Portalak
Producer: BELUPO, Pharmaceuticals & Cosmetics, d.d. Republic of Croatia
Code of automatic telephone exchange: A06AD11
Release form: Liquid dosage forms. Syrup.
General characteristics. Structure:
Active agent: 66,7g concentrate lactuloses.
Excipients: the water purified.
Pharmacological properties:
Has hyperosmotic, laxative effect, stimulates an intestines peristaltics, improves absorption of phosphates and Sa2+ salts, promotes removal of ions of ammonium. Under the influence of lactulose there is a reproduction of Lactobacillus acidophilus, Lactobacillus bifidus in intestines that in turn leads to decrease рН in a gleam of a large intestine and activation of its vermicular movement. Along with it volume increases and there is a softening of fecal masses. Drug has laxative effect, without influencing at the same time directly a mucous membrane and smooth muscles of a large intestine.
Under the influence of lactulose formation of nitrogen-containing toxic substances in proximal department of a large intestine and their absorption in a system blood stream decreases.
Concentration of ions of ammonium decreases in blood by 25 - 50%, reduces expressiveness of hepatic encephalopathy, improves a mental state and normalizes EEG.
Drug has ability to slow down growth of salmonellas in a large intestine. Effect of drug comes in 24 - 48 hours after intake in process of passing of drug through a GIT.
Lactulose is practically not absorbed from digestive tract (no more than 3% of the accepted dose are soaked up), does not reduce absorption of vitamins, does not cause accustoming.
Indications to use:
- lock (including chronic)
- need of a softening of a chair for the medical purposes (at hemorrhoids, need of surgery on a large intestine and/or an anus, a pain syndrome after removal - hemorrhoidal nodes, the postoperative period)
- intestinal dysbiosis
- hepatic encephalopathy
- hepatic prekoma and coma (treatment and prevention)
- giperammoniyemiya
- the enteritis caused by salmonellas, shigellas, a salmonellonositelstvo;
- a syndrome of putrefactive dyspepsia (at children of early age as a result of acute food poisonings).
Route of administration and doses:
The dose of drug is selected individually.
At treatment of locks and for a chair softening:
initial dose (three days) | treatment continuation | |
Children till 1 year | 5 ml of syrup (1 teaspoon) |
5 ml of syrup (1 teaspoon) |
children from 1 year to 6 years | 5-10 ml of syrup (1-2 teaspoons) |
5-10 ml of syrup (1-2 teaspoons) |
children from 7 to 14 years | 15 ml of syrup (1 tablespoon) |
10 ml of syrup (2 teaspoons) |
adults | 15-45 ml of syrup (1-3 tablespoons) |
15-30 ml of syrup (1-2 tablespoons) |
It is better to accept drug in the morning in time or after food, once or dividing into two receptions. Drug can be washed down with water or other liquid. The patient can select and change a dose and time of administration of drug on requirement. The laxative effect of drug develops during the first two days of reception.
Treatment duration at locks makes from 4 weeks to 3-4 months.
At treatment of hepatic (portal) encephalopathy, a hepatic coma and prekoma:
30-50 ml of syrup (2-3 tablespoons) three times a day.
In an initial phase of treatment doses of 30-45 ml of syrup for achievement of bystry effect (the first bowel emptying) can be appointed each 1-2 hours. Then pass to a maintenance dose, selecting it individually to receive a soft chair 2-3 times a day.
At treatment of dysbacteriosis and for intestinal microflora normalization:
Drug is appointed in time or after food, by 2 - 4 times a day.
Single dose | |
Children till 1 year | 1,5-3 ml of syrup |
Children from 1 year to 3 years | 3 ml of syrup |
Children from 3 to 7 years | 5 ml of syrup (1 teaspoon) |
Adults and children are more senior than 7 years | 5 - 10 ml of syrup (1-2 teaspoons) |
Duration of treatment makes 10-14 days, repeated courses are appointed with week breaks.
Features of use:
If the lock is not eliminated within several days of administration of drug, and also when resuming a lock after the termination of administration of drug, it is necessary to consult with the doctor.
Due to the presence at drug of insignificant quantities Sakharov (15 ml of syrup contain up to 1,7 g of a galactose and to 1 g of lactose) patients need to observe precautionary measures at purpose of drug with a diabetes mellitus and a lactose intolerance.
With care appoint drug to patients with a gastrocardial syndrome. In this case treatment is begun with low doses and raise them gradually to avoid emergence of a meteorism.
At treatment of hepatic encephalopathy, especially in an initial phase of therapy, it is impossible to use other purgatives. The strengthened bowel emptying can lead to the wrong conclusion that the adequate dose for therapy of encephalopathy is reached.
Lactulose can safely be applied at pregnant women and nursing mothers.
Side effects:
By-effects carry, as a rule, slight and reversible character and are a consequence of exceeding of a dose. Spasms, a sensation of discomfort or an abdominal pain, and also diarrhea can be eliminated with a dose decline.
The meteorism appearing, as a rule, passes in an initiation of treatment in 1 - 2 day.
Cases of skin reactions were noted (rash).
At long therapy by high doses of lactulose at treatment of hepatic encephalopathy disturbance of water and electrolytic balance, and, as a result, spasms, nausea, a headache, dizziness, arrhythmias, a mialgiya, increased fatigue, weakness can develop.
Interaction with other medicines:
When using therapeutic doses of lactulose clinically reliable interactions with other medicines were not noted, nevertheless, it is not recommended to accept PORTALAK within two hours after reception of other medicine.
At a concomitant use lactulose can inactivate drugs for which release in a large intestine an adverse environment will be created (for example, the drugs containing месалазин).
Antibiotics (Neomycinum) and antacids reduce effect.
Influence on ability of control of vehicles and mechanisms
In the recommended doses of PORTALAK does not exert impact on ability of control of vehicles and mechanisms.
Contraindications:
Hypersensitivity to lactulose or other components of drug, a galactosemia, impassability of intestines, rectal bleedings (which reason hemorrhoids are not), kolo-, an ileostoma, suspicion of appendicitis.
Overdose:
Reception of too high doses of drug can cause diarrhea and disturbance of water and electrolytic balance.
Treatment: drug withdrawal.
Storage conditions:
At a temperature not above 25 °C. Not to freeze because of possible crystallization of lactulose!
To store in the place, unavailable to children!
Issue conditions:
According to the recipe
Packaging:
Syrup of 667 mg/ml.
On 250 ml and 500 ml of drug in a bottle from polyethylene of high density with the screwing-up polypropylene cover, with the condensed ring from the made foam polyethylene. One bottle together with the application instruction is placed in a cardboard pack.