OMNOPON® 10 Ampoules; OMNOPON® 20 Ampoules

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

OMNOPON® 10 Ampoules
OMNOPON® 20 Ampoules

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

OMNOPON^® 10 Ampoules
OMNOPON^® 20 Ampoules

COMPOSITION:

Omnopon 10 ampoules contain:	Morphine HCl 6,72 mg/mL
	Papaverine HCl 0,6 mg/mL
	Codeine HCl 0,52 mg/mL
	Ethyl alcohol 6,44% v/v
Omnopon 20 ampoules contain	Morphine HCl 13,44 mg/mL
	Papaverine HCl 1,20 mg/mL
	Codeine HCl 1,04 mg/mL
	Ethyl alcohol 6,44% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 –other analgesics

PHARMACOLOGICAL ACTION:
Omnopon contains both the phenanthrene and isoquinoline groups of opium alkaloids. The former includes codeine and morphine, which exert a marked narcotic action on the central nervous system. The second group is represented by papaverine which acts as an antispasmodic, in vitro. Its effects in vivo are limited.
Omnopon has the analgesic and narcotic properties of morphine.

INDICATIONS:
Omnopon may be used in all cases in which morphine or opium is indicated.
Omnopon 20 is clinically equivalent to 10 -15 mg of morphine. Indications include the following: Pre- and post-operative medication; severe or intractable pain; cardiac asthma; pulmonary oedema; coronary occlusion; pulmonary embolism.

CONTRA-INDICATIONS:
Omnopon is an addicting drug with an addiction liability equal to morphine. It should not be administered in the presence of bronchial asthma, narcotic idiosyncrasies, respiratory depression, head injuries, raised intracranial pressure, patients on monoamine oxidase inhibitors or within 10 days of stopping such treatment.
Omnopon should not be given to patients with a history of hypersensitivity or idiosyncratic response to opium alkaloids.

DOSAGE AND DIRECTIONS FOR USE:

Adults:	0,5 - 1,0 mL by subcutaneous or intramuscular injection usually not given more often than four hourly.
Children: 1 –12 Years:	Usual dose 0,02 - 0,03 mL/kg Omnopon 10 or 0,01 - 0,015 mg/kg Omnopon 20 as maximum single dose.

Age	Approx. body mass	Quantity of Omnopon 10 solution rquired	Quantify of Omnopon 20 solution rqired
1 year	10 kg	0,2 - 0,3 mL	0,1 - 0,15 mL
12 year	40 kg	0,8 - 1,2 mL	0,4 - 0,6 mL

The use of a small graduated syringe is recommended for the accurate administration of dosages given to children. In the absence of graduated syringes, Omnopon ampoule should be diluted with Water for Injections before measuring the dose. Maintenance of stability cannot be guaranteed when Omnopon ampoule solution is diluted. Omnopon ampoules are not recommended for use in babies under one year of age.

Elderly:

Elderly patients are more sensitive to the actions of narcotic analgesics: the initial dose of Omnopon should not exceed 0,5 mL.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The commonest side-effects that may occur with Omnopon, as with other narcotics, are nausea, anorexia, constipation, confusion, sweating and occasionally vomiting. Micturition may be difficult and there may be ureteric or biliary spasm; an antidiuretic effect is also possible. Dry mouth, facial flushings, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, changes of mood, and miosis may also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure may occur in some patients. Due to the histamine-releasing effect allergic reactions such as urticaria, pruritus, and itching in the nose occur in some individuals and idiosyncrasy to morphine and other narcotic analgesics is fairly common. Omnopon, like other narcotics should be given with caution or in reduced doses to infants, old or debilitated patients and to patients with toxic psychosis prostatic obstruction, hyperthyroidism, adrenal insufficiency or impaired liver function.
Like all medicaments of this type, Omnopon may modify patients' reactions (driving ability, behaviour in traffic. etc.) to a varying extent depending on dosage, administration and individual susceptibility. The depressant effects are enhanced by depressants of the central nervous system such as sedatives, phenothiazines, etc.
The established medical principle of prescribing medicaments in early pregnancy only when absolutely indicated should be observed. Omnopon crosses the placenta and is also excreted in breast milk. This should be borne in mind when considering its use in patients during pregnancy or breast feeding. Administration in labour may cause respiratory depression in the newborn infant.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdosage:

1.	Coma
2.	Depressed respiration
3.	Pinpoint pupils
4.	Cold, clammy skin
5.	Muscle flaccidity
6.	Nausea and vomiting
7.	Hypotension

Treatment:

1.	Maintain respiratory status by suitable means such as establishing a patent airway and to ventilate the patient.
2.	Narcotic antagonists such as naloxone should be administered to reverse severe narcotic induced respiratory depression. If naloxone is not available, nalorphine or levallorphan should be used.

IDENTIFICATION:
A clear liquid in colourless ampoules.

PRESENTATION:

Omnopon 10	Containers with 10 x 1 mL ampoules
Omnopon 20	Containers with 10 x 1 mL ampoules

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

REGISTRATION NUMBER/APPLICATION NUMBER:

Omnopon 10	K/2.9/304
Omnopon 20	B1006 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23/04/1992

	12-855/12-94
	KOHLER C&P P.E.