Unispaz® (Unispaz® )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDrotaverin + Codeine + ParacetamolDrotaverin + Codeine + Paracetamol
Dosage form: & nbsppills
Composition:

1 tablet contains:

Active substances:

Paracetamol......................... 500 mg

Drotaverina hydrochloride ...... 40.0 mg

Codeine phosphate.................... 8,0 mg

Excipients:

Corn starch....45.0 mg; Povidone; Corn starch pregelatinized.....50.0 mg; Magnesium stearate; Talcum purified; Crospovidone; Cellulose microcrystalline..20.0 mg; Dye: iron oxide red.................. 2.0 mg

Description:

Oblong tablets are brownish-pink in color with dark and light impregnations and risk on one side.

Pharmacotherapeutic group:Analgesic agent (analgesic non-narcotic agent + analgesic opioid + antispasmodic).
ATX: & nbsp

N.02.B.E   Anilides

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components.

Paracetamol has an analgesic and antipyretic effect mainly by inhibiting 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 - an isoquinoline derivative with spasmolytic effect on smooth muscle (inhibition of the phosphodiesterase IV enzyme, an increase in the concentration of cAMP, which inactivating the enzyme - myosinkinase, results in relaxation of smooth muscle). Drotaverine also has a weak inhibitory effect on calmodulin-dependent calcium channels. Regardless of the type of autonomic innervation, drotaverine Effective in spasms of smooth muscles. It acts on smooth muscles, which are in the vascular, gastrointestinal, biliary and urogenital systems (the content of phosphodiesterase IV in different tissues is different). Codeine is an antitussive drug of central action, which also has an anesthetic effect by interacting with opiate receptors involved in the transmission of painful impulses to the central nervous system. It has its own analgesic effect and potentiates the action of paracetamol.

Pharmacokinetics:

Paracetamol is rapidly absorbed in the gastrointestinal tract and is distributed to most organs and tissues. The half-life is between 1.25 and 3 hours. Metabolized mainly by conjugation with the subsequent excretion of metabolites through the kidneys. About 85 % taken inside the dose is withdrawn within 24 hours. Codeine quickly absorbed in the gastrointestinal tract, distributed to most organs and tissues, mainly - to the parenchymal organs (liver, spleen, kidneys). Penetrates through the blood-brain barrier, the placenta, is distributed into breast milk. The half-life of codeine is about 2.9 hours. It is excreted mainly by the kidneys. Approximately 90% of the dose taken internally is excreted within 24 hours.

Indications:

Pain syndrome of mild and moderate intensity: (dental and headache, joint pain, muscle, neuralgia, sciatica, periodic pain in women), including, and spasms of smooth muscles (renal colic, spasms of the ureter and bladder, bilious colic, intestinal colic, spastic constipation and other spastic conditions of internal organs).

Contraindications:

Hypersensitivity, severe renal and hepatic insufficiency, severe heart failure, atrioventricular blockade of P-S st., Respiratory insufficiency, bronchial asthma, glucose-6-phosphate dehydrogenase deficiency, chronic alcoholism and drug addiction, condition after craniocerebral trauma, intracranial hypertension, blood diseases (thrombocytopenia, leukopenia, agranulocytosis), treatment with MAO inhibitors (for 14 days), simultaneous application of other drugs containing paracetamol; children's age (up to 6 years), pregnancy and lactation.

Carefully:FROM caution prescribe the drug to patients with constitutional hyperbilirubinemia (Gilbert's syndrome) and elderly patients.
Pregnancy and lactation:contraindicated
Dosing and Administration:

Inside. The drug is recommended to use 1-2 tablets at a time, if necessary, you can repeat the procedure after 8 hours. With a short (not more than 3 days) course of treatment, the maximum daily dose is 6 tablets, with a long course it should not exceed 4 tablets per day. To achieve a quick effect, the drug should not be taken with food.

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

Side effects:

From the side of the nervous system, headache, dizziness, drowsiness.

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

From the gastrointestinal tract: nausea, constipation, rarely (with

application of high doses) - toxic liver damage.

On the part of the hematopoiesis system: agranulocytosis, thrombocytopenia. Allergic reactions: skin rash, very rarely - bronchospasm, swelling of the nasal mucosa.

Overdose:

Symptoms include nausea, vomiting, poor circulation and respiratory depression, liver toxicity, until the development of necrosis.

Treatment: gastric lavage, saline laxatives. In severe damage to the CNS for status monitoring may be required assisted ventilation of the lungs and the oxygen supply, and naloxone.

Interaction:

Drotaverin reduces the action of levodopa (tremor and stiffness may increase). When using paracetamol 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 absorption of paracetamol, and colestramine it reduces.With prolonged use of the drug, the risk of bleeding increases due to the presence of paracetamol.

Codeine enhances the effect of sleeping pills, analgesic and sedatives.

Special instructions:

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 high doses, control of 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 "hepatic" enzymes in the blood) is necessary. Clinical and laboratory symptoms of the hepatotoxic effect begin to appear within 48 to 72 hours after taking large doses of the drug.

Effect on the ability to drive transp. cf. and fur: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.
Form release / dosage:

Pills.

Packaging:

6 tablets in a blister AL / AL; 2 blisters (12 tablets) with instructions for use are placed in a cardboard box.

Storage conditions:

Store in a dry place at a temperature not exceeding 30 ° C.

Keep out of the reach of children

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:LSR-003584/07
Date of registration:06.11.2007
The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
Manufacturer: & nbsp
Information update date: & nbsp14.08.2012
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