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Tenoretic

Tenoretic

SIDE EFFECTS

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

Atenolol

The frequency estimates in the following table were derived from controlled studies in which adverse reactions were either volunteered by the patient (US studies) or elicited, eg, 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 for atenolol and placebo is similar, causal relationship to atenolol is uncertain.

  Volunteered (US Studies) Total-Volunteered and Elicited (Foreign + US 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

During postmarketing experience, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie's disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. TENORETIC (atenolol and chlorthalidone) , like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud's

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 (atenolol and chlorthalidone) conducted in the United States (89 patients treated with TENORETIC (atenolol and chlorthalidone) ) 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 CONTRAINDICATIONS); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fevercombined with aching and sore throat, laryngospasm and respiratory distress.

Miscellaneous

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and, in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy. (See DOSAGE AND ADMINISTRATION.)

The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with atenolol (TENORMIN). Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol (TENORMIN) therapy with subsequent resolution or quiescence of the reaction.

Clinical Laboratory Test Findings

Clinically important changes in standard laboratory parameters were rarely associated with the administration of TENORETIC (atenolol and chlorthalidone) . The changes in laboratory parameters were notprogressive and usually were not associated with clinical manifestations. The most common changes were increases inuric acid and decreases in serum potassium.

Read the Tenoretic (atenolol and chlorthalidone) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

TENORETIC (atenolol and chlorthalidone) may potentiate the action of other antihypertensive agents used concomitantly. Patients treatedwith TENORETIC (atenolol and chlorthalidone) 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 WARNINGS.)

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect. 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 (atenolol and chlorthalidone) .

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.

Other Precautions

In patients receiving thiazides, sensitivity reactions may occurwith 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.

Read the Tenoretic Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

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