Duloxetine Teva

Duloxetine HCl

Adults w/ major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder, fibromyalgia, chronic musculoskeletal pain.

Major depressive disorder; diabetic peripheral neuropathic pain Starting & maintenance dose: 60 mg once daily. Max dose: 120 mg daily. Generalised anxiety disorder Initially 30 mg once daily, then increase to 60 mg if insufficient response. May consider escalation up to 90 mg or 120 mg if insufficient response to 60 mg. Patient w/ co-morbid major depressive disorder Starting & maintenance dose: 60 mg once daily. Fibromyalgia; chronic musculoskeletal pain Initially 30 mg once daily for 1 wk, then increase to 60 mg once daily.

Major depressive disorder/generalised anxiety disorder/diabetic peripheral neuropathic pain: May be taken with or without food.

Hypersensitivity. Treatment initiation in patients w/ uncontrolled HTN that could expose patients to potential risk of hypertensive crisis. Liver disease resulting in hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Concomitant use w/ non-selective irreversible MAOIs; potent CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin, enoxacin.

Avoid abrupt discontinuation. Gradually reduce dose over a period of at least 1-2 wk to reduce risk of w/drawal symptoms when discontinuing treatment. BP monitoring is recommended in patients w/ known HTN &/or other cardiac disease, especially during the 1st mth of treatment. Increased plasma conc in patients w/ severe renal impairment on haemodialysis (CrCl <30 mL/min). Risk of mydriasis; increased BP, clinically significant HTN, hypertensive crisis; serotonin syndrome; suicidal ideation/thoughts/behaviours; bleeding abnormalities eg, ecchymoses, purpura & GI haemorrhage; hyponatraemia; akathisia; liver injury, including severe liver enzyme elevations, hepatitis & jaundice; sexual dysfunction. Concomitant use w/ other serotonergic agents (eg, SSRIs, SNRIs, TCAs, triptans), agents that impair serotonin metabolism (eg, MAOIs), or antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems; herbal prep containing St. John's wort. Avoid concomitant use of >1 duloxetine-containing medicinal products. Caution in patients w/ history of mania or diagnosis of bipolar disorder, &/or seizures; patients w/ increased IOP or those at risk of acute narrow-angle glaucoma; patients whose conditions could be compromised by increased heart rate or BP; patients taking anticoagulants &/or medicinal products known to affect platelet function (eg, NSAIDs or ASA), & those w/ known bleeding tendencies; patients at increased risk for hyponatraemia eg, elderly, cirrhotic, or dehydrated patients or those treated w/ diuretics; patients treated w/ other medicinal products associated w/ hepatic injury. Should not be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May impair ability to drive or operate machinery. May increase risk of postpartum haemorrhage. Should be used in pregnancy only if potential benefit justifies potential risk to foetus. Not recommended while breast-feeding. Do not use for the treatment of major depressive disorder in childn & adolescents <18 yr. Safety & efficacy for the treatment of generalised anxiety disorder in paed patients 7-17 yr have not been established. Safety & efficacy for the treatment of diabetic peripheral neuropathic pain in the paed population have not been studied. Limited data on use of 120 mg in elderly patients w/ major depressive disorder & generalised anxiety disorder.

Headache, somnolence; nausea, dry mouth. Decreased appetite; insomnia, agitation, decreased libido, anxiety, abnormal orgasm, abnormal dreams; dizziness, lethargy, tremor, paraesthesia; blurred vision; tinnitus; palpitations; increased BP, flushing; yawning; constipation, diarrhoea, abdominal pain, vomiting, dyspepsia, flatulence; increased sweating, rash; musculoskeletal pain, muscle spasm; dysuria, pollakiuria; erectile dysfunction, ejaculation disorder/delayed; falls, fatigue; decreased wt.

Risk of serotonin syndrome w/ serotonergic agents eg, SSRIs, SNRIs, TCAs (eg, clomipramine, amitriptyline), MAOIs (eg, moclobemide, linezolid), St. John's wort, triptans, tramadol, pethidine, tryptophan. Decreased plasma clearance w/ potent CYP1A2 inhibitors (eg, fluvoxamine). Increased AUC of CYP2D6 substrates (eg, desipramine, tolterodine). Potential increased risk of bleeding w/ oral anticoagulants or antiplatelet agents. Caution if co-administered w/ other centrally acting medicinal products or substances, including alcohol & sedative medicinal products (eg, benzodiazepines, morphinomimetics, antipsychotics, phenobarb, sedative antihistamines); medicinal products that are predominantly metabolised by CYP2D6 (eg, risperidone, nortriptyline, amitriptyline, imipramine) particularly those w/ narrow therapeutic index (eg, flecainide, propafenone, metoprolol). Lower plasma conc in smokers.

Antidepressants / Drugs for Neuropathic Pain / Other Drugs Acting on Musculo-Skeletal System

N06AX21 - duloxetine ; Belongs to the class of other antidepressants.

P₁S₁S₃