sertraline hydrochloride- Sertraline Hydrochloride tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

Sertraline Hydrochloride (UNII: UTI8907Y6X) (Sertraline - UNII:QUC7NX6WMB)

Inapatikana kutoka:

Watson Laboratories, Inc.

INN (Jina la Kimataifa):

Sertraline Hydrochloride

Dawa fomu:

TABLET

Tungo:

25 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Major Depressive Disorder –Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (seeClinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydr

Bidhaa muhtasari:

Sertraline hydrochloride tablets are supplied in capsule-shaped tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. Sertraline hydrochloride 25 mg Tablets: green film coated tablets debossed WPI on one side and on the other side debossed 32 to the left of the score line and 38 to the right of the score line. Bottles of 30 and 90 Sertraline hydrochloride 50 mg Tablets: blue film coated tablets debossed WPI on one side and on the other side 32 debossed to the left of the score line and 39 to the right of the score line. Bottles of 30, 90 and 1000 Sertraline hydrochloride 100 mg Tablets: yellow film coated tablets debossed WPI on one side and on the other side 32 to the left of the score line and 40 to the right of the score line. Bottles of 30, 90 and 1000 Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PHARMACIST: Watson has included a minimum quantity of Medication Guides to be dispensed with Sertraline Hydrochloride Tablet prescriptions Rx only Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Cipla Ltd. Kurkumbh, India Revised: August 2007 0807B

Taarifa za kipeperushi

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
Watson Laboratories, Inc.
----------
MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESSES,
AND SUICIDAL THOUGHTS OR ACTIONS
Read the Medication Guide that comes with you or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or

Tabia za bidhaa

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
WATSON LABORATORIES, INC.
----------
SERTRALINE HYDROCHLORIDE TABLETS
REVISED: AUGUST 2007
RX ONLY
SUICIDALITY AND ANTIDEPRESSANT DRUGS
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
SERTRALINE HYDROCHLORIDE TABLETS OR ANY OTHER ANTIDEPRESSANT IN A
CHILD, ADOLESCENT, OR YOUNG
ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM
STUDIES DID NOT SHOW AN
INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO
PLACEBO IN ADULTS
BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS
COMPARED TO PLACEBO IN
ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC
DISORDERS ARE
THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS
OF ALL AGES WHO ARE
STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY
AND OBSERVED CLOSELY
FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR.
FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION
WITH THE PRESCRIBER.
SERTRALINE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS EXCEPT FOR
PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER (OCD). (SEE WARNINGS:
CLINICAL WORSENING
AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE)
DESCRIPTION
Sertraline hydrochloride tablets are a selective serotonin reuptake
inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline
hydrochloride has the following chemical
name:
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride.
The molecular formula C
H NCl
•HCl is represented by the following structural formula:
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water and isopropyl
17
17
2
alcohol, and