Nadolol

Common Side Effects of Nadolol

Tell your doctor if any of the following side effects become severe or don't go away:

• Mild dizziness or lightheadedness
• Tiredness
• Headache

Serious Side Effects of Nadolol

Tell your doctor right away if you experience any of the following serious side effects:

• Blurred vision or other vision problems
• Fainting
• Severe dizziness or lightheadedness
• Fever, chills, or sore throat
• Shortness of breath
• Chest pain or discomfort
• Slow or irregular heartbeat
• Sudden, unexplained weight gain
• Swelling of the hands, ankles, or feet
• Unusual bleeding or bruising
• Pain in the upper right part of the stomach
• Yellowing of the skin or eyes
• Dark-colored urine
• Clay-colored stools
• Behavior changes
• Hallucinations
• Short-term memory problems
• Burning, numbness, or tingling
• Cold fingers or toes
• Signs of a severe allergic reaction, which may include hives, rash, difficulty breathing, tightness in the chest, or swelling of the mouth, lips, face, or tongue

Nadolol comes as a tablet to take by mouth, usually once a day.

Your dose will depend on your medical condition and response to treatment.

Your doctor may start you on a low dose and gradually increase it.

Try to take nadolol around the same time each day, without missing a dose.

You can take this medicine with or without food.

Follow the instructions on your prescription label carefully. Don't take more or less nadolol than is recommended.

It may take a few weeks before you experience the full benefits of this drug.

Continue to take nadolol even if you feel well. Don't stop using it without talking to your doctor.

Nadolol Overdose

Symptoms of a nadolol overdose may include:

• Severe dizziness or lightheadedness
• Fainting
• Difficulty breathing or swallowing
• Slow heartbeat
• Sudden, unexplained weight gain
• Swelling of the hands, ankles, lower legs, or feet

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Nadolol

If you miss a dose of nadolol, take it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular medication schedule.

Don't take extra medicine to make up for a missed dose.

CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula:

C17H27NO4     MW 309.40

Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide.

CORGARD (nadolol) is available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, colorant (FD&C Blue No. 2), corn starch, magnesium stearate, povidone (except 20 mg and 40 mg), and other ingredients.

Nadolol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of nadolol.

Nadolol is a prescription medication used to used to treat high blood pressure. It is also used to prevent angina (chest pain).

Nadolol belongs to a group of drugs called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

This medication comes in tablet form and is taken typically once a day, with or without food.

Common side effects of nadolol include dizziness, fatigue, and gastrointestinal issues.

Nadolol can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how nadolol affects you.

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

• insulin and oral hypoglycemics
• reserpine (Serpalan)
• digoxin (Lanoxin)
• beta blockers such as metoprolol (Toprol XL, Lopressor), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal), carvedilol (Coreg)
• anesthesia used in surgery

This is not a complete list of nadolol drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with nadolol including the following:

• Bradycardia (slow heart rate). Tell your healthcare provider right away if you experience any new or increasing irregularities in your heart rate.
• Hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure too. Lie down if you feel faint or dizzy. Call your doctor right away.
• Heart failure. Tell your healthcare provider right away if you experience any of the following symptoms:
  • sudden weight gain
  • worsening shortness of breath
  • increased swelling of your feet, legs, or abdomen
  • needing to use more pillows to go to sleep or sleeping in a recliner
  • waking from sleep to catch your breath
  • a cough that does not go away
  • new or increasing irregularities in your heart rate
• Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid using nadolol in patients with these conditions. 
• Diabetes: Monitor glucose as nadolol may mask symptoms of hypoglycemia or worsen hyperglycemia.
• Nadolol may mask the symptoms of hyperthyroidism (overactive thyroid).

While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to the allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.

Nadolol can cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how nadolol affects you.

Do not take nadolol if you:

• are allergic to nadolol or to any of its ingredients
• have non-allergic bronchospasm (e.g., chronic bronchitis and emphysema)
• are prone to asthma or other breathing problems
• have sinus bradycardia (slow heart rate)
• have a heart conduction block
• have cardiogenic shock
• have heart failure

Take nadolol exactly as prescribed.

Nadolol comes in tablet form and is taken once every day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of nadolol at the same time.

Nadolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Nadolol is used to treat angina (chest pain) or hypertension (high blood pressure).

Nadolol may also be used for other purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not take extra medicine to make up the missed dose.

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• slow heartbeats;

• shortness of breath (even with mild exertion), swelling, rapid weight gain; or

• bronchospasm (wheezing, chest tightness, trouble breathing).

Common side effects may include:

• numbness or cold feeling in your hands or feet;

• dizziness;

• feeling tired;

• upset stomach, vomiting, diarrhea, constipation;

• vision problems; or

• mood changes, confusion, memory problems.

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.

• Inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium and β2-adrenergic receptors within bronchial and vascular smooth muscle.a b

• Decreases resting heart rate, inhibits exercise-induced increases in heart rate, and decreases cardiac output at rest and during exercise.a

• Decreases AV node conduction velocity and decreases myocardial automaticity.a

• No intrinsic sympathomimetic activity, little direct myocardial depressant activity, and no membrane-stabilizing effect on the heart.a

• Reduces BP by blocking peripheral (especially cardiac) adrenergic receptors (decreasing cardiac output), by decreasing sympathetic outflow from the CNS, and/or by suppressing renin release.a

• Decreases BP in both supine and standing positions.a

• In patients with angina, blocks catecholamine-induced increases in heart rate, velocity and extent of myocardial contraction, and BP resulting in a net decrease in myocardial oxygen consumption.a

• May increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure in patients with heart failure.a

• Increases airway resistance (especially in asthmatic patients) and inhibits the release of free fatty acids and insulin.a

Nadolol is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Nadolol is also used to treat severe chest pain (angina) .

nadolol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

nadolol is available only with your doctor's prescription .

Along with its needed effects, a medicine 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:

• Blurred vision
• chest pain or discomfort
• confusion
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• extreme fatigue
• irregular breathing
• lightheadedness, dizziness, or fainting
• paleness or cold feeling in fingertips and toes
• shortness of breath
• slow or irregular heartbeat
• sweating
• swelling of face, fingers, feet, or lower legs
• tingling or pain in fingers or toes when exposed to cold
• unusual tiredness or weakness
• weight gain
• wheezing

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in behavior
• cough
• difficulty breathing
• noisy breathing
• slurred speech
• tightness in chest

Some side effects 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:

• Bloated
• continuing ringing or buzzing or other unexplained noise in ears
• decreased interest in sexual intercourse
• diarrhea
• difficulty having a bowel movement (stool)
• drowsiness
• dry mouth, eyes, or skin
• excess air or gas in stomach or intestines
• full feeling
• gas in stomach
• hair loss, thinning of hair
• headache
• hearing loss
• heartburn
• inability to have or keep an erection
• itching skin
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• nausea
• passing gas
• rash
• relaxed and calm
• sleepiness
• stomach pain
• stomach soreness or discomfort
• stuffy nose
• vomiting
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Nadolol Tablets, USP are supplied as:

20 mg tablets: Yellow, round, biconvex tablets debossed “347” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.
Supplied in bottles of 30s (NDC 67787–347–30) and 1000s (NDC 67787-347-10)

40 mg tablets: Yellow, round, biconvex tablets debossed “348” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.
Supplied in bottles of 30s (NDC 67787–348–30) and 1000s (NDC 67787-348-10)

80 mg tablets: Yellow, round, biconvex tablets debossed “349” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.
Supplied in bottles of 30s (NDC 67787–349–30) and 1000s (NDC 67787-349-10)

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Revised: 11/15

17 to 24 hours

Half-Life Elimination

Infants 3 to 22 months (n=3): 3.2 to 4.3 hours (Mehta 1992)

Children 10 years (n=1): 15.7 hours (Mehta 1992)

Children ~15 years (n=1): 7.3 hours (Mehta 1992)

Adults: 20 to 24 hours; prolonged with renal impairment; (up to 45 hours in severe impairment) (Herrera 1979)

Protein Binding

30%

Bronchial asthma; sinus bradycardia; heart block greater than first degree (except in patients with a functioning artificial pacemaker); cardiogenic shock; uncompensated cardiac failure

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to nadolol or any component of the formulation; cor pulmonale; anesthesia with agents that produce myocardial depression; allergic rhinitis, bronchospasm, or severe chronic obstructive pulmonary disease (COPD)

May be administered without regard to meals.

>10%: Central nervous system: Drowsiness, insomnia

1% to 10%:

Cardiovascular: Atrioventricular block, bradycardia, cardiac conduction disturbance, cardiac failure, cold extremities, edema, hypotension, palpitations, peripheral vascular insufficiency, Raynaud's phenomenon

Central nervous system: Depression, dizziness, fatigue, sedation

<1% (Limited to important or life-threatening): Anorexia, bloating, bronchospasm, cardiac arrhythmia, confusion (especially in the elderly), cough, decreased libido, diarrhea, dyspepsia, facial edema, hallucination, headache, impotence, nasal congestion, nausea, paresthesia, pruritus, skin rash, slurred speech, thrombocytopenia, transient alopecia, weight gain, xeroderma, xerophthalmia