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

Logo ALKALITE D SUSPENSION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ALKALITE D SUSPENSION

COMPOSITION:
Each 10 mL of suspension contains:

Dicyclomine hydrochloride         5 mg
Compressed aluminium hydroxide gel 
equivalent to dried aluminium hydroxide         400 mg
Light magnesium oxide         200 mg
Preservatives:
Nipastat 0,2% m/v
Chloroform 0,2% V/V
Benzyl alcohol 0,3% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.2 Acid neutralisers with antispasmodics.

PHARMACOLOGICAL ACTION:
ALKALITE D has antacid properties

INDICATIONS:
ALKALITE D is indicated as an antacid.

CONTRA-INDICATIONS:
Prostatic enlargement, paralytic ileus or pyloric stenosis where its use may lead to obstruction, severe ulcerative colitis, myasthenia gravis, glaucoma.
Patients with renal failure. Obstructive uropathy, thyrotoxicosis, cardiac failure. Sensitivity to any of the ingredients.

WARNINGS:
ALKALITE D should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis and cardiac insufficiency or cardiac failure.

DOSAGE AND DIRECTIONS FOR USE:
Adults:                Two to four medicine measures (10 - 20 mL) three to four times daily.
Children over 2 years of age: One to two medicine measures (5 - 10 mL) three to four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects that may occur because of the dicyclomine include dry mouth, blurred vision, flushing and dryness of skin, tachycardia with palpitations and arrhythmias, urinary retention and constipation. Its effect may be enhanced by other drugs with anticholinergic properties. Fatigue, sedation, rash, thirst, nausea and vomiting, headache and dizziness have been reported.
Preparations containing dicyclomine should be used with caution in elderly men. 5 - 10% of magnesium is absorbed, and retention in patients with impaired renal function may lead to neurological, neuromuscular and cardiovascular impairment. The urine of normal persons may become alkaline which decreases excretion of drugs that are weak bases. Magnesium may cause diarrhoea and mucosal irritation.
Aluminium hydroxide absorbs phosphates and excessive doses or normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or oesteomalacia. Use with care in patients with hiatal hernia associated with reflux oesophagitis - anticholinergic drugs may aggravate the condition.
ALKALITE D may interefere with or reduce the absorption of anticholinergic medicines, barbiturates, digoxin, quinine, warfarin, tetracycline and vitamins.
The effects of dicyclomine hydrochloride may be enhanced by the concomitant administration of anticholinergic medicines such as antihistamines, amantadine, butyrophenones, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses of dicyclomine causes tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement , and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with hypertension or circulatory failure and respiratory depression. See further under "Side effects and Special Precautons". Treatment is symptomatic and supportive.

IDENTIFICATION:
A white homogenous suspension with a slight peppermint flavour.

PRESENTATION:
In bottles containing 200 mL.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/11.4.2/332

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GAREC (PTY) LIMITED
43 Richards Drive
Halfway Houe 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 June 1992

New addition to this site: October 2004
Source: Pharmaceutical Industry

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