Clinical Pharmacology Details


DULOXETINE


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Indications & Dose:


Adults:


Major DepressiveEpisodes:


The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses.


Diabetic Peripheral Neuropatic Pain:



60 mg daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses.


Hepatic impairment: Should not be used in patients with liver disease resulting in hepatic impairment


Renal insufficiency: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients. Liver disease resulting in hepatic impairment, should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i.e., potent CYP1 A2 inhibitors) . 

Side Effects:

Common or very common Abdominal pain . abnormal dreams . anorexia . anxiety . constipation . decreased appetite . diarrhoea . dizziness . drowsiness . dry mouth . dyspepsia . fatigue . flatulence . headache . hot flush . insomnia . nausea . nervousness . palpitation . paraesthesia . pruritus . sexual dysfunction . sweating . tremor . visual disturbances . vomiting . weakness . weight changes


Uncommon Bruxism . cold extremities . dysphagia . gastritis . halitosis . hepatitis . hypertension . hypothyroidism . impaired attention . impaired temperature regulation . movement disorders . muscle twitching . musculoskeletal pain . photosensitivity . postural hypotension . raised cholesterol . stomatitis . syncope . tachycardia . taste disturbance . thirst . urinary disorders . vertigo Rare Mania


Very rare Angle-closure glaucoma


Frequency not known Anaphylaxis . angioedema . chest pain . hallucinations . hypersen sitivity reactions . hyponatraemia . rash . seizures . Stevens-Johnson syndrome . suicidal behaviour . supraventricular arrhythmia . urticaria 


PREGNANCY Toxicity in animal studies—avoid in patients with stress urinary incontinence; in other conditions use only if potential benefit outweighs risk. Risk of neonatal withdrawal symptoms if used near term.


BREAST FEEDING Present in milk—manufacturer advises avoid.


HEPATIC IMPAIRMENT Manufacturer advises avoid.


RENAL IMPAIRMENT Avoid if eGFR less than 30 mL/minute/1.73m2. 

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: