INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ZYNOX INJECTION 0,4 mg/1 mL
ZYNOX NEONATAL INJECTION 0,02 mg/mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ZYNOX INJECTION 0,4 mg/1 mL
ZYNOX NEONATAL INJECTION 0,02 mg/mL

COMPOSITION:
Each 1 mL ampoule contains 0,4 mg and each 2 mL ampoule 0,02 mg/mL naloxone hydrochloride and methyl paraben 0,17% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A.1.4 Respiratory stimulants.

PHARMACOLOGICAL ACTION:
Naloxone hydrochloride is a competitive antagonist at opioid receptors. The duration of naloxone hydrochloride is usually 1 to 4 hours and its half life in plasma is about 1 hour. Naloxone hydrochloride is metabolized in the liver, primarily by conjugation with glucuronic acid.

INDICATIONS:
Opioid-induced toxicity especially respiratory depression.
Post operative opioid depression.
Neonatal respiratory depression secondary to the administration of opioids to the mother.

CONTRA-INDICATIONS:
Known sensitivity to naloxone hydrochloride. Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Zynox (naloxone hydrochloride) may be administered subcutaneously, intramuscularly or intravenously. In emergency situations intravenous administration is recommended. Suitable diluents for intravenous administration are sterile solutions containing sodium chloride or dextrose.

i)	Adults
A:	Opioid toxicity: 0,4 to 2 mg intravenously repeated if necessary at two to three minute intervals as needed. If no response has been observed after a total dose of 10 mg, then the diagnosis of overdosage with agents other than opioids should be considered.
B:	Postoperative Opioid Depression: 0,1 to 0,2 mg intravenously at intervals of at least 2 minutes to obtain and optimum respiratory response while maintaining adequate analgesia.
ii)	Paediatrics:
	Neonates –Opioid-induced depression (resulting from the administration of opioid analgesics to the mother during labour): 0,01 mg/kg body mass of the infant by intramuscular, intravenous or subcutaneous injection repeated at two to three minute intervals if necessary. Alternatively, a single intramuscular dose of 0,06 mg/kg body mass may be given at birth for a more prolonged action.
	Children –Opioid toxicity: 0,01 mg/kg body mass intravenously followed, if necessary, by a larger dose of 0,1 mg/kg body mass.

All patients receiving Zynox (naloxone hydrochloride) should be closely observed as the duration of action of some opioids exceeds that of Zynox (naloxone hydrochloride) and repeated doses may be required.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Nausea and vomiting, hypertension, cardiac arrhythmias, pulmonary oedema and seizures.
Continuous monitoring of the patient is necessary especially when treating opioid toxicity. The duration of action of the opioid may exceed that of Zynox (naloxone hydrochloride), and continuous monitoring is necessary to detect re-emergence of opioid toxicity following initial reversal. Patients physically dependent on opioids or who have received large doses of opioids should be administered Zynox (naloxone hydrochloride) with caution as an acute withdrawal syndrome may be precipitated.
Caution should be taken when administering it to neonates of mothers who are physically dependent on opioids as a withdrawal syndrome may be precipitated.
Zynox (naloxone hydrochloride) should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high molecular weight anions, or solutions with an alkaline pH.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless solution in amber ampoules.

PRESENTATION:
1 mL amber ampoules in containers of 10.
2 mL amber ampoules in containers of 10.

STORAGE INSTRUCTIONS:
Protect from light. Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:

Zynox Injection 0,4 mg/1 mL	–27/1.4/0157
Zynox Injection 0,02 mg/mL	–27/1.4/0158

NAME AND BUSINESS ADDRESS OF APPLICANT:

PHARMACARE LIMITED 7 Fairclough Road Port Elizabeth 6001

Marketed by: Intramed, Division of Pharmacare 6 Gibaud Road Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1993
                12-492/8-97
                KOHLER C&P P.E.
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