Cymbalta

Duloxetine HCl

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.

Major depressive disorder 60 mg once daily. Max: 120 mg daily. Patient w/ history of repeated episodes of major depression Further long-term treatment at 60-120 mg daily. Generalized anxiety disorder 30 mg once daily, increased to 60 mg if response is insufficient. Patient w/ co-morbid major depressive disorder 60 mg once daily. Patient w/ insufficient response to 60 mg Dose escalation up to 90 mg or 12 mg. Diabetic peripheral neuropathic pain 60 mg once daily. Max: Up to 20 mg daily in evenly divided doses.

May be taken with or without food.

Hypersensitivity. Uncontrolled HTN that could expose patients to a potential risk of hypertensive crisis. 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).

History of mania or diagnosis of bipolar disorder &/or seizures. Increased IOP or those at risk of acute narrow-angle glaucoma. Monitor BP in patients w/ known HTN &/or other cardiac disease especially during the 1st mth of treatment. Serotonin syndrome. Suicidal thoughts/behaviors during therapy or early after treatment. Bleeding abnormalities eg, ecchymoses, purpura & GI hemorrhage; may increase risk of postpartum hemorrhage; patients w/ known bleeding tendencies. Hyponatremia. W/drawal symptoms w/ abrupt discontinuation; gradually taper treatment over a period of no <2 wk. Akathisia/psychomotor restlessness. Liver injury including severe elevations of liver enzymes (>10x ULN), hepatitis & jaundice. Sexual dysfunction. Fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency. Concomitant use w/ herbal prep containing St. John's wort; anticoagulants &/or medicinal products known to affect platelet function (eg, NSAIDs, ASA). Avoid use of >1 medicinal products containing duloxetine. Severe renal impairment on hemodialysis (CrCl <30 mL/min). Avoid hazardous tasks eg, driving or operating machinery if patient experiences sedation or dizziness. Pregnancy. Not recommended during lactation. Should not be used in childn & adolescents <18 yr. Elderly.

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

Risk of serotonin syndrome w/ non-selective irreversible MAOIs (in combination or w/in at least 14 days of discontinuation); selective reversible MAOIs (eg, moclobemide); reversible non-selective MAOIs (eg, linezolid); SSRIs, SNRIs, TCAs (eg, clomipramine or amitriptyline), St. John's wort or triptans, tramadol, pethidine & tryptophan. Higher conc w/ potent CYP1A2 inhibitor (eg, fluvoxamine). Increased AUC of desipramine & steady state AUC of tolterodine. Increased risk of bleeding w/ oral anticoagulants or antiplatelet agents. Lower plasma conc w/ smokers. Other centrally acting medicinal products & substances including alcohol & sedative medicinal products (eg, benzodiazepines, morphinomimetics, antipsychotics, phenobarb, sedative antihistamines). Medicinal products that are predominantly metabolized by CYP2D6 (risperidone, TCAs eg, nortriptyline, amitriptyline, and imipramine) & w/ narrow therapeutic index (eg, flecainide, propafenone & metoprolol).

Antidepressants / Drugs for Neuropathic Pain

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

Rx