Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
A daily dose of 125-250 mg per day is recommended for the first month, increasing by the same amount every four to twelve weeks until remission occurs. The minimum maintenance dose to achieve suppression of symptoms should be used and treatment should be discontinued if no improvement occurs within 12 months. Improvement may not occur for some months. The usual maintenance dose is 500 mg to 750 mg daily. However, up to 1500 mg daily may be required.
Reduction in maintenance dosage by 125 mg to 250 mg every 12 weeks may be attempted after a period of 6 months continuous remission.
The initial dose should not exceed 125 mg daily for the first month, increasing by similar increments every four to twelve weeks until the minimum maintenance dose to supress symptoms is reached. Daily dosage should not exceed 1000 mg (see section 4.4).
The usual maintenance dose is 15 to 20 mg/kg/day. The initial dose should be lower (2.5 to 5 mg/kg/day) and increased every four weeks over a period of three to six months.
Penicillamine therapy should be initiated at a low dose with intervals between dose increase of at least twelve weeks. Fortnightly monitoring for toxicity is mandatory throughout treatment for rheumatoid arthritis.
Patients must be maintained in negative copper balance and the minimum dose of Penicillamine required to achieve this should be given.
1500 mg to 2000 mg daily in divided doses. Dose reduction may be attempted when remission occurs, decreasing to 750 mg to 1000 mg per day. It is advisable that a dose of 2000 mg per day should not be continued for more than 12 months.
20 mg/kg/day in divided doses adjusting the dose minimal level necessary to control disease.
20 mg/kg/day in two or three divided doses, given 1 hour before meals. For older children (>12 years) the usual maintenance dose is 750 mg to 1000 mg daily.
Extra precautions should be taken to monitor for adverse effects in patients with Wilson’s disease and renal insufficiency.
The lowest effective dose should be used and this is determined by quantitative amino acid chromatography of urine.
Dissolution of cystine stones:
1000 mg to 3000 mg daily, in divided doses. Cystine levels in urine should not exceed 200 mg/litre.
Prevention of cystine stones:
500 mg to 1000 mg at bedtime. Maintenance of adequate fluid intake (not less than 3 litres/day is important). Cystine levels in the urine should not exceed 300 mg/litre.
Use the minimum dose to maintain urinary cystine levels below 200 mg/litre.
20 to 30 mg/kg/day in two or three divided doses, given 1 hour prior to meals, adjusted to maintain urinary cystine level below 200 mg/litre.
If renal insufficiency is present at the onset of therapy, the starting dose should be lower, but it will be necessary to give sufficient Penicillamine to achieve urine cystine levels of not more than 300 mg/litre. The maintenance dose should be reviewed at intervals of not more than four weeks.
1000 mg to 1500 mg daily, in divided doses until urinary lead is stabilised at less than 0.5 mg per day.
20 mg/kg/day in divided doses until lead levels in the urine is stabilised at less than 0.5 mg per day.
Penicillamine should only be used in cases where blood lead levels <45 mcg/dL. A total of 15–20 mg/kg/day in 2–3 doses should be used.
For maintenance treatment after the disease process has been brought under control with corticosteroids. The initial dose of 500 mg daily in divided doses, should be increased gradually over three months to a maintenance dose of 1250 mg daily. During this period, the dose of corticosteroids should be phased out. Throughout therapy, liver function tests should be carried out periodically to assess the disease status.
Not recommended.
The safety and efficacy of penicillamine in children less than 18 years with chronic active hepatitis has not been established. No data are available.
For oral administration.
Penicillamine should be taken on an empty stomach at least half an hour before meals in adults and one hour before meals in paediatric patients, or on retiring.
As the smallest available tablet is 125 mg, this might not be suitable for very young children.
There are no reported cases of undesirable reactions to penicillamine overdosage and no special treatment is recommended.
3 years.
Store in a cool, dry place below 25°C.
Penicillamine Tablets are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
No special requirements.
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