ZALDIAR

What it is

ZALDIAR is a film-coated tablet containing 37.5 mg tramadol hydrochloride and 325 mg paracetamol as the active ingredients. Tramadol is an opioid analgesic that acts on the central nervous system and is a pure non-selective agonist of the μ, δ, and κ opioid receptors with a higher affinity for the μ receptors. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. The precise mechanism of the analgesic properties of paracetamol is unknown and may involve central and peripheral effects.

Approved indications

— Moderate pain.

Dosing overview

The dose should be individually adjusted according to intensity of the pain and the sensitivity of the individual patient, with the lowest effective dose for analgesia generally selected. An initial dose of two tablets (equivalent to 75 mg tramadol hydrochloride and 650 mg paracetamol) is recommended. Additional doses can be taken as needed, not exceeding 8 tablets per day (equivalent to 300 mg tramadol and 2600 mg paracetamol), with a dosing interval of not less than 6 hours. Patients weighing between 37.5 kg and 50 kg should receive a maximum of 6 tablets daily. Patients weighing less than 37.5 kg should not receive ZALDIAR. ZALDIAR should under no circumstances be administered for longer than is strictly necessary.

Key safety warnings

Because of the risks associated with the use of opioids, ZALDIAR 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 ZALDIAR. Situations which increase the risk of respiratory depression should be recognised, dosing should be modified in patients at risk and patients should be monitored closely, especially on initiation or following a dose increase. The risk of life-threatening respiratory depression is higher in elderly, frail, or debilitated patients, in patients with renal and hepatic impairment and in patients with existing impairment of respiratory function such as chronic obstructive pulmonary disease or asthma, and opioids should be used with caution and with close monitoring in these patients. 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. Patients should be cautioned not to drink alcohol while taking ZALDIAR. ZALDIAR contains the opioid tramadol hydrochloride and is a potential drug of abuse, misuse and addiction, with addiction occurring in patients appropriately prescribed ZALDIAR at recommended doses. ZALDIAR poses risks of hazardous and harmful use which can lead to overdose and death. Paracetamol has been associated with cases of acute liver failure, at times resulting in liver transplant and death, with most cases of liver injury associated with the use of paracetamol at doses that exceed 4,000 milligrams per day, and often involving more than one paracetamol-containing product.

Contraindications

ZALDIAR is contraindicated in hypersensitivity to tramadol, paracetamol or to any other components of the tablet; acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs; in patients receiving monoamine oxidase inhibitors or within two weeks of their withdrawal; in cases of severe hepatocellular insufficiency; in patients with severe respiratory disease, acute respiratory disease and respiratory depression; in patients with hepatic failure or decompensated active liver disease; and in epilepsy not controlled by treatment.

PBS listing

No information on PBS listing is available in the provided sources.

Regulatory history

ZALDIAR was first registered on the ARTG on 19 March 2012 as film-coated tablets and effervescent tablets. The AusPAR approval date was 5 March 2012, with the indication of treatment of moderate pain.