Pharmaniaga Morphine Sulphate

Pharmaniaga Morphine Sulphate



Pharmaniaga LifeScience


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Full Prescribing Info
Morphine sulphate.
Each mL contains Morphine Sulphate 10mg.
Pharmacology: Pharmacodynamics: Morphine acts as agonists interacting with stereospecific and saturable binding sites or receptors in the brain and other tissues. They are present in highest concentration in the limbic system, thalamus, hypothalamus, midbrain and spinal cord. The affinity of opioid analgesics for the binding sites correlates well with their potency as analgesics.
Pharmacokinetics: Absorption: Rapidly absorbed after subcutaneous or intramuscular administration with rapid disappearance from plasma, especially after IV administration.
Blood Concentration: After IV injection of 10 mg, serum concentrations of about 60 ng/mL are obtained in 15 minutes falling to 30 ng/mL after 30 minutes and to 10 ng/mL after 3 hours. After an intramuscular dose of 10 mg, peak serum concentrations of 70 to 80 ng/mL are attained in 10 to 20 minutes; subcutaneous doses given similar concentrations to intramuscular doses at 15 minutes but remain slightly higher during the following 3 hours.
Excretion: After a parenteral dose, about 90% is excreted in 24 hours, with about 10% as free morphine, 65 to 75% as conjugated morphine, 1% as normorphine and 3% as normorphine glucuronide.
Distribution: Widely distributed throughout the body, mainly in the kidneys, liver, lungs and spleen; lower concentrations appear in the brain and muscles; morphine crosses the placenta and traces are secreted in sweat and milk; protein binding, about 35% bound to albumin and to immunoglobulins at concentrations within the therapeutic range.
Metabolic Reactions: Inactivated in the liver, primarily by conjugation with glucuronic acid.
Half-Life: Serum half-life in the period 10 minutes to 6 hours following intravenous administration, 2 to 3 hours; serum half-life in the period 6 hours onwards, 10 to 44 hours.
It is used for symptomatic relief of moderate to severe pain, especially that associated with neoplastic disease, myocardial infarction, and surgery. It is also indicated as adjunctive therapy in the treatment of acute pulmonary oedema secondary to left ventricular failure.
Dosage/Direction for Use
Morphine sulphate should be given in the smallest effective dose and as infrequent as possible in order to minimise the development of tolerance and physical dependence. In patients with exceptionally severe, chronic pain or those who have become tolerant to the analgesic effect of opiate agonist, it may be necessary to exceed the usual dose.
Usual Adult dose: Analgesic: IM or SC: 5 - 20 mg (usually 10 mg initially) every 4 hours as needed.
IV: 4 - 10 mg diluted in 4 - 5 mL of sterile WFI administered slowly.
Epidural (in the lumbar region), 5 mg with incremental doses of 1 to 2 mg per hour if needed, up to a maximum of 10 mg per 24 hours.
Intrathecal, 0.2 mg - 1 mg as a single dose.
Usual Paediatric dose: Analgesic: SC: 0.1 to 0.2 mg/kg body weight every 4 hours as needed, not to exceed 15 mg per dose.
IV: 0.05 to 0.1 mg/kg body weight, administered very slowly.
Preoperative: IM : 0.05 mg to 0.1 mg/kg body weight, not to exceed 10 mg per dose.
ROUTE OF ADMINISTRATION: Parenteral [By IM, SC, Epidural, Intrathecal or slow IV injection].
Symptoms: Large doses produce respiratory depression and hypertension with circulatory failure and deepening coma.
Treatment: Correct respiratory failure and shock with intensive supportive therapy. In addition, the specific antagonist naloxone hydrochloride is used to counter react very rapidly the severe respiratory depression and coma produced by excessive doses of morphine. A dose of 0.4 to 2 mg of Naloxone Hydrochloride is given by I/V injection repeated at intervals of 2 to 3 minutes, if necessary up to 10 mg. May also be given by subcutaneous or I/M injection or I/V infusion.
Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, and after operation on biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised, hypotension, asthma, hepatic impairment, during pregnancy and breast feeding, in patient taking MAO-inhibitors, those with a history of drug abuse. The administration of morphine and other narcotic analgesic are also contraindicated.
Special Precautions
Morphine is not usually given preoperatively to children under 1 year of age, and it should be given with extreme care to newborn or premature infants for other conditions. The administration of opioid analgesic during labour may cause respiratory depression in the newborn infant. It should be used with extreme caution in patients with decreased respiratory reserve. It should be used with caution in patients with myasthenia gravis. Alarming and atypical effects sometimes occur in the elderly and the dosage should be reduced in elderly and debilitated patient.
It should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock or inflammatory or obstructive bowel disorders.
Effects on Ability to Drive and Use Machine: Morphine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. Morphine in combination with other narcotic analgesics, phenothiazines, sedative hypnotics, and alcohol have additive depressant effects.
Patients should not drive or operate machinery.
Use In Pregnancy & Lactation
Pregnancy: An association with increased frequency of inguinal hernias in Infants has been postulated in man. Pregnant patients should only be given morphine when the benefits clearly outweigh potential risks to the foetus.
Breast-feeding: Morphine is excreted in human milk and breastfeeding is not recommended while a patient is receiving morphine. Withdrawal syndrome was observed in breastfed infants after maternal administration of morphine sulfate had been stopped.
Use in labour/delivery: Morphine may prolong labour by temporarily reducing the strength, duration and frequency of uterine contractions. Conversely, it may tend to shorten labour by increasing the rate of cervical dilatation. Infants born to mothers receiving opioid analgesics during labour should be observed closely for signs of respiratory depression. In such infants a specific opioid antagonist, naloxone hydrochloride, should be available for reversal of narcoticinduced respiratory depression. After chronic morphine use by the mother, newborns may develop withdrawal symptoms.
Side Effects
Nausea and vomiting, constipation and drowsiness; larger doses produce respiratory depression and hypotension ; other include difficulty with micturition, ureteric or biliary spasm, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, postural hypotension, hypothermia, hallucinations, mood changes, dependence, miosis, urticaria and pruritus.
Drug Interactions
Serious and sometimes fatal reaction have occurred when given to patients already receiving monoamine oxidase inhibitors. Depressant effects of morphine are enhanced by CNS depressants such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. Opioid analgesics with some antagonist activity such as buprenorphine, butorphenol, nalbuphine or pentazocine may precipitate withdrawal symptoms in patients who have recently used morphine. The actions of opioid may in turn affect the activities of other compounds e.g. their gastro-intestinal effects may delay absorption as with maxiletine or may be counter-active as with metoclopramide.
Incompatibilities: Morphine sulphate is physically incompatible with acyclovir sodium, aminophylline, amobarbital sodium, cefepime hydrochloride, chlorothiazide sodium, floxacillin sodium, furosemide, gallium nitrate, heparin sodium, meperidine hydrochloride, meperidine sodium, methicillin sodium, minocycline hydrochloride, pentobarbital sodium, phenobarbital sodium, phenytoin sodium, sargramostim, sodium bicarbonate, thiopental sodium.
Store below 30°C. Protect from light.
Do not use if solution contains growth, particles, turbidity or if its color is darker than pale yellow.
Shelf-Life: 3 years from date of manufacture.
MIMS Class
ATC Classification
N02AA01 - morphine ; Belongs to the class of natural opium alkaloids. Used to relieve pain.
Inj 10 mg/mL (a colourless solution to pale yellow solution in amp) x 1 mL x 10's.
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