Dulot Capsules (Generic Duloxetine Hydrochloride)

Dulot (Generic Duloxetine Capsules)
© The Swiss Pharmacy

Dulot Capsules (Generic Duloxetine Hydrochloride) is
used to treat depression and anxiety.
Duloxetine capsules are also used to help relieve nerve
pain (peripheral neuropathy) in people with diabetes or
ongoing pain due to medical conditions such as
arthritis, chronic back pain, or fibromyalgia (a condition
that causes widespread pain).

Dulot capsules are
manufactured by Lupin
Limited, India.

Chemical Structure

The active ingredient contained in Dulot
capsules is Duloxetine Hydrochloride.
Each Dulot capsule contains Duloxetine
Hydrochloride equivalent to 20 mg, 30
mg or 40 mg of Duloxetine respectively.

Uses of Dulot 20 mg, 30 mg and 40 mg Capsules:
Dulot (Generic Duloxetine capsules) is a serotonin and norepinephrine
reuptake inhibitor (SNRI) indicated for the treatment of Major depressive
disorder (MDD) in adults, Generalized anxiety disorder (GAD) in adults and
pediatric patients 7 years of age and older, Diabetic peripheral neuropathic
pain (DPNP) in adults, Fibromyalgia (FM) in adults and pediatric patients 13
years of age and older and Chronic musculoskeletal pain in adults.
Generic Duloxetine capsules could improve your mood, sleep, appetite, and
energy level, and decrease nervousness. It can also decrease pain due to
certain medical conditions. Duloxetine works by helping to restore the
balance of certain natural substances (serotonin and norepinephrine) in the
brain.

Recommended Adult Dosage
The dose of Dulot (Generic Duloxetine Capsules) for various
indications is given below:
Major Depressive Disorder (MDD): 40 mg/day to 60 mg/day
Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day
(once daily or as 30 mg twice daily); Maintenance Treatment: 60
mg/day
Generalized Anxiety Disorder (GAD): Adults 60 mg/day (once
daily) with a maximum dose of 60 mg/day (once daily)

Recommended Adult Dosage
Fibromyalgia (FM): Adults and Pediatrics (13 to 17 years
of age) 30 mg/day with a maximum dose of 60 mg/day
(once daily)
Chronic Musculoskeletal Pain: 30 mg/day with a
maximum dose of 60 mg/day (once daily)

Contraindications
➔Dulot Capsules is contraindicated in patients with a
known hypersensitivity to Duloxetine Hydrochloride or
any component of the tablet.
➔Concomitant use of an MAOI antidepressant with Dulot
Capsules (Generic Duloxetine Hydrochloride) is
contraindicated. Use of Dulot within 14 days of stopping
an MAOI antidepressant is contraindicated.
➔In linezolid- or intravenous methylene blue-treated
patients,initiation of Dulot Capsules is contraindicated.

Storage Instructions
Dulot Capsules (Generic Duloxetine
Hydrochloride) 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.

Warnings
Increased risk of suicidal thinking and behavior in children, adolescents, and young
adults taking antidepressants including Dulot (Generic Duloxetine capsules). Doctors are
advised to monitor for worsening and emergence of suicidal thoughts and behaviors.
Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported. Discontinue Dulot
in patients who develop jaundice or other evidence of clinically significant liver
dysfunction and should not be resumed unless another cause can be established. Avoid
use in patients with substantial alcohol use or evidence of chronic liver disease.
Orthostatic Hypotension, Falls and Syncope: Consider dosage reduction or
discontinuation if these events occur.
Serotonin Syndrome: Increased risk when co-administered with other serotonergic
agents (e.g., SSRIs, SNRIs, triptans), but also when taken alone. If it occurs, discontinue
Dulot.

Warnings
Increased Risk of Bleeding: May increase the risk of bleeding events. Concomitant
use of antiplatelet drugs and anticoagulants may increase this risk.
Severe Skin Reactions: Severe skin reactions, including erythema multiforme and
Stevens-Johnson Syndrome (SJS), can occur; Discontinue at the first appearance of
blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no
other etiology can be identified.
Activation of Mania or Hypomania: Prior to initiating, screenpatients for personal
or family history of bipolar disorder, mania, or hypomania.
Angle-Closure Glaucoma: Has occurred in patients with untreated anatomically
narrow angles treated with antidepressants.

Warnings
Seizures: Prescribe with care in patients with a history of seizure disorder.
Blood Pressure Increases: Monitor blood pressure prior to initiating
treatment and periodically throughout treatment.
Inhibitors of CYP1A2 or Thioridazine: Avoid co-administration with Dulot.
Hyponatremia: Can occur in association with SIADH; consider
discontinuation.
Glucose Control in Diabetes: In DPNP patients, increases in fasting blood
glucose, and HbA1c have been observed.
Conditions that Slow Gastric Emptying: Use cautiously in these patients.

Possible Side Effects
Most common Dulot Capsules (Generic Duloxetine
Hydrochloride) side effects with an incidence rate of
greater than or equal to 5% and at least twice the
incidence of placebo patients: Nausea, dry mouth,
constipation, somnolence, hyperhidrosis, and decreased
appetite.

Possible Side Effects
Below is the incidence of treatment-emergent side effects in MDD and GAD
placebo-controlled trials for approved indications that occurred in 2% or more
of patients treated with Duloxetine capsules and with an incidence greater
than placebo:
Palpitations, Vision blurred, Nausea, Dry mouth, Diarrhea, Constipation,
Abdonimal pain, Vomiting, Fatigue, Weight decreased, Decreased appetite,
Dizziness, Somnolence, Tremor, Insomnia, Agitation, Anxiety, Libido decreased,
Orgasm abnormal, Abnormal dreams, Erectile dysfunction, Ejaculation delayed,
Ejaculation disorder, Yawning, Hyperhidrosis and Hot flush.

Dulot Capsules Overdosage
During postmarketing experience, fatal outcomes have been
reported for acute overdoses, primarily with mixed
overdoses, but also with Duloxetine (Dulot capsules) 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.

Treatment of Overdosage
There is no specific antidote to Duloxetine (Dulot capsules), but if serotonin
syndrome ensues, specific treatment may be considered.
In case of acute overdose, treatment should consist of those general measures
employed in the management of overdose with any medication.
An adequate airway, oxygenation, and ventilation should be assured, and
cardiac rhythm and vital signs should 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.

Pregnancy
Duloxetine Hydrochloride (Dulot capsules) has been classified by the
US FDA as Pregnancy Category C.
In animal reproduction studies, Duloxetine has been shown to have
adverse effects on embryo/fetal and postnatal development.
When Duloxetine was administered orally to pregnant rats and rabbits
during the period of organogenesis, there was no evidence of
teratogenicity at doses up to 45 mg/kg/day.
There are no adequate and well-controlled studies in pregnant women.
Therefore, Duloxetine capsules should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.

Dulot Capsules are manufactured by Lupin
Limited, India.
For More details Click Here

Dulot Capsules (Generic Duloxetine Hydrochloride)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Dulot Capsules (Generic Duloxetine Hydrochloride)

Similar to Dulot Capsules (Generic Duloxetine Hydrochloride) (20)

More from The Swiss Pharmacy

More from The Swiss Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Dulot Capsules (Generic Duloxetine Hydrochloride)