PRODUCT INFORMATION ANAMORPH

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1 PRODUCT INFORMATION ANAMORPH NAME OF DRUG ANAMORPH Tablets contain morphine sulfate 30 mg. DESCRIPTION Morphine is a phenanthrene-derivative opiate agonist. Morphine is the chief opium alkaloid which is dried or partially dried latex from the capsules of Papaver sonniferum. Morphine sulfate has the following structural formula (CAS ): HO O H HO H H NMe.H 2 SO 4.5H 2 O 2 Morphine sulfate is chemically known as 7,8-didehydro-4,5-epoxy-17-methylmorphinan- 3,6-diol sulfate (2:1) (salt) pentahydrate. Morphine sulfate has a molecular formula of (C 17 H 19 NO 3 ) 2, H 2 SO 4, 5H 2 O and a molecular weight of Morphine sulfate is an odourless, white or almost white, acicular crystals, cubical masses, or crystalline powder. When exposed to air it gradually loses water of hydration. It darkens on prolonged exposure to light. Solubility: Morphine sulfate is very soluble in water, and is very slightly soluble in alcohol. It is practically insoluble in toluene, and insoluble in chloroform and in ether. Excipients: Anamorph tablets contain the following excipients: lactose, carmellose sodium and magnesium stearate. ANAMORPH- Product Information Page 1 of 8

2 PHARMACOLOGY Actions Morphine is an opioid analgesic, which binds with stereospecific receptors at many sites within the central nervous system (CNS) to alter processes affecting both the perceptions of pain and the emotional response to pain. There are multiple subtypes of opioid receptors, each mediating various therapeutic and/or side effects of morphine. Morphine exerts its agonist activity primarily at the mu () opioid receptors. In addition to analgesia, alterations in mood including euphoria and dysphoria, drowsiness and mental clouding commonly occur. Cough suppression is mediated through direct effect on the medullary centre. Respiratory depression results from reduced responsiveness of the respiratory centre to carbon dioxide. Even at therapeutic doses, all phases of respiratory activity (rate, minute volume and tidal exchange) are depressed. Nausea and emesis are a consequence of direct stimulation of the chemoreceptor trigger zone. Biliary tract pressure may result from morphine induced spasm of the Sphincter of Oddi. Constipation is secondary to the narcotic action on bowel wall nerve plexuses. Pharmacokinetics Absorption: Morphine salts are well absorbed from the gastrointestinal tract but have poor oral bioavailability since they undergo extensive first pass metabolism in the liver and gut. The majority of a dose of morphine is conjugated with glucuronic acid in the liver, and the gut to produce morphine-3-glucuronide and morphine-6-glucuronide. The latter is considered to contribute to the analgesic effects of morphine, especially when repeated doses are given by mouth. Other active metabolites include normorphine, codeine, and morphine ethereal sulfate. Distribution: Morphine is distributed throughout the body, but mainly in the kidneys, lungs, liver and spleen, with lower concentrations in the brain and muscles. Morphine crosses the blood brain barrier less readily than more lipid-soluble opioids such as diamorphine, but it has been detected in the CSF, as have its highly polar metabolites. Excretion: About 90% of the total morphine is excreted in the urine as morphine or its metabolites within the first 24 hours of administration. Up to 10% of a dose of morphine may eventually be excreted, as conjugates through the bile into the faeces. The reminder is excreted in the urine, mainly as conjugates. Mean plasma elimination half-lives of 1.7 hours for morphine. INDICATIONS Relief of severe pain (medical and surgical) where non-narcotic analgesics and other measures do not provide satisfactory relief. Except in patients with terminal conditions, use of Anamorph should be restricted to short-term administration. CONTRAINDICATIONS Morphine is contraindicated in the following conditions: ANAMORPH- Product Information Page 2 of 8

3 Hypersensitivity to morphine or any of the ingredients in Anamorph tablets (see Description) Respiratory depression, or where respiratory reserve is depleted (e.g. severe emphysema, severe chronic bronchitis, kyphoscoliosis) Raised intracranial pressure or cerebrospinal pressure Acute bronchial asthma Patients with head injury or brain tumor Cardiac arrhythmias Severe CNS depression Heart failure secondary to chronic pulmonary disease Acute alcoholism or delirium tremens Severe liver or renal disease Incipient hepatic encephalopathy After operations on the biliary tract In the presence of gastrointestinal obstruction Convulsive states such as status epilepticus, tetanus and strychnine poisoning due to the stimulatory effects of morphine in the spinal cord Obstructive bowel disorders. Morphine should not be given to patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment. PRECAUTIONS Impaired Respiration: Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs most frequently in elderly and debilitated patients, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may significantly decrease pulmonary ventilation. Morphine should be used with extreme caution in patients with chronic pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with pre-existing respiratory depression, hypoxia or hypercapnia. In such patients, even the usual therapeutic doses of morphine may decrease respiratory drive while simultaneously increasing airways resistance to the point of apnoea. Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of morphine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, morphine produces adverse reactions that may obscure the clinical course of patients with head injuries. In such patients, morphine must be used only if its use is deemed essential and then with extreme caution. Hypotensive Effect: Morphine sulfate may cause severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as phenothiazines or certain anaesthetics (see Interactions with Other Drugs). Morphine sulfate may produce orthostatic hypotension in ambulatory patients. Morphine sulfate, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. ANAMORPH- Product Information Page 3 of 8

4 Supraventricular Tachycardias: Because of possible vagolytic action that may produce a significant increase in the ventricular response rate, morphine should be used with caution in patients with atrial flutter and other supraventricular tachycardias. Convulsions: Morphine may exacerbate pre-existing convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders. Hepatic or Renal Disease: Morphine may have a prolonged duration and cumulative effect in patients with kidney or liver dysfunction, with the potential for an increase of adverse effects. Biliary Surgery or Pancreatitis: Morphine may cause spasm of the biliary tract and sphincter of Oddi and should be used only when necessary, and with caution, in patients with biliary colic, operations on the biliary tract and acute pancreatitis. Acute Abdominal Condition: Morphine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Other Special Risk Patients: Reduced doses and caution is required when prescribing morphine for certain patients such as the elderly or debilitated, those with hypothyroidism, ulcerative colitis, adrenocortical insufficiency (e.g. Addison s disease), and prostatic hypertrophy. Carcinogenicity, Mutagenicity, Impairment of Fertility: Adequate studies in animals have not been conducted to determine whether morphine sulfate has the potential for carcinogenesis or mutagenesis. Adequate studies in animals have not been performed to determine whether morphine sulfate has potential to impair fertility. Use in Pregnancy: (Category C) Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Pregnant women should only be given Anamorph when the benefits clearly outweigh the potential risks to the fetus. The Australian categorisation definition of: Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be further consulted for further details. Use in Lactation: Morphine is excreted in breast milk, therefore is not recommended for nursing mothers. Use in Children: Caution is advised in the administration of morphine to children up to two years of age, who may be more sensitive to the effects, especially the respiratory depressant effects. Paradoxical excitation is likely to occur in children receiving morphine. ANAMORPH- Product Information Page 4 of 8

5 Use in the Elderly: Care should be taken when prescribing for the elderly and debilitated patients. Morphine can show atypical effects. Driving and Operating Machinery: Morphine may impair the mental and/or physical ability required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients must be cautioned accordingly. Drug Dependence: Repeated administration may lead to physical and/or psychological dependence. Tolerance may also develop following repeated administration. Dependence, however, is not of paramount importance in the management of terminally ill patients or any patients in severe pain. Abrupt cessation, a sudden reduction in dose after prolonged use, or administration of a narcotic antagonist may result in withdrawal symptoms. If withdrawal is necessary, it must be undertaken gradually. INTERACTION WITH OTHER DRUGS Atropine: May counteract morphine-induced miosis. Cimetidine: A potentially lethal interaction causing apnoea, reduced respiratory rate and grand mal seizure has been reported. Naloxone increased respiratory rate, however confusion, disorientation, generalised twitching and periods of apnoea persisted for 80 hours. CNS depressant medications (including other opioids, sedatives or hypnotics, barbiturates, general anaesthetics, phenothiazines, tricyclic antidepressants, tranquillisers and alcohol): When combined with morphine, the additive depressant effects may produce respiratory depression, hypotension and profound sedation or coma. When such therapy is contemplated, the dose of one or both agents should be reduced. Dexamphetamine: Enhances the analgesic effects of morphine, decreases sedation and lack of alertness. Diazepam: Exacerbates hypotension produced by high dose of morphine as well as enhancing CNS depressant effects of morphine. Doxapram: Antagonises morphine-induced respiratory depression. Monoamine Oxidase Inhibitors (MAOIs): Because severe and sometimes fatal reactions have occurred in patients concurrently administered MAOIs and pethidine, morphine should not be given to patients taking non-selective MAOIs or within 14 days of stopping such treatment. It is unknown whether there is an interaction between the new selective MAOIs (e.g. moclobemide, selegiline) and morphine, therefore caution is advised with this combination (see Contraindications). Paracetamol: Morphine delays gastric emptying and will delay the absorption of paracetamol. Pentazocine, Buprenorphine (mixed agonist/antagonist opioid analgesics): May inhibit the effects of morphine or may precipitate withdrawal symptoms. Propanolol: Causes a potentially lethal increase in CNS toxicity. Thiopentone: Inactivates morphine in solution. ANAMORPH- Product Information Page 5 of 8

6 Tubocurarine and other muscle relaxants: Morphine augments the neuromuscular blockade. ADVERSE REACTIONS The major hazards associated with morphine, as with other opioid analgesics, are respiratory depression and to a lesser degree, circulatory depression. Respiratory arrest, shock and cardiac arrest have occurred. Other adverse effects include: Cardiovascular: Bradycardia, palpitations, hypotension (usually with larger doses), circulatory failure (usually at high doses), faintness, syncope, tachycardia, hypertension, facial flushing, chills. Respiratory: Respiratory depression (usually with large doses). Neurological: Confusion, vertigo, sedation, restlessness, mood changes, deepening coma (usually with high doses), increased intracranial pressure, headache, drowsiness, weakness, euphoria, dysphoria, seizures, dizziness, nervousness, agitation, hallucinations, delirium, insomnia, mental clouding or depression, physical dependence (with repeated administration) and tolerance development (with repeated administration). Dermatological and Hypersensitivity Reactions: Urticaria, pruritis, and other skin rashes including contact dermatitis. Gastrointestinal: Nausea, vomiting, constipation, anorexia, and dry mouth. Genitourinary: Urinary retention or hesitancy, ureteric spasm, oliguria, reduced libido or potency. Hepatobiliary: Biliary spasm. Endocrine: Anti-diuretic effect. Ophthalmic: Miosis. Other: Sweating, muscle rigidity, orthostatic hypotension and hypothermia. Withdrawal (Abstinence) Syndrome Physical dependence, with or without psychological dependence tends to occur on chronic administration. A withdrawal may be precipitated when morphine is abruptly discontinued or opioid antagonists administered. The following symptoms may be observed: body aches, diarrhoea, gooseflesh, anorexia, nervousness or restlessness, rhinorrhoea, sneezing, tremors or shivering, stomach cramps, nausea, sleep disturbance, unusual increase in sweating and yawning, weakness, tachycardia, unexplained fever and mydriasis. ANAMORPH- Product Information Page 6 of 8

7 DOSAGE AND ADMINISTRATION Adults: Usually half to one tablet initially; may be repeated every 4 to 6 hours. In chronic pain of carcinoma doses should be individually adjusted to provide analgesia. Geriatric: Plasma half-life is prolonged in the elderly. Longer dosage intervals or lower doses may be required. OVERDOSAGE Symptoms: Acute morphine overdosage is characterised by cold, clammy skin; confusion; convulsions; severe dizziness, severe drowsiness; low blood pressure; severe nervousness or restlessness; pinpoint pupils of eyes; slow heartbeat; slow or troubled breathing; severe weakness; and unconsciousness. Severe overdosage may result in apnoea, circulatory collapse, cardiac arrest and death. Treatment: Immediate attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. If clinically significant respiratory or cardiovascular depression is present, naloxone (a specific antidote for opioid overdose) is given. The usual initial adult dose is 0.40 to 2.0 mg intravenously, administered at 2 to 3 minute intervals if necessary. If no response is observed after 10 mg has been administered, the diagnosis of opioid-induced toxicity should be questioned. Children may receive an initial IV dose of 0.01 mg/kg; if this dose does not produce the desired degree of response, a subsequent dose of 0.1 mg/kg may be administered. Since the duration of action of morphine may exceed that of the antidote, the patient should be carefully monitored, and doses of the antidote repeated as needed. In physically dependent patients, use of naloxone will precipitate withdrawal symptoms. Naloxone should only be used when necessary, and the dose will need to be titrated in such patients. Naloxone should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated. PRESENTATION 30 mg tablets; round, white, flat bevelled edge tablets, scored on one side and marked with letter M above breakline and numeral 30 below the breakline; blister pack; 20 s. STORAGE Store below 30C in a dry place. POISON SCHEDULE Controlled Drug (S8) ANAMORPH- Product Information Page 7 of 8

8 NAME AND ADDRESS OF SPONSOR Aspen Pharma Pty Ltd Chandos Street, St. Leonards NSW 2065 Australia Approved by the Therapeutic Goods Administration on May Last revision approved by the Therapeutic Goods Administration on 7 May ANAMORPH- Product Information Page 8 of 8

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