Duloxetine

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Ariclaim, Cymbalta, Duloxetine (d), Xeristar, Yentreve; Belgium: Cymbalta, Yentreve; Bulgaria: Ariclaim, Cymbalta, Xeristar, Yentreve; Cyprus: Ariclaim, Cymbalta, Xeristar, Yentreve; Czech Republic: Ariclaim, Cymbalta, Xeristar, Yentreve; Denmark: Ariclaim, Cymbalta, Xeristar, Yentreve; Estonia: Ariclaim, Cymbalta, Xeristar, Yentreve; Finland: Ariclaim, Cymbalta, Xeristar, Yentreve; France: Ariclaim, Cymbalta, Xeristar, Yentreve; Germany: Ariclaim, Cymbalta, Xeristar, Yentreve; Greece: Ariclaim, Cymbalta, Xeristar, Yentreve; Hungary: Ariclaim, Cymbalta, Xeristar, Yentreve; Ireland: Ariclaim, Cymbalta, Xeristar, Yentreve; Italy: Ariclaim, Cymbalta, Xeristar, Yentreve; Latvia: Ariclaim, Cymbalta, Xeristar, Yentreve; Lithuania: Ariclaim, Cymbalta, Xeristar, Yentreve; Luxembourg: Cymbalta, Xeristar, Yentreve; Malta: Ariclaim, Cymbalta, Xeristar, Yentreve; Netherlands: Ariclaim, Cymbalta, Xeristar, Yentreve; Poland: Ariclaim, Cymbalta, Xeristar, Yentreve; Portugal: Ariclaim, Cymbalta, Xeristar, Yentreve; Romania: Ariclaim, Cymbalta, Xeristar, Yentreve; Slovakia: Ariclaim, Cymbalta, Xeristar, Yentreve; Slovenia: Ariclaim, Cymbalta, Xeristar, Yentreve; Spain: Ariclaim, Cymbalta, Xeristar; Yentreve; Sweden: Ariclaim, Cymbalta, Xeristar, Yentreve; UK: Ariclaim, Cymbalta, Xeristar, Yentreve.

North America

Canada: Cymbalta; USA: Cymbalta.

Latin America

Argentina: Cymbalta, Duxetin; Brazil: Cymbalta; Mexico: Cymbalta.

Drug combinations

Chemistry

Duloxetine Hydrochloride: C~18~H~19~NOS HCl. Mw: 333.88. (1) 2-Thiophenepropanamine, N-methyl-γ-(1-naphthalenyloxy)-, hydrochloride, (S)-; (2)(+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. CAS-136434-34-9; CAS-116539-59-4(duloxetine)(1992).

Pharmacologic Category

Antidepressants; Selective Serotonin- and Norepinephrine-reuptake Inhibitors. Fibromyalgia Agents. (ATC-Code: N06AX21).

Mechanism of action

Duloxetine, a selective serotonin- and norepinephrine-reuptake inhibitor (SNRI) and a weak inhibitor of dopamine reuptake, is an antidepressant and anxiolytic agent.

Therapeutic use

Acute and maintenance treatment of major depressive disorder. Treatment of generalized anxiety disorder. Management of pain associated with diabetic neuropathy. Management of fibromyalgia.

Pregnancy and lactiation implications

Some neonates exposed to SNRIs or SSRIs late in the third trimester of pregnancy have developed complications that have sometimes been severe. As the safety of duloxetine in infants is not known, use in nursing women is not recommended.

Unlabeled use

Treatment of stress incontinence in women. Management of chronic pain syndromes.

Contraindications

Hypersensitivity to duloxetine or any component of the formulation. Hepatic impairment. Concomitant use with thioridazine or with CYP1A2 inhibitors. Concomitant use or within 2 weeks of MAO inhibitors. Uncontrolled narrow-angle glaucoma.

Warnings and precautions

Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with major depressive disorder and other psychiatric disorders. Duloxetine is not FDA approved for use in children. May worsen psychosis in some patients or precipitate a shift to mania or hypomania in bipolar disorder. Monotherapy in bipolar disorder should be avoided. Duloxetine is not FDA approved for the treatment of bipolar depression. Bleeding risk. Has a low potential to impair cognitive or motor performance. Hepatotoxicity (avoid use in substantial ethanol intake, evidence of chronic liver disease or hepatic impairment). Rare cases of hepatic failure (including fatalities) reported with use. Hyperglycemia observed in some diabetic patients receiving duloxetine therapy for diabetic peripheral neuropathy. May cause orthostatic hypotension/syncope, especially within the first week of therapy and after dose increases. May cause or exacerbate sexual dysfunction. SSRIs and SNRIs associated with the development of SIADH. Hyponatremia reported rarely (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. May cause increased urinary resistance. Use with caution in hypertension (rare cases of hypertensive crisis reported in pre-existing hypertension). Increased risk of mydriasis in controlled narrow-angle glaucoma. Not recommended for use in CrCl <30 mL/minute or end-stage renal disease. Not recommended for use in hepatic impairment. Use caution with previous seizure disorder, condition predisposing to seizures, or concurrent therapy with other drugs which lower the seizure threshold. Use caution with concomitant use of NSAIDs, ASA, or other drugs that affect coagulation (risk of bleeding may be potentiated). Caution in concomitant use with CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin)(may increase levels/adverse effects of duloxetine). Potential for severe reaction when used with MAO inhibitors. Serotonin syndrome may occur with concomitant proserotonergic drugs (i.e. SSRIs/SNRIs or triptans) or agents which reduce the metabolism of duloxetine. Concurrent use of serotonin precursors (e.g. tryptophan) is not recommended. Concomitant use with thioridazine is contraindicated. Formulation contains sucrose. May increase the risks associated with electroconvulsive therapy. May cause withdrawal syndrome.

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