Ziprasidone Hydrochloride (Page 8 of 9)

14.2 Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)

Acute Manic and Mixed Episodes Associated with Bipolar I Disorder
The efficacy of ziprasidone was established in 2 placebo-controlled, double-blind, 3-week monotherapy studies in patients meeting DSM-IV criteria for bipolar I disorder, manic or mixed episode with or without psychotic features. Primary rating instruments used for assessing manic symptoms in these trials were: (1) the Mania Rating Scale (MRS), which is derived from the Schedule for Affective Disorders and Schizophrenia-Change Version (SADS-CB) with items grouped as the Manic Syndrome subscale (elevated mood, less need for sleep, excessive energy, excessive activity, grandiosity), the Behavior and Ideation subscale (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment) and impaired insight; and (2) the Clinical Global Impression-Severity of Illness Scale (CGI-S), which was used to assess the clinical significance of treatment response.

The results of the oral ziprasidone trials in adult bipolar I disorder, manic/mixed episode follow: in a 3-week placebo-controlled trial (n=210), the dose of ziprasidone was 40 mg twice daily on Day 1 and 80 mg twice daily on Day 2. Titration within the range of 40-80 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of the study. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. The mean daily dose of ziprasidone in this study was 132 mg. In a second 3-week placebo-controlled trial (n=205), the dose of ziprasidone was 40 mg twice daily on Day 1. Titration within the range of 40-80 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of study (beginning on Day 2). Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. The mean daily dose of ziprasidone in this study was 112 mg.

Maintenance Therapy
The efficacy of ziprasidone as adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder was established in a placebo-controlled trial in patients who met DSM-IV criteria for bipolar I disorder. The trial included patients whose most recent episode was manic or mixed, with or without psychotic features. In the open-label phase, patients were required to be stabilized on ziprasidone plus lithium or valproic acid for at least 8 weeks in order to be randomized. In the double-blind randomized phase, patients continued treatment with lithium or valproic acid and were randomized to receive either ziprasidone (administered twice daily totaling 80 mg to 160 mg per day) or placebo. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. The primary endpoint in this study was time to recurrence of a mood episode (manic, mixed or depressed episode) requiring intervention, which was defined as any of the following: discontinuation due to a mood episode, clinical intervention for a mood episode (e.g., initiation of medication or hospitalization), or Mania Rating Scale score≥18 or a MADRS score≥18 (on 2 consecutive assessments no more than 10 days apart). A total of 584 subjects were treated in the open-label stabilization period. In the double-blind randomization period, 127 subjects were treated with ziprasidone, and 112 subjects were treated with placebo. Ziprasidone was superior to placebo in increasing the time to recurrence of a mood episode. The types of relapse events observed included depressive, manic, and mixed episodes. Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5420

NDC: 50090-5420-0 60 CAPSULE in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Administration with Food
Instruct patients to take ziprasidone capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Drug Interactions (7.10) and Clinical Pharmacology (12.3)].

QTc Prolongation
Advise patients to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see Contraindications (4.1) and Warnings and Precautions (5.3)].

Instruct patients to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. In addition, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.3) ].

Severe Cutaneous Adverse Reactions
Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome [see Warnings and Precautions (5.5) ].
Pregnancy
Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Ziprasidone capsules. Advise patients that Ziprasidone capsules may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Ziprasidone capsules during pregnancy [see Use in Specific Populations (8.1)].

Lactation
Advise breastfeeding women using Ziprasidone capsules to monitor infants for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors, and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Infertility
Advise females of reproductive potential that Ziprasidone capsules may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Warnings and Precautions (5.15) and Use in Specific Populations (8.3)].

The brand mentioned is trademark of its respective owner and are not trademark Macleods pharmaceuticals Ltd.

SPL PATIENT PACKAGE INSERT SECTION


PATIENT SUMMARY OF INFORMATION ABOUT
ZIPRASIDONE CAPSULES
(zi pras’ i done)
Information for patients taking ziprasidone capsules or their caregivers
This summary contains important information about ziprasidone capsules. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you take ziprasidone capsules. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about ziprasidone capsules.
What are ziprasidone capsules?

Ziprasidone capsules is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. Ziprasidone capsules can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Ziprasidone capsules can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate.
Who Should Take Ziprasidone Capsules?

Only your doctor can know if ziprasidone capsules are right for you. Ziprasidone capsules may be prescribed for you if you have schizophrenia or bipolar disorder.

Symptoms of schizophrenia may include:

• hearing voices, seeing things, or sensing things that are not there (hallucinations)
• beliefs that are not true (delusions)
• unusual suspiciousness (paranoia)
• becoming withdrawn from family and friends

Symptoms of manic or mixed episodes of bipolar disorder may include:

• extremely high or irritable mood
• increased energy, activity, and restlessness
• racing thoughts or talking very fast
• easily distracted
• little need for sleep

If you show a response to ziprasidone capsules, your symptoms may improve. If you continue to take ziprasidone capsules there is less chance of your symptoms returning. Do not stop taking the capsules even when you feel better without first discussing it with your doctor.

It is also important to remember that ziprasidone capsules should be taken with food.
What is the most important safety information I should know about ziprasidone capsules?

Ziprasidone capsules are not approved for the treatment of patients with dementia-related psychosis. Elderly patients with a diagnosis of psychosis related to dementia treated with antipsychotics are at an increased risk of death when compared to patients who are treated with placebo (a sugar pill).

Ziprasidone capsule is an effective drug to treat the symptoms of schizophrenia and the manic or mixed episodes of bipolar disorder. However, one potential side effect is that it may change the way the electrical current in your heart works more than some other drugs. The change is small and it is not known whether this will be harmful, but some other drugs that cause this kind of change have in rare cases caused dangerous heart rhythm abnormalities. Because of this, ziprasidone capsules should be used only after your doctor has considered this risk for ziprasidone capsules against the risks and benefits of other medications available for treating schizophrenia or bipolar manic and mixed episodes.

Your risk of dangerous changes in heart rhythm can be increased if you are taking certain other medicines and if you already have certain abnormal heart conditions. Therefore, it is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines. You must also tell your doctor about any heart problems you have or have had.

Who should NOT take ziprasidone capsules?

Elderly patients with a diagnosis of psychosis related to dementia. Ziprasidone capsule is not approved for the treatment of these patients.

Anything that can increase the chance of a heart rhythm abnormality should be avoided. Therefore, do not take ziprasidone capsules if:

• You have certain heart diseases, for example, long QT syndrome, a recent heart attack, severe heart failure, or certain irregularities of heart rhythm (discuss the specifics with your doctor)
• You are currently taking medications that should not be taken in combination with ziprasidone, for example, dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
What To Tell Your Doctor Before You Start Ziprasidone Capsules
Only your doctor can decide if ziprasidone capsule is right for you. Before you start ziprasidone capsule, be sure to tell your doctor if you:

• have had any problem with the way your heart beats or any heart related illness or disease
• any family history of heart disease, including recent heart attack
• have had any problem with fainting or dizziness
• are taking or have recently taken any prescription medicines
• are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
• have had any problems with your liver
• are pregnant, might be pregnant, or plan to get pregnant
• are breast feeding or plan to breastfeed
• are allergic to any medicines
• have ever had an allergic reaction to ziprasidone or any of the other ingredients of ziprasidone capsules. Ask your doctor or pharmacist for a list of these ingredients
• have low levels of potassium or magnesium in your blood
Your doctor may want you to get additional laboratory tests to see if ziprasidone capsules are an appropriate treatment for you.

Ziprasidone Capsules And Other Medicines

There are some medications that may be unsafe to use when taking ziprasidone capsules, and there are some medicines that can affect how well ziprasidone capsules works. While you are on ziprasidone capsules, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies.

How To Take Ziprasidone Capsules

• Take ziprasidone capsules only as directed by your doctor.
• Swallow the capsules whole.
• Take ziprasidone capsules with food.
• It is best to take ziprasidone capsules at the same time each day.
• Ziprasidone capsules may take a few weeks to work. It is important to be patient.
• Do not change your dose or stop taking your medicine without your doctor’s approval.
• Remember to keep taking your capsules, even when you feel better.
Possible Side Effects

Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you:

• Faint or lose consciousness
• Feel a change in the way that your heart beats (palpitations)

Common side effects of ziprasidone capsules include the following and should also be discussed with your doctor if they occur:

• Feeling unusually tired or sleepy
• Nausea or upset stomach
• Constipation
• Dizziness
• Restlessness
• Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
• Diarrhea
• Rash
• Increased cough / runny nose

If you develop any side effects that concern you, talk with your doctor. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts after such illnesses.
For a list of all side effects that have been reported, ask your doctor or pharmacist for the ziprasidone hydrochloride capsules Professional Package Insert.

What To Do For An Overdose

In case of an overdose, call your doctor or poison control center right away or go to the nearest emergency room.

Other Important Safety Information

A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including ziprasidone capsules. Signs of NMS include very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. NMS is a rare but serious side effect that could be fatal. Therefore, tell your doctor if you experience any of these signs.
Delayed-onset drug reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.

Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with ziprasidone capsules, and it is not known if ziprasidone capsules are associated with these reactions. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
Dizziness caused by a drop in your blood pressure may occur with ziprasidone capsules, especially when you first start taking this medication or when the dose is increased. If this happens, be careful not to stand up too quickly, and talk to your doctor about the problem.
Before taking ziprasidone capsules, tell your doctor
• are pregnant or plan on becoming pregnant.
o If you become pregnant while receiving ziprasidone capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• are breastfeeding or plan to breastfeed. Ziprasidone capsules can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive ziprasidone capsules.
Because ziprasidone capsules can cause sleepiness, be careful when operating machinery or driving a motor vehicle.
Since medications of the same drug class as ziprasidone capsules may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity.
It is best to avoid consuming alcoholic beverages while taking ziprasidone capsules.
Call your doctor immediately if you take more than the amount of ziprasidone capsules prescribed by your doctor.

Ziprasidone capsules has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.

Keep ziprasidone capsules and all medicines out of the reach of children.

How To Store Ziprasidone Capsules

Store ziprasidone capsules at 20°C to 25°C (68°F to 77°F); excursions permitted up to 15°C to 30° (59°F to 86°F).

For More Information About Ziprasidone Capsules
This sheet is only a summary. Ziprasidone capsules are a prescription medicine and only your doctor can decide if it is right for you. If you have any questions or want more information about ziprasidone capsules, talk with your doctor or pharmacist.

Manufactured for:
Macleods Pharma USA, Inc.
Plainsboro, NJ08536

Manufactured by:
Macleods Pharmaceuticals Limited
Daman (U.T.), INDIARevision May 2020

PM02474705

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