Name:
Duphalac syrup 667mg/ml in a bottle. 200ml
Description:
The syrup is transparent, viscous, colorless to light yellow with a brownish tint. The main active ingredient is Lactulose Release form The syrup is transparent, viscous, from colorless to light yellow with a brownish tint. 100 ml lactulose 66.7 g Excipients: purified water – up to 100 ml. 200 ml – high-density polyethylene bottles (1) with a polyethylene cap (measuring cup). 500 ml – high-density polyethylene bottles (1) with a polyethylene cap (measuring cup). Dosage 667mg/ml per vial. 200 ml Special instructions In case of abdominal pain of unknown origin, before starting therapy or the absence of a therapeutic effect for several days, the patient should consult a doctor. Please note that Dufalac® may contain trace amounts of associated sugars (eg lactose, galactose, epilactose and fructose). The content of residual sugars present in the Dufalac® preparation is about 0.075 XE in 5 ml of syrup. When used at the recommended dose for the treatment of constipation, sugar content should not be a problem for diabetic patients. In the treatment of hepatic encephalopathy, higher doses of the drug are usually prescribed, which should be taken into account in patients with diabetes mellitus. Prolonged use at doses exceeding those recommended in the instructions, or improper use, can lead to diarrhea and electrolyte imbalance. In the treatment of children, laxatives should be used in exceptional cases and under medical supervision. It must be borne in mind that during treatment, disorders of the emptying reflex may occur. Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention The use of the drug Dufalac® does not affect or has a slight effect on the ability to drive a car or drive machines and mechanisms. Pharmacological actionDuphalac – stimulating intestinal motility, detoxification, laxative. Pharmacokinetics Laxative drug. It has a hyperosmotic laxative effect, stimulates intestinal motility, improves the absorption of phosphates and calcium salts, promotes the excretion of ammonium ions. Lactulose is broken down by the intestinal flora of the large intestine into low molecular weight organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, as a result, an increase in the volume of intestinal contents. These effects stimulate intestinal motility and affect the consistency of the stool. As a result, the physiological rhythm of bowel emptying is restored. In hepatic encephalopathy, the effect is attributed to the suppression of proteolytic bacteria by increasing the number of acidophilus bacteria (eg, lactobacilli), the conversion of ammonia to the ionic form due to acidification of the contents of the colon, bowel movements due to a decrease in pH in the colon and osmotic effect, and the reduction of nitrogen-containing toxic substances by stimulation of bacteria that utilize ammonia for bacterial protein synthesis. Lactulose as a prebiotic substance enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, while it becomes possible to inhibit the growth of potentially pathogenic bacteria such as Clostridium spp. and Escherichia coli, which provides a more favorable balance of intestinal flora. Pharmacokinetics Absorption is low. After ingestion, it reaches the large intestine unchanged, where it is cleaved by the intestinal flora. Completely metabolized when used in doses up to 45-70 ml. When used in higher doses, it is partially excreted unchanged. Indications for use Constipation: regulation of the physiological rhythm of colon emptying; softening of the stool for medical purposes (with hemorrhoids, conditions after surgery on the colon and in the anus); hepatic encephalopathy in adults: treatment and prevention of hepatic coma or precoma. Dosage and administration The drug is intended for oral administration. Lactulose solution can be taken both diluted and undiluted. It is necessary to immediately swallow the accepted single dose, without holding it in the mouth. All doses must be selected individually. In the case of a single daily dose, it must be taken at the same time, for example, during breakfast. During therapy with laxatives, it is recommended to take a sufficient amount of fluid (1.5-2 liters, which is equal to 6-8 glasses) per day. For accurate dosing of the drug in vials, use the enclosed measuring cup. When using the drug in sachets, it is necessary to tear off the corner of the sachet and immediately take the contents. Dosage in the treatment of constipation or to soften stools for medical purposes: The daily dose of lactulose can be taken once, or divided into two, using a measuring cup. After a few days, the initial dose may be adjusted to a maintenance dose, depending on the response to the drug. The therapeutic effect may appear 2-3 days after the start of the drug. Adults and adolescents: the initial daily dose is 15-45 ml (1-3 sachets); maintenance daily dose – 15-30 ml (1-2 sachets). Children 7-14 years old: initial daily dose – 15 ml (1 sachet); maintenance daily dose – 10-15 ml (1 sachet). Children 1-6 years old: initial daily dose – 5-10 ml; maintenance daily dose – 5-10 ml. Children under 1 year old: initial daily dose – up to 5 ml; maintenance daily dose – up to 5 ml. If the maintenance daily dose is less than 15 ml, as well as for accurate dosing in children under the age of 7 years, it is recommended to use the drug in vials. Dosage in the treatment of hepatic encephalopathy (adults) Initial dose: 3-4 times / day, 30-45 ml. Then they switch to an individually selected maintenance dose so that the soft stool is a maximum of 2-3 times / day. The safety and efficacy of the drug in children and adolescents under the age of 18 with hepatic encephalopathy has not been established due to lack of data. In elderly patients and patients with renal or hepatic insufficiency, there are no special dosage recommendations, because. systemic exposure to lactulose is negligible. Use during pregnancy and lactation No effect on the fetus or infant is expected. the systemic exposure of lactulose to a pregnant or lactating woman is negligible. Duphalac® can be prescribed during pregnancy and during breastfeeding. No effect on reproductive function is expected, because. systemic exposure to lactulose is negligible. Precautions With caution: the drug should be prescribed for undiagnosed rectal bleeding; with colostomy, ileostomy. Interaction with other drugs Interaction studies with other drugs have not been conducted. Contraindications Galactosemia; intestinal obstruction; perforation or risk of perforation of the gastrointestinal tract; intolerance to galactose or fructose, lactase deficiency or glucose-galactose malabsorption; hypersensitivity to any component of the drug. Composition 100 ml contain: Active substances: lactulose 66.7 g; Excipients: purified water – up to 100 ml. OverdoseSymptoms: when taking the drug in a very high dose, pain in the abdomen and diarrhea are possible. Treatment: discontinuation of the drug or dose reduction. In case of large fluid loss due to diarrhea or vomiting, correction of water and electrolyte imbalance may be required. Side effectIn the first days of lactulose use, flatulence may occur. It usually disappears after a few days. If high doses are used for a long time in the treatment of hepatic encephalopathy, the patient may develop fluid and electrolyte imbalance due to diarrhea. From the digestive system: very often (? 1/10) – diarrhea; often (?1/100, <1/10) - flatulence, abdominal pain, nausea, vomiting. Others: infrequently (≥1/1000, <1/100) - disturbances in water and electrolyte balance due to diarrhea. When used in children, a similar safety profile is expected compared to that in adults. Storage conditionsKeep out of the reach of children at a temperature not exceeding 25°C. Buy Duphalac syrup 667mg/ml in 200ml vial
INN | LACTULOSE |
---|---|
The code | 71 920 |
Barcode | 8 002 660 030 696 |
Dosage | 200ml |
Active substance | Lactulose |
Manufacturer | Abbott Biologicals B.V., The Netherlands |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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