TeraFlu ExtraTab
TeraFlu ExtraTab: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: TeraFlu ExtraTab
ATX code: N02BE51
Active ingredient: paracetamol (Paracetamol) + phenylephrine (Phenylephrine) + chlorphenamine (Chlorphenamine)
Producer: Novartis Saglik Gida ve Tarim Yuryunleri Sanayi ve Tikaret A. S. (Novartis Saglik Gida ve Tarim Urunlery San.ve Ticaret AS) (Turkey)
Description and photo update: 2020-06-02
Prices in pharmacies: from 120 rubles.
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TeraFlu ExtraTab is a combined preparation for eliminating the symptoms of colds and acute respiratory viral infections (ARVI).
Release form and composition
The drug is released in the form of film-coated tablets: biconvex, oblong, with beveled edges; the shell of the tablet and the core at the fracture are pale yellow (10 pcs. in a blister of PVC and aluminum foil, in a cardboard box 1 or 2 blisters and instructions for use of TeraFlu ExtraTab).
1 tablet contains:
- active ingredients: paracetamol - 650 mg, phenylephrine hydrochloride - 10 mg, chlorphenamine maleate - 4 mg;
- additional components: sodium croscarmellose, hyprolose, colloidal silicon dioxide, lactose, quinoline yellow dye-based varnish, corn starch, magnesium stearate;
- film shell: titanium dioxide, quinoline yellow dye, colloidal silicon dioxide, quinoline yellow dye-based varnish, povidone, methylcellulose, methyl parahydroxybenzoate, macrogol-400.
Pharmacological properties
Pharmacodynamics
TeraFlu ExtraTab is a combined remedy for the symptomatic treatment of colds and viral respiratory diseases, exhibiting analgesic, antipyretic, anti-inflammatory, anti-allergic and anti-edema effects. The therapeutic effect of the drug is due to the properties of its constituent components:
- paracetamol: a non-narcotic analgesic; has an antipyretic effect, affects the centers of thermoregulation and pain as a result of blocking cyclooxygenase (COX), mainly in the central nervous system (CNS); practically does not show anti-inflammatory action; does not affect the production of prostaglandins in peripheral tissues and, therefore, does not have a negative effect on water-salt metabolism (water and Na + retention) and the mucous membrane of the gastrointestinal tract (GIT);
- phenylephrine: α-adrenergic agonist; constricts blood vessels, helps to eliminate hyperemia and swelling of the mucous cavity and paranasal sinuses, and the mucous membrane of the pharynx, weakens exudative manifestations, stopping the runny nose;
- chlorphenamine: a blocker of H 1 -histamine receptors; reduces the severity of symptoms of allergic rhinitis, such as sneezing, mucous discharge, itching in the nose, throat, eyes.
Pharmacokinetics
The main pharmacokinetic characteristics of paracetamol:
- absorption: paracetamol is rapidly and almost completely absorbed from the digestive tract. Maximum plasma concentrations (C max) are observed 10–60 minutes after oral administration;
- distribution: found in all tissues and organs, characterized by a wide distribution; passes through the placental barrier and is excreted in breast milk. Reception in usual therapeutic concentrations provides a slight connection with blood plasma proteins, but it increases with an increase in the content of the drug in the blood;
- metabolism: biotransformation of paracetamol occurs in the liver, mainly by sulfation and glucuronidation;
- excretion: the substance is excreted mainly by the kidneys in the form of conjugates (sulfate and glucuronide). The half-life (T 1/2) is 1-3 hours.
The main pharmacokinetic characteristics of phenylephrine hydrochloride are:
- absorption: Phenylephrine hydrochloride after oral administration is absorbed in the digestive tract. In plasma, C max of the drug is reached within 45–120 minutes;
- distribution and metabolism: the substance is metabolized by monoamine oxidase (MAO) during its primary passage through the intestinal wall and in the liver, as a result of which, after oral administration, it has limited bioavailability;
- excretion: phenylephrine hydrochloride is excreted by the kidneys almost completely in the form of sulfate conjugates, its T 1/2 from plasma is from 2 to 3 hours.
The main pharmacokinetic characteristics of chlorphenamine maleate:
- absorption: chlorphenamine is relatively slowly absorbed from the gastrointestinal tract, after taking C max in blood plasma is achieved in 2.5–6 hours;
- distribution: the substance exhibits low bioavailability at the level of 25-50%, binds to plasma proteins in the bloodstream by about 70%, is intensively distributed in the tissues of the body, including in the nervous tissue;
- metabolism: Chlorphenamine is largely metabolized as a result of primary passage;
- Excretion: T 1/2 can vary from 2 to 43 hours, even with an average duration of the effect of chlorphenamine 4-6 hours. Part of the drug unchanged with metabolites is excreted by the kidneys. With the use of chlorphenamine in children, there is a faster and more complete absorption, a higher clearance and a shorter T 1/2.
Indications for use
TeraFlu ExtraTab is recommended for the symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), occurring with nasal congestion, runny nose, sneezing, fever, headache, high fever and muscle pain.
Contraindications
Absolute:
- arterial hypertension;
- severe cardiovascular lesions;
- angle-closure glaucoma;
- hyperthyroidism;
- pheochromocytoma;
- glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
- age up to 12 years;
- pregnancy and lactation;
- combination therapy with MAO inhibitors, including the previous 14 days before taking the drug, since the effect of MAO inhibitors is potentiated and a hypertensive crisis is induced;
- combined use with β-blockers, tricyclic antidepressants (including amitriptyline), other sympathomimetics, since the risk of negative effects from the cardiovascular system (CVS) is aggravated;
- hypersensitivity to any component of TeraFlu ExtraTab tablets.
Relative contraindications (the drug should be taken with caution): functional disorders of the liver and / or kidneys, acute hepatitis, cardiovascular lesions, chronic obstructive pulmonary disease (chronic bronchitis), bronchial asthma, pulmonary emphysema, hemolytic anemia, prostatic hyperplasia, sugar diabetes, chronic wasting / dehydration, pyloroduodenal stenosis, glucose-6-phosphate dehydrogenase deficiency, alcohol dependence, epilepsy.
Do not use other paracetamol-containing drugs, as well as other drugs that affect liver function, simultaneously with TeraFlu ExtraTab.
TeraFlu ExtraTab, instructions for use: method and dosage
TheraFlu ExtraTab tablets are taken orally. They should be swallowed whole, without crushing or chewing, with water.
It is recommended to take 1 piece every 4-6 hours. The maximum daily dose for adolescents over 12 years old is 4 pcs., For adults - 6 pcs.
The maximum course of treatment is 5 days. If there is no relief of symptoms within 3 days after starting the use, you should consult your doctor.
Side effects
- immune system: rarely - urticaria, hypersensitivity, angioedema; with an unknown frequency - anaphylactic reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome;
- nervous system: often - drowsiness; rarely - headache, dizziness;
- hematopoietic system: extremely rarely - pancytopenia, thrombocytopenia, leukopenia, agranulocytosis;
- mental disorders: rarely - insomnia, nervousness;
- CVS: rarely - heart palpitations, tachycardia, arterial hypertension;
- liver and biliary tract: rarely - increased activity of hepatic transaminases;
- Gastrointestinal tract: often - nausea, vomiting; rarely - dryness of the oral mucosa, constipation;
- skin and subcutaneous tissues: rarely - itching, skin rash, erythema.
Overdose
Paracetamol
In the event of an acute overdose, paracetamol can have a hepatotoxic effect and provoke liver necrosis. The drug, with prolonged use and a general high dose level, aggravates the threat of nephropathy caused by analgesics, with irreversible liver failure. The greatest risk of intoxication is in young children, the elderly, patients with liver disease, systematic malnutrition, chronic alcoholism, and patients receiving treatment with inducers of microsomal enzymes. An overdose of the substance can cause liver failure, encephalopathy, coma and death.
Symptoms of an overdose on the first day may include pallor of the skin, anorexia, nausea, and vomiting. Abdominal pain is one of the first signs of liver damage and can be observed only after 24-48 hours, and sometimes 4-6 days after using the drug. The most common symptoms of toxic liver damage appear after 72–96 hours. Disorders of glucose metabolism and metabolic acidosis are possible, in some cases - cardiac arrhythmia and pancreatitis. The development of acute renal failure and acute renal tubular necrosis may occur even in the absence of severe liver damage.
Therapy should be started immediately; during the first 48 hours, it is advisable to administer N-acetylcysteine intravenously (IV) or orally as an antidote to paracetamol. The use of activated charcoal, gastric lavage and / or oral methionine is recommended. Monitoring of respiration and circulation is necessary; diazepam is used for convulsions.
Phenylephrine
Symptoms of a phenylephrine overdose may be drowsiness, with possible subsequent agitation (mainly in children), skin rash, vomiting, nausea, nervousness, insomnia, dizziness, visual impairment, bradycardia, arterial hypertension, hematopoietic disorders (leukopenia, pancytopenia, thrombocytopenia) convulsions, coma.
Treatment includes urgent gastric lavage, symptomatic and supportive therapy. Hypertension can be eliminated by intravenous administration of α-blockers, convulsions - by administration of diazepam.
Chlorphenamine
Symptoms of a chlorphenamine overdose include drowsiness, convulsions, anticholinergic effects, dystonic reactions, cardiovascular collapse (arrhythmia), and respiratory arrest. Children may experience agitation, behavioral changes, tremors, impaired coordination, anticholinergic effects, seizures, and hallucinations.
Against the background of a significant overdose, gastric lavage or stimulation of vomiting is prescribed, then - the intake of activated charcoal and a laxative to reduce absorption. With the development of seizures, intravenous diazepam / phenytoin is administered, in serious cases, hemoperfusion is performed.
special instructions
During therapy with the drug, you should not drink alcoholic beverages in order to avoid toxic liver damage.
Influence on the ability to drive vehicles and complex mechanisms
During the period of taking TheraFlu ExtraTab, it is recommended to refrain from driving vehicles and operating other complex mechanisms.
Application during pregnancy and lactation
TheraFlu ExtraTab is contraindicated for pregnant and lactating women. The safety of drug therapy during pregnancy and lactation has not been specifically studied.
With oral use of paracetamol in recommended doses during epidemiological studies during pregnancy, its adverse effect was not found. According to the results of reproductive toxicity studies, there were no signs of fetotoxic effects or fetal malformations. Paracetamol in therapeutic doses can be used throughout pregnancy after careful assessment of the risks and benefits.
The use of phenylephrine during pregnancy should be avoided, since the vasoconstriction of the uterus caused by it and the weakening of uterine blood flow can cause fetal hypoxia.
The relationship between chlorphenamine and the appearance of congenital malformations in humans has not been found. However, due to the lack of adequate clinical trials, treatment with chlorphenamine maleate should be avoided during pregnancy.
Paracetamol passes into breast milk, but in clinically insignificant quantities. During lactation, according to published data, its use is not contraindicated.
There is no data on the excretion of phenylephrine and chlorphenamine in human milk, therefore, the use of these substances during breastfeeding should be avoided.
Pediatric use
TheraFlu ExtraTab treatment is contraindicated for children under 12 years of age.
With impaired renal function
In patients with severe renal impairment with creatinine clearance (CC) less than 30 ml / min, the elimination of paracetamol and its metabolites slows down. In this connection, in severe renal failure, the interval between doses of TheraFlu ExtraTab should be at least 8 hours.
For violations of liver function
In patients with impaired liver function or Gilbert's syndrome, it is necessary to reduce the dose of the drug or increase the interval between doses.
Use in the elderly
For the elderly, changes in the TeraFlu ExtraTab dose are not required.
Drug interactions
In the case of using paracetamol with other medicinal substances / preparations, the following pharmacological interaction may develop:
- drugs that induce liver microsomal enzymes, including antiepileptic drugs (phenobarbital, phenytoin, carbamazepine), barbiturates, and drugs for the treatment of tuberculosis (isoniazid, rifampicin): the risk of paracetamol hepatotoxicity is aggravated, its cumulation and overdose are possible;
- warfarin and other coumarins: the anticoagulant effect of these drugs increases against the background of long-term regular use of paracetamol, while the risk of bleeding increases; periodic administration of the drug does not have a significant effect;
- lamotrigine: it is possible to reduce the bioavailability of this substance while reducing its effect, which can induce the induction of metabolism in the liver;
- zidovudine: increased risk of neutropenia and liver damage;
- chloramphenicol: there is an increase in T 1/2 of this substance;
- metoclopramide, domperidone: the rate of absorption of paracetamol and its C max in blood plasma increases;
- cholestyramine: it is possible to suppress the absorption of paracetamol with simultaneous use, however, its decrease may be insignificant if cholestyramine is taken 1 hour after paracetamol;
- probenecid: there is an effect on the biotransformation of paracetamol, it is recommended to lower the dose of the latter;
- ethanol: the hepatotoxicity of paracetamol increases in case of prolonged and excessive use of ethanol;
- phosphotungstate precipitating reagent: erroneous uric acid test results may occur with this reagent.
Clinically significant interactions with the simultaneous use of drugs with phenylephrine hydrochloride:
- digoxin and cardiac glycosides: the threat of arrhythmia or heart attack is aggravated;
- β-blockers, guanethidine, debrisoquine, reserpine, methyldopa and other antihypertensive drugs: it is possible to reduce the effectiveness of these drugs and increase the risk of developing arterial hypertension and other negative effects from CVS;
- ergot alkaloids (ergotamine): increased risk of ergotism.
With the simultaneous use of chlorphenamine maleate:
- opioid analgesics, anxiolytics, anticonvulsants, other antihistamines, antipsychotic and antiemetic drugs, hypnotics, ethanol and other CNS depressants: the effect of these drugs is enhanced;
- phenytoin: the metabolism of this substance is inhibited, while the risk of developing its toxicity increases;
- anticholinergic drugs, including atropine, some psychotropic drugs and drugs for urinary incontinence: dryness of the oral mucosa, development of tachycardia, gastrointestinal disorders (colic), headache and urinary retention may occur, as a result of increased action of these drugs.
Analogs
TheraFlu ExtraTab analogs are: Aspirin Complex, Antigrippin, AntiFlu, Vicks Active, Grippoflu for colds and flu, Symptomax, Coldakt Flu Plus, Caffetin KOLDmax, Coldrex MaxGripp, Colds, Fervex, etc.
Terms and conditions of storage
Store out of the reach of children at a temperature not exceeding 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about TeraFlu ExtraTab
According to reviews, TheraFlu ExtraTab is an effective and easy-to-use tool for relieving symptoms of colds and SARS. The drug quickly eliminates nasal congestion, runny nose, headache and muscle pain, and also reduces high body temperature. The drug has proven itself especially well when used at an early stage of the disease, in this case, many patients note a significant improvement in their condition already 2-3 days after the start of the drug intake.
The disadvantages of TeraFlu ExtraTab include a large number of contraindications and the possible development of undesirable phenomena (especially drowsiness and nausea).
Price for TeraFlu ExtraTab in pharmacies
The price of TeraFlu ExtraTab in the form of film-coated tablets can be 150–190 rubles. for 10 pcs.
TeraFlu ExtraTab: prices in online pharmacies
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Drug name Price Pharmacy |
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TeraFlu Ekstratab film-coated tablets 10 pcs. 120 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
