Fibolac 10 gm/sachet (Oral Powder)

Indications

• Chronic idiopathic constipation (CIC)
• Acute and chronic portal systemic encephalopathy

Pharmacology

• Lactitol Monohydrate is a disaccharide derivative
• Consists of galactose and sorbitol
• Not hydrolysed by the disaccharidases of the GIT
• Broken down to short chain low molecular weight organic acids by the intestinal flora
• Results in an increase in osmotic pressure in the colon
• Causes an increase in stool water content and stool volume
• Produces its effect in the lumen of the colon
• Virtually 100% bioavailable

Dosage & Administration

• Can be mixed with hot or cold beverages, puddings etc.
• Requires adjustment to obtain one daily bowel movement in constipated patients
• Requires adjustment to obtain two daily bowel movements in patients with portal systemic encephalopathy
• Initial daily dosage for adults
• Mean dosage for children
• Laxative response may be delayed until the second or third day of administration
• Patients should maintain an adequate daily fluid intake

Interaction

• Should not be given simultaneously with antacids and neomycin to cirrhotic patients with portal systemic encephalopathy
• May increase potassium loss caused by other drugs
• May enhance the risk of toxic effects of glycosides in patients receiving concomitant therapy

Contraindications

• Known hypersensitivity to any of the ingredients of this preparation

Side Effects

• At the start of the treatment may produce abdominal discomforts
• Effects tend to diminish or disappear after a few days of regular intake
• Occasional reports of nausea or anal pruritus

Pregnancy & Lactation

• Minimally absorbed systemically following oral administration
• Unknown whether maternal use will result in fetal exposure to the drug
• No data on the presence of lactitol in human or animal milk or the effects on the breastfed infant

Precautions & Warnings

• Elderly or debilitated patients receiving long-term treatment should have their serum electrolytes monitored regularly
• Pre-existing fluid or electrolyte imbalance should be corrected before starting treatment
• Hydrogen may accumulate in the bowel following treatment
• Not recommended in cases of ileostomy or colostomy
• Prolonged use of laxatives without interruption should be avoided

Therapeutic Class

• Osmotic purgatives

Storage Conditions

• Store in a cool, dry place and away from light
• Keep out of reach of children

Related Brands

• Laxitol 10 gm/sachet (Oral Powder) - eskayef-pharmaceuticals-ltd
• Maxilax 10 gm/15 ml (Oral Solution) - opsonin-pharma-ltd