Kodelmikst - instructions for use, doses, side effects, contraindications

Active substanceCodeine + ParacetamolCodeine + Paracetamol

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Codeine + Paracetamol

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MOSCOW ENDOCRINE FACTORY, FSUE Russia

Kodelmikst®

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Roushan Pharma Co., Ltd. India

Dosage form: & nbsppills

Composition:

Composition per one tablet:

Active substances:

Codeine phosphate hemihydrate in terms of codeine phosphate - 8 mg;

Paracetamol - 500 mg;

Excipients: pregelatinized starch, corn starch, magnesium stearate, sodium disulphite, povidone K-30.

Description:

White, round, flat tablets with beveled edges and notched on one side.

Pharmacotherapeutic group:Analgesic combined (analgesic opioid + analgesic non-narcotic)

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 the effects of its constituent components.

Paracetamol - non-narcotic analgesic, has analgesic and antipyretic effect. It blocks COX1 and COX2 mainly in the central nervous system, affecting the centers of pain and thermoregulation.In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effect. No blocking effect on synthesis Pg in peripheral tissues determines the absence of a negative effect on water-salt metabolism (delay Na+ and water) and gastrointestinal mucosa.

Codeine has a central antitussive effect (by suppressing the excitability of the cough center), as well as an analgesic effect caused by the excitation of opiate receptors in various parts of the central nervous system and peripheral tissues, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain. To a lesser extent than morphine, depresses breathing, rarely causes miosis, nausea, vomiting and constipation (activation of opioid receptors in the intestine causes relaxation of smooth muscles, decreased peristalsis and spasm of all sphincters). The duration of the analgesic action is -4 hours, the antitussive action is 4-6 hours.

Pharmacokinetics:

Paracetamol well and completely absorbed from the digestive tract. TCmax is achieved after 0.5-2 h;

Cmax - 5-20 mcg / ml. Connection with plasma proteins - 15%. Penetrates through the BBB.Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk.

Therapeutically effective paracetamol concentration in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

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. In the metabolism of the drug is also involved isoenzyme CYP2E1. T1 / 2 1-4 h. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and T1 / 2 increases.

Codeine after oral intake quickly absorbed from the gastrointestinal tract. Connection with plasma proteins - 30%. TSam - after 2-4 hours.

Metabolised in the liver to active metabolites; in the metabolism of the drug takes part isoenzyme CYP2D6. 10% by demethylation is converted into morphine.

It is excreted by the kidneys (5-15% unchanged and 10% in the form of morphine and its metabolites) and with bile. T1 / 2 - 2,5-4 hours.

Indications:

Pain syndrome mild to moderate severity: headache, migraine, myalgia, neuralgia, arthralgia, tuberculosis, dental pain, post-traumatic pain.

Catarrhal diseases, influenza (as an antipyretic and antitussive drugs).

Contraindications:Hypersensitivity to the drug component, expressed renal / hepatic failure, impaired hematopoiesis, genetically caused deficiency of glucose-6-phosphate dehydrogenase, respiratory disorders due to depression of the respiratory center, bronchial asthma, pulmonary insufficiency, cardiac insufficiency, increased intracranial pressure, head injury in history, acute abdominal pain of unclear etiology, risk of functional intestinal obstruction, administration of drugs containing paracetamol, administration of MAO inhibitors within the last 14 days, alcoholism, pregnancy, lactation, children under 12 years.

Carefully:

Hypotension, arrhythmias, cholelithiasis, myasthenia gravis, adrenal gland diseases, prostatic hyperplasia, seizures,drug dependence (including in history), elderly age.

Dosing and Administration:

Inside. Adults and children over 12 years: 1-2 tablets every 4 hours, but not more than 8 tablets per day.

As an antipyretic drug, it is not recommended to take more than 3 days without consulting a doctor, and more than 5 days as an analgesic drug.

Side effects:

Often: drowsiness, constipation.

Less often: skin rash, itching, angioedema and other allergic reactions; nausea, vomiting, dry mouth, epigastric pain, anorexia; sweating, flushing of the face, blurring of vision, doubling, fatigue, headache, dizziness, difficulty breathing, bradycardia / tachycardia, hypotension; convulsions, involuntary muscle contractions or muscle rigidity, hallucinations, nightmares, depression, a feeling of discomfort, a sense of euphoria.

Rarely: anemia, thrombocytopenia, methemoglobinemia, impaired liver and kidney function. With long-term admission Kodelmiksta its effectiveness is reduced. It can also be addictive due to the codeine contained in it. When discontinuing treatment, symptoms of anxiety and irritability may appear.

Overdose:

Symptoms: agitation, nausea, heaviness in the head, insomnia, hypoglycemia, hemolytic anemia, cyanosis, bronchospasm. May accelerate the development of severe respiratory failure. When using paracetamol in high doses (more than 10 g / day) or with a continuous intake of 3-4 g / day, liver necrosis and kidney damage occur. In high doses paracetamol metabolized in N-acetyl-p-benzoquinone, which the is an reason defeat liver.

Treatment: gastric lavage, reception of activated charcoal.

Interaction:

Simultaneous reception with MAO inhibitors causes ataxia, hypotension, paresthesia, accommodation disorder.

Increases the effect of antiaggregants, which can lead to the occurrence of adverse reactions.

Prolonged regular intake of paracetamol strengthens the anticoagulant effect warfarin and other coumarins, which may increase the risk of bleeding; individual doses have no significant effect.

Codeine enhances the effect of ethanol on the psychomotor function. Codeine can slow the absorption of mexiletine and quinidine, thus, reduce its antiarrhythmic effect.

The use of metoclopramide, cisapride or domperidone may increase the rate of absorption of paracetamol. Cholestyramine reduces paracetamol absorption. Drugs that depress the central nervous system, enhance the sedative effect and depressant effect on the respiratory center. Inductors of microsomal oxidation (barbiturates, antiepiletic drugs, rifampicin and ethanol) increase the risk of hepatotoxicity. Oral contraceptives reduce the rate of metabolism of paracetamol by 20-30%.

Special instructions:

Do not take the drug for more than 3 days without a doctor's supervision.

Codeine, contained in the drug Kodelmikst, can be addictive.

Avoid alcohol during treatment with Kodelmikst, since codeine strengthens the action of ethanol.

Avoid joint taking with other drugs containing paracetamol, as well as with expectorants. Do not exceed the recommended dose.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions,as there is a risk of drowsiness.

Form release / dosage:

Pills.

Packaging:For 10 tablets in PVC / aluminum blister. 1 blister with instructions for use in a cardboard package.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

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

Terms of leave from pharmacies:Without recipe

Registration number:LSR-009492/08

Date of registration:27.11.2008

Expiration Date:Unlimited

Date of cancellation:2018-04-12

The owner of the registration certificate:Roushan Pharma Co., Ltd.Roushan Pharma Co., Ltd. India

Manufacturer: & nbsp

RUSAN PHARMA, Ltd. India

Representation: & nbspRoushan Pharma Co., Ltd.Roushan Pharma Co., Ltd.

Information update date: & nbsp12.04.2018

Illustrated instructions

Instructions

Kodelmikst® (Codelmicst®)