Belax Bisacodyl Tablets

Belax Tablets

(Bisacodyl)

 

COMPOSITION

Each Enteric-coated tablet contains

Bisacodyl B.P. 5 mg

 

INDICATION

Short term relief of constipation.

Constipation, either chronic or of recent onset, whenever a stimulant laxative is required. Bowel clearance before surgery or radiological investigation. Replacement of the evacuant enema in all its indications.

 

PHARMACOKINETICS PROPERTIES

Bisacodyl is rapidly hydrolyzed to the active principle bis(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa. Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 – 10 hours post administration whereas the laxative effect occurred between 6 – 12 hours post administration. Hence, the laxative effect of bisacodyl does not correlate with the plasma level of BHPM instead, BHPM acts locally in the lower part of the intestine and there is no relationship between the laxative effect and plasma levels of the active moiety. For this reason bisacodyl coated tablets are formulated to be resistant to gastric and small intestinal juice. This results in a main release of the drug in the colon, which is the desired site of action.

After oral administration, only small amounts of the drug are absorbed and are almost completely conjugated in the intestinal wall and the liver to form the inactive BHPM glucuronide. The plasma elimination half-life of BHPM glucuronide was estimated to be approximately 16.5 hours. Following the administration of bisacodyl coated tablets, an average of 51.8% of the dose was recovered in the faeces as free BHPM and an average of 10.5% of the dose was recovered in the urine as BHPM glucuronide.

 

PHARMACODYNAMIC PROPERTIES

Bisacodyl is a locally acting laxative from the diphenylmethane derivative group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, 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 a stimulation of defecation, reduction of transit time and softening of the stool. Stimulation 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.

 

PREGNANCY AND LACTATION

There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy. Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females. Nevertheless, as with all medicines, Belax should not be taken in 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.

 

UNDESIRABLE EFFECTS

The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea. Adverse events have been ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/1000); rare (≥1/10000, <1/1000); very rare (<1/10000).

 

Immune system disorders

Rare: anaphylactic reactions, angioedema, hypersensitivity.

 

Metabolism and nutrition disorders

Rare: dehydration.

 

Nervous system disorders

Uncommon: dizziness.

Rare: Syncope.

Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).

 

Gastrointestinal disorders

Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort.

Common: abdominal cramps, abdominal pain, diarrhoea and nausea.

Rare: colitis.

 

OVERDOSAGE

Symptoms

If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur. Laxatives when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy

After ingestion of oral forms of BELAX, absorption can be minimised 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 value.

 

STORAGE

Store below 30oC.

Protect from light, heat and moisture.

Keep all medicines out of the reach of children.

 

PRESENTATION

Belax 5mg tablets: Pack of 10 x 10’s tablets.

 

Manufactured by

ROCK PHARMACEUTICAL LABORATORIES (PVT) LTD.

134-B & 135-B Nowshera Industrial Estate

Risalpur Parkistan.

 

Marketed by

Sunlight Links Pharm Ltd.

135, Brono Way, Ebute-Metta

Lagos, Nigeria.

Sorbitol STADA D Glucitol Crystalline Powder

Sorbitol STADA®

 

COMPOSITION

Each sachet contains:

Sorbitol 5.0g

 

DESCRIPTION

White, odourless, crystalline powder, sweet taste.

 

PHARMACODYNAMICS

Sorbitol (D-glucitol) is a polyhydric alcohol. It will promote the hydration of the intestinal content. Sorbitol stimulates the secretion of cholecystokininpancreazymine and accelerates intestinal motility by its osmotic-laxative effect.

 

PHARMACOKINETICS

Sorbitol is poorly absorbed from the gastrointestinal tract after oral. It is metabolised mainly in the liver, to fructose, a reaction catalysed by the enzyme sorbitol dehydrogenase. Some sorbitol may be converted directly to glucose by the enzyme aldose reductase. A very small part of non-metabolized sorbitol is eliminated by the kidney. The remaining part is eliminated, in the form of CO2 in the expired air.

 

INDICATIONS

Used in the symptomatic treatment for dyspeptic disorders and constipation.

 

DOSAGE AND ADMINISTRATION

Administration

Only use the drug with osmotic laxative with single dose and not frequently.

Sorbitol STADA 5 g is orally taken. Dissolve 1 sachet in ½ glass of water, orally administer 10 minutes before meals.

Dosage

– Symptomatic treatment of dyspeptic disorders: 1 to 3 sachets daily in adult, take the drug before meals or during dyspeptic trouble.

– Treatment of constipation: 1 sachet in adult at fasting in the morning. Children should be given ½ of the adult dose.

 

CONTRAINDICATIONS

Sorbitol is contraindicated in these cases:

– Organic inflammatory enteropathies, ulcerative rectocolitis, Crohn’s disease and occlusive or subocclusive syndrome.

– Undiagnosed abdominal painful syndrome

– Patients with genetic fructose intolerance (rare metabolic disease).

 

PRECAUTIONS

– Prolonged use of a laxative is not recommended.

– Treatment of constipation with sorbitol is only an adjuvant to hygiene-dietetic treatment.

– Do not administer in case of biliary tract obstruction.

– In patients with irritable colon, avoid the administration of sorbitol while fasting and reduce the dosage.

 

DRUG INTERACTIONS

By increasing intestinal motility, all laxatives may potentially decrease transit time of concomitantly administered oral drugs and thereby decrease their absorption.

 

PREGNANCY AND LACTATION

Not known.

 

ADVERSE REACTIONS

Possibility of diarrhea and abdominal pains, especially in patients with irritable colon or with abdominal bloating. Discontinue using the drug if have any adverse reaction.

 

OVERDOSAGE

Disorder fluid and electrolyte if using high doses again. It has been recommended that fluid and electrolyte balance be monitored closely.

 

STORAGE

Store in a well-closed container, in a dry place, protect from light. Do not store above 30°C.

 

SHELF-LIFE

36 months from the date of manufacturing.

 

PACKAGING

Sachet of 5 g. Box of 20 sachets

 

SPECIFICATION

Manufacturer’s specification.

 

Keep out of reach of children
Do not use after the expiry date
Read the package insert carefully before use
For further information, do not hesitate to ask your physicians
Notify your physicians if you should experience any of adverse effects

 


STADA-VN J.V. Co., Ltd.

K63/1 Nguyen Thi Soc, Xuan Thoi Dong,

HM, HCM City, VN

Sorbozim Sorbitol Powder

SORBOZIM POWDER
(Sorbitol 5gm)

 

Composition

Each Packet contains Sorbitol 5 gm.

 

Properties

Sorbozim contains Sorbitol powder form, which is useful as an osmotic laxative. Its laxative effects are equivalent to lactulose. Sorbozim is helpful in promoting secretion of the gall bladder. Sorbozim hastens elimination of toxins from the gastrointestinal tract.

 

Indications

• Constipation

• Gall bladder insufficiency

• Management of poison ingestion along with activated charcoal.

 

Contraindications

• Liver failure

• Renal failure

• Hereditary fructose intolerance.

 

Adverse Reaction

• None at the stated dosage.

 

Dosage and Administration

– Constipation

Dissolve the contents of 2-3 packets in ½ glass of water, drink at bedtime or as recommended by physician.

Children: Half the dose

– Gall Bladder insufficiency

Dissolve the contents of one packet in ½ glass of water, drink at 10 minutes before meals 1-3 times daily or as recommended by physician.

Children: Half the dose.

– Poisoning

Dissolve Sorbozim (1g/kg body weight), in 250ml water, mix with activated charcoal (1g/kg) and give orally by gastric tube.

Repeat one-half the dose if there is no charcoal stool after 4-6 hours.

 

Interactions

No drug-drug or drug-food interactions are reported.

 

How supplied

Box containing 20 packets of 5gm Sorbitol.
N.R.N No: A4-7314

 

Manufactured by

The Pharmaceutical Products of India Limited.

Plot No. D-312/313, Turbhe M.I.D.C.,

Navi Mumbai – 400705, India.

 

Exported by

Naturon Healthcare Limited

Plot No. 233, Dheku

Khalapur, Dist – Raigad (M.S.) – 410203

 

Marketed by

Eminent Drugs & Pharma. Ltd.

6B Omonubi Street, Off Omilani Street,

Ijeshatedo, Surulere, Lagos, Nigeria.