Taylol Hot

General characteristics. Structure:

Active ingredients: 500 mg of paracetamol, 4 mg of chlorpheniramine of a maleate, 60 mg of NSL pseudoephedrine.

Excipients: citric acid (anhydrous), tartaric acid, sodium bicarbonate, sodium carbonate (anhydrous), PVP K 30, the refined sugar, sodium benzoate, quinoline yellow Cl No. 47005, lemon fragrance.

Pharmacological properties:

Pharmacodynamics. Paracetamol is the clinically tested anesthetic and an antipyretic. It renders analgesic effect by increase in a pain threshold and febrifugal effect by impact on the center of thermal control in a hypothalamus. Also possesses weak antiinflammatory action. Chlorpheniramine the maleate is an antagonist histamine H1 receptors and, thus, removes the following symptoms: rhinorrhea, obstruction of the nasal channel, reddening and/or hypersensitivity of eyes. Pseudoephedrine the hydrochloride is a sympathomimetic amine which has strong vasoconstrictive effect on upper respiratory tracts.

Pharmacokinetics. At peroral appointment paracetamol is quickly and fully soaked up from digestive tract, is preferential in a small bowel. The maximum concentration in plasma is observed in 10 - 60 minutes. Paracetamol is quickly and evenly distributed in the majority of body tissues, except for fatty tissue and cerebrospinal fluid. Linkng with proteins makes less than 10% and slightly increases at overdose. Sulphatic and glyukuronidny metabolites do not contact proteins of plasma even in rather high concentration. The elimination half-life makes 1,25 - 3 hours. It is metabolized in a liver in system of microsomal enzymes by conjugation with a glucuronide, conjugation with sulfate and oxidations with the participation of the mixed oxidases of a liver and P450 cytochrome. The hydroxylated metabolite with negative action - N-acetyl-r-benzokhinonimin which is formed in very small amounts in a liver and kidneys under the influence of the mixed oxidases and detoksitsirutsya usually by linkng with glutathione can collect at overdose of paracetamol and cause damages of fabrics. About 85% of orally applied dose of paracetamol are allocated with urine in a free and connected look within 24 hours. The renal clearance makes 5%.

Chlorpheniramine the maleate is slowly and fully soaked up from digestive tract. At oral administration the maximum concentration in plasma is observed in 2,5 - 6 hours. Level of bioavailability makes 25 - 50%. The most part of the soaked-up drug (70%) contacts proteins of plasma. Chlorpheniramine the maleate is distributed on the majority of fabrics, including the central nervous system. The elimination half-life makes 2 - 43 hours, action duration - 4 - 6 hours. The most part of drug is metabolized. Not changed drug and its metabolites are emitted with urine and in insignificant quantities with excrements.

Pseudoephedrine is soaked up in digestive tract. It is steady against effect of monoamine oxidase. A small amount of its metabolites and not changed drug are allocated with urine.

Indications to use:

Taylol Hot is applied at the cold, flu and other upper respiratory tract infections which are shown the following symptoms: indisposition, temperature increase and headache, rhinorrhea, obstruction of the nasal channel, sneezing, general painful states.

Route of administration and doses:

Taylol Hot is accepted orally as shown below:

Contents of a package need to be dissolved in hot water of 160 ml (the size of a standard cup) and to drink immediately. At repeated use the interval has to be 6 hours. The recommended maximum daily dose - 4 packages.

Features of use:

At patients with disturbances of functions of a liver, kidneys, heart and lungs and with anemia drug has to be used under control of the doctor. Taylol Hot should not be applied more than 5 days at children and more than 10 days at adults to elimination of pain and should not be applied to treatment of recurrent feverish states at which more than 3 days temperature makes more than 39,5 °C if it is not appointed the therapist. Though the pressor action connected with pseudoephedrine with a normal arterial pressure is insignificant, at patients with hypertensia drug has to be used under control of the doctor.

At use Taylol Hot weakness emergence therefore it is necessary to be careful during the driving of the car or control of potentially dangerous devices is possible. Simultaneous alcohol intake at use Taylol Hot as decrease in attention is possible is undesirable. Patients, the accepting anti-hypertensive and/or antidepressant drugs, need receiving the correct medical consultation. At children aged up to 12 years Taylol Hot has to be applied only under control of the doctor.

Use at pregnancy and a lactation. At use of drug for pregnant women and the feeding women control of the doctor is necessary.

Paracetamol gets through a placental barrier. So far the negative impact of paracetamol on a fruit at the person is noted. Paracetamol is emitted with breast milk: content in milk makes 0,04 - 0,23% of the dose accepted by mother. In pilot studies embriotoksichesky, teratogenic and mutagen effect of paracetamol is not established.

Side effects:

Taylol Hot, as a rule, is well had. In therapeutic doses paracetamol has no toxic effect. In rare instances it can cause the dispepsichesky phenomena, such reactions of hypersensitivity as rash, an itch and urticaria, and at prolonged use and high doses the hepatotoxic action, thrombocytopenia, a leukopenia and a pancytopenia are possible. The neutropenia, a Werlhof's disease and an agranulocytosis are very seldom observed.

Side effects of pseudoephedrine are very rare. Sleep disorders as result of impact on the central nervous system are possible. Very seldom there can be hallucinations. Developing of urticaria and an ischuria which can also be result of the accompanying prostate hyperplasia is also possible.

Braking and antimuskarinovy reactions can be observed as a result of effect of chlorpheniramine of a maleate.

In case of undesirable effects, consult with the doctor. 

Interaction with other medicines:

At therapeutic doses of interaction it is not established. At prolonged use and high doses drug strengthens effect of anticoagulants.

The paracetamol accepted in high doses for a long time can interact with coumarin (possibly development of a small prothrombinopenia), derivatives of an indandion and a fenotiazidama.

Alcohol, barbiturates, anticonvulsants, rifampicin and tricyclic antidepressants can strengthen a hepatotoxic action of paracetamol.

At simultaneous use of paracetamol with Metoclopramidum increase in absorption of paracetamol is possible; with probenetsidy - change of excretion and concentration of paracetamol in a blood plasma is possible.

At use of a holestiramin during the period less than an hour after reception of paracetamol reduction of absorption of the last is possible.

Rise in arterial pressure in case of simultaneous use of pseudoephedrine of a hydrochloride with the vasoconstrictors, tricyclic antidepressants, means reducing appetite, psychostimulants like amphetamine and monoamine oxidase inhibitors is seldom possible.

Methyldopum, α-and β-adrenoblockers, гуанетидин can lose efficiency at their simultaneous use from pseudoephedrine a hydrochloride.

Contraindications:

Taylol Hot should not be applied at hypersensitivity to any of its ingredients. Also it is contraindicated to patients with a serious illness of a liver, kidneys, hearts, with a diabetes mellitus, bronchial asthma, glaucoma, a hyperthyroidism.

Before use Taylol Hot patients have to be informed that it is impossible to accept at the same time monoamine oxidase inhibitors, and after their use there have to pass 2 weeks before appointment Taylol Hot.

Overdose:

At suspicion on overdose of the patient it is necessary to bring to medical institution urgently.

At some patients at overdose of paracetamol the hepatotoxic effect is possible. It depends on amount of the accepted drug. In 12 - 48 hours the level of liver enzymes can rise, increase a prothrombin time. However clinical symptoms become explicit in 1 - 6 hours after administration of drug. Total quantity in 10 g of paracetamol can cause toxic effect in adults. At children the paracetamol dose less than 150 mg/kg is not connected with a hepatotoxic.

The early symptoms relating to a hepatotoxic: nausea, vomiting, the increased perspiration, an indisposition. Confirmatory results of blood test can be received in 48 - 72 hours after administration of drug. Purpose of Acetylcysteinum, as soon as possible after drug overdose is recommended, without waiting for results of definition of paracetamol in plasma. The gastric lavage, purpose of tincture of a root of an ipecacuanha in quality emetic is reasonable. Observation has to include definition of concentration of paracetamol in plasma after not less than 4 hours after overdose.

If concentration of paracetamol in plasma indicates possible hepatotoxic effect, implementation of functional tests of a liver through 24-hour intervals within at least 96 hours after overdose is necessary. Owing to difference of metabolism of paracetamol at children cases of heavy intoxication and a lethal outcome are rather rare. It is easy to assume the maximum potential at children. If the overdose exceeds 150 mg/kg it is necessary to define concentration of paracetamol in plasma, but 4 hours later after administration of drug. Purpose of tincture of a root of an ipecacuanha as emetic is reasonable. If concentration of paracetamol in plasma exceeds a limit, as shown in "the nomogram of overdose", treatment by Acetylcysteinum is necessary. If definition of concentration of paracetamol is impossible, and total quantity presumably will exceed 150 mg/kg, it is necessary to begin treatment with Acetylcysteinum.

The toxic effect of chlorpheniramine is shown in several hours after overdose. Treatment has to be carried out according to the scheme of treatment of overdose by antihistaminic/anticholinergic drugs.

Overdose symptoms pseudoephedrine: easy irritability, tachycardia and/or insignificant hypertensia. Symptoms are shown 4 - 8 hours later after overdose. All symptoms are temporary, specific treatment is not required.

Storage conditions:

To store drug in packaging at a temperature not above 25 °C, in protected from light, the place, unavailable to children. A period of validity 3 years - at observance of storage conditions. Not to use after expiry date.

Issue conditions:

Without recipe

Packaging:

In the packages containing 500,0 mg of paracetamol, 4,0 mg of chlorpheniramine of a maleate, 60,0 mg of NSL pseudoephedrine; in packaging of 12 packages.