HealthyStockprescription drugs overview

Facts
Triazolopyridine derivative
Trazodone
Selective Serotonin Reuptake Inhibitors (SSRIs)
Celexa (Citalopram)
Lexapro (Escitalopram)
Prozac (Fluoxetine)
Paxil (Paroxetine)
Zoloft (Sertraline)
Norepinephrine and dopamine reuptake inhibitors (NDRIs)
Wellbutrin (Bupropion)
Wellbutrin SR
Wellbutrin XL
Serotonin and norepinephrine reuptake inhibitors (SNRIs)
Cymbalta (Duloxetine)
Effexor XR (Venlafaxine)
Miscellaneous Anxiolytics
Buspar (Buspirone)
Noradrenergic and specific serotonergic antidepressants
Remeron
Tricyclic Antidepressants
Amitriptyline
Medical Information
Triazolopyridine derivative
Trazodone (Desyrel)
Selective Serotonin Reuptake Inhibitors (SSRIs)
Celexa (Citalopram)
Lexapro (Escitalopram)
Paxil (Paroxetine)
Prozac (Fluoxetine)
Zoloft (Sertraline)
Norepinephrine and dopamine reuptake inhibitors (NDRIs)
Wellbutrin (Bupropion)
Serotonin and norepinephrine reuptake inhibitors (SNRIs)
Cymbalta (Duloxetine)
Effexor XR (Venlafaxine)
Miscellaneous Anxiolytics
Buspar (Buspirone)
Tricyclic Antidepressants
Amitriptyline (Elavil)

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Generic Name: Duloxetine hydrochloride

Common Brand Names Cymbalta

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The following product information is not intended to replace the physician's or manufacturer's instructions.

Duloxetine medical uses:
Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor (SNRI), was launched for the treatment of major depressive episodes in January 2005, under the trade name Cymbalta. It has also been licensed for moderate to severe stress urinary incontinence under the trade name Yentreve (in Europe), and Cymbalta is now licensed for the treatment of diabetic peripheral neuropathic pain and generalized anxiety disorder (GAD).

Contraindications:

  • Uncontrolled narrow-angle glaucoma
  • MAOI therapy
  • Hypersensitivity to any component of product

Duloxetine dosage:

  • Diabetic peripheral neuropathic pain (Adults): 60 mg once daily without regard to meals.
  • Major depressive disorder (Adults): 40 mg daily (given as 20 mg twice daily) to 60 mg daily (given once daily or as 30 mg twice daily) without regard to meals.
  • Generalized anxiety disorder: 30 mg daily for 1 week then increas to 60 mg/day. Dosage increases should be made in increments of 30 mg/day. Dosages up to 120mg/day have been studied, however, no greater benefit over 60 mg/day was realized.

Side effects:

  • Cardiovascular: Hot flushes (3%); palpitations (at least 1%); hypertensive crisis, orthostatic hypotension, supraventricular arrhythmia, syncope (postmarketing).
  • CNS: Somnolence (21%); dizziness (17%); headache (15%); fatigue, insomnia (13%); asthenia (8%); decreased libido (7%); tremor (5%); abnormal orgasm, agitation (4%); anxiety, pyrexia (3%); paresthesia (2%); anorgasmia, dysgeusia, hypersomnia, hypesthesia, initial insomnia, irritability, lethargy, middle insomnia, nervousness, nightmare, restlessness, sleep disorder, vertigo (at least 1%); extrapyramidal disorder, hallucinations, mania, seizures (postmarketing).
  • Dermatologic: Hyperhidrosis (8%); increased sweating (6%); night sweats, pruritus, rash, skin ulcer (at least 1%); erythema multiforme, Stevens-Johnson syndrome, urticaria (postmarketing).
  • EENT: Nasopharyngitis (9%); blurred vision (4%); glaucoma (postmarketing).
  • Gastrointestinal: Nausea (38%); constipation, dry mouth (15%); diarrhea (8%); vomiting (5%); abdominal pain, dyspepsia (4%); gastritis (at least 1%); flatulence (postmarketing).
  • Genitourinary: Delayed ejaculation, erectile dysfunction, frequent micturition (5%); ejaculation dysfunction (3%); dysuria, urinary hesitation (at least 1%); abnormal orgasm, urinary retention (postmarketing).
  • Hepatic: Hepatitis, jaundice (postmarketing).
  • Hypersensitivity: Anaphylactic reaction, angioneurotic edema, hypersensitivity (postmarketing).
  • Metabolic-Nutritional: Decreased appetite, hyponatremia (11%); anorexia (5%); decreased weight (2%); hypoglycemia, increased appetite (at least 1%).
  • Musculoskeletal: Muscle cramp, myalgia (4%); rigors (at least 1%); trismus (postmarketing).
  • Respiratory: Pharyngolaryngeal pain (6%); cough (5%); yawning (3%).
  • Other: Chills, serotonin syndrome (postmarketing).

Lab Tests: Increased alkaline, ALT, AST, and bilirubin (postmarketing).

Precautions:

  • Children: Safety and efficacy not established.
  • Renal dysfunction: Duloxetine is not recommended for patients with a CrCl<30ml/min.
  • Hepatic dysfunction: Not recommended in patients with any hepatic dysfunction
  • Hepatotoxicity: Duloxetine may increase serum transaminase levels. Post marketing reports have described hepatitis, abdominal pain, hepatomegaly and increased transaminases to greater than 20 times the upper limit of normal. Additionally there have been cases of cholestatic jaundice with or without increases in transaminases. Duloxetine should not be given to any patient who drinks alcohol heavily or who has chronic liver disease.
  • Narrow-angle glaucoma: This population should not be prescribed duloxetine without careful clinical examination. Duloxetine increases the chances of mydriasis.
  • Blood pressure: Elevations in BP may occur.
  • Diabetes: May worsen glycemic control in some patients with diabetes.
  • Hyponatremia: Hyponatremia and SIADH have been reported and appear to be reversible when duloxetine is discontinued.
  • Mania/Hypomania: May be activated. Caution should be exhibited when prescribing this drug for patients with a history of mania.
  • Seizures: Because seizures have been reported in a small number of patients, use with caution in patients with history of seizures.

Drug interactions:

  • Alcohol: avoid, alcohol may increase CNS depression and/or hepatotoxic potential of duloxetine.
  • Buspirone: concurrent use of duloxetine with buspirone may cause serotonin syndrome.
  • Aminoglutethimide, carbamazepine, phenobarbital, rifampin: these medications may decrease the levels/effects of duloxetine.
  • CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, ketoconazole, norfloxacin, ofloxacin, rofecoxib): may increase the levels/effects of duloxetine.
  • CYP2D6 inhibitors (chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole): may increase the levels/effects of duloxetine.
  • Desipramine: duloxetine may increase desipramine levels.
  • Linezolid: hyperpyrexia, hypertension, tachycardia, confusion, seizures, and deaths have been reported with agents which inhibit MAO (serotonin syndrome); this combination should be avoided.
  • MAO inhibitors: hyperpyrexia, hypertension, tachycardia, confusion, seizures, and deaths have been reported with MAO inhibitors (serotonin syndrome); this combination is contraindicated. Wait 5 days after discontinuation of duloxetine before initiating therapy with a MAO inhibitor.
  • Meperidine: combined use theoretically may increase the risk of serotonin syndrome.
  • Moclobemide: concurrent use of duloxetine with moclobemide may cause serotonin syndrome.
  • Nefazodone: concurrent use of duloxetine with nefazodone may cause serotonin syndrome.
  • Selegiline: concurrent use with SSRIs has been reported to cause serotonin syndrome; as an MAO type B inhibitor, the risk of serotonin syndrome may be less than with nonselective MAO inhibitors, and reports indicate that this combination has been well tolerated in Parkinson's patients.
  • Serotonin agonists (eg, triptans, lithium): Concurrent use of duloxetine with these agents may increase the risk of serotonin syndrome.
  • SSRIs, SNRIs: concurrent use of duloxetine with these agents may increase the risk of serotonin syndrome.
  • Sibutramine: may increase the risk of serotonin syndrome with SNRIs.
  • Thioridazine: duloxetine may increase serum concentrations of thioridazine, which has been associated with the development of malignant ventricular arrhythmias; use caution.
  • Tramadol: concurrent use of duloxetine with tramadol may cause serotonin syndrome.
  • Trazodone: concurrent use of duloxetine with trazodone may cause serotonin syndrome.
  • Tricyclic antidepressants: serum levels/effects may be increased by duloxetine.

Pregnancy & Lactation
Pregnancy category C
Decreased fetal weight and behavioral effects have been reported in animal studies. Nonteratogenic effects including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor have been reported in the neonate immediately following delivery after exposure late in the third trimester. Exposure to SSRIs late in pregnancy has also been associated with persistent pulmonary hypertension of the newborn (PPHN). Adverse effects may be due to toxic effects of SNRI or drug discontinuation. In some cases, effects may present clinically as serotonin syndrome. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus. If treatment during pregnancy is required, consider tapering therapy during the third trimester.

Nursing mothers
Cymbalta (duloxetine) enters breast milk. Cymbalta have been associated with excessive somnolence, decreased feeding, and weight loss in nursing infants.

Overdose:
Symptoms of Cymbalta (duloxetine) overdose include seizures, serotonin syndrome, somnolence, vomiting.

Storage:
Store at controlled room temperature (59° to 86°F).

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References:

  • 1. U.S. Food and Drug Administration. Cymbalta (Duloxetine) U.S. Prescribing Information. Available at (PDF format): Prescribing Information


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