KOLDREKS MaksGripp

Active material: Vitamin C, Paracetamol, Phenylephrine
When ATH: N02BE51
CCF: The drug for the symptomatic treatment of acute respiratory diseases
ICD-10 codes (testimony): J06.9, J10, R50
At KFU: 03.02.01.03
Manufacturer: GlaxoSmithKline Consumer Healthcare (Great Britain)

Pharmaceutical form, composition and packaging

◊ Powder for oral solution (lemon) light yellow, loose, heterogeneous, lemon-scented; the powder is dissolved in hot water to form a turbid yellowish-green solution without surface scum and solids, lemon-scented.

Excipients: sucrose, lemon acid, sodium citrate, corn starch, lemon flavor, sodium cyclamate, sodium saccharin, dye curcumin (E100), colloidal silicon dioxide.

6.427 g – laminated bags (5) – packs cardboard.
6.427 g – laminated bags (10) – packs cardboard.

Pharmacological action

Combined preparation for the symptomatic treatment of colds and other infectious and inflammatory diseases.

Paracetamol okazыvaet zharoponizhayushtee, analgesic effect. The content of paracetamol in the product corresponds to the maximum single dose, permitted for OTC use.

Phenylephrine – vasoconstrictor agent, relieves nasal congestion (It constricts blood vessels of the mucous membranes of the nose and paranasal sinuses) and makes breathing easier.

Ascorbic acid compensates for the increased need for vitamin C for colds and flu.

The active ingredients of the drug does not cause drowsiness.

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, distribution in the body fluids is relatively evenly.

It is metabolized primarily in the liver with the formation of several metabolites.

T_1/2 upon receipt of the therapeutic dose of 2-3 no. The basic amount of the drug is excreted after conjugation in the liver. In unaltered stands no more 3% received a dose of paracetamol.

Ascorbic acid is well absorbed from the gastrointestinal tract, connection to plasma proteins 25%, distribution into body tissues wide.

It is metabolized in the liver, excreted in the urine in the form of oxalate and unaltered.

Vitamin C, Adopted in excessive amounts, It is rapidly excreted in the urine as unchanged.

Phenylephrine is poorly absorbed from the gastrointestinal tract and metabolized first pass in the intestine and liver under the action of monoamine oxidase. When receiving phenylephrine into the limited bioavailability.

Excreted in the urine almost entirely in the form of sulfuric acid conjugate.

Testimony

Elimination of symptoms of colds and flu:

- Increased body temperature;

- Headache;

- Chills;

- Pain in joints and muscles,

- Nasal congestion;

- Sore throat;

- Pain in the sinuses.

Dosage regimen

Adults recommended for 1 Every sachet 4-6 no, but not more 4 bags for 24 no. The interval between doses should be at least 4 no.

Contents 1 bags must be emptied into a cup, half filled with hot water, stir until dissolved and add cold water or sugar if desired.

The maximum duration of the drug – 5 days.

Side effect

Side effects, caused part of the drug paracetamol.

Allergic reactions: sometimes – skin rash, hives, angioedema.

From the hematopoietic system: rarely – thrombocytopenia, leukopenia, agranulocytosis.

Prolonged use in excess of the recommended dose can be observed hepatotoxicity and nephrotoxicity.

Side effects, caused part of the drug phenylephrine.

Cardio-vascular system: increased blood pressure; rarely – heartbeat.

CNS: headache, dizziness, insomnia.

From the digestive system: vomiting, diarrhea.

Side effects, caused part of the preparation ascorbic acid.

Allergic reactions: skin rash, dermahemia.

From the hematopoietic system: thrombocytosis, erythropenia, neutrophilic leukocytosis.

From the urinary system: upon receipt of ascorbic acid more 600 mg / day – moderate thamuria.

Other: irritation of the gastrointestinal mucosa, giperprotrombinemiya, kaliopenia.

Contraindications

- Severe liver disease;

- Severe kidney disease;

- Diseases of the hematopoietic system;

- Thyrotoxicosis;

- Arterial hypertension;

- Heart disease (marked aortic stenosis, acute myocardial infarction, taxiaritmii);

- Benign prostatic hyperplasia;

- Zakrыtougolynaya glaucoma;

- Diabetes;

- Hereditary deficiency of lactase (Each packet contains 4 g sugar);

- The absence of a genetic glucose-6-phosphate dehydrogenase;

- Concomitant use of tricyclic antidepressants, beta-blockers, MAO inhibitors and the period up to 14 days after their cancellation;

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

- Hypersensitivity to the drug.

FROM caution use in patients with benign hyperbilirubinemia.

Pregnancy and lactation

The drug Coldrex^® MaksGripp with lemon flavor is contraindicated during pregnancy.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Cautions

The patient should be informed, if symptoms persist after 5 days of the drug, should stop taking it and consult a doctor.

The drug should only be taken in recommended doses.

The drug should not be taken simultaneously with other medications, soderzhashtimi paracetamol, as well as other non-narcotic analgesics (Metamizole), NSAIDs (acetylsalicylic acid, Ibuprofen), ʙarʙituratami, anticonvulsant drugs, rifampitsinom and hloramfenikolom.

Precautions should be taken Coldrex^® MaksGripp concurrently with metoclopramide, domperidone, kolestiraminom, nepryamыmy anticoagulants (warfarin).

Patients, receiving the drug Coldrex^® MaksGripp, should refrain from drinking alcohol. Not recommended to prescribe the drug for alcoholism.

Patients, diet with low-sodium, should be considered, what 1 sachet formulation Coldrex^® MaksGripp contains 0.12 g of sodium.

When conducting tests to determine the levels of uric acid and blood glucose should tell your doctor about use of the drug Coldrex^® MaksGripp, as the drug can distort the results of laboratory tests, assessing the concentration of glucose and uric acid.

Overdose

In the case of drug overdose Coldrex^® MaksGripp (even if the well-being) should take into account the risk of delayed signs of serious liver damage.

Overdose due, usually, paracetamol. Liver damage is possible in adults when receiving ≥ 10 g paracetamol.

Admission ≥ 5 g of acetaminophen can cause liver damage in patients, having the following risk factors:

- Long-term treatment with carbamazepine, fenoʙarʙitalom, phenytoin, primidone,
rifampicin, Hypericum perforatum preparations, or other drugs,
stimulating liver enzymes;

- The regular use of alcohol in excessive amounts;

- May have glutathione deficiency (with malnutrition,
mukovystsydoz, HIV infection, starving, depleted)

Symptoms: in flow 24 h are possible pallor, nausea, vomiting, anorexia, abdominal pain; during 12-48 h can manifest symptoms of liver dysfunction, signs of impaired glucose metabolism and metabolic acidosis. In case of severe poisoning may develop severe liver failure until hepatic encephalopathy, coma and death. Acute renal failure with acute tubular necrosis, which diagnostsiruetsya of severe pain in the lumbar region, gematurii and proteinuria, can develop without severe liver function abnormalities. There are reports of cardiac arrhythmias and pancreatitis with an overdose of paracetamol.

At the first sign of overdose is an urgent need to seek medical help, even when no distinct poisoning symptoms. In the early period of symptoms may be limited only by nausea and vomiting, and may not reflect the severity of overdose or the risk of internal organ.

Treatment: within the first hour after the alleged overdose expedient appointment of activated charcoal inside. Through 4 hours or more after the intended overdosing is necessary to determine the concentration of paracetamol in plasma (earlier determination of the concentration of paracetamol may be misleading). The antidote is acetylcysteine. Acetylcysteine ​​treatment can be carried out up to 24 h adopted after paracetamol, However, the maximum hepatoprotective effect can be obtained in the first 8 h after overdose. After that, the effectiveness of antidote falls sharply. If necessary, it can be administered acetylcysteine ​​/ in. In the absence of vomiting, alternative embodiment (In the absence of quick-patient care) is the appointment of methionine into. Treatment of patients with severe hepatic impairment through 24 h after administration of paracetamol should be carried out in conjunction with specialists poison control center or a specialized department of liver disease.

Overdose phenylephrine It may be accompanied by the following symptoms: irritability, headache, increased blood pressure, reflektornaya bradycardia, nausea and vomiting.

Symptoms overdose ascorbic acid (when using more 1 g): headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, oppression of the insular apparatus of the pancreas (giperglikemiâ, glyugokozuriya), giperoksalurija, nephrolithiasis (of calcium oxalate), glomerular kidney damage, decrease in capillary permeability (possible deterioration of the trophic tissue, increased blood pressure, hypercoagulation, the development of microvascular complications).

Drug Interactions

Paracetamol when taking a long time proximity effect anticoagulants (warfarin and other coumarin), which increases the risk of bleeding.

Inductors of microsomal oxidation enzymes in the liver (barbiturates, difenin, Carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumetsinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity with overdoses and concomitantly with paracetamol.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretic drugs.

Metoclopramide and domperidone increase, and cholestyramine reduces the absorption rate of paracetamol.

Paracetamol intensifies effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine when taken with MAO inhibitors may increase blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and antihypertensives.

Tricyclic antidepressants increase the sympathomimetic effects of phenylephrine, co-administration of halothane with phenylephrine increased risk of ventricular arrhythmia.

Phenylephrine reduce the hypotensive effect of guanethidine, which, in turn, It increases the activity of alpha-adrenostimuliruyuschee phenylephrine.

Antidepressants, antiparkinsonian agents, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.

Co-administration of corticosteroids with phenylephrine increases the risk of glaucoma.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 3 year.