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Droxiem

Droxiem

hydroxyzine

Manufacturer:

Alvita Pharma

Distributor:

I.E. Medica

Marketer:

Zyre Pharma
Full Prescribing Info
Contents
Hydroxyzine hydrochloride.
Description
Each mL contains: Hydroxyzine hydrochloride USP 50 mg, Benzyl alcohol USP 0.9% v/v (as preservative), Water for injection USP q.s.
Action
Antihistamine.
Indications/Uses
Used as anxiolytic, as an adjunct to pre and postoperative medication, and in the management of pruritus and urticaria. It has been used as an adjunct to opioid analgesia in the management of cancer pain.
Dosage/Direction for Use
Hydroxyzine may be given orally as the hydrochloride or the embonate; doses are expressed in terms of the hydrochloride. Hydroxyzine embonate 170 mg is equivalent to about 100 mg of hydroxyzine hydrochloride. The usual oral doses 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 times daily; and 50 to 100 mg for pre- or postoperative sedation.
For pruritus in children over 6 years of age the initial dose is 15 to 25 mg daily increased if necessary to 50 to 100 mg daily in divided doses; for children 6 months to 6 years old the initial dose is 5 to 15 mg daily increased if necessary to 50 mg daily in divided doses. Alternatively, 1 mg/kg daily may be given in divided doses, to a maximum of 2.5 mg/kg daily in children aged 1 to 6 years, and to a maximum of 2 mg/kg daily in those aged 6 years and over. The pre- or postoperative sedative dose in children is 600 micrograms/kg. Dosage should be reduced in patients with hepatic or renal impairment.
For adult psychiatric and emotional emergencies including acute alcoholism: IM: 50-100 mg stat., and q.4-6h., p.r.n.
Nausea and Vomiting excluding Nauseas and Vomiting of Pregnancy: Adults: 25-200 mg IM.
Children: 0.5 mg/lb body weight IM.
Pre and postoperative adjunctive medication: Adults: 25-200 mg IM.
Children: 0.5 mg/lb body weight IM.
Pre and postpartum adjunctive therapy: 25-100 mg IM.
Adverse Reactions
The most common adverse effect of the sedating antihistamines is CNS depression, with effects varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and incoordination (although paradoxical stimulation may occasionally occur, especially at high doses and in children or the elderly). These sedative effects, when they occur, may diminish after a few days of treatment.
Other adverse effects that are more common with the sedating antihistamines 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.
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, tremor, sleep disturbances, depression, confusion, tinnitus, hypotension and hair loss.
Despite reports suggesting a possibility of human fetal abnormalities resulting from the use of some antihistamines, especially the piperazine derivatives, a causal relationship has largely been rejected.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
MIMS Class
Antihistamines & Antiallergics / Anxiolytics
ATC Classification
N05BB01 - hydroxyzine ; Belongs to the class of diphenylmethane derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Presentation/Packing
Form
Droxiem soln for inj 100 mg/2 mL
Packing/Price
2 mL x 10 × 1's
Form
Droxiem soln for inj 50 mg/1 mL
Packing/Price
1 mL x 10 × 1's
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