Atenolol and, Chlorthalidone, Tablets, USP, Revised: February 2015, Rx only

/Atenolol and, Chlorthalidone, Tablets, USP, Revised: February 2015, Rx only
Atenolol and, Chlorthalidone, Tablets, USP, Revised: February 2015, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Atenolol and, Chlorthalidone, Tablets, USP, Revised: February 2015, Rx only

ID:

c439ab45-ce66-47df-a4cf-3fa488afe80f

Code:

34391-3

DESCRIPTION


id: cc93935a-e99d-4365-94fc-052c23ba4892
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihy‑pertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula: Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula: Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

INDICATIONS AND USAGE


id: decd208f-c0e3-4e49-955a-c84fc553f600
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Atenolol and chlorthalidone 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 and chlorthalidone. 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient’s needs, it may be more convenient than the separate components.

CONTRAINDICATIONS


id: be9dba5e-e1af-4960-a6cf-4784bc0c5d72
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Atenolol and chlorthalidone tablets are contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see WARNINGS ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.

ADVERSE REACTIONS


id: f0308dff-03b7-4305-82b7-245ac47b42ad
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Atenolol and chlorthalidone tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for atenolol and chlorthalidone are essentially the same as those seen with the individual components.

POTENTIAL ADVERSE EFFECTS


id: cc94ddf9-f2d8-43a6-b79b-5615726cb313
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

In addition, a variety of adverse effects not observed in clinical trials with atenolol but reported with other beta-adrenergic blocking agents should be considered potential adverse effects of atenolol. Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, decreased performance on neuropsychometrics; Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS ); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress.

OVERDOSAGE


id: c130aef3-6a93-4386-8e83-6a8e7e2330ed
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

No specific information is available with regard to overdosage and atenolol and chlorthalidone in humans. Treatment should be symptomatic and supportive and directed to the removal of any unabsorbed drug by induced emesis, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Further consideration should be given to dehydration, electrolyte imbalance and hypotension by established procedures.

DOSAGE AND ADMINISTRATION


id: 29c98e8b-c991-45c9-a9aa-9aa1f60f12b0
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

DOSAGE MUST BE INDIVIDUALIZED (SEE INDICATIONS AND USAGE ): Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50 mg-25 mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100 mg-25 mg tablet given once a day. When necessary, another antihypertensive agent may be added gradually beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure. Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m2 (normal range is 100-150 mL/min/1.73 m2); therefore, the following maximum dosages are recommended for patients with renal impairment.

 Creatinine Clearance  Atenolol Elimination  
 (mL/min/1.73 m2)  Half-life (hrs)  Maximum Dosage
 15-35  16-27  50 mg daily
 <15  >27  50 mg every other day

HOW SUPPLIED


id: d52bee13-6d29-4320-ab26-5cc535ea1245
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atenolol and Chlorthalidone Tablets USP, 100 mg-25 mg are 12/32”, unscored, round, white tablets imprinted “DAN 5783” supplied as Bottles of 30 – 68788-9041-3 Bottles of 60 – 68788-9041-6 Bottles of 90 – 68788-9041-9 Bottles of 100 – 68788-9041-1 Bottles of 120 – 68788-9041-8 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well- closed,  light-resistant  container  with  a  child-resistant  closure.  Protect  from  heat,  light  and moisture. Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA  
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA 
Revised: February 2015 Repackaged by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL


id: b92eb4d3-88cc-46e3-b4e3-f9a21679bf5c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Atenolol and Chlorthalidone Tablets, USP
100 mg/25 mg
Rx only