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Duloxpra

Duloxpra

duloxetine

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Concise Prescribing Info
Contents
Duloxetine HCl
Indications/Uses
Major depressive disorder, generalised anxiety disorder. Management of diabetic peripheral neuropathic pain in adults.
Dosage/Direction for Use
Major depressive disorder Initial & maintenance dose: 60 mg once daily. Max: 120 mg daily. Generalised anxiety disorder Initially 30 mg once daily, may be increased up to usual maintenance dose: 60 mg. Patient w/ co-morbid major depressive disorder 60 mg once daily, may be increased up to 90-120 mg. Diabetic peripheral neuropathic pain 60 mg once daily. Max: 120 mg daily in divided doses.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Uncontrolled HTN. Concomitant use w/ non-selective, irreversible MAOIs & potent CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin or enoxacin). Hepatic & severe renal impairment (CrCl <30 mL/min).
Special Precautions
History of mania, bipolar disorder &/or seizures; suicide-related events or exhibiting significant degree of suicidal thoughts or behaviour. Patients w/ increased IOP & risk of narrow-angle glaucoma; conditions compromised by increased heart rate or BP. Haemorrhage, known bleeding tendencies; hyponatraemia, dehydrated patients; akathisia/psychomotor restlessness; sexual dysfunction. Monitor BP during 1st mth of treatment. Avoid abrupt discontinuation. Avoid multiple use w/ duloxetine-containing medicinal products. Concomitant use w/ SSRIs, SNRIs, TCAs, triptans; St. John's wort; anticoagulants, NSAIDs, ASA; diuretics. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May affect ability to drive & use machines. Not to be used in hepatic & severe renal impairment (CrCl <30 mL/min). Hepatitis/increased hepatic enzymes, cirrhosis. Pregnancy. Not recommended during lactation. Not to be used in childn & adolescents <18 yr. Elderly.
Adverse Reactions
Headache, somnolence; nausea, dry mouth. Decreased appetite; insomnia, agitation, decreased libido, anxiety, abnormal orgasm & 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 ejaculation; falls, fatigue; decreased wt.
Drug Interactions
Serotonin syndrome w/ nonselective irreversible MAOIs; selective reversible MAOIs (eg, moclobemide); nonselective reversible MAOIs (eg, linezolid); SSRIs, SNRIs, TCAs (eg, clomipramine, amitriptyline), St. John's wort, triptans, tramadol, pethidine, tryptophan. Higher conc w/ potent CYP1A2 inhibitors eg, fluvoxamine. Increased risk of bleeding w/ anticoagulants, antiplatelet agents. Lower plasma conc w/ CYP1A2 inducers. Concomitant use w/ CNS (eg, alcohol, benzodiazepines, morphinomimetics, antipsychotics, phenobarb, sedative antihistamines) & CYP2D6-metabolised (eg, risperidone, nortriptyline, amitriptyline, imipramine, flecainide, propafenone, metoprolol) medicinal products.
MIMS Class
Antidepressants / Anxiolytics / Drugs for Neuropathic Pain
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Duloxpra ME-EC cap 30 mg
Packing/Price
10 × 10's
Form
Duloxpra ME-EC cap 60 mg
Packing/Price
10 × 10's
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