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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

ZOLOFT Film-coated tablet / Oral solution (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Roerig

Λέξεις κλειδιά

0049-0050 0049-4900 0049-4910 0049-4960

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1. Indications and Usage

ZOLOFT is indicated for the treatment of the following <em>[See Clinical Studies (14)]</em>: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress ...

2. Dosage and Administration

2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of ...

3. Dosage Forms and Strengths

<u>25 mg tablets:</u> light green film-coated, engraved on one side with ZOLOFT and on the other side scored and engraved with 25 mg. <u>50 mg tablets:</u> light blue film-coated, engraved on one side ...

4. Contraindications

ZOLOFT is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome <em> ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included ...

6. Adverse Reactions

The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline <em>[See Contraindications (4)]</em> Disulfiram-alcohol ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ZOLOFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

7.1 Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with ZOLOFT <em>[See Clinical Pharmacology (12.3)]</em>. <b>Table 5. Clinically-Significant Drug Interactions ...

8.1. Pregnancy

Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background ...

8.2. Lactation

Risk Summary Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk <em>[See Data]</em>. There are no data on the effects of sertraline on milk ...

8.4. Pediatric Use

The safety and efficacy of ZOLOFT have been established in the treatment of OCD in pediatric patients aged 6 to 17 <em>[See Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)] ...

8.5. Geriatric Use

Of the total number of patients in clinical studies of ZOLOFT in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 797 (17%) were ≥65 years old, while 197 (4%) were ≥75 years old. No overall differences ...

8.6. Renal Impairment

No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment <em>[See Clinical Pharmacology (12.3)]</em>.

8.6. Hepatic Impairment

The recommended dosage in patients with mild hepatic impairment (Child-Pugh score 5 or 6) is half the recommended dosage due to increased exposure in this patient population. The use of ZOLOFT in patients ...

9. Drug Abuse and Dependence

9.1 Controlled Substance ZOLOFT contains sertraline, which is not a controlled substance. 9.2 Abuse In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of ZOLOFT, ...

10. Overdosage

Human Experience The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage ...

11. Description

ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)4(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine ...

12.1. Mechanism of Action

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

12.2. Pharmacodynamics

Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. <em>In vitro</em> studies in animals also suggest that sertraline is a potent ...

12.3. Pharmacokinetics

Absorption Following oral once-daily ZOLOFT dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (C<sub>max</sub>) of sertraline occurred between 4.5 to 8.4 hours post-dosing. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended ...

14. Clinical Studies

Efficacy of ZOLOFT was established in the following trials: MDD: two short-term trials and one maintenance trials in adults <em>[See Clinical Studies (14.1)]</em>. OCD: three short-term trials in adults ...

16.1. How Supplied

<u>ZOLOFT 25 mg tablets:</u> light green, film-coated, capsular-shaped tablets engraved on one side with ZOLOFT and on the other side scored and engraved with "25 mg" NDC 0049-4960-30 Bottles of 30 ...

16.2. Storage and Handling

Store ZOLOFT at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early ...

BOXED WARNING SECTION

<b>WARNING: SUICIDAL THOUGHTS AND BEHAVIORS</b> <b>Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all ...