Pharmacological properties
Pharmacodynamics. Gripgo Hotmix is a combined drug, the effect of which is due to the components that make up its composition.
Paracetamol is an analgesic-antipyretic that has antipyretic and analgesic properties, which is associated with the effect of paracetamol on the hypothalamic thermoregulation center and its ability to inhibit prostaglandin synthesis.
Phenylephrine hydrochloride is a sympathomimetic agent, reduces swelling of the nasal mucosa and paranasal sinuses, the severity of exudative manifestations, and improves nasal breathing. It stimulates mainly α-adrenoreceptors, which causes narrowing of peripheral vessels and a decrease in their permeability, and reduces the formation of mucous secretions.
Ascorbic acid is a vital vitamin that is added to the composition of the drug to compensate for the loss of vitamin C, which may occur at the beginning of the development of a viral infection. Ascorbic acid takes an active part in the redox reactions of the body. It stimulates tissue respiration, oxidative phosphorylation in the liver, activates proteolytic and microsomal enzymes, promotes the transition of folic acid to folinic acid. Ascorbic acid is necessary for the synthesis of steroid hormones and procollagen. It regulates the permeability of the vascular wall, blood clotting, promotes regeneration processes, and promotes the formation of supporting tissues. Ascorbic acid helps activate the immune system, replenishes the increased need for vitamin C during flu and colds, and strengthens the body's defense mechanisms.
Pharmacokinetics: There are no relevant pharmacokinetic data.
Indication
Short-term reduction in the severity of symptoms of SARS and flu, including headache, fever, nasal congestion, sinusitis and associated pain, sore throat, body aches.
Application
The drug is intended for oral administration. Pour the contents of one sachet into a glass and add half a glass of hot water, mix well, add cold water if necessary. Take warm.
Adults and children over 12 years of age: single dose - 1 sachet. If necessary, the dose can be repeated every 4-6 hours. Do not take more than 4 sachets per day.
The interval between doses is at least 4 hours.
The course of treatment should not exceed 3-5 days. The duration of treatment is determined by the doctor.
Do not exceed the recommended dose.
Do not take simultaneously with other medicines containing paracetamol.
Contraindication
Hypersensitivity to any of the components of the drug.
Severe liver dysfunction, congenital hyperbilirubinemia, acute hepatitis, Gilbert's syndrome.
Blood diseases, glucose-6-phosphate dehydrogenase deficiency, leukopenia, anemia, thrombosis, thrombophlebitis.
Rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency.
Severe diseases of the cardiovascular system, including severe hypertension, severe atherosclerosis, ischemic heart disease, decompensated heart failure; conduction disorders; tendency to vasospasm.
Severe renal dysfunction, prostatic hypertrophy with difficulty urinating.
A state of increased arousal, sleep disturbances, epilepsy.
Hyperthyroidism, severe forms of diabetes mellitus, phenylketonuria.
Acute pancreatitis.
Angle-closure glaucoma.
Alcoholism.
Age up to 12 years; elderly.
Pregnancy and breastfeeding.
Simultaneous reception with:
MAO inhibitors and within 2 weeks after discontinuation of MAO inhibitors; tricyclic antidepressants; β-adrenergic blockers or other antihypertensive drugs; drugs that suppress or increase appetite; amphetamine-like psychostimulants.
Side effects
Immune system disorders: hypersensitivity reactions, including anaphylaxis, anaphylactic shock.
Skin and subcutaneous tissue disorders: allergic dermatitis, itching, skin and mucous membrane rashes (usually erythematous, urticaria), angioedema, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), purpura, hemorrhages.
From the nervous system: headache, tremor, paresthesia, feeling of fear, anxiety, nervous excitement, irritability, confusion, sleep disturbances, insomnia, drowsiness, sedation, depression, hallucinations, anxiety, tinnitus, vertigo, general weakness, dizziness, agitation; impaired concentration of attention during the next day, especially with insufficient sleep duration after taking the drug.
Gastrointestinal: nausea, vomiting, epigastric discomfort and pain, heartburn, decreased appetite, constipation, diarrhea, flatulence, dry mouth, oral mucosal ulcers, hypersalivation, hemorrhages.
On the part of the hepatobiliary system: increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect), impaired liver function.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
On the part of the organ of vision: mydriasis, impaired vision and accommodation, increased intraocular pressure.
On the part of the kidneys and urinary system: (when taking high doses) urination disorders, nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis), oliguria, aseptic pyuria.
From the cardiovascular system: increased blood pressure, heart pain, palpitations, sinus tachycardia, shortness of breath, edema, reflex bradycardia.
Respiratory, thoracic and mediastinal disorders: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
The drug may have a slight laxative effect.
Special instructions
Do not exceed the indicated doses.
Concomitant use with other drugs intended for the symptomatic treatment of colds and flu, vasoconstrictor drugs for the treatment of rhinitis, as well as drugs containing paracetamol should be avoided.
It is necessary to consult a doctor regarding the possibility of using the drug in patients with impaired kidney and liver function.
The risk of overdose occurs in patients with non-cirrhotic alcoholic liver disease. Avoid alcohol consumption during treatment.
It should be noted that patients with alcoholic liver disease are at increased risk of hepatotoxic effects of paracetamol; the drug may affect the results of laboratory tests for blood glucose and uric acid.
Patients who take analgesics every day for mild arthritis should consult a doctor.
Before using the drug, it is necessary to consult a doctor if the patient is using warfarin or similar drugs that have an anticoagulant effect.
Use of the drug by fasting individuals may pose a risk of liver damage.
The drug should be used with caution in people prone to high blood pressure and patients with bronchial asthma.
Use with caution in elderly patients, those with difficulty urinating, Raynaud's disease (which may manifest as pain in the fingers and toes in response to cold or stress). Phenylephrine, which is part of the drug, can cause angina attacks.
If, on the recommendation of a doctor, the drug is used for a long period, it is necessary to monitor the functional state of the liver and peripheral blood.
Patients with severe infections such as sepsis, accompanied by a decrease in glutathione levels, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should seek immediate medical attention if these symptoms occur.
If the headache becomes persistent, you should see a doctor.
If the signs of the disease do not disappear within 3 days of treatment or, conversely, the state of health worsens, you should consult a doctor.
Keep the drug out of the sight and reach of children.
Excipients: This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The drug contains Ponceau 4R (E124), so it may cause allergic reactions.
Use during pregnancy and breastfeeding. The drug is contraindicated during these periods.
Children. The drug is contraindicated in children under 12 years of age.
Ability to influence the reaction speed when driving or working with other mechanisms. During treatment, you should refrain from driving a car or machinery that requires increased concentration.
Interactions
The simultaneous use of the drug with other medicines containing paracetamol or other active substances included in the preparation Gripgo Hotmix should be avoided.
The peculiarities of the drug interaction are due to the properties of its components.
Paracetamol. The rate of absorption of paracetamol may increase with simultaneous use with metoclopramide and domperidone and decrease with cholesterol. The anticoagulant effect of warfarin and other coumarins may be enhanced with an increased risk of bleeding with simultaneous long-term regular daily use of paracetamol. With short-term use according to the recommended regimen, these interactions are not clinically significant.
Barbiturates reduce the antipyretic effect of paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine) that stimulate the activity of liver enzymes may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug into hepatotoxic metabolites.
The simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. With the simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases.
Phenylephrine hydrochloride. The interaction of phenylephrine with monoamine oxidase inhibitors causes a hypertensive effect, with tricyclic antidepressants (e.g. amitriptyline) - increases the risk of cardiovascular side effects, with digoxin and cardiac glycosides - leads to heart palpitations or myocardial infarction. Phenylephrine with other sympathomimetics increases the risk of adverse reactions from the cardiovascular system. Phenylephrine may reduce the effectiveness of β-blockers and antihypertensive drugs (reserpine, methyldopa) with an increased risk of hypertension and other adverse reactions from the cardiovascular system. α-blockers (phentolamine), phenothiazines, furosemide and other diuretics prevent vasoconstriction. Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride.
Ascorbic acid (vitamin C). Ascorbic acid when taken orally enhances the absorption of penicillin, iron, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. GCS increase the risk of glaucoma.
Vitamin C absorption is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks. Simultaneous administration of vitamin C and deferoxamine increases tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. Vitamin C can be taken only 2 hours after the injection of deferoxamine. Long-term administration of high doses by persons treated with disulfiram inhibits the disulfiram-alcohol reaction. High doses of the drug reduce the effectiveness of tricyclic antidepressants. High doses of the drug reduce the effectiveness of neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, disrupt the excretion of mexiletine by the kidneys, and affect the resorption of vitamin B12. Ascorbic acid when taken orally promotes the absorption of aluminum in the intestines, which should be taken into account when simultaneously treated with antacids containing aluminum.
Overdose
Symptoms. Signs and symptoms of overdose of individual components of the drug Gripgo Hotmix can be divided as follows.
Paracetamol-related. Liver damage is possible in adults who have taken ≥10 g of paracetamol and in children who have taken 150 mg/kg of body weight. In patients with risk factors (long-term use of carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes, alcohol abuse, insufficiency of the glutathione system, for example: digestive disorders, HIV infection, starvation, cystic fibrosis, cachexia) taking ≥5 g of paracetamol can lead to liver damage.
Symptoms of overdose in the first 24 hours: pale skin, nausea, vomiting, loss of appetite and abdominal pain. Liver damage may become apparent 12-48 hours after overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma and be fatal. AKI with acute tubular necrosis may manifest as severe lumbar pain, hematuria, proteinuria and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis have also been reported.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking high doses, dizziness, psychomotor agitation and disorientation are possible from the CNS; nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) from the urinary system.
Associated with phenylephrine hydrochloride. Overdose due to the action of phenylephrine can cause increased sweating, psychomotor agitation or depression of the central nervous system, headache, dizziness, drowsiness, impaired consciousness, cardiac arrhythmias, tachycardia, extrasystole, tremor, hyperreflexia, convulsions, nausea, vomiting, irritability, anxiety, increased blood pressure, hallucinations.
Treatment. In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or may lead to organ damage. Treatment with activated charcoal should be considered if the overdose was taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine can be used within 24 hours of ingestion, but the maximum protective effect occurs when it is used within 8 hours of ingestion.
The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be given N-acetylcysteine intravenously according to current recommendations. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
In addition to the above, symptomatic or supportive therapy is recommended.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
