Unispas N, tablets 12 pcs

Unispas-N is a combined drug with analgesic and antispasmodic effect.

Paracetamol is an analgesic-antipyretic, has a weak anti-inflammatory effect, whose mechanism is related to the 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 with antispasmodic effect on smooth muscles (inhibition of the enzyme phosphodiesterase IV, increased concentration of CAMF, which inactivates the enzyme myosin kinase and leads to relaxation of smooth muscles of vessels, gastrointestinal tract, biliary tract and the genitourinary system.

Pharmacokinetics

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

It is metabolized primarily by conjugation with subsequent excretion of metabolites through the kidneys. About 85% of the dose taken orally is excreted within 24 hours, mainly as glucuronide compounds with small amounts of other compounds and drug residues.

Drotaverine hydrochloride is rapidly absorbed after oral administration.

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

Indications

Menstrual pain (algodysmenorrhea), Colic, Gallic colic, Constipation, Neuritis, Muscle pain (myalgia), Biliary dyskinesia, Colitis, Arthrosis, Myositis, Joint pain (arthralgia), Headache, Myalgia (muscle pain), Toothache, Arthritis

Pain syndrome caused by smooth muscle spasm:

• Gastrointestinal (spastic constipation, irritable colon syndrome);
• Biliary tract (cholelithiasis, cholecystitis, cholangitis);
• biliary tract (urolithiasis, pyelitis, cystitis);
• brain vessels (headaches);
• women’s genital diseases (dysmenorrhea, adnexitis);
• myalgia, arthralgia, neuralgia, ischialgia;
• dental pain.

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Active ingredient

Drotaverine, Paracetamol

Composition

1 tablet contains:

The active ingredients:

Drotaverine hydrochloride…………………….. 40.0 mg

Paracetamol………………………………………… 500 mg

Excipients: corn starch, pregelatinized starch, quinoline yellow dye, sodium carboxymethyl starch, magnesium stearate, talc, microcrystalline cellulose.

How to take, the dosage

Ingestion.

The drug Unispas N is recommended to be used 1 to 2 tablets at a time; if necessary, the dose may be repeated after 8 hours.

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

The drug should not be taken with food to get a quick effect.

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

In elderly patients with normal hepatic and renal function, no adjustment of the drug dose is required.

In patients with severe hepatic and renal impairment the dose of the drug should be reduced. If the glomerular filtration rate is less than 10 ml/minute, the time 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 medical advice is 3 days.

Interaction

When using paracetamol with drugs that cause induction of liver enzymes (salicylamide, barbiturates, antiepileptics, tricyclic antidepressants, alcohol, rifampicin), the concentration of toxic metabolites of paracetamol increases.

In case of concomitant use of paracetamol with chloramphenicol the half-life of the latter increases and its toxicity increases.
Concomitant use of paracetamol with doxyrubicin 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.

Long-term use of the drug increases the risk of bleeding due to the presence of paracetamol.

Special Instructions

If it is necessary to use the drug for more than 3 days, a physician should be consulted.

Patients with constitutional hyperbilirubinemia (Gilbert syndrome), elderly patients and patients with arterial hypotension are prescribed the drug with caution.

When taking the drug it is prohibited to drink alcoholic beverages.

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

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

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

Impact on ability to drive and operate machinery

The possibility of engaging in activities requiring increased concentration and quick psychomotor reactions should be decided after assessing the patient’s individual reaction to the drug.

Contraindications

• Hypersensitivity to components of Unispase N;
• severe renal and hepatic failure;

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• severe heart failure;
• AV blockade of degree I and III;
• deficiency of glucose-6-phosphate dehydrogenase;

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• chronic alcoholism and drug addiction;
• intracranial hypertension;
• thrombocytopenia, leukopenia, agranulocytosis;
• treatment with MAO inhibitors (for 14 days);
• current use of other drugs containing paracetamol.

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Side effects

CNS disorders: headache, dizziness.

Cardiovascular system disorders: arterial hypotension, tachycardia, hot flashes.

Digestive system disorders: nausea, constipation; rarely (in high doses) – toxic liver damage.

Hematopoietic system: rare – agranulocytosis, thrombocytopenia.

Allergic reactions: skin rash; very rare – bronchospasm, nasal mucous membrane edema.

Overdose

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

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

Pregnancy use

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

Similarities

No-Spa