Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Distributed on behalf of Mundipharma New Zealand Limited by: Pharmaco (N.Z.) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Ph: (09) 377-3336, Toll Free [Medical Enquiries]: 0800 773 310
DHC CONTINUS tablets should be administered with caution in the elderly or patients with:
DHC CONTINUS tablets should be administered with caution in patients taking:
The major risk of opioid excess is respiratory depression.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of DHC CONTINUS with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anaesthetics, medicines with antihistamine-sedating actions such as antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of medicine-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics (see Section 4.5 Interactions with other medicines and other forms of interaction).
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when DHC CONTINUS is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs (see Section 4.5 Interactions with other medicines and other forms of interaction).
DHC CONTINUS tablets should be administered with caution in patients with a history of opiate abuse or dependence. Patients may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of DHC CONTINUS tablets may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with DHC CONTINUS tablets, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Dihydrocodeine has a recognized abuse and addiction profile similar to other opioids. Dihydrocodeine may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence [addiction] to opioid analgesics, including dihydrocodeine. Dihydrocodeine should be used with particular care in patients with a history of alcohol and drug abuse.
The controlled release tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed controlled release tablets leads to a rapid release and absorption of a potentially fatal dose of dihydrocodeine and may result in overdose effects (see section 4.9). Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
DHC CONTINUS tablets are not recommended for use in children under twelve years of age.
The depressant effects of dihydrocodeine may be exaggerated in the presence of increased intracranial pressure or head injury. In such patients, dihydrocodeine must be used with caution and only if it is judged essential.
As dihydrocodeine may cause the release of histamine, it should be given with caution to asthmatics. As dihydrocodeine may cause the release of histamine it should not be given during an asthma attack.
The dosage of dihydrocodeine should be reduced in the elderly, in hypothyroidism, chronic hepatic disease, biliary tract disorder, pancreatitis, impairment of hepatic function, prostatic hypertrophy, severe renal dysfunction, severe chronic obstructive airways disease, severe cor pulmonale, and renal insufficiency (see section 4.2). Use with caution in patients suffering constipation. DHC CONTINUS tablets should not be used where there is a possibility of paralytic ileus. Should paralytic ileus be suspected or occur during use, DHC CONTINUS tablets should be discontinued immediately.
Opioids, such as dihydrocodeine, may influence the hypothalamic-pituitary-adrenal or gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes
Dihydrocodeine should be used with great caution and in reduced dosage in patients concurrently receiving other central nervous system depressants including other opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, other tranquillisers, gabapentin and alcohol because of the risk of respiratory depression, hypotension and profound sedation or coma. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Significant impairment of motor function has also been noted following concomitant dihydrocodeine administration and alcohol ingestion.
Concurrent administration with tricyclic antidepressants or beta-blockers may enhance the CNS depressant effects of dihydrocodeine.
Diazepam, when used following high doses of dihydrocodeine hydrogen tartrate, exacerbates the hypotensive effects produced by dihydrocodeine, and is associated with reduced plasma catecholamine levels.
| Clinical Impact | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. |
|---|---|
| Intervention | Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Section 4.4 Warnings and Precautions]. |
| Examples | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anaesthetics, drugs with antihistamine-sedating actions such as antipsychotics, other opioids, alcohol. |
Dihydrocodeine should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy.
There is limited published evidence on safety in human pregnancy. DHC CONTINUS tablets should be avoided to the extent possible in patients who are pregnant and only be used where the benefit outweighs risk to the foetus.
Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine should be avoided to the extent possible and only be administered to breast-feeding mothers if considered essential. Prolonged use of dihydrocodeine tartrate during pregnancy can result in neonatal opioid withdrawal syndrome.
Prolonged treatment with DHC CONTINUS tablets may potentially affect the reproductive function including menstrual disturbances, decreased libido and infertility.
Dihydrocodeine may impair the ability of the patient to drive or operate machinery. If so affected, patients should be warned against these activities.
The adverse effects listed below are classified by body system according to their incidence (common [≥1%] or uncommon [<1%]).
Uncommon: angioedema
Uncommon: confusional state, drug dependence, hallucination, mood altered, dysphoria
Uncommon: hypotension
Common: somnolence
Uncommon: convulsions, dizziness, headache, paraesthesia, sedation
Uncommon: vertigo
Uncommon: hyperhidrosis, pruritus, rash, urticaria
Common: abdominal pain, constipation, dry mouth, nausea, vomiting
Uncommon: diarrhoea, paralytic ileus
Uncommon: biliary colic, hepatic enzymes increased
Uncommon: urinary retention
Uncommon: dyspnoea, respiratory depression
Uncommon: asthenia, fatigue, malaise, withdrawal syndrome
Not Known: drug withdrawal syndrome neonatal
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/
None known.
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