Caffetine Cald N10 coated pills
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Active ingredients
Dextromethorphan + Paracetamol + Pseudoephedrine
Release form
Pills
Composition
Paracetamol granules (Paracetamol 90%, starch pregelatinized 8.4%, Povidone-K30 0.6%, stearic acid 1%) 555.5 mg,; which corresponds to the content of paracetamol 500 mg; dextromethorphan hydrobromide 15 mg; pseudoephedrine hydrochloride 30 mg; ascorbic acid 30 mg; 30%; 97%, hypromellose 3%) 62 mg, which corresponds to the content of ascorbic acid 60 mg
Pharmacological effect
Paracetamol has analgesic and antipyretic effects. In the central nervous system, it blocks cyclooxygenase by acting on the centers of pain and thermoregulation. Unlike nonsteroidal anti-inflammatory drugs, paracetamol has virtually no anti-inflammatory effect. Does not cause irritation of the mucous membrane of the stomach and intestines. No effect on water-salt metabolism, because it does not affect the synthesis of prostaglandins in peripheral tissues.; Pseudoephedrine helps to narrow the vessels of the nasal mucosa and pharynx, reduces puffiness, which leads to a decrease in secretion in the nasal cavity and facilitate nasal breathing.; Dextromethorphan acts on cough center and increases the cough threshold, which leads to a decrease in dry cough associated with irritation of the mucous membrane of the nasopharynx in most "colds" diseases. Ascorbic acid niva deficiency of vitamin C with "cold" diseases.
Pharmacokinetics
Paracetamol absorption occurs mainly in the small intestine and the maximum concentration in the blood plasma is usually reached in 0.5-1.5 hours after ingestion. The half-life of paracetamol from blood plasma is 1.5-2.5 hours. Metabolized in the liver (90-95%): 80% reacts conjugation 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 the hepatocytes and cause their necrosis. The metabolism of the drug is also involved CYP2E1 isoenzyme, T1 / 2 - 1-4 hoursExcreted by the kidneys as metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of pre-airata decreases and T1 / 2 increases.; Pseudoephedrine is well absorbed after ingestion, the maximum concentration in the blood plasma is reached in 1.5-2 hours. The half-life from blood plasma is approximately 5.5 hours. Pseudoephedrine is partially metabolized in liver with the formation of the active metabolite and excreted in the urine. Dextromethorphan is well absorbed after ingestion and the maximum concentration in the blood plasma is usually achieved 2 hours after the dose. Dextromethorphan is metabolized in the liver and excreted in the urine unchanged and in the form of metabolites. Ascorbic acid is completely absorbed in the gastrointestinal tract and is well distributed in the tissues of the body. Ascorbic acid is reversibly oxidized to dehydroxyascorbic acid, and partially metabolized to ascorbate 2-sulfate; excreted in the urine.
Indications
- symptomatic treatment of colds and flu (headache, muscle pain, sore throat, fever, dry cough, runny nose, nasal congestion and paranasal sinuses).
Contraindications
- hypersensitivity to the drug or any of its components; - arterial hypertension, ischemic heart disease (coronary heart disease), angina pectoris; - severe violations of the liver or kidneys, hepatitis; - simultaneous use of MAO inhibitors (monoamine oxidase), antidepressants, anti-parky drugs; - the use of MAO inhibitors (monoamine oxidase) in the previous two weeks before starting the drug; - congenital deficiency of glucose-6-phosphate dehydrogenase; - children's age up to 12 years; - pregnancy, lactation period.; With care: benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholism, arrhythmias, prostatic hyperplasia with urinary retention, diabetes mellitus, hyperthyroidism, bronchial asthma, COPD (chronic spermatic lung disease ), debilitated and emaciated patients.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Dosage and administration
The recommended dose of Cuffetin; Calde for adults and children over 12 years old is one tablet 4 times a day. You can take 2 pills at once. The interval between doses should be at least 4 hours. The maximum single dose is 2 pills and the maximum daily dose is 2 pills 4 times within 24 hours. If the fever persists for more than 3 days from the start of treatment, and cough more than 5 days, should see a doctor.
Side effects
On the part of the digestive system: nausea, dry mouth, rarely epigastric pain; with long-term use in large doses - hepatotoxicity. From the side of the central nervous system: drowsiness, irritability, agitation, rarely - dizziness.; Allergic reactions: skin rash, pruritus urticaria, angioedema; From the side of the cardiovascular system: increased blood pressure, tachycardia.; From the side of hematopoietic organs: rarely - anemia, thrombocytopenia, agranulocytosis, with long-term use in large doses - hemolytic anemia, aplastic anemia, pancytopenia.; From the urinary system: Call duration use at high doses, nephrotoxicity (renal colic, interstitsnalny nephritis, papillary necrosis).
Overdose
Symptoms Pseudoephedrine - irritability, anxiety, tremor, convulsions, arrhythmias, arterial hypertension. Paracetamol (especially in patients with renal dysfunction of the liver) - pale skin, anorexia, nausea, vomiting, abnormal liver function.; Dextromethorphan - nausea, vomiting, dizziness, drowsiness, blurred vision, lethargy, incoordination, difficulty breathing.; Treatment. Gastric lavage in the first 6 hours, followed by the appointment of activated carbon, simtomaticheskaya therapy, the introduction of donators of SH-groups and precursors of the synthesis of glutathione-methionine 8-9 hours after overdose and acetylcysteine - 12 hours.
Interaction with other drugs
The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs.; Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) and hepatotoxic drugs increase the production of hydroxylated active metabolites.which makes it possible to develop severe intoxication even with a small dose.; Long-term use of barbiturates reduces the effectiveness of paracetamol.; Simultaneous long-term administration of paracetamol in high vines and salicylates increases the risk of developing kidney and bladder cancer. Prolonged use of paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of "analgesic" nephropathy and renal papillary necrosis, accelerates the onset of end-stage renal failure.; Diflunisal increases the plasma concentration of paracetamol by 50%, thereby increasing the risk of developing hepatotoxicity. the use of pseudoephedrine with other sympathomimetic drugs possible additive action and the development of toxic effects who in; with monoamine oxidase inhibitors - a hypertensive crisis may develop (the drug can be used no earlier than 2 weeks after discontinuation of monoamine oxidase inhibitors); Propranolol may enhance the pressor effect of pseudoephedrine; pseudoephedrine reduces the hypotensive effect of reserpine, methyldopa, mecamylamine, and hellebore alkaloids. Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, can increase the concentration of dextromethorphan in the blood.
special instructions
During the treatment period, monitoring of the peripheral blood and liver functional status is carried out. During the treatment period, it is necessary to refrain from using ethanol (possibly developing a hepatotoxic effect) and caffeine driving vehicles and practicing other potentially hazardous activities requiring increased concentration and psychomotor reactions.