Atenolol and Chlorthalidone, Tablets USP, Revised: June 2009, Rx only    190808

/Atenolol and Chlorthalidone, Tablets USP, Revised: June 2009, Rx only    190808
Atenolol and Chlorthalidone, Tablets USP, Revised: June 2009, Rx only    1908082018-09-06T09:12:40+00:00

Prescription Drug Name:

Atenolol and Chlorthalidone, Tablets USP, Revised: June 2009, Rx only    190808

ID:

cd4f6a14-a2eb-4157-83a7-91ab4e9926e5

Code:

34391-3

DESCRIPTION


id: 269935c8-3cc6-483e-8b12-376d1071e410
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive 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:                                                   C14H22N2O3            M.W. 266.34 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:                                                   C14H11ClN2O4S            M.W. 338.77 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: eb64a1d3-68c9-481d-a3a3-20c5aff16625
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Atenolol and chlorthalidone tablets are indicated in the treatment of hypertension. 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: cc823f1c-7062-4af2-9909-f69042e95cd1
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: 66f6ae97-d079-4ffa-a519-5e623e32bba0
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: de6b3e08-b257-4476-bd28-568bd5119e08
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, and 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: cf791f29-f4ae-4f74-878e-9d49aac1e029
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: 31b869f8-ff0e-4848-a960-f809a950e3d1
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: 504862be-8a34-43f1-a548-156d8a973ebc
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg are 10/32”, scored, round, white tablets imprinted DAN 5782 supplied in bottles of 100. Atenolol and Chlorthalidone Tablets USP, 100 mg-25 mg are 12/32”, unscored, round, white tablets imprinted DAN 5783 supplied in bottles of 100. Dispense in a well-closed, light-resistant container with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from heat, light and moisture. Manufactured by:
Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA
Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320 Revised: June 2009        190808
0609B

Principal Display Panel


id: aedf2aae-06b1-480d-a30e-6b563c697ebf
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 21695-744-30
Atenolol and
Chlorthalidone
Tablets USP
100mg/25mg
30 Tablets  Rx only

Each tablet contains:

Atenolol USP,  100 mg
Chlorthalidone USP, 25 mg
Usual dosage: One tablet daily or as
directed by physician. See package insert
for dosage and full prescribing information.
Dispense in a well-closed, light-resistant
container with a chlid-resistant closure.
Store at 20º-25ºC (68º-77ºF).[See
USP controlled room temperature.]Protect from heat, light and moisture.

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Code No. GO/DRUGS/741   190807 Distributed By: Watson Pharma, Inc.