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Matzim LA
Overview
What is Matzim LA?
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, (+)--. 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 450.99. Matzim LA extended-release tablets, for oral administration, are formulated as a once-a-day extended release tablet containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride.
Also contains: candelilla wax powder, colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, nonoxynol 100, polyacrylate dispersion, polyethylene oxide, polysorbate 80, povidone, sucrose, talc, titanium dioxide and triacetin.
What does Matzim LA look like?
What are the available doses of Matzim LA?
Sorry No records found.
What should I talk to my health care provider before I take Matzim LA?
Sorry No records found
How should I use Matzim LA?
Matzim LA extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications.
Matzim LA extended-release tablets are indicated for the management of chronic stable angina.
Matzim LA extended-release tablets are an extended release formulation intended for once-a-day administration.
Patients controlled on diltiazem alone or in combination with other medications may be switched to Matzim LA extended-release tablets once-a-day at the nearest equivalent total daily dose. Higher doses of Matzim LA extended-release tablets once-a-day dosage may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but the safety and efficacy of doses as high as 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.
The tablet should be swallowed whole and not chewed or crushed.
What interacts with Matzim LA?
Sorry No Records found
What are the warnings of Matzim LA?
Sorry No Records found
What are the precautions of Matzim LA?
Sorry No Records found
What are the side effects of Matzim LA?
Sorry No records found
What should I look out for while using Matzim LA?
Diltiazem 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 Matzim LA?
The oral LD's in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD's 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 18 g. Sixteen of these reports involved multiple drug ingestion. 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, gastric lavage, 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. 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:
How should I store and handle Matzim LA?
Store at room temperature 20° to 25°C (68°to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3Matzim LA Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “ 690”on the other. Matzim LA Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “ 691”on the other. Matzim LA Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “ 692”on the other. Matzim LA Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “ 693”on the other. Matzim LA Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “ 694”on the other. Matzim LA Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “ 695”on the other. Storage conditions: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USADistributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USARevised: December 2014 191716-3
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The therapeutic effects of diltiazem 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 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.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 P-450 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. 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. 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.
In the hypertension study, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg.
In the angina study, the adverse event profile of diltiazem hydrochloride extended-release tablets was consistent with what has been previously described for diltiazem hydrochloride extended-release tablets and other formulations of diltiazem HCl. The most frequent adverse effects experienced by diltiazem hydrochloride extended-release tablets-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).
In clinical trials of other diltiazem formulations involving over 3200 patients, the most common events (i.e. greater than 1%) were edema (4.6%), headache (4.6%), dizziness (3.5%), asthenia (2.6%), first-degree AV block (2.4%), bradycardia (1.7%), flushing (1.4%), nausea (1.4%), and rash (1.2%).
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: 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 therapy is yet to be established.
To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 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/"
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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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