SEDAZINE Hydroxyzine Hydrochloride 10mg Film-Coated Tablet 1's
RXDRUG-DRP-7082-1pc
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Features
Brand
Sedazine
Full Details
Dosage Strength
10 mg
Drug Ingredients
- Hydroxyzine
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Hydroxyzine
Dosage Form
Film-Coated Tablet
Registration Number
DRP-7082
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
It is used as an anxiolytic, and adjunct to pre- and post-operative medication and in the management of pruritus and urticaria. It has also been used as an anti-emetic and an adjunct to opioid analgesic in the management if cancer pain.
Dosage/Direction for Use
The usual doses by mouth in adults are: 50 to 100 mg four times daily for the short-term management of anxiety; for pruritus an initial dose of 25 mg given at night, increased if necessary to 25 mg three or four time daily; and 50 to 100 mg for pre- or post-operative sedation. For pruritus in children over 6 years of age the initial dose is 15 to 25 mg daily increased to 50 to 100 mg daily in divided doses.
Administration in Hepatic or Renal Impairment: In patients with hepatic impairment, UK licensed product information recommends a 33% reduction in the total daily dose of hydroxyzine by mouth. In patients with moderate or severe renal impairment, a dose reduction of 50% is recommended.
Administration in Hepatic or Renal Impairment: In patients with hepatic impairment, UK licensed product information recommends a 33% reduction in the total daily dose of hydroxyzine by mouth. In patients with moderate or severe renal impairment, a dose reduction of 50% is recommended.
Contraindications
Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.
Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.
Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.
Special Precautions
The potentiating action of hydroxyzine must be considered when the drug in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics and barbiturates. Therefore when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.
Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect if alcohol may be increased.
Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect if alcohol may be increased.
Adverse Reactions
The most common adverse effect of the hydroxyzine hydrochloride is CNS depression, with effects varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and in coordination (although paradoxical stimulation may occasionally occur, especially at high doses and in children or the elderly). These effects, when they occur, may diminish after a few days of treatment.
Other adverse effects that are more common with the antihistamine include headache, psychomotor impairment, and antimuscarinic effects, such as dry mouth thickened respiratory-tract secretions, blurred vision, urinary difficulty or retention, constipation, and increased gastric reflux.
Occasional gastrointestinal adverse effects of antihistamines include nausea, vomiting, diarrhea, or epigastric pain. Those with antiserotonin actions, such as cyproheptadine, may cause an increase in appetite with resultant weight gain, whereas anorexia has been reported with some other antihistamines.
Palpitations and arrthymias have been reported occasionally with most antihistamine. Antihistamines sometimes cause rashes and hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis) and cross-sensitivity to related drugs may occur. Photosensitivity can be a problem, particularly with the phenothiazine antihistamines.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, although rare, have been reported. Jaundice has also been observed, particularly with the phenothiazine antihistamines.
Other adverse effects that have been reported with the antihistamines include convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, tremors, sleep disturbances, depression, confusion, tinnitus, hypotension, and hair loss.
Other adverse effects that are more common with the antihistamine include headache, psychomotor impairment, and antimuscarinic effects, such as dry mouth thickened respiratory-tract secretions, blurred vision, urinary difficulty or retention, constipation, and increased gastric reflux.
Occasional gastrointestinal adverse effects of antihistamines include nausea, vomiting, diarrhea, or epigastric pain. Those with antiserotonin actions, such as cyproheptadine, may cause an increase in appetite with resultant weight gain, whereas anorexia has been reported with some other antihistamines.
Palpitations and arrthymias have been reported occasionally with most antihistamine. Antihistamines sometimes cause rashes and hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis) and cross-sensitivity to related drugs may occur. Photosensitivity can be a problem, particularly with the phenothiazine antihistamines.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, although rare, have been reported. Jaundice has also been observed, particularly with the phenothiazine antihistamines.
Other adverse effects that have been reported with the antihistamines include convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, tremors, sleep disturbances, depression, confusion, tinnitus, hypotension, and hair loss.
Drug Interactions
Antihistamines may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics. Sedative interactions apply to a lesser extent with the non-sedating antihistamines; they do not appear to potentiate the effects of alcohol, but it should be avoided in excess.
Antihistamines have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MOAIs).
Potentially hazardous ventricular arrhythmias have occurred when the non-sedating antihistamines astemizole and terfenadine have been given with drugs liable to interfere with their hepatic metabolism, with other potentially arrhythmogenic drugs including those that prolong the QT interval, or with those likely to cause electrolyte imbalance.
It has been suggested that some antihistamines could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.
Antihistamines have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MOAIs).
Potentially hazardous ventricular arrhythmias have occurred when the non-sedating antihistamines astemizole and terfenadine have been given with drugs liable to interfere with their hepatic metabolism, with other potentially arrhythmogenic drugs including those that prolong the QT interval, or with those likely to cause electrolyte imbalance.
It has been suggested that some antihistamines could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Hydroxyzine is rapidly absorbed and distributed in oral and intramuscular administration, and is metabolized in the liver, the main metabolite (45%) through oxidation of the alcohol moiety to a carboxylic acid, is cetirizine and overall effects are observed within one hour of administration. It has a half-life observed on average of around 7-10 hours in adults, 6-7 hours in children, and 18-21 hours in the elderly, or those with renal insufficiency, with higher concentrations found in the skin than in the plasma. Cetirizine, although less sedating, is non-dialyzable and possesses similar anti-histaminergic properties. In animals, hydroxyzine and its metabolites are excreted via biliary excretion.
Administration in geriatrics differs from the administration of hydroxyzine in younger patients; according to the FDA, there have not been significant studies made (2004), which include population groups over 65, which provide a distinction between elderly aged patients and other younger groups. Hydroxyzine should be administered carefully in the elderly with consideration given to possible reduced elimination.
Similarly, the use of sedating drugs alongside hydroxyzine can cause over-sedation and confusion if administered in large amounts, any form of treatment along side sedatives should be done under supervision of the patient.
Administration in geriatrics differs from the administration of hydroxyzine in younger patients; according to the FDA, there have not been significant studies made (2004), which include population groups over 65, which provide a distinction between elderly aged patients and other younger groups. Hydroxyzine should be administered carefully in the elderly with consideration given to possible reduced elimination.
Similarly, the use of sedating drugs alongside hydroxyzine can cause over-sedation and confusion if administered in large amounts, any form of treatment along side sedatives should be done under supervision of the patient.
MedsGo Class
Anxiolytics
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