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Diltiazem Hydrochloride
Overview
What is Diltiazem HCl CD?
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)--. 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. It has a molecular weight of 450.98. Diltiazem HCl CD is formulated as a once-a-day extended-release capsule containing 360 mg diltiazem hydrochloride.
Capsules also contain: FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide.
For oral administration.
What does Diltiazem HCl CD look like?
What are the available doses of Diltiazem HCl CD?
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What should I talk to my health care provider before I take Diltiazem HCl CD?
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How should I use Diltiazem HCl CD?
Diltiazem HCl CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Diltiazem HCl CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem HCl CD capsules at the nearest equivalent total daily dose. Higher doses of diltiazem HCl CD may be needed in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension:
Angina:
Concomitant Use with Other Cardiovascular Agents:
What interacts with Diltiazem HCl CD?
Diltiazem HCl is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
What are the warnings of Diltiazem HCl CD?
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What are the precautions of Diltiazem HCl CD?
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General
Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Laboratory parameters of renal and hepatic function should be monitored at regular intervals. 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.
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Drug Interactions
Because of the potential for additive effects, slow titration is 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 diltiazem hydrochloride (see ).
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 this 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.
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Beta-blockers:
Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).
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Cyclosporine:
The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.
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Ivabradine
Quinidine:
Rifampin:
Statins:
In a healthy volunteer crossover study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14-day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.
In a ten-subject randomized, open-label, 4-way crossover study, coadministration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and C during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.
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Carcinogenesis, Mutagenesis, Impairment of Fertility
A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic response or in mammalian cell assays or in bacteria. No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day.
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Pregnancy
Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities. In the perinatal/postnatal studies, there was an increased incidence of stillbirths at doses of 20 times the human dose or greater.
There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus.
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Nursing Mothers
Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of diltiazem hydrochloride is deemed essential, an alternative method of infant feeding should be instituted.
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Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
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Geriatric Use
Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Diltiazem HCl CD?
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 HCl CD 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:
Nervous System:
Gastrointestinal:
Dermatological:
Other:
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 Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or .
| Headache | 5.4% | 5.0% |
| Dizziness | 3.0% | 3.0% |
| Bradycardia | 3.3% | 1.3% |
| AV Block First Degree | 3.3% | 0.0% |
| Edema | 2.6% | 1.3% |
| Asthenia | 1.8% | 1.7% |
What should I look out for while using Diltiazem HCl CD?
Diltiazem HCl is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
What might happen if I take too much Diltiazem HCl CD?
The oral LD50s in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50s in these species were 60 and 38 mg/kg, respectively. The oral LD50 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. Because of its 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 reports of diltiazem overdose in amounts ranging from <1 g to 18 g. Of cases with known outcome, most patients recovered and in cases with a fatal outcome, the majority involved multiple drug ingestion.
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, gastric lavage, activated charcoal, and/or intravenous calcium.
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. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. 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:
Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.
How should I store and handle Diltiazem HCl CD?
Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pantoprazole Sodium Delayed-Release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole.The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6688-77bottles of 90 tabletsThe 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-6689-77bottles of 90 tabletsNDC 0378-6689-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The therapeutic effects of diltiazem HCl CD are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.
Non-Clinical Toxicology
Diltiazem HCl is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.Because of the potential for additive effects, slow titration is 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 diltiazem hydrochloride (see ).
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 this 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.
Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Laboratory parameters of renal and hepatic function should be monitored at regular intervals. 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 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 HCl CD 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:
Nervous System:
Gastrointestinal:
Dermatological:
Other:
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 Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or .
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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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