Presentation

Tablet: 5mg: sugar-enteric coated.

Uses

Actions

LAX-TAB is a locally acting laxative from the triarylmethane group, which, after metabolism by hydrolysis stimulates the mucosa of the intestine causing peristalisis of the colon.

Pharmacokinetics

Absorption

Hydrolysis of bisacodyl by enzymes of the enteric mucosa forms desacetylbisacodyl, which is absorbed, and excreted partly via urine and bile as glucuronide. By bacterial cleavage the active form., the free diphenol, is formed in the colon. Formulations of bisacodyl which are resistant to gastric and small intestine juice, like LAX-TAB sugar-coated tables, reach the colon without any appreciable absorptions and therefore avoid enterohepatic circulation. Consequently, these forms have an onset of action between 6 to 12 hours.

Excretion

After administration, only small amounts of the drug are systemically available. Urinary excretion reflects low systemic burden after oral and rectal administration. There is no relationship between the laxative effect and plasma levels of the active diphenol.

Indications

For the use in cases of constipation. In preparation for diagnostic procedures, in pre- and postoperative treatment and in conditions, which require defecation, the use of LAX-TAB must be under medical supervision.

Dosage and Administration

Unless otherwise prescribed by a physician, the following doses are recommended:

Tablets:

Adults and children over 10 years:

1 to 2 sugar-coated tablets at night (5 to 10mg).

Children 4 to 10 years

One tablet at night (5mg).

Notes:

LAX-TAB tablets are sugar-enteric coated. Do not take with milk or administer antacids (eg bicarbonate of soda, magnesia, etc) within half an hour of taking the tablets. The tablets should be taken at night to produce evacuation the following morning. Swallow the tablets whole with adequate fluid.

Contraindications

LAX-TAB should not be used by patients with ileus, intestinal obstruction, acute surgical abdominal conditions like acute appendicitus, acute inflammatory bowel diseases, and in severe dehydration. LAX-TAB is also contraindicated in patients with known sensitivity to substances of the triarylmethane group.

Warnings and Precautions

As with all laxatives, LAX-TAB should not be taken on a continuous basis for long periods. If laxatives are needed every day, the case of constipation should be investigated. Prolonged excessive use may lead to electrolyte imbalance and hypokalaemia, and may precipitate onset of rebound constipation. Children should not take LAX-TAB without medical advice.

Use in Pregnancy and Lactation

Long experience has shown no evidence of undesirable or damaging effects during pregnancy. Nevertheless, as with all drugs, LAX-TAB should only be taken during pregnancy on medical advice. LAX-TAB is classified in a group of medications which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed. Even though investigations have shown that the active substance does not enter breast milk, breast-feeding is not recommended.

Adverse Effects

Rarely, abdominal discomfort and diarrhoea have been reported.

Interactions

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of LAX-TAB are taken. Electrolyte imbalance may lease to increased sensitivity to cardiac glycosides.

Overdosage

Symptoms:

If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of potassium and other electrolytes can occur.

Therapy:

Within a short time after ingestion of oral forms of LAX-TAB, absorption can be minimized or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of some value.

Pharmaceutical Precautions

Store in a safe place out of reach of children. Store below 25degC.

Medicine Classification

Pharmacy-only Medicine.

Package Quantities

Tablets:

5mg, 200s.

Further Information

Nil

Name and Address

AFT Pharmaceuticals Limited PO Box 33-203 Takapuna Auckland E-mail: customer.service @aftpharm.com

Date of Preparation

Jul 2009