SERTRALINE HYDROCHLORIDE: Package Insert and Label Information (Page 6 of 6)

14.6 Premenstrual Dysphoric Disorder

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC: 71335-1078-1: 30 Tablets in a BOTTLE

NDC: 71335-1078-2: 60 Tablets in a BOTTLE

NDC: 71335-1078-3: 90 Tablets in a BOTTLE

NDC: 71335-1078-4: 180 Tablets in a BOTTLE

NDC: 71335-1078-5: 28 Tablets in a BOTTLE

NDC: 71335-1078-6: 120 Tablets in a BOTTLE

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 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)] .

Serotonin Syndrome

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)] .

Discontinuation Syndrome

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)].

Allergic Reactions

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)] .

Pregnancy

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.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad-380 054,
India.

10 0223 4 6004614 Issued October 2020

Medication Guide Sertraline Hydrochloride Tablets (ser′ tra leen hye″ droe klor′ ide)
What is the most important information I should know about sertraline hydrochloride tablets? Sertraline hydrochloride tablets 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. 1. Suicidal thoughts or actions: Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline hydrochloride tablets are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
attempts to commit suicide acting aggressive or violent new or worse depression feeling agitated, restless, angry or irritable an increase in activity or talking more than what is normal for you		acting on dangerous impulses thoughts about suicide or dying new or worse anxiety or panic attacks trouble sleeping other unusual changes in behavior or mood
2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include:
agitation, hallucinations, coma, or other changes in mental status racing heartbeat, high or low blood pressure coordination problems or muscle twitching (overactive reflexes)		nausea, vomiting, or diarrhea sweating or fever muscle rigidity
3. Increased chance of bleeding: Sertraline hydrochloride tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 4. Manic episodes. Symptoms may include:
greatly increased energy racing thoughts unusually grand ideas	severe trouble sleeping reckless behavior		excessive happiness or irritability talking more or faster than usual
5. Seizures or convulsions. 6. Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline hydrochloride tablets may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment. 8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
headache	weakness or feeling unsteady		confusion, problems concentrating or thinking, memory problems
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or changes in sleep habits headache, sweating, nausea, dizziness electric shock-like sensations, shaking, confusion
What are sertraline hydrochloride tablets? Sertraline hydrochloride tablets are prescription medicines used to treat:
Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD)		Obsessive Compulsive Disorder (OCD) Post-Traumatic Stress Disorder (PTSD) Premenstrual Dysphoric Disorder (PMDD)
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. Sertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years. It is not known if sertraline hydrochloride tablets are 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 sertraline hydrochloride tablets treatment.
Who should not take sertraline hydrochloride tablets? Do not take sertraline hydrochloride tablets if you: take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. have taken an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your healthcare provider. have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride). take the antipsychotic medicine pimozide (Orap ®) because this can cause serious heart problems. are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets. People who take sertraline hydrochloride tablets 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:
high fever rapid changes in heart rate or blood pressure	uncontrolled muscle spasms confusion		stiff muscles loss of consciousness (pass out)
What should I tell my healthcare provider before taking sertraline hydrochloride tablets? Before starting sertraline hydrochloride tablets, tell your healthcare provider:
liver problems heart problems bipolar disorder or mania	kidney problems. or have had seizures or convulsions low sodium levels in your blood		a history of a stroke high blood pressure or have had bleeding problems
are pregnant or plan to become pregnant. Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride tablets during pregnancy. are breastfeeding or plan to breastfeed. A small amount of sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sertraline hydrochloride tablets 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 sertraline hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.
How should I take sertraline hydrochloride tablets? Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you. Sertraline hydrochloride tablets may be taken with or without food. If you miss a dose of sertraline hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline hydrochloride tablets at the same time. If you take too much sertraline hydrochloride tablets, 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 sertraline hydrochloride tablets? Sertraline hydrochloride tablets 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 sertraline hydrochloride tablets affect you. Do not drink alcohol while you take sertraline hydrochloride tablets.
What are the possible side effects of sertraline hydrochloride tablets? Sertraline hydrochloride tablets may cause serious side effects, including: See “What is the most important information I should know about sertraline hydrochloride tablets?” The most common side effects in adults who take sertraline hydrochloride tablets include:
nausea, loss of appetite, diarrhea, or indigestion increased sweating tremor or shaking agitation		change in sleep habits including increased sleepiness or insomnia sexual problems including decreased libido and ejaculation failure feeling tired or fatigued anxiety
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 sertraline hydrochloride tablets. 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 sertraline hydrochloride tablets. 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 sertraline hydrochloride tablets? Store sertraline hydrochloride tablets at room temperature, 68°F to 77°F (20°C to 25°C). Keep sertraline hydrochloride tablets bottle closed tightly. Keep sertraline hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of sertraline hydrochloride tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which they were not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. They may harm them. This Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals. For more information, go to www.accordhealthcare.us or call Accord Healthcare at 1-866-941-7875.
What are the ingredients in sertraline hydrochloride tablets? Active ingredient: sertraline hydrochloride Inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 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, iron oxide yellow (in 100 mg tablet), and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

^® The brands listed are trademarks of their respective owners.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad-380 054,
India.

10 0223 4 6004614 Issued October 2020

Sertraline Hcl 25mg Tablet

SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1078(NDC:16729-215) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 25 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE POLYSORBATE 80 D&C YELLOW NO. 10 FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE (90000 WAMW)

Product Characteristics Color green (light green) Score 2 pieces Shape ROUND (Biconvex) Size 6mm Flavor Imprint Code S1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71335-1078-1 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:71335-1078-2 60 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:71335-1078-3 90 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:71335-1078-4 180 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:71335-1078-5 28 TABLET, FILM COATED in 1 BOTTLE None 6 NDC:71335-1078-6 120 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202825 02/09/2017

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK (71335-1078), RELABEL (71335-1078)

Revised: 03/2023 Bryant Ranch Prepack