Professional Documents
Culture Documents
MPharm (Hons)
Resource Pack
Instructions to candidates:
1. This resource pack is available to use for questions 37, 38, 39 and 40.
All question papers, answer sheets and resource packs must be handed
in at the end of the examination.
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Contents
40 BNF (domperidone) 6
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Summary of product characteristics – Epanutin (phenytoin) Capsules, Oral Suspension and Infatabs
Dosage:
Dosage should be individualised as there may be wide interpatient variability in phenytoin serum
levels with equivalent dosage. Epanutin should be introduced in small dosages with gradual
increments until control is achieved or until toxic effects appear. In some cases serum level
determinations may be necessary for optimal dosage adjustments - the clinically effective level is
usually 10 mcg/mL - 20 mcg/mL (40-80 micromoles/l) although some cases of tonic-clonic seizures
may be controlled with lower serum levels of phenytoin. With recommended dosage a period of 7 to
10 days may be required to achieve steady state serum levels with Epanutin and changes in dosage
should not be carried out at intervals shorter than 7 to 10 days. Maintenance of treatment should be
the lowest dose of anticonvulsant consistent with control of seizures.
Epanutin Capsules contain phenytoin sodium whereas Epanutin Oral Suspension and Epanutin
Infatabs contain phenytoin. Although 100 mg of phenytoin sodium is equivalent to 92 mg of
phenytoin on a molecular weight basis, these molecular equivalents are not necessarily biologically
equivalent. Physicians should therefore exercise care in those situations where it is necessary to
change the dosage form and serum level monitoring is advised.
Posology
Adults:
Initially 3 to 4 mg/kg/day with subsequent dosage adjustment if necessary. For most adults a
satisfactory maintenance dose will be 200 mg to 500 mg daily in single or divided doses.
Exceptionally, a daily dose outside this range may be indicated. Dosage should normally be adjusted
according to serum levels where assay facilities exist.
As with adults the dosage of Epanutin should be titrated to the patient's individual requirements
using the same guidelines. As older people tend to receive multiple drug therapies, the possibility of
drug interactions should be borne in mind.
Paediatric population:
Initially, 5 mg/kg/day in two divided doses, with subsequent dosage individualised to a maximum of
300 mg daily. A recommended daily maintenance dosage is usually 4 mg/kg - 8 mg/kg.
Neonates:
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monitor serum levels in the neonate.
Furosemide 10mg/ml Injection is a diuretic indicated for use when a prompt and effective diuresis is
required. The intravenous formulation is appropriate for use in emergencies or when oral therapy is
precluded. Indications include cardiac, pulmonary, hepatic and renal oedema.
Adults
Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be
exceeded. In patients with severe impairment of renal function (serum creatinine>5 mg/dl), it is
recommended that an infusion rate of 2.5 mg per minute is not exceeded.
Intramuscular administration must be restricted to exceptional cases where neither oral nor
intravenous administration are feasible. It must be noted that intramuscular injection is not suitable
for the treatment of acute conditions such as pulmonary oedema.
Elderly: The dosage recommendations for adults apply, but in the elderly furosemide is generally
eliminated more slowly. Dosage should be titrated until the required response is achieved.
Children: Parenteral doses for children range from 0.5 to 1.5 mg/kg body weight daily up to a
maximum total daily dose of 20 mg.
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