Best Medicine for Vomiting, Nausea, Intestinal obstruction & severe abdominal pain

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Gerbisa-L

Sodium Picosulfate

Oral Solution BP

120ml Bottle Price : Rs. 145

Composition

Each 5 ml contains
Sodium Picosulfate BP 5 mg

Description

Gerbisa-L contains sodium Picosulfate a locally action laxative The chemical name of sodium Picosulfate is Disodium 4,4'-(2-pyridylmethylene) di (phenyl sulphate).

Clinical Pharmacology

Sodium Picosulfate is locally acting laxative from the triaryimethane group which after bacterial cleavage in the colon, has a dual action with stimulation of the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of accumulation of water and consequently electrolytes in the colonic lumen. This results in simulation of defaecation, reduction of transit time and softening of the stool. Simulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the 'call to stool' although its clinical relevance remains to be established.

Pharmacokinetics

After oral ingestion sodium Picosulfate reaches the colon without any appreciable absorption. Therefore, enterohepatic circulation is avoided. The active laxative compound, bis(p-hydroxypheny)-pyridyl-2-methane (BHPM) is formed by bacterial cleavage in the intestine. Consequently the onset of action of the preparation is usually between 6-12 hours, which is determined by the release of the active substance. After oral administration, only small amounts of the drug are systemically available. There is no relationship between the laxative effect and plasma levels of the active moiety.

Indications

Gerbisa-L is indicated for relief of constipation and bowel clearance before labour, surgery or radiological examination.

Contraindications

Gerbisa-L is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

             Gerbisa-L is also contraindicated in severe dehydration and in patients with known hypersensitivity to sodium Picosulfate or any other components of the product.

Precautions and Warnings

As with all laxatives, Gerbisa-l should not be taken on a continuous daily basic for more than five days without investigating the cause of constipation. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

            Dizziness and/or syncrope have been reported in patients who have taken sodium Picosulfate. The details available for these cases suggest that the events would be consistent with defaecation syncope(or syncope attributable to straining at stool) or with a vasovagal response to abdominal pain related to the constipation and not necessary to the administration of sodium Picosulfate itself.

            Gerbisa-l should not be taken by children under 10 years without medical advice.

Usage in Pregnancy and Lactation

There are no adequate and well-controlled studied in pregnant woman. Long Experience has show no evidence of undesirable or damaging effects during pregnancy. Clinical data show that neither the active moiety of sodium Picosulfate (BHPM or bis-(p-hydroxypheny)-pyridy-2-methane) not its glucuronides are excreted into the milk of healthy lactating females. Nevertheless, as with all medicines. Gerbisa-l should not be taken pregnancy. Especially the first trimester and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice. No studies on the effect on human fertility have been conducted. Nonclinical studies did not reveal any effect on fertility.

Drug Interactions

The concomitant use of diuretic or adreno corticosteroids may increase the risk of electrolyte imbalance if excessive doses of sodium Picosulfate are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. Concurrent administration of antibiotics may reduce the laxative action of this product.

Adverse Effects

Adverse events reported with use of sodium Picosulfate are: Gastrointestinal discovered: Diarrhea, abdominal discomfort, abdominal pain, abdominal cramps, nausea, vomiting.

Nervous system disorders : Dizziness, syncope (dizziness and syncope occurring after talking sodium Picosulfate appear to be consistent with a vasovagal response e.g. to abdominal spasm, defaecation) 
Immune system disorders : Hypersensitivity including angioneurotic oedema and skin reactions.

Overdosage

Symptoms : if high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur. Furthermore, cases of colonic mucosal ischemia have been reported in association with doses of sodium Picosulfate considerably higher than those recommended for the routine management of constipation. Laxative when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and rental calculi. Rental tubular damage, metabolic alkaloais and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy

          Within a short time of ingestion, absorption can be minimised or prevented by including vomiting or by 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.

Dose and Method of Administration

Unless otherwise prescribed by the doctor, the following dosages are recommended

Adult and children over 10 years : 
one to two 5ml spoonfuls (5-10mg) at night.

Children (4-10 years) :
Half to one 5 ml spoonful (2.5-5mg) at night.

Children under 4 years :
The recommended dosage is 250 micrograms per kilogram body weight.

For oral administration only. Not to be taken by children under 10 years without medical advice. In the management of constipation, once regularly has restarted dosage should be reduced and can usually be stopped. Can be diluted with purified water.

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