Coldrex Hot Me for Lemon N10 Pack Pore for R-ra
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Active ingredients
Paracetamol + Phenylephrine + Ascorbic Acid
Release form
Powder
Composition
Paracetamol 750 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 60 mg. Additional substances: citric acid - 600 mg, sodium saccharin - 10 mg, sodium citrate - 500 mg, lemon flavoring PHS-163671 - 100 mg, honey flavoring PFW PHS-050860 - 75 mg, Felton F7624P honey flavoring - 125 mg, caramel dye 626 - 50 mg, corn starch - 200 mg, aspartame - 50 mg, sucrose - 2468.5 mg.
Pharmacological effect
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, the distribution in body fluids is relatively even. Metabolized mainly in the liver with the formation of several metabolites. T1 / 2 when taking a therapeutic dose is 2-3 hours. The main amount of the drug is removed after conjugation in the liver. In unchanged form, not more than 3% of the received dose of paracetamol is released. Phenylephrine is poorly absorbed from the gastrointestinal tract and is metabolized during the first passage in the intestine and liver under the influence of MAO. When taking phenylephrine inside the drug's bioavailability is limited. Excreted in the urine almost completely as a sulfuric acid conjugate. Ascorbic acid is well absorbed from the gastrointestinal tract, binding to plasma proteins is 25%. The distribution in the tissues of the body is broad. Metabolized in the liver, excreted in the urine as oxalate and unchanged. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.
Pharmacokinetics
Combined drug for the symptomatic treatment of acute respiratory diseases. Paracetamol has antipyretic, analgesic effect. Phenylephrine hydrochloride is a sympathomimetic, narrows the vessels of the nasal mucosa and the paranasal sinuses, resulting in reduced swelling and easier nasal breathing. and flu, especially in the initial stages of the disease. The active components of the drug do not cause drowsiness.
Indications
To eliminate the symptoms of acute respiratory infections and flu, including: - increased body temperature; - headache; - chills; - joint and muscle pain; - nasal congestion; - sore throat and sinuses.
Contraindications
- severe liver dysfunction; - severe kidney dysfunction; - hyperthyroidism (including thyrotoxicosis); - diabetes mellitus; - sucrase / isomaltase deficiency, fructose intolerance, glucose / galactose malabsorption syndrome, the drug contains sucrose; - heart disease (marked stenosis of the aortic orifice, acute myocardial infarction, tachyarrhythmia); - arterial hypertension; - simultaneous administration of tricyclic antidepressants, beta-adrenergic blockers, MAO inhibitors and a period of up to 14 days after their cancellation; - simultaneous administration of other paracetamol containing means and means to relieve symptoms of a cold, flu and nasal congestion; - benign prostatic hyperplasia; - angle-closure glaucoma; - children under 12 years old; - heightened feelings telnost to the drug.
Precautionary measures
Do not exceed the recommended dose. With caution, the drug should be used with a deficiency of glucose-6-phosphate dehydrogenase, with benign hyperbilirubinemia, with liver and kidney diseases, with increased blood pressure, vascular obliterans (Raynaud's syndrome), glaucoma (except for angle-closure glaucoma), feohromocytoma.
Use during pregnancy and lactation
With caution should use the drug during pregnancy and during breastfeeding.
Dosage and administration
Adults are advised to take 1 sachet every 4-6 hours, but not more than 4 sachets for 24 hours. The interval between doses should be at least 4 hours. For children over 12 years old, take 1 sachet every 6 hours, but not more than 3 sachets 24 hours. The contents of 1 sachet should be poured into a glass with hot water (about 250 ml), stirred until complete dissolution, if necessary, you can add cold water or sugar. The maximum duration of the drug is 5 days. If symptoms persist for more than 5 days, the patient should consult a doctor.
Side effects
In recommended doses, the drug is usually well tolerated. Paracetamol rarely has side effects. From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis. Allergic reactions: very rarely - anaphylactic shock, skin rash, urticaria, angioedema,Stevens-Johnson syndrome. On the respiratory system: very rarely - bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs. On the side of the liver and biliary tract: very rarely - impaired liver function. nephrotoxic action. Phenylephrine From the nervous system: often - anxiety, headache, dizziness, insomnia; very rarely - irritability, nervous tension. From the side of the cardiovascular system: often - increase in blood pressure; rarely - tachycardia, feeling of heartbeat. From the digestive system: often - nausea, vomiting. From the senses: rarely - mydriasis, acute glaucoma attack in most cases in patients with angle-closure glaucoma. Allergic reactions: rarely - skin rash, urticaria, allergic dermatitis. From the urinary system: rarely - dysuria, urinary retention in patients with obstruction of the outlet of the bladder with hypertrophy of the prostate gland. Ascorbic acid Frequency of development of side effects Allergic reactions: skin rash, skin hyperemia. On the digestive system: irritation of the mucous membrane of the gastrointestinal tract. On the hematopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis. Others: hypokalemia. moderate pollakiuria is possible. In the event of side effects, the patient should immediately stop taking the drug and consult a doctor as soon as possible. If any of the above side effects worsen I, or there any other side effects, the patient should inform the doctor.
Overdose
In case of drug overdose Coldrex; HotRem (even with good health) should take into account the risk of delayed signs of serious liver damage. Symptoms caused by paracetamol: within 24 hours - pale skin, nausea, vomiting, anorexia, abdominal pain; during 12-48 hours, signs of abnormal liver function, signs of impaired glucose metabolism and metabolic acidosis may appear.Toxic effect in adults is possible after a single dose of more than 10 g of paracetamol - an increase in liver transaminase activity, the clinical picture of liver damage occurs after 1-6 days. In case of severe poisoning, severe hepatic failure can develop, up to and including hepatic encephalopathy, coma and death. Acute renal failure with acute necrosis of the tubules, which is diagnosed for severe pain in the lumbar region, hematuria and proteinuria, can develop without severely impaired liver function. There are reports of cases of cardiac arrhythmia and pancreatitis with paracetamol overdose. In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of the overdose or the risk of damage to internal organs. inside. After 4 or more hours after the presumptive overdose, it is necessary to determine the concentration of paracetamol in plasma (an earlier determination of the concentration of paracetamol may be unreliable). Acetylcysteine is a specific antidote for paracetamol poisoning. Treatment with acetylcysteine can be carried out up to 24 hours after taking paracetamol, however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine can be administered in / in. In the absence of vomiting, an alternative option (in the absence of the possibility of quickly receiving inpatient care) is the appointment of methionine inside. Treatment of patients with severely impaired liver function 24 hours after taking paracetamol should be carried out in conjunction with specialists from a toxicology center or a specialized department of liver diseases. Symptoms caused by phenylephrine: irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability , reflex bradycardia. In severe cases of overdose may develop hallucinations, confusion, seizures, arrhythmias. An overdose of phenylephrine can cause symptomssimilar to side effects. Treatment: symptomatic therapy, with severe arterial hypertension, use of alpha-blockers such as phentolamine. Symptoms caused by ascorbic acid: ascorbic acid in high doses (more than 3000 mg) can cause temporary osmotic diarrhea and disorders of the gastrointestinal tract, such as nausea, discomfort in the stomach. Manifestations of ascorbic acid overdose can be categorized as those caused by severe liver damage as a result of paracetamol overdose. Treatment: symptomatic, forced diuresis. At the first signs of overdose, it is urgent to seek medical help, even in the absence of clear symptoms of poisoning.
Interaction with other drugs
Paracetamol, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic administration of a single dose of the drug does not have a significant effect on the effect of indirect anticoagulants. Indications of anti-CI antioxidation in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenybutazone, tricyclic antihydrin, antihydrogen, phenytocin, tricyclic fraction, antihydrogen, phenytoin, ethanol, flumecinol, phenytozonone, tricyclic fraction, antihydrogen, antihypertensives when taken with paracetamol. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic action. Paracetamol reduces the effectiveness of diure metoclopramide and domperidone increase, and colestyramine reduces the rate of absorption of paracetamol. Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol. Phenylephrine when taken with MAO inhibitors may lead to an increase in blood pressure. risk of developing hypertension and disorders of the cardiovascular system. Simultaneous use of phenylephrine with sympathomimetic amines and may increase the risk of side effects from the cardiovascular system. Tricyclic antidepressants increase the sympathomimetic effect of phenylephrine,can increase the risk of side effects from the cardiovascular system. Simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmias. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, increases the alpha-adrenostimuliruyuschuyu activity of phenylephrine. , phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation. Simultaneous administration of GCS with phenylephrine increases the risk of developing glaucoma. When used simultaneously with digoxin and cardiac glycosides, the risk of developing heart rhythm disorders or a heart attack may increase. Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows down the kidneys of acids, increases the excretion of drugs with alkaline reaction (including alkaloids), reduces the concentration in the blood of oral contraceptives. Ethanol contributes to the development of acute pan reatita.Mielotoksichnye medicines contribute to the manifestation of gematotoksichnosti drug.
special instructions
The patient should be informed that if the symptoms of the disease persist after 5 days of use of the drug, stop taking it and consult a doctor. The drug should be taken only in recommended doses. The patient should stop taking the drug and immediately consult a doctor if the following side effects occur. effects: -allergic reactions: itchy skin or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat, or face; rash or peeling on the skin, formation of sores on the oral mucosa; blues and whether bleeding; -loss of sight. This may be due to an increase in intraocular pressure. Very rarely, but this side effect is most likely to occur in patients with glaucoma, a feeling of palpitations or an increase in heart rate or heart rhythm disturbances, and difficulty urinating. More often this side effect is observed in patients with prostatic hypertrophy. The drug should not be taken.if respiratory disorders were previously observed while taking acetylsalicylic acid or other NSAIDs. The drug should not be taken concurrently with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsant drugs, rifampa, ibuprofen, barbiturates, anticonvulsant drugs, rifamp, anti-aversion drugs, acetylsalicylic acid, ibuprofen, barbiturates, anticonvulsant drugs, rifampa, ibuprofen, barbiturates, anticonvulsant drugs, rifampa, ibuprofen, barbiturates, anticonvulsant drugs, rifamp, izuprofenom and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like stimulants), with other means for relief of cold and flu symptoms. When testing for the determination of uric acid and the blood glucose level, the patient should inform the doctor about the use of Coldrex; HotRem, because the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid. Before taking the drug Coldrex; HotRem (lemon) requires consultation with a doctor in the event of: - taking metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestiramine, used to lower cholesterol concentration in the blood; with low sodium content - each bag contains 0.12 g of sodium; - severe infectious diseases (including sepsis) in patients with glutathione deficiency, because while taking paracetamol, the risk of metabolic acidosis may increase, and symptoms include a violation of the frequency and depth of breathing, accompanied by a feeling of lack of air (shortness of breath), nausea, vomiting, loss of appetite. If the patient finds these in himself, he should immediately consult a doctor. Patients suffering from phenylketonuria are not recommended to take Coldrex; HotRem (lemon honey), because It contains aspartame, which is a source of phenylalanine. Before taking the drug Coldrex; HotRem (lemon-honey) requires consulting a doctor in the following cases: - taking warfarin or other indirect anticoagulants; - taking drugs to control blood pressure, such as beta-blockers; appetite medication for the treatment of depression (tricyclic antidepressants — amitriptyline); estiramina,used to lower cholesterol in the blood vehicles and mechanismsWhen taking in recommended doses, the drug does not affect the ability to drive vehicles and mechanisms, as well as engage in other and potentially hazardous activities that require concentration and psychomotor speed reactions. If dizziness occurs, it is not recommended to drive vehicles or work with machinery.