Pentaflucine for children (PENTAFLUCIN CHILD)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspGranules for solution for oral administration
Composition:

1 sachet (3 g) contains

Active substances:

ascorbic acid

0.05 g

diphenhydramine hydrochloride

0.01 g

calcium gluconate monohydrate

0.1 g

paracetamol

0.25 g

rutoside trihydrate

0.01 g

Excipients:

lemon acid

0.03 g

sucrose (sugar)

2.523 grams

sodium saccharinate dihydrate (saccharin soluble)

0.015 g

povidone (polyvinylpyrrolidone K17)

0.012 g
Description:

A mixture of granules of round, cylindrical or irregular shape, white, white with a creamy hue and a yellow-green color.

Pharmacotherapeutic group:ORZ and "colds" of symptoms remedy
ATX: & nbsp
  • Other combined drugs used for catarrhal diseases
    • Pharmacodynamics:

    Pentaflucin for children is a combined medicinal product and has antipyretic and anti-inflammatory effect.

    Paracetamol - has antipyretic, analgesic and weak anti-inflammatory effect. The mechanism of action is associated with inhibition of the synthesis of prostaglandins and a predominant effect on the center of thermoregulation in the hypothalamus.

    Ascorbic acid - plays an important role in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulability, tissue regeneration, and increases the body's resistance.

    Diphenhydramine hydrochloride - has antihistamine and anti-inflammatory action, as well as soothing and hypnotic.

    Calcium gluconate - is a source of calcium in the body.

    Rutozid - reduces permeability and fragility of capillaries, has antioxidant properties.

    Indications:

    Symptomatic treatment of influenza and other acute respiratory viral infections (ARVI), accompanied by the following symptoms: fever, chills, nasal congestion, sore throat and nasal sinuses, headache, joint and muscle pain.

    Contraindications:

    Hypersensitivity to paracetamol, ascorbic acid, diphenhydramine, calcium gluconate, rutoside or any of the components of the drug; deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption; severe dysfunction of the liver, kidney, angle-closure glaucoma, prostatic hyperplasia, stenosing peptic ulcer of the stomach and duodenum, stenosis of the bladder neck, epilepsy, hypercalciuria, nephrourolythiasis, sarcoidosis, simultaneous reception of cardiac glycosides, hypercalcemia, hyperoxaluria,pronounced changes in the rheological properties of blood, a deficiency of glucose-6-phosphate dydrogenase, children under 6 years of age, concurrent use of other paracetamol-containing drugs, diabetes mellitus.

    Carefully:

    Benign hyperbilirubinemia (Gilbert's syndrome), violations of the liver, kidneys of mild and moderate severity, diseases of the cardiovascular system, hypercoagulation, dehydration, diarrhea, bronchial asthma.

    Pregnancy and lactation:

    The use of the drug in the first trimester of pregnancy is contraindicated.

    In the II and III trimesters of pregnancy with caution, under strict medical supervision, only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

    If it is necessary to use the drug during breastfeeding, stop breastfeeding for the entire treatment period.

    Dosing and Administration:

    The drug is taken orally after a meal.

    Children from 6 to 10 years 1 packet 2 times a day.

    Children over 10 years old 1 packet 2-3 times a day.

    The contents of one sachet of the drug are dissolved in 1/2 cup (125 ml) of hot water (t=70 °C), cool (t= 50 ° C) and drink.Allowed a slight deposit in the glass. Apply freshly prepared mortar, mix before use.

    The interval between doses should be at least 4 hours.

    Do not give the drug to children under 6 without consulting a doctor.

    In patients with impaired liver or kidney function, the interval between doses should be at least 8 hours.

    Duration of admission without consulting a doctor is no more than 5 days when used as an anesthetic and 3 days as an antipyretic.

    Side effects:

    Ascorbic acid:

    From the urinary system: moderate pollakiuria (when taking a dose of more than 600 mg / day), with prolonged use of large doses - hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys.

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

    Allergic reactions: skin rash, skin hyperemia.

    Other: oppression of the insular pancreas function (hyperglycemia, glucosuria).

    Changes in laboratory indicators (thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia).

    Diphenhydramine:

    From the side of the cardiovascular system: lowering blood pressure, palpitations, tachycardia, extrasystole.

    From the respiratory system: dryness of the mucous membrane of the nose and throat, increased viscosity of phlegm, a feeling of compression in the chest or throat, sneezing, nasal congestion.

    From the nervous system: headache, sedation, drowsiness, dizziness, impaired coordination, weakness, confusion, anxiety, agitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, neuritis, convulsions.

    From the sense organs: impaired visual perception, diplopia, vertigo, tinnitus, acute labyrinths.

    From the digestive system: dryness of the oral mucosa, epigastric pain, anorexia, nausea, vomiting, diarrhea, constipation.

    From the genitourinary system: rapid or difficult urination, urinary retention, early menstruation.

    On the part of the organs of hematopoiesis: hemolytic anemia, thrombocytopenia, agranulocytosis.

    Allergic reactions: urticaria, drug rash, anaphylactic shock, photosensitivity.

    Other: increased sweating, chills.

    Calcium gluconate:

    Hypercalcemia.

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

    Paracetamol:

    From the digestive system: nausea, pain in epigastrium.

    On the part of the hematopoiesis system: anemia, thrombocytopenia, methemoglobinemia.

    Allergic reactions: Stevens-Johnson syndrome, skin rash, itching, urticaria, angioedema.

    With prolonged use in high doses, hepatotoxic and nephrotoxic effects are possible.

    Bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

    Rutozid:

    Allergic reactions: skin rash.

    From the digestive system: nausea, diarrhea, heartburn.

    From the nervous system: headache.

    From the side of the cardiovascular system: "tides" of blood to the face.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Taking 5 or more grams of paracetamol can lead to liver damage in patients who have the following risk factors: prolonged treatment with carbamazepine,phenobarbital, phenytoin, primidon, rifampicin, preparations of St. John's wort perforated or other drugs that stimulate liver enzymes; regular consumption of ethanol in excess quantities; Deficiency of glutathione (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

    Symptoms of an overdose of paracetamol: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction 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.

    Treatment: the affected person should be rinsed stomach, appoint adsorbents (Activated carbon) and see a doctor.

    Symptomatic therapy: In the first hour after the proposed overdose, it is advisable to use activated carbon inside.Four or more hours after the alleged overdose, a determination of the paracetamol concentration in the plasma is required (an earlier determination of the paracetamol concentration may be unreliable). Treatment with acetyl cysteine ​​can be carried out up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary acetylcysteine can be administered intravenously. In the absence of vomiting, an alternative option (in the absence of the possibility of rapid receipt of inpatient care) is the use of methionine inside. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

    Symptoms due to diphenhydramine: oppression or excitation (especially in children) of the central nervous system, depression, dilated pupils, dry mouth, upset of the functions of the gastrointestinal tract.

    Treatment: there is no specific antidote, the treatment is symptomatic.

    Symptoms of an overdose of ascorbic acid: diarrhea, nausea, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia. When using more than 1000 mg - headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the mucous membrane of the gastrointestinal tract, suppression of the function of the insulin pancreas apparatus (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis, damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possibly worsening trophism of tissues, increased blood pressure, hypercoagulation, development of microangiopathies). High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disruptions to the gastrointestinal tract, such as nausea, discomfort in the stomach.

    Treatment: symptomatic, forced diuresis.

    Symptoms of calcium overdose gluconate: hypercalcemia, chronic overdose may develop general and muscle weakness, depression, mental disorders, anorexia, nausea, vomiting, constipation, lowering blood pressure, disturbing the heart rhythm.

    Treatment: parenteral administration of calcitonin in a dose of 5-10 IU / kg / day in 500 ml of 0.9% sodium chloride solution for 6 hours.

    Rutozid. There is no information about overdose.

    Interaction:

    Inductors of microsomal oxidation enzymes in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, ethanol) increase the production of hydroxylated active metabolites of paracetamol and increase the risk of hepatotoxic action.

    Ascorbic acid: increases the concentration in the blood of benzyl penicillin and tetracyclines.

    At a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives).

    Reduces the effectiveness of heparin and indirect anticoagulants.

    Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous use with deferoxamine.

    Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce the absorption and absorption of ascorbic acid.

    With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%.

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

    With simultaneous use reduces the chronotropic effect of isoprenaline.

    Diphenhydramine: potentiates the action of ethanol and drugs that depress the central nervous system.

    Monoamine oxidase inhibitors increase the anticholinergic activity of diphenhydramine.

    Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning.

    Enhances the anticholinergic effects of drugs with m-cholinoblocking activity.

    Calcium gluconate: with concomitant use with quinidine, it is possible to slow intraventricular conduction and increase the toxicity of quinidine.

    Forms insoluble complexes with antibiotics of the tetracycline series and reduces the antibacterial effect.

    Slows the absorption of tetracyclines, digoxin, iron preparations for oral administration (the interval between their administration should be at least 2 hours).

    When combined with thiazide diuretics can increase hypercalcemia, reduce the effect of calcitonin in hypercalcemia.

    Reduces the bioavailability of phenytoin.

    Pharmaceutically incompatible with carbonates, salicylates, sulfates (forms insoluble or hardly soluble calcium salts).

    Reduces the effect of blockers of "slow" calcium channels.

    Paracetamol: reduces the effectiveness of uricosuric medicines.

    The concomitant use of paracetamol in high doses increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.

    Prolonged sharing of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.

    Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Metoclopramide increases the absorption of paracetamol.

    Domperidone has no effect on the concentration of paracetamol in the blood.

    Colestyramine slows down absorption of paracetamol.

    Ethanol, when combined with paracetamol, promotes the development of acute pancreatitis.

    Ethanol increases the risk of hepatotoxic effects of paracetamol when used concomitantly, especially when ego overdose.

    Paracetamol reduces the effectiveness of diuretic drugs.

    Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.

    Rutozid: the pharmacological effect is enhanced by ascorbic acid.

    Special instructions:

    With continued febrile syndrome, with the use of the drug for more than 3 days and pain syndrome for more than 5 days, a doctor's consultation is required.

    Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

    Simultaneous reception with ethanol is not recommended.

    Drinking plenty is recommended to reduce the risk of nephrourolythiasis.

    The composition of the drug includes sucrose, which should be taken into account for people suffering from diabetes. The maximum daily dose of the drug (3 sachets) contains about 7.5 g of sucrose, which corresponds to 0.6 XE.

    Effect on the ability to drive transp. cf. and fur:

    The drug causes drowsiness and disrupts the speed of the reaction, so during the treatment period it is necessary to refrain from driving transport and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Granules for solution for oral administration.

    Packaging:

    3 grams of granules per bag.

    Each 5 bags are fastened to the tape.

    For 5, 10 bags together with instructions for medical use put in a pack of cardboard.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the product after the expiration date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003181
    Date of registration:07.09.2015
    Date of cancellation:2020-09-07
    The owner of the registration certificate:URALBIOFARM, OJSC URALBIOFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspURALBIOFARM, OJSCURALBIOFARM, OJSCRussia
    Information update date: & nbsp28.01.2016
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