In the intact animal, prolongation of the AH interval can be seen at higher doses. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE 300 mg/1 Oceanside Pharmaceuticals Oceanside Pharmaceuticals; Share. Diltiazem Hydrochloride by Oceanside Pharmaceuticals is a gree capsule capsule extended release about 22 mm in size, imprinted with bvf;180. One report suggests that concentrations in breast milk may approximate serum levels. It is soluble in water, methanol, and chloroform. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose. There are as yet few data on the interaction of diltiazem and beta-blockers. It has a molecular weight of 450.98. Postural hypotension is infrequently noted upon suddenly assuming an upright position. In hypertensive patients, diltiazem hydrochloride CD produces antihypertensive effects both in the supine and standing positions. Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. There were no instances of greater than first-degree AV block in any of the clinical trials (see WARNINGS). Although individual patients may respond to any dosage level, the average optimum dosage range appears to be 180 to 360 mg/day. In vitro binding studies show diltiazem hydrochloride is 70% to 80% bound to plasma proteins. Diltiazem hydrochloride tablets are contraindicated in: 1. Revised: 06/2020 Oceanside Pharmaceuticals. Diltiazem Hydrochloride tablets may be swallowed whole, crushed, or chewed. There is a departure from linearity when dose strengths are increased. It has a molecular weight of 450.98. The generic name of Diltiazem Hcl Cd is diltiazem hydrochloride. In two short-term, double-blind, placebo-controlled studies in 256 hypertensive patients with doses up to 540 mg/day, diltiazem hydrochloride extended-release capsules showed a clinically unimportant but statistically significant, dose-related increase in PR interval (0.008 seconds). In the intact animal, prolongation of the AH interval can be seen at higher doses. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Angina: Diltiazem hydrochloride has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. Intravenous diltiazem in doses of 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%. Diltiazem produces relaxation of the coronary vascular smooth muscle and dilation of both large and small coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels which cause little or no negative inotropic effect. The apparent elimination half-life after single or multiple dosing is 5 to 8 hours. . Diltiazem Hydrochloride Tablets: Diltiazem is absorbed from the tablet formulation to about 98% of a reference solution. The plasma elimination half-life following single or multiple drug administration is approximately 3.0 to 4.5 hours. Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm: Dosage must be adjusted to each patients needs. Hemodynamic and Electrophysiologic Effects. Diltiazem Hydrochloride | Oceanside Pharmaceuticals while Breastfeeding. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE 420 mg/1 Oceanside Pharmaceuticals Oceanside Pharmaceuticals; Share. If the drug must be used in such patients, titration should be carried out with particular caution. There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. 10 Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA. A 24-month study in rats and a 21-month study in mice showed no evidence of carcinogenicity. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. . It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure, and in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given workload. 90 Capsules OCEANSIDE PHARMACEUTICALS (click image for full-size original) PRINCIPAL DISPLAY PANEL 240 mg Capsule Bottle Label NDC 68682-369-90 Rx only DILTIAZEM HYDROCHLORIDE 240 mg Extended-Release Capsules, USP* DILTIAZEM HYDROCHLORIDE 180 mg Extended-Release Capsules, USP* Do not use if bottle closure seal is broken. A single 360 mg dose of the capsule results in detectable plasma levels within 2 hours and peak plasma levels between 10 and 14 hours; absorption occurs throughout the dosing interval. https://medlibrary.org/lib/rx/meds/diltiazem-hydrochloride-62/page/3/. It has a molecular weight of 450.98. Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first-degree heart block. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE 360 mg/1 Oceanside Pharmaceuticals Oceanside Pharmaceuticals; Share. A study that compared patients with normal hepatic function to patients with cirrhosis who received immediate-release diltiazem found an increase in diltiazem elimination half-life and a 69% increase in bioavailability in the hepatically impaired patients. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance. The apparent elimination half-life after single or multiple dosing is 4 to 9.5 hours (mean 6.5 hours). It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure in normotensive individuals and, in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given workload. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. Exfoliative dermatitis (proven by rechallenge) has also been reported. In the intact animal, prolongation of the AH interval can be seen at higher doses. There are few data on the interaction of diltiazem and beta-blockers in patients with poor ventricular function. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE 240 mg/1 Oceanside Pharmaceuticals Oceanside Pharmaceuticals; Share. In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm. Exfoliative dermatitis (proven by rechallenge) has also been reported. The desacetyl metabolite is approximately 25% to 50% as potent a coronary vasodilator as diltiazem and is present in plasma at concentrations of 10% to 20% of parent diltiazem. PRINCIPAL DISPLAY PANEL - 120 mg Bottle Label NDC 68682-704-90 Rx only DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS 120 mg 90 Tablets OCEANSIDE PHARMACEUTICALS label-120mg.jpg Information For Patients As many as nine diltiazem metabolites have been identified in the urine of humans. Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial. Diltiazem Hydrochloride Extended-Release Capsules: When compared to a regimen of immediate-release tablets at steady-state, approximately 93% of drug is absorbed from the diltiazem hydrochloride extended-release capsules formulation. It has a molecular weight of 450.98. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal workloads. Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. 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. Hypertension: In short-term, double-blind, placebo-controlled clinical trials diltiazem hydrochloride extended-release capsules demonstrated a dose-related antihypertensive response among patients with mild to moderate hypertension. Oceanside Pharmaceuticals product information by RSS, Additional medications in the Prescription Medications section by. Oceanside Pharmaceuticals. At peak, 8 hours after dosing, exercise tolerance times relative to baseline were statistically significantly increased by 13, 38, 64, 55 and 42 seconds for placebo and 120 mg, 240 mg, 360 mg, and 540 mg diltiazem hydrochloride extended-release capsule treated patients, respectively. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. It is soluble in water, methanol, and chloroform. Manufactured by: Bausch Health Companies Inc. No intrinsic effect on fertility was observed in rats. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. It has a molecular weight of 450.98. The product's dosage form is tablet, extended release and is administered via oral form. https://medlibrary.org/lib/rx/meds/diltiazem-hydrochloride-62/. Diltiazem hydrochloride decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate. Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. The two primary metabolites of diltiazem are desacetyldiltiazem and desmethyldiltiazem. It is supplied by Oceanside Pharmaceuticals, Inc. Diltiazem is used in the treatment of atrial fibrillation; atrial flutter; heart failure; angina pectoris prophylaxis; high blood pressure and belongs to the drug classes calcium channel blocking agents, group IV antiarrhythmics . 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. Hypertension: Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride tablets: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), 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. https://medlibrary.org/lib/rx/meds/diltiazem-hcl-cd/. Chronic therapy with diltiazem hydrochloride produces no change or an increase in plasma catecholamines. Adverse Reactions . During dynamic exercise, increases in diastolic pressure are inhibited, while maximum achievable systolic pressure is usually reduced. It is soluble in water, methanol, and chloroform. Starting with 30 mg four times daily, before meals and at bedtime, dosage should be increased gradually (given in divided doses three or four times daily) at 1- to 2-day intervals until optimum response is obtained. If use of diltiazem hydrochloride is deemed essential, an alternative method of infant feeding should be instituted. Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis -. Patients with severely impaired renal function (creatinine clearance <50 mL/min) who received immediate-release diltiazem had modestly increased diltiazem concentrations compared to patients with normal renal function. Diltiazem hydrochloride reduces the renal and peripheral effects of angiotensin II. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE 360 mg/1 Oceanside Pharmaceuticals; FDA Drug information . Diltiazem hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem Hydrochloride Extended-Release Capsules, USP also contain: black iron oxide, D&C Red No. Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first-degree heart block. As the dose of diltiazem hydrochloride CD capsules is increased from a daily dose of 120 mg to 240 mg, there is an increase in the area under the curve of 2.7 times. Gastrointestinal: Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT, and LDH (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase. Oceanside Pharmaceuticals Drugs Pyridostigmine Bromide More Info Ethacrynic Sodium More Info Tretinoin Gel More Info Hydrocortisone Butyrate. Oceanside Pharmaceuticals - NDC products NDC labeler, manufacturer of drugs and pharmaceuticals. The plasma elimination half-life of diltiazem is approximately 3.0 to 4.5 hours. DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- diltiazem hydrochloride capsule, extended releaseOceanside Pharmaceuticals. The absolute bioavailability of an oral dose of an immediate-release formulation (compared to intravenous administration) is approximately 40%. The product is a human prescription drug with active ingredient (s) diltiazem hydrochloride. Total radioactivity measurement following short IV administration in healthy volunteers suggests the presence of other unidentified metabolites, which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. Hemodynamic and Electrophysiologic Effects. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. 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. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Privacy Policy | Copyright 2022. 60 mg, 90 mg, and 120 mg Diltiazem Hydrochloride tablets may be swallowed whole, crushed, or chewed. Risk cannot be ruled out during pregnancy. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose. Adverse Reactions . It causes excitation-contraction uncoupling in various myocardial tissues without changes in the configuration of the action potential. Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. Each light yellow, round tablet is engraved with MARION on one side and 1772 on the other. It has a molecular weight of 450.98. . DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride tabletOceanside Pharmaceuticals. Oceanside Pharmaceuticals product information by RSS, Additional medications in the Prescription Medications section by. Diltiazem Hydrochloride CD is formulated as a once-a-day extended-release capsule containing 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). A significant increase in time to termination of exercise and a significant decrease in overall angina frequency was observed. Diltiazem Hydrochloride CD is formulated as a once-a-day extended-release capsule containing 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). In a study involving single oral doses of 300 mg of diltiazem hydrochloride in six normal volunteers, the average maximum PR prolongation was 14% with no instances of greater than first-degree AV block. If there is no response to vagal blockade, administer isoproterenol cautiously. The following represent occurrences observed in clinical studies of angina patients. 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