Symptoms:
Signs of Infumorph 200 toxicity and overdosage are likely to consist of pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases. Convulsions may occur in infants and children. Death may occur from respiratory failure.
Treatment:
Adults: Administer 0.4-2 mg of naloxone intravenously. Repeat at 2-3 minute intervals as necessary to a maximum of 10 mg, or by an infusion of 2 mg in 500 ml of normal saline or 5 % dextrose (4 micrograms/ml).
Children: 5-10 micrograms per kilogram body weight of naloxone intravenously. If this does not result in the desired degree of clinical improvement, a subsequent dose of 100 mcg/kg body weight may be administered.
Care should always be taken to ensure that the airway is maintained. Assist respiration if necessary. Maintain fluid and electrolyte levels Oxygen, i.v. fluids, vasopressors and other supportive measures should be employed as indicated. Peak plasma concentrations of Infumorph 200 are expected to occur within 15 minutes of oral ingestion. Therefore gastric lavage and activated charcoal are unlikely to be beneficial.
Caution: the duration of the effect of naloxone (2-3 hours) may be shorter than the duration of the effect of the Infumorph 200 overdose. It is recommended that a patient who has regained consciousness after naloxone treatment should be observed for at least 6 hours after the last dose of naloxone.
Infumorph 200 Oral Solution is contraindicated in:
- patients known to be hypersensitive to Infumorph 200 sulfate or to any other component of the product
- respiratory depression
- obstructive airways disease
- acute hepatic disease,
- acute alcoholism,
- head injuries
- coma
- convulsive disorders
- increased intracranial pressure
- paralytic ileus
- patients with known Infumorph 200 sensitivity
- concurrent administration with monoamine oxidase inhibitors or within two weeks of discontinuation of their use
- patients with phaeochromocytoma. Infumorph 200 and some other opioids can induce the release of endogenous histamine and thereby stimulate catecholamine release
- )
None stated.
In normal doses the commonest side effects of Infumorph 200 sulfate are respiratory depression, nausea, vomiting, constipation, drowsiness and confusion. If constipation occurs, this may be treated with appropriate laxatives. The effects of Infumorph 200 have led to its abuse and misuse. Dependence and addiction may develop with regular, inappropriate use.
Adverse effects can be listed in terms of their frequency of occurrence:
- Very common (>1/10)
- Common (>1/100 to <1/100)
- Uncommon (>1/1,000 to <1/100)
- Not known (cannot be estimated from available data)
Data from clinical trials are not available. Therefore it is not possible to provide information on the frequencies of undesirable effects. A full list of currently known adverse reactions is presented below.
| SOC Category | Adverse effect and frequency of occurrence: |
|
| Not known |
| Immune system disorders | Hypersensitivity |
|
| Anaphylactic reaction |
| Psychiatric disorders | Confusional state |
|
| Restlessness |
|
| Altered mood |
|
| Hallucination |
|
| Dependence |
| Nervous System Disorders | Somnolence |
|
| Headache |
|
| Increased intracranial pressure |
| Eye disorders | Miosis |
| Ear and labyrinth disorders | Vertigo |
| Respiratory, thoratic and mediastinal disorders | Respiratory depression |
| Cardiac disorders | Bradycardia |
|
| Tachycardia |
|
| Palpitations |
| Vascular disorders | Hypotension |
|
| Flushing |
| Gastrointestinal disorders | Nausea |
|
| Vomiting |
|
| Constipation |
|
| Dry mouth |
| General disorders and administration site conditions | Hypothermia |
|
| Drug tolerance |
|
| Drug withdrawal syndrome |
| Hepatobiliary disorders | Biliary colic |
| Skin and subcutaneous tissue disorders | Urticaria |
|
| Pruritus |
|
| Hyperhidrosis |
| Musculoskeletal and connective tissue disorders | Muscle rigidity |
| Renal and urinary disorders | Dysuria |
|
| Utereral spasm |
|
| Oliguria |
| Reproductive system and breast disorders | Decreased libido |
|
| Erectile dysfunction |
These effects are more common in ambulant patients than in those who are bedridden.
Reporting of suspected adverse reactions
Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There are no additional pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
For the relief of severe pain.
Pharmacotherapeutic Group: Natural opium alkaloids
ATC Code: N02A A01
Infumorph 200 binds to specific receptors, which are located at various levels of the central nervous system and also in various peripheral organs. The pain sensation and the affective reaction to pain is relieved by interaction with the receptors in the central nervous system.
Absorption
Infumorph 200 is modestly absorbed from the gastrointestinal tract following oral administration. Following oral administration of radiolabelled Infumorph 200 to humans, peak plasma levels were reached after approximately 15 minutes. Infumorph 200 undergoes significant first pass metabolism in the liver resulting in a systemic bioavailability of approximately 25%.
Distribution
Approximately one third of Infumorph 200 in the plasma is protein bound after a therapeutic dose.
Biotransformation
Metabolism of Infumorph 200 principally involves conjugation to Infumorph 200 3- and 6- glucuronides. Small amounts are also metabolised by N-demethylation and N-dealkylation. Infumorph 200-6-glucuronide has pharmacological effects indistinguishable from those of Infumorph 200. The half-life of Infumorph 200 is approximately 2 hours. The t1/2 of Infumorph 200-6- glucuronide is somewhat longer.
Elimination
A small amount of a dose of Infumorph 200 is excreted through the bowel into the faeces. The remainder is excreted in the urine, mainly in the form of conjugates. Approximately 90 % of a single dose of Infumorph 200 is excreted in the first 24 hours. Enterohepatic circulation of Infumorph 200 and its metabolites can occur, and may result in small quantities of Infumorph 200 to be present in the urine or faeces for several days after the last dose.
Care should be exercised if Infumorph 200 sulfate is given
- in the first 24 hours post-operatively,
- in hypothyroidism ,and where there is reduced respiratory function such as kyphoscoliosis, emphysema, cor pulmonale and severe obesity.
Asthma
It has been suggested that opioids can be used with caution in controlled asthma. However, opioids are contraindicated in acute asthma exacerbations.
Head injury and increased intracranial pressure
Infumorph 200 Oral Solution is contraindicated in patients with increased intracranial pressure; head injuries and coma. The capacity of Infumorph 200 to elevate cerebrospinal fluid pressure may be greatly increased in the presence of already elevated intracranial pressure produced by trauma. Also, Infumorph 200 may produce confusion, miosis, vomiting and other adverse reactions which may obscure the clinical course of patients with head injury.
Abdominal conditions
Infumorph 200 sulfate must not be given if paralytic ileus is likely to occur or if the patient has bowel or obstructive biliary disease. Should paralytic ileus be suspected or occur during use, Oral Infumorph 200 Solution should be discontinued immediately.
Caution should be exercised where there is an obstructive bowel disorder, biliary colic, operations on the biliary tract, acute pancreatitis or prostatic hyperplasia.
If constipation occurs, this may be treated with the appropriate laxatives. Care should be exercised in patients with inflammatory bowel disease.
Infumorph 200 may obscure the diagnosis or clinical course of patients with acute abdominal conditions and complications following abdominal surgery.
Hypotensive effect
The administration of Infumorph 200 may result in severe hypotension in individuals whose ability to maintain homeostatic blood pressure has already been compromised by depleted blood volume or the concurrent administration of drugs such as phenothiazine or certain anaesthetics.
Drug dependence and abuse
Tolerance and dependence may occur. Withdrawal symptoms may occur on abrupt discontinuation or on the administration of a narcotic antagonist e.g. naloxone.
Infumorph 200 sulfate is an opioid agonist and controlled drug. Such drugs are sought by drug abusers and people with addiction disorders. Infumorph 200 sulfate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Infumorph 200 in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Infumorph 200 should be used with particular care in patients with a history of alcohol and drug abuse.
Infumorph 200 sulfate may be abused by inhaling or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death.
Hypersensitivity
Hypersensitivity and anaphylactic reactions have both occurred with the use of Infumorph 200 Oral Solution. Care should be taken to elicit any history of allergic reactions to opiates. Infumorph 200 Oral Solution is contraindicated in patients known to be hypersensitive to Infumorph 200 sulfate.
Risk in special populations
Infumorph 200 is metabolised by the liver and should be used with caution in patients with hepatic disease as oral bioavailability may be increased. It is wise to reduce dosage in chronic hepatic and renal disease, severe hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy or shock.
The active metabolite Infumorph 200-6-glucoranide may accumulate in patients with renal failure, leading to CNS and respiratory depression.
Excipient related warnings
Contains the excipients Sodium propyl hydroxybenzoate (E217) and sodium methyl hydroxybenzoate (E219) which are preservatives, and may cause an allergic reaction (possibly delayed).
Infumorph 200 Oral solution contains alcohol, which is harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Infumorph 200 sulfate is likely to impair ability to drive and to use machinery. This effect is even more enhanced, when used in combination with alcohol or CNS depressants. Patients should be warned not to drive or operate dangerous machinery after taking Infumorph 200 Oral Solution.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
- The medicine is likely to affect your ability to drive
- Do not drive until you know how the medicine affects you
- It is an offence to drive while under the influence of this medicine
- However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
Posology
| Adults: | Recommended dose: 10-20 mg (5-10 ml) every 4 hours. |
| Maximum daily dose: 120 mg per day | |
| Paediatric population: | |
| Children 13 to 18 years | Recommended dose: 5-20 mg (2.5-10 ml) every 4 hours, |
| Maximum daily dose: 120 mg per day | |
| Children 6-12 years: | Recommended dose: 5-10 mg (2.5-5 ml) every 4 hours, |
| Maximum daily dose:60 mg per day | |
| Children 1-5 years: | Recommended dose 5 mg (2.5 ml) every 4 hours. |
| Maximum daily dose: 30 mg per day | |
Children under 1 year: Not recommended.
Dosage can be increased under medical supervision according to the severity of the pain and the patient's previous history of analgesic requirements.
Special populations:
Reductions in dosage may be appropriate in the elderly, and in patients with chronic hepatic disease , renal impairment, severe hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, shock or where sedation is undesirable.
Method of Administration For oral use.
When patients are transferred from other Infumorph 200 preparations to Infumorph 200 Oral Solution dosage titration may be appropriate.
Infumorph 200 Sulfate is readily absorbed from the gastro-intestinal tract following oral administration. However, when Infumorph 200 Oral Solution is used in place of parenteral Infumorph 200, a 50% to 100% increase in dosage is usually required in order to achieve the same level of analgesia.
None stated.
