The effectiveness of ZOLOFT in the treatment of SAD (also known as social phobia) was established in two multicenter, randomized, placebo-controlled studies (Study SAD-1 and SAD-2) of adult outpatients who met DSM-IV criteria for SAD.
Study SAD-1 was a 12-week, flexible dose study comparing ZOLOFT (50–200 mg/day), n=211, to placebo, n=204, in which ZOLOFT was initiated at 25 mg/day for the first week, then titrated to the maximum tolerated dose in 50 mg increments biweekly. Study outcomes were assessed by the:
- Liebowitz Social Anxiety Scale (LSAS), a 24-item clinician administered instrument that measures fear, anxiety, and avoidance of social and performance situations, and
- Proportion of responders as defined by the Clinical Global Impression of Improvement (CGI-I) criterion of CGI-I ≤ 2 (very much or much improved).
ZOLOFT was statistically significantly more effective than placebo as measured by the LSAS and the percentage of responders.
Study SAD-2 was a 20-week, flexible dose study that compared ZOLOFT (50–200 mg/day), n=135, to placebo, n=69. ZOLOFT was titrated to the maximum tolerated dose in 50 mg increments every 3 weeks. Study outcome was assessed by the:
- Duke Brief Social Phobia Scale (BSPS), a multi-item clinician-rated instrument that measures fear, avoidance and physiologic response to social or performance situations,
- Marks Fear Questionnaire Social Phobia Subscale (FQ-SPS), a 5-item patient-rated instrument that measures change in the severity of phobic avoidance and distress, and
- CGI-I responder criterion of ≤ 2.
ZOLOFT was shown to be statistically significantly more effective than placebo as measured by the BSPS total score and fear, avoidance and physiologic factor scores, as well as the FQ-SPS total score, and to have statistically significantly more responders than placebo as defined by the CGI-I. Subgroup analyses did not suggest differences in treatment outcome on the basis of gender. There was insufficient information to determine the effect of race or age on outcome.
In Study SAD-3, patients meeting DSM-IV criteria for SAD who had responded while assigned to ZOLOFT (CGI-I of 1 or 2) during a 20-week placebo-controlled trial on ZOLOFT 50–200 mg/day were randomized to continuation of ZOLOFT or to substitution of placebo for up to 24 weeks of observation for relapse. Relapse was defined as ≥ 2 point increase in the Clinical Global Impression Severity of Illness (CGI-S) score compared to baseline or study discontinuation due to lack of efficacy. Patients receiving ZOLOFT continuation treatment experienced a statistically significantly lower relapse rate during this 24-week period than patients randomized to placebo substitution.
The effectiveness of ZOLOFT for the treatment of PMDD was established in two double-blind, parallel group, placebo-controlled flexible dose trials (Studies PMDD-1 and PMDD-2) conducted over 3 menstrual cycles in adult female patients. The effectiveness of ZOLOFT for PMDD for more than 3 menstrual cycles has not been systematically evaluated in controlled trials.
Patients in Study PMDD-1 met DSM-III-R criteria for Late Luteal Phase Dysphoric Disorder (LLPDD), the clinical entity referred to as PMDD in DSM-IV. Patients in Study PMDD-2 met DSM-IV criteria for PMDD. Study PMDD-1 utilized continuous daily dosing throughout the study, while Study PMDD-2 utilized luteal phase dosing (intermittent dosing) for the 2 weeks prior to the onset of menses. The mean duration of PMDD symptoms was approximately 10.5 years in both studies. Patients taking oral contraceptives were excluded from these trials; therefore, the efficacy of ZOLOFT in combination with oral contraceptives for the treatment of PMDD is unknown.
Efficacy was assessed with the Daily Record of Severity of Problems (DRSP), a patient-rated instrument that mirrors the diagnostic criteria for PMDD as identified in the DSM-IV, and includes assessments for mood, physical symptoms, and other symptoms. Other efficacy assessments included the Hamilton Rating Scale for Depression (HAMD-17), and the Clinical Global Impression Severity of Illness (CGI-S) and Improvement (CGI-I) scores.
- In Study PMDD-1, involving 251 randomized patients, (n=125 on ZOLOFT and n=126 on placebo), ZOLOFT treatment was initiated at 50 mg/day and administered daily throughout the menstrual cycle. In subsequent cycles, ZOLOFT was titrated in 50 mg increments at the beginning of each menstrual cycle up to a maximum of 150 mg/day on the basis of clinical response and tolerability. The mean dose for completers was 102 mg/day. ZOLOFT administered daily throughout the menstrual cycle was statistically significantly more effective than placebo on change from baseline to endpoint on the DRSP total score, the HAMD-17 total score, and the CGI-S score, as well as the CGI-I score at endpoint.
- In Study PMDD-2, involving 281 randomized patients, (n=142 on ZOLOFT and n=139 on placebo), ZOLOFT treatment was initiated at 50 mg/day in the late luteal phase (last 2 weeks) of each menstrual cycle and then discontinued at the onset of menses (intermittent dosing). In subsequent cycles, patients were dosed in the range of 50–100 mg/day in the luteal phase of each cycle, on the basis of clinical response and tolerability. Patients who received 100 mg/day started with 50 mg/day for the first 3 days of the cycle, then 100 mg/day for the remainder of the cycle. The mean ZOLOFT dose for completers was 74 mg/day. ZOLOFT administered in the late luteal phase of the menstrual cycle was statistically significantly more effective than placebo on change from baseline to endpoint on the DRSP total score and the CGI-S score, as well as the CGI-I score at endpoint (Week 12).
There was insufficient information to determine the effect of race or age on outcome in these studies.
ZOLOFT 25 mg tablets: 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|
|NDC 0049-4960-50||Bottles of 50|
ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with “50 mg”
|NDC 0049-4900-30||Bottles of 30|
|NDC 0049-4900-66||Bottles of 100|
|NDC 0049-4900-73||Bottles of 500|
|NDC 0049-4900-94||Bottles of 5000|
|NDC 0049-4900-41||Unit Dose Packages of 100|
ZOLOFT 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with “100 mg”
|NDC 0049-4910-30||Bottles of 30|
|NDC 0049-4910-66||Bottles of 100|
|NDC 0049-4910-73||Bottles of 500|
|NDC 0049-4910-94||Bottles of 5000|
|NDC 0049-4910-41||Unit Dose Packages of 100|
ZOLOFT oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol
|NDC 0049-0050-01||Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.|
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].
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 during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1)] .
Important Administration Instructions for Oral Solution
For patients prescribed ZOLOFT oral solution, inform them that:
- ZOLOFT oral solution must be diluted before use. Do not mix in advance.
- Use the dropper provided to remove the required amount of ZOLOFT oral solution and mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix ZOLOFT oral solution with anything other than the liquids listed.
- Take the dose immediately after mixing. At times, a slight haze may appear after mixing; this is normal.
- The dropper dispenser contains dry natural rubber, a consideration for patients with latex sensitivity.
Disulfiram Contraindication for ZOLOFT Oral Solution
Inform patients not to take disulfiram when taking ZOLOFT oral solution. Concomitant use is contraindicated due the alcohol content of the oral solution [See Contraindication (4)] .
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of ZOLOFT with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] .
Increased Risk of Bleeding
Inform patients about the concomitant use of ZOLOFT with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3)].
Activation of Mania/Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them
to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4)] .
Advise patients not to abruptly discontinue ZOLOFT and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when ZOLOFT is discontinued [See Warnings and Precautions (5.5)].
Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2)] .
Inform pregnant women that ZOLOFT may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)] .
This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.
|This Medication Guide has been approved by the U.S. Food and Drug Administration|
|Medication Guide ZOLOFT (ZOH-loft) (sertraline hydrochloride) Tablets and Oral Solution|
|What is the most important information I should know about ZOLOFT? ZOLOFT and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.|
|Do not stop ZOLOFT without first talking to your healthcare provider. Stopping ZOLOFT too quickly may cause serious symptoms including:|
|What is ZOLOFT? ZOLOFT is a prescription medicine used to treat:|
|It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. ZOLOFT is safe and effective in treating children with OCD age 6 to 17 years. It is not known if ZOLOFT is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions. Talk to your healthcare provider if you do not think that your condition is getting better with ZOLOFT treatment.|
|Who should not take ZOLOFT? Do not take ZOLOFT if you:|
|People who take ZOLOFT close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:|
|What should I tell my healthcare provider before taking ZOLOFT? Before starting ZOLOFT, tell your healthcare provider: |
|Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZOLOFT and some medicines may interact with each other, may not work as well, or may cause serious side effects. Your healthcare provider or pharmacist can tell you if it is safe to take ZOLOFT with your other medicines. Do not start or stop any medicine while taking ZOLOFT without talking to your healthcare provider first.|
|How should I take ZOLOFT? |
|If you take too much ZOLOFT, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.|
|What should I avoid while taking ZOLOFT? ZOLOFT can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZOLOFT affects you. Do not drink alcohol while you take ZOLOFT.|
|What are the possible side effects of ZOLOFT? ZOLOFT may cause serious side effects, including:
|The most common side effects in adults who take ZOLOFT include:|
|The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with ZOLOFT. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZOLOFT. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.|
|How should I store ZOLOFT? |
|Keep ZOLOFT and all medicines out of the reach of children.|
|General information about the safe and effective use of ZOLOFT Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZOLOFT for a condition for which it was not prescribed. Do not give ZOLOFT to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ZOLOFT. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about ZOLOFT that is written for healthcare professionals. For more information about ZOLOFT call 1-800-438-1985 or go to www.pfizer.com|
|What are the ingredients in ZOLOFT? Active ingredient: sertraline hydrochloride Inactive ingredients: Tablets: dibasic calcium phosphate dihydrate, D&C Yellow #10 aluminum lake (in 25 mg tablet), FD&C Blue #1 aluminum lake (in 25 mg tablet), FD&C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide . Oral solution: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)|
LAB-0540-9.0 Revised January 2018
GENERIC: sertraline hydrochloride
DOSAGE: TABLET, FILM COATED
SCORE: Two even pieces
SIZE: 10 mm
PACKAGING: 30 in 1 BLISTER PACK
- SERTRALINE HYDROCHLORIDE 50mg in 1
- ALUMINUM OXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 80
- TITANIUM DIOXIDE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C BLUE NO. 2
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
|ZOLOFT sertraline hydrochloride tablet, film coated|
|Labeler — REMEDYREPACK INC. (829572556)|
Revised: 11/2019 REMEDYREPACK INC.
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