ATERAX PARENTERAL SOLUTION

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

ATERAX PARENTERAL SOLUTION

SCHEDULING STATUS:
S5

PROPRIETARY NAME:
(and dosage form)

ATERAX PARENTERAL SOLUTION

COMPOSITION:
ATERAX parenteral solution contains

50 mg hydroxyzine dihydrochloride.

Chemically it is 1-(p-chlorobenzydryl)-4-(2-hydroxyethoxy)-ethyl) piperazine dihydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
2.6.3 Tranquillisers : Diphenylmethane and its derivatives.

PHARMACOLOGICAL ACTION:
ATERAX induces a calming effect in anxious, tense, psychoneurotic adults and also in anxious children. Primary skeletal muscle relaxation has been demonstrated experimentally. Secondary skeletal muscle relaxation due to ataraxia should be regarded as additive to this primary effect. ATERAX has been shown experimentally to have antispasmodic properties, apparently due to antagonism of acetylcholine and histamine. Antihistamine effects have been demonstrated experimentally, and confirmed clinically. An anti-emetic effect, both by the apomorphine test and the veriloid test has been demonstrated in animals.

INDICATIONS:
ATERAX is indicated in the management of anxiety, tension and psychomotor agitation in conditions of emotional stress. ATERAX is useful in alleviating the manifestations of anxiety and tension in situations in which the causative stress is temporary, as in the preparation for dental and other minor surgical procedures and in acute emotional problems. In addition, it has been used as adjunctive therapy in allergic conditions with strong emotional overlay, as in urticaria and pruritus. The efficacy of ATERAX as adjunctive pre-and post-operative sedative medication has also been well established especially as regards its ability to allay anxiety, control emesis and reduce the amount of narcotic required. ATERAX may possibly be effective in certain cardiac arrhythmias. The cardiac glycosides are not affected by ATERAX.
ATERAX parenteral is useful in treating the following types of patients when parenteral administration is indicated:

1.	The acutely anxious or hysterical patient.
2.	As pre- and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis.

CONTRA-INDICATIONS:
ATERAX is contra-indicated for patients who have shown a previous hypersensitivity to it. Subcutaneous and intra-arterial injections are contra-indicated.

USAGE IN PREGNANCY:
The safety of ATERAX in pregnancy has not been established. ATERAX should not be administered during pregnancy.

WARNING:
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:

–	For psychiatric and emotional emergencies in adults:	50 - 100 mg stat, and 4 to 6 hourly p.r.n. intramuscularly
–	Nausea and vomiting excluding nausea and vomiting of pregnancy:	Adults: 25 - 100 mg intramuscularly Children: 1 mg/kg body mass I.M.
–	Pre- and postoperative adjunctive medication:	Adults: 25 - 100 mg intramuscularly Children: 1 mg/kg body mass I.M.
–	Cardiac arrhythmias:	Adults: initially 50 -100 mg I.M. or I.V. Maintenance: 25 mg tablet three to four times per day.

As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.
–Adults: The preferred site for intramuscular injection is the upper outer quadrant of the buttock, i.e. gluteus maximus, or the mid-lateral thigh. If the intravenous route is used, ATERAX should be injected slowly (2 min.), otherwise it is preferable to dilute the contents of an ampoule in 20 mL of physiological saline, as intravenous injections of ATERAX may occasionally produce a certain degree of haemolysis.
–Children: It is recommended that intramuscular injection should be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatica nerve. The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower and mid-third of the upper arm. As with all intramuscular injections, aspiration is necessary to help avoid inadvertent injection into a blood vessel.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of hydroxyzine include drowsiness and dryness of the mouth. Tremor and convulsions have been reported occasionally. Intramuscular injection of hydroxyzine has been reported to cause marked discomfort. Because of drowsiness, patients taking hydroxyzine should be warned not to take charge of machinery or vehicles. Hydroxyzine enhances the action of alcohol, barbiturates, narcotics and other central nervous system depressants; the dose of central nervous system depressants should be reduced if hydroxyzine is given concomitantly. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered.

IDENTIFICATION:
ATERAX parenteral is a clear colourless solution.

PRESENTATION:
ATERAX parenteral injection is available as 100 mg ampoules in packs of 6 ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C
Keep out of reach of children.

APPLICATION NUMBERS:
B784 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
UCB SA (PTY) LTD
2nd Floor Pharmacy House
26 Juta Street
BRAAMFONTEIN
Johannesburg
2001

SHOULD ANY COMPLAINT ARISE ABOUT THE CONTENTS OF THIS PACKAGE, PLEASE MENTION THE LOT NO. INDICATED ON THE LABEL.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4/83

	12-248/12-93
	Tradepak PE