TIXOL

What it is

TIXOL contains duloxetine hydrochloride and is available in two strengths: 30 mg and 60 mg enteric capsules. Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor, and weakly inhibits dopamine uptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.

Approved indications TIXOL is indicated for the treatment of:

— Major depressive disorder (MDD) — Diabetic peripheral neuropathic pain (DPNP) — Generalised anxiety disorder (GAD)

Dosing overview

For treatment-naïve patients or those with a history of adverse events with other medications, a lower starting dose of 30 mg once daily for one week before increasing to 60 mg once daily may be considered. A lower dose of 30 mg once daily should be used in patients with end stage renal disease (creatinine clearance < 30 mL/min). When discontinuing TIXOL after more than one week of therapy, the dose should be tapered by reducing by half or administering on alternate days over a period of not less than two weeks to minimise the risk of discontinuation symptoms.

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any worsening of their condition and/or the emergence of suicidal ideation/behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present. TIXOL should ordinarily not be prescribed to patients with evidence of acute or chronic liver disease as it may aggravate pre-existing liver disease. Duloxetine increases the risk of elevation of serum transaminase levels. In placebo controlled trials, elevations of alanine transaminase (ALT) to more than 3 times the upper limit of normal occurred in 1.1% of duloxetine-treated patients and in 0.2% of placebo treated patients. Postmarketing reports have described cases of hepatitis with abdominal pain, hepatomegaly and elevation of transaminase levels to more than twenty times the upper limit of normal with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury. Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Isolated cases of liver failure, including fatal cases, have been reported. TIXOL may increase the risk of bleeding events, including gastrointestinal bleeding. Caution is advised in patients taking TIXOL concomitantly with anticoagulants and/or medicinal products known to affect platelet function (e.g., NSAIDs, aspirin) and in patients with known bleeding tendencies. TIXOL is associated with an increase in blood pressure in some patients. Treatment was associated with small increases in systolic blood pressure averaging 2 mm Hg and small increases in diastolic blood pressure averaging 0.5 mm Hg compared to placebo. Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt. In clinical trials, adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with TIXOL and 23% of patients taking placebo. The most commonly reported symptoms have included dizziness, nausea, headache, paraesthesia, fatigue, vomiting, irritability, nightmares, insomnia, diarrhoea, anxiety, hyperhidrosis, vertigo, somnolence and myalgia.

Contraindications

TIXOL is contraindicated in patients with known hypersensitivity to duloxetine or to any of the excipients in the formulation. TIXOL should not be used in combination with monoamine oxidase inhibitors (MAOI) or moclobemide, or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 5 days should be allowed after stopping TIXOL before starting a MAOI. TIXOL is contraindicated in patients with liver disease resulting in hepatic impairment. TIXOL should not be used in combination with potent CYP1A2 inhibitors.

PBS listing

Information regarding PBS listing, item count, restriction type and ex-manufacturer price for TIXOL is not available in the provided source documents.

Regulatory history

TIXOL 30 mg and TIXOL 60 mg enteric capsules were first registered on the Australian Register of Therapeutic Goods on 15 July 2024.