Gripnut Hotmiks
Producer: Agio Pharmaceuticals Ltd. (Adzhio Pharmasyyutikals Ltd.) India
Code of automatic telephone exchange: N02BE51
Release form: Firm dosage forms. Powder for oral solution.
General characteristics. Structure:
Active ingredients: 750 mg of paracetamol, 10 mg of Phenylephrinum of a hydrochloride, 60 mg of ascorbic acid in 1 bag.
Excipients: anhydrous citric acid, saccharin of sodium, sodium citrate, sucrose, fragrance orange / fragrance lemon, dye yellow "sunset" (Е 110) / dye quinolinic yellow (Е 104).
Pharmacological properties:
Pharmacodynamics. The combined drug. Paracetamol blocks cyclooxygenase that leads to the termination of synthesis of prostaglandins, has febrifugal and analgeziruyushchy effect.
Phenylephrinum a hydrochloride – a stimulator preferential alpha 1 - adrenoceptors. Finds sudinozvuzhuyuchy effect, mainly concerning vessels of upper respiratory tracts, reduces raised слизоутворення and thus promotes elimination of a congestion of a nose. Ascorbic acid takes active part in organism redoxreactions. It stimulates tissue respiration, oxidizing phosphorylation in a liver, activates proteolytic and microsomal enzymes, promotes transition of folic acid to foliniyevy.
Ascorbic acid is necessary for synthesis of steroid hormones and procollagen. It regulates permeability of a wall of vessels, blood coagulations, promotes regeneration processes, influences formation of basic fabrics. Ascorbic acid promotes activation of immune system, fills the increased need for vitamin C at flu and catarrhal diseases, strengthens protective mechanisms of an organism.
Pharmacokinetics. Paracetamol quickly and almost is completely absorbed from digestive tract, is preferential in a small bowel. After a single dose in a dose of 500 mg the maximum concentration in a blood plasma is reached in 10-60 minutes. Paracetamol is quickly and evenly distributed in the majority of body tissues. About 25% of paracetamol in blood contact proteins of plasma. Paracetamol is metabolized by means of microsomal enzymatic system of a liver. About 80-85% of paracetamol in an organism are exposed to conjugation generally with glucuronic acid and to a lesser extent – with sulphuric acid. The elimination half-life makes 1-3 hours. Paracetamol is removed with urine generally in a look paracetamol glucuronide with small amounts paracetamol-sulfate and a merkaptata and in not changed look.
Phenylephrinum is unevenly absorbed from digestive tract and easily metabolized. After oral administration its action is shown in 15-20 minutes and remains within 2-4 hours. Bioavailability of Phenylephrinum low. Fenilefrin biotransformirutsya in intestines walls at absorption and in a liver. Less than 16% of the entered dose in not reversed look together with metabolites are almost removed with urine.
Ascorbic acid quickly and almost completely (70-90% of the accepted dose) is soaked up after oral administration. It is evenly distributed in body tissues, easily crosses a placental barrier, gets to breast milk. About 25% of ascorbic acid contact proteins of plasma. Ascorbic acid reversibly is oxidized to dehydroascorbic acid. A small amount of vitamin C is metabolized to inactive components, such as a disulphate of ascorbic acid and oxalic acid. Products of metabolism and a small amount of not changed substance are removed by kidneys.
Indications to use:
Symptomatic treatment of cold and flu which are followed by head and muscular pain, fever, dacryagogue, cold, a nose congestion.
Route of administration and doses:
At the first symptoms of flu or cold drug is used inside on 1 bag to 4 times a day with an interval of 4-6 hours. Before use contents of 1 bag are dissolved in a glass of hot water. Duration of use makes no more than 5 days.
Features of use:
Drug is not used along with monoamine oxidase inhibitors and with the drugs containing paracetamol and Phenylephrinum. It is necessary to appoint drug with care at arterial hypertension, to persons with heart diseases, at atherosclerosis of cerebral vessels, diseases of kidneys and a liver.
Drug contains sugar in number of 2895,92 mg in 1 bag therefore a sick diabetes mellitus it is necessary to use drug with extra care.
During treatment it is impossible to take alcohol.
Use during pregnancy or feeding by a breast. Not to use drug during pregnancy or feeding by a breast.
Ability to influence speed of response at control of motor transport or work with other mechanisms. During therapy it is not recommended to work with vehicles and mechanisms.
Children. Drug is not used to children age up to 12 years.
Side effects:
From skin and hypodermic cellulose: rash, itch, urticaria, multiformny exudative erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis.
From immune system: in isolated cases – an acute anaphylaxis, a Quincke's disease.
Neurologic frustration: a headache, dizziness, psychomotor initiation and disturbance of orientation, concern, nervous irritability, sensation of fear, irritability, a sleep disorder, sleeplessness, confusion of consciousness, depressions, a tremor, feeling of a pricking and weight in extremities, a sonitus.
From an organ of sight: vision disorder and accommodations, increase in intraocular pressure.
From system of digestion: nausea, vomiting, dryness in a mouth, discomfort and pain in epigastric area, hypersalivation, a loss of appetite, increase in activity of liver enzymes, гепатонекроз (at use of high doses).
From bodies of a hemopoiesis: anemia, a sulfhemoglobinemia and a methemoglobinemia, hemolitic anemia (especially for patients with deficit glyukozo-6-fosfatdegidrogenazy). At prolonged use in high doses – aplastic anemia, a pancytopenia, an agranulocytosis, a neutropenia, a leukopenia, thrombocytopenia.
From an urinary system: at use of high doses – nephrotoxicity (renal colic, intersticial nephrite, a papillary necrosis), disturbance of an urination.
From cardiovascular system: arterial hypertension, tachycardia or reflex bradycardia, asthma, heartaches.
Others: the general weakness, the strengthened sweating, a hypoglycemia.
Interaction with other medicines:
At simultaneous use of barbiturates, tricyclic antidepressants, and also ethanol increase in an elimination half-life of paracetamol is possible. Long reception of anticonvulsant drugs can reduce activity of paracetamol. Simultaneous use of high doses of paracetamol with an isoniazid increases risk of development of a hepatotoxic syndrome. Paracetamol reduces efficiency of diuretics. At simultaneous use of Phenylephrinum of a hydrochloride with atropine tachycardia can be observed.
Drug reduces hypotensive action of a guanetidin who, in turn, increases alpha адреностимулирующие activity of Phenylephrinum.
Paracetamol strengthens effect of indirect anticoagulants (coumarin derivatives). Metoclopramidum raises, and холестирамин reduces absorption speed. Barbiturates reduce febrifugal effect of drug. At simultaneous use with barbiturates, dipheninum, carbamazepine, rifampicin, inductors of makrosomalny enzymes of a liver the risk of a hepatotoxic action of paracetamol increases. At simultaneous use of paracetamol with a zidovudine toxicity of both medicines increases; the granulocytopenia is more often noted.
Interaction of Phenylephrinum with Mao's inhibitors causes hypertensive effect. Fenilefrin reduces efficiency of beta-blockers and anti-hypertensive drugs. Simultaneous use of MAO inhibitors exponentiates effects of Phenylephrinum.
Ascorbic acid strengthens penicillin absorption, reduces effect of heparin and anticoagulants of indirect action. At simultaneous use with salicylates the risk of emergence of a crystalluria increases.
Antidepressants, protivoparkinsonichesky and antipsychotic drugs, fenotiazinovy derivatives increase risk of development of an ischuria, dryness in a mouth, locks. Glucocorticosteroids increase risk of development of glaucoma.
Alcohol reduces therapeutic effect of paracetamol, and also can lead to development of acute pancreatitis.
Contraindications:
Hypersensitivity to drug components, heavy abnormal liver functions and/or kidneys, an inborn hyperbilirubinemia, deficit glyukozo-6-fosfatdegidrogenazy, the period of pregnancy or feeding by a breast, alcoholism, epilepsy, heavy arterial hypertension, unstable stenocardia, the acute period of a myocardial infarction, a hyperthyroidism, dekompensirovanny heart failure, disturbance of cordial conductivity, acute pancreatitis, a prostatauxe, severe forms of a diabetes mellitus, closed-angle glaucoma, the expressed anemia, a leukopenia, children's age up to 12 years.
Not to apply together with monoamine oxidase inhibitors (MAO) and within 2 weeks after phase-out of MAO inhibitors.
Overdose:
Overdose it is, as a rule, caused by paracetamol and it is shown by pallor of skin, anorexia, nausea, vomiting, an abdominal pain, gepatonekrozy, increase in activity of "hepatic" transaminases, increase in a prothrombin ratio.
Symptoms of damage of a liver are observed in 12-48 hours after overdose. There can be disturbances of metabolism of glucose and a metabolic acidosis. At a serious poisoning the liver failure can progress and lead to development of toxic encephalopathy with consciousness disturbance, in some cases – with a lethal outcome. The acute renal failure with an acute necrosis of tubules can develop even in the absence of severe damage of kidneys. Also cardiac arrhythmia was noted. Damage of a liver is possible at adults who accepted 10 g and more paracetamol and at children who accepted more than 150 mg/kg of body weight.
In case of overdose the increased sweating, psychomotor excitement or oppression of the central nervous system, drowsiness, consciousness disturbance, disturbance of a cordial rhythm, tachycardia, premature ventricular contraction, a tremor, a hyperreflexia, spasms can be observed.
Treatment: a gastric lavage with the subsequent use of absorbent carbon, symptomatic therapy. Methionine use orally or Acetylcysteinum it is intravenously effective within 48 hours after overdose. It is necessary to accept also general supporting actions. If necessary apply alpha adrenoblockers.
Storage conditions:
Period of validity - 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store at a temperature not over 25 ºС in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
On 5 g of powder in bags and cardboard packs.