Sertima (Sertraline Hydrochloride Tablets) is a serotonin reuptake inhibitors (SSRIs) which is used to treat depression and conditions called obsessive compulsive disorder (OCD), panic disorder, social phobia (social anxiety disorder) and premenstrual dysphoric disorder (PMDD).

1. Sertraline Hydrochloride Tablets
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Sertima (Sertraline Hydrochloride Tablets) is a
serotonin reuptake inhibitors (SSRIs) which is
used to treat depression and conditions called
obsessive compulsive disorder (OCD), panic
disorder, social phobia (social anxiety disorder)
and premenstrual dysphoric disorder (PMDD).

2. Sertima Tablets
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Sertima Tablets are manufactured by
Intas Pharmaceuticals Ltd., India.
(Website: www.intaspharma.com)

3. Sertraline Hydrochloride Tablets – Brand Names
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Sertraline Hydrochloride tablets are
available as Zoloft, Sertima, Daxid,
Inosert, Serdep, Serenata, Sertil and
Zosert.

4. Active Ingredient
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The active ingredient contained in Sertima
tablets is Sertraline Hydrochloride. Each
Sertima tablet contains 50 mg or 100 mg of
Sertraline.

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

6. Uses of Sertima Tablets
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Sertima (Sertraline Hydrochloride Tablets)
are used to treat symptoms of depression
(feelings of sadness, tearfulness, inability to
sleep or enjoy life as you once used to) ,
Obsessive-compulsive disorder (OCD),
Panic disorder (PD), Social anxiety disorder
(SAD), Premenstrual dysphoric disorder
(PMDD) and Post traumatic stress disorder
(PTSD).

7. Sertima Dosage
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➢Depression - Adults: The normal starting dose is
one 50 mg tablet each day. The dose can be
increased gradually up to a maximum of 200 mg a
day if necessary.
➢Obsessive Compulsive Disorder - Children (6
years to 12 Years): The normal starting dose is 25
mg a day which is half a 50 mg tablet. Increase to
one 50 mg tablet a day after one week.
➢Obsessive Compulsive Disorder - Adults and
Adolescents (13 years to 18 Years): The normal
starting dose is one 50 mg tablet each day.
The dosage of Sertima tablets (Sertraline
Hydrochloride) is given below:

8. Sertima Dosage
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➢Panic Disorder - Adults: The normal starting dose is 25
mg day which is half a 50 mg tablet. Increase to one 50 mg
tablet a day after one week.
➢Social Phobia (Social Anxiety Disorder) - Adults: The
normal starting dose is 25 mg a day which is half a 50 mg
tablet. Increase to one 50 mg a day after one week.
➢Premenstrual Dysphoric Disorder (PMDD): In case taking
throughout the menstrual cycle, the normal starting dose is
one 50 mg tablet a day. This may be increased to a
maximum of 150 mg a day if necessary. In case taking the
medicine in the last 14 days of the menstrual cycle, the
normal starting dose is one 50 mg tablet a day. This may
be increased to a maximum of 100 mg a day.
The dosage of Sertima tablets (Sertraline
Hydrochloride ) is given below:

9. Storage Instructions
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Sertima (Sertraline Hydrochloride
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) .
Keep this as well as all other medicines
away from children and pets.

10. Sertima Tablets
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Contraindications
Sertima is contraindicated in patients with a
hypersensitivity to Sertraline Hydrochloride or
any other component of this medication.
Concomitant use in patients taking monoamine
oxidase inhibitors (MAOIs) is contraindicated.
Concomitant use in patients taking pimozide is
also contraindicated.

11. Warnings
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Serotonin Syndrome: Increased risk when co-
administered with other serotonergic agents (e.g.,
SSRI, SNRI, triptans), but also when taken alone. In
case it occurs, discontinue Sertima (Sertraline
Hydrochloride Tablets) and begin supportive
treatment.
Increased Risk of Bleeding: Concomitant use of
aspirin, nonsteroidal anti-inflammatory drugs
(NSAIDs), other antiplatelet drugs, warfarin, and other
anticoagulants can increase the risk of bleeding.
Activation of Mania/Hypomania: Patients must be
screened for bipolar disorder.
Seizures: Use with caution in patients with seizure
disorders.

12. Warnings
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Angle Closure Glaucoma: Avoid use of
antidepressants, including Sertraline Hydrochloride
tablets, in patients with untreated anatomically narrow
angles.
Do not drive, use machinery, or do any activity that
requires alertness until you are sure you can perform
such activities safely.
Avoid alcoholic beverages when undergoing therapy
with Sertima tablets.
Hyponatraemia can occur as a result of treatment with
SSRIs or SNRIs including Sertraline HCl tablets. In
many cases, hyponatraemia seems to be the result of
a syndrome of inappropriate antidiuretic hormone
secretion (SIADH).

13. Warnings
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Withdrawal symptoms when treatment is
discontinued are common, specially if
discontinuation is abrupt.
The use of Sertima (Sertraline Hydrochloride
Tablets) has been associated with the
development of akathisia, characterised by a
subjectively unpleasant or distressing
restlessness and necessity to move often
accompanied by an inability to sit or stand still.
Interference with urine screening tests: False-
positive urine immunoassay screening tests for
benzodiazepines have been observed in patients
taking Sertraline tablets.

14. Sertraline Hydrochloride Side Effects
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➢Sertraline Hydrochloride side effects
with an incidence rate of 5% or more and
twice placebo in pooled placebo-
controlled MDD, OCD, PD, PTSD, SAD
and PMDD clinical trials were nausea,
diarrhea/loose stool, tremor, dyspepsia,
decreased appetite, hyperhidrosis,
ejaculation failure, and decreased libido.

15. Sertima Overdose
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The most common signs and symptoms associated with
non-fatal Sertraline Hydrochloride overdosage were
somnolence, vomiting, tachycardia, nausea, dizziness,
agitation and tremor.
The largest reported ingestion was 13.5 grams in a
patient who took Sertraline HCl tablets alone and
subsequently recovered. However, another patient who
took 2.5 grams of Sertraline Hydrochloride alone
experienced a fatal outcome.
Other important adverse events reported with Sertraline
Hydrochloride (Sertima Tablets) overdose (single or
multiple drugs) include bradycardia, bundle branch
block, coma, convulsions, delirium, hallucinations,
hypertension, hypotension, manic reaction, pancreatitis,
QT-interval prolongation, serotonin syndrome, stupor
and syncope.

16. Sertraline Overdose
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Ensure an adequate airway, oxygenation
and ventilation. Monitor cardiac rhythm
and vital signs of the patients.
General supportive and symptomatic
measures are also recommended.
Induction of emesis is not recommended.
Gastric lavage with a large-bore orogastric
tube with appropriate airway protection, if
required, can be indicated if performed
soon after ingestion, or in symptomatic
patients.
Activated charcoal must be administered.

17. Sertraline During Pregnancy
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Sertraline Hydrochloride (Sertima tablets) has
been classified by the US FDA as Pregnancy
Category C.
Reproduction studies performed on animals
with approximately 4 times the maximum
recommended human dose (MRHD) on a
mg/m2 basis have not revealed any
evidence of teratogenicity.
There are no adequate and well-controlled
studies in pregnant women. Sertima (Sertraline
Hydrochloride Tablets) should be used during
pregnancy only if the potential benefit justifies
the potential risk to the fetus.

18. Sertima Tablets
For more details on
Sertima Tablets click here
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Sertima (Sertraline Hydrochloride Tablets)
by Intas Pharmaceuticals Limited, India.