More info
Active ingredients
Paracetamol + Phenylephrine + Pheniramine
Release form
Powder
Composition
Package 1 contains: Paracetamol 325 mg; phenylephrine hydrochloride 10 mg; Pheniramine Maleate 20 mg; ascorbic acid 50 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 blood vessels and eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx. Paracetamol has anesthetic and antipyretic effect by suppressing the synthesis of prostaglandins in the central nervous system. It does not affect platelet function and hemostasis. Pheniramine is an antiallergic, histamine H1 receptor blocker. Eliminates allergic symptoms, moderately has a sedative effect, and also exhibits antimuscarinic activity. Phenylephrine is an alpha1-adrenomimetic, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.
Pharmacokinetics
ParacetamolParacetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached in 10-60 minutes after ingestion. Distributed in most body tissues. Gets through a placental barrier, it is allocated with breast milk. At therapeutic concentrations, plasma protein binding is low, but increases with increasing concentration. Subject to primary metabolism in the liver. Excreted mainly in the urine in the form of glucuronides and sulfates. T1 / 2 is from 1 to 3 hours. Pheniramine Cmax of phenyramine in plasma is reached in approximately 1-2.5 hours. T1 / 2 of phenyramine - 16-19 hours. 70-83% of the dose is excreted in the urine as metabolites or unchanged. PhenylephrinePhenylephrine is absorbed from the gastrointestinal tract. It is metabolized at the first passage through the intestinal wall and in the liver, therefore, when ingested phenylephrine hydrochloride is characterized by limited bioavailability. Cmax in plasma is achieved in the range from 45 minutes to 2 hours. It is excreted by the kidneys almost completely as sulphate compounds. T1 / 2 is 2-3 hours. Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Plasma protein binding - 25%. Excreted in the form of metabolites in the urine. Ascorbic acid, taken in excessive quantities, is rapidly excreted unchanged in the urine.
Indications
Symptomatic treatment of infectious and inflammatory diseases (ARVI, incl.flu), accompanied by fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing.
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: in severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostatic hyperplasia, difficulty urinating due to hypertrophy of the prostate gland, blood diseases, glucose deficiency 6 -ylagus, and chromic-6-fibrosis. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), with exhaustion, dehydration, pyloroduodenal obstruction, stenosing gastric ulcer and / or duodenum, epilepsy, while taking drugs can adversely affect the liver (e.g., inducers of microsomal liver enzymes); in patients with recurrent formation of urate kidney stones.
Use during pregnancy and lactation
It is not recommended to use Theraflu; from flu and cold during pregnancy and lactation (breastfeeding).
Dosage and administration
Inside The contents of one sachet are dissolved in 1 cup of hot, but not boiling water. Take hot. A repeated dose can be taken every 4-6 hours (no more than 3-4 doses within 24 hours). Theraflu; for flu and cold, you can use at any time of the day, but the best effect comes from taking the drug at bedtime, at night. If there is no relief of symptoms within 3 days after the start of the drug, you should consult a doctor. Do not use Theraflu; from flu and cold for more than 5 days. In patients with impaired liver function or Gilbert's syndrome, reduce the dose or increase the interval between doses. In severe renal failure (CK <10 ml / min), the interval between doses should be at least 8 hours. elderly patients dose adjustment is not required.
Side effects
On the part of the hematopoietic system: very rarely - thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. Allergic reactions: rarely - hypersensitivity (rash, shortness of breath, anaphylactic shock), 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 - increased excitability, sleep disturbance. On the part of the organ of vision: rarely - mydriasis, accommodation paresis, increased intraocular pressure. On the part of the cardiovascular system: rarely - tachycardia, heartbeat, hypertension From the digestive system: often - nausea, vomiting; rarely - constipation, dryness of the oral mucosa, abdominal pain, diarrhea. From the side of the liver and biliary tract: rarely - increased activity of hepatic transaminases. From the skin and subcutaneous tissues: rarely - skin rash, itching, erythema. From the urinary system: rarely - difficulty urinating. General reactions: rarely - indisposition. If any of the above side effects get worse and any other side effects appear, the patient should see a doctor.
Overdose
Symptoms of overdose are mainly due to paracetamol. Paracetamol Symptoms: generally appear after taking 10-15 g of paracetamol. In severe cases of overdose, paracetamol has a hepatotoxic effect, including may cause liver necrosis. Overdose can also cause irreversible nephropathy and irreversible damage to the liver. The severity of overdose depends on the dose, so patients should be warned about the prohibition of the simultaneous administration of paracetamol-containing drugs. The risk of poisoning is expressed especially in elderly patients, in children, in patients with liver diseases, in cases of chronic alcoholism, in patients with exhaustion, and in patients receiving inducers of microsomal liver enzymes. Overdosing of paracetamol can lead to liver failure, encephalopathy, coma and death. Symptoms of paracetamol overdose in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, seizures.Abdominal pain can be the first sign of liver damage and usually does not manifest itself within 24-48 hours and sometimes can appear later, after 4-6 days. Liver damage is manifested to the maximum extent after 72-96 hours after taking the drug. There may also be impaired glucose metabolism and metabolic acidosis. Even in the absence of liver damage, acute renal failure and acute tubular necrosis can develop. Cases of cardiac arrhythmia and development of pancreatitis have been reported. Treatment: the introduction of acetylcysteine IV or orally as an antidote, gastric lavage, ingestion of methionine can have a positive effect, at least 48 hours after an overdose. Recommended reception of activated carbon, monitoring of respiration and blood circulation. If seizures develop, diazepam may be prescribed. Pheniramine and phenylephrine (symptoms of overdose are combined due to the risk of mutual potentiation of the parasympatholytic effect of pheniramine and the sympathomimetic effect of phenylephrine in case of drug overdose) disturbances, rash, nausea, vomiting, headache, irritability. dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral changes, increased blood pressure and bradycardia. In case of overdose of pheniramine, cases of atropine-like psychosis have been reported. Treatment: There is no specific antidote. Conventional care measures are needed, including the appointment of activated carbon, salt laxatives, measures to support cardiac and respiratory functions. Psycho-stimulants (methylphenidate) should not be prescribed because of the risk of seizures. In case of arterial hypotension, it is possible to use vasopressor drugs. In the event of an increase in blood pressure, it is possible to / in the administration of alpha-blockers, since Phenylephrine is a selective α1 -adrenoreceptor agonist, therefore, the hypotensive effect in overdose should be treated by blocking α1-adrenoreceptors. With the development of seizures enter diazepam.
Interaction with other drugs
Paracetamol Enhances the effects of MAO inhibitors, sedatives,ethanol. The risk of hepatotoxic action of paracetamol is increased with the simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inductors of microsomal liver enzymes. A single use of paracetamol has no significant effect. Metoclopramide increases the speed of absorption of paracetamol and reduces the time it takes to reach Cmax in the 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. Absorption of paracetamol can be reduced with simultaneous use Kolestiramine, but the decrease in absorption is insignificant if Kolestiramine is taken an hour later. Regular use of paracetamol at the same time as Z ovudinom can cause neutropenia and an increased 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 may affect the results of the test for the determination of uric acid using precipitating phosphofistramate. Pheniramine It is possible that the influence of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, anti-parkinsonian drugs, barbiturates, tranquilizers and narcotic funds). Pheniramine can inhibit the action of anticoagulants. Phenylephrine Theraflu; Flu and cold are not recommended for patients who have received or received MAO inhibitors in the last 2 weeks. Phenylephrine can potentiate the action of MAO inhibitors and cause 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. Phenylephrine may decrease the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisochin, guanethidine, reserpine, methyldopa). The risk of arterial hypertension and other side effects of the cardiovascular system may be increased. Simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm disturbances or myocardial infarction. Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and ergot alkaloids (ergotamine and heart failure) (ergotamine and ergot alkaloids (ergotamine and myocardial myocardial infarction).
special instructions
To avoid toxic liver damage, the drug should not be combined with the use of alcoholic beverages. Patients should consult a doctor if: - there is asthma, emphysema or chronic bronchitis; - symptoms do not disappear within 5 days or are accompanied by severe fever that lasts for 3 days , rash or persistent headache. These may be signs of more serious irregularities. Theraflu; for flu and cold contains: -sugarose 20 g per sachet. This should be taken into account in patients with diabetes. Patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take Theraflu; from flu and cold; dye sunset sun yellow (E110). May cause allergic reactions; -sodium 28.3 mg per sachet. This should be taken into account in patients who are on a sodium-restricted diet. The drug should not be taken from damaged sachets. The effect on the ability to drive vehicles and mechanisms Theraflu; from flu and cold can cause drowsiness, therefore during treatment it is not recommended to drive vehicles or to engage in other activities requiring concentration of attention and high speed of psychomotor reactions.