GUTTALAX ® Sodium Picosulfate

GUTTALAX ® is a drug based on sodium picosulfate

THERAPEUTIC GROUP: Laxatives - Stimulative laxative

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications GUTTALAX ® Sodium Picosulfate

GUTTALAX ® is indicated for the short-term treatment of occasional constipation.

Mechanism of action GUTTALAX ® Sodium Picosulfate

Sodium picosulfate, taken orally by GUTTALAX ® is able to reach intact the intestinal mucosa of the large intestine, where it is hydrolysed in its active form by the local bacterial flora, and performs the laxative action through a contact mechanism.

The pharmacokinetic properties of this active principle make GUTTALAX ® unavailable for intestinal absorption, allowing an optimization of laxative activity, which occurs on average between the sixth and twelfth hours, and minimizes the urinary excretion of metabolites glucoronati.

Like other stimulant laxatives belonging to the category of triarylmethane derivatives, the derivatives of sodium picosulfate can act at the level of the intestinal mucosa, stimulating the nerve endings and increasing the peristalsis of the colon, with consequent evacuation.

Studies carried out and clinical efficacy

PICOSOLFATE SODIUM IN THE TREATMENT OF CHRONIC COSTIPATION

The short-term treatment, in particular for 3 days, with 7 mg of sodium picosulfate in patients with repeated episodes of constipation in the last 3 months, has proved to be particularly effective and safe in improving symptoms, ensuring an increase in the frequency of evacuation without effort and a reduction in abdominal pain

2. SODIUM PICOSOLFATO AND CLEANING OF THE COLON

Proper colon cleansing is an important practice so that colonoscopy can ensure a good diagnostic result without any bacterial infections. The administration of sodium picosulfate as a laxative has proven to be useful in ensuring a correct colon cleansing, without such side effects as to compromise the inspection procedure.

3. SODIUM PICOSOLFATE AND UREA AND ELECTROLYTES

This study conducted on 147 patients suffering from constipation, and treated with sodium picosulfate, has demonstrated how the assumption of this active principle according to therapeutic schemes, can determine a reduction of the plasma concentrations of urea, sodium and potassium without however causing clinically relevant side effects

Method of use and dosage

GUTTALAX ® oral drops of 7.5mg sodium picosulfate per ml : 7 - 8 drops daily, taken in a little water, should be sufficient to overcome episodes of occasional constipation. However, in case of obstinate constipation it is possible to increase the dose to 15-20 drops.

GUTTALAX ® soft capsules of 2.5 mg sodium picosulfate : the recommended dose is 2-3 capsules per day.

In both cases, treatment with this medicine should be limited to a few days, given the uselessness and danger of prolonged administration, preferring the evening intake so that the laxative effect can manifest itself the following morning.

The medical check-up is necessary in case of administration of GUTTALAX ® children under the age of 10 years, and in case of possible dosage increase.

Warnings GUTTALAX ® Sodium Picosulfate

The intake of stimulant laxatives should be linked exclusively to the need to overcome episodes of temporary constipation.

The finding of a continuous and prolonged constipation over time, should instead provide a different therapeutic protocol, in which the feeding represents one of the basic foundations (see diet for constipation).

In fact, it is known that the use of laxatives, including GUTTALAX ® at high doses and prolonged over time, may be associated with chronic diarrhea with altered electrolyte balance, followed by loss of the functionality of the active ingredient and intestinal atony.

Medical monitoring would be necessary in the case of patients suffering from hypertension, heart disease, endocrine-metabolic disorders and in children under the age of 10 years.

GUTTALAX ® does not interfere with the normal ability to drive vehicles and use machinery.

PREGNANCY AND BREASTFEEDING

During the entire period of pregnancy and subsequent breastfeeding, it would be advisable to avoid taking GUTTALAX ® resorting to it exclusively in case of real need and under strict medical supervision, given the absence of well documented clinical trials capable of highlighting all the possible adverse reactions of sodium picosulfate and its metabolites on the health of the fetus and newborn.

Interactions

The intake of GUTTALAX ® should take place at least two hours after that of other drugs, given the ability of laxatives to reduce intestinal transit time and the consequent absorption of nutrients and active ingredients.

On the contrary, the concomitant intake of gastric antacids could reduce the intestinal availability of sodium picosulfate, resulting in a significant decrease in the therapeutic effects of GUTTALAX ®

The increased intestinal excretion induced by stimulant laxatives could expose the patient to the risk of hypokalaemia and its electrolyte imbalance, especially in the case of concomitant intake of diuretics or adrenocotricosteroids.

Contraindications GUTTALAX ® Sodium Picosulfate

The administration of GUTTALAX ® should be avoided in case of nausea, diarrhea and various diseases of the gastro-intestinal tract, even acute, such as during appendicitis, intestinal and biliary tract obstructions, dehydration and liver failure.

Naturally, sodium picosulfate is contraindicated in case of hypersensitivity to the active ingredient or to triarylmethane derivatives.

Undesirable effects - Side effects

Intake of GUTTALAX ® could lead to the occurrence of side effects predominantly affecting the gastro-intestinal tract, such as nausea, cramps, diarrhea and abdominal pain. More rarely, symptoms associated with hypersensitivity to the active ingredient, such as edema and skin reactions, have been observed.

Definitely more serious and potentially dangerous are the side effects due to the quantitative abuse of GUTTALAX ® that occur with acute abdominal pain, hypokalemia, chronic diarrhea, dehydration, myalgia and muscle fatigue, and in some cases even kidney stones.

The prolonged administration of GUTTALAX ® strongly not recommended, could instead be responsible for the progressive loss of efficacy of the drug, with consequent reduction of intestinal tone and peristalsis, and constipation.