Theraflu extrapill N10 pills
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Active ingredients
Paracetamol + Phenylephrine + Pheniramine
Release form
Coated pills
Composition
1 tablet contains: Paracetamol (paracetamol) 650 mg; phenylephrine (phenylephrine) 10 mg; chlorphenamine (chlorphenamine) 4 mg. Excipients: colloidal silicon dioxide - 0.4 mg, lacquer based on quinoline yellow dye - 0.85 mg, lactose - 3.1 mg, magnesium stearate - 3.5 mg, hyprolosis - 17 mg, croscarmellose sodium - 57 mg, corn starch - 124 mg. Composition of film shells: quinoline yellow dye-based varnish - 0.0331 mg, quinoline yellow dye - 0.0392 mg, titanium dioxide - 1.0882 mg, methyl para-hydroxybenzoate - 0.0889 mg, povidone - 0.4353 mg, colloidal silicon dioxide - 0.6529 mg, macrogol 400 - 1.7412 mg, methylcellulose - 3.9176 mg.
Pharmacological effect
Combined medication, the action of which is due to its constituent components. It has antipyretic, analgesic, vasoconstrictor effect, eliminates cold symptoms. It constricts the blood vessels and eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx. Paracetamol has an antipyretic effect, blocking COX mainly in the central nervous system, affecting the centers of pain and thermoregulation. Practically does not possess anti-inflammatory action. Paracetamol does not affect the synthesis of prostaglandins in peripheral tissues, thus not adversely affecting the water-salt metabolism (sodium and water ion retention) and the gastrointestinal mucosa. Phenylephrine is an alpha adrenomimetic, causes vasoconstriction, eliminates edema and mucosal hyperemia shell of the nasal cavity, nasopharynx and paranasal sinuses, reduces exudative manifestations (runny nose). Chlorphenamine is a blocker of histamine H1-receptors, suppresses the symptoms of allergic rhinitis: sneezing, runny nose, itchy eyes, nose, irritation in the area of the pharynx and larynx. Duration of action is 6 hours.
Pharmacokinetics
ParacetamolParacetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached in 10-60 minutes after ingestion. Paracetamol is widely distributed in all tissues of the body. It penetrates the placental barrier and is secreted with breast milk. Binding to plasma proteins is not significant at normal therapeutic concentrations, but increases with increasing concentrations. Paracetamol is metabolized in the liver primarily by glucuronization and sulfation. It is excreted by the kidneys mainly in the form of glucuronide and sulphate conjugates.T1 / 2 is from 1 to 3 hours. In case of severe impaired renal function (CC <30 ml / min), paracetamol and its metabolites are excreted. Phenylephrine hydrochloridePhenylephrine hydrochloride is absorbed from the gastrointestinal tract. MAO is metabolized during the first passage through the intestinal wall and in the liver; therefore, when ingested phenylephrine, the hydrochloride is characterized by limited bioavailability. Cmax in plasma is reached within 45 min-2 h. It is excreted by the kidneys almost entirely as sulfate conjugates. T1 / 2 of the drug from plasma is 2-3 hours. Chlorphenamine maleate Chlorphenamine is relatively slowly absorbed from the gastrointestinal tract, Cmax of chlorphenamine in the blood plasma is reached 2.5-6 hours after taking the drug. The substance has a low bioavailability of 25-50%. The binding of chlorphenamine to plasma proteins is about 70%. Widely distributed in the tissues of the body, including the central nervous system. Chlorphenamine undergoes significant first-pass metabolism. In children, a faster and more complete absorption, a higher clearance value and a shorter T1 / 2 were noted. T1 / 2 ranges from 2 to 43 hours, even with an average duration of action of 4-6 hours. A part of chlorphenamine, unchanged with metabolites, is excreted by the kidneys.
Indications
Symptomatic treatment of infectious and inflammatory diseases (ARVI, including flu), accompanied by high fever, chills, headache, runny nose, nasal congestion, sneezing, muscle pain.
Contraindications
Hypersensitivity to the drug; severe cardiovascular diseases; arterial hypertension; hyperthyroidism; angle-closure glaucoma; pheochromocytoma; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; taking MAO inhibitors (simultaneously or in the preceding 14 days), tricyclic antidepressants, beta-blockers, other sympathomimetics; pregnancy; breastfeeding period; children's age up to 12 years.
Precautionary measures
With caution: diabetes, liver dysfunction, kidney dysfunction, prostatic hyperplasia, hemolytic anemia, deficiency of glucose-6-phosphate dehydrogenase, bronchial asthma, chronic obstructive pulmonary disease (chronic bronchitis), pulmonary emphysema, acute hepatitis,chronic exhaustion or dehydration, pyloroduodenal stenosis, epilepsy, cardiovascular diseases; alcohol dependence. Other paracetamol-containing drugs should not be taken at the same time, as well as other drugs that affect liver function.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding). The safety of the drug Theraflu; ExtraTab when used during pregnancy and during breastfeeding has not been specifically studied. Pregnancy Epidemiological studies during pregnancy showed no adverse effect when using paracetamol orally at the recommended dose. In oral reproductive toxicity studies of paracetamol, there were no signs of malformations or fetotoxicity. Paracetamol can be used in therapeutic doses throughout pregnancy after evaluating the benefit-risk ratio of therapy. There are limited data on the use of phenylephrine in pregnant women. Constriction of uterine vessels and reduced blood flow in the uterus when using phenylephrine can lead to fetal hypoxia. The use of phenylephrine during pregnancy should be avoided. Epidemiological data on the use in humans have not revealed a connection between chlorphenamine and congenital malformations. However, controlled clinical trials are not enough, so the use of chlorphenamine maleate during pregnancy should be avoided. Breastfeeding Paracetamol is excreted in breast milk, but in quantities that are not clinically significant. According to published data, paracetamol is not contraindicated during breastfeeding. There is no data on the release of phenylephrine from breast milk. The use of phenylephrine during breastfeeding should be avoided. There is no data on the release of chlorphenamine in breast milk. The use of chlorphenamine during breastfeeding should be avoided.
Dosage and administration
Is ingested. It is recommended to swallow the tablet whole, without chewing, drinking water. Adults - 1 tablet every 4-6 hours, but not more than 6 pills per day. Children over 12 years old - 1 tablet every 4-6 hours,but no more than 4 pills per day. The treatment course is no more than 5 days. If there is no relief of symptoms within 3 days after starting the drug, you should consult a doctor. In patients with impaired liver function or Gilbert's syndrome, reduce the dose or increase the interval between doses. In case of severe renal failure (CK <10 ml / min), the interval between doses must be at least 8 hours. In elderly patients, dose adjustment is not required.
Side effects
From the hematopoietic system: very rarely - thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. Allergic reactions: rarely - hypersensitivity, urticaria, angioedema; frequency is unknown - anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis. From the nervous system: often - drowsiness; rarely - dizziness, headache. Psychiatric disorders: rarely - nervousness, insomnia. From the cardiovascular system: rarely - tachycardia, rapid heartbeat, arterial hypertension. From the digestive system: often - nausea, vomiting; rarely - constipation, dryness of the oral mucosa. From the side of the liver and biliary tract: rarely - increased activity of hepatic transaminases. From the side of skin and subcutaneous tissues: rarely - skin rash, itching, erythema.
Overdose
Paracetamol Symptoms: mainly due to the presence of paracetamol. In acute overdose, paracetamol can have a hepatotoxic effect and even cause liver necrosis. Paracetamol overdose, including a general high dose level after a long period of therapy, can lead to analgesic nephropathy with irreversible liver failure. Patients should be warned about the inadmissibility of the simultaneous administration of other drugs containing paracetamol. There is a risk of poisoning, especially in older patients and young children, those with liver disease, in the case of chronic alcoholism, patients with chronic malnutrition and patients receiving inducers of microsomal enzymes. Overdose of paracetamol can lead to liver failure, encephalopathy, coma and death .Symptoms of a paracetamol overdose on the first day include pallor, nausea, vomiting, and anorexia. Abdominal pain can be the first sign of liver damage, and it can appear only 24-48 hours, sometimes 4-6 days after taking the drug. Most often, signs of liver damage occur 72-96 hours after taking the drug. Possible impaired glucose metabolism and metabolic acidosis. Acute renal failure and acute necrosis of the renal tubules can develop even in the absence of severe damage to the liver. There have been cases of cardiac arrhythmia and pancreatitis. Treatment: treatment of paracetamol overdose should be started immediately. During the first 48 hours after an overdose, it is advisable to use N-acetylcysteine intravenously or orally as paracetamol antidote, gastric lavage and / or the use of methionine orally is possible. It is advisable to use activated carbon. The control of respiration and blood circulation is necessary. In the case of seizures, diazepam can be used. Phenylephrine Symptoms: sympathomimetic action, which causes hemodynamic changes and cardiovascular collapse with respiratory depression, manifested in the form of, for example, drowsiness, followed by agitation (especially in children), blurred vision, skin rash, nausea , vomiting, persistent headaches, nervousness, dizziness, insomnia, hematopoietic disorders (thrombocytopenia, agranulocytosis, leukopenia, pancytopenia), coma, convulsions, arterial hypertension and scraps ikardiya.Lechenie: immediate gastric lavage, symptomatic and supportive therapy. The hypertensive effect can be arrested with the help of intravenous alpha adrenergic blocker. In the case of seizures, diazepam may be used. Chlorphenamine Symptoms: drowsiness, respiratory arrest, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse, including arrhythmia. In children, overdose symptoms may include impaired coordination, agitation, tremor, behavior changes, hallucinations, convulsions, and anticholinergic effects. Treatment: gastric lavage in the event of a massive overdose, or vomiting stimulation. After this, it is possible to use activated carbon and a laxative to slow absorption.In the case of convulsions, diazepam or phenytoin should be given. In severe cases, hemoperfusion may be performed.
Interaction with other drugs
Paracetamol With prolonged regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may increase, and the risk of bleeding increases. Periodic use of paracetamol has no significant effect. Hepatotoxic substances can lead to paracetamol accumulation and overdose. The risk of hepatotoxicity of paracetamol is enhanced with the use of drugs that induce microsomal liver enzymes, such as barbiturates, anti-epileptic drugs (for example, phenytoin, phenobarbital, carbamazepine) and drugs for treating tuberculosis, such as rifampicin and isoniazid. in blood plasma. Similarly, domperidone may lead to an increase in the absorption rate of paracetamol. Paracetamol can lead to an increase in T1 / 2 chloramphenicol. Paracetamol can reduce the bioavailability of lamotrigine, while it may decrease the effectiveness of lamotrigine due to the induction of its metabolism in the liver. Kolestiramine, but the decrease in absorption is insignificant, if I take Kolestiramine one hour later. Regular use of paracetamol simultaneously with zid vudinom can cause neutropenia and increase the risk of damage pecheni.Probenetsid affect the metabolism of paracetamol. In patients using probenecid, paracetamol dose should be reduced. Paracetamol increases in hepatotoxicity with prolonged excessive use of ethanol (alcohol). Paracetamol can affect the results of the test for the determination of uric acid using precipitating phosphofistramate reagent. over the past 2 weeks. Phenylephrine can potentiate the action of MAO inhibitors and induce hypertensive crisis. Simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (for example,amitriptyline) can lead to an increased risk of adverse reactions from the cardiovascular system. The use of phenylephrine can lead to a decrease in the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrizochin, guanethidine, reserpine, methyldopa). The risk of arterial hypertension and other adverse reactions of the cardiovascular system may increase. Simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm disturbances or heart attacks. Simultaneous use of ergot alkaloids (ergotamine) may increase the risk of ergotism. like other antihistamines, can enhance the effect of opioid analgesics, anticonvulsants, antidepressants (tricyclic and other antihistamine, antiemetic, and antipsychotic drugs, anxiolytics, hypnotics, ethanol (alcohol), and drugs that have a depressant effect on the central nervous system. Since chlorphenamine to some extent has anticholinergic activity, the effects of anticholinergic drugs (for example, some psychoses) and urinary incontinence drugs) can be enhanced with this drug. This can lead to tachycardia, dryness of the oral mucosa, disorders of the digestive system (eg, colic), urinary retention and headache. Chlorphenamine can inhibit the metabolism of phenytoin, with the possible development of toxicity of phenytoin.
special instructions
In order to avoid toxic damage to the liver, taking the drug should not be combined with the use of alcoholic beverages. Effects on the ability to drive vehicles and mechanisms During treatment, it is not recommended to drive vehicles or other mechanisms that require concentration of attention and high speed psychomotor reactions.