Tenoretic

DRUG DESCRIPTION

TENORETIC® (atenolol and chlorthalidone) is for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol, TENORMIN®) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-.

Atenolol structural formula illustration

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 structural formula illustration

Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C.

Each TENORETIC (atenolol and chlorthalidone) 100 Tablet contains:

Atenolol (TENORMIN®).......................................100 mg
Chlorthalidone........................................................25 mg

Each TENORETIC (atenolol and chlorthalidone) 50 Tablet contains:

Atenolol (TENORMIN®).........................................50 mg
Chlorthalidone..........................................................25 mg

Inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

What are the possible side effects of atenolol and chlorthalidone (Tenoretic 100, Tenoretic 50)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • slow or uneven heartbeats;
  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • ...

Read All Potential Side Effects and See Pictures of Tenoretic »

What are the precautions when taking atenolol and chlorthalidone (Tenoretic)?

Before taking this product, tell your doctor or pharmacist if you are allergic to atenolol or chlorthalidone; or to thiazide diuretics (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block, sick sinus syndrome), an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation...

Read All Potential Precautions of Tenoretic »


Tenoretic Consumer (continued)

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness, lightheadedness, slow heartbeat, tiredness, nausea, and diarrhea may occur. Decreased sexual ability has been reported infrequently. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The chlorthalidone in this product may cause your body to lose too much water and salt (dehydration). Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration: very dry mouth, extreme thirst, muscle cramps/weakness, fast heartbeat, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow/irregular heartbeat, new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain), mental/mood changes (such as depression, mood swings), toe/joint pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: trouble breathing, blue fingers/toes, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to atenolol or chlorthalidone; or to thiazide diuretics (such as hydrochlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block, sick sinus syndrome), an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease, peripheral vascular disease), pheochromocytoma, liver disease, kidney disease, heart failure, overactive thyroid (hyperthyroidism), gout, untreated salt imbalance (for example, high calcium, low potassium, low magnesium), loss of too much body water (dehydration), a certain muscle/nerve disease (myasthenia gravis), lupus, breathing problems (such as asthma, chronic bronchitis, emphysema), serious allergic reactions including those needing treatment with epinephrine, mental/mood disorders (such as depression).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To help prevent dizziness, drink plenty of fluids while taking this medication unless your doctor directs you otherwise. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

This medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. Your doctor may prescribe a potassium supplement.

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your diabetes medication or diet may need to be adjusted.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the side effects of this drug, including dizziness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

Atenolol and chlorthalidone pass into breast milk. Atenolol may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.


Tenoretic Patient Information Including Side Effects

Brand Names: Tenoretic 100, Tenoretic 50

Generic Name: atenolol and chlorthalidone (Pronunciation: a TEN oh lole and klor THAL i done)

  • What is atenolol and chlorthalidone (Tenoretic)?
  • What are the possible side effects of atenolol and chlorthalidone (Tenoretic)?
  • What is the most important information I should know about atenolol and chlorthalidone (Tenoretic)?
  • What should I discuss with my healthcare provider before taking atenolol and chlorthalidone (Tenoretic)?
  • How should I take atenolol and chlorthalidone (Tenoretic)?
  • What happens if I miss a dose (Tenoretic)?
  • What happens if I overdose (Tenoretic)?
  • What should I avoid while taking atenolol and chlorthalidone (Tenoretic)?
  • What other drugs will affect atenolol and chlorthalidone (Tenoretic)?
  • Where can I get more information?

What is atenolol and chlorthalidone (Tenoretic)?

Atenolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Chlorthalidone is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

The combination of atenolol and chlorthalidone is used to treat hypertension (high blood pressure).

Atenolol and chlorthalidone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of atenolol and chlorthalidone (Tenoretic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • slow or uneven heartbeats;
  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, decreased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • easy bruising or bleeding, unusual weakness;
  • confusion, hallucinations; or
  • cold feeling in your hands and feet.

Less serious side effects may include:

  • dizziness, tired feeling, depressed mood;
  • dreaming more than usual;
  • mild nausea, diarrhea, constipation, loss of appetite;
  • headache, blurred vision, dry eyes;
  • skin rash, itching; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about atenolol and chlorthalidone (Tenoretic)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to atenolol (Tenormin) or chlorthalidone (Hygroton, Thalitone), or if you have a serious heart problem such as heart block or slow heart rate, if you are unable to urinate, or if you are allergic to sulfa drugs (such as Bactrim, Septra, and others).

Before you take atenolol and chlorthalidone, tell your doctor if you have congestive heart failure, angina (chest pain), liver or kidney disease, a lung disorder, diabetes, gout, lupus, a thyroid disorder, adrenal gland tumor, psoriasis, or circulation problems.

If you need to have any type of surgery or medical tests, tell the surgeon or doctor ahead of time that you are using atenolol and chlorthalidone.

Do not stop taking atenolol and chlorthalidone without the advice of your doctor. Stopping suddenly may make your condition worse or cause withdrawal symptoms.

If you do stop taking this medication for any reason, limit your physical activity to prevent heart problems. Your doctor may recommend that you start taking the medication again if you have withdrawal symptoms.

Atenolol and chlorthalidone is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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