Buy Coldrex HotRem tea bags 5 g 5 pcs
  • Buy Coldrex HotRem tea bags 5 g 5 pcs

Paracetamol, Phenylephrine, Ascorbic Acid

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2019-09-19
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Clinical Pharmacology

Pharmacotherapeutic group:
Means for eliminating the symptoms of acute respiratory infections and "cold" (analgesic non-narcotic agent + alpha adrenergic drug + vitamin)
ATX Code: N02BE51
Pharmacological properties
Combined agent, the action of which is due to its constituent components: paracetamol has antipyretic, analgesic effect; phenylephrine - sympathomimetic, narrows the vessels of the nasal mucosa and paranasal sinuses, resulting in reduced swelling and facilitated nasal breathing; ascorbic acid replenishes the increased need for vitamin C in colds and flu, especially in the initial stages of the disease.
Does not cause drowsiness and does not violate the concentration of attention.

Indications

Elimination of cold and flu symptoms:

  • increased body temperature
  • headache,
  • chills
  • pains in the joints and muscles
  • nasal congestion
  • pain in the sinuses and throat.

Composition

The composition of one bag 5 g:
Active substances: paracetamol 750 mg, phenylephrine hydrochloride 10 mg and ascorbic acid 60 mg.
Excipients: citric acid 600.0 mg, sodium saccharinate 10.0 mg, sodium citrate 500.0 mg, lemon flavor PHS-163671 100.0 mg, honey flavor PFW PHS-050860 75.0 mg, honey flavor Felton F7624P 125 , 0 mg, caramel dye 626 50.0 mg, corn starch 200.0 mg, aspartame 50.0 mg, sucrose 2468.50 mg.

Paracetamol, Phenylephrine, Ascorbic Acid is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Coldrex HotRem GlaxoSmithKline UK tea bags
Rinzasip d/children Yunik Pharmaceutical India powder
Cold Synthesis AKOMP Russia tea bags
Maxicold Pharmstandard Russia pills
Coldrex GlaxoSmithKline UK tea bags
Coldrex MaxGripp with Lemon Flavor GlaxoSmithKline UK tea bags

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Paracetamol, Phenylephrine, Ascorbic Acid

Dosage and Administration

For adults It is recommended to take 1 sachet every 4-6 hours, but not more than 4 sachets within 24 hours. The interval between doses should be at least 4 hours.

Children over 12 years old appoint 1 sachet every 6 hours, but not more than 3 sachets for 24 hours.

The contents of 1 sachet must be poured into a glass of 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.

Adverse reactions

Are possible allergic reactions: skin rash, urticaria, broichospasm, angioedema.

Side effects caused by the drug paracetamol.

From the hemopoietic system: rarely - thrombocytopenia, leukopenia, agranulocytosis.

With prolonged use, hepatotoxic and nephrotoxic effects may occur.

Side effects caused by the drug phenylephrine.

From the digestive system: nausea, vomiting.

From the side of the central nervous system: headache, irritability, nervous tension, sleep disturbance.

Since the cardiovascular system: a slight increase in blood pressure; rarely - palpitations.

Side effects caused by the drug ascorbic acid.

From the digestive system: irritation of the mucous membrane of the gastrointestinal tract.

From the hemopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis.

Other: hypokalemia.

 

Contraindications

  • Hypersensitivity to any component of the drug.
  • Severe liver and kidney function.
  • Hyperthyroidism (thyrotoxicosis).
  • Diabetes and hereditary sugar absorption disorders (contains sugar).
  • Heart diseases (marked stenosis of the aortic mouth, acute myocardial infarction, tachyarrhythmias).
  • Arterial hypertension .
  • Simultaneous administration of tricyclic antidepressants, beta-blockers, MAO inhibitors, including up to 14 days after their withdrawal.
  • Simultaneous use of other paracetamol-containing agents and agents to relieve cold, flu, and nasal congestion.
  • Prostate adenoma.
  • Closed angle glaucoma.
  • Children's age up to 12 years.

With care when:

  • Genetic absence of glucose-6-phosphate dehydrogenase.
  • Benign hyperbilirubinemia.
  • Pregnancy.
  • Breastfeeding.

Drug interactions

Coldrex HotRem enhances the effects of MAO inhibitors, sedatives and ethanol.

When used simultaneously with Coldrex HotRem antidepressants, anti-Parkinsonian drugs, antipsychotics, phenothiazine derivatives increases the risk of urinary retention, dry mouth, and constipation.

Combined use with GCS increases the risk of developing glaucoma.

Paracetamol reduces the effectiveness of diuretics.

The simultaneous use of the drug with halothane increases the risk of ventricular arrhythmias.

Phenylephrine reduces the hypotensive effect of guanethidine.

Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine.

The risk of hepatotoxic action is increased while taking barbiturates, phenytoin, carbamazepine, rifampicin, zidovudia, and other inducers of liver microsomal enzymes.

Paracetamol absorption rate may increase when taking metoclopramide, domperidone, and decrease when taking Kolestiramine.

With prolonged regular use of paracetamol, the effect of warfarin or other indirect anticoagulants may increase, increasing the risk of bleeding.

When taken with digoxin or other cardiac glycosides, the risk of arrhythmia and myocardial infarction may increase.

Paracetamol reduces the efficacy of uricosuric drugs.

Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows kidney excretion of acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces blood concentration of oral contraceptives.

Ethanol when applied simultaneously with Coldrex HotRem contributes to the development of acute pancreatitis.

Myelotoxic drugs increase the hematotoxicity of the drug.

Pregnancy and Lactation

The use of Coldrex HotRem during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus and only under strict medical supervision.

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 patient should be informed that he should stop taking the drug and immediately consult a doctor if he has:

  • allergic reactions are observed: itchy skin or reddening of the skin, difficulty breathing or swelling of the lips, tongue, throat or face;
  • there is a rash or peeling on the skin, formation of ulcers on the oral mucosa;
  • respiratory disorders were previously observed when taking acetylsalicylic acid or other NSAIDs;
  • hematomas or bleeding have appeared;
  • visual disturbances have occurred. 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;
  • heart palpitations appear or he feels an increase in frequency or rhythm disturbance abbreviations hearts;
  • there are difficulties when urinating. More often, this side effect is observed in patients with prostatic hypertrophy.

The drug should be taken only in recommended doses.

With caution and after consulting a doctor, Coldrex HotRem should be taken simultaneously with metoclopramide, domperidone, Kolestiramine and indirect anticoagulants (warfarin).

The drug should not be taken simultaneously with other drugs containing paracetamol, decongestants and means to alleviate the symptoms of colds and flu.

Patients taking Coldrex HotRem should refrain from alcohol in order to avoid toxic liver damage. It is not recommended to prescribe a drug for chronic alcoholism.

Patients on low-sodium diets should take into account that 1 bag of Coldrex HotRem contains 0.12 g of sodium.

Before taking Coldrex HotRem, you should consult with your doctor if a patient is taking:

  • warfarin or other indirect anticoagulants;
  • antihypertensive drugs, for example, beta-blockers;
  • digoxin or other cardiac glycosides;
  • appetite suppressants or psychostimulants;
  • tricyclic antidepressants (including amitriptyline).

Influence on ability to drive motor transport and control mechanisms

Since the active components of the drug do not have a sedative effect, when taken at the recommended doses there are no restrictions on driving a car or working with mechanisms.

Overdosage

In case of an overdose of Coldrex HotRem (even with good health), the risk of delayed signs of serious liver damage should be considered.

Overdose is usually caused by paracetamol.

Symptoms: pallor of the skin, nausea, vomiting, anorexia, hepatocyte necrosis, increased activity of hepatic transaminases, an increase in prothrombin time. Symptoms of abnormal liver function may appear 12-48 hours after an overdose.In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Treatment: gastric lavage followed by the appointment of Activated charcoal; symptomatic therapy is carried out if necessary. Acetylcysteine ​​is a specific antidote for paracetamol poisoning.

  • Brand name: Coldrex HotRem
  • Active ingredient: Paracetamol, Phenylephrine, Ascorbic Acid
  • Manufacturer: GlaxoSmithKline

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