Unispaz N, pills, 12pcs

Composition

1 tablet contains:

active ingredients:

paracetamol 500 mg,

drotaverine hydrochloride 40 mg

Pharmacological action

Unispaz-N is a combined drug that has analgesic and antispasmodic effects.

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

Drotaverine is an isoquinoline derivative that has an antispasmodic effect on smooth muscles (inhibition of the enzyme phosphodiesterase IV, an increase in the concentration of cAMP, which inactivates the enzyme myosine kinase, leading to relaxation of the smooth muscles of blood vessels, gastrointestinal tract, biliary tract and genitourinary system.

Pharmacokinetics

Paracetamol is rapidly absorbed in the upper gastrointestinal tract and distributed to most organs and tissues. T1 / 2 is between 1.25 and 3 hours.

It is mainly metabolized by conjugation followed by excretion of metabolites through the kidneys. About 85% of the oral dose is eliminated within 24 hours, mainly in the form of glucuronide compounds with a small amount of other compounds and drug residues.

Drotaverine hydrochloride is rapidly absorbed after oral use.

It undergoes biotransformation in the liver to monophenolic compounds, which, in turn, are conjugated with glucuronic acid. T1 / 2 is 16-22 hours, while about half of the dose is excreted in the urine, with feces – from 10 to 30%.

Indications

Pain syndrome caused by smooth muscle spasms:

• Gastrointestinal tract (spastic constipation, irritable bowel syndrome);
• biliary tract (cholelithiasis, cholecystitis, cholangitis);
• urinary tract (urolithiasis, pyelitis, cystitis);
• brain vessels (headaches);
• in diseases of the female genital organs (dysmenorrhea, adnexitis);
• myalgia, arthralgia, neuralgia, sciatica;
• toothache.

Use during pregnancy and lactation

The drug is contraindicated in children under 6 years of age, during pregnancy and lactation.

Contraindications

• hypersensitivity to the drug Urispas N;
• severe renal and hepatic impairment;
• severe heart failure;
• AV-block I and III degree;
• deficiency of glucose-6-phosphate dehydrogenase;
• chronic alcoholism and drug addiction;
• intracranial hypertension;
• anemia, leukopenia, agranulocytosis;
• treatment with MAO inhibitors (within 14 days);
• simultaneous reception of other medicines containing paracetamol.

Side effects

From the central nervous system:  headache, dizziness.

From the cardiovascular system: hypotension, tachycardia, hot flashes.

From the digestive system:  nausea, constipation; rarely (at high doses) – toxic liver damage.

From the hematopoietic system:  rarely-agranulocytosis, thrombocytopenia.

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

Interaction

Drotaverine reduces the effect of levodopa (tremor and rigidity may increase). When using paracetamol together with drugs that cause the induction of liver enzymes (salicylamide, barbiturates, antiepileptic, tricyclic antidepressants, alcohol, rifampicin), the concentration of toxic metabolites of paracetamol increases.

When using paracetamol simultaneously with chloramphenicol, the half-life of the latter increases and its toxicity increases. Concomitant use of paracetamol with doxyrubicin increases the risk of developing liver function disorders.

Paracetamol reduces the effect of uricosuric drugs.

Metoclopramide and domperidone enhance the absorption of paracetamol, while colestyramine reduces it.

Prolonged use of the drug increases the risk of bleeding due to the presence of paracetamol.

How to take, course of use and dosage

Inside.

The drug Unispaz H is recommended to be used 1-2 tablets at a time, if necessary, you can repeat the reception after 8 hours.

The maximum daily dose is 6 tablets, with a long course it should not exceed 4 tablets per day.

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

For children aged 6-12 years, the drug is prescribed in a single dose of 1/2-1 tablet. Repeated use of the drug is possible after 10-12 hours, the maximum dose is 2 tablets per day.

Elderly patients with normal liver and kidney function do not need to adjust the dose of the drug.

In case of severe liver and kidney dysfunction, the dose of the drug should be reduced. If the glomerular filtration rate is less than 10 ml / min, the time elapsing between 2 doses should be more than 12 hours. In this category of patients, only occasional use of the drug is allowed.

The maximum duration of treatment without consulting a doctor is 3 days.

Overdose

Symptoms: pallor of the skin, nausea, vomiting, toxic liver damage, up to the development of necrosis, increased activity of hepatic transaminases, increased prothrombin time. In case of overdose, immediately consult a doctor.

Treatment: gastric lavage followed by use of activated charcoal; symptomatic therapy, use of methionine and N-acetylcysteine.

Special instructions

If you need to use the drug for more than 3 days, you should consult your doctor.

With caution, the drug is prescribed to patients with constitutional hyperbilirubinemia (Gilbert’s syndrome), elderly patients and with arterial hypotension.

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

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

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

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

Influence on the ability to drive motor vehicles and manage mechanisms

The question of the possibility of engaging in activities that require increased concentration of attention and speed of psychomotor reactions should be decided after evaluating the individual patient’s response to the drug.

Form of production

Tablets

Storage conditions

In a dry place, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Drotaverine, Paracetamol

Dosage form

Tablets

Description

Children over 6 years of age, For adults, Children as prescribed by a doctor

Indications

Myositis, Gastrointestinal Spasm, Osteoarthritis, Colitis, Constipation, Arthritis, Neuritis, Biliary Dyskinesia