PANAMAX

What it is

PANAMAX is a paracetamol and codeine phosphate hemihydrate tablet preparation. The formulation contains codeine phosphate hemihydrate in plain white round biconvex 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

Initial dosing requirements depend on the patient's medical and analgesic history, age, weight and severity of pain. Dosage may need to be reduced in elderly or debilitated patients. For adults, the dose is 30 to 60 mg every four to six hours, with a usual dose of 30 mg. If 60 mg of codeine every four to six hours fails to relieve pain, larger doses rarely succeed and may give rise to restlessness and excitement.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of PANAMAX. Patients at risk require dose modification and close monitoring, especially on initiation or following a dose increase. Concomitant use 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 respiratory depression and sedation. Patients should not drink alcohol while taking PANAMAX. PANAMAX contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed at recommended doses, with increased risk in patients with a personal or family history of substance abuse or mental illness. PANAMAX is contraindicated in patients who are CYP2D6 ultra-rapid metabolisers due to increased risk of opioid toxicity. Ultra-rapid metabolisers convert codeine into morphine rapidly, resulting in higher than expected serum morphine levels. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Children are particularly susceptible due to their immature airway anatomy, and deaths have been reported in children with rapid metabolism given codeine following adenotonsillectomy.

Contraindications

PANAMAX is contraindicated in patients with hypersensitivity to any ingredient. Due to codeine's structural similarity to morphine and oxycodone, patients experiencing systemic allergy to these drugs should not receive codeine. Codeine is contraindicated in respiratory depression (such as acute asthma or acute exacerbations of chronic pulmonary disease), especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, and in patients with severe or acute respiratory disease. Codeine is contraindicated in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Administration is contraindicated in patients taking monoamine oxidase inhibitors or within ten days of stopping such treatment. PANAMAX is contraindicated in patients who are CYP2D6 ultra-rapid metabolisers, younger than 12 years, aged between 12–18 years in whom respiratory function might be compromised (including post tonsillectomy or adenoidectomy for obstructive sleep apnoea), or breastfeeding.

PBS listing

PANAMAX oral liquid 240 mg per 5 mL, 200 mL is listed on the PBS with 2 items under restricted authority required status. The ex-manufacturer price is A$3.44.

Regulatory history

PANAMAX was first registered on the ARTG in 1991, with the paracetamol 500 mg tablet listed on 10 September 1991 and the paracetamol 240 mg per 5 mL elixir listed on 30 August 1991. A combination formulation of paracetamol 500 mg and codeine phosphate hemihydrate 8 mg tablets was registered on 15 December 1997.