PANADEINE

What it is

Panadeine Forte contains paracetamol 500 mg and codeine phosphate hemihydrate 30 mg . Panadeine Forte is available as capsule-shaped tablets .

Approved indications

— Short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain .

Dosing overview

For adults and children 12 years of age and over, the dose is 1 or 2 tablets every 4 to 6 hours if necessary for relief of severe pain, not exceeding 8 tablets in a 24-hour period .

Key safety warnings

Panadeine Forte should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain . Serious, life-threatening or fatal respiratory depression may occur with the use of Panadeine Forte. Situations which increase the risk of respiratory depression should be identified, dosing modified in patients at risk, and patients monitored closely, especially on initiation or following a dose increase . Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Patients should be cautioned not to drink alcohol while taking Panadeine Forte . Panadeine Forte contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Panadeine Forte at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness, and increases the longer the drug is used and with higher doses . Life-threatening cutaneous reactions including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with the use of paracetamol. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If progressive skin rash often with blisters or mucosal lesions occur, patients should stop paracetamol treatment immediately and seek medical advice .

Contraindications

Panadeine Forte must not be used in patients with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product . It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency, severe respiratory disease, acute respiratory disease and respiratory depression for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition . Paracetamol should not be used in patients with severe hepatocellular insufficiency . Patients experiencing systemic allergy to morphine and oxycodone should not receive codeine due to codeine's structural similarity . Paracetamol should not be used in patients with active alcoholism as chronic excessive alcohol ingestion predisposes patients to paracetamol hepatotoxicity . Panadeine Forte is contraindicated during breast-feeding . Panadeine Forte is contraindicated for use in patients younger than 12 years, and in patients aged between 12–18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious life-threatening adverse reactions . Panadeine Forte is contraindicated for use in patients who are CYP 2D6 ultra-rapid metabolisers .

PBS listing

No source documents provide information on PBS listing for Panadeine Forte.

Regulatory history

Panadeine Forte was first registered on the Australian Register of Therapeutic Goods on 21 March 2000 . In July 2020, the PBAC recommended a change for palliative care use, relating to a new pack size .