Dihydrocodeine

Registered South African indications:

• Pain

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Respiratory depression  
• Obstructive airways disease
• Risk of paralytic ileus  
• Acute alcoholism (tab)
• Head injuries or conditions in which intracranial pressure is raised (tab)
• Phaeochromocytoma (inj)
• Acute asthma attack (inj)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Debilitated patients
• Adrenocortical insufficiency
• Hypothyroidism
• Hypotension
• Impaired respiratory function
• History of asthma
• Head injury
• Increased intracranial pressure  
• Prostatic hypertrophy/hyperplasia
• Convulsive disorders
• Urethral stricture
• Shock
• Inflammatory or obstructive bowel disorders
• Addiction history  
• Alcoholuse
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, inj

Pain - moderate to severe

• Oral (tab): 30mg, 4-6hrly  
• SC/IM: 50mg, 4-6hrly  

Administer with or after food

Not established for use in children

Pregnancy 

• Caution

• Whilst there is no adequate evidence of safety in human pregnancy, dihydrocodeine has been widely used without apparent ill-effect for many years and studies in animals have not yet demonstrated any hazard. The administration of opioid analgesics during labour may cause respiratory depression in the new-born infant, therefore administration should be avoided during the later stages of pregnancy. Babies born to opioid-dependent mothers may suffer withdrawal symptoms

Breastfeeding 

• Caution; not recommended
• Dihydrocodeine passes into breast milk in very small amounts which are probably insignificant, however, it is recommended that administration should be avoided if the mother is breastfeeding

Renal Impairment 

• Caution; dose adjustment recommended

Hepatic Impairment 

• Caution; dose adjustment recommended
• Mild (Child-Pugh Class A): No dose adjustment is recommended
• Moderate (Child-Pugh Class B): Initiate dose with (Tab 30mg; S.C/I.M. 50mg) every 12 hrs. Limit the daily dose to a maximum of 60mg/24 hrs (oral) and 100mg/24 hrs (parenteral). Close monitoring of liver function (LFT). If changes in ALT observed, then discontinue
• Severe (Child-Pugh Class C): Contraindicated

Elderly 

• Caution; dose adjustment recommended  
• Limit use to a maximum of 60mg/24 hrs (oral) and 50mg/24 hrs (S.C.)
• Avoid I.M. administration due to the risk of painful abscess formation

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Paraesthesia
• Dizziness
• Headache
• Vertigo
• Respiratory depression
• Muscle rigidity
• Drowsiness
• Changes of mood
• Confusion
• Sexual dysfunction
• Hallucinations
• Euphoria
• Addiction 
• Tolerance

Cardiovascular Disorders

• Hypotension
• Bradycardia
• Tachycardia
• Palpitations

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Abdominal pain
• Constipation

Hepatobiliary Disorders

• Biliary spasm
• Alterations in liver enzyme values

Genitourinary Disorders

• Micturition difficulties
• Ureteric spasm

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritius
• Sweating
• Facial flushing  

Sensory Disorders

• Visual disturbances 
• Miosis  

• Alcohol
• Monoamine oxidase inhibitors or within two weeks of their withdrawal
• Central nervous system depressants
• Anaesthetics
• Antihistamines
• Tricyclic antidepressants
• Antipsychotics
• Metoclopramide
• Domperidone
• Cyclizine
• Mexiletine
• Cimetidine

None routine. Specific cases may require

• Respiratory function
• Renal function
• Liver function

The analgesic effect is not materially enhanced by increasing the dose above that recommended above; in severe cases the interval between doses should be reduced to obtain the requisite analgesic cover.

Patients who, for one reason or another, are unable to be treated with the tablets may be given up to 50mg by intramuscular or deep subcutaneous injection.

Pure agonist at the mu, kappa & delta receptors in the central nervous system.

Tablet 30mg

• DF-118 (Pharmacare) originator

Injection (per ml) 50mg

• DF-118 (Pharmacare) originator