Joytor-30/Joytor-60

Major depressive disorder; diabetic neuropathic pain; generalized anxiety disorder; fibromyalgia w/ or w/o depression; chronic pain states associated w/ diabetic peripheral neuropathic pain, fibromyalgia, chronic lower back pain, OA.

Starting & recommended maintenance dose: 60 mg once daily.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ non-selective irreversible MAOIs. Combination w/ fluvoxamine, ciprofloxacin, or enoxacine (ie, potent CYP1A2 inhibitors). Liver disease resulting in hepatic impairment. Severe renal impairment (CrCl <30 mL/min).

Increased risk of suicidal thinking & behavior (suicidality) in childn & adolescents w/ major depressive disorder & other psychiatric disorders. Reports of mydriasis; cutaneous bleeding abnormalities eg, ecchymoses & purpura; hyponatremia. May increase risk of bleeding events, including GI bleeding. Caution in patients w/ history of mania or diagnosis of bipolar disorder &/or seizures; raised IOP or at risk of acute narrow-angle glaucoma; mild or moderate renal dysfunction; substantial alcohol use or pre-existing liver disease; bleeding tendencies; elderly. Avoid abrupt discontinuation of therapy. Monitor BP in patients w/ known HTN &/or cardiac disease. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Caution when used in combination w/ antidepressants; herbal prep containing St. John's wort (Hypericum perforatum); anticoagulants &/or medicinal products known to affect platelet function. Not recommended w/ selective reversible MAOIs. May be associated w/ undesirable effects eg, sedation & dizziness; caution when operating hazardous machinery, including automobiles. Should be used in pregnancy only if potential benefit justifies potential risk to the fetus. Breastfeeding during treatment is not recommended. Not intended for use in childn <18 yr. Discontinuation symptoms may occur in neonate after maternal duloxetine use near term.

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, diarrhea, abdominal pain, vomiting, dyspepsia, flatulence; increased sweating, rash; musculoskeletal pain, muscle spasm; dysuria, pollakiuria; erectile dysfunction, ejaculation disorder, delayed ejaculation; falls, fatigue; decreased wt.

Risk of serotonin syndrome w/ non-selective irreversible MAOIs; selective, reversible MAOIs (eg, moclobemide); serotonergic antidepressants [eg, SSRIs, tricyclics (eg, clomipramine or amitriptyline), St. John's wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine & tryptophan]. Females w/ lower CYP1A2 activity & higher plasma conc of duloxetine may experience interaction w/ CYP1A2 substrate. Higher conc w/ potent CYP1A2 inhibitors (eg, fluvoxamine); potent CYP2D6 inhibitors (eg, paroxetine). Smokers have lower plasma conc of duloxetine compared w/ non-smokers. Increased AUC of CYP2D6 substrates (eg, desipramine, tolterodine). Increased free conc of either duloxetine or other highly protein bound drug when co-administered. Caution when combined w/ other centrally acting medicinal products & substances including alcohol & sedative medicinal products (eg, benzodiazepines, morphinomimetics, antipsychotics, phenobarb, sedative antihistamines).

Antidepressants

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

Rx