Generic Duloxetine (Duzela Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressants used to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM) and Chronic Musculoskeletal Pain.

1. Generic Duloxetine Capsules
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Generic Duloxetine (Duzela Capsules) is a selective
serotonin and norepinephrine reuptake inhibitor
(SNRI) antidepressants used to treat Major
Depressive Disorder (MDD), Generalized Anxiety
Disorder (GAD), Diabetic Peripheral Neuropathic Pain
(DPNP), Fibromyalgia (FM) and Chronic
Musculoskeletal Pain.

2. Duzela Capsules
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Duzela Capsules are manufactured by
Sun Pharmaceutical Industries Ltd.
(Website: www.sunpharma.com)

3. Duloxetine Hydrochloride Tablets – Brand
Names
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Duloxetine Hydrochloride tablets are
available as Cymbalta, Irenka,
Duzela, Dutin, Dulojoy, Dumore,
Ariclaim, Xeristar and Yentreve.

4. Active Ingredient
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The active ingredient contained in Duzela
capsules is Duloxetine Hydrochloride. Each
Duzela 60 mg capsules contains enteric-
coated pellets of Duloxetine Hydrochloride
equivalent to 60 mg of Duloxetine.

5. Chemical Structure
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The structure of Duloxetine Hydrochloride
is given below:

6. Uses of Duzela Capsules
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Generic Duloxetine (Duzela Capsules) is
used to treat Anxiety, Back Pain, Bipolar
Disorder, Chronic Fatigue Syndrome,
Chronic Pain, Depression, Diabetic
Peripheral Neuropathy, Dysthymia,
Fibromyalgia, Generalized Anxiety Disorder,
Hot Flashes, Major Depressive Disorder,
Osteoarthritis, Pain, Peripheral Neuropathy,
Small Fiber Neuropathy, Somatoform Pain
Disorder and Urinary Incontinence.

7. Storage Instructions
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Generic Duloxetine (Duzela Capsules)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F
to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

8. Warnings
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Warnings associated with Generic Duloxetine
(Duzela Capsules) use are given below:
Suicidality: Monitor for clinical worsening
and suicide risk.
Hepatotoxicity: Hepatic failure,
sometimes fatal, has been reported in
patients treated with Duzela.
Orthostatic Hypotension and Syncope:
Cases have been reported with Generic
Duloxetine therapy.

9. Warnings
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Warnings associated with Generic Duloxetine
(Duzela Capsules) use are given below:
Serotonin Syndrome, or Neuroleptic Malignant
Syndrome (NMS)-like reactions: Serotonin
syndrome or NMS-like reactions have been reported
with SSRIs and SNRIs. Discontinue Duzela and
initiate supportive treatment.
Abnormal Bleeding: Cymbalta may in crease the risk
of bleeding events.
Discontinuation: May result in symptoms, including
dizziness, nausea, headache, paresthesia, fatigue,
vomiting, irritability, insomnia, diarrhea, anxiety, and
hyperhidrosis.

10. Warnings
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Warnings associated with Generic Duloxetine
(Duzela Capsules) use are given below:
Activation of mania or hypomania has occurred
Blood Pressure: Monitor blood pressure prior to
initiating treatment and periodically throughout
treatment.
Inhibitors of CYP1A2 or Thioridazine: Should not
administer with Generic Duloxetine.
Hyponatremia: Cases of hyponatremia have been
reported.
Hepatic Insufficiency and Severe Renal Impairment:
Should ordinarily not be administered to these
patients.
Controlled Narrow-Angle Glaucoma: Use cautiously
in these patients.

11. Warnings
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Warnings associated with Generic Duloxetine
(Duzela Capsules) use are given below:
Glucose Control in Diabetes: In diabetic
peripheral neuropathic pain patients, small
increases in fasting blood glucose, HbA
1c, and total cholesterol have been observed.
Conditions that Slow Gastric Emptying: Use
cautiously in these patients.
Urinary Hesitation and Retention

12. Generic Duloxetine (Duzela Capsules) Dosage
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➢ Dosage for Treatment of Major Depressive
Disorder (MDD):
➢Starting Dose: 40mg/day to 60mg/day
➢Target Dose Acute Treatment: 40 mg/day (20
mg twice daily) to 60 mg/day (once daily or as
30 mg twice daily);
➢Target Dose Maintenance Treatment: 60
mg/day
Take Duzela capsules once daily, with or without
food. Swallow Generic Duloxetine capsules whole.
The dosage of Duzela Capsules (Duloxetine
Hydrochloride) is given below:

13. Generic Duloxetine Dosage
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➢ Dosage for Treatment of Diabetic Peripheral
Neuropathic Pain (DPNP):
➢Starting Dose: 60mg/day
➢Target Dose: 60 mg/day (once daily)
➢Dosage for Treatment of Generalized Anxiety
Disorder (GAD):
➢Starting Dose:60mg/day
➢Target Dose: 60 mg/day (once daily)
➢Dosage for Treatment of Fibromyalgia (FM):
➢Starting Dose:30mg/day
➢Target Dose: 60 mg/day (once daily)
The dosage of Generic Duloxetine tablets
(Duzela Capsules) is given below:

14. Duzela Capsules
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Contraindications
Duzela is contraindicated in patients with a
hypersensitivity to Duloxetine Hydrochloride or any other
component of this medication.
Generic Duloxetine is contraindicated in patients with
hepatic impairment.
Generic Duloxetine should not be used in combination
with potent CYP1A2 inhibitors.
Use of Monoamine Oxidase Inhibitors (MAOIs) to treat
psychiatric disorders along with Generic Duloxetine or
within five days of stopping treatment with Generic
Duloxetine is contraindicated.
Starting treatment with Duzela in a patient who is being
treated with MAOIs such as linezolid or intravenous
methylene blue is also contraindicated.

15. Generic Duloxetine Side Effects
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➢The most common Generic Duloxetine side
effects with an incidence rate of of at least 5%
and at least twice the incidence of placebo
patients can include nausea, dry mouth,
somnolence, fatigue, constipation, decreased
appetite, and hyperhidrosis.
➢ In a trial conducted for mild major depressive
disorder (MDD), the most commonly reported
treatment-emergent adverse events among
duloxetine-treated patients were nausea
(34.7%), dry mouth (22.7%), headache (20.0%)
and dizziness (18.7%).
➢Duloxetine and SSRIs have been shown to
cause sexual side effects in some patients, both
males and females.

16. Generic Duloxetine Side Effects
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➢The following side effects were reported
very rarely: rash, alanine
aminotransferase increased, alkaline
phosphatase increased, anaphylactic
reaction, angioneurotic edema, aspartate
aminotransferase increased, bilirubin
increased, glaucoma, hepatitis,
hyponatremia, jaundice, orthostatic
hypotension, Stevens-Johnson syndrome,
syncope, and urticaria.

17. Duzela Overdose
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Fatal outcomes have been reported for
acute overdoses, primarily with mixed
overdoses, but also with Generic
Duloxetine only, at doses as low as 1000
mg. Signs and symptoms of overdose
(Duloxetine alone or with mixed drugs)
included somnolence, coma, serotonin
syndrome, seizures, syncope, tachycardia,
hypotension, hypertension, and vomiting.

18. Duzela Overdose
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In case of acute Duzela overdose, treatment
should consist of those general measures
employed in the management of overdose with
any medicine.
An adequate airway, oxygenation, and ventilation
should be assured, and cardiac rhythm and vital
signs must be monitored. Induction of emesis is
not recommended. Gastric lavage with a large-
bore orogastric tube with appropriate
airway protection, if needed, may be indicated if
performed soon after ingestion or in symptomatic
patients. Activated charcoal may be useful in
limiting absorption of Duloxetine from the
gastrointestinal tract.

19. Duloxetine During Pregnancy
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Duzela (Duloxetine Hydrochloride capsules) has
been classified by the US FDA as Pregnancy
Category C.
There are no adequate and well-controlled
studies of Duloxetine administration in pregnant
women. In animal studies with Duloxetine, there
was no evidence of teratogenicity in pregnant rats
and rabbits at oral doses administered during the
period of organogenesis up to 4 and 7 times the
maximum recommended human dose.
Generic Duloxetine should be used in pregnancy
only if the potential benefit justifies the potential
risk to the fetus.

20. Duzela Capsules
For more details on
Duzela Capsules click here
© Clearsky Pharmacy
Duzela (Duloxetine Hydrochloride
Capsules) by Sun Pharmaceutical
Industries Ltd., India.