² Reproduced from The use of essential drugs: second report of the WHO Expert Committee on the Use of Essential Drugs (WHO Technical Report Series, No. 722,1985, p. 43.

Drug information sheets

Various types of information are needed by prescriber and consumers to ensure the safe and effective use of drugs. The following list is a sample that should be adjusted to meet the needs and abilities of the prescriber.

(1) International Nonproprietary Name (INN) of each active substance.

(2) Pharmacological data:. a brief description of pharmacological effects and mechanism of action.

(3) Clinical information:

(a) Indications: whenever appropriate, simple diagnostic criteria should be provided.

(b) Dosage regimen and relevant pharmacokinetic data:

X average and range for adults and children;
X dosing interval;
X average duration of treatment;
X special situations, e.g., renal, hepatic, cardiac, or nutritional insufficiencies that require either increased or reduced dosage.

(c) Contra-indications.

(d) Precautions and warnings (reference to pregnancy, lactation, etc.).

(e) Adverse effects (quantify by category, if possible).

(f) Drug interactions (include only if clinically relevant; drugs used for self-medication should be included).

(g) Overdosage:

X brief clinical description of symptoms;
X non-drug treatment and supportive therapy;
X specific antidotes.

(4) Pharmaceutical information:

(a) Dosage forms.
(b) Strength of dosage form.
(c) Excipients.
(d) Storage conditions and shelf-life (expiry date).
(e) Pack sizes.
(f) Description of the product and package.
(g) Legal category (narcotic or other controlled drug, prescription or non-prescription).
(h) Name and address of manufacturer(s) and importer(s).