occur at any time, haemoglobin determination, white and differential cell count, direct platelet count and urinalysis should be carried out at weekly intervals for the first four weeks, then at two-weekly intervals for the next five months and monthly thereafter for the duration of therapy. A nephrotic syndrome may develop during therapy, and proteinuria may be a warning sign of its development. Treatment should be withdrawn if albumin in the urine increases progressively to exceed 2 g per day. D-PENAMINE increases the requirement of pyridoxine (Vitamin B6) and in rare cases causes central and peripheral nervous symptoms which could be due to pyridoxine deficiency. Patients being treated with D-penicillamine should not be subjected to elective surgical procedures, especially vascular surgery, and therapy should, if possible, be discontinued for at least six weeks prior to surgery.

Contraindications

D-PENAMINE is contraindicated in patients with hypersensitivity to D-penicillamine or to any of the excipients. D-PENAMINE should not be used in patients who are receiving gold therapy or antimalarial drugs.

PBS listing

D-PENAMINE 125 mg tablets are listed on the PBS as restricted items with an ex-manufacturer price of A$47.39. D-PENAMINE 250 mg tablets are listed on the PBS as restricted items with an ex-manufacturer price of A$59.53.

Regulatory history

D-PENAMINE 125 mg and 250 mg tablets were first listed on the Australian Register of Therapeutic Goods on 5 September 1991. The product is registered as AUST R 14625 (125 mg) and AUST R 14626 (250 mg).