Atenolol 25 mg/1
Atenolol · TABLET · Preferred Pharmaceuticals Inc.
Atenolol is a beta-blocker tablet taken by mouth that is used to treat high blood pressure and heart conditions such as angina and irregular heartbeat. It works by slowing your heart rate and reducing the force of heart contractions to help lower blood pressure and improve heart function.
Key Facts
- Brand Name
- Atenolol
- Generic Name
- Atenolol
- NDC Code (Product)
68788-8527- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077443
- Drug Class
- beta-Adrenergic Blocker [EPC]
- Marketing Start
- 10/06/2023
Recall History
Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Golden State Medical Supply Inc.
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Zydus Pharmaceuticals USA Inc
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Legacy Pharmaceutical Packaging LLC
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Aidapak Services, LLC
Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014; PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded t…
Dosage & Administration
DOSAGE AND ADMINISTRATION Hypertension The initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit. Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa. Angina Pectoris The initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 mg to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed wit…
Warnings
WARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta-blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients with acute myocardial infarction, cardiac failure which is not promptly and effectively controlled by 80 mg of intravenous furosemide or equivalent therapy is a contraindication to beta-blocker treatment. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, atenolol should be withdrawn. (See DOSAGE AND ADMINISTRATION . ) Cessation of Therapy with Atenolol Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infa…
Contraindications
CONTRAINDICATIONS Atenolol tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. (See WARNINGS .) Atenolol tablets are contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.
Drug Interactions
Drug Interactions Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension. Calcium channel blockers may also have an additive effect when given with atenolol (see WARNINGS ). Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers. Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta-blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped. Concomi…
Adverse Reactions
ADVERSE REACTIONS Most adverse effects have been mild and transient. The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol and placebo is similar, causal relationship to atenolol is uncertain. Volunteered (U.S. Studies) Total - Volunteered and Elicited (Foreign + U.S. Studies) Atenolol (n=164) % Placebo (n=206) % Atenolol (n=399) % Placebo (n=407) % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2 0.2 Light-headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fatigue 3 1 6 5 Lethargy 1 0 3 0.7 Drowsiness 0.6 0 2 0.5 Depression 0.6 0.5 12 9 Dreaming 0 0 3 1 GASTROINTESTINAL Diarrhea 2 0 3 2 Nausea 4 1 3 1 RESPIRATORY (See WARNINGS ) Wheeziness 0 0 3 3 Dyspnea 0.6 1 6 4 Acute Myoc…
Frequently Asked Questions
What is Atenolol used for?
Atenolol is a beta-blocker tablet taken by mouth that is used to treat high blood pressure and heart conditions such as angina and irregular heartbeat. It works by slowing your heart rate and reducing the force of heart contractions to help lower blood pressure and improve heart function.
Is Atenolol a controlled substance?
Atenolol is not classified as a controlled substance by the DEA.
What is the generic name for Atenolol?
The generic name for Atenolol is Atenolol. There are 1 other brand versions of Atenolol.
What is the NDC code for Atenolol 25 mg/1?
The NDC (National Drug Code) for Atenolol 25 mg/1 is 68788-8527, listed by Preferred Pharmaceuticals Inc..