Pikodinar drops vn.pr. 7.5mg / ml 30ml vial

Description

Composition
Active substance:
1 ml of the preparation contains:
Monohydrate Sodium picosulfate 7.5 mg.
Excipients:
Sorbitol liquid (non-crystallizing) 643.7 mg Sodium benzoate 2.0 mg, Sodium citrate dihydrate 1.5 mg Citric acid anhydrous 1.28 mg, 10 M sodium hydroxide solution to pH 4.5-7.5, Water for injection to 1.0 ml.
Description:
Transparent slightly viscous, colorless or slightly colored liquid.
Product form:
Drops for oral administration of 7.5 mg / ml.
15 or 30 ml in a vial with a dropper of low density polyethylene and the lid from the first control opening.
1 bottle together with instructions for use in a stack of cardboard.
Contraindications
Ileus or obstructive bowel disease; acute abdominal disease or severe abdominal pain, which may be accompanied by nausea, vomiting, fever, including appendicitis; acute inflammatory bowel disease; Hypersensitivity to sodium picosulphate or other components of the formulation; severe dehydration; fructose intolerance; pregnancy (I term).
Carefully
Used with care for older people, with hypokalemia, increasing magnesium concentration in the blood, in patients with asthenia.
Use of the drug in patients with renal insufficiency, severe only under medical supervision.
Dosage
7.5 mg / ml
Indications
As a laxative in the following cases: constipation due to atony and hypotonia of the colon (including the elderly, in bedridden patients, after surgery, after childbirth and lactation); constipation caused by the intake of drugs; for regulation of the chair with hemorrhoids, proctitis, anal fissures (for softening feces consistency); gallbladder disease, irritable bowel syndrome with constipation-predominant; constipation caused by intestinal dysbiosis, diet violations.
Interaction with other drugs
Diuretics and steroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug. Electrolyte imbalance may increase susceptibility to cardiac glycosides. The combined use of the drug and antibiotics may reduce the laxative effect of the drug.
Overdose
Symptoms high doses are possible: diarrhea, dehydration, reduction of blood pressure, disturbance of water-electrolyte balance, hypokalemia, convulsions. In addition, there are reports of cases of ischemic colon musculature associated with taking doses significantly higher than recommended for the routine treatment of constipation.
Pikodinar as other laxative in chronic overdose may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. Due to the chronic abuse of laxatives can develop damage to the kidney tubules, metabolic alkalosis and muscle weakness associated with hypokalemia.
Treatment: to reduce the absorption of the drug after ingestion can cause vomiting or to gastric lavage. May need fluid replacement and correction of electrolyte balance as well as the appointment of antispasmodics.
pharmachologic effect
Pharmacological group:
Laxative. ATC code: A06AV08.
Pharmacodynamics:
The active ingredient – sodium picosulfate is a laxative triarylmethane groups. As local laxative, sodium picosulphate after bacterial cleavage in the colon has a stimulating effect on the mucosa of colon, increasing motility, promotes accumulation of water and electrolytes into the colon. This leads to the stimulation of defecation, reduction of evacuation time and softening stool. Sodium picosulphate being a laxative, acting at the level of the colon, it stimulates the natural process of evacuation of the contents of the lower gastrointestinal tract. Therefore, picosulfate sodium has no effect on the digestion or absorption of food or calorie essential nutrients in the small intestine.
Pharmacokinetics:
Absorption: insignificant, the drug is almost completely metabolized in the intestinal wall and liver to inactive glucuronide. After oral administration of sodium picosulfate enters the large intestine; absorption of the drug is low, which excludes its enterohepatic circulation. The distal large intestine occurs sodium picosulphate cleavage to form the active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane. Time development of a laxative effect of the drug is determined by the release rate of the active metabolite and is 6-12 hours. In the systemic circulation enters a small portion of the drug. The relationship between the laxative effect of the active metabolite and its concentration in serum is absent. Upon receiving the 10 mg dose inwardly about 10.4% of the total dose is excreted by the kidneys as glucuronide after 48 hours. In the application of higher doses its excretion by the kidneys generally decreases.
Pregnancy and breast-feeding
Data on the reliable and well-controlled studies in pregnant women are missing. Long experience with did not reveal the negative impact of the drug on pregnancy. Acceptance of the drug in the I trimester of pregnancy is contraindicated. In II and III trimesters of pregnancy (as with other laxatives) taking the drug can only be prescribed by a doctor. The active metabolite and its glucuronide is not excreted in breast milk. Thus, the drug can be used during breastfeeding.
Conditions of supply of pharmacies
Without a prescription.
side effects
By briefly taking the drug side effects are rare. Possible side effects are ranked according to frequency of occurrence as follows: Very often (> 1/10), often (> 1/100, 1/1000, 1/10000,
With prolonged use of the drug in significantly higher doses, the following disorders: Skin and subcutaneous tissue frequency is unknown: skin rash, hives, itching; by metabolism and power frequency is unknown: increased excretion of potassium, sodium and other electrolytes, may develop dehydration; on the part of the gastrointestinal tract is very common: diarrhea; common: dyspepsia, cramping and abdominal pain, bloating; uncommon: vomiting, nausea; frequency is unknown: pain in the stomach and the anus, increased intestinal motility, which are smaller doses of the drug; by the immune system frequency is unknown: allergic reactions, angioedema, atopic dermatitis; the nervous system Uncommon: dizziness; Frequency unknown: headache, fatigue, drowsiness, convulsions, fainting.
special instructions
As with other laxatives, Pikodinar drug should not be taken daily without consulting a doctor for more than 10 days. If necessary daily intake of laxatives should find out the cause of constipation.
Prolonged use of laxatives can lead to disruption of fluid and electrolyte balance and hypokalemia, and cause “addiction” and constipation due to the effect of “bounce”. Pikodinar be taken under medical supervision for conditions associated with impaired water and electrolyte balance (e.g., in severe renal dysfunction). Reported cases of dizziness and / or fainting, which coincides in time with the use of sodium picosulfate. Analysis of cases showed that these states are associated with defecation syncope (fainting or induced voltage during defecation) or associated with vasovagal reaction to abdominal pain, which can be caused by constipation and is not necessarily associated with administration of the drug.
Pikodinar effective in eliminating constipation in cancer patients receiving high doses of opioids.
Studies on the effect of the drug have not been conducted on fertility. In preclinical studies of teratogenic effects on fertility were observed. The drug contains sorbitol, therefore patients with rare hereditary fructose intolerance it is not recommended to take. The drug has no taste, so it can be added for children to eat. Children should take the medication only on doctor’s prescription.
Effects on ability to drive vehicles and mechanisms:
Special clinical studies of the effect of the drug on the ability to drive and work not carried out with other mechanisms. Despite that patients should be warned about the possibility of development due to a vasovagal reaction (particularly abdominal spasm) of such side reactions as dizziness and / or syncope. In the case of abdominal cramps patient should avoid potentially hazardous activities such as operating a vehicle or working with other mechanisms.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Inside.
We recommend the following dosing regimen:
Adults and children over 10 years: 10-20 drops (5-10 mg) per day.
Children 4-10 years: 5-10 drops (2.5-5 mg) per day.
It is recommended to start with the lowest dose. In order to achieve a regular chair, the dose may be increased to the maximum recommended. Do not exceed the maximum recommended daily dose.
The recommended dose for children under 4 years of 0.25 mg / kg body weight per day. This corresponds to 1 drop of the preparation (0.5 mg of sodium picosulfate) 2 kg of body weight per day.
For a laxative effect in the morning should take the drug on the eve of the night.
During the application of the vial should be held vertically.
The drug is not necessarily dissolved in the liquid.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist