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The description is actual on 16.10.2014
- Latin name: Caffetin Cold
- ATH code: R01BA52
- Active ingredient: Dextromethorphan + Paracetamol + Pseudoephedrine + Ascorbic acid (Dextromethorphan + Paracetamol + Pseudoephedrine + Ascorbic acid)
- Producer: ALKALOID of the joint-stock company, Republic of Macedonia
Structure Kaffetin Kold
Kaffetin Kold as active agents contains in each tablet:
- 500-555 mg of paracetamol (in the form of granules which consist for 90% of paracetamol, and also excipients: 8,4% of prozhelatinizirovany starch, 0,6% of povidone, 1% of stearic acid);
- 30 mg of a hydrochloride of pseudoephedrine;
- 15 mg of hydrobromide of dextromethorphan;
- 60-62 mg of ascorbic acid (granulate which contains 97% of ascorbic acid and 3% of a gidroksipropilmetiltsellyuloza is used).
As excipients as a part of Kaffetin Kold use colloid silicon dioxide, magnesium stearate, croscarmellose sodium, microcellulose and talc.
The film cover is made of blue Opadry II (E132 — indigo carmine), a macrogoal, the polyvinyl alcohol which is (partially hydrolyzed) of titanium dioxide (E171) and talc.
Drug Kaffetin Kold is issued in the form of blue, oblong, biconvex, film coated tablets, on each tablet on one of the parties is risk.
Each 10 tablets place in the perforated blister which part aluminum foil and a transparent three-layered film is. Blisters on 1 piece display in cardboard packs.
Kaffetin Kold has antibechic and analgeziruyushchy effect.
Pharmacodynamics and pharmacokinetics
Effect of drug is caused by total action of components of drug:
- Paracetamol causes anesthetic and febrifugal action. It blocks cyclooxygenase in the central nervous system, by impact on the centers of thermal control and pain. A distinctive feature of paracetamol from non-steroidal anti-inflammatory drugs is almost total absence of antiinflammatory effect. It does not irritate a mucous membrane of a stomach and intestines and does not influence course of a water salt metabolism as does not make impact on synthesis of prostaglandins in peripheral body tissues.
- Pseudoephedrine has the narrowing effect on the vessels which are in a mucous membrane of a nasal cavity and a throat considerably reduces hypostasis thanks to what secretion in a nasal cavity decreases and nasal breath is facilitated.
- Dextromethorphan influences the tussive center – has the raising effect on a tussive threshold, thereby reduces dry cough which is connected with irritation at cold of a mucous membrane of a nose and throat.
Ascorbic acid – recovers a lack of vitamin C which is often observed during catarrhal diseases.
The considerable part of paracetamol is soaked up in a small intestine, and the maximum concentration in a blood plasma is reached during the period of half an hour till one and a half o'clock after administration of drug inside.
The paracetamol metabolism (about 90-95%) occurs in a liver: from 80% of substance inactive metabolites owing to a conjugation test with sulfates and glucuronic acid are formed, 17% are hydroxylated and form 8 active substances metabolites which have then a conjugation test to glutathione as a result of which already inactive metabolites are formed.
In case of a lack of glutathione the formed metabolites can have the blocking effect on fermental systems of cells of a liver and provoke their death. Also CYP2E1 isoenzyme takes part in a metabolism. The elimination half-life makes of an organism from 1 to 4 hours. Drug by kidneys as metabolites, mainly in the form of conjugates is removed, only about 3% are brought from them invariable. In old age decrease in clearance of drug and increase in an elimination half-life is possible.
Pseudoephedrine is quickly soaked up after reception of tablets inside, the maximum concentration in a blood plasma is reached in 1,5–2 hours. The elimination half-life from a blood plasma is equal about 5,5 hours. The pseudoephedrine metabolism partially occurs in a liver — the active metabolite which then is brought out of an organism with urine is formed.
Dextromethorphan absorption after it got to an organism, happens quickly, and the maximum concentration in blood comes approximately in 2 hours after reception of tablets. The metabolism of dextromethorphan passes in a liver. The metabolite is removed with urine in not changed look and in the form of metabolites.
Ascorbic acid is soaked up in a digestive tract and is fast is distributed on body tissues. It is oxidized to degidroksiaskorbinovy acid (reversibly), and the part of amount of the ascorbic acid which came to an organism is metabolized in substance ascorbate-2-sulfate. Ascorbic acid is removed from an organism together with urine.
Indications to use
Apply to a symptomatic treatment of catarrhal diseases and flu (in the presence of a headache, muscular pain, pains in a throat, at the increased body temperature, dry cough, cold, a congestion of a nose and okolonosovy bosoms).
To drug use Kaffetin Kold refer existence to contraindications:
- hypersensitivity to this drug or to any of its components;
- diagnosis of arterial hypertension, coronary heart disease or stenocardia;
- heavy disturbances of functions of a liver or kidneys, and also hepatitis;
- the simultaneous use of inhibitors of monoaminoxidase, antidepressants, medicines used in protivoparkinsonichesky therapy or uses of inhibitors of monoaminoxidase within the last 2 weeks prior to Kaffetin Kold's reception;
- inborn deficit glyukozo-6-fosfatdegidrogenazy;
- lactation period;
- age less than 12 years.
It is necessary to be careful in administration of drug at:
- high-quality hyperbilirubinemia (including at Gilbert's syndrome);
- viral hepatitis;
- prostate hyperplasia (especially if at the same time the ischuria is observed);
- diabetes mellitus;
- to bronchial asthma;
- chronic obstructive pulmonary disease;
- general exhaustion.
Side effect of drug can be shown by various symptoms from almost all systems of an organism:
- the alimentary system – emergence of nausea, dryness in a mouth is possible, pain in epigastriums is sometimes observed; in cases of prolonged use in high doses gepatotoksichny effect of drug is shown;
- the central nervous system – side effect of drug is shown by drowsiness, irritability, excitement; in certain cases – dizziness;
- allergic reactions in the form of skin rash, a skin itch, the small tortoiseshell, a Quincke's disease can be observed;
- the cardiovascular system – sometimes raises arterial pressure, emergence of tachycardia is possible;
- bodies of a hemopoiesis – development of anemia, thrombocytopenia, an agranulocytosis is occasionally observed if drug is accepted long and the probability of development of hemolitic anemia, aplastic anemia, a pancytopenia increases in a large number;
- urinary system — at the long period of use of drug in a large number Kaffetin has nephrotoxic effect which can be shown by renal colic, development of intersticial nephrite, a papillary necrosis).
Application instruction (Way and dosage)
Kaffetin Kold is intended for intake.
The drug dose intended for adults and children at the age of more than 12 years is equal to 1 tablet, reception is repeated by 4 times in a day. Reception and 2 tablets for once is allowed. The interval between receptions does not owe not less than 4 hours. The single dose should not be more than 2 tablets, the dose should not make per day more than 8 tablets.
If temperature is increased more than 3 days from the moment of the beginning of drug intake, and cough does not pass within 5 days, it is necessary to ask for medical assistance.
At overdose emergence of nausea, a ring in ears, pain in a stomach is observed, sweating increases, skin becomes pale, heartbeat becomes frequent.
At overdose it is necessary to wash out a stomach. Then it is necessary to accept the dose of absorbent carbon corresponding to weight. If there is a need, it is necessary to carry out symptomatic therapy.
The simultaneous use of paracetamol in high doses strengthens effect of anticoagulating medicines.
Administration of drugs, belonging to inductors of a microsomal oxidation which occurs in a liver (Phenytoinum, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), and gepatotoksichny medicines increases formation of hydroxylated active metabolic products of paracetamol, and it causes probability emergence of heavy intoxication even at reception of a small dose of drug.
Long use of barbiturates lowers effect of reception of paracetamol.
The combination of reception of paracetamol in a large number and salicylates (especially cases of prolonged simultaneous use) increases probability of development of cancer diseases of kidneys or a bladder.
Long combined use of paracetamol and non-steroidal anti-inflammatory drugs increases risk of emergence of an analgetic nephropathy or renal papillary necrosis, considerably brings closer the moment of approach of an end-stage of development of a renal failure.
Reception of a diflunisal which possesses property to increase plasma concentration half leads to increase of risk of development of gepatotoksichny effect of drug.
Simultaneous use of pseudoephedrine and other sympathomimetic medicines can have the additive effect, promote development of toxic effects. The pseudoephedrine combination to inhibitors of monoaminoxidase can lead to development of hypertensive crisis. Therefore use of drug is authorized not earlier, than in two weeks after reception of inhibitors of monoaminoxidase was stopped.
The concomitant use of propranolol can strengthen the pressor effect rendered by pseudoephedrine. Also at the use of pseudoephedrine reduction of hypotensive effect of such drugs as Reserpinum, Methyldopum, Mekamilamin and alkaloids of a false hellebore is possible.
Terms of sale
Is on sale in the presence of the recipe.
It is necessary to store at a temperature which is not exceeding 25 °C.
Period of validity
It is suitable during 2 flyings.
During use of drug it is necessary to watch indicators of peripheral blood, a functional condition of a liver.
During the period of treatment it is forbidden to use ethanol (can lead to development of gepatotoksichny effect of drug) and kofeinsoderzhashchy drugs and products.
Drug influences ability of the person to control of vehicles and occupation by any other types of activity which demand concentration of attention, the high speed of psychomotor reactions.
It is a little reviews of use of drug. Tablets have noticeable effect, but it is necessary to watch accepting drug strictly according to the instruction. Absence at the patient of states which are contraindications for use of this medicine is important.
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