For the relief of severe pain.

Adults:
Subcutaneous or intramuscular injection:
10 mg every four hours if necessary (the dose may vary from 5-20 mg depending on the individual patient).
Slow intravenous injection (2 mg/minute):
Quarter to half of the corresponding intramuscular dose, not more than four hourly.
Elderly and debilitated patients: The dose should be reduced because of the depressant effect on respiration. Caution is required.
Children: Use in children is not recommended.
Hepatic Impairment:
A reduction in dosage should be considered in hepatic impairment.
Renal Impairment
The dosage should be reduced in moderate to severe renal impairment.

• Hypersensitivity to any of the product’s ingredients • Acute respiratory depression or Chronic Obstructive Airways Disease • Asthma attack • Acute alcoholism • Biliary colic • Head injuries or increased intracranial pressure • Heart failure secondary to lung disease • Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal • Risk of paralytic ileus • Phaeochromocytoma • Liver failure in children may precipitate coma

Repeated use can cause tolerance and dependence. Caution in use should be exercised and a reduction in dose may be advisable in the elderly and in the following cases:
• Hypotension
• Hypothyroidism
• Depressed respiratory reserve
• Prostatic hypertrophy
• Hepatic or renal impairment (avoid or reduce dose)
• Convulsive disorders
• Administration of morphine to children with hepatic impairment may precipitate coma
• The subcutaneous route is not suitable if tissue perfusion impaired or if oedema is present
• Consideration should be given to prescribing prophylactic laxatives when initiating treatment with major opioids to children
• Asthma (avoid during attack)
• Prophylactic laxatives should always be prescribed when commencing major opioids to children.
• Respiratory support should be available for non-ventilated neonates and children < 1 year as such patients show an increased susceptibility to respiratory depression.

Alcohol : Enhanced sedative and hypertensive effects.
Antidepressants: The use of morphine should be avoided or used with caution in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal.
Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use of morphine.
Antimuscarinics: agents such as atropine antagonise morphine-induced respiratory depression and can partially reverse biliary spasm but are additive to the gastrointestinal and urinary tract effects. Consequently, severe constipation and urinary retention may occur during intensive antimuscarinic-analgesic therapy.
Ciprofloxacin: Morphine Sulfate should not be used as a premedication when ciprofloxacin is used for surgical prophylaxis as serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery.

Morphine should not be used during pregnancy or lactation as it crosses the placenta and is secreted in breast milk and can cause respiratory depression in the neonate.

May cause drowsiness, if affected patients should not drive or operate machinery.

Cardiac disorders
• Bradycardia
• Tachycardia
• Palpitations
Vascular disorders
• Postural hypotension
• Hypotension due to large doses
Nervous system disorders
• Headache
• Vertigo
• Dizziness
• Drowsiness
• Restlessness
• Seizure, particularly with infants and children
• Raised intracranial pressure
Eye disorders
• Miosis
Respiratory, thoracic and mediastinal disorders
• The most serious hazrd of the therapy is respiratory depression, especially with large doses. Neonates and children < 1 year show an increased susceptibility to respiratory depression
• Bronchospasm

Gastrointestinal disorders
• Constipation
• Ileus
• Nausea
• Vomiting
• Dry mouth
Renal and urinary disorders
• Ureteric spasm
• Difficulty in micturition
• Urinary retention
Skin and subcutaneous disorders
• Sweating
• Facial flushing
• Rashes and pruritis
• Contact dermatitis
• Urticaria
• Angioedema
Musculoskeletal and connective tissue disorders
• Muscle rigidity
• Myoclonus with higher doses
Hepatobiliary disorders
• Increase in liver enzymes as a result of spasm of the sphincter of Oddi
• Biliary spasm
Immune system disorders
• Allergic reactions (including anaphylaxis)
Reproductive system and breast disorders
• Decrease in libido or potency

Psychiatric disorders
• Hallucination
• Confusion
• Mood change
• Dysphoria
• Dependence
General disorders and administration site conditions
• Hypothermia
• Pain and irritation at the site of injection has been reported
• Syndrome of inappropriate anti diuretic hormones (SIADH)
- To reports any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

Symptoms: Progressive depression of the central nervous system leading to deep coma, cyanosis and marked reduction of the respiratory rate before respiratory arrest occurs. The pupils are usually pin-point in size. Hypotension, tachycardia, hallucinations and rhabdomyolysis have been reported.
Treatment: Maintain fluid and electrolyte levels and provide assisted respiration if necessary.
Naloxone is indicated if coma or respiratory depression is present. Patients should be carefully observed for recurrence of CNS and respiratory depression. The plasma half-life of naloxone is shorter than that of all opioid analgesics-repeated doses of naloxone may be required.
In children, the usual initial dose of naloxone is 10 micrograms per kg body-weight intravenously followed, if necessary, by a larger dose of 100 micrograms per kg.

Morphine is a powerful analgesic and narcotic and has central stimulant action. It depresses the thalamus, sensory cortex , respiratory and cough centres but stimulates the vomiting centre. Morphine increases the tone of involuntary muscles especially the sphincters of the gastro-intestinal tract.

Morphine is distributed throughout the body but mainly in the kidneys, liver, lungs and spleen. Morphine is conjugated with glucuronic acid in the liver and gut into the active metabolites morphine-3-glucuronide and morphine-6-glucuronide. Up to 10% of a dose may be excreted through the bile into the faeces; the remainder is excreted in the kidneys.
It crosses the placenta and traces are found in sweat and milk. It is about 35% plasma protein bound. The plasma half life is 2 - 3 hours and about 60% of the dose is excreted in the urine after 24 hours. A small proportion of this
is free morphine (higher in alkaline urine) and about 60 - 70% is conjugated. A small amount may be excreted in the bile.
The pharmacokinetics of morphine in children aged >1 year are similar to adults, with an elimination half-life of about 2 hours following IV administration.

No additional pre-clinical data of relevance to the prescriber.

Sodium Chloride, Sodium Metabisulphite and Water for Injection.
The pH may be adjusted with Sodium Hydroxide or Sulphuric Acid Solution.

Specialised references should be consulted for specific compatibility information.

36 months.

Do not store above 25°C and protect from light.

Clear, colourless 1ml glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton.

None stated.