DilTIAzem Hcl ER 360mg Capsule

ADVERSE REACTIONS

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsules up to 360 mg with rates in placebo patients shown for comparison.

In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials:

**Cardiovascular:**Congestive heart failure, palpitations, syncope, ventricular extrasystoles.

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

G****astrointestinal:Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (seeWARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.

**Dermatological:**Petechiae, photosensitivity, pruritus, urticaria.

**Other:**Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

The following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun- exposed skin areas), purpura, retinopathy, myopathy, 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, some 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 REACTIONS, contact Ingenus Pharmaceuticals,LLC Toll-Free at 1-877-748-1970 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch**.**

DESCRIPTION

Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:

USP Dissolution pending.

Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride.

Capsules also contain: hypromellose, sucrose, starch (maize), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc, hydroxypropylcellulose, ammonio methacrylate copolymer, ethylcellulose, diethyl phthalate, magnesium stearate, titanium dioxide, polydextrose, triacetin, Macrogol/PEG, gelatin, sodium lauryl sulphate, shellac, potassium hydroxide, black iron oxide, FD&C Blue #1(180 mg, 240 mg, 300 mg and 360 mg) and FD&C Yellow#6 (180 mg and 240 mg).

HOW SUPPLIED

Diltiazem hydrochloride Extended-Release Capsules, USP are Dark blue/Dark blue capsule (size 00) imprinted with N369 on one end and 360

on the other end.

NDC: 71335-1897-1: 30 CAPSULEs in a BOTTLE

NDC: 71335-1897-2: 90 CAPSULEs in a BOTTLE

Storage Conditions: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid

excessive humidity.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504