Importal N (Powder) Instructions for Use

Marketing Authorization Holder

Novartis Consumer Health S.A. (Switzerland)

Manufactured By

Famar France (France)

ATC Code

A06AD12 (Lactitol)

Active Substance

Lactitol (Rec.INN registered by WHO)

Dosage Form

Importal N

Powder for oral solution 10 g: sachet 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution white, fine-crystalline, odorless; the presence of soft lumps is allowed.

10 g – multilayer sachets (20) – cardboard packs.
10 g – multilayer sachets (50) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties. Hypoammonemic agent

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Lactitol is a disaccharide derivative consisting of galactose and sorbitol, which is not hydrolyzed by disaccharidases in the small intestine. As a result, it passes through the small intestine with minimal absorption and enters the large intestine unchanged. In the large intestine, under the influence of microflora (mainly Bacteroides and Lactobacilli), Lactitol is metabolized primarily to acetic, propionic, and butyric acids. Acidification of the contents of the large intestine reduces the absorption of ammonia. The conversion of lactitol into short-chain organic acids increases the osmotic pressure in the large intestine. This leads to an increase in the water content and volume of feces, which is the cause of the laxative effect.

It is not dangerous for tooth enamel.

Pharmacokinetics

The effect of lactitol develops in the large intestine, where its bioavailability is practically 100%. The compound is absorbed in minimal amounts. Up to 2% is found unchanged in the urine.

Indications

• Constipation, regulation of bowel movements (including for hemorrhoids, preparation for surgery and after operations on the rectum, anal sphincter and adjacent area);
• Hepatic encephalopathy;
• Hepatic coma and precoma;
• Hyperammonemia.

ICD codes

Dosage Regimen

Constipation

Recommended dosages are given below. Due to individual differences, dose adjustment is required to achieve a bowel movement once a day.

Orally.

Adults (including the elderly)

The initial dose is 20 g (2 sachets of 10 g powder) as a solution once in the morning or evening. In some patients, after a few days, the dose can be reduced to 10 g per day.

Children

The average initial dose is 0.25 g/kg of body weight

From 1 to 6 years the contents of 0.25-0.5 sachet as a solution orally per day.

From 6 to 12 years the contents of 0.5-1 sachet as a solution orally per day.

From 12 to 16 years the contents of 1-2 sachets as a solution orally per day.

Importal N should be taken once a day, in the morning or evening, with food or liquid (as a solution). Depending on the individual response, the patient chooses the regimen – morning or evening. The laxative effect develops several hours after administration.

The first laxative effect may appear on the second or third day of use.

Hepatic encephalopathy

The dosage is selected depending on the individual response of the patient. The dosage is increased or decreased until the effect is achieved: soft stools twice a day.

Orally.

The initial daily dose ranges from 0.5 to 0.7 g/kg of body weight per day, divided into 3 doses with meals (as a solution).

Use via nasogastric tube in hospitalized patients

Preparation of a 40% solution

Dissolve 200 g of lactitol in 200 ml of hot distilled water, then bring the volume of the solution to 500 ml with water.

When administered via a nasogastric tube or orally, the initial daily dose ranges from 1 to 2 ml/kg of body weight of a 40% solution prepared as above. This corresponds to 0.4-0.8 g/kg of body weight per day.

Adverse Reactions

At the beginning of treatment, Importal N may cause abdominal discomfort, mainly intestinal bloating, less often abdominal pain. These effects weaken or disappear after a few days of regular use of Importal N.

Nausea, abnormal abdominal sounds, or anal itching are sometimes noted, less often vomiting, electrolyte imbalance (with long-term use of high doses in the treatment of hepatic encephalopathy). In some patients, due to individual differences, the drug in recommended doses may cause diarrhea. Reducing the dosage weakens or eliminates these effects.

Contraindications

• Hypersensitivity to lactitol;
• Obstructions (intestinal obstruction, etc.);
• Children under 1 year of age.

Like all laxatives, Importal N should not be used for any symptoms or suspicions of organic lesions of the gastrointestinal tract, as well as in cases of abdominal pain of unknown etiology or rectal bleeding. In such situations, other measures to eliminate constipation should be used before using laxatives.

Importal N is contraindicated in galactosemia.

Use in Pregnancy and Lactation

Due to the lack of data on the use of Importal N in pregnant women, the use of the drug during the first and second trimester of pregnancy is recommended only as prescribed by a doctor, comparing the benefit to the mother and the risk to the fetus. The excretion of lactitol in breast milk has not been studied. It seems unlikely that this effect could be of clinical importance due to the minimal absorption of the compound.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

Long-term continuous use of laxatives is not recommended. In all cases of chronic constipation, a fiber-rich diet, adequate fluid intake, and physical activity should be used first. In order to prevent diarrhea caused by excessive doses of the laxative from disturbing the electrolyte balance, the doctor should select the optimal dose to ensure a bowel movement once a day in patients with constipation and twice a day in patients with cirrhosis.

In elderly and debilitated patients during long-term treatment with Importal N, serum electrolytes should be regularly monitored. When treating with any laxatives, if present, the disturbed electrolyte balance should be restored before starting their use. During treatment with Importal N, hydrogen may accumulate in the intestines. If such a patient requires galvanocautery procedures, the intestines must first be cleansed with solutions that do not cause fermentation. In patients with nausea, Importal N should be taken with meals.

Importal N is not recommended for ileostomy and colostomy. In cases of persistent constipation, a doctor’s consultation is necessary.

The calorie content of lactitol is extremely insignificant (2 kcal/g or 8.5 kJ/g). The drug does not affect the content of insulin or glucose in the blood plasma and therefore can be used in patients with diabetes.

Effect on the ability to drive vehicles and operate machinery

No effect.

Overdose

Signs of overdose are diarrhea, which can be stopped by reducing the dose; vomiting. Violation of the electrolyte balance of the blood serum is also possible, which requires appropriate correction.

Drug Interactions

Since antacids and neomycin can neutralize the acidifying effect of lactitol on stools, they should not be used together in patients with cirrhosis and hepatic encephalopathy; however, the combination of these drugs in patients with constipation will not disrupt the laxative effect.

Like other laxatives, Importal N may enhance potassium losses caused by other drugs (for example, thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B). With potassium deficiency, the risk of toxic effects of cardiac glycosides may increase during concomitant therapy.

Storage Conditions

At a temperature not exceeding 30°C (86°F). Store the prepared solution at a temperature of 2-8°C (35.6-46.4°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

Without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.