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Duloxetine – Usages, Side effects, Risk factors, Precautions
Here in this post, we are discussing the “Duloxetine”. You can read usages, side effects, Risk factors, and warning information. Keep visiting Psychology Roots.
About Duloxetine
Duloxetine is an antidepressant SNRIs.
Brand name
Duloxetine is available with the following brand name.
● Cymbalta
● Irenka
● Drizalma Sprinkle
Disorder to treat
It is used for the treatment of the following disorder
● Generalized Anxiety Disorder
Duloxetine – Usages, Side effects, Risk factors, Precautions
Forms of Duloxetine
Duloxetine is available in the following form
● Capsule
Capsule
Duloxetine capsules are available in the following doses
● 20mg (Cymbalta, Drizalma Sprinkle, generic)
● 30mg (Cymbalta, Drizalma Sprinkle, generic)
● 40mg (Drizalma Sprinkle, Irenka)
● 60mg (Cymbalta, Drizalma Sprinkle, generic)
Major Depressive Disorder
Initially, 40-60 mg per day orally is given (in a single daily dose or divided every 12 hr for 1 week if the patient needs to adjust to therapy)
For some patients, consider starting at 30 mg every day for 1 week, to allow patients to adjust to the medication before increasing to 60 mg every day
Target dosage: 60 mg per day orally is given and do not exceed 120 mg per day
Generalized Anxiety Disorder
Initially 60 mg per day orally (in single daily dose or divided every 12hr); may be increased in increments of 30 mg per day if tolerability is concerned.
Target dosage: 60 mg per day orally is given and do not exceed 120 mg per day.
Dosing considerations
Dosages ≥60 mg/day have not been shown to offer additional benefits; safety and efficacy of doses >120 mg qDay have not been adequately evaluated
Discontinuance
● Gradually reduce dosage
● Abrupt discontinuance may result in symptoms e.g,
○ Dizziness
○ Nausea
○ Headache
○ Paresthesia
○ Fatigue
○ Vomiting
○ Irritability
○ Insomnia
○ Diarrhea
○ Anxiety
○ Hyperhidrosis
Wait ≥14 days after discontinuance of monoamine oxidase inhibitor (MAOI) therapy to initiate duloxetine therapy; wait ≥5 days after discontinuance of duloxetine therapy to initiate MAOI therapy
Side effects
There are the following side effects of duloxetine
● Headache
● Dry mouth
● Nausea
● Somnolence
● Insomnia
● Vomiting
● Fatigue
● Hyperhidrosis
● Decreased libido
● Dizziness
● Constipation
● Agitation
● Nasopharyngitis
● Erectile dysfunction
● Diarrhea
● Agitation
● Decrease appetite
● Abnormal orgasm
● Anxiety
● Male sexual dysfunction
● Cough
● Abdominal pain
● Anorexia
● Abnormal dreams
● Oropharyngeal pain
● Blurred visions
● Tremor
● Musculoskeletal pain
● Blood pressure increase
● Influenza
● Dyspepsia
● Palpitations
● Ejaculation delayed
● Paresthesia
● Hot flushes
● Weight loss
● Yawning
● Dysuria
● Rash
● Gastritis
Warnings
Suicidal thoughts and behaviors
- Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.
- These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients >24 yr.
- There was a reduction in risk with antidepressant use in patients ≥65 yr.
- In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors.
- Advise families and caregivers of the need for close observation and communication with the prescriber.
Contraindications
- Concomitant use of duloxetine with MAOIs intended to treat psychiatric disorders.
- Initiating duloxetine in patients who are being treated with MAOIs (eg, linezolid or IV methylene blue).
Cautions
Suicidality; monitor for clinical worsening and suicide risk, especially in children, adolescents, and young adults (18-24 years) during early phases of treatment and alterations in dosage.
Serotonin syndrome or neuroleptic malignant syndrome-like reactions may occur; discontinue and initiate supportive therapy; closely monitor patients concomitantly receiving triptans, antipsychotics and serotonin precursors.
Neonates exposed to serotonin-norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) late in 3rd trimester of pregnancy have developed complications necessitating prolonged hospitalization, respiratory support, and tube feeding.
Increased risk of hepatotoxicity, sometimes fatal; monitor for abdominal pain, hepatomegaly, elevations in hepatic transaminases exceeding 20 times the upper limit of normal; jaundice; cholestatic jaundice with minimal elevations of hepatic transaminases have also been reported; use not recommended in patients with substantial alcohol use or chronic liver disease.
SSRIs and SNRIs may impair platelet aggregation and increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and GI hemorrhage to life-threatening hemorrhage; concomitant use of aspirin, NSAIDs, warfarin, other anticoagulants, or other drugs known to affect platelet function may add to this risk.
Severe skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome); discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified.
Monitor weight and growth in adolescents and children; decrease in appetite and weight loss reported.
Urinary hesitation and retention.
Cognitive or motor function impairment; use with caution when operating heavy machinery.
Bone fractures reported with antidepressant treatment; consider the possibility of bone fracture if the patient complains of unexplained bone pain or joint tenderness or experiences bruising or swelling.
May cause or exacerbate sexual dysfunction.
Therapy may increase blood pressure; measure blood prior to initiating treatment and periodically throughout treatment.
Use with caution in patients with conditions that slow gastric emptying.
Increased Risk of Bleeding Postpartum
Drugs that interfere with serotonin reuptake inhibition may increase risk of bleeding; case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and occurrence of gastrointestinal bleeding.
A post-marketing study showed a higher incidence of postpartum hemorrhage in mothers receiving therapy.
Other bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages; concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anti-coagulants may add to this risk.
Inform patients about the risk of bleeding associated with concomitant use of drugs and NSAIDs, aspirin, or other drugs that affect coagulation.
Pregnancy
Data from a postmarketing retrospective cohort study indicate that use in the month before delivery may be associated with an increased risk of postpartum hemorrhage; data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes; there are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs, during pregnancy.
Women who discontinued antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continued antidepressants; consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
Clinical considerations
Neonates exposed during pregnancy to serotonin – norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which can arise immediately upon delivery.
Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.
These features are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome.
In some cases, the clinical picture is consistent with serotonin syndrome.
Lactation
Cymbalta
Drugs present in human milk in a published study, lactating women who were weaning their infants were given duloxetine.
At steady state, duloxetine concentration in breast milk was ~25% that of maternal plasma.
The estimated daily infant dose was ~0.14% of the maternal dose. Exercise caution when administering to a nursing woman.
Drizalma Sprinkle
Data from the published literature report the presence of duloxetine in human milk.
There are reports of sedation, poor feeding, and poor weight gain in infants exposed to duloxetine through breast milk.
There are no data on the effect of duloxetine on milk production.
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition.
Women are given 40 mg of duloxetine PO BID for 3.5 days; peak concentration measured in breast milk occurred at a median of 3 hrs post-dose.
The amount of duloxetine in breast milk was ~7 mcg/day while on that dose; the estimated daily infant dose was ~2 mcg/kg/day, which is <1% of the maternal dose.
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