1. Name Of The Medicinal Product
DHC® Continus® prolonged release tablets 60 mg, 90 mg, 120 mg.
2. Qualitative And Quantitative Composition
Dihydrocodeine tartrate 60 mg, 90 mg, 120 mg.
3. Pharmaceutical Form
Prolonged release tablet.
White capsule shaped tablets, 60 mg are marked DHC 60, 90 mg are marked DHC 90 and 120 mg are marked DHC 120.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of severe pain in cancer and other chronic conditions.
4.2 Posology And Method Of Administration
Adults and children over 12 years: 60 mg - 120 mg every 12 hours.
Elderly: Dosage should be reduced.
Children 12 years or under: Not recommended.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.4 Special Warnings And Precautions For Use
Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.
Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.
Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration.
The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.
DHC Continus tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Other central nervous system depressants, including sedatives or hypnotics, phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.
4.6 Pregnancy And Lactation
There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.
4.7 Effects On Ability To Drive And Use Machines
Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.
4.8 Undesirable Effects
Common adverse drug reactions seen during therapy are constipation, nausea, vomiting, headache, somnolence, pruritus and rash.
Uncommon adverse reactions are urinary retention, ureteric or biliary spasm, dry mouth, mood changes, blurred vision, sweating, decreased libido, flushing, abdominal pain, hypotension, paraesthesia, confusion, dizziness, hallucinations, urticaria, paralytic ileus and respiratory depression.
Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped.
Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.
As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Additional/other considerations:
• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.
•DHC Continus tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.
5.2 Pharmacokinetic Properties
Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC Continus tablets and plasma levels are maintained throughout the twelve hour dosing interval.
Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose (anhydrous)
Hydroxyethylcellulose
Cetostearyl alcohol
Magnesium stearate
Purified talc
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Polypropylene containers with polyethylene lids (56 tablets)
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Napp Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
8. Marketing Authorisation Number(S)
PL 16950/0019 - 0021
9. Date Of First Authorisation/Renewal Of The Authorisation
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10. Date Of Revision Of The Text
February 2007
Legal Category
POM
® The Napp device, DHC and DHC CONTINUS are Registered Trade Marks
© Napp Pharmaceuticals Ltd 2007.
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