Universal reference book for medicines
Product name: UNISPAZ ® H (UNISPAZ ® N)

Active substance: drotaverine, paracetamol

Type: Spasmoanalgesic

Manufacturer: UNIQUE PHARMACEUTICAL Laboratories (India) JB Chemicals & Pharmaceuticals (India)
Composition, form of production and packaging
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Tablets 1 tab.
paracetamol 500 mg

drotaverina hydrochloride 40 mg

6 pcs.
- packings of cellular contour (1) - packs cardboard.
6 pcs.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Yunispaz-N is a combined preparation that has analgesic and spasmolytic effects.

Paracetamol, an analgetic-antipyretic, has a weakly expressed anti-inflammatory effect, the mechanism of which is associated with inhibition of the synthesis of prostaglandins in the central nervous system, and to a lesser extent by peripheral action, the blocking of prostaglandins and other active substances that stimulate pain receptors.

Drotaverine is an isoquinoline derivative with spasmolytic effect on smooth muscle (inhibition of the enzyme phosphodiesterase IV, an increase in the concentration of cAMP, which inactivating the enzyme - myosinkinase, results in relaxation of the smooth muscles of blood vessels, gastrointestinal tract, bile ducts and organs of the genitourinary system.

PHARMACOKINETICS

Paracetamol is rapidly absorbed into the upper gastrointestinal tract and distributed to most organs and tissues.
T 1/2 is between 1.25 and 3 hours. It is metabolized predominantly by conjugation and subsequent excretion of metabolites through the kidneys. About 85% of the ingested dose is withdrawn within 24 hours, mainly in the form of glucuronide compounds with a small number of other compounds and drug residues.
Drotaverina hydrochloride is rapidly absorbed after oral administration.
It undergoes biotransformation in the liver to monophenolic compounds, which, in turn, are conjugated to glucuronic acid. T 1/2 is 16-22 hours, while about half the dose is excreted in the urine, and from 10 to 30% with feces.
INDICATIONS

Pain syndrome caused by spasms of smooth muscles:

- Gastrointestinal tract (spastic constipation, irritable bowel syndrome);


- biliary tract (cholelithiasis, cholecystitis, cholangitis);

- urinary tract (urolithiasis, pyelitis, cystitis);

- vessels of the brain (headaches);

- with diseases of female genital organs (dysmenorrhea, adnexitis);

- myalgia, arthralgia, neuralgia, ischialgia;

- toothache.

DOSING MODE

Inside.
The drug is recommended for use on 1-2 tablets. at one time, if necessary, you can repeat the reception after 8 hours.
The maximum daily dose is 6 tab., With a long course, it should not exceed 4 tab. / Day.

To achieve a quick effect, the drug should not be taken with food.

Children aged 6 to 12 years, the drug is prescribed in a single dose of 1 / 2-1 tab.
Repeated use of the drug is possible in 10-12 hours, the maximum dose is 2 tab. / Day.
Older patients with normal liver and kidney function are not required to adjust the dose.

In severe violations of the liver and kidneys, the dose of the drug should be reduced.
At a glomerular filtration rate of less than 10 ml / min, the time passing between taking 2 doses should be more than 12 hours. Only occasional use of the drug is allowed in this category of patients.
The maximum duration of treatment without consulting a doctor is 3 days.

SIDE EFFECT

From the side of the central nervous system: headache, dizziness.

From the cardiovascular system: arterial hypotension, tachycardia, hot flushes.

On the part of the digestive system: nausea, constipation;
rarely (with high doses) - toxic liver damage.
From the hemopoietic system: rarely - agranulocytosis, thrombocytopenia.

Allergic reactions: skin rash;
very rarely - bronchospasm, swelling of the nasal mucosa.
CONTRAINDICATIONS

hypersensitivity to the components of the drug;

- severe renal and hepatic insufficiency;

- severe heart failure;

- AV blockade of I and III degree;

- deficiency of glucose-6-phosphate dehydrogenase;

- chronic alcoholism and drug addiction;

- intracranial hypertension;

- thrombocytopenia, leukopenia, agranulocytosis;

- treatment with MAO inhibitors (within 14 days);

- simultaneous reception of other drugs containing paracetamol;

- Children's age (up to 6 years);

- Pregnancy;

lactation period.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe renal failure.

In severe violations of the liver and kidneys, the dose of the drug should be reduced.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency.

In severe violations of the liver and kidneys, the dose of the drug should be reduced.

APPLICATION FOR CHILDREN

Contraindicated in children under 6 years.

Children aged 6 to 12 years, the drug is prescribed in a single dose of 1 / 2-1 tab. Repeated use of the drug is possible in 10-12 hours, the maximum dose is 2 tablets / day.

APPLICATION IN ELDERLY PATIENTS

With caution appoint the drug to elderly patients.

Older patients with normal liver and kidney function are not required to adjust the dose.

SPECIAL INSTRUCTIONS

If it is necessary to use the drug for more than 3 days, consult a doctor.

With caution appoint the drug to patients with constitutional hyperbilirubinemia (Gilbert's syndrome), patients of advanced age and with arterial hypotension.

When taking the drug is prohibited the consumption of alcoholic beverages.

In renal and hepatic insufficiency, the dose should be set individually.

When using the drug for more than 3 days and / or at high doses, it is necessary to monitor the picture of peripheral blood and the functional state of the liver (the number of leukocytes, platelets, and the level of creatinine and the activity of liver enzymes in the blood).

Clinical and laboratory symptoms of hepatotoxic effect begin to appear within 48-72 hours after taking large doses of the drug.

Impact on the ability to drive vehicles and manage mechanisms

The question of the possibility of engaging in activities requiring an increased concentration of attention and speed of psychomotor reactions should be resolved after assessing the patient's individual response to the drug.

OVERDOSE

Symptoms: pallor of the skin, nausea, vomiting, toxic damage to the liver, until the development of necrosis, increased activity of hepatic transaminases, an increase in prothrombin time.
When overdosing, it is urgent to see a doctor.
Treatment: gastric lavage followed by administration of activated charcoal;
symptomatic therapy, the introduction of methionine and N-acetylcysteine.
DRUG INTERACTION

Drotaverin reduces the action of levodopa (tremor and stiffness may increase).

When paracetamol is used together with drugs that induce the induction of liver enzymes (salicylamide, barbiturates, antiepileptic, tricyclic antidepressants, alcohol, rifampicin), the concentration of toxic metabolites of paracetamol increases.

When applying paracetamol simultaneously with chloramphenicol, the half-life of the latter increases and its toxicity increases.

Simultaneous use of paracetamol with doxirubicin increases the risk of liver function disorders.

Paracetamol reduces the effect of uricosuric drugs.

Metoclopramide and domperidone increase the absorption of paracetamol, and colestyramine decreases it.

With prolonged use of the drug, the risk of bleeding increases due to the presence of paracetamol.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature of no higher than 30 ° C in a dry place.
Keep out of the reach of children! Shelf life - 3 years.
Do not use after the expiry date printed on the package.

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