Instructions for use Picolax oral drops 0.75% bottle 30 ml
Composition
active ingredient: sodium picosulfate;
1 ml of the drug contains sodium picosulfate, calculated as 100% anhydrous substance, 7.5 mg (20 drops);
excipients: sorbitol (E 420); sodium benzoate (E 211); citric acid monohydrate; sodium citrate; water for injections.
Dosage form
Oral drops.
Main physicochemical properties: transparent colorless or yellowish liquid.
Pharmacotherapeutic group
Contact laxatives. ATX code A06A B08.
Pharmacological properties
Pharmacodynamics.
Sodium picosulfate, the active ingredient of Picolax®, is a local laxative of the triarylmethane group. Sodium picosulfate, after bacterial cleavage in the colon, stimulates its mucosa, accelerating peristalsis, and promotes the accumulation of water and electrolytes in the lumen of the colon. The result is stimulation of defecation, reduction of transit time, and softening of feces.
Pharmacokinetics.
After oral administration, sodium picosulfate reaches the large intestine without significant absorption.
The active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane is formed after bacterial cleavage in the colon, the onset of action of Picolax® usually occurs 6-12 hours after taking the drug, depending on the release of the active metabolite. After oral administration, only a small amount of the drug can be detected in the organs and systems of the body.
The laxative effect of the drug does not correlate with the level of the active metabolite in blood plasma.
Indication
Constipation or cases requiring easier defecation.
Like other laxatives, Picolax® should not be used daily or for a long period of time without establishing the cause of constipation.
Contraindication
Hypersensitivity to the active substance, other triarylmethanes or to any of the excipients of the drug. Intestinal obstruction or acute abdominal disease, such as appendicitis. Acute inflammatory bowel disease.
Acute abdominal pain accompanied by nausea and vomiting, which may indicate the above-mentioned acute diseases. Severe dehydration.
Rare hereditary intolerance to any of the excipients of the drug, for example, there is a possibility of undiagnosed fructose intolerance (see section "Special instructions"). Picolax® should be taken under medical supervision in conditions associated with impaired water and electrolyte balance (for example, severe renal impairment).
Interaction with other medicinal products and other types of interactions
Concomitant use of high doses of Picolax® and diuretics or corticosteroids may increase the risk of electrolyte imbalance, which may lead to increased sensitivity to cardiac glycosides.
Concomitant use with antibiotics may weaken the laxative effect of Picolax®.
Application features
Patients suffering from chronic constipation should undergo a complete diagnosis and determine the cause of the constipation.
Long-term use of the drug may lead to fluid and electrolyte imbalance and hypokalemia.
Cases of dizziness and/or syncope have been reported to occur in association with the use of sodium picosulfate. Available information suggests that these events are consistent with syncope during defecation (associated with the Valsalva maneuver) or are related to a vasovagal response to abdominal pain.
Patients with rare hereditary problems of fructose intolerance should not take this medicine because it contains sorbitol.
This medicinal product contains less than 1 mmol sodium/dose, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
There are no adequate studies of sodium picosulfate in pregnant women. For safety reasons, Picolax® should not be used during pregnancy if possible.
Clinical data show that neither the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) nor its glucuronides pass into breast milk. Thus, Picolax® can be used during breastfeeding.
Studies to assess the effect on fertility have not been conducted.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effects on the ability to drive and use machines have not been conducted.
However, patients should be warned about the possibility of developing adverse reactions such as dizziness and/or syncope due to vasovagal reactions (including abdominal spasms). In the event of abdominal spasms, the patient should avoid potentially hazardous activities such as driving or operating machinery.
Method of administration and doses
The drug is dosed using the manufacturer's dispenser.
Adults: 13-27 drops (corresponding to 5-10 mg of sodium picosulfate);
Picolax® should be taken at night. After using Picolax®, bowel movements occur 10-12 hours later. The drug can be used with or without liquid.
Picolax® should not be used daily or for a long period of time without determining the cause of constipation.
Children
The drug should be used in children over 4 years of age only as prescribed by a doctor.
Overdose
Overdose may result in loose stools (diarrhea), intestinal spasms, and clinically significant loss of fluid, potassium, and other electrolytes.
In acute overdose, the effects can be minimized or eliminated by inducing vomiting or gastric lavage shortly after taking Picolax®. Fluid replacement and correction of electrolyte balance may be necessary. Antispasmodics may be used.
Ischemia of the colonic mucosa has been reported with the use of large doses of Picolax®, significantly higher than those usually recommended for constipation.
Picolax®, like other laxatives, in case of prolonged overdose can lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism and, possibly, to the formation of kidney stones. With prolonged abuse of laxatives, damage to the renal tubules, metabolic alkalosis, muscle weakness as a result of hypokalemia have been reported.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including angioedema, skin reactions (rash, itching, urticaria).
Nervous system: dizziness, syncope. The likelihood of dizziness and syncope is associated with a vasovagal reaction (such as abdominal spasm or defecation) (see section "Special warnings and precautions for use").
Gastrointestinal: diarrhea, abdominal cramps, abdominal pain, abdominal discomfort, vomiting, nausea.
Prolonged and excessive use of the drug may lead to loss of fluid, potassium, and other electrolytes. This, in turn, may lead to muscle weakness and impaired cardiac function, especially when the drug is used simultaneously with diuretics or corticosteroids.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
15 ml or 30 ml in a bottle. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 63.
