Hospira Inc.
Product Description:Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern:U.S. Nationwide including Guam.
Classification:Class I
Product Quantity:150,950 Vials
Reason For Recall:Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Recall Initiation Date:20150423
Report Date:20150715

Atenolol

Atenolol

Atenolol Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

 

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 If cardiac failure continues despite adequate treatment, atenolol should be withdrawn (see DOSAGE AND ADMINISTRATION).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 infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension (see DOSAGE AND ADMINISTRATION).

 

Bradycardia and heart block can occur and the left ventricular end diastolic pressure can rise when beta blockers are administered with verapamil or diltiazem. Patients with preexisting conduction abnormalities or left ventricular dysfunction are particularly susceptible (see PRECAUTIONS).

 

PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Because of its relative beta1 selectivity, however, atenolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta1 selectivity is not absolute, the lowest possible dose of atenolol should be used with therapy initiated at 50 mg and a beta2- stimulating agent (bronchodilator) should be made available. If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels.

 

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

 

Atenolol should be used with caution in diabetic patients if a beta-blocking agent is required. Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. At recommended doses atenolol does not potentiate insulin-induced hypoglycemia and, unlike nonselective beta blockers, does not delay recovery of blood glucose to normal levels.

 

Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom atenolol therapy is to be withdrawn should be monitored closely (see DOSAGE AND ADMINISTRATION).

 

Atenolol should not be given to patients with untreated pheochromocytoma.

 

Atenolol can cause fetal harm when administered to a pregnant woman. Atenolol crosses the placental barrier and appears in cord blood. Administration of atenolol, starting in the second trimester of pregnancy, has been associated with the birth of infants that are small for gestational age. No studies have been performed on the use of atenolol in the first trimester and the possibility of fetal injury cannot be excluded. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk for hypoglycemia and bradycardia. Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding (see PRECAUTIONS/ Nursing Mothers).

Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats at doses equal to or greater than 50 mg/kg/day or 25 or more times the maximum recommended human antihypertensive dose*. Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg/day or 12.5 times the maximum recommended human antihypertensive dose*.

________________________________________________________________________

*Based on the maximum dose of 100 mg/day in a 50 kg patient.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Atenolol is 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 that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Atenolol may be administered with other antihypertensive agents.

 

Atenolol is indicated for the long-term management of patients with angina pectoris.

 

Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.

 

History

There is currently no drug history available for this drug.

Other Information

Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:

MM1

Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether.

Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets.

Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.

 

Atenolol Manufacturers


  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Atenolol Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Proficient Rx Lp
    Atenolol Tablet [Proficient Rx Lp]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Northwind Pharmaceuticals, Llc
    Atenolol Tablet [Northwind Pharmaceuticals, Llc]
  • Blenheim Pharmacal, Inc.
    Atenolol Tablet [Blenheim Pharmacal, Inc.]
  • State Of Florida Doh Central Pharmacy
    Atenolol Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Atenolol Tablet [State Of Florida Doh Central Pharmacy]
  • Direct Rx
    Atenolol Tablet [Direct Rx]
  • Direct Rx
    Atenolol Tablet [Direct Rx]
  • Legacy Pharmaceutical Packaging
    Atenolol Tablet [Legacy Pharmaceutical Packaging]
  • Golden State Medical Supply, Inc.
    Atenolol Tablet [Golden State Medical Supply, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Atenolol Tablet [Preferred Pharmaceuticals, Inc.]
  • Genpharm Inc.
    Atenolol (Atenolol) Tablet [Genpharm Inc.]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Atenolol (Atenolol) Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
  • Rebel Distributors Corp.
    Atenolol Tablet [Rebel Distributors Corp.]
  • Contract Pharmacy Services-pa
    Atenolol Tablet [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Atenolol Tablet Atenolol ( Atenolol ) Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Atenolol Tablet [State Of Florida Doh Central Pharmacy]
  • Pack Pharmaceuticals Llc
    Atenolol Tablet [Pack Pharmaceuticals Llc]
  • State Of Florida Doh Central Pharmacy
    Atenolol Tablet [State Of Florida Doh Central Pharmacy]
  • Stat Rx Usa Llc
    Atenolol Tablet [Stat Rx Usa Llc]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Contract Pharmacy Services-pa
    Atenolol Tablet [Contract Pharmacy Services-pa]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Aurolife Pharma Llc
    Atenolol Tablet [Aurolife Pharma Llc]
  • Rebel Distributors Corp.
    Atenolol Tablet [Rebel Distributors Corp.]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Redpharm Drug Inc.
    Atenolol Tablet [Redpharm Drug Inc.]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Redpharm Drug Inc.
    Atenolol Tablet [Redpharm Drug Inc.]
  • Redpharm Drug Inc.
    Atenolol Tablet [Redpharm Drug Inc.]
  • Redpharm Drug Inc.
    Atenolol Tablet [Redpharm Drug Inc.]
  • Cadila Healthcare Limited
    Atenolol Tablet [Cadila Healthcare Limited]
  • Unit Dose Services
    Atenolol Tablet [Unit Dose Services]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Ingenus Pharmaceuticals, Llc
    Atenolol Tablet [Ingenus Pharmaceuticals, Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol (Atenolol) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Mckesson Contract Packaging
    Atenolol Tablet [Mckesson Contract Packaging]
  • Medvantx, Inc.
    Atenolol Tablet [Medvantx, Inc.]
  • Medvantx, Inc.
    Atenolol Tablet [Medvantx, Inc.]
  • H.j. Harkins Company, Inc.
    Atenolol Tablet [H.j. Harkins Company, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Atenolol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Rebel Distributors Corp
    Atenolol Tablet [Rebel Distributors Corp]
  • Legacy Pharmaceutical Packaging
    Atenolol Tablet [Legacy Pharmaceutical Packaging]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Atenolol Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Rebel Distributors Corp
    Atenolol Tablet [Rebel Distributors Corp]
  • Physicians Total Care, Inc.
    Atenolol Tablet [Physicians Total Care, Inc.]
  • Mckesson Contract Packaging
    Atenolol Tablet [Mckesson Contract Packaging]
  • American Health Packaging
    Atenolol Tablet [American Health Packaging]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Atenolol Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Aidarex Pharmaceuticals Llc
    Atenolol Tablet [Aidarex Pharmaceuticals Llc]
  • Bryant Ranch Prepack
    Atenolol Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Atenolol Tablet [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Atenolol Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Mutual Pharmaceutical Company, Inc.
    Atenolol Tablet [Mutual Pharmaceutical Company, Inc.]
  • Unit Dose Services
    Atenolol Tablet [Unit Dose Services]
  • Unit Dose Services
    Atenolol Tablet [Unit Dose Services]
  • Remedyrepack Inc.
    Atenolol (Atenolol ) Tablet [Remedyrepack Inc. ]
  • Med-health Pharma, Llc
    Atenolol Tablet [Med-health Pharma, Llc]
  • Mylan Pharmaceuticals Inc.
    Atenolol Tablet [Mylan Pharmaceuticals Inc.]
  • Sandoz Inc
    Atenolol Tablet [Sandoz Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Atenolol Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Zydus Pharmaceuticals (Usa) Inc.
    Atenolol Tablet [Zydus Pharmaceuticals (Usa) Inc.]
  • Sandoz Inc
    Atenolol Tablet [Sandoz Inc]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Avkare, Inc.
    Atenolol (Atenolol) Tablet [Avkare, Inc.]
  • Northstar Rxllc
    Atenolol Tablet [Northstar Rxllc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Atenolol Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Atenolol Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • International Labs, Inc.
    Atenolol Tablet [International Labs, Inc.]
  • Major Pharmaceuticals
    Atenolol Tablet [Major Pharmaceuticals]
  • Medvantx, Inc.
    Atenolol Tablet [Medvantx, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Atenolol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • St Marys Medical Park Pharmacy
    Atenolol Tablet [St Marys Medical Park Pharmacy]
  • Clinical Solutions Wholesale
    Atenolol Tablet [Clinical Solutions Wholesale]
  • Aurobindo Pharma Limited
    Atenolol Tablet [Aurobindo Pharma Limited]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Atenolol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Blenheim Pharmacal, Inc.
    Atenolol Tablet [Blenheim Pharmacal, Inc.]
  • Ranbaxy Pharmaceuticals Inc.
    Atenolol Tablet [Ranbaxy Pharmaceuticals Inc.]
  • Blenheim Pharmacal, Inc.
    Atenolol Tablet [Blenheim Pharmacal, Inc.]
  • Mylan Institutional Inc.
    Atenolol Tablet [Mylan Institutional Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Atenolol Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Atenolol Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Atenolol Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Proficient Rx Lp
    Atenolol Tablet [Proficient Rx Lp]
  • Readymeds
    Atenolol Tablet [Readymeds]
  • Preferred Pharmaceuticals, Inc.
    Atenolol Tablet [Preferred Pharmaceuticals, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Atenolol Tablet [Teva Pharmaceuticals Usa Inc]
  • Bryant Ranch Prepack
    Atenolol Tablet [Bryant Ranch Prepack]
  • Northwind Pharmaceuticals, Llc
    Atenolol Tablet [Northwind Pharmaceuticals, Llc]
  • Cardinal Health
    Atenolol Tablet [Cardinal Health]
  • Tya Pharmaceuticals
    Atenolol Tablet [Tya Pharmaceuticals]
  • St Marys Medical Park Pharmacy
    Atenolol Tablet [St Marys Medical Park Pharmacy]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceutials Inc.
    Atenolol Tablet [Preferred Pharmaceutials Inc.]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Atenolol Tablet [Proficient Rx Lp]
  • Remedyrepack Inc.
    Atenolol Tablet [Remedyrepack Inc. ]
  • Directrx
    Atenolol Tablet [Directrx]

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