Atarax coated pills 25mg N25
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Active ingredients
Hydroxyzine
Release form
Pills
Composition
The composition and the form of release Tablets, coated 1 table. active ingredient: hydroxyzine hydrochloride 25 mg excipients: MCC (Avitsel PH 102), magnesium stearate, silicon colloidal anhydride (Aerosil 200), lactose monohydrate, Opadry Y-1-7000, titanium dioxide, hydroxypropyl methylcellulose 2910 5сР, macrogol 400 in a blister 25 pcs., in a box 1 blister.
Pharmacological effect
A derivative of diphenylmethane, has a moderate anxiolytic activity; also has a sedative, antiemetic, antihistamine and m-anticholinergic action. Blocks central m-cholinergic receptors and histamine H1 receptors and inhibits the activity of certain subcortical zones. Does not cause psychological dependence and addiction. The clinical effect occurs within 15-30 minutes after taking the drug inside. It has a positive effect on cognitive abilities, improves memory and attention. Relaxes skeletal and smooth muscles, has bronchodilating and analgesic effects, moderate inhibitory effect on gastric secretion. Hydroxysin significantly reduces itching in patients with urticaria, eczema and dermatitis. With long-term admission, there was no marked withdrawal and impairment of cognitive functions. Polysomnography in patients with insomnia and anxiety clearly demonstrates the lengthening of the duration of sleep, a decrease in the frequency of nightly awakenings after a single or repeated administration of hydroxyzine in a dose of 50 mg. Reduced muscle tension in patients with anxiety was observed when taking the drug in a dose of 50 mg 3 times / day.
Pharmacokinetics
Hydroxysin absorption is highly absorbed from the gastrointestinal tract. Cmax occurs 2 hours after taking the drug. After a single dose of 25 mg or 50 mg in adults, the plasma concentration is 30 ng / ml and 70 ng / ml, respectively. Bioavailability when administered orally and intramuscularly is 80%. Distribution: Hydroxysin is more concentrated in the tissues (in particular, in the skin) than in the plasma. The distribution coefficient is 7-16 l / kg. Hydroxyzine penetrates the BBB and placental barrier, concentrating more in the tissues of the fetus than in the mother's body. Metabolites are found in breast milk.Metabolism and excretion: Hydroxysin is metabolized in the liver. The main metabolite (45%) is cetirizine, which is a blocker of histamine H1 receptors. The total clearance of hydroxyzine is 13 ml / min / kg. T1 / 2 in adults is 14 hours. Only 0.8% of hydroxyzine is excreted unchanged in the urine. Pharmacokinetics in special clinical situations: In children, the total clearance is 4 times less than in adults, T1 / 2 in children at the age of 14 years old is 11 hours, in children at the age of 1 year it is 4 hours. In elderly patients, T1 / 2 is 29 h, the distribution coefficient is 22.5 l / kg. In patients with impaired liver function, T1 / 2 increases to 37 hours, the concentration of metabolites in the serum is higher than in young patients with normal liver function. The antihistamine effect may persist for 96 hours.
Indications
Adults for relief of anxiety, psychomotor agitation, feelings of internal tension, increased irritability in neurological, mental (generalized anxiety and adaptation disorder) and somatic diseases, as well as in chronic alcoholism, alcohol withdrawal syndrome, accompanied by symptoms of psychomotor agitation as a sedative during premedication itching therapy.
Contraindications
Hypersensitivity to any of the components of the drug, cetirizine and other piperazine derivatives, aminophylline or ethylenediamine. Porphyria. Pregnancy. Birth period. Breastfeeding period. With care: myasthenia. Prostate hyperplasia with clinical manifestations, incl. Difficult urination, constipation. Increased intraocular pressure. Dementia. Tendency to convulsive seizures. Patients prone to arrhythmias or receiving drugs that can cause arrhythmias. Patients who are simultaneously receiving treatment with other means of CNS depressants or anticholinergic drugs (the dose should be reduced). Patients with severe and moderate severity of renal failure, as well as liver failure (dose reduction is necessary). Elderly patients (the dose is reduced in case of reduced glomerular filtration.
Precautionary measures
With caution should be prescribed the drug for myasthenia, prostatic hyperplasia with clinical manifestations, difficulty urinating, constipation, with an increase in intraocular pressure, dementia, a tendency to convulsive seizures; with a predisposition to the development of arrhythmia; with the simultaneous use of drugs with arrhythmogenic effect; simultaneously with other means of depressing the central nervous system, or anticholinergics (required dose reduction). A reduction in the dose of the drug is required in patients with severe and moderate renal insufficiency, with hepatic insufficiency, in elderly patients with a decrease in glomerular filtration.
Use during pregnancy and lactation
Atarax is contraindicated for use during pregnancy, during labor. If necessary, use Atarax during lactation should stop breastfeeding.
Dosage and administration
Inside Children: for the symptomatic treatment of itching. At the age of 12 months to 6 years - from 1 to 2.5 mg / kg / day in several doses, from 6 years and older - from 1 to 2 mg / kg / day in several doses. For sedation - 1 mg / kg for 1 hour before surgery, as well as an additional night before anesthesia. Adults: for the symptomatic treatment of anxiety - 25-100 mg per day in separate dosage during the day or overnight. The standard dose is 50 mg per day (12.5 mg in the morning, 12.5 mg in the afternoon, and 25 mg per night). In severe cases, the dose may be increased to 300 mg per day. For sedation in surgical practice, 50–200 mg (1.5–2.5 mg / kg IM) is administered 1 hour before surgery. For symptomatic treatment of itching - the initial dose of 25 mg, if necessary, the dose can be increased 4 times (25 mg 4 times a day). In older patients, treatment begins with a half dose. In renal and / or hepatic insufficiency, the doses should be reduced. A single maximum dose should not exceed 200 mg, the maximum daily dose - not more than 300 mg.
Side effects
Weakly expressed and transient, usually disappear after a few days from the start of treatment or after dose reduction. Side effects are mainly associated with CNS depression or paradoxical stimulating effect on the CNS, anticholinergic activity or hypersensitivity reaction. Anticholinergic effects dry mouth, urinary retention, constipation or disturbance of accommodation are rare and, mainly, in elderly patients. Drowsiness, general weakness may occur, especially at the beginning of drug treatment.If these effects do not disappear after a few days from the start of therapy, the dose of the drug should be reduced. There were reports of other side effects, such as headache, dizziness, excessive sweating, hypotension, tachycardia, allergic reactions, nausea, fever, changes in liver function tests. , bronchospasm. Clinically significant respiratory depression when prescribing the recommended doses is not noted. Involuntary physical activity, including very rare cases of tremor and convulsions, disorientation was observed with a significant overdose.
Overdose
Symptoms: increased anticholinergic effects, depression or paradoxical stimulation of the central nervous system, nausea, vomiting, involuntary physical activity, hallucinations, impaired consciousness, arrhythmia, arterial hypotension; rarely - tremor, convulsions, disorientation, which occur with a significant overdose. Treatment: if spontaneous vomiting is absent, it is necessary to cause it artificially or to wash the stomach. Conduct general activities aimed at maintaining the vital functions of the body, and monitor monitoring of the patient until the symptoms of intoxication disappear in the next 24 hours. If it is necessary to obtain a vasopressor effect, norepinephrine or metaramenol is prescribed. Epinephrine should not be used. There is no specific antidote. The use of hemodialysis is ineffective.
Interaction with other drugs
Atarax potentiates the action of drugs that inhibit the central nervous system, such as opioid analgesics, barbiturates, tranquilizers, sleeping pills, ethanol (when combinations require individual selection of doses of drugs). Atarax with simultaneous use interferes with the pressor action of epinephrine (adrenaline) and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and cholinesterase blockers. With the simultaneous use of Atarax does not affect the activity of atropine, belladonna alkaloids, cardiac glycosides, antihypertensive drugs, histamine H2 receptor blockers. Co-administration of Atarax with MAO inhibitors and holinoblockers should be avoided.Hydroxyzine is a CYP2D6 isoenzyme inhibitor and, when used in high doses, may be the cause of interaction with CYP2D6 substrates. Since hydroxyzine is metabolized in the liver, an increase in its concentration in the blood can be expected when it is co-administered with hepatic enzyme inhibitors.
special instructions
If allergic tests are necessary, taking Atarax should be discontinued 5 days before the test. Patients taking Atarax should refrain from drinking alcohol. Impact on the ability to drive vehicles and control mechanisms: Patients taking Atarax, if necessary, driving and mechanisms, should be warned that the drug can affect the concentration and speed of psychomotor reactions.