INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SODIUM SALICYLATE MIXTURE BPC 1968

SCHEDULING STATUS:

PROPRIETARY NAME
(and dosage form):

SODIUM SALICYLATE MIXTURE BPC 1968

COMPOSITION :
Each 10 mL contains:
Sodium Salicylate BP:        0,5 g

PHARMACOLOGICAL CLASSIFICATION:
2.8 Non narcotic analgesics, antipyretics.

PHARMACOLOGICAL ACTION:
Sodium Salicylate has analgesic, anti-inflammatory and antipyretic action. The types of pain amenable to relief by salicylates are those of low intensity, whether circumscribed or wide spread in origin; particularly amenable are headache, myalgia, arthralgia and other pains arising from integumental structures rather than from viscera. Salicylates alleviate pain by virtue of both a peripheral and a C.N.S. effect. Salicylates, by inhibiting the synthesis of prostaglandins that occur in inflamed tissues, prevent the sensitization of the pain receptors to mechanical stimulation or to chemicals, such as bradykinin, that appear to mediate pain response.
The antipyretic effect is usually rapid and effective in febrile patients. Regulation of body temperature requires a delicate balance between heat production and heat loss. The C.N.S., especially the hypothalamic nuclei, plays an indispensable role in regulating the peripheral mechanisms concerned with the production and loss of body heat. The hypothalamus regulates the set point at which body temperature is maintained. In fever, the balance between heat production and heat loss still persists except that the set point is at a higher level. The salicylates act to reset the "Thermostat" for normal temperature. Heat production is not inhibited, but heat dissipation is augmented by peripheral blood flow and sweating.

INDICATIONS:
The principal use of Sodium Salicylate is in the treatment of acute rheumatic fever. It may be used for the relief of pain of low intensity e.g. headache, arthralgia.

CONTRA-INDICATIONS:
Sodium salicylate is contra-indicated in the presence of severe renal disease. It should not be administered to patients with haemophilia or to those with an intolerance to aspirin, and is not recommended for infants under 1 year of age.

WARNINGS:
Aspirin (and salicylates) has been implicated in Reye's syndrome, a rare but serious illness, in children and teenagers with chicken pox and influenza. A doctor should be consulted before aspirin is used in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 10 –30 mL daily in divided doses.
Do not use continuously for more than 10 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Sodium Salicylate is a gastric irritant and sodium bicarbonate is often given with it to reduce this effect (however the bicarbonate also increases rate of excretion and this lowers the concentration of salicylate in the blood). Some persons, especially asthmatics, exhibit notable sensitivity to aspirin which may provoke various reactions including urticaria, angioneurotic oedema, rhinitis and severe, even fatal, paroxysmal bronchospasm and dyspnoea. Aspirin increases the bleeding time, decreases platelet adhesiveness, modifies fibrinolyses and in large doses, may cause hypoprothrombinaemia.
The haemorrhagic effects of aspirin on gastric mucosa may be enhanced by anticoagulants. The activity of methotrexate may be markedly enhanced and its toxicity, increased. Aspirin diminishes the effects of uricosuric agents such as probenecid and sulphapyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Mild symptoms of intoxication include dizziness, tinnitus, sweating, nausea and vomiting and mental confusion. More serious signs include hyperventilation, fever, ketosis and respiratory alkalosis and metabolic acidosis. Depression of the C.N.S. may lead to coma, cardiovascular collapse and respiratory failure.
Treatment of toxic effects: for mild intoxication, emptying the stomach by emesis or aspiration or gastric lavage with 5% sodium bicarbonate solution will usually suffice. Patients suffering from severe intoxication (a plasma-salicylate concentration above 500 mg/mL in adults or 300 mg/mL in children) should be given gastric lavage together with forced diuresis by I/V infusions of saline with sodium bicarbonate or of compound sodium lactate injection or dextrose solution. An osmotic diuretic may be necessary to enhance the diuresis in some patients. Potassium salts should be given to correct deficiencies.
Electrolyte and acid-base balance should be monitored regularly. In patients suffering from acute allergic reactions to aspirin, adrenaline and corticosteroids, followed by an antihistamine, should be given.

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A pale yellow/brown liquid.

PRESENTATION:
100 mL amber plastic bottle with white snap on cap.
2,5 litre polyethylene bottle with screw on cap.

STORAGE INSTRUCTIONS:
Store below 30°C out of direct sunlight. Keep out of reach of children.

REGISTRATION NUMBER:
F/2.8/237

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adco Drug Company (Pty) Ltd.,
491 Sydney Road
Durban 4001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

Proprint

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