Coldrex MaxGripp powder for preparing a solution with lemon flavor 10 pcs
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Active ingredients
Paracetamol + Phenylephrine + Ascorbic Acid
Release form
Powder
Composition
Paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 40 mg. Auxiliary substances: sucrose - 3725 mg, citric acid - 680 mg, sodium citrate - 430 mg, corn starch - 200 mg, lemon flavoring - 200 mg, sodium cyclamate - 79 mg, sodium saccharinate - 54 mg, dye curcumin (E100) - 7 mg, colloidal silicon dioxide - 2 mg.
Pharmacological effect
Combined preparation for the symptomatic treatment of colds and other infectious and inflammatory diseases. Paracetamol has an antipyretic, analgesic effect. The content of paracetamol in the preparation corresponds to the maximum single dose allowed for non-prescription use. Phenylephrine - a vasoconstrictor, relieves nasal congestion (narrows the vessels of the nasal mucosa and paranasal sinuses) and makes breathing easier. Ascorbic acid replenishes the increased need for vitamin C for colds and flu. The active ingredients of the drug do not cause drowsiness.
Pharmacokinetics
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. PhenylephrineIs poorly absorbed from the gastrointestinal tract and is metabolized during the first passage in the intestine and liver under the action of MAO. When taking phenylephrine orally, the bioavailability of the drug is limited. Excreted in the urine almost entirely as a conjugate of sulfuric acid. Ascorbic acid is well absorbed from the gastrointestinal tract, binding to plasma proteins - 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.
Indications
Elimination of cold and flu symptoms: - increased body temperature; - headache; - chills; - pains in joints and muscles; - nasal congestion; - sore throat; - pain in the sinuses.
Contraindications
- hypersensitivity to the components of the drug; - severe liver disease; - severe kidney disease; - diseases of the hematopoietic system; - thyrotoxicosis; - arterial hypertension; - heart disease (marked stenosis of the aorta mouth, acute myocardial infarction; tachyarrhythmia); - prostatic hyperplasia; - angle-closure glaucoma; - diabetes mellitus; - diseases associated with hereditary sugar absorption, because each bag contains 4 g of sucrose; - genetic lack of glucose-6-phosphate dehydrogenase; - sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, since the preparation contains sucrose; - simultaneous administration of tricyclic antidepressants, beta-blockers, MAO inhibitors and a period of up to 14 days after their withdrawal; - pregnancy; - lactation (breastfeeding); - children and adolescents under 18 years of age.
Precautionary measures
Do not exceed the recommended dose. With caution, you should use the drug for benign hyperbilirubinemia, pheochromocytoma, vasospastic diseases (Raynaud's syndrome), diseases of the cardiovascular system, concomitant use with other antihypertensive drugs.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and during breastfeeding.
Dosage and administration
Adults are recommended 1 sachet every 4-6 hours, but no more than 4 sachets within 24 hours. The interval between doses should be at least 4 hours. The contents of 1 sachet should be poured into a mug half filled with hot water, stir until dissolved. cold water or sugar at will. The maximum duration of the drug is 5 days.
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, Syndrome-Stiva syndrome, Syvenal shock On the part of the respiratory system: very rarely - bronchospasm in patientssensitive to acetylsalicylic acid and other NSAIDs. From the liver and biliary tract: very rarely - impaired liver function. From the urinary system: long-term use with an excess of the recommended dose nephrotoxic effect may be observed. Phenylephrine From the nervous system: very rarely - nervousness, headache pain, dizziness, insomnia. From the side of the cardiovascular system: very rarely - increase in blood pressure, tachycardia, feeling of heartbeat. From the side of the digestive system: very rarely - nausea, vomiting. From the sense organs: very rarely - mydriasis, acute glaucoma attack in most cases in patients with angle-closure glaucoma. Allergic reactions: very rarely - skin rash, urticaria, allergic dermatitis. From the urinary system: very rarely - dysuria, urinary retention in patients with obstruction of the outlet of the bladder with hypertrophy of the prostate gland. Ascorbic acid The frequency of side effects is not installed. On the part of the digestive system: irritation of the mucous membrane of the gastrointestinal tract. On the side of the hemopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis. Others: hypokalemia. stop taking the drug immediately and consult a doctor as soon as possible. If any of the above side effects get worse or any other side effects appear, the patient should tell the doctor about it.
Overdose
In case of drug overdose Coldrex; MaksGripp (even if you feel well) should take into account the risk of delayed signs of serious liver damage. Overdose is usually caused by paracetamol. Liver damage in adults is possible when taking ≥ 10 g of paracetamol. Taking ≥ 5 g of paracetamol can lead to liver damage in patients who have the following risk factors: - long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, preparations of St. John’s wort, or other drugs ,stimulating liver enzymes; -regular alcohol consumption in excessive quantities; -glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion). Symptoms (caused by paracetamol): within 24 h, 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. 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 by 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). The antidote is acetylcysteine. 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. Patients with severe liver dysfunction 24 hours after taking paracetamol should be treated in conjunction with specialists from a toxicology center or a specialized department of liver diseases. At the first signs of overdose, you should urgently seek medical help even in the absence of clear symptoms of poisoning. , headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, irritability, reflex bradyk Diya.In severe cases of overdose may develop hallucinations, confusion, seizures, arrhythmias. An overdose of phenylephrine can cause symptoms similar to side effects. Treatment: symptomatic therapy, with severe hypertension, use of alpha-blockers, such as phentolamine. Symptoms caused by ascorbic acid: when using more than 1 g - headache, increased CNS excitability, insomnia, nausea , vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosocuria), hyperoxaluria, nephrolithiasis (and calcium oxalate), damage to the glomerular apparatus of the kidneys, reduced capillary permeability (possibly worsening tissue trophism, increased blood pressure, hypercoagulation, microangiopathy development). High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disorders of the gastrointestinal tract, such as nausea, discomfort in the stomach. Overdose manifestations of ascorbic acid can be categorized as those caused by severe liver damage as a result of an overdose of paracetamol. Treatment: sim -automatic, forced diuresis.
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 ble preparatov.Metoklopramid and domperidone is increased, and reduces the rate of absorption colestyramine paratsetamola.Paratsetamol MAO inhibitors enhances effects, sedation,Phenylephrine when taken with MAO inhibitors can lead to an increase in blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of arterial hypertension and cardiovascular disorders. Simultaneous use of phenylephrine with sympathomimetic amines may increase the risk of developing side effects effects of the cardiovascular system. Tricyclic antidepressants increase the sympathomimetic effect of phenylephrine, may increase l 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, enhances the alpha-adrenostimuliruyuschuyu activity of phenylephrine. phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. The simultaneous administration of GCS with phenylephrine increases the to the development of glaucoma. When used simultaneously with digoxin and cardiac glycosides, the risk of developing heart rhythm disorders or heart attack may increase. Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the kidneys excretion of acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration in the blood of oral contraceptives. Ethanol contributes to the development of acute pancreatitis. Myelotoxic drugs enhance the manifestation of the hematotoxicity of the drug.
special instructions
The patient should be informed that if the symptoms of the disease persist after 5 days of use of the drug, you should stop taking it and consult with your doctor. The drug should be taken only in recommended doses. The drug should not be taken simultaneously with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsant drugs, rifampicin and chloramphenicol,sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other means to relieve cold and flu symptoms. When testing for uric acid and blood glucose, the patient should inform the doctor about Coldrex; MaksGripp, because the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid. Before taking the drug Coldrex; MaxGripp requires consultation with a doctor in the event of: - taking metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine, used to lower cholesterol concentration in the blood; sodium - each sachet 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 a patient discovers these, you should immediately consult a doctor. In order to avoid toxic liver damage, paracetamol should not be combined with alcohol, as well as those who chronically consume alcohol. Effect on the ability to drive vehicles and mechanismsWhen taking the recommended doses does not affect the ability to drive vehicles and mechanisms, as well as engage in other potentially hazardous activities that require concentration radios of attention and speed of psychomotor reactions. If dizziness occurs, it is not recommended to drive vehicles or work with machinery.