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TENORETIC
Overview
What is TENORETIC?
TENORETIC® (atenolol and chlorthalidone) is for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta-selective (cardioselective) hydrophilic blocking agent (atenolol, TENORMIN) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-.
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) benzene sulfonamide:
Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C.
Each TENORETIC 100 Tablet contains:
Atenolol (TENORMIN®).......................................100 mg
Chlorthalidone........................................................ 25 mg
Each TENORETIC 50 Tablet contains:
Atenolol (TENORMIN®).........................................50 mg
Chlorthalidone..........................................................25 mg
Inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.
What does TENORETIC look like?
What are the available doses of TENORETIC?
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What should I talk to my health care provider before I take TENORETIC?
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How should I use TENORETIC?
TENORETIC 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, on 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.
DOSAGE MUST BE INDIVIDUALIZED. (See .)
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 TENORETIC 50 tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one TENORETIC 100 tablet given once a day.
When necessary, another antihypertensive agent may be added gradually beginning with 50 percent 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/1.73m (normal range is 100-150 mL/min/1.73m); therefore, the following maximum dosages are recommended for patients with renal impairment.
What interacts with TENORETIC?
TENORETIC is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.
What are the warnings of TENORETIC?
Cardiac Failure
S
I
Renal and Hepatic Disease and Electrolyte Disturbances
S
I
I
Ischemic Heart Disease
Following abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported. Therefore, such patients should be cautioned against interruption of therapy without the physician's advice. Even in the absence of overt angina pectoris, when discontinuation of TENORETIC is planned, the patient should be carefully observed and should be advised to limit physical activity to a minimum. TENORETIC should be reinstated if withdrawal symptoms occur. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TENORETIC therapy abruptly even in patients treated only for hypertension.
Concomitant Use of Calcium Channel Blockers
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 pre-existing conduction abnormalities or left ventricular dysfunction are particularly susceptible. (See .)
Bronchospastic Diseases
PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Because of its relative beta-selectivity, however, TENORETIC may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate, other antihypertensive treatment. Since beta-selectivity is not absolute, the lowest possible dose of TENORETIC should be used and a beta-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.
Major Surgery
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.
Metabolic and Endocrine Effects
T
I
B
B
H
Untreated Pheochromocytoma
TENORETIC should not be given to patients with untreated pheochromocytoma.
What are the precautions of TENORETIC?
General
TENORETIC may aggravate peripheral arterial circulatory disorders.
Electrolyte and Fluid Balance Status
P
P
M
H
I
A
Drug Interactions
T
C
D
A
T
C
L
B
W
B
Other Precautions
In patients receiving thiazides, sensitivity reactions may occur with or without a history of allergy or bronchial asthma. The possible exacerbation or activation of systemic lupus erythematosus has been reported. The antihypertensive effects of thiazides may be enhanced in the postsympathectomy patient.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
T
F
Animal Toxicology
S
C
Use in Pregnancy
Pregnancy Category D: See
Nursing Mothers
A
N
What are the side effects of TENORETIC?
TENORETIC is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for TENORETIC are essentially the same as those seen with the individual components.
Atenolol
T
D
| 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 |
| 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 ) | ||||
| Wheeziness | 0 | 0 | 3 | 3 |
| Dyspnea | 0.6 | 1 | 6 | 4 |
Chlorthalidone
Cardiovascular: orthostatic hypotension; Gastrointestinal: anorexia, gastric irritation, vomiting, cramping, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis; CNS: vertigo, paresthesia, xanthopsia; Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia; Hypersensitivity: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell's syndrome (toxic epidermal necrolysis); Miscellaneous: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness. Clinical trials of TENORETIC conducted in the United States (89 patients treated with TENORETIC) revealed no new or unexpected adverse effects.
POTENTIAL ADVERSE EFFECTS
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 ); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress.
Miscellaneous
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 ); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress.
Clinical Laboratory Test Findings
Clinically important changes in standard laboratory parameters were rarely associated with the administration of TENORETIC. The changes in laboratory parameters were not progressive and usually were not associated with clinical manifestations. The most common changes were increases in uric acid and decreases in serum potassium.
What should I look out for while using TENORETIC?
TENORETIC is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.
What might happen if I take too much TENORETIC?
No specific information is available with regard to overdosage and TENORETIC 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.
How should I store and handle TENORETIC?
Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].TENORETIC 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), NDC 0310-0115, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 115 on the other side, bisected) are supplied in bottles of 100 tablets. TENORETIC 100 Tablets (atenolol 100 mg and chlorthalidone 25 mg), NDC 0310-0117, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 117 on the other side) are supplied in bottles of 100 tablets.TENORETIC 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), NDC 0310-0115, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 115 on the other side, bisected) are supplied in bottles of 100 tablets. TENORETIC 100 Tablets (atenolol 100 mg and chlorthalidone 25 mg), NDC 0310-0117, (white, round, biconvex, uncoated tablets with TENORETIC on one side and 117 on the other side) are supplied in bottles of 100 tablets.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Atenolol and chlorthalidone have been used singly and concomitantly for the treatment of hypertension. The antihypertensive effects of these agents are additive, and studies have shown that there is no interference with bioavailability when these agents are given together in the single combination tablet. Therefore, this combination provides a convenient formulation for the concomitant administration of these two entities. In patients with more severe hypertension, TENORETIC may be administered with other antihypertensives such as vasodilators.
Non-Clinical Toxicology
TENORETIC is contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.TENORETIC may potentiate the action of other antihypertensive agents used concomitantly. Patients treated with TENORETIC plus a catecholamine depletor (eg, reserpine) should 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 TENORETIC. (See .)
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.
Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude the therapeutic effectiveness of norepinephrine. Thiazides may increase the responsiveness to tubocurarine.
Concomitant use of prostaglandin synthase inhibiting drugs, eg, indomethacin, may decrease the hypotensive effects of beta blockers.
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such preparations with TENORETIC.
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.
While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
TENORETIC may aggravate peripheral arterial circulatory disorders.
TENORETIC is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for TENORETIC are essentially the same as those seen with the individual components.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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