Duloxetine

May be taken with or without food. Swallow whole, do not chew/crush.

Uncontrolled hypertension. Hepatic and severe renal (CrCl <30 mL/min) impairment. Concomitant use with or within 14 days of discontinuing nonselective, irreversible MAOIs. Concomitant use with linezolid, IV methylthioninium chloride (also known as methylene blue), thioridazine, and potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin, enoxacin).

Patient with history of mania or bipolar disorder; history of seizure disorder or condition predisposing to seizures (e.g. brain damage); history of suicide-related events or exhibiting a significant degree of suicidal thoughts or behaviour; increased IOP or those at risk of acute angle-closure glaucoma; controlled hypertension and/or other cardiac diseases, condition that may be compromised by an increased heart rate or blood pressure; known bleeding tendencies, susceptibility to hyponatraemia (e.g. dehydration, concomitant use with diuretics), impaired gastric motility. Smokers and heavy alcohol drinkers. Avoid abrupt discontinuation. Mild to moderate renal impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause sedation or dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Screen patients for personal or family history of bipolar disorder, mania, or hypomania before treatment. Monitor blood pressure (at baseline and periodically during treatment), hepatic and renal functions; blood glucose and HbA_1c in diabetic patients (at baseline and as clinically indicated). Closely monitor for clinical worsening, suicidality, or unusual changes in behaviour (particularly during the initial 1-2 months of therapy or during periods of dosage adjustments). Monitor for signs and symptoms of serotonin syndrome (e.g. mental status changes, seizures, tachycardia, hyperthermia, diaphoresis, tremor, rigidity).

Significant: Suicidal thoughts and behaviour (particularly in children and young adults), activation of mania or hypomania, mydriasis, increase in blood pressure and clinically significant hypertension, bleeding abnormalities (e.g. ecchymoses, purpura, gastrointestinal haemorrhage), hyponatraemia, akathisia, increased liver enzymes, hepatitis, jaundice, withdrawal symptoms (particularly upon abrupt discontinuation), increased fasting blood glucose and HbA_1c, orthostatic hypotension, syncope, falls, acute angle-closure glaucoma, urinary hesitation and retention; decreased libido, erectile dysfunction, ejaculatory delay or failure (male), delayed or absent orgasm (female); severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome). Rarely, hypertensive crisis. Cardiac disorders: Palpitations. Ear and labyrinth disorders: Tinnitus, vertigo. Eye disorders: Blurred vision. Gastrointestinal disorders: Dry mouth, nausea, vomiting, constipation, diarrhoea, abdominal pain, dyspepsia, flatulence. General disorders and administration site conditions: Fatigue, asthenia, chills. Investigations: Decreased weight. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Musculoskeletal pain, muscle spasm. Nervous system disorders: Headache, somnolence, dizziness, tremor, paraesthesia, lethargy. Psychiatric disorders: Insomnia, agitation, anxiety, abnormal dreams, sleep disorder. Renal and urinary disorders: Dysuria, pollakiuria. Respiratory, thoracic and mediastinal disorders: Yawning. Skin and subcutaneous tissue disorders: Hyperhidrosis, rash. Vascular disorders: Flushing.
Potentially Fatal: Serotonin syndrome, hepatic failure.

May increase the risk of serotonin syndrome with other serotonergic agents such as selective, reversible MAOIs (e.g. moclobemide), SSRIs, other SNRIs, TCAs, triptans, tramadol, pethidine, buspirone, and tryptophan. May increase the risk of bleeding with anticoagulants, antiplatelet agents, and other drugs known to affect platelet function (e.g. NSAIDs). May increase the CNS effects with other centrally acting drugs (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines). May increase the plasma concentrations of drugs predominantly metabolised by CYP2D6 (e.g. risperidone, amitriptyline, desipramine, flecainide, propafenone, metoprolol). Increased plasma concentration with potent CYP2D6 inhibitors (e.g. paroxetine, quinidine).

Antidepressants / Anxiolytics / Drugs For Neuropathic Pain / Other Drugs Acting on Musculo-Skeletal System / Other Drugs Acting on the Genito-Urinary System

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