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Lactulose and Ispaghula Husk Granules Only for the use of a Registered Medical Practitioner or a Hospital or a Laboratory Lactulose and Ispaghula Granules Ispaghula Husk Lactulose and BULKOSE Husk Granules oÉsÉM É å BULKOSE x oÉsÉM ÉåxÉ É Composition: Each 20 g of granules contains: 120g Lactulose Concentrate USP Equivalent to Lactulose 10 g Ispaghula Husk IP 3.5 g Excipients q.s. Colour : Quinoline Yellow Description: Lactulose is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration. The chemical name for Lactulose is 4-O-b-D-Galactopyranosyl-D- fructofuranose. The molecular formula is C12H22O11. The molecular weight is 342.30. It is freely soluble in water. Ispaghula Husk (also known as psyllium husk) is a well-known, safe, natural, non-habit forming, effective bulk forming laxative (agent that facilitates bowel evacuation). Clinical Pharmacology: Lactulose is a synthetic disaccharide that consists of fructose and galactose. As there is no corresponding disaccharidase in the human intestinal mucosal cells, Lactulose is not split in the small intestine and therefore it is not absorbed. In the colon it is metabolized to organic acids in short chains (acetic and lactic acids) by the gut flora. This fermentation acidifies the content of DRUG INTERACTIONS: the intestine and it has an osmotic effect. The higher the dose of Nonabsorbable antacids given concurrently with Lactulose may Lactulose, the stronger the osmotic effect. Lactulose is poorly inhibit the desired Lactulose-induced drop in colonic pH. absorbed from the gastrointestinal tract and no enzyme capable Therefore, a possible lack of desired effect of treatment should be of hydrolysis of this disaccharide is present in human taken into consideration before such drugs are given gastrointestinal tissue. As a result, oral doses of Lactulose reach concomitantly with Lactulose. Concomitant use of antibiotic with the colon virtually unchanged, in the colon; Lactulose is broken Lactulose may inhibit the desired Lactulose induced drop in down primarily to lactic acid, by the action of colonic bacteria, colonic pH by interfering with the bacterial activity which might which result in an increase in osmotic pressure and slight affect laxative activity and activity in treatment of hepatic acidification of the colonic contents. encephalopathy. Hence status of the Lactulose-treated patient with hepatic encephalopathy should be closely monitored in the event of concomitant oral anti-infective therapy. Use of Ispaghula This in turn causes an increase in stool water content and softens Husk concomitant with thyroid hormones require medical the stool. Since Lactulose does not exert its effect until it reaches supervision because the doses of the thyroid hormones may have the colon, and since transit time through the colon may be slow, to be adjusted. 24 to 48 hours may be required to produce desired bowel movement. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. Urinary excretion has been determined to be 3% or less and PREGNANCY AND LACTATION: essentially complete within 24 hours. If drug therapy is needed during pregnancy & lactation, the use of this drug is accepted. Ispaghula Husk is capable of absorbing up to 40 times its own weight of water in vitro, and part of its activity can be attributed to ADVERSE REACTION: TM its action as a simple bulking agent. In addition, colonic bacteria BULKOSE may produce flatulence and intestinal cramps, which are believed to use the hydrate material as a metabolic substrate. are usually transient. A small amount of abdominal distension This results in an increase in the bacterial cell mass with may sometime occur. consequent softening of the faeces. INDICATION : For the treatment of chronic idiopathic constipation in adult patient only. DOSAGE AND ADMINISTRATION: Adult: 20 g of BULKOSETM to be taken orally twice daily with plenty OVERDOSAGE: of water or as directed by the Physician. Lactulose: There have been no reports of accidental over dosage. Excessive dosage of Lactulose can lead to diarrhea with potential DIRECTION OF USE: complications such as loss of fluids, hypokalemia, and Disperse four spoonful of BULKOSETM in 150 ml of water. Stir hypernatremia. Nausea and vomiting have been reported. briskly and consume the contents immediately. After consuming Medication should be terminated. Dialysis data are not available the dispersed liquid, drink a glass of water. for Lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable. Ispaghula Husk: The patient may notice abdominal discomfort and flatulence and attention should be paid in maintaining an adequate fluid intake. CONTRAINDICATIONS: Lactulose may contain very small amount of galactose, hence it is contraindicated in patients who require a low galactose diet. Ispaghula Husk is contra-indicated in case of intestinal obstruction, faecal impaction and colonic atony such as senile STORAGE: mega colon. BULKOSETM is contraindicated in following Store below 30°C. Protect from moisture. Keep container tightly conditions: Patients with a sudden change in bowel habit that closed after use. persists for more than 2 weeks. Patients with undiagnosed rectal bleeding. PRESENTATION: Container of 120g. Patients who fail to defecate following the use of laxatives. Patients with diseases of the oesophagus and cardia. Patients who have difficulty in swallowing or any other throat problems. Patients with Phenylketonuria. WARNINGS: Lactulose: A theoretical hazard may exist for patients being treated with Lactulose who may be required to undergo electrocautery procedure during proctoscopy or colonoscopy. Accumulation of H2 gas in significant concentration in the For further details, please contact: presence of an electrical spark may result in an explosive reaction. Medical Advisor Biocon Limited Although this complication has not been reported with Lactulose, 20th KM, Hosur Road, Electronics City, patients on Lactulose therapy undergoing such procedure should Bangalore - 560 100. India have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO2 as an additional safeguard may be Manufactured by: pursued but is considered to be a redundant measure. Ispaghula Biocon Limited Husk: It should not be given to patients with phenylketonuria. at, Village & P.O. Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 174101. Marketed by: Biocon Limited 20th KM, Hosur Road, Electronics City, Bangalore - 560 100. India PRECAUTIONS: TM - Trade Mark of Biocon Limited Since Lactulose contains very small amount of galactose and lactose, it should be used with caution in diabetic. Ispaghula husk contains aspartame because of which it should not be given to patients with phenylketonuria. To report adverse events and/or product complaints visit our website www.biocon.com or call toll free No: 1800 102 9465 or LABORATORY TEST: e mail us at [email protected] Elderly, debilitated patients who receive Lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. BF/LL/0166/01.
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