Description
Trade name
Antiflu® Kids
International nonproprietary name
No
Dosage form
Powder with raspberry taste
Composition
1 sachet includes
active substance: acetaminophen 160 mg,
ascorbic acid 50 mg,
chlorpheniramine maleate 1 mg;
adjuvants:sugar (powdered sugar), sugar (sucrose), raspberry flavouring agent, lemon acid, silica dioxide, silica dioxide (syloid), tribasic sodium citrate (three- sodium citrate dehydrate), Titanium dioxide (E 171), tricalcium phosphate (tribasic calcium phosphate), amylum maidis, red colourant red FD&C No40 (Е 129).
Description
Free-flowing powder of white color with some gradations that includes crystalline particles with light raspberry odor.
Pharmacotherapeutic group
Analgesics.Analgesics- alexipyretic, etc. Anilides. Paracetamol, combination except for neuroleptics.
Code АТХ N02BE51
Pharmacological properties
Pharmacokinetics
Acetaminophen (paracetamol) is absorbed in upper bowels by passive diffusion, effective half-life (Т½) of acetaminophen is 2-2.5 hours. It is longer after large doses and fi taken by persons with hepatic disorders. Acetaminophen is excreted with urine (85% of single dose of acetaminophen is excreted within 24 hours).
Chlorpheniramine maleate is absorbed in small intestine, passes biological transformation in lever. Period of semielimination is 8 hours. Products of metabolism and non-metabolised part of the drug is excreted with urine.
Ascorbic acid is actively absorbed in small intestine. Maximal concentration in plasma after ingestion is in 4 hours. From plasma it easily transfers intoleucocytes, platelets and practically all tissues. Ascorbic acid is eliminated by way of excretion in unchanged form with urine as well as biological transformation in deoxy- ascorbic and diketogulon acid (the last one transforms into oxalic acid), excreted with urine.
Pharmacodynamics
Acetaminophen (paracetamol) has analgesic, antifebrile and slightly expressed antiphlogistic effect thanks to influence on heat regulating and inhibiting center of prostaglandin synthesis in central nervous system.
chlorpheniramine maleate – blocker of H1- histamine receptors, prevents fromactivity of one of main inflammatory mediators – histamine. It decreases penetrance of capillary wall, decreases intensity of local exudative occurrences, edema of mucosa of nose, pharyngonasal cavity, upper respiratory tracts, blear-eyedness.
Ascorbic acid (Vinamin C) has antioxidant characteristics, activates defence mechanisms, increases resistance of body to infections. It activates oxidation-reduction processes, stimulates regeneration processes, glucocorticoid synthesis and catecholamine; inspissates capillary wall (due to increased formation of intercellular substance and decrease activity of hyaluronidase).
Antiflu Kids decreases headache, muscle and joint pain, sore throat, eliminates rhinorrhea, irrigation in eyes and nose.
Indications
Children from 2 to 12 years
For elimination of symptoms of acute respiratory viral infection, flue and cold:
- increased body temperature, chill
- nasal congestion, sneezing
- blear-eyedness
- headache, muscle and joint pain
- sore throat and other symptoms of inflammation of upper respiratory tracts and paranasal sinus.
Dosage and methods of use
Take irrespective of meal. Prior taking, dissolve content of one sachet in 150 ml of warm water. Single dose for children of 2-6 years is 1 sachet, for children of 6-12 years – content of 2 sachet. If necessary repeatedly take each 4-6 hours but not more than 4 doses. Period of treatment shall not exceed 3 days. The further use is possible only under supervision of doctor.
Adverse reaction
In most cases the drug is well tolerated. The following adverse reactions can be observed:
Hematopoietic system: anemia, hemolytic anemia (in case if patient has glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia or agranulocytosis, thrombocytopenic purpura, leucocytopenia.
Respiratory apparatus: bronchospasm of patients with susceptibility to acetylsalicylic acid and other nonsteroidal antiinflammatory drug.
Digestive system: nausea, vomit, dryness of the mouth, pain in pit of the stomach, loss of appetite, dyspepsia, diarrhea.
Endocrine system: hypoglycaemia up to hypoglycemic coma.
Hepatobiliary system: increased activity of hepatic ferments (usually without symptoms of yellow sickness), hepatic necrosis (dose-dependent relationship).
Immune system: Hypersensitivity (allergic reactions, anaphylactic reaction, acute anaphylaxis).
Nervous system disorder:headache, dizziness, psychic tension, distribution of sleep, sleepiness, confusional state, abnormal behavior, convulsion, coma.
Sleepiness
Heart-vascular system: tachyrhythmia, breast-pang, hypertension, arrythmia
Visual organ disorders: impairment of vision, dry eye syndrome, mydriasis,ocular hypertension.
Disorders of urinary tracts: urinary difficulty, dysuria
Dermatopathy and areolar tissue: Irritation, rash, nettle rash, changes of mucosae,acute generalised exanthematous pustulosis, erythema multiforme (including Stereos-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome).
Contraindications
- increased individual sensibility to drug components
- signified liver and/or kidney function abnormality
- deprivation of enzyme of glucose-6-phosphate dehydrogenase
- Gilbert's syndrome
- hematopoietic dysfunction
- patients taking inhibitors of monoamine oxidase (MAO)
- fructose intolerance, malabsorption of glucose/ galactose or sucrase-isomaltase insufficiency
- children under 2 years
Drug interaction
The known following interactions are known for separate active ingredients.
Paracetamol:
- anticonvulsant drugs (phenytoin, barbiturates, carbamazepine), rifampicin and alhogol can increase hepatotoxicity of paracetamol;
- simultaneous use of high dosages of paracetamol with isoniaside or rifampicin can increase risk of development of hepatotoxic syndrome;
- rate of absorption of paracetamol can be increased by metoclopramide and domperidone and decreased by cholestyramine;
- simultaneous long use of coumarin derivatives (for example, warfarin) can strengthen their activity with increase of risk of bleeding; patients taking oral anticlotting agents shall consult with doctor. Monitoring of blood clotting is recommended;
- tropisetron and granisetron, antagonists of 5-hydroxy-tryptamine of type 3 can block analgesic effect of paracetamol;
- simultaneous use of paracetamol and zidovudine can lead to decrease of number of leucocytes (neutropenia);
Chlorphenamine maleate:
- inhibitors of monoamine oxidase (MAO) shall not be taken together with antihistaminic agents. They can prolong and strengthen anticholinergic effect of antihistaminic agents.
Special indications
It is not recommended to use together with sedative and sleeping aids.
The drug shall be taken in the following cases only after benefits/risks assessment by doctor:
- arterial hypertension
- heart rhythm disorder
- bronchial asthma
- pyloroduodenal stenosis
- hepatic disorders
- Gilbert's syndrome
- glaucoma
- diabetes mellitus
- epilepsy
- thyrotoxicosis
- inappropriate urination
- deficit of glutathione
- oxalatury
Do not exceed recommended dose and period of treatment. Long use of high doses can lead to damage of liver and kidneys; in case of alhogolism, alcoholic liver disease, sepsic or diabetes mellitus a concurrent use of a lot of drugs can increase risk of toxic disease of liver when paracetamol is prescribed in therapeutic dose. Paracetamol and ascorbic acid can alter indicators of laboratory researches (quantitative measurement of content of glucose and uric acid in plasma). Each sachet includes 11.59 g of sucrose that shall be taken into account during daily use in case of diet with low content of sugar or diabetes mellitus. Signs and symptoms of reaction of hypersensitivity can be hidden by chlorphenamine maleate. Take into account that chlorphenamine maleate can influence on results of skin tests.
Pregnancy and lactation period
Not applied
Effects on ability to drive and use potentially dangerous machines
Taking into account that the drug has sleepiness effect, it is required to prevent children from activities requiring enhanced concentration within 4 hours.
Overdosage
Symptoms of overdosage of paracetamol: within the first 24 hours paleness, nausea, vomit, abepithymia and stomach ache. Activation, dizziness, distribution of sleep can be observed in case of overdosage. There were individual cases of acute renal insufficiency in case of overdosage by paracetamol. In heavy cases there can be liver injury (hepatocellular necrosis) and liver function abnormality that can lead to encephalopathy, hepatic coma and death. Clinical signs of liver injury can appear from 12 to 48 hours after overdosage. Glucose metabolic disturbance and metabolic acidosis can be observed. Hepatic failure can be developed after use over 150 mg/kg. overdosage of chlorphenamine maleate is connected with antimuscarinic, extrapyramidal, gastrointestinal and central nervous system effects. Activation of nervous system effect of infants and children dominates over inhibition of nervous system effect that lead to ataxy, activation, tremor, psychosis,hallucinations and convulsions. Other symptoms of overdosage of children includes enlarged pupils, dryness of the mouth, paleness, deep coma and cardiorespiratory collapse.
Treatment: gastric lavage within the first 6 hours after overdosage by paracetamol. Cellulotoxic effects can be decreased by methionine or intravenous administration of N-acetylcysteine within eight hours after overdosage. Symptomatic treatment.
Form of output and packing
Powder is leakproof packed in sachet made of laminate material (paper/ polyethylene/foil/ polyethylene). 5 sachets together with medical use instruction in Kazakh and Russian is placed in cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf life
3 years.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Over the counter
Name of manufacturer/packer, country, address
Contract Pharmacal Corporation
135 Adams Ave, Hauppauge, NY 11788, USA
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact data (telephone, fax, e-mail) of the organization receiving claims (offers) from consumers regarding the quality of products on the territory of the Republic of Kazakhstan:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
tel.: +7 727 258 80 40, fax: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Name, address and contact data (telephone, fax, e-mail) of the organization responsible for post-registration supervision over the drug safety on the territory of the Republic of Kazakhstan:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax: +7 727 258 80 39
e-mail: pv.centralasia@bayer.com
