Instructions Astracitron powder for oral solution sachet 20 g No. 10
Composition
active ingredients: 1 sachet contains paracetamol 500 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg, ascorbic acid 50 mg;
excipients: citric acid, monohydrate; glucose, monohydrate; sodium citrate; silicon dioxide colloidal anhydrous; flavoring "Lemon"; dye "Yellow sunset FCF" (E 110).
Dosage form
Powder for oral solution.
Main physicochemical properties: white or almost white powder with a fruity odor.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics
Paracetamol has antipyretic, analgesic and mild anti-inflammatory effects. It inhibits the synthesis of prostaglandins in the central nervous system (CNS) and blocks the conduction of pain impulses.
Pheniramine maleate is a histamine H1 receptor blocker that reduces vascular permeability, eliminates tearing, and itching of the eyes and nose.
Phenylephrine hydrochloride is an α-adrenomimetic, has a vasoconstrictor effect, reduces swelling of the nasal mucosa and paranasal sinuses.
Ascorbic acid enhances the body's nonspecific resistance.
Pharmacokinetics
Paracetamol is well absorbed, crosses the placental barrier, penetrates to a small extent into breast milk, is metabolized by the cytochrome P450 system, is excreted by the kidneys, the half-life is 1–4 hours. The duration of action is 3–4 hours.
Pheniramine maleate is well absorbed from the digestive tract. It is metabolized in the liver by the cytochrome P450 system, the half-life is 16–18 hours, 70–83% is excreted by the kidneys.
The action of phenylephrine hydrochloride occurs quickly and lasts about 20 minutes. It is metabolized in the liver or in the digestive tract, and is excreted by the kidneys.
Ascorbic acid is rapidly absorbed from the digestive tract, metabolized in the liver, and excreted by the kidneys.
Indication
Symptomatic treatment of acute respiratory infections and influenza:
fever, headache, nasal congestion, runny nose, muscle aches and pains.
Contraindication
Hypersensitivity to the active substances or to other components of the drug; severe liver and/or kidney dysfunction; congenital hyperbilirubinemia; glucose-6-phosphate dehydrogenase deficiency; phenylketonuria, alcoholism; blood diseases; leukopenia; anemia; severe forms of arrhythmia, arterial hypertension, atherosclerosis, ischemic heart disease; hyperthyroidism; acute pancreatitis; prostatic hypertrophy with urinary retention; bladder neck obstruction; pyloroduodenal obstruction; bronchial asthma; angle-closure glaucoma; pheochromocytoma; thrombosis; thrombophlebitis; diabetes mellitus; epilepsy; states of increased excitement; sleep disorders, concomitant treatment with tricyclic antidepressants, β-blockers, other sympathomimetics, drugs that suppress or increase appetite, and amphetamine-like psychostimulants; use simultaneously and within 2 weeks after treatment with MAO inhibitors.
Interaction with other medicinal products and other types of interactions
The interaction of phenylephrine with MAO inhibitors causes a hypertensive effect, with tricyclic antidepressants (amitriptyline) - increases the risk of cardiovascular side effects, with digoxin and cardiac glycosides - leads to arrhythmias and heart attack, with other sympathomimetics increases the risk of adverse cardiovascular reactions and hypertension, may reduce the effectiveness of β-blockers and other antihypertensive drugs (reserpine, methyldopa, debrisoquine, guanethidine) with an increased risk of arterial hypertension and adverse cardiovascular reactions. Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.
Ascorbic acid when taken orally enhances iron absorption; increases the level of ethinyl estradiol, penicillins, tetracyclines; reduces the level of antipsychotics, phenothiazine derivatives in the blood; reduces the effectiveness of heparin and indirect anticoagulants; increases the risk of crystalluria in treatment with salicylates and the risk of glaucoma in treatment with glucocorticosteroids; large doses reduce the effectiveness of tricyclic antidepressants. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous administration increases iron toxicity, especially in the myocardium, which can lead to cardiac decompensation. Long-term administration of large doses during treatment with disulfiram inhibits the disulfiram-alcohol reaction. Absorption of ascorbic acid is reduced when taking oral contraceptives, drinking fruit or vegetable juices, and drinking alkaline drinks.
Pheniramine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, antiparkinsonian drugs, inhibits the effect of anticoagulants. Simultaneous use of pheniramine with hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics, alcohol can significantly increase its suppressive effect.
Application features
Do not exceed the recommended doses. If symptoms do not improve within 5 days or are accompanied by a high fever, fever lasting more than 3 days, rash or persistent headache, you should consult a doctor, as these phenomena may be symptoms of a more serious illness.
Due to the risk of severe liver damage in case of overdose, do not use simultaneously with other drugs for the symptomatic treatment of colds and rhinitis (vasoconstrictors and drugs containing paracetamol). Use with caution in Raynaud's disease, arterial hypertension, heart disease, arrhythmias, bradycardia, thyroid, liver and kidney diseases, acute hepatitis, glaucoma, chronic lung diseases, prostatic hypertrophy (since there is a risk of urinary retention), the elderly, with increased blood clotting, hemolytic anemia, chronic malnutrition, dehydration, stenosing peptic ulcer. The risk of hepatotoxicity increases in people with alcoholic liver damage and who abuse alcohol.
The drug contains: phenylephrine, which may cause angina attacks; sucrose, which is contraindicated in patients with intolerance and malabsorption of fructose, glucose-galactose or sucrose-isomaltose. If the patient has been diagnosed with intolerance to some sugars, consult a doctor before taking this medicine, use with caution in diabetics. May be harmful to teeth.
Before using the drug, you should consult a doctor if you have: liver or kidney diseases; taking warfarin or similar anticoagulants; taking analgesics every day for mild arthritis; bronchopulmonary diseases (asthma, emphysema, chronic bronchitis).
The drug may affect the results of laboratory tests for blood glucose, uric acid, creatinine, inorganic phosphates. The result of the study of occult blood in the stool may be negative.
In patients with severe infections (sepsis) in which glutathione levels are reduced, taking paracetamol increases the risk of metabolic acidosis, its symptoms are deep, rapid or difficult breathing, nausea, vomiting, loss of appetite, in which case you should immediately consult a doctor.
It is not recommended to take this drug at the end of the day, since ascorbic acid in large doses has a mild stimulating effect. Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, monitoring of kidney function and blood pressure is required.
With special caution, prescribe to patients with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia), with a history of nephrolithiasis (risk of hyperoxaluria and oxalate precipitation in the urinary tract after taking large doses of ascorbic acid).
Long-term use of large doses of ascorbic acid may accelerate its own metabolism, which is why paradoxical hypovitaminosis is possible after discontinuation of treatment. It should not be used simultaneously with other drugs containing vitamin C. Absorption of ascorbic acid may change in case of impaired intestinal motility, enteritis or reduced gastric secretion.
Excipients.
Sunset Yellow FCF (E 110) dye. May cause allergic reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since the drug may cause drowsiness and other adverse reactions from the nervous system and visual organs, it is not recommended to drive a car or operate complex mechanisms when using it.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy or breastfeeding. The effect of the drug on fertility has not been specifically studied. Preclinical studies have not revealed any special effect of paracetamol on fertility when used in therapeutic doses. Adequate studies of the effects of phenylephrine and pheniramine on reproductive toxicity in animals have not been conducted.
Method of administration and doses
The medicine is for use by adults and children over 14 years of age.
Dissolve the contents of the sachet in a glass of hot water (not boiling water) and drink. The drug can be taken again every 3–4 hours, but no more than 3 sachets per day.
The maximum period of use is 5 days.
Children
The drug is contraindicated in children under 14 years of age.
Overdose
Paracetamol: in the first 24 hours, pallor of the skin, nausea, vomiting, anorexia and abdominal pain appear. When taking large doses, disorientation, psychomotor agitation, dizziness, sleep disorders, heart rhythm disorders, pancreatitis, hepatonecrosis may occur. The first sign of liver damage may be abdominal pain, which does not always appear in the first 12–48 hours, but may occur later, up to 4–6 days after taking the drug. Liver damage, as a rule, occurs a maximum of 72–96 hours after taking the drug. Glucose metabolism disorders and metabolic acidosis, hemorrhages may occur. With prolonged use of high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia are possible.
In isolated cases, acute renal failure with tubular necrosis has been reported, which is possible even in the absence of severe liver damage, manifested by severe lumbar pain, hematuria, proteinuria. Nephrotoxicity is possible: renal colic, interstitial nephritis, capillary necrosis.
The use of 10 g or more of paracetamol in adults and more than 150 mg/kg of body weight in children, especially with alcohol, can lead to hepatocellular necrosis with the development of encephalopathy, hemorrhages, hypoglycemia, hepatic coma and death. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; alcohol abuse; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) the use of 5 g or more of paracetamol can lead to liver damage.
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 the risk of organ damage. Activated charcoal should be administered within the first hour after overdose. The concentration of paracetamol in the blood should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine can be used for 24 hours after ingestion of paracetamol, but the maximum effect occurs when used within the first 8 hours, after which its effectiveness decreases sharply. If intravenous N-acetylcysteine is necessary, it should be administered according to the established dose schedule. Alternatively, oral methionine can be used in the absence of vomiting in remote areas.
Phenylephrine: hyperhidrosis, psychomotor agitation or CNS depression, headache, dizziness, drowsiness, impaired consciousness, arrhythmias, tremor, hyperreflexia, convulsions, nausea, vomiting, irritability, restlessness, arterial hypertension; in severe cases - coma. To eliminate hypertensive effects, an alpha-receptor blocker can be used intravenously; for convulsions - diazepam.
Ascorbic acid: nausea, vomiting or diarrhea occur (which disappear after its withdrawal); bloating and abdominal pain, itching, skin rashes, increased excitability. Doses over 3000 mg can cause temporary osmotic diarrhea and gastrointestinal disorders, impaired zinc and copper metabolism, myocardial dystrophy, with prolonged use in large doses, inhibition of the function of the insular apparatus of the pancreas and glucosuria are possible. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the precipitation of oxalate stones.
Treatment is symptomatic: within the first 6 hours, it is necessary to wash the stomach, and within the first 8 hours, administer methionine orally or cysteamine or N-acetylcysteine intravenously.
Adverse reactions
Skin and subcutaneous tissue disorders: rash, itching, dermatitis, urticaria, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome.
Immune system disorders: hypersensitivity reactions, including anaphylactic shock, angioedema.
From the nervous system: headache, dizziness, tremor, anxiety, nervousness, irritability, feeling of fear, insomnia, drowsiness, confusion, hallucinations, psychomotor agitation, disorientation, depressive states, paresthesia, tinnitus, in some cases - coma, convulsions, dyskinesia, behavioral changes.
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and nonsteroidal anti-inflammatory drugs.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure, dry eyes.
On the part of the digestive tract: nausea, vomiting, heartburn, dry mouth, abdominal discomfort and pain, constipation, diarrhea, flatulence, anorexia, aphthae, hypersalivation, hemorrhages, irritation of the mucous membranes.
On the part of the hepatobiliary system: impaired liver function, hypertransaminasemia, usually without jaundice, hepatonecrosis (when using high doses).
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the blood and lymphatic system: anemia, including hemolytic, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart area), bruising or bleeding, thrombocytopenia, neutropenia, agranulocytosis, leukopenia, pancytopenia,
From the urinary system: nephrotoxicity, interstitial nephritis, capillary necrosis, dysuria, urinary retention and difficulty urinating, renal colic, renal failure.
From the cardiovascular system: arterial hypertension, tachycardia, bradycardia, palpitations, arrhythmia, shortness of breath, heart pain, angina attacks.
Others: general weakness, malaise.
Unlike second-generation antihistamines, the use of pheniramine is not associated with QT prolongation and cardiac arrhythmia.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 g per sachet. 10 sachets per cardboard box.
Vacation category
Without a prescription.
Producer
ASTRAPHARM LLC, Ukraine.
Location of the manufacturer and its business address
08132, Kyiv region, Kyiv-Svyatoshynskyi district, Vyshneve town, Kyivska st., 6.
