Drotaverine, Paracetamol

Brand Yunik Pharmaceutical

In stock 767 Items

Available since: 2019-09-19

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Clinical Pharmacology

Unispaz-N has an analgesic and antispasmodic effect.

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

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

Indications

Pain syndrome caused by smooth muscle spasms:

GIT (spastic constipation, irritable bowel syndrome);
biliary tract (cholelithiasis, cholecystitis, cholangitis);
urinary tract infections (urolithiasis, pielitis, cystitis);
cerebral vessels (headaches);
with diseases of the female genital organs (dysmenorrhea, adnexitis);
myalgia, arthralgia, neuralgia, sciatica;
toothache.

Composition

1 tablet contains:
active ingredients: paracetamol 500 mg, drotaverine hydrochloride 40 mg

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Dosage and Administration

Inside The drug is recommended for use on 1-2 tab. 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.

Elderly patients with normal liver and kidney function do not require dose adjustment.

In severe impaired liver and kidney function, the dose of the drug should be reduced.

With a glomerular filtration rate of less than 10 ml / min, the time 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.

Adverse reactions

When using the recommended therapeutic doses, side effects are rare.

The following undesirable effects are presented by organ systems in accordance with the following gradation of the frequency of their occurrence: very often ≥10%; often - ≥1– <10%; infrequently - ≥0.1– <1%; rarely - ≥0.01–0.1%; very rarely - <0.01%.

From the skin and subcutaneous fat: Hypersensitivity reactions (rash, hyperemia) may occur in persons with hypersensitivity.

From the CCC: rarely - decreased blood pressure, palpitations.

From the nervous system: rarely - headache, dizziness, drowsiness.

From the digestive tract: rarely - nausea, constipation, pancreatitis (due to the content in the composition of the drug codeine).

From the hematopoietic system and lymphatic system: rarely - blood disorders (agranulocytosis, thrombocytopenia).

On the part of the immune system: very rarely - systemic allergic reactions, bronchospasm, hay fever, swelling of the nasal mucosa.

Liver and biliary tract: when taking the drug in high doses, especially for a long time, toxic liver damage is possible, and when taking the drug in very high doses (exceeding the recommended doses), life-threatening liver damage (irreversible hepatic tissue necrosis) can develop.

From the urinary system: long-term intake in high doses may reduce renal function.

Contraindications

hypersensitivity to the drug;
intracranial hypertension;
thrombocytopenia, leukopenia, agranulocytosis;
treatment with MAO inhibitors (for 14 days);
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;
simultaneous use of other drugs containing paracetamol;
children's age (up to 6 years).

Drug interactions

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

When paracetamol is used simultaneously with chloramphenicol, the half-life of the latter increases and its toxicity increases.
The simultaneous use of paracetamol with doxirubicin increases the risk of liver dysfunction.

Paracetamol reduces the effect of uricosuric drugs.

Metoclopramide and domperidone increase the absorption of paracetamol, and Kolestiramine reduces it.

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

Pregnancy and Lactation

Contraindicated in pregnancy and lactation.

Special instructions

When using the drug for more than 3 days and / or in high doses, control of the pattern of peripheral blood and the functional state of the liver (the number of leukocytes, platelets, as well as the creatinine level and activity of liver enzymes in the blood) is necessary.

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

Overdosage

In case of an overdose of drotaverine, a violation of atrioventricular conduction is possible, a decrease in the excitability of the heart muscle, cardiac arrest and paralysis of the respiratory center are possible.

Treatment: recommended gastric lavage and the appointment of saline laxatives. Treatment should be aimed at maintaining the vital functions of the body, in case of respiratory depression may require artificial respiration, oxygen inhalation, naloxone, and for signs of liver damage, use of the antidote paracetamol (acetylcysteine) and glutathione precursor (methionine).