Qutan Tablets (Generic Quetiapine Fumarate Tablets)

Qutan Tablets (Generic Quetiapine Fumarate Tablets)
© The Swiss Pharmacy

Qutan (Generic Quetiapine Fumarate Tablets) is used alone
or together with other medicines for treating schizophrenia,
bipolar disorder (depressive and manic episodes), recurrent
major depressive disorder (MDD) and generalised anxiety
disorder (GAD).
Quetiapine extended-release tablet is also used together
with other antidepressants to treat major depressive
disorder. This medicine should not be used to treat
behavioral problems in older adult patients who have
dementia or Alzheimer disease. Quetiapine is an
antipsychotic medicine that works in the brain.

Qutan Tablets are manufactured by Intas Pharmaceuticals Limited, India
in the strengths of 25 mg, 50 mg, 100 mg, 200 mg and 300 mg. Qutan
tablets are also available as Extended Release (XR or XL) or Sustained
Release (SR) version in strengths of SR 50 mg, SR 100 mg, SR 200 mg, SR
300 mg and SR 400 mg.

Chemical Structure

The active ingredient contained in Qutan tablets is Quetiapine Fumarate.
Each film-coated Qutan tablet contains Quetiapine Fumarate equivalent to
25 mg, 50 mg, 100 mg, 200 mg or 400 mg of Quetiapine.
Each film-coated sustained release Qutan tablet contains Quetiapine
Fumarate equivalent to 50 mg, 100 mg, 200 mg, 300 mg or 400 mg of
Quetiapine.

Uses of Qutan Tablets:
Qutan (Generic Quetiapine Fumarate tablets) is used to treat certain
mental/mood conditions (such as schizophrenia, bipolar disorder,
sudden episodes of mania or depression associated with bipolar
disorder). Quetiapine is known as an anti-psychotic drug (atypical type).
It works by helping to restore the balance of certain natural substances
(neurotransmitters) in the brain. This medication can decrease
hallucinations and improve your concentration. It helps you to think
more clearly and positively about yourself, feel less nervous, and take
a more active part in everyday life. It may also improve your mood,
sleep, appetite, and energy level. Quetiapine can help prevent severe
mood swings or decrease how often mood swings occur.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html

Recommended Adult Dosage
For most adult patients, the starting dose of Qutan tablets
(Generic Quetiapine tablets) for treatment of Schizophrenia is 25
mg taken twice daily on day 1.
Increase in increments of 25 mg to 50 mg divided two or three
times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further
adjustments can be made in increments of 25 to 50 mg twice a
day, in intervals of not less than 2 days.
The recommended dose is 150 mg to 750 mg/day and the
maximum dose is 750 mg/day.

Treatment of Bipolar Mania in Adults (Monotherapy or as an
Adjunct to Lithium or Divalproex):
Day 1: Twice daily dosing totaling 100 mg. Day 2: Twice daily
dosing totaling 200 mg.Day 3: Twice daily dosing totaling 300
mg.Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6
should be in increments of no greater than 200 mg/day.
The recommended dose is 400 mg to 800 mg/day and the
maximum dose is 800 mg/day.

Treatment of Bipolar Depression in Adults:
Qutan (Generic Quetiapine Fumarate tablets) has to be administered once
daily at bedtime as given below:
Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg and Day 4: 300 mg
The recommended dose is 300 mg and the maximum dose is 300 mg/day.

Contraindications
➔
Qutan is contraindicated in patients with a known hypersensitivity to
Quetiapine Fumarate or any component of the tablet. Anaphylactic
reactions have been reported in patients treated with Quetiapine Fumarate.

Storage Instructions
Qutan tablets (Generic Quetiapine Fumarate 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
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis: Elderly patients with dementia-related psychosis
treated with anti-psychotic drugs are at an increased risk of death.
Quetiapine Fumarate tablets are not approved for elderly
patients with dementia-related psychosis.
Suicidal Thoughts and Behaviors: Increased risk of suicidal
thoughts and behavior in children, adolescents and young adults
taking antidepressants. Monitor for worsening and emergence of
suicidal thoughts and behaviors.

Warnings
Cerebrovascular Adverse Reactions: Increased incidence of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack) has been seen in elderly patients with dementia-related
psychoses treated with atypical antipsychotic medications.
Neuroleptic Malignant Syndrome (NMS): Manage with immediate
discontinuation and close monitoring
Metabolic Changes: Atypical anti-psychotics have been associated
with metabolic changes. These metabolic changes include
hyperglycemia, dyslipidemia, and weight gain.
Tardive Dyskinesia: Discontinue if clinically appropriate.

Warnings
Hypotension: Use with caution in patients with known cardiovascular or
cerebrovascular disease.
Increased Blood Pressure in Children and Adolescents: Monitor blood
pressure at the beginning of, and periodically during treatment in
children and adolescents.
Leukopenia, Neutropenia and Agranulocytosis: Monitor complete
blood count frequently during the first few months of treatment in
patients with a pre-existing low white cell count or a history of
leukopenia/neutropenia and discontinue Qutan tablets at the first sign
of a decline in WBC in absence of other causative factors.

Warnings
Cataracts: Lens changes have been observed in patients during
long-term quetiapine treatment. Lens examination is
recommended when starting treatment and at 6-month intervals
during chronic treatment.
Anticholinergic (antimuscarinic) Effects: Use with caution with
other anticholinergic drugs and in patients with urinaryretention,
prostatic hypertrophy, constipation, or increased intraocular
pressure.

Possible Side Effects
Most common Quetiapine Fumarate (Qutan tablets) side effects with an
incidence rate of greater than or equal to 5% observed in adults include
somnolence, dry mouth, constipation, dizziness, increased appetite,
dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion.

Possible Side Effects
The following Qutan (Generic Quetiapine Fumarate Tablets)
side effects have also been reported with Quetiapine:
nightmares, hypersensitivity and elevations in serum creatine
phosphokinase (not associated with NMS), galactorrhea,
bradycardia (which may occur at or near initiation of treatment
and be associated with hypotension and/ or syncope) decreased
platelets, somnambulism (and other related events), elevations in
gamma-GT levels, hypothermia, and priapism.

Overdosage
During clinical trials, survival has been reported in acute overdoses of up to 30
grams of Quetiapine. Most patients who overdosed experienced no adverse
reactions or recovered fully from the reported events. Death has been reported
in a clinical trial following an overdose of 13.6 grams of Quetiapine alone.
In general, reported signs and symptoms were those resulting from an
exaggeration of the medicine’s known pharmacological effects, i.e., drowsiness,
sedation, tachycardia, hypotension, and anti-cholinergic toxicity including coma
and delirium.
Patients with pre-existing severe cardiovascular disease may be at an
increased risk of the effects of overdose. One case, involving an estimated
overdose of 9600 mg, was associated with hypokalemia and first degree heart
block. In post-marketing experience, there were cases reported of QT
prolongation with Quetiapine overdose.

Treatment of Qutan Tablets Overdosage
Establish and maintain an airway and ensure adequate oxygenation and
ventilation.
In cases of severe intoxication, the possibility of multiple drug involvement
should be considered, and intensive care procedures are recommended,
including establishing and maintaining a patent airway, ensuring adequate
oxygenation and ventilation, and monitoring and support of the cardiovascular
system.
In cases of Quetiapine overdose, refractory hypotension should be treated
with appropriate measures such as intravenous fluids and/or
sympathomimetic agents (adrenaline and dopamine should be avoided,
since beta stimulation may worsen hypotension in the setting of quetiapine-
induced alpha blockade).
Appropriate supportive measures are the mainstay of Qutan (Generic
Quetiapine Fumarate Tablets) overdose management.

Qutan Tablets During Pregnancy
Quetiapine Fumarate (Qutan tablets) has been classified by the US FDA as
Pregnancy Category C.
Neonates exposed to antipsychotic medicines during the third trimester
of pregnancy are at risk of experiencing extrapyramidal neurological
disturbances and/or withdrawal symptoms following delivery. There
have been post-market reports of agitation, hypertonia, hypotonia, tremor,
somnolence, respiratory distress, and feeding disorder in these neonates.
Following some pregnancies in which Quetiapine was used, neonatal
withdrawal symptoms have been reported.
There are no adequate and well-controlled studies in pregnant women and
Quetiapine Fumarate (Qutan tablets) should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus.

are manufactured by Intas Pharmaceuticals Limited,
India.

Qutan Tablets (Generic Quetiapine Fumarate Tablets)

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