Cymbalta

Cymbalta

duloxetine

Manufacturer:

Eli Lilly

Distributor:

DKSH
Concise Prescribing Info
Contents
Duloxetine HCl
Indications/Uses
Major depressive disorder (MDD), generalized anxiety disorder (GAD) & diabetic peripheral neuropathic pain (DPNP). Management of pain associated w/ fibromyalgia.
Dosage/Direction for Use
MDD Starting & recommended maintenance dose: 60 mg once daily. Max: 120 mg/day in evenly divided doses. GAD Recommended starting dose: 60 mg once daily (may start at 30 mg once daily for 1 wk before increasing to 60 mg once daily). If required, dose increments of 30 mg once daily. Max: 120 mg once daily. DPNP Starting & recommended maintenance dose: 60 mg once daily. Max: 120 mg/day. Fibromyalgia 60 mg once daily (may start at 30 mg once daily for 1 wk before increasing to 60 mg once daily).
Administration
May be taken with or without food: Swallow whole, do not chew/crush/open cap.
Contraindications
Hypersensitivity. Concomitant use w/ non-selective irreversible MAOIs, potent CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin or enoxacin. Patients w/ pre-existing liver diseases & substantial alcohol use or evidence of chronic liver disease. Severe renal impairment (CrCl <30 mL/min). Patients w/ uncontrolled HTN.
Special Precautions
Patients w/ history of mania or bipolar disorders &/or seizures, increased IOP, risk of acute narrow-angle glaucoma, conditions that could be compromised by increased heart rate or BP. Potentially life-threatening serotonin syndrome, particularly w/ concomitant use of other serotonergic agents. Concomitant use w/ St. John's wort. Close monitoring for any clinical worsening suicidal behavior/thoughts & unusual changes in behavior. Risk of bleeding abnormalities; concomitant use w/ anticoagulants &/or medical products known to affect platelet function (eg, NSAIDs or aspirin); patients w/ known bleeding tendencies. Patient at increased risk for hyponatremia. Avoid abrupt discontinuation of treatment; gradually taper over a period of no <2 wk. May develop akathisia/psychomotor restlessness; urinary hesitation & retention. Avoid concomitant use of ≥1 duloxentine products. Discontinue in patients w/ jaundice, hepatitis or laboratory evidence of liver injury; not for patients w/ substantial alcohol use or evidence of chronic liver disease. Not for patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. May affect ability to drive or operate machinery. Renal impairment. Pregnancy; not recommended during breastfeeding. Not for childn & adolescent <18 yr. Elderly treated w/ 120 mg/day dose for MDD & GAD.
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; sweating, increased rash; musculo-skeletal pain, muscle spasm; dysuria, pollakiuria; erectile dysfunction, ejaculation disorder, delayed ejaculation; falls, fatigue; decreased wt.
Drug Interactions
Elevated plasma conc w/ potent CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin or enoxacin. AR may be more common w/ St. John's wort. Higher conc w/ potent CYP1A2 (eg, fluvoxamine). Risk of serotonin syndrome w/ serotonergic agents eg, SSRIs, serotonin-norepinephrine reuptake inhibitors, TCAs, MAOIs, St. John's wort or triptans, tramadol, pethidine & tryptophan. Caution in combination w/ centrally-acting medicinal products or substances including alcohol & sedatives; medicinal products predominantly metabolised by CYP2D6 (risperidone, TCAs, flecainide, propafenone, metoprolol). May increase free conc of drugs highly bound to plasma proteins. Potential increased risk of bleeding w/ oral anticoagulants or antiplatelets. Lower plasma conc w/ CYP1A2 inducers.
MIMS Class
Antidepressants / Drugs for Neuropathic Pain
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Cymbalta gastro-resistant cap 30 mg
Packing/Price
28's
Form
Cymbalta gastro-resistant cap 60 mg
Packing/Price
28's
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