Tenoretic

GENERIC AVAILABLE: yes

TENORETIC (atenolol and chlorthalidone) 50 Tablets (atenolol 50 mg and chlorthalidone 25 mg), NDC 0310-0115, (white, round, biconvex, uncoated tablets with TENORETIC (atenolol and chlorthalidone) on one side and 115 on the other side, bisected) are supplied in bottles of 100 tablets.

TENORETIC (atenolol and chlorthalidone) 100 Tablets (atenolol 100 mg and chlorthalidone 25 mg), NDC 0310-0117, (white, round, biconvex, uncoated tablets with TENORETIC (atenolol and chlorthalidone) on one side and 117 on the other side) are supplied in bottles of 100 tablets.

Storage

Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in well-closed, light-resistant containers.

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. By: IPR Pharmaceuticals, Inc. Carolina, PR 00984. Rev 02/05. FDA Rev date: 10/29/2008

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.

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.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

• Atenolol
• Tenormin IV Injection

• Thalitone

Read the Tenoretic User Reviews »

© Tenoretic Patient Information is supplied by Cerner Multum, Inc. and Tenoretic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Before taking Tenoretic, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tenoretic or any of its ingredients or sulfonamide-derived drugs
• have a condition where your heart suddenly can't pump enough blood to meet your body's needs (cardiogenic shock)
• have heart failure
• have a condition that blocks the conduction of impulses in the heart (heart block greater than first degree) 
• severely slow heart rate (sinus bradycardia)
• your kidneys fail to produce urine (anuria) or you have kidney disease
• have lung disease
• are about to have major surgery
• have diabetes or low blood sugar
• have pheochromocytoma
• have a circulation disorder that affects blood vessels outside of the heart and brain (peripheral vascular disease)
• are pregnant or plan to become pregnant
• are breastfeeding or plan on breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling cold.
• Very bad dizziness or passing out.
• Slow heartbeat.
• Restlessness.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Low mood (depression).
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Fever or chills.
• Sore throat.
• Yellow skin or eyes.
• A burning, numbness, or tingling feeling that is not normal.

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.

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 Tenoretic is administered during pregnancy or to a woman who is breast-feeding. (See PRECAUTIONS, Nursing Mothers.)

Tenoretic was studied for teratogenic potential in the rat and rabbit. Doses of atenolol/chlorthalidone of 8/2, 80/20, and 240/60 mg/kg/day were administered orally to pregnant rats with no evidence of embryofetotoxicity observed. Two studies were conducted in rabbits. In the first study, pregnant rabbits were dosed with 8/2, 80/20, and 160/40 mg/kg/day of atenolol/chlorthalidone. No teratogenic effects were noted, but embryonic resorptions were observed at all dose levels (ranging from approximately 5 times to 100 times the maximum recommended human dose1). In the second rabbit study, doses of atenolol/chlorthalidone were 4/1, 8/2, and 20/5 mg/kg/day. No teratogenic or embryotoxic effects were demonstrated.

Atenolol

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 dose1. 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 dose1.

Chlorthalidone

Thiazides cross the placental barrier and appear in cord blood. The use of chlorthalidone and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia and possibly other adverse reactions which have occurred in the adult.

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 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/1.73m2 (normal range is 100-150 mL/min/1.73m2); therefore, the following maximum dosages are recommended for patients with renal impairment.

Applies to atenolol / chlorthalidone: oral tablet

Along with its needed effects, atenolol / chlorthalidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atenolol / chlorthalidone:

• Cold arms or legs
• difficult or labored breathing
• shortness of breath
• tightness in chest
• wheezing

• Chest pain or discomfort
• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• leg pain
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• unusual tiredness or weakness

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• fever
• general feeling of discomfort, illness, or weakness
• paleness or cold feeling in fingertips and toes
• pinpoint red spots on skin
• seeing, hearing, or feeling things that are not there
• severe mood or mental changes
• skin irritation or rash, including rash that looks like psoriasis
• tingling or pain in fingers or toes when exposed to cold
• unusual behavior
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur while taking atenolol / chlorthalidone:

• Blurred vision
• decreased urination
• dry mouth
• increase in heart rate
• muscle cramps or pain
• numbness, tingling, pain, or weakness in hands or feet
• rapid breathing
• seizures
• sunken eyes
• sweating
• thirst
• trembling
• weakness and heaviness of legs
• wrinkled skin

Some side effects of atenolol / chlorthalidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• tiredness
• trouble concentrating
• trouble sleeping

• Diarrhea
• feeling of constant movement of self or surroundings
• nausea
• sensation of spinning
• unusual drowsiness, dullness, or feeling of sluggishness

• Decreased interest in sexual intercourse
• disturbed color perception
• double vision
• hair loss, thinning of hair
• halos around lights
• headache
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• loss of vision
• night blindness
• overbright appearance of lights
• pain of penis on erection
• tunnel vision