ZYDOL

What it is

ZYDOL contains the active ingredient tramadol hydrochloride. Tramadol is a centrally acting synthetic analgesic of the aminocyclohexanol group with opioid-like effects and is not derived from natural sources, nor is it chemically related to opiates. Its mode of action involves binding to mu-opioid receptors and inhibition of reuptake of noradrenaline and serotonin. ZYDOL modified release tablets are available in 100 mg, 150 mg, or 200 mg strengths.

Approved indications

ZYDOL is indicated for the management of severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long-term treatment. ZYDOL is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. ZYDOL is not indicated as an as-needed (PRN) analgesia.

Dosing overview

The recommended dose of ZYDOL in adults and adolescents over the age of 12 years is 100 mg to 200 mg twice daily, preferably morning and evening. The maximum daily dose should not exceed 400 mg per day. The tablets are to be taken whole, not divided or chewed, with sufficient liquid, irrespective of food intake. In patients with renal insufficiency the elimination of tramadol is delayed and prolongation of the dosage intervals should be carefully considered; in cases of severe renal insufficiency tramadol modified release tablets are not recommended. ZYDOL should not be used in patients with severe hepatic insufficiency.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of ZYDOL, and patients should be 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. ZYDOL contains the opioid tramadol hydrochloride and is a potential drug of abuse, misuse and addiction, and addiction can occur in patients appropriately prescribed ZYDOL at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness, and the risk increases the longer the drug is used and with higher doses. ZYDOL can cause sleep-related breathing disorders including central sleep apnoea, and use increases the risk in a dose-dependent fashion. Serotonin syndrome, a potentially life-threatening condition, has been reported in patients receiving tramadol in combination with other serotonergic agents or tramadol alone. Convulsions have been reported in patients receiving tramadol at the recommended dose levels, and the risk may be increased when doses exceed the recommended upper daily dose limit.

Contraindications

ZYDOL is contraindicated in individuals with known hypersensitivity to tramadol or any excipients, acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs, patients with severe respiratory disease, acute respiratory disease and respiratory depression, all children younger than 12 years of age, postoperative management of children younger than 18 years following tonsillectomy and/or adenoidectomy, patients receiving monoamine oxidase inhibitors or who have taken them within the last 14 days, those with known sensitivity to opioids, and patients with uncontrolled epilepsy or epilepsy not adequately controlled by treatment.

PBS listing

Information regarding PBS listing for ZYDOL is not available in the provided documents.

Regulatory history

ZYDOL SR 100 mg, ZYDOL SR 150 mg, and ZYDOL SR 200 mg modified release tablets were first listed on the ARTG on 2 November 2001. ZYDOL 50 mg capsules were first listed on 23 November 2001, and ZYDOL SR 50 mg modified release tablets were first listed on 28 September 2006.