Ziprasidone Hydrochloride (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ziprasidone hydrochloride capsules are differentiated by capsule color/size and are imprinted in black ink with “APO ZIP” and a unique number. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (purple/white), 40 mg (purple/purple). They are supplied in the following strengths and package configurations:

20MG:

NDC 63187-448-30 Bottle of 30

NDC 63187-448-60 Bottle of 60

NDC 63187-448-90 Bottle of 90

40MG

NDC 63187-431-30 Bottle of 30

NDC 63187-431-60 Bottle of 60

NDC 63187-431-90 Bottle of 90

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.4).

Please refer to the patient package insert. To assure safe and effective use of ziprasidone hydrochloride capsules, the information and instructions provided in the patient information should be discussed with patients.

17.1 Administration with Food

Patients should be instructed to take ziprasidone hydrochloride capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Drug Interactions (7.8) and Clinical Pharmacology (12.3)].

17.2 QTc Prolongation

Patients should be advised 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 (5.2)].

Patients should be instructed 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, patients should be instructed to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.2)].

17.3 DRESS

Patients should be instructed 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) [see Warnings and Precautions (5.4)].

17.4 FDA-Approved Patient Labeling

Maalox® is a Registered Trademark of Novartis Consumer Health Inc.

APOTEX INC.
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, 40 mg

Manufactured by

Manufactured for

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, Florida

Canada M9L 1T9

33326

Revised: December 2014
Revision: 9

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

PATIENT SUMMARY OF INFORMATION ABOUT

Ziprasidone Hydrochloride Capsules

(zi pras’ i done hye” droe klor” ide)

Information for patients taking ziprasidone hydrochloride capsules or their caregivers

This summary contains important information about ziprasidone hydrochloride capsules. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you take ziprasidone hydrochloride capsules. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about ziprasidone hydrochloride capsules.

What are ziprasidone hydrochloride capsules?

Ziprasidone hydrochloride capsules are a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. Ziprasidone hydrochloride capsules can be used to treat symptoms of schizophrenia.

Who should take ziprasidone hydrochloride capsules?

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

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

If you show a response to ziprasidone hydrochloride capsules, your symptoms may improve. If you continue to take ziprasidone hydrochloride 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 hydrochloride capsules should be taken with food.

What is the most important safety information I should know about ziprasidone hydrochloride capsules?

Ziprasidone hydrochloride 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 hydrochloride capsule is an effective drug to treat the symptoms of schizophrenia. 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 hydrochloride capsules should be used only after your doctor has considered this risk for ziprasidone hydrochloride capsules against the risks and benefits of other medications available for treating schizophrenia.

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 hydrochloride capsules?

Elderly patients with a diagnosis of psychosis related to dementia. Ziprasidone hydrochloride capsules are 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 hydrochloride 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 hydrochloride capsules

Only your doctor can decide if ziprasidone hydrochloride capsules are right for you. Before you start ziprasidone hydrochloride capsules, 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
are allergic to any medicines
have ever had an allergic reaction to ziprasidone or any of the other ingredients of ziprasidone hydrochloride 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 hydrochloride capsules are an appropriate treatment for you.

Ziprasidone Hydrochloride Capsules And Other Medicines

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

How to take ziprasidone hydrochloride capsules

Take ziprasidone hydrochloride capsules only as directed by your doctor.
Swallow the capsules whole.
Take ziprasidone hydrochloride capsules with food.
It is best to take ziprasidone hydrochloride capsules at the same time each day.
Ziprasidone hydrochloride 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 hydrochloride 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 hydrochloride 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. DRESS is 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 hydrochloride capsules, and it is not known if ziprasidone hydrochloride 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 hydrochloride 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 hydrochloride capsules, tell your doctor if you are pregnant or plan on becoming pregnant. It is advised that you don’t breast feed an infant if you are taking ziprasidone hydrochloride capsules.

Because ziprasidone hydrochloride capsules can cause sleepiness, be careful when operating machinery or driving a motor vehicle.

Since medications of the same drug class as ziprasidone hydrochloride 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 hydrochloride capsules.

Call your doctor immediately if you take more than the amount of ziprasidone hydrochloride capsules prescribed by your doctor.

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

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

How to store ziprasidone hydrochloride capsules

Store ziprasidone hydrochloride capsules at room temperature (59° to 86°F or 15° to 30°C).

For More Information About Ziprasidone Hydrochloride Capsules

This sheet is only a summary. Ziprasidone hydrochloride 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 hydrochloride capsules, talk with your doctor or pharmacist.


APOTEX INC.
ZIPRASIDONE HYDROCHLORIDE CAPSULES
20 mg, 40 mg


Manufactured by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida Canada M9L 1T9 33326

Revised: December 2014

Revision: 9

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL — 20 mg BOTTLE

63187-448-30

Ziprasidone Hydrochloride Capsules

20 mg

Rx

30 bottle count

63187-448-30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg BOTTLE

NDC 63187-431-60

Ziprasidone Hydrochloride Capsules

40 mg

Rx

60 bottle count

63187-431-60
(click image for full-size original)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-448(NDC:60505-2528)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
AMMONIA
FERROSOFERRIC OXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PURPLE (purple body) , WHITE (white cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;ZIP;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-448-30 30 CAPSULE in 1 BOTTLE None
2 NDC:63187-448-60 60 CAPSULE in 1 BOTTLE None
3 NDC:63187-448-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-431(NDC:60505-2529)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
AMMONIA
FERROSOFERRIC OXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PURPLE (purple body) , PURPLE (purple cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code APO;ZIP;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-431-30 30 CAPSULE in 1 BOTTLE None
2 NDC:63187-431-60 60 CAPSULE in 1 BOTTLE None
3 NDC:63187-431-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-431), REPACK (63187-448), RELABEL (63187-431), RELABEL (63187-448)

Revised: 01/2021 Proficient Rx LP

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