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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDextromethorphan + Paracetamol + Phenylephrine + ChlorphenamineDextromethorphan + Paracetamol + Phenylephrine + Chlorphenamine
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    Panacea Biotech Co., Ltd.     India
    • Dosage form: & nbspcapsules
    Composition:

    Each capsule contains:

    active substances: paracetamol 500.00 mg, dextromethorphan hydrobromide 15.00 mg, chlorpheniramine maleate 2.00 mg, phenylephrine hydrochloride 10.00 mg;

    Excipients: croscarmellose sodium 10.00 mg, povidone (K-30) 20.00 mg, gelatin 5.00 mg, talc 10.00 mg, sodium disulfite 0.50 mg, microcrystalline cellulose 18.64 mg, sucrose 52.00 mg , cellulose acetate phthalate 4.50 mg, diethylphthalate 0.60 mg, quinoline yellow 0.13 mg, 0.13 mg diamond brilliant blue, 1.50 mg pencil dye (Ponso 4R).

    Composition of an empty gelatin capsule:

    capsule cover: water 6.5250 mg, gelatin 37.8765 mg, methyl parahydroxybenzoate 0.3600 mg, propyl parahydroxybenzoate 0.0900 mg, sodium lauryl sulfate 0.0360 mg, dye brilliant blue 0.1125 mg;

    body capsule: water 10.7300 mg, gelatin 62.4708 mg, methyl parahydroxybenzoate 0.5920 mg, propyl parahydroxybenzoate 0.1480 mg, sodium lauryl sulfate 0.0592 mg.

    Description:

    Transparent, gelatin capsule size "00", which bear the logo and the name of the manufacturer - PANACEA VIOTES, the body is transparent, the lid is blue.

    Contents of the capsule: a mixture of red, yellow, white and blue granules.

    Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic remedy + antitussive opioid + alpha-adrenomimetic + H1-histamine receptor blocker)
    ATX: & nbsp

    N.02.B.E   Anilides

    Pharmacodynamics:

    Combined drug.

    Paracetamol has antipyretic and analgesic effect.

    Phenylephrine - alpha-adernomimetic, has vasoconstrictive effect, helps to eliminate nasal congestion, reduce mucosal secretion from the nasal cavity.

    Chlorphenamine - H1-gistaminoblokator, has an anti-allergic effect, suppresses the symptoms of allergic rhinitis (reduces vascular permeability, eliminates edema and flushing of the mucous membrane of the nasal cavity).

    Dextromethorphan - antitussive, by force of action is close to codeine, increases the threshold of sensitivity of the cough center of the medulla oblongata, suppresses cough of any origin, eliminates the irritating effect of dry, unproductive cough and is well tolerated by all age groups. Has some sedative effect. Does not have analgesic, narcotic and hypnotic effects.Does not depress respiratory center and activity of ciliated epithelium. The onset of action is in 20-30 minutes, the duration is 4-4.5 hours.

    Pharmacokinetics:

    Paracetamol: Paracetamol quickly and completely absorbed after oral administration. Absolute bioavailability after oral administration is about 80% and is dose-dependent in the dose range from 5 to 20 mg / kg body weight. It practically does not bind to plasma proteins, and its volume distribution is about 0.91 kg.

    After oral administration, the half-life (T1/2) of paracetamol from plasma is about 2.3 hours in healthy adults, varying from 1.5 to 3.0 hours.

    Paracetamol undergoes intensive biotransformation in the liver, its main metabolites are inactive phenolsulfate and glucuronide conjugates. The intermediate product of the metabolism of paracetamol is usually excreted by the kidneys in the form of conjugates of mercapturic acid and cysteine. Glutathione conjugate can be excreted with bile, but in this case it is cleaved by intestinal peptidases and the cleavage products are reabsorbed.

    Chlorpheniramine maleate: After oral administration, it is almost completely absorbed and distributed in the tissues.The maximum concentrations in the plasma were achieved in 2-3 hours after a single dose on an empty stomach at a dose of 12 mg.

    Unchanged chlorpheniramine (35%), as well as monodemethylated (20%) and demodetylated (10%) metabolites were detected in human urine. Chlorpheniramine and its demethylated metabolites are slowly excreted over time.

    Dextromethorphan hydrobromide: After oral administration, dextromethorphan is well absorbed, but is subjected to intensive pre-systemic metabolism in the liver, resulting in a plasma concentration of only 0.1 μg / L after 0.5 hours and an average maximum concentration 2.5 hours after a single dose of 20 mg is 1.8 μg / l. Dextromethorphan undergoes intensive metabolism in the liver; about 50% of the dose is excreted by the kidneys within 24 hours. The intestine excretes less than 1% of the dose. About 8% of the dose is excreted unchanged by the kidneys for 6 hours.

    Phenylephrine hydrochloride: Absorption of phenylephrine after oral administration varies significantly, it undergoes intensive presystemic metabolism. As a result, its systemic bioavailability is only 40%, and the maximum plasma concentrations are achieved 1-2 hours after ingestion. The volume of distribution is 200-500 liters, and the average T1/2 from the plasma is 2-3 hours.

    After absorption phenylephrine is subjected to intensive biotransformation in the intestinal wall. After oral administration, 24% of phenylephrine is deaminated, since most of the ingested drug is metabolized by sulphation even before it reaches the liver.

    Indications:

    Symptomatic treatment of colds, flu, ARVI, infectious and allergic rhinitis (febrile syndrome, pain syndrome, rhinorrhea).

    Contraindications:

    Hypersensitivity to the components of the drug; simultaneous reception of tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-blockers; deficiency of glucose-6-phosphate dehydrogenase; deficiency of sucrose / isomaltase; intolerance to fructose; glucose-galactose malabsorption; blood diseases; hepatic and / or renal insufficiency; angle-closure glaucoma; hyperplasia of the prostate; Gilbert's syndrome; arterial hypertension; thyrotoxicosis; pheochromocytoma; diabetes; bronchial asthma; bronchitis; pregnancy; lactation period; children's age (up to 14 years).

    Carefully:

    Angina pectoris, hypertrophic obstructive cardiomyopathy (GOKMP), advanced age.

    Dosing and Administration:

    Inside, adults - one capsule every 4-6 hours, but not more than 4 capsules per day.

    Admission as an antipyretic agent for no more than 3 days without consulting a doctor.

    Side effects:

    From the cardiovascular system: arterial hypertension.

    From the nervous system and sensory organs: dizziness, drowsiness, increased excitability, mydriasis, paresis of accommodation, increased intraocular pressure.

    From the digestive system: dry mouth, epigastric pain, nausea, vomiting, hepatotoxic effect.

    From the hematopoiesis: anemia, thrombocytopenia, hemolytic anemia, aplastic anemia.

    From the urinary system: retention of urine, nephrotoxicity (papillary necrosis).

    Allergic reactions (including skin rash, itching, angioedema), bronchial obstruction.

    Allergic reactions can be delayed (due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate).

    Overdose:

    Symptoms (due to paracetamol, manifested after taking more than 10-15 g): pallor of the skin, anorexia, nausea, vomiting, hepatonecrosis, increased activity of "liver" transaminases, increased prothrombin time.

    Treatment: gastric lavage followed by administration of activated charcoal, symptomatic therapy.

    Interaction:

    Strengthens the effects of MAO inhibitors, sedatives, ethanol.

    Antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.

    Glucocorticosteroids (GCS) increase the risk of developing glaucoma.

    Paracetamol reduces the effectiveness of uricosuric drugs.

    Chlorpheniramine, administered simultaneously with MAO inhibitors and furazolidone, can lead to the development of hypertensive crisis, psychomotor agitation, and fever.

    Tricyclic antidepressants enhance sympathomimetic action; simultaneous administration of halothane increases the risk of ventricular arrhythmia.

    Reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.

    Special instructions:

    During the treatment period, do not take other medications containing substances that are part of the drug.

    In people with chronic alcoholism, taking therapeutic doses of the drug can cause severe hepatic insufficiency.

    During the treatment it is necessary to refrain from using ethanol (it is possible to develop hepatotoxic action), driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:
    Capsules, 15 mg + 500 mg + 10 mg + 2 mg.
    Packaging:

    Primary packaging:

    10 capsules in PVC and aluminum foil blisters.

    Secondary packaging:

    For 1 or 2 blisters, together with instructions for medical use, put in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013449 / 01
    Date of registration:07.10.2008 / 12.02.2014
    The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspPANACEA BIOTEC Co., Ltd. PANACEA BIOTEC Co., Ltd. India
    Information update date: & nbsp14.01.2016
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