Instructions for Combigrip Dexa tablets No. 80
Composition
active ingredients: 1 tablet contains paracetamol 500 mg, caffeine 30 mg, phenylephrine hydrochloride 10 mg, chlorpheniramine maleate 2 mg, dextromethorphan hydrobromide 10 mg;
Excipients: corn starch, microcrystalline cellulose, povidone, magnesium stearate, talc, sodium starch glycolate (type A), croscarmellose sodium, green apple dye.
Dosage form
Pills.
Main physicochemical properties: uncoated tablets of green color with inclusions, oval shape, with a score, with imprints of "S" and "L" on the side where the score is.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Combined drug for the treatment of flu and colds. Has antitussive, antipyretic, analgesic, antiallergic and weak anti-inflammatory properties. Soothes dry unproductive cough. Eliminates symptoms of nasal congestion, runny nose, tearing, sneezing, headache, improves general well-being.
Paracetamol acts as an analgesic and antipyretic. The analgesic and antipyretic effects of paracetamol are associated with the drug's effect on the thermoregulatory center in the hypothalamus and its ability to inhibit prostaglandin synthesis.
Phenylephrine hydrochloride acts as a vasoconstrictor, reducing swelling of the nasal mucosa and paranasal sinuses.
Chlorpheniramine maleate has an antiallergic effect, relieves tearing and itching in the nose.
Caffeine has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers, increases mental and physical performance, reduces drowsiness, fatigue, and weakens the effect of drugs that depress the central nervous system.
Dextromethorphan hydrobromide is a centrally acting antitussive. It reduces the sensitivity of receptors and increases the threshold of sensitivity of the cough center to irritants from the respiratory tract. Therapeutically relieves the symptoms of dry cough, reduces irritation of the respiratory tract.
Pharmacokinetics.
Paracetamol is rapidly absorbed from the gastrointestinal tract, binds to plasma proteins. The half-life from plasma is 1-4 hours. It is metabolized in the liver to form paracetamol glucuronide and sulfate. It is excreted by the kidneys, mainly in the form of conjugation products, less than 5% is excreted unchanged.
Caffeine and its water-soluble salts are rapidly absorbed in the intestine (including the colon). The half-life from blood plasma is about 5 hours, in some individuals up to 10 hours. The main part is demethylated and oxidized. About 10% is excreted by the kidneys unchanged. In the body of full-term newborns and infants (aged 1.5-2 months) it is eliminated more slowly (T1/2 - from 80 to 26.3 hours, respectively).
Phenylephrine hydrochloride has low bioavailability due to uneven absorption and the influence of monoamine oxidase in the gastrointestinal tract and liver during the "first pass". It is excreted by the kidneys in the form of metabolites. Acidification of urine accelerates excretion from the body.
Chlorpheniramine maleate is absorbed relatively slowly from the gastrointestinal tract, the maximum concentration in the blood plasma is reached 2.5-6 hours after oral administration. Bioavailability is low and ranges from 25% to 50% of the amount taken. Chlorpheniramine undergoes metabolism during the "first pass" in the liver. Chlorpheniramine maleate is extensively metabolized in the liver with the formation of the metabolites desmethyl- and didesmethylchlorpheniramine. About 70% of it is bound to proteins in the blood plasma. Chlorpheniramine is distributed in all organs and tissues, passes through the blood-brain barrier. The component in unchanged form and metabolites are excreted mainly in the urine, the excretion depends on the pH of the urine and the degree of excretion; only traces are found in the feces. The duration of action is from 4 to 6 hours. More rapid and extensive absorption, more rapid elimination, and a shorter half-life have been noted in children.
Dextromethorphan hydrobromide is rapidly absorbed from the gastrointestinal tract. It is metabolized in the liver and excreted in the urine in unchanged form and as demethylated metabolites, including dextrorphan, which suppresses cough. The half-life of dextromethorphan hydrobromide is 4 hours.
Indication
Treatment of symptoms of influenza and acute respiratory viral infections (hyperthermia, headache, runny nose, cough) in adults and children aged 12 years and older.
Contraindication
Hypersensitivity to any component of the drug, other xanthine derivatives (theophylline, theobromine), opioids, antihistamines, sympathomimetic amines. Severe cardiovascular diseases, including uncompensated heart failure, conduction disorders, arrhythmias, severe atherosclerosis, tendency to vasospasm, severe ischemic heart disease; severe arterial hypertension. Severe liver and kidney dysfunction, prostate adenoma with difficulty urinating, bladder neck obstruction. Stenosing gastric and duodenal ulcer, pyloroduodenal obstruction; acute pancreatitis, epilepsy. Blood diseases (including severe anemia, leukopenia), hyperthyroidism, diabetes mellitus, bronchial asthma, angle-closure glaucoma, glucose-6-phosphate dehydrogenase deficiency, alcoholism, increased excitability, sleep disorders, congenital hyperbilirubinemia, pheochromocytoma, emphysema. Elderly age. Simultaneous use with tricyclic antidepressants, ß-blockers; with MAO inhibitors and for 2 weeks after stopping their use. Contraindicated in patients at risk of respiratory failure.
Interaction with other medicinal products and other types of interactions
Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. When used simultaneously with paracetamol, the following types of interactions may be observed: the elimination of antibiotics from the body may be slowed down; tetracycline increases the risk of anemia and methemoglobinemia caused by paracetamol; antacids and food reduce the absorption of paracetamol. With simultaneous long-term use, the anticoagulant effect of coumarins (e.g., warfarin) is enhanced. Barbiturates reduce the antipyretic activity of paracetamol. Anticonvulsants (phenytoin, barbiturates, carbamazepine), which stimulate microsomal liver enzymes and isoniazid, may increase the hepatotoxicity of paracetamol. When used simultaneously with hepatotoxic drugs, the toxic effect of drugs on the liver increases. Paracetamol reduces the effectiveness of diuretics.
The use of phenylephrine hydrochloride with indomethacin and bromocriptine can cause severe arterial hypertension; with sympathomimetic amines, digoxin and cardiac glycosides increases the risk of arrhythmias and myocardial infarction.
May reduce the effectiveness of ß-blockers and other antihypertensive drugs (reserpine, methyldopa) with an increased risk of arterial hypertension and adverse cardiovascular reactions.
Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride;
α-blockers (phentolamine), phenothiazines, furosemide, and other diuretics prevent vasoconstriction.
Chlorpheniramine maleate enhances the anticholinergic effect of atropine, antispasmodics, central nervous system depressants (tranquilizers, barbiturates), and antiparkinsonian drugs.
Do not use simultaneously with alcohol. Chlorpheniramine maleate, when used simultaneously with alcohol, potentiates the effects of each other.
Simultaneous use with hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics, and alcohol enhances the effect of chlorpheniramine maleate.
Maprotiline (a tetracyclic antidepressant) and other anticholinergic drugs: the anticholinergic effect of these drugs or antihistamines such as chlorpheniramine may be enhanced.
Caffeine, when used simultaneously, enhances the effect of analgesics-antipyretics (improves bioavailability), xanthine derivatives, α- and β-adrenomimetics, psychostimulants, thyroid-stimulating agents, and ergotamine (improves the absorption of ergotamine from the digestive tract).
Cimetidine, hormonal contraceptives, and isoniazid enhance the effects of caffeine.
Caffeine increases the likelihood of liver damage from hepatotoxic drugs.
Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics and sedatives, is an antagonist of anesthetics and other drugs that depress the central nervous system, a competitive antagonist of adenosine and ATP drugs; reduces the concentration of lithium in the blood.
Dextromethorphan hydrobromide should not be taken with enzyme inhibitors, including amiodarone, fluoxetine, haloperidol, paroxetine, propafenone, and thioridazine.
Ototoxic and photosensitizing drugs may increase side effects when used simultaneously.
Application features
Do not exceed recommended doses.
Do not use simultaneously preparations containing paracetamol and other anti-cold remedies; with sedatives, hypnotics. The risk of overdose increases in alcoholic liver diseases. During treatment, alcohol consumption should be excluded, which enhances the sedative effect of chlorpheniramine maleate and the hepatotoxicity of paracetamol.
If the symptoms of the disease do not disappear or the headache becomes constant, you should consult a doctor.
When using the drug, you should avoid excessive consumption of coffee, strong tea, other tonic drinks and medications containing caffeine. This may cause sleep problems, tremors, tension, irritability, and palpitations.
3 should be used with caution in compensated heart failure, patients at risk of seizures, patients with chronic obstructive airway diseases, persistent or chronic cough resulting from smoking or emphysema, when the cough is accompanied by excessive sputum secretion, patients with congenitally prolonged QT interval or in cases of prolonged use of drugs that can prolong the QT interval.
The drug may affect the results of laboratory tests for blood glucose. The use of the drug may cause a positive analytical result in doping control.
Before using the drug, you should consult a doctor if you are using warfarin or similar drugs that have an anticoagulant effect and in patients with impaired kidney and liver function.
Phenylephrine may cause increased heart rate, dizziness, or palpitations; patients should be warned accordingly.
In case of accidental overdose, the patient should immediately consult a doctor, even if his/her well-being has not worsened.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
During treatment, you should avoid driving vehicles, working with mechanisms and other dangerous activities.
Method of administration and doses
Adults and children over 12 years of age – 1 tablet 4 times a day no more often than every 3-4 hours. The drug is taken at least half an hour after meals.
The duration of treatment is no more than 5 days.
Children
The drug should be used in children over 12 years of age.
Overdose
Paracetamol in large doses causes hepatonecrosis. Clinical and biochemical signs of liver damage appear after 12-48 hours. Glucose metabolism disorders and metabolic acidosis may occur. In case of overdose, symptoms develop in the first 24 hours - pallor of the skin, nausea, vomiting, anorexia and abdominal pain. The activity of hepatic transaminases increases, the concentration of bilirubin increases and the level of prothrombin decreases. The use of 10 g or more of paracetamol by adults and more than 150 mg of paracetamol per kg of body weight by children can lead to hepatocellular necrosis with the development of encephalopathy with impaired consciousness, hepatic coma and death. In isolated cases, acute renal failure with acute tubular necrosis, manifested by pain in the lumbar region, hematuria, proteinuria, nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis), has been reported. Cardiac arrhythmias have also been noted. With prolonged use of high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, and myocardial dystrophy are possible.
In case of overdose, increased sweating, dizziness, psychomotor agitation or depression of the central nervous system, drowsiness, impaired consciousness, heart rhythm disturbances, tachycardia, extrasystole, tremor, hyperreflexia, convulsions, pancreatitis, and sleep disturbances may occur.
In patients with risk factors (long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) the use of 5 g or more of paracetamol can lead to liver damage.
Symptoms of overdose due to the action of phenylephrine and chlorpheniramine maleate: headache, hyperhidrosis, drowsiness, insomnia, behavioral changes, arrhythmias, tremor, seizures, hyperreflexia, dizziness, nausea, vomiting, irritability, restlessness.
In case of overdose with chlorpheniramine maleate, the condition may vary from depressed to excited (restlessness and convulsions). Atropine-like symptoms may be observed, including mydriasis, photophobia, dryness of the skin and mucous membranes, fever, intestinal atony; CNS depression is accompanied by respiratory disorders and cardiovascular disorders.
Symptoms of overdose of dextromethorphan hydrobromide: drowsiness, confusion, dizziness, ataxia, blurred vision, nystagmus, nausea, vomiting, irritability, hyperactivity, agitation and mental disorders. Very large doses can cause respiratory depression. Toxic psychosis (hyperactivity and hallucinations) was observed when taking 300 mg of dextromethorphan once.
Treatment of overdose: In case of suspected overdose, the patient should be taken to hospital. Intravenous acetylcysteine is administered within 24 hours after paracetamol ingestion, with the maximum effect being achieved within the first 8 hours after ingestion. Oral methionine may be administered within the first 8 hours after overdose.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including pruritus, rash (erythematous, urticaria), anaphylactic shock, angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis.
From the side of the central nervous system: psychomotor agitation and disorientation, anxiety, behavioral changes, feelings of fear, anxiety, irritability, sleep disturbances, insomnia, drowsiness, dizziness, confusion, hallucinations, depressive states, tremor, tingling and heaviness in the limbs, tinnitus, headache, in some cases - coma, convulsions, dyskinesia.
Respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure, dry eyes.
Gastrointestinal: decreased appetite, nausea, vomiting, dry mouth, hypersalivation, heartburn, discomfort and pain in the epigastrium, exacerbation of peptic ulcer, flatulence, diarrhea, constipation.
On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (when using high doses), hepatotoxicity.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the blood and lymphatic system: anemia, including hemolytic anemia, bruising or bleeding; sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain).
With prolonged use in high doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.
On the part of the kidneys and urinary system: when using high doses - nephrotoxicity (including papillary necrosis), urination disorders, urinary retention and difficulty urinating, dysuria, interstitial nephritis, increased creatinine clearance, increased sodium and calcium excretion, aseptic pyuria, renal colic.
Cardiovascular system: arterial hypertension, tachycardia or reflex bradycardia, arrhythmia, shortness of breath, heart pain.
Others: general weakness, increased sweating, hypoglycemia, which may progress to hypoglycemic coma, nasal congestion, possible false increase in uric acid in the blood, determined by the Bittner method; slight increase in 5-hydroxyindoleacetic acid, vanillylmandelic acid and catecholamines in the urine.
The excipients methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed) and in some cases bronchospasm.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
4 tablets in a blister made of aluminum foil and polyvinyl chloride film. 1 blister in a cardboard pack.
8 tablets in a blister of aluminum foil and polyvinyl chloride film. 1 blister in a cardboard pack. 10 packs are placed in a group cardboard pack.
4 tablets in an aluminum foil blister. 1 blister in a cardboard pack.
8 tablets in an aluminum foil blister. 1 blister in a cardboard pack. 10 packs are placed in a cardboard group pack.
Vacation category
Without a prescription.
Producer
Optimus Generics Limited.
Location of the manufacturer and its business address
Plot No. S-8, S-9, S-13 and S-14, A.P.I.C, S.I.Z Pharma, Green Industrial Park, Polepally (BI), Yedcherla (EM), Mahabubnagar, IN - 509 301, India/
Plot No. S-8, S-9, S-13 & S-14, APIIC, Pharma Sez, Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, In-509 301, India.
