Avelac

Avelac

lactulose

Manufacturer:

Aeva

Distributor:

Apex
Full Prescribing Info
Contents
Lactulose.
Description
Avelac contains lactulose, a laxative that producing bowel movement and softening the stools.
Action
Pharmacology: Pharmacodynamics: Lactulose is a synthetic disaccharide osmotic laxative used in the treatment of constipation and in hepatic encephalopathy. Lactulose is broken down by colonic bacteria mainly into lactic acid. This exerts a local osmotic effect in the colon resulting in increased faecal bulk and stimulation of peristalsis. It may take up to 48 hours before an effect is obtained. When larger doses are given for hepatic encephalopathy, the pH in the colon is reduced significantly and the absorption of ammonium ions ad other toxic nitrogenous compounds is decreased, leading to a fall in blood-ammonia concentration and an improvement in mental function.
Pharmacokinetics: Taken orally, lactulose passes essentially unchanged into the large intestine where it is metabolized by saccharolytic bacteria with the formation of simple organic acids, mainly lactic acid and small amounts of acetic and formic acids. The small amount of absorbed lactulose is subsequently excreted unchanged in the urine.
Indications/Uses
AVELAC helps in softening the stools and relieves constipation.
Hepatic encephalopathy (HE): treatment and preventive of hepatic coma or precoma.
Dosage/Direction for Use
Constipation: It may take up to 48 hours before an effect is obtained. The dose is gradually adjusted according to response. (See table.)

Click on icon to see table/diagram/image

Hepatic Encephalopathy: For Adults only.
30ml - 45ml, 3 to 4 times daily. The dose is subsequently adjusted to produce 2 - 3 soft stools daily.
AVELAC is for oral consumption only. Shake well before use.
Overdosage
Overdose may lead to diarrhoea with excessive loss of water and electrolytes, particularly potassium. Hypernatraemia has been reported.
Contraindications
AVELAC does not contain any excipients, but may contain small amounts of related sugars (e.g. lactose, galactose, epilactose, tagatose and fructose).
Do not use AVELAC if the patient: have galactosaemia (genetic disorder where sugar galactose taken is not able to metabolise properly).
have intestinal obstruction (blockage of bowel).
Special Precautions
Tell the doctor or pharmacist if the patient: are on a galactose diet,
are lactose intolerance (inability to digest sugar lactose),
are a diabetic patient,
are pregnant or breast-feeding,
are taking any medications.
Use In Pregnancy & Lactation
If dietary and lifestyle changes fail to control constipation in pregnancy and lactation, moderate doses of poorly absorbed laxatives may be used. A bulk-forming laxative should be tried first. An osmotic laxative, such as lactulose, can also be used. No effect during pregnancy and lactation are anticipated since the systemic exposure to lactulose is negligible. The use of lactulose may be considered during pregnancy and lactation if necessary.
Side Effects
May result in abdominal discomfort, flatulence, cramps, nausea and vomiting.
Prolonged use may result in diarrhoea and hypernatraemia (an elevated sodium level in blood).
Drug Interactions
None known.
Storage
Store below 30°C.
ATC Classification
A06AD11 - lactulose ; Belongs to the class of osmotically acting laxatives.
Presentation/Packing
Oral soln 667 mg/mL (clear, viscous liquid, colorless to brownish yellow aqueous solution) x 100 mL.
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