Portalac, syrup 250 ml

Portalac is a hypoazotemic, stimulating intestinal peristalsis laxative.

Pharmacodynamics

It has hyperosmotic, laxative effect, stimulates intestinal peristalsis, improves absorption of phosphates and Ca2+ salts, promotes excretion of ammonium ions.

Lactulose causes multiplication of Lactobacillus acidophilus, Lactobacillus bifidus in the intestine, which in its turn lowers pH in the lumen of the large intestine and activates its peristalsis. At the same time, the volume increases and softening of stools occurs. The drug has a laxative effect without affecting directly the mucosa and smooth muscles of the large intestine.

Lactulose decreases formation of nitrogen-containing toxic substances in the proximal colon and their absorption into the systemic blood flow.

The concentration of ammonium ions in the blood is reduced by 25-50%; it reduces the severity of hepatic encephalopathy, improves mental state and normalizes the EEG.

The drug has the ability to inhibit the growth of Salmonella in the large intestine.

The action of the drug occurs 24-48 hours after oral administration as the drug passes through the gastrointestinal tract.

Pharmacokinetics

Lactulose is practically not absorbed from the gastrointestinal tract (absorption is less than 3% of the dose taken), it does not reduce absorption of vitamins and is not addictive.

Indications

Constipation of various etiologies (including chronic);
the need to soften stool for medical purposes (for hemorrhoids, the need for surgery on the colon and/or anus, pain after removal of hemorrhoids, the postoperative period);
intestinal dysbiosis;
hepatic encephalopathy;
hepatic precoma and coma (treatment and prevention);
hyperammonemia;
enteritis caused by Salmonella, Shigella, Salmonella carriage;
putrefactive dyspepsia syndrome (in young children as a result of acute food poisoning).

Pharmacological effect

Portalac is a hypoazotemic, stimulating intestinal motility, laxative.

Pharmacodynamics

It has a hyperosmotic, laxative effect, stimulates intestinal motility, improves the absorption of phosphates and Ca2+ salts, and promotes the excretion of ammonium ions.

Under the influence of lactulose, Lactobacillus acidophilus and Lactobacillus bifidus multiply in the intestine, which in turn leads to a decrease in pH in the lumen of the large intestine and activation of its peristalsis. Along with this, the volume increases and the stool softens. The drug has a laxative effect without directly affecting the mucous membrane and smooth muscles of the large intestine.

Under the influence of lactulose, the formation of nitrogen-containing toxic substances in the proximal colon and their absorption into the systemic circulation decreases.

The concentration of ammonium ions in the blood decreases by 25–50%; reduces the severity of hepatic encephalopathy, improves mental state and normalizes the EEG.

The drug has the ability to inhibit the growth of salmonella in the large intestine.

The effect of the drug occurs 24–48 hours after oral administration, as the drug passes through the gastrointestinal tract.

Pharmacokinetics

Lactulose is practically not absorbed from the gastrointestinal tract (no more than 3% of the dose taken is absorbed), does not reduce the absorption of vitamins, and is not addictive.

Special instructions

If constipation does not resolve within a few days of taking the drug, or if constipation returns after stopping the drug, you should consult your doctor.

Due to the presence of small amounts of sugars in the drug (15 ml of syrup contains up to 1.7 g of galactose and up to 1 g of lactose), caution must be exercised when prescribing the drug to patients with diabetes mellitus and lactose intolerance.

The drug is prescribed with caution to patients with gastrocardial syndrome: treatment is started with low doses and increased gradually to avoid flatulence.

When treating hepatic encephalopathy, especially in the initial phase of therapy, other laxatives should not be used, because increased bowel movement may lead to the erroneous conclusion that an adequate dose has been achieved for the treatment of encephalopathy.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. In recommended doses, the drug does not affect the ability to drive vehicles and machinery.

Active ingredient

Lactulose

Composition

100 ml of syrup contains:

Active substance:

lactulose concentrate 66.7 g;

Excipients:

purified water.

Pregnancy

Lactulose can be used safely in pregnant and nursing mothers.

Contraindications

Hypersensitivity to lactulose or other components of the drug;
galactosemia;
intestinal obstruction;
rectal bleeding (not caused by hemorrhoids);
colo- or ileostomy;
suspicion of appendicitis.

The drug is prescribed with caution to patients with gastrocardial syndrome: treatment is started with low doses and increased gradually to avoid flatulence.

Due to the presence of small amounts of sugars in the drug (15 ml of syrup contains up to 1.7 g of galactose and up to 1 g of lactose), caution must be exercised when prescribing the drug to patients with diabetes mellitus and lactose intolerance.

Side Effects

Side effects are usually mild and reversible and are a consequence of exceeding the dose.

Cramps, abdominal discomfort or pain, and diarrhea may be relieved by reducing the dose. Flatulence that appears at the beginning of treatment usually goes away after 1-2 days.

There have been cases of skin reactions (rash).

With long-term therapy and the use of high doses of lactulose in the treatment of hepatic encephalopathy, water-electrolyte imbalance may develop, and as a result, convulsions, nausea, headache, dizziness, arrhythmia, myalgia, increased fatigue, and weakness.

Interaction

When using therapeutic doses of lactulose, no clinically significant interactions with other drugs were observed. However, it is not recommended to take Portalac® within 2 hours after taking another drug.

When taken concomitantly, lactulose may interfere with the action of drugs for which an unfavorable environment is created in the large intestine (for example, drugs containing mesalazine).

Antibiotics (neomycin) and antacids reduce the effect.

Overdose

Symptoms: taking too high doses of the drug can cause diarrhea and fluid and electrolyte imbalance.
Treatment: drug withdrawal.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia