Instructions for Theraflu Extra
Pharmacological properties Theraflu:
Combined preparation for the symptomatic treatment of flu and colds. It has antipyretic, analgesic and anti-allergic effects.
Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects. Phenylephrine hydrochloride has a sympathomimetic effect, causes vasoconstriction, reduces edema and hyperemia of the mucous membrane of the nasal cavity and paranasal sinuses. Pheniramine maleate, a blocker of H 1 -receptors, has an antiallergic effect, reduces the severity of local exudative manifestations, eliminates lacrimation, rhinorrhea.
After oral administration, paracetamol is rapidly absorbed into the digestive tract. The maximum concentration in blood plasma is reached after 30-60 minutes. When using therapeutic doses, the half-life is 1–4 hours. Paracetamol is metabolized in the liver mainly by means of a conjugation reaction. Depending on the concentration in the blood plasma, it is partially deacetylated or hydroxylated. The main route of excretion is in the urine (90-100% for 24 hours), in the form of conjugates - glucuronides (60%), sulfates (35%) or cysteine (3%). Theraflu Extra
The maximum plasma concentration of pheniramine maleate is reached after 1–2.5 hours; the half-life is 16-19 hours. 70-83% of the dose taken orally is excreted in the urine unchanged or in the form of metabolites.
Phenylephrine has limited bioavailability due to insufficient absorption in the gastrointestinal tract and presystemic metabolism in the intestine and liver, which is caused by the action of MAO. Theraflu Extra
Indications Theraflu:
Symptomatic short-term treatment of infectious and inflammatory diseases in adults (flu, ARVI), accompanied by high fever, chills and fever, headache, runny nose, nasal congestion, sneezing and muscle pain. Theraflu Extra
Application Theraflu:
Adults and children over the age of 12 are prescribed 1 sachet every 4–6 hours, but no more than 3 sachets per day. It is not recommended to use the drug Theraflu Extra for more than 5 days. Before use, the contents of 1 packet must be dissolved in a glass of hot water, taken hot.
Contraindications Theraflu:
- The use is contraindicated in the following conditions
- hypersensitivity to drug Theraflu Extra components
- severe cardiovascular, hepatic or renal diseases
- AG
- adenoma of the prostate with difficulty urinating
- obstruction of the bladder neck
- pyloroduodenal obstruction
- stenosing ulcer of the stomach and duodenum
- diabetes
- lung disease (including asthma)
- angle-closure glaucoma
- deficiency of glucose-6-phosphate dehydrogenase
- epilepsy
- During pregnancy and breastfeeding
- age up to 12 years.
Side effects Theraflu:
The most common adverse reactions are drowsiness, dizziness, dry mouth and throat, fatigue, headache, insomnia, irritability or nervousness, tachycardia and palpitations. Rarely, especially in children, agitation and sleep disturbance.
From the gastrointestinal tract : nausea, vomiting, constipation, diarrhea or flatulence.
Adverse reactions associated with the action of paracetamol : rarely, urticaria and skin rashes, thrombocytopenia, leukopenia, hemolytic anemia , in rare cases - agranulocytosis. Sometimes reactions develop in patients with intolerance to acetylsalicylic acid (for example, with asthma).
Adverse reactions associated with the sympathomimetic effect of phenylephrine : increased blood pressure (especially in patients with hypertension), reflex bradycardia, mydriasis (with an effect on glaucoma). Possible effects on the endocrine and other systems that regulate metabolism, urinary retention and stranguria (difficulty urinating). Theraflu Extra
Adverse reactions associated with the peripheral anticholinergic effect of pheniramine : dry mouth, dryness of the mucous membrane of the eyes, delay and difficulty urinating in men. Theraflu Extra
Adverse reactions associated with the central effect of pheniramine : drowsiness, in isolated cases - coma, epileptic seizures, dyskinesia, behavior change. Unlike second generation antihistamines, the use of pheniramine is not associated with prolongation of the Q – Tc interval and arrhythmia.
special instructions Theraflu:
It is not recommended to exceed the recommended dose or to take the drug Theraflu Extra for more than 5 consecutive days.
Paracetamol in high doses, including long-term use, can cause nephropathy or irreversible liver failure. It is necessary to warn patients about the impossibility of the simultaneous use of other drugs containing paracetamol Theraflu Extra
To prevent toxic damage to the liver, taking the drug Theraflu Extra should not be combined with drinking alcoholic beverages.
Take the drug Theraflu Extra with caution in case of prostatic hyperplasia, diseases of the thyroid gland, liver and kidneys.
Due to the possible vasoconstrictor effect of phenylephrine, it is necessary to take the drug with caution in patients over the age of 70 years with cardiovascular diseases.
You should not use the drug Theraflu Extra without a doctor's prescription in patients receiving a course of treatment with other drugs, such as MAO inhibitors.
The period of pregnancy and lactation . Since the clinical experience of using the drug in women during pregnancy and lactation is limited and the safety of its use is not well understood, it is not recommended to use the drug during this period.
Influence on the ability to drive vehicles and work with mechanisms. The drug can cause drowsiness, therefore, during treatment, it is not recommended to drive vehicles and work with complex mechanisms, to perform work that requires increased concentration of attention and high speed of psychomotor reactions. Children. Taking the drug is contraindicated in children under 12 years of age.
Interactions Theraflu:
The interaction of other drugs Theraflu Extra with paracetamol is usually insignificant, but it can manifest itself in cases where drugs with a low therapeutic index are used simultaneously with paracetamol , for example, anticoagulants (warfarin and coumarin) or anticonvulsants. Simultaneous use with NSAIDs may increase the risk of developing adverse reactions of the latter from the kidneys. The pharmacodynamic interaction of paracetamol with other analgesics (caffeine, opiates) has been noted .
The half-life of chloramphenicol increases with simultaneous use with paracetamol . Paracetamol also affects the metabolism of probenecid.
Modern research shows that antiepileptic drugs (phenobarbital, phenytoin , carbamazepine) do not increase the risk of hepatotoxic action of paracetamol . The risk of developing a hepatotoxic effect of the drug Theraflu Extra increases with the simultaneous use of anti-tuberculosis drugs - rifampicin and isoniazid .
Phenylephrine may be the cause of adverse reactions interaction with MAO inhibitors, blockers of α- and β-adrenergic receptors, antihistamines type phenothiazine (e.g. promethazine), bronchodilators, sympathomimetics, tricyclic antidepressants (e.g. imipramine), guanethidine or atropine, digitalis drugs, Rauwolfia alkaloids, indomethacin , methyldopa, other CNS stimulants, and possibly theophylline . In isolated cases, an increase in the vasoconstrictor effect was observed with simultaneous use with stimulants of labor and the appearance of arrhythmias when used in combination with anesthetics. Perhaps an excessive increase in blood pressure with simultaneous intravenous administration of ergot alkaloids.
Pheniramine potentiates the action of drugs that depress the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, antiparkinsonian drugs, barbiturates, tranquilizers, drugs Theraflu Extra), as well as alcohol. Pheniramine can suppress the effect of anticoagulants and interact with progesterone , reserpine, thiazide diuretics. The simultaneous use of oral contraceptives can lead to a decrease in the effectiveness of the antihistamine component.
Overdose Theraflu:
Symptoms
Hepatotoxic effect, in severe cases, liver necrosis develops. The first symptoms (nausea, vomiting, and epigastric pain) may appear within 24–48 hours or later.
Symptoms
Drowsiness followed by excitement (especially in children); visual impairment; nausea, vomiting, headache; circulatory disorders; coma; convulsions; change in behavior; AG; bradycardia; atropine psychosis. Theraflu Extra
Treatment
Timely intravenous or oral administration of N-acetylcysteine as an antidote to paracetamol , gastric lavage, administration of activated charcoal, monitoring of the state of the respiratory and circulatory systems (adrenaline should not be used). If seizures occur, diazepam is prescribed . Theraflu Extra