Components:
Method of action:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 01.04.2022
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For the relief of severe pain in cancer and other chronic conditions.
DF-118 tablets are indicated for use in adults and children over 12 years of age.
Posology
60 mg:
Adults and children over 12 years: One or two tablets 12-hourly.
90 mg and 120 mg:
Adults: The usual dose is one tablet 12-hourly.
Elderly: Dosage should be reduced.
Paediatric population
Children 12 years or under: Not recommended.
Method of administration
Oral.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Dihydrocodeine should be administered with caution to the elderly or patients with:
- a history of opioid abuse or dependence
- raised intracranial pressure or head injury
- biliary tract disorders
- prostatic hypertrophy
- pancreatitis
- impairment of hepatic function
- severe renal dysfunction
- constipation
- an obstructive bowel disorder
- respiratory depression with hypoxia
- chronic obstructive lung disease
- cor pulmonale
- bronchial asthma
- hypothyroidism
Dihydrocodeine must be administered with caution in patients taking:
- Monoamine oxidase inhibitors
Risk from concomitant use of benzodiazepines (and other CNS depressants):
Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death.). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with dihydrocodeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Dihydrocodeine has a recognised abuse and addiction profile similar to other agonist 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 opiod analgesics, including dihydrocodeine. The product should be used with particular care in patients with a history of alcohol and drug abuse.
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
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.
Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.
DF-118 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 potentially fatal dose of dihydrocodeine and may result in overdose effects.
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 decrease in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.
Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.
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 you have this medicine in your body over a specified limit unless you have a defence (called the 'statutory defence').
- This defence applies when:
| - The medicine has been prescribed to treat a medical or dental problem; and - You have taken it according to the instructions given by the prescriber and in the information provided with the medicine. |
- Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).â€
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
The adverse experiences listed below are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of > 1% and uncommon adverse drug experiences have an incidence of < 1%.
| Undesirable Effects | Common (> 1%) | Uncommon (< 1%) | Not Known (frequency cannot be estimated from the available data) |
| Immune system disorders | Angioedema | ||
| Psychiatric disorders | Confusional state Drug dependence Hallucination Mood altered Dysphoria | ||
| Nervous system disorders | Somnolence | Convulsions Dizziness Headache Paraesthesia Sedation | |
| Eye disorders | Blurred vision | ||
| Ear and labyrinth disorders | Vertigo | ||
| Vascular disorders | Hypotension Flushing | ||
| Respiratory, thoracic and mediastinal disorders | Dyspnoea Respiratory depression | ||
| Gastrointestinal disorders | Abdominal pain Constipation Dry mouth Nausea Vomiting | Diarrhoea Paralytic ileus | |
| Hepato-biliary disorders | Biliary colic Hepatic enzymes increased | ||
| Skin and subcutaneous tissue disorders | Hyperhidrosis Pruritus Rash Urticaria | ||
| Renal and urinary disorders | Urinary retention Ureteric spasm | ||
| Reproductive system and breast disorders | Decreased libido | ||
| General disorders and administration site conditions | Asthenia Fatigue Malaise Withdrawal syndrome Drug tolerance | Drug withdrawal syndrome neonatal |
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 then stopped.
Prolonged use of a painkiller for headaches can make them worse.
Paediatric population
Neonatal respiratory depression and withdrawal symptoms may occur in the newborn of mothers undergoing treatment with dihydrocodeine.
Reporting of adverse reactions
Reporting suspected adverse reactions 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 , which may in severe cases result in a fatal outcome.
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.
- DF-118 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.
Pharmacotherapeutic group: Natural opium alkaloids
ATC code: N02A A08
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.
Central Nervous System
The principal actions of therapeutic value of dihydrocodeine are analgesia and an antitussive effect (depression of the cough reflex by direct effect on the cough centre in the medulla). Antitussive effects may occur with doses lower than those usually required for analgesia.
Dihydrocodeine may produce respiratory depression by direct action on brain stem respiratory centres.
Gastrointestinal Tract and Other Smooth Muscle
Dihydrocodeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation.
Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DF-118 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.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
No special requirements.
