Taztia XT

Name: Taztia XT

What should I discuss with my healthcare provider before taking Taztia XT (diltiazem)?

You should not use diltiazem if you are allergic to it, or if you have:

  • a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

  • very low blood pressure; or

  • if you have recently had a heart attack and you have a build-up of fluid in your lungs.

To make sure diltiazem is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • congestive heart failure; or

  • if you also take digoxin, or a beta blocker (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Diltiazem can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Proper Use of diltiazem

This section provides information on the proper use of a number of products that contain diltiazem. It may not be specific to Taztia XT. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended-release tablet, extended-release capsule, or tablet whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For chest pain:
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 120 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 180 milligrams (mg) once a day, either in the morning or evening. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
      • Children—Use and dose must be determined by your doctor.
  • For high blood pressure:
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 180 to 240 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 180 to 240 milligrams (mg) once a day, either in the morning or at bedtime. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Taztia XT

  • It is used to treat high blood pressure.
  • It is used to treat chest pain or pressure.
  • It may be given to you for other reasons. Talk with the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Taztia XT, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Taztia XT. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Taztia XT.

Review Date: October 4, 2017

Indications and Usage for Taztia XT

Hypertension

Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Chronic Stable Angina

Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of chronic stable angina.

Adverse Reactions

Serious adverse reactions have been rare in studies with diltiazem hydrochloride extended-release capsules USP (once-a-day dosage), as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) ranging from 120 to 540 mg once daily. Two patients experienced first-degree AV block at the 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS*

Adverse
Events
(COSTART
Term)

Placebo
n=57
# pts (%)

Diltiazem Hydrochloride
Extended-Release
Capsules USP
(Once-a-Day Dosage)

Up to 360 mg
n = 149
# pts (%)

480-540 mg
n = 48
# pts (%)

edema,
peripheral

1 (2)

8 (5)

7 (15)

dizziness

4 (7)

6 (4)

2 (4)

vasodilation

1 (2)

5 (3)

1 (2)

dyspepsia

0 (0)

7 (5)

0 (0)

pharyngitis

2 (4)

3 (2)

3 (6)

rash

0 (0)

3 (2)

0 (0)

infection

2 (4)

2 (1)

3 (6)

diarrhea

0 (0)

2 (1)

1 (2)

palpitations

0 (0)

2 (1)

1 (2)

nervousness

0 (0)

3 (2)

0 (0)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS*

Adverse
Events
(COSTART
Term)

Placebo

Diltiazem Hydrochloride
Extended-Release
Capsules USP
(Once-a-Day Dosage)

n = 50
# pts (%)

Up to 360 mg
n = 158
# pts (%)

540 mg
n = 49
# pts (%)

headache

1 (2)

13 (8)

4 (8)

edema,
peripheral

1 (2)

3 (2)

5 (10)

pain

1 (2)

10 (6)

3 (6)

dizziness

0 (0)

5 (3)

5 (10)

asthenia

0 (0)

1 (1)

2 (4)

dyspepsia

0 (0)

2 (1)

3 (6)

dyspnea

0 (0)

1 (1)

3 (6)

bronchitis

0 (0)

1 (1)

2 (4)

AV block

0 (0)

0 (0)

2 (4)

infection

0 (0)

2 (1)

1 (2)

flu syndrome

0 (0)

0 (0)

1 (2)

cough increase

0 (0)

2 (1)

1 (2)

extrasystoles

0 (0)

0 (0)

1 (2)

gout

0 (0)

2 (1)

1 (2)

myalgia

0 (0)

0 (0)

1 (2)

impotence

0 (0)

0 (0)

1 (2)

conjunctivitis

0 (0)

0 (0)

1 (2)

rash

0 (0)

2 (1)

1 (2)

abdominal
enlargement

0 (0)

0 (0)

1 (2)

*Adverse events occurring in treated patients at 2% or more than placebo-treated patients.

In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:

Cardiovascular

Angina, arrhythmia, AV block (second-or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System

Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal

Anorexia, constipation, diarrhea, dry mouth, dysgeusia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury), nausea, thirst, vomiting, weight increase.

Dermatological

Petechiae, photosensitivity, pruritus.

Other

Albuminuria, allergic reaction, amblyopia, asthenia, CPK increase, crystalluria, dyspnea, edema, epistaxis, eye irritation, headache, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, neck rigidity, nocturia, osteoarticular pain, pain, polyuria, rhinitis, sexual difficulties, gynecomastia.

In addition, the following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), leukopenia, purpura, retinopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at       1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

PRINCIPAL DISPLAY PANEL - 180mg

NDC 62037-697-30

Taztia XT®
(diltiazem HCI extended-
release capsules, USP)
ONCE-A-DAY DOSAGE

180 mg

Watson® 30 Capsules Rx only

Each capsule contains:
Diltiazem Hydrochloride USP, 180 mg

Usual dosage: Administer once daily,
see insert for full prescribing information.

Dispense in tight containers with
safety closures.

Store at controlled room temperature,
20º-25ºC (68º-77ºF). [See USP.]

Keep this and all medication out of the
reach of children.

Manufactured By:
Watson Laboratories, Inc.
Corona, CA 92880 USA                7094 (03/08)

Distributed By:
Watson Pharma, Inc.

PRINCIPAL DISPLAY PANEL - 360mg

NDC 62037-700-30

Taztia XT®
(diltiazem HCI extended-
release capsules, USP)
ONCE-A-DAY DOSAGE

360 mg

Watson® 30 Capsules Rx only

Each capsule contains:
Diltiazem Hydrochloride USP, 360 mg

Usual dosage: Administer once daily,
see insert for full prescribing information.

Dispense in tight containers with
safety closures.

Store at controlled room temperature,
20º-25ºC (68º-77ºF). [See USP.]

Keep this and all medication out of the
reach of children.

Manufactured By:
Watson Laboratories, Inc.
Corona, CA 92880 USA                7100 (03/08)

Distributed By:
Watson Pharma, Inc.

TAZTIA  XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62037-696
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
ETHYLCELLULOSE (10 MPA.S)  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
ALUMINUM OXIDE  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
MAGNESIUM STEARATE  
NONOXYNOL-100  
POLYSORBATE 80  
POVIDONE  
PROPYLENE GLYCOL  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
D&C RED NO. 28  
SHELLAC  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)  
HYPROMELLOSE 2910 (5 MPA.S)  
Product Characteristics
Color PINK (pink opaque) , PINK (pink opaque) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code Andrx;696;120;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:62037-696-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:62037-696-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
3 NDC:62037-696-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
4 NDC:62037-696-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
TAZTIA  XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62037-697
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
ETHYLCELLULOSE (10 MPA.S)  
D&C YELLOW NO. 10  
ALUMINUM OXIDE  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GELATIN  
HYPROMELLOSE 2910 (5 MPA.S)  
MAGNESIUM STEARATE  
NONOXYNOL-100  
SHELLAC  
POLYSORBATE 80  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)  
POVIDONE  
PROPYLENE GLYCOL  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (light blue opaque) , BROWN (buff opaque) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code Andrx;697;180;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:62037-697-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:62037-697-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
3 NDC:62037-697-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
4 NDC:62037-697-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
TAZTIA  XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62037-698
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
ETHYLCELLULOSE (10 MPA.S)  
D&C RED NO. 28  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
HYPROMELLOSE 2910 (5 MPA.S)  
MAGNESIUM STEARATE  
NONOXYNOL-100  
SHELLAC  
POLYSORBATE 80  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)  
POVIDONE  
PROPYLENE GLYCOL  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
ALUMINUM OXIDE  
Product Characteristics
Color PINK (pink opaque) , BLUE (light blue) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code Andrx;698;240;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:62037-698-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:62037-698-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
3 NDC:62037-698-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
4 NDC:62037-698-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
TAZTIA  XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62037-699
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
ETHYLCELLULOSE (10 MPA.S)  
D&C RED NO. 28  
D&C YELLOW NO. 10  
ALUMINUM OXIDE  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GELATIN  
HYPROMELLOSE 2910 (5 MPA.S)  
MAGNESIUM STEARATE  
NONOXYNOL-100  
SHELLAC  
POLYSORBATE 80  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)  
POVIDONE  
PROPYLENE GLYCOL  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color PINK (pink opaque) , BROWN (buff opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code Andrx;699;300;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:62037-699-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:62037-699-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
3 NDC:62037-699-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
4 NDC:62037-699-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
TAZTIA  XT
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62037-700
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 360 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
ETHYLCELLULOSE (10 MPA.S)  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
HYPROMELLOSE 2910 (5 MPA.S)  
MAGNESIUM STEARATE  
NONOXYNOL-100  
SHELLAC  
POLYSORBATE 80  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)  
POVIDONE  
PROPYLENE GLYCOL  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
ALUMINUM OXIDE  
Product Characteristics
Color BLUE (light blue opaque) , BLUE (light blue opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code Andrx;700;360;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:62037-700-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:62037-700-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
3 NDC:62037-700-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
4 NDC:62037-700-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075401 04/10/2003
Labeler - Actavis Pharma, Inc. (119723554)
Revised: 01/2015   Actavis Pharma, Inc.

In Summary

More frequent side effects include: dizziness, edema, asthenia, headache, and vasodilatation. See below for a comprehensive list of adverse effects.

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