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TIAZAC
Overview
What is TIAZAC?
Tiazac (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). 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:
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg.
Tiazac also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. For oral administration.
What does TIAZAC look like?
What are the available doses of TIAZAC?
Sorry No records found.
What should I talk to my health care provider before I take TIAZAC?
Sorry No records found
How should I use TIAZAC?
Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Hypertension:
What interacts with TIAZAC?
- Diltiazem is contraindicated in:
- •
- •
- •
- •
- •
What are the warnings of TIAZAC?
1. Cardiac Conduction:
2. Congestive Heart Failure:
3. Hypotension:
4. Acute Hepatic Injury:
Array
What are the precautions of TIAZAC?
What are the side effects of TIAZAC?
Serious adverse reactions have been rare in studies with Tiazac, 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 Tiazac 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 Tiazac up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.
In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:
Cardiovascular:
Nervous System:
Gastrointestinal:
Dermatological:
Other:
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 REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| Placebo | Tiazac | ||
|---|---|---|---|
| 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) |
| Placebo | Tiazac | ||
| 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) |
What should I look out for while using TIAZAC?
Diltiazem is contraindicated in:
What might happen if I take too much TIAZAC?
The oral LDs in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LDs in these species were 60 and 38 mg/kg, respectively. The oral LD in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.
The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of diltiazem overdose in doses ranging from less than 1 g to 10.8 g. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from diltiazem overdose ranging from less than 1 g to 10.8 g. There were seven reports with a fatal outcome; although the amount of diltiazem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports.
Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with ventilatory support, activated charcoal, and/or intravenous calcium. Evidence of the effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose was conflicting.
In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Based on the known pharmacological effects of diltiazem and/or reported clinical experiences, the following measures may be considered:
Bradycardia:
High-Degree AV Block:
Cardiac Failure:
Hypotension:
In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride.
Due to extensive metabolism, plasma concentrations after a standard dose of diltiazem can vary over tenfold, which significantly limits their value in evaluation cases of overdosage.
Charcoal hemoperfusion has been used successfully as an adjunct therapy to hasten drug elimination. Overdoses with as much as 10.8 g of oral diltiazem have been successfully treated using appropriate supportive care.
How should I store and handle TIAZAC?
Tiazac (diltiazem hydrochloride) Extended-Release Capsules
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanisms of Action
Non-Clinical Toxicology
Diltiazem is contraindicated in:Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiazac (see ). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of the enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.
General
Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.
Dermatological events (see ) may be transient and may disappear despite continued use of diltiazem hydrochloride. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, the drug should be discontinued.
Serious adverse reactions have been rare in studies with Tiazac, 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 Tiazac 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 Tiazac up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.
In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:
Cardiovascular:
Nervous System:
Gastrointestinal:
Dermatological:
Other:
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 REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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