Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets)

Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets)
© The Swiss Pharmacy

Duvanta (Generic Duloxetine Hydrochloride Tablets) is
used for the symptomatic relief of major depressive disorder
(MDD).
Duvanta is used for the symptomatic relief of anxiety
causing clinically significant distress in patients with
generalized anxiety disorder (GAD).
This medicine is also used to treat neuropathic pain
associated with diabetic peripheral neuropathy, chronic low
back pain and osteoarthritis of the knee.

Duvanta Tablets are manufactured by Intas Pharmaceuticals
Limited, India in the strengths of 20 mg, 30 mg, 40 mg and 60
mg.

Chemical Structure

The active ingredient contained in Duvanta tablets is Duloxetine
Hydrochloride.
Each gastro-resistant Duvanta tablet contains Duloxetine
Hydrochloride equivalent to 20 mg, 30 mg, 40 mg or 60 mg of
Duloxetine.

Uses of Duvanta 20 mg, 30 mg, 40 mg and 60 mg Tablets:
Duvanta tablets (Generic Duloxetine Hydrochloride tablets) contain
the active substance Duloxetine Hydrochloride. Duvanta increases the
levels of serotonin and noradrenaline in the nervous system.
Duvanta is used in adult patients to treat: depression and generalised
anxiety disorder (chronic feeling of anxiety or nervousness).
It is also used for pain caused by nerve damage associated with
diabetes called diabetic neuropathic pain (often described as burning,
stabbing, stinging, shooting or aching or like an electric shock.
There may be loss of feeling in the affected area, or sensations such as
touch, heat, cold or pressure may cause pain).
Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness)
and chronic (long-lasting) pain that is related to muscles and bones.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html

Uses of Duvanta 20 mg, 30 mg, 40 mg and 60 mg Tablets:
Duloxetine belongs to a group of medicines known as selective serotonin
and norepinephrine reuptake inhibitors (SSNRIs). These medicines are
thought to work by increasing the activity of chemicals called serotonin and
norepinephrine in the brain.
Duvanta starts to work in most people with depression or anxiety within two
weeks of starting treatment, but it may take 2 to 4 weeks before you feel
better. Inform your doctor if you do not start to feel better after this time.
Your doctor may continue to give you Duvanta when you are feeling better
to prevent your depression or anxiety from returning.
In patients with diabetic neuropathic pain it can take some weeks before
you feel better. Talk to your doctor if you do not feel better after 2 months.

Recommended Adult Dosage
For the treatment of is Major Depressive Disorder
should be administered at a total dose of 40 mg/day (given as 20
mg twice daily) to 60 mg/day (given either once daily or as 30 mg
twice daily).
For some patients, it may be desirable to start at 30 mg once daily
for 1 week, to allow patients to adjust to the medication before
increasing to 60 mg once daily.

Recommended Adult Dosage
Generalized Anxiety Disorder: For most patients, the recommended starting
dose for Duvanta tablets is 60 mg administered once daily. For some patients, it
may be desirable to start at 30 mg once daily for 1 week, to allow patients to
adjust to the medication before increasing to 60 mg once daily.
Diabetic Peripheral Neuropathic Pain: The recommended dose for Duvanta
tablets is 60 mg administered once daily. There is no evidence that doses
higher than 60 mg confer additional significant benefit and the higher dose is
clearly less well tolerated.
Fibromyalgia: The recommended dose for Duvanta tablets is 60 mg
administered once daily. Treatment should begin at 30 mg once daily for 1
week, to allow patients to adjust to the medication before increasing to 60 mg
once daily. Some patients may respond to the starting dose. There is no
evidence that doses greater than 60 mg/day confer additional benefit.

Contraindications
➔
Duvanta tablets are contraindicated in patients with a known
hypersensitivity to Duloxetine Hydrochloride or any component
of the tablet.
➔
Monoamine Oxidase Inhibitors: Concomitant use in patients
taking Monoamine Oxidase Inhibitors (MAOIs) is contraindicated
due to the risk of serious, sometimes fatal, drug interactions with
serotonergic drugs. These interactions may include hyperthermia,
rigidity, myoclonus, autonomic instability with possible rapid
fluctuations of vital signs, and mental status changes that include
extreme agitation progressing to delirium and coma.

Contraindications
➔
Uncontrolled Narrow-Angle Glaucoma: During clinical trials,
Duloxetine use was associated with an increased risk of mydriasis;
therefore, its use should be avoided in patients with uncontrolled
narrow-angle glaucoma.
➔
Do not start treatment with Duvanta (Generic Duloxetine
Hydrochloride Tablets) in a patient who is being treated ,with
Linezolid or intravenous Methylene Blue

Storage Instructions
Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) 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
Suicidality: Antidepressants increased the risk compared to placebo of suicidal
thinking and behavior (suicidality) in children, adolescents, and young adults in
short-term studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering the use of Duvanta (Generic Duloxetine tablets)
or any other antidepressant in a child, adolescent, or young adult must balance
this risk with the clinical need. Monitor for clinical worsening and suicide risk.
Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients
treated with Duvanta. Duvanta should be discontinued in patients who develop
jaundice or other evidence of clinically significant liver dysfunction and should
not be resumed unless another cause can be established. Duvanta should not
be prescribed to patients with substantial alcohol use or evidence of chronic
liver disease.
Orthostatic Hypotension and Syncope: Cases have been reported with
Duloxetine therapy.

Warnings
Serotonin Syndrome, or Neuroleptic Malignant Syndrome (NMS)-like
reactions: Serotonin syndrome or NMS-like reactions have been reported with
SSRIs and SNRIs. Discontinue Duvanta and initiate supportive treatment.
Abnormal Bleeding: Duvanta may increase the risk of bleeding events.
Patients should be cautioned about the risk of bleeding associated with the
concomitant use of duloxetine and NSAIDs, Aspirin, or other drugs that affect
coagulation.
Severe Skin Reactions: Severe skin reactions, including erythema multiforme
and Stevens-Johnson Syndrome (SJS), can occur with Duvanta (Generic
Duloxetine Hydrochloride tablets). Duvanta should be discontinued 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 has occurred.

Warnings
Discontinuation: May result in symptoms, including dizziness, headache,
nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety,
hyperhidrosis, and fatigue.
Seizures: Prescribe with care in patients with a history of seizure disorder
Blood Pressure: Monitor blood pressure prior to initiating treatment and
periodically throughout treatment
Inhibitors of CYP1A2 or Thioridazine: Should not administer with Duvanta
tablets.
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

Warnings
Glucose Control in Diabetes: In diabetic peripheral neuropathic
pain patients, small increases in fasting blood glucose, and
HbA1c have been observed
Conditions that Slow Gastric Emptying: Use cautiously in these
patients
Urinary Hesitation and Retention

Possible Side Effects
Most common Duloxetine Hydrochloride (Duvanta
tablets) side effects with an incidence rate of greater than
or equal to 5% and at least twice the incidence of placebo
patients include nausea, dry mouth, somnolence,
constipation, decreased appetite, and hyperhidrosis

The other side effects observed during clinical trials include:
Cardiac Disorders — Frequent: palpitations; Infrequent: myocardial infarction and
tachycardia.
Ear and Labyrinth Disorders — Frequent: vertigo; Infrequent: ear pain and tinnitus.
Endocrine Disorders — Infrequent: hypothyroidism.
Eye Disorders — Frequent: vision blurred; Infrequent: diplopia and visual disturbance.
Gastrointestinal Disorders — Frequent: flatulence; Infrequent: eructation, gastritis,
halitosis, and stomatitis; Rare: gastric ulcer, hematochezia, and melena.
General Disorders and Administration Site Conditions — Frequent: chills/rigors;
Infrequent: feeling abnormal, feeling hot and/or cold, malaise, and thirst; Rare: gait
disturbance.
Infections and Infestations — Infrequent: gastroenteritis and laryngitis.
Investigations — Frequent: weight increased; Infrequent: blood cholesterol increased.
Metabolism and Nutrition Disorders — Infrequent: dehydration and hyperlipidemia;
Rare: dyslipidemia.

Musculoskeletal and Connective Tissue Disorders — Frequent: musculoskeletal
pain; Infrequent: muscle tightness and muscle twitching.
Nervous System Disorders — Frequent: dysgeusia, lethargy, and parasthesia /
hypoesthesia; Infrequent: disturbance in attention, dyskinesia, myoclonus, and
poor quality sleep; Rare: dysarthria.
Psychiatric Disorders — Frequent: abnormal dreams and sleep disorder;
Infrequent: apathy, bruxism, disorientation/confusional state, irritability, mood
swings, and suicide attempt; Rare: completed suicide.
Renal and Urinary Disorders — Infrequent: dysuria, micturition urgency,
nocturia, polyuria, and urine odor abnormal.
Reproductive System and Breast Disorders — Frequent: anorgasmia/orgasm
abnormal; Infrequent: menopausal symptoms, and sexual dysfunction.

Respiratory, Thoracic and Mediastinal Disorders — Frequent:
yawning; Infrequent: throat tightness.
Skin and Subcutaneous Tissue Disorders — Infrequent: cold
sweat, dermatitis contact, erythema, increased tendency to
bruise, night sweats, and photosensitivity reaction; Rare:
ecchymosis.
Vascular Disorders — Frequent: hot flush; Infrequent: flushing,
orthostatic hypotension, and peripheral coldness

Duvanta Tablets Overdosage
Cases of Duloxetine Hydrochloride (Duvanta tablets) overdoses, alone
or in combination with other medicinal products, with Duloxetine doses
of 5400 mg were reported. Some fatalities have occurred, primarily
with mixed overdoses, but also with Duloxetine alone at a dose of
approximately 1000 mg.
Signs and symptoms of overdose (Duloxetine alone or in combination
with other medicinal products) included somnolence, coma, serotonin
syndrome, seizures, vomiting and tachycardia.

Treatment of Duvanta Tablets Overdosage
No specific antidote is known for Duloxetine Hydrochloride (Duvanta
tablets), but if Serotonin syndrome ensues, specific treatment (such as
with Cyproheptadine and/or temperature control) may be considered.
A free airway should be established. Monitoring of cardiac and vital
signs is recommended, along with appropriate symptomatic and
supportive measures.
Gastric lavage may be indicated if performed soon after ingestion or in
symptomatic patients. Activated charcoal may be useful in limiting
absorption. Duloxetine has a large volume of distribution and forced
diuresis, haemoperfusion, and exchange perfusion are unlikely to be
beneficial.

Duvanta Tablets During Pregnancy
Duloxetine Hydrochloride (Duvanta tablets) has been classified by the
US FDA as Pregnancy Category C.
During 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 during the
period of organogenesis, there was no evidence of teratogenicity at
doses up to 45 mg/kg/day (7 times the maximum recommended
human dose [MRHD, 60 mg/day]) in rat.
There are no adequate and well-controlled studies in pregnant
women; therefore, Duloxetine should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.

Duvanta Tablets (Generic Duloxetine Hydrochloride
Tablets) are manufactured by Intas Pharmaceuticals
Limited, India.

Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets)

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