Yunispaz® H (Unispaz® H)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDrotaverin + ParacetamolDrotaverin + Paracetamol
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  • Yunispaz® H
    pills inwards 
    Unik Pharmaceutical Laboratories     India
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    Active substances:

    Drotaverina hydrochloride 40.0 mg

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

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

    Description:

    Yellow, oblong tablets with a risk on one side.

    Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic remedy + antispasmodic)
    ATX: & nbsp

    N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

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

    Drotaverine is an isoquinoline derivative that has an antispasmodic effect on smooth muscle (inhibition of the enzyme phosphodiesterase IV, an increase in the concentration of cAMP, which, inactivating the enzyme myosinkinase, leads to a relaxation of smooth muscles). Drotaverine also has a weak inhibitory effect on calmodulin-dependent calcium channels. Regardless of the type of vegetative innervation, drotaverine Effective in spasms of smooth muscles.It acts on smooth muscles, which are in the vascular, gastrointestinal, bile excretory and urogenital systems (the content of phosphodiesterase IV in different tissues is different).

    Paracetamol has an analgesic and antipyretic effect mainly by inhibiting the synthesis of prostaglandinsandnew in the central nervous system. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol, which explains the almost complete absence of anti-inflammatory effect. The absence of a blocking effect on the synthesis of Pg in peripheral tissues causes the absence of paracetamol negative effects on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.
    Pharmacokinetics:

    Paracetamol is rapidly absorbed in the gastrointestinal tract and is distributed to most organs and tissues. Absorption is high, the time to reach the maximum concentration is reached after 0.5-2 h; the maximum concentration is 5-20 μg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk.Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isozyme CYP2E1 also participates in the metabolism of the drug. The half-life is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% - in unchanged form. In elderly patients the clearance of the drug decreases and the half-life Drotaverine when ingested quickly and almost completely absorbed, absorption - high, the half-absorption period - 12 min. Bioavailability is 100%. Evenly distributed in tissues, penetrates smooth muscle cells. Time to reach the maximum concentrationtradio-2 hours. The connection with plasma proteins is 95-98%. The half-life is 1-4 hours. It is mainly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the blood-brain barrier.

    Indications:

    Pain syndrome of mild and moderate intensity (dental and headache, joint pain, muscle, neuralgia, algodismenorea), caused, including spasms of smooth muscles of the internal organs (renal colic, biliary colic, dyskinesia of the biliary tract and gallbladder hyperkinetic type , intestinal colic, spastic constipation, spastic colitis, tenesmus).

    Contraindications:

    Hypersensitivity; severe renal and hepatic insufficiency; severe chronic heart failure (III-IV functional class according to NYHA classification), atrioventricular blockade of II-III degree, cardiogenic shock; respiratory insufficiency, bronchial asthma; chronic alcoholism; blood diseases (thrombocytopenia, leukopenia, agranulocytosis); deficiency of glucose-6-phosphate dehydrogenase; intracranial hypertension; application of other drugs containing paracetamol; treatment with monoamine oxidase inhibitors (and for another 14 days after their withdrawal); pregnancy and lactation; children's age till 6 years.

    Carefully:Carefully prescribe to patients with benign hyperbilirubinemia (Gilbert's syndrome),patients with atrioventricular blockade of the I degree, and also to the elderly.
    Pregnancy and lactation:Pregnancy, Lactation - CONTRAINDICATED
    Dosing and Administration:

    Inside, with a lot of liquid 1-2 hours after eating (taking the drug immediately after eating leads to a delay in the onset of action). For children aged 6 to 12 years, the drug is prescribed in a single dose of 1/2 tablets, repeated use of the drug is possible in 10-12 hours, the maximum dose is 2 tablets per day. For adults and adolescents over 12 years of age, the drug is recommended to use 1 -2 tablets at a time, and if necessary, it can be repeated after 8 hours. With a short (no more than 3 days) course of treatment, the maximum daily dose is 6 tablets, with a longer course of treatment, it should not exceed 4 tablets per day. Older patients with normal liver and kidney function are not required to adjust the dose, in patients with hepatic and / or renal insufficiency, the dose of the drug should be reduced and set individually.

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


    Side effects:

    From the side of the central nervous system (usually develops when taking high doses): dizziness, headache, drowsiness.

    From the cardiovascular system: arterial hypotension, arrhythmia, tachycardia, "hot flashes".

    From the digestive system: nausea, constipation, rarely (with high doses) - toxic liver damage.

    From the hematopoiesis: with prolonged use in large doses - aplastic anemia, agranulocytosis, thrombocytopenia.

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

    Overdose:

    Symptoms caused by overdose of paracetamol: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis.

    Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose - liver failure with progressive encephalopathy, coma; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.Hepatotoxic effect in adults is manifested when taking 10 g or more.

    Treatment: gastric lavage, saline laxatives, administration of SM group donors and glutathione-methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine ​​after 12 hours. The need for additional therapeutic measures (continued methionine administration, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration. If severe damage to the central nervous system may require artificial ventilation, oxygen therapy.

    Interaction:

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

    With the combined use of paracetamol with chloramphenicol, the half-life of chloramphenicol is increased and its toxicity is increased.

    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.The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Inductors of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose. Long-term use of barbiturates reduces the effectiveness of paracetamol. Ethanol promotes the development of acute pancreatitis. Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects. Long-term, joint use of paracetamol and other non-specific anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity. Myelotoxic drugs enhance the manifestation of hematotoxicity of paracetamol.

    Special instructions:The risk of liver damage increases in patients with alcoholic hepatosis. For renal and hepatic insufficiency of mild and moderate severity, the dose should be set individually. When using the drug for more than 3 days and / or high doses, it is necessary to monitor the pattern of peripheral blood (number of leukocytes, thrombocytes) and the functional state of the liver (the activity of "liver" enzymes). Clinical and laboratory symptoms of hepatotoxic effects begin to appear within 48-72 hours after taking large doses of the drug. During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Pills.

    Packaging:6 tablets per blister AL / AL; 1 blister (6 tablets) or 2 blisters (12 tablets) together with instructions for use 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:Without recipe
    Registration number:LSR-000858/10
    Date of registration:10.02.2010
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India
    Information update date: & nbsp08.12.2015
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