Codeine + Paracetamol - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Opioid narcotic analgesics

Other non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Included in the formulation

Codeine + Paracetamol

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MOSCOW ENDOCRINE FACTORY, FSUE Russia

Kodelmikst®

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Roushan Pharma Co., Ltd. India

АТХ:

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

Pharmacodynamics:

The opioid activity of codeine is due to the transformation into morphine. Weak agonist opioidnyh λ- and φ-receptors (activation of λ-receptors is 3 times stronger than φ): suppression of interneuronal transmission of pain impulses in the afferent ways of the central nervous system, a decrease in the emotional evaluation of pain and reaction to it.

Paracetamol is a non-narcotic analgesic, a derivative of para-aminophenol, an active metabolite of phenacetin. Has analgesic and antipyretic effect. Anti-inflammatory activity is absent. The analgesic effect is associated with the inhibition of cyclooxygenase in the central nervous system.

Pharmacokinetics:

The components of the drug are well absorbed into the digestive tract.

Paracetamol penetrates the blood-brain barrier. Metabolised in the liver. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged.

Codeine slightly binds to plasma proteins. It is subject to biotransformation in the liver (10% by demethylation passes into morphine). It is excreted by the kidneys (5-15% - unchanged).

Indications:

Pain syndrome of mild to moderate severity (migraine, headache and toothache, neuralgia, radicular syndrome, arthralgia, musculoskeletal injuries), symptomatic therapy acute respiratory viral infections.

ICD-10

VI.G40-G47.G43.1 Migraine with aura [classic migraine]

VI.G40-G47.G43.0 Migraine without aura [simple migraine]

VI.G40-G47.G43.9 Migraine, unspecified

VI.G40-G47.G43.8 Another migraine

VI.G40-G47.G43 Migraine

XIII.M50-M54.M54.4 Lumbago with sciatica

XIII.M50-M54.M54.3 Sciatica

XIII.M70-M79.M79.1 Myalgia

XIII.M50-M54.M54.1 Radiculopathy

XIII.M45-M49.M47.2 Other spondylosis with radiculopathy

XIII.M70-M79.M79.2 Neuralgia and neuritis, unspecified

VI.G50-G59.G53.0 * Neuralgia after shingles (B02.2 +)

VI.G50-G59.G50.0 Neuralgia of the trigeminal nerve

XVIII.R50-R69.R52.9 Pain, unspecified

XVIII.R50-R69.R52.2 Another constant pain

XVIII.R50-R69.R51 Headache

XIII.M20-M25.M25.5 Pain in the joint

VI.G40-G47.G44.2 Headache of intense type

VI.G40-G47.G44.1 Vascular headache, not elsewhere classified

Contraindications:

Hypersensitivity, expressed renal / hepatic insufficiency, violation of hemopoiesis, genetically caused deficiency of glucose-6-phosphate dehydrogenase,breathing disorders due to respiratory center depression, pulmonary insufficiency, pregnancy, lactation period, children's age (up to 12 years).

Carefully:

Stomach ulcer and duodenal ulcer (remission stage), elderly age.

Pregnancy and lactation:

The category of FDA recommendations is not defined.

Adequate and well-controlled studies of the components of the drug in humans have not been conducted. Do not apply. The components of the drug penetrate into breast milk. For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Inside, 1-2 tablets every 4 hours, but not more than 8 tablets per day.

As an antipyretic agent - no more than 3 days, and as an analgesic - no more than 5 days.

Side effects:

Nausea, vomiting, pain in the epigastric region. Allergic reactions (skin rash, itching, angioedema), very rarely - anemia, thrombocytopenia, methemoglobinemia and impaired liver and kidney function.

With prolonged use in high doses - the development of drug dependence.

Overdose:

Symptoms: excitement, 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 per day) or with a continuous intake of 3-4 grams per day, liver necrosis and kidney damage occur. In high doses paracetamol is metabolized to N-acetyl-p-benzoquinone, which is the cause of liver damage.

Interaction:

When concomitantly with barbiturates, tricyclic antidepressants, rifampicin, ethanol increases the risk of hepatotoxicity (these combinations should be avoided).

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Special instructions:

It is possible to reduce the concentration and speed of psychomotor reactions, therefore, during the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

With prolonged, uncontrolled use, it is possible to develop addiction (weakening analgesic effect) and drug dependence.

Instructions

Codeine + Paracetamol (Codeinum + Paracetamolum)