The effectiveness of sertraline hydrochloride 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 sertraline hydrochloride 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 sertraline hydrochloride 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 sertraline hydrochloride and n=126 on placebo), sertraline hydrochloride treatment was initiated at 50 mg/day and administered daily throughout the menstrual cycle. In subsequent cycles, sertraline hydrochloride 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. Sertraline hydrochloride 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 sertraline hydrochloride and n=139 on placebo), sertraline hydrochloride 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 mg to 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 sertraline hydrochloride dose for completers was 74 mg/day. Sertraline hydrochloride 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.
Sertraline hydrochloride tablets, USP having functional scoring containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline, are supplied as.
25 mg: light green to green colored, round, biconvex, film coated tablets, debossed with “S1” on one side and breakline on other side.
NDC 16729-215-10 Bottles of 30’s count with child-resistant closure
NDC 16729-215-11 Bottles of 50’s count with child-resistant closure
NDC 16729-215-15 Bottles of 90’s count with child-resistant closure
NDC 16729-215-43 Unit Dose Packages of 100’s count
NDC 16729-215-16 Bottles of 500’s count
50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side.
NDC 16729-216-10 Bottles of 30’s count with child-resistant closure
NDC 16729-216-15 Bottles of 90’s count with child-resistant closure
NDC 16729-216-01 Bottles of 100’s count with child-resistant closure
NDC 16729-216-16 Bottles of 500’s count with child-resistant closure
NDC 16729-216-43 Unit Dose Packages of 100’s count
100 mg: yellow colored, round biconvex, film coated tablets, debossed with “S3” on one side and breakline on other side.
NDC 16729-217-10 Bottles of 30’s count with child-resistant closure
NDC 16729-217-15 Bottles of 90’s count with child-resistant closure
NDC 16729-217-01 Bottles of 100’s count with child-resistant closure
NDC 16729-217-16 Bottles of 500’s count with child-resistant closure
NDC 16729-217-43 Unit Dose Packages of 100’s count
Store at 25°C (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)] .
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride tablets 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 sertraline hydrochloride tablets 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 sertraline hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride tablets are 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 sertraline hydrochloride tablets may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)] .
® The brands listed are trademarks of their respective owners.
Accord Healthcare, Inc.,
1009 Slater Road,
Durham, NC 27703,
Intas Pharmaceuticals Limited,
10 0223 4 6004614 Issued October 2020
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