Force-OUT

 

TRADE NAME

Force-Out

 

INTERNATIONAL NON-PROPRIETARY NAME

Lactulose

 

CHEMICAL NAME

4-O-beta-D-galactopyranosyl-D-fructose

 

PHARMACEUTICAL FORM

Syrup for oral administration.

Description: Clear, colourless or brownish-yellow viscous liquid.

                                    

COMPOSITION

1 ml of syrup contains

Active substance: lactulose 667 mg.

 

ATC CODE         А06АD11  

 

PHARMACOTHERAPEUTIC GROUP

Laxatives.

  

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Lactulose is a synthetic derivative of lactose. It is not exposed to degradation in the stomach and small intestine due to the absence of necessary enzymes and practically does not absorb. On reaching the intestine it stimulates peristalsis, improves the absorption of phosphates and calcium salts, increases the diffusion of ammonia from blood to the intestine and promotes its elimination.

In the colon, lactulose is broken down by intestinal flora to low-molecular-weight organic acids, primarily to lactic acid and partially to formic and acetic acids. In addition, there is an increase in osmotic pressure, a decrease in colonic luminal pH and an increase in fecal mass, which stimulates peristalsis in the colon and normalizes fecal consistency. It favours prevention of constipation and recovery of physiological rhythm of bowel evacuation.

Elimination of bound ammonium ions takes place along with the development of laxative effect. The laxative effect is achieved in 24-48 hours after administration. In addition, lactulose promotes the excretion of bile acids with faeces resulting in a decrease of cholesterol level in blood and bile. It is able to inhibit the growth of Salmonella in the colon. It does not decrease absorption of vitamins and minerals. The drug does not produce habituation (absence of withdrawal syndrome).

In case of hepatic encephalopathy or hepatic precoma/coma the effect is attributed to inhibition of proteolytic bacteria by means of the increase in the count of acidophilic bacteria (e.g., lactobacteria); conversion of ammonia into the ionic form at the expense of acidification of the colonic contents; bowel evacuation due to a decrease in colon pH and osmotic effect as well as reduction in the content of toxic nitrogen-containing substances by means of stimulation of bacteria utilizing ammonia for microbial protein synthesis.

 

 

 

PHARMACOKINETICS

The absorption is poor. The drug reaches the colon in the unchanged form where it is degraded by intestinal flora. The drug is fully metabolized when taken in a dose of up to 45-70 mL; in higher doses it is partially excreted unchanged.

 

THERAPEUTIC INDICATIONS

- constipation: regulation of the intestinal physiological rhythm;

- stool softening for medical purposes (haemorrhoids, operations on the colon and in the region of anus, in postoperative period);

- intestinal dysbacteriosis;

- hepatic precoma and coma, hepatic encephalopathy, hyperammoniemia.

 

METHOD OF ADMINISTRATION AND DOSAGE

Force-Out is administered orally. The duration of treatment and doses are determined by the doctor.

For the treatment of constipation:

The drug should be taken once daily in the morning during the meal. The clinical effect is observed in 1-2 days. The dose is increased if there is no improvement of the patient’s condition during 2 days of treatment with the drug.

Adults: the initial dose is 15-45 ml and the maintenance dose is 10-25 ml.

Children: under three years old: the initial dose is 5 ml and the maintenance dose is 5 ml.

                3-6 years old: the initial dose is 5-10 ml and the maintenance dose is 5-10 ml.

                7-14 years old: the initial dose is 15 ml and the maintenance dose is 10 ml.

The dose can be usually decreased after 2 days of application depending on the patient’s need.

For stool softening:

The doses are the same as those administered in case of constipation.

In case of intestinal dysbacteriosis (daily doses):

Adults: 10 ml a day.

Children: 7 years old and older - 10 ml a day;

                4-7 years old – 5 ml a day.

                under 1 year old – 1.5 – 3 ml a day.

In case of hepatic encephalopathy, hepatic precoma and coma: 30-50 ml three-four times daily, then in individually adjusted maintenance dose (producing рН of faeces 5 – 5.5) 2-3 times daily.

In case of hepatic encephalopathy the dose is adjusted so that there should be soft stool 2-3 times daily. The duration of treatment can be up to 3 months and longer.

 

CONTRAINDICATIONS

- hypersensitivity to the preparation components;

- galactosemia;

- intolerance to lactose, galactose or fructose;

- intestinal obstruction.

 

SIDE EFFECTS

Gastrointestinal tract: flatulence, stomachache, nausea, vomiting.

In case of long-term treatment there is a possibility of water-electrolytic disturbances.

 

PARTICULAR INDICATIONS

The drug should be administered with care to patients with diabetes mellitus, especially for the treatment of hepatic encephalopathy.

The drug should not be taken in case of stomachache, nausea and vomiting.

In case of diarrhea, the treatment should be stopped. In case of gastro-cardiac syndrome it is necessary to increase doses gradually to avoid flatulence (usually flatulence disappears by itself after 2-3 days of the treatment).

In case of long-term treatment (more than 6 months) with high doses, regular control of serum electrolyte levels is necessary. If the therapeutic effect is not observed during 2 days or in case of rebound constipation after the treatment the patient should consult the doctor.

It is recommended to refrain from alcohol during the treatment.

 

THE INFLUENCE ON THE ABILITY FOR DRIVING VEHICLES AND OPERATING OF MECHANISMS

Force-Out doesn’t influence the ability for driving vehicles and fulfilling operations requiring high psychomotor performance.

 

APPLICATION DURING PREGNANCY AND LACTATION

Force-Out is safe for administration during pregnancy and lactation.

 

DRUG INTERACTIONS

The concurrent administration with broad-spectrum antibiotics and antacids decreases the therapeutic efficacy of lactulose.

In case of concurrent administration of Force-Out and enterosoluble preparations with pH-dependent release, it is necessary to take into account that lactulose decreases рН of the intestinal contents and changes the release of these drugs.

 

OVERDOSE

Symptoms: There is a possibility of diarrhea and stomachache.

Treatment: Dose reduction or discontinuation of drug treatment.

 

PACKAGING

Syrup for oral administration is in a 250 mL amber coloured glass bottle with plastic cap.

1 bottle with a measuring cup with a leaflet in a carton box.

 

STORAGE CONDITIONS

Store at temperature not exceeding 25°С.

Keep out of reach of children!

Do not freeze.

Do not use the medicine longer than 28 days after first opening.

 

SHELF LIFE

3 years from the date of manufacture.

Do not use after the expiry date.

 

SALES TERMS

Sold without prescription.

 

MANUFACTURER

The holder of trade mark and Marketing Authorization is 

“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.

Manufactured by

“Abdi İbrahim İlaç San. ve Tic. A.Ş.”, Turkey

(Sanayi Mahallesi, Tunç Caddesi No: 3 Esenyurt 34555 / İstanbul).