Grippotsitron powder

General characteristics. Structure:

GRIPPOTSITRON FORTE

time. for оральн. solution package of 4 g, No. 10

Paracetamol	650 mg
Ascorbic acid	50 mg
Pheniramine maleate	20 mg
Phenylephrinum hydrochloride	10 mg

No. UA/1470/01/02 from 30.12.2009 to 30.12.2014

GRIPPOTSITRON OF JOTAS LEMON

time. for оральн. solution package of 4 g, No. 5, No. 10

Paracetamol	500 mg
Ascorbic acid	50 mg
Phenylephrinum hydrochloride	10 mg
Pheniramine maleate	20 mg

No. UA/10174/01/01 from 22.10.2009 to 25.06.2014

GRIPPOTSITRON OF ORANZH JOTAS

time. for оральн. solution package of 4 g, No. 5, No. 10

Paracetamol	500 mg
Ascorbic acid	50 mg
Phenylephrinum hydrochloride	10 mg
Pheniramine maleate	20 mg

No. UA/1470/01/01 from 25.06.2009 to 25.06.2014

Pharmacological properties:

Pharmacodynamics. Grippotsitron — febrifugal, anesthetic, the antihistaminic, vasoconstrictive, anti-inflammatory combined medicine. The pharmacological effect is caused by action of the components which are a part of drug — paracetamol, ascorbic acid, pheniramine of a maleate and Phenylephrinum of a hydrochloride.
Paracetamol inhibits synthesis of prostaglandins and other mediators of pain and an inflammation is preferential in TsNS. To a lesser extent influences a peripheral nervous system, blocking carrying out painful impulses. Renders the febrifugal, anesthetizing and weak antiinflammatory action.
Ascorbic acid (vitamin C) compensates the increased need of an organism for vitamin C at respiratory infections, increases nonspecific resistance of an organism. Has antioxidant properties, takes part in regulation of oxidation-reduction processes, carbohydrate metabolism, reduces the need for B1, B2, A, E vitamins, folic acid, pantothenic acid. Improves portability of paracetamol and increases the period of its action (T1/2).
Pheniramine a maleate — a blocker histamine H1 receptors on effector cells, have antiallergic effect, reduce vascular and fabric permeability of mucous membranes of upper respiratory tracts, prevent edematization of fabrics, reduce expressiveness of local exudative processes, eliminate dacryagogue, an itch in eyes and a nose.
Phenylephrinum a hydrochloride — a sympathomimetic, a stimulator preferential? - adrenoceptors, has moderate vasoconstrictive effect, promoting elimination of hypostasis of mucous membranes of upper respiratory tracts and okolonosovy bosoms, reduction of a rhinorrhea, dacryagogue and improvement of nasal breath.

Pharmacokinetics. Paracetamol after intake is quickly and almost completely soaked up in a GIT, is preferential in upper parts of intestines.
Cmax in a blood plasma is reached in 30–60 min. Communication with proteins of a blood plasma — 25%. Gets through a placental barrier, an insignificant part is excreted in breast milk.
95% of paracetamol are metabolized in a liver by sulfo-and glyukuronokonjyugation with formation of sulfate and a glyukorunid, and also oxidation by system of tsitokhrom P450. Depending on concentration in a blood plasma partially is exposed to deacetylation or a hydroxylation. At use in therapeutic doses of T? makes 1–4 h. At reception of a dose of 650 mg of Cmax in a blood plasma makes 5–20 mkg/ml. Action duration — 3–4 h. The main way of removal — with urine (90–100% during 24 h), in the form of conjugates of glucuronides (60%), sulfates (35%) or cysteine (3%); less than 3% are excreted in not changed state.
Ascorbic acid is well soaked up in a small intestine. Bioavailability makes about 70%. Level of linkng with proteins of a blood plasma low. Collects in a blood plasma and cells, Cmax is created in ferruterous fabrics. It is metabolized preferential in a liver. It is removed in the form of metabolites, partially — in not changed look, generally with urine, and also with a stake, then, breast milk.
Pheniramine the maleate is well soaked up in a GIT. Cmax in a blood plasma is reached in 1–2,5 h. Biotransformation occurs in a liver by oxidation by system of tsitokhrom P450; T1/2 makes 16–19 h. It is allocated generally with kidneys, with urine in not changed state or in the form of metabolites 70–83% of the dose accepted inside are removed. Fenilefrin at intake is badly soaked up in a GIT, characterized by low bioavailability. Action comes quickly and about 20 min. last. Is exposed to biotransformation with the participation of MAO in an intestines wall, and also to presistemny metabolism in a liver. It is allocated with kidneys.

Indications to use:

Symptomatic treatment of infectious and inflammatory diseases (flu, SARS, catarrhal diseases) which are followed by the increased body temperature, a fever, a headache, cold, a rhinedema (rhinitis), sneezing and muscle pain (ache) and also allergic rhinitis, a nasopharyngitis.

Route of administration and doses:

Inside to adults and children at the age of 12 years (Grippotsitron Hot a lemon) and 14 years (Gippotsitron Frote) on 1 bag each 4–6 h, but is no more than 3 packages in days. Before use to dissolve contents of 1 package in a glass of boiled hot water (not boiled water); to accept warm.
Treatment duration — up to 5 days (but no more).

Features of use:

It is not necessary to exceed the recommended dose or to use drug more than 5 days in a row. <> rb Long use of paracetamol in a high dose, including the general high levels of doses, can cause a nephropathy and development of a liver failure, sometimes irreversible. Contraindicated simultaneous use with other drugs containing paracetamol.

For prevention of toxic damage of a liver during administration of drug it is not necessary to take alcoholic drinks.

Due to the vasoconstrictive influence of Phenylephrinum patients of advanced age need to take with caution drug with cardiovascular diseases. Take drug at a prostate hyperplasia, diseases of a thyroid gland, liver and kidneys, at an alcoholism with caution.

It is not necessary to use drug to patients who take a therapy course using other medicines, in particular MAO inhibitors.

Drug contains lactose owing to what it with care is appointed to patients with a hereditary lactose intolerance, a galactosemia and disturbance of absorption of a glucose/galactose.

Phenylephrinum can cause a pseudo-positive take when carrying out a drug test at athletes.

Only the doctor resolves an issue concerning a possibility of use and purpose of drug in the following cases:

– at AG, heart diseases and a thyroid gland, glaucoma, OH and other chronic diseases of lungs, a prostatauxe;

- chronic diseases of a liver and kidneys;

- alcoholism.

At preservation of symptoms of a disease, despite administration of drug more than 5 days, it is necessary to stop treatment and to see behind consultation a doctor for clarification of expediency of further administration of drug and additional inspection.

Not to exceed the dose specified in the instruction.

Use during pregnancy and feeding by a breast.

Drug is contraindicated during pregnancy. In need of drug use feeding by a breast should be stopped.

Children: see CONTRAINDICATIONS.

Ability to influence speed of response at control of vehicles or work with other mechanisms. At Grippotsitron Forte's use it is not recommended to manage vehicles and to work with difficult mechanisms as drug can cause drowsiness.

Side effects:

Drowsiness, dizziness, dryness in a mouth or a throat, fatigue, a headache, sleeplessness, irritability or nervousness, tachycardia and a heart consciousness, allergic reactions (skin rash, an itch, a small tortoiseshell) are possible. Seldom (it is preferential at children) excitement and a sleep disorder. From a GIT: nausea, vomiting, lock, diarrhea or meteorism.

The side reactions connected with effect of paracetamol:

allergic reactions — occasionally urticaria, an itch, skin rash, rash on mucous membranes, a Quincke's disease, a multiformny exudative erythema (including Stephens's syndrome — Johnson), a toxic epidermal necrolysis (Lyell's disease);

from TsNS: psychomotor initiation and disturbance of orientation (usually develops at reception in high doses);

from a GIT: occasionally — pain in epigastriums, nausea, increase in activity of hepatic transaminases, as a rule, without development of jaundice, гепатонекроз (dozozavisimy effect); at long use, especially in high doses, perhaps hepatotoxic action;

from bodies of a hemopoiesis: occasionally — thrombocytopenia, a leukopenia, a neutropenia; in isolated cases — an agranulocytosis; at long use, especially in high doses, anemia (hemolitic and aplastic), a pancytopenia, a methemoglobinemia, a sulfhemoglobinemia is possible;

from an urinary system: at long use, especially in high doses, perhaps nephrotoxic action (including renal colic, intersticial nephrite, a capillary necrosis);

others: occasionally — decrease in the ABP level; at patients with intolerance of acetylsalicylic acid (at OH in the anamnesis) sometimes hypersensitivity reactions.

The side reactions connected with sympathomimetic action of Phenylephrinum: slight increase of the ABP (especially at patients with AG), reflex bradycardia, a mydriasis; ischuria and difficulty of urination; influence on endocrine and other systems participating in metabolism is possible.

The side reactions connected with peripheral anticholinergic influence of pheniramine: dryness in a mouth, dryness of a mucous membrane of eyes, an urination delay, difficulty of urination at men.

The side reactions connected with the central influence of pheniramine: drowsiness, in isolated cases — a coma, epileptic attacks, dyskinesia, change of behavior.

Interaction with other medicines:

Strengthens effects of MAO inhibitors, sedative medicines, ethanol. The concomitant use with MAO inhibitors is not recommended or if there passed less than 2 weeks after the termination of therapy by them.
Drug reduces hypotensive action of a guanetidin who, in turn, increases α-adrenostimuliruyushchy activity of Phenylephrinum.
The risk of a hepatotoxic action of drug amplifies at simultaneous use of barbiturates, tricyclic antidepressants, rifampicin, an isoniazid, and also at alcohol intake. Simultaneous use with GKS increases risk of development of glaucoma in genetically predisposed patients, with NPVP — risk of side reactions from an urinary system. Antidepressants, protivoparkinsonichesky and antipsychotic medicines, fenotiazinovy derivatives increase risk of an ischuria, dryness in a mouth, locks.
Long reception of anticonvulsant drugs can reduce efficiency of paracetamol. Paracetamol reduces efficiency of uricosuric medicines, increases effect of indirect anticoagulants, increases chloramphenicol T½. Paracetamol and пробенецид exert mutual impact on metabolism.
Phenylephrinum can be the cause of undesirable reactions of interaction with MAO inhibitors, blockers α-and β-adrenoceptors, the antihistaminic drugs derivative of a fenotiazin (promethazine), bronkhodilatatorny sympathomimetic means, tricyclic antidepressants (Imipraminum), guanetidiny or atropine, foxglove drugs, Rauwolfia alkaloids, indometacin, metildopy, other means stimulating TsNS and with theophylline. In isolated cases increase in vasoconstrictive effect at simultaneous use with stimulators of patrimonial activity and arrhythmias — was noted at use with anesthetics. Perhaps substantial increase of the ABP at simultaneous intravenous administration of alkaloids of an ergot.
Pheniramine exponentiates effect of medicines, the oppressing TsNS (MAO inhibitors, tricyclic antidepressants, protivoparkinsonichesky means, barbiturates, tranquilizers, drugs), and also alcohol. Pheniramine can oppress effect of anticoagulants and interact with progesterone, Reserpinum, thiazide diuretics. Simultaneous use of oral contraceptives can lead to decrease in efficiency of an antihistaminic component. Ethanol strengthens sedative effect of pheniramine.
Tricyclic antidepressants strengthen sympathomimetic effect of drug, simultaneous use of a halothane increases risk of development of ventricular arrhythmia.

Contraindications:

The increased individual sensitivity to drug components; a serious cardiovascular illness, the expressed AG, ventricular tachycardia, a heavy liver and/or renal failure, prostate adenoma with the complicated urination, obstruction of a neck of a bladder, piloroduodenalny obstruction, the stenosing round ulcer of a stomach and duodenum, a disease of lungs (including OH), closed-angle glaucoma, deficit glyukozo-6-fosfatdegidrogenazy, epilepsy, blood diseases; period of pregnancy and feeding by a breast; children's age up to 12 years for drug Grippotsitron Hot a lemon; children's age up to 14 years — to Grippotsitron Forta.

Overdose:

In case of exceeding of the recommended doses the overdose caused generally by effect of paracetamol and Phenylephrinum can be observed.
Paracetamol overdose symptoms: pallor of integuments, loss of appetite, nausea, vomiting; the hepatotoxic effect, in hard cases develops a liver necrosis (expressiveness of a necrosis owing to intoxication directly depends on extent of overdose). The first symptoms of hepatotoxic effect can appear during 24–48 h or later, after overdose, and include nausea, vomiting and pain in epigastric area; the developed clinical picture of damage of a liver is shown in 1–6 days. Use of paracetamol in high doses (10–15 g) can cause development of a liver failure. Seldom liver failure develops immediately and can be complicated by a renal failure (a tubular necrosis).
Symptoms of overdose of Phenylephrinum: drowsiness which can be replaced by excitement (especially at children), a vision disorder, nausea, vomiting, a headache, blood circulation disturbance, coma, spasms, change of behavior, increase in the ABP, bradycardia, an atropinopodobny syndrome.
Treatment: drug withdrawal, gastric lavage, reception of absorbent carbon. In hard cases oral administration or in/in introduction of N-Acetylcysteinum as paracetamol antidote, monitoring of a condition of respiratory and cardiovascular systems (it is impossible to apply Epinephrinum). In case of spasms appoint diazepam.

Storage conditions:

To store at a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging: