Moviprep - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspPowder for solution for oral administration

Composition:

Sasha A:

active ingredients: macrogol-3350 100.00 g, sodium sulfate 7,500 g, sodium chloride 2,691 g, potassium chloride 1,015 g;

Excipients: aspartame (E951) 0.233 g, acesulfame potassium 0,117 g, lemon flavor V3938-1 N1 0.340 g.

Sasha B:

active ingredients: ascorbic acid 4,700 g, sodium ascorbate 5,900 g.

Description:

Sasha A: Powder from white to yellow, with a characteristic smell of lemon.

Sasha B: Powder from white to light brown in color.

Pharmacotherapeutic group:cradle

ATX: & nbsp

Macrogol in combination with other drugs

Pharmacodynamics:

Oral administration of a solution of electrolytes based on macrogol, causes mild diarrhea, which results in rapid emptying of the contents of the colon.

Macrogol-3350, sodium sulfate and ascorbic acid have an osmotic effect that causes a laxative effect.

Macrogol-3350 increases the volume of feces, which leads to an increase in the intestinal peristalsis.

Electrolytes that are part of the drug, as well as additional fluid intake prevent the violation of the water-electrolyte balance.

Pharmacokinetics:

Macrogol-3350 does not change while being in the intestine. It is practically not absorbed from the gastrointestinal tract.The absorbed amount of macrogol-3350 is excreted through the kidneys.

Acid ascorbic is absorbed mainly in the small intestine by active sodium-dependent saturable transport. There is an inverse relationship between the dose received and the absorbed dose percentage. When administered orally at a dose of 30 to 180 mg, about 70-80% of this dose is absorbed. At the subsequent oral intake of ascorbic acid in a volume of up to 12 g, only 2 g is absorbed. After oral administration of large doses of ascorbic acid and in case of exceeding its concentration in plasma, 14 mg / l absorbed ascorbic acid is excreted mainly unchanged through the kidneys.

Indications:

Preparation for diagnostic studies (endoscopic, radiologic and other studies of the intestine) and surgical interventions requiring bowel movement.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- violation of gastric emptying (gastroparesis);

- intestinal obstruction;

- perforation or perforation risk of the gastrointestinal tract;

- phenylketonuria (due to the content of aspartame);

- deficiency of glucose-6-phosphate dehydrogenase (due to the content of ascorbic acid);

- severe inflammatory bowel disease or toxic megacolon, which is a complication of pronounced inflammatory processes in the intestine, including Crohn's disease and ulcerative colitis;

- age to 18 years;

- unconsciousness.

Carefully:

- Violated gag reflex, tendency to aspiration or belching;

- impaired consciousness;

- dehydration;

- severe heart failure (III-IV functional class by classification NYHA);

- severe renal failure (creatinine clearance <30 mL / min);

- severe acute inflammatory diseases;

- abdominal pain of unclear etiology.

If you have any of these diseases, consult a doctor before taking MOVIPREP®.

Pregnancy and lactation:

Experience of application of MOVIPREP® during pregnancy and during breastfeeding is limited.

The drug MOVIPREP® should be used only if the intended benefit to the mother exceeds the potential risk to the fetus or child (consultation with the doctor is necessary).

Dosing and Administration:

Inside.

To prepare one liter of the drug solution, the contents of one sachet A and one sachet B must be dissolved in a small amount of water, then bring the volume of the solution to one liter with water.

To prepare the second liter of the drug solution, the contents are leftwtheir second sachet A and the second sachet B to dissolve in a small amount of water, then bring the volume of the solution to one liter with water.

The total dose is two liters of MOVIPREP solution®.

The solution can be taken once (two liters in the evening or two liters in the morning on the eve of the study) or divided into two doses (one liter the night before and one liter in the morning).

Before surgery, take once two liters of the drug solution the night before. The prepared solution should be drunk within 1-2 hours.

During the course of preparation, it is strongly recommended to use one liter of another liquidwater, broth, fruit juice without pulp, soft drinks, tea, coffee without milk). The drug and other fluids should be discontinued 1-2 hours before the procedure. Do not eat solid foods since the beginning of taking MOVIPREP® andbefore the end of the clinical procedure.

Side effects:

Diarrhea is an expected effect in the preparation of the intestine. Due to the nature of the effect of the drug during preparation of the intestine for the procedure, undesirable effects are recorded in most patients. Despite some differences in specific cases, the most common side effects are: nausea, vomiting, bloating, abdominal pain, irritation in the anus and sleep disorders.

As with the reception of other products, which include macrogol, various allergic reactions are possible, including rashes, hives, itching, Quincke's edema and anaphylactic shock.

Side effects are classified according to the frequency of occurrence:

Very Frequent: ≥1/10

Frequent: ≥1/100, <1/10

Infrequent: ≥1/1000, <1/100

Rare: ≥1/10000, <1/1000

Very rare: <1/10000

It is not known (it is impossible to estimate on the basis of the received data).

Immune system disorders:

Unknown: anaphylactic shock.

Disorders of the psyche:

Frequent: sleep disorders.

Impaired nervous system:

Frequent: dizziness, headache;

Unknown: convulsions associated with acute hyponatraemia.

Disorders from the cardiovascular system:

Unknown: short-term increase in blood pressure.

Disorders from the gastrointestinal tract:

Very Frequent: abdominal pain, nausea, bloating, irritation in the anus;

Frequent: vomiting, indigestion;

Rare: difficulty swallowing;

Unknown: flatulence, the urge to vomit.

Disorders from the liver and bile ducts:

Infrequent: deviation of functional liver samples.

Disturbances from the skin and subcutaneous tissues:

Unknown: itching, hives, rash.

General disorders:

Very Frequent: malaise;

Frequent: chills, thirst, hunger;

Infrequent: discomfort.

Laboratory research:

Unknown: changes in the content of electrolytes, including a decrease in bicarbonate in the blood, hyper- and hypocalcemia, hypophosphatemia, hypokalemia and hyponatremia (more common in patients using concomitant therapy that affects the kidneys, such as ACE inhibitors or diuretics) and changes in the chloride content in the blood.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: severe diarrhea, which can lead to a disturbance of the water-electrolyte balance.

Treatment: it is usually sufficient to consume a large amount of liquid, preferably fruit juices. If necessary, intravenous infusion solutions to restore the water-electrolyte balance.

Interaction:

Diarrhea caused by taking MOVIPREP®, can lead to a violation of absorption of other concurrently taken drugs. Drugs taken orally within one hour prior to the onset of laxative action of the drug (eg, oral contraceptives) are removed from the digestive tract without being absorbed.

Special instructions:

Older patients, weakened or depleted patients with various concomitant diseases, patients prone to aspiration or belching, with impaired consciousness, especially if the drug is injected through a nasogastric tube, the drug should be administered under medical supervision.

Effect on the ability to drive transp. cf. and fur:

During the course of preparation for medical manipulations with the drug MOVIPREP® it is recommended to refrain from managing vehicles and other mechanisms (see para.section "Side effect").

Form release / dosage:

Powder for solution for oral administration.

Packaging:

By 111.896 g of the drug in a laminated sachet A.

For 10,600 g of the drug in a laminated sachet B.

One sachet A and a sachet B in a plastic bag. Two bags are placed in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Store the reconstituted solution at a temperature not exceeding 8 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

The reconstituted solution is 24 hours.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002630

Date of registration:22.09.2014

Date of cancellation:2019-09-22

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp30.01.2016

Illustrated instructions

Instructions

Moviprep® (Moviprep®)