Alti-Nadolol

This section provides information on the proper use of a number of products that contain nadolol. It may not be specific to Alti-Nadolol. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

You may take this medicine with or without food .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .
  • For severe chest pain:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Nadolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

Applies to nadolol: oral tablet

Along with its needed effects, nadolol 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 nadolol:

• 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 of nadolol 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

Applies to nadolol: compounding powder, oral tablet

General

The most common adverse reactions were bradycardia, cardiac failure, rhythm/conduction disturbances, symptoms of peripheral vascular insufficiency, hypotension, dizziness, and fatigue.[Ref]

Cardiovascular

Common (1% to 10%): Heart rate less than 60 beats per minute (bpm), heart rate less than 40 bpm, cardiac failure, rhythm/conduction disturbances, symptoms of peripheral vascular insufficiency usually of the Raynaud type, hypotension
Frequency not reported: First degree and third degree heart block, cold extremities[Ref]

Nervous system

Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Paresthesias, sedation, headache, slurred speech, tinnitus
Frequency not reported: Lightheadedness[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, bloating, flatulence, dry mouth[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, dry skin, sweating, facial swelling
Frequency not reported: Reversible alopecia[Ref]

Respiratory

Uncommon (0.1% to 1%): Cough, nasal stuffiness, bronchospasm[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, weight gain
Frequency not reported: Hypoglycemia[Ref]

Ocular

Uncommon (0.1% to 1%): Dry eyes, blurred vision[Ref]

Psychiatric

Uncommon (0.1% to 1%): Change in behavior
Frequency not reported: Insomnia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Impotence or decreased libido[Ref]

Some side effects of nadolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes

Summary of Use during Lactation

Because of its relatively extensive excretion into breastmilk and its renal excretion, other beta-adrenergic blocking drugs are preferred to nadolol, especially while nursing a newborn or preterm infant.

Drug Levels

The excretion of beta-adrenergic blocking drugs into breastmilk is largely determined by their protein binding. Those with low binding are more extensively excreted into breastmilk.[1] Accumulation of the drugs in the infant is related to the fraction excreted in urine. With 25% protein binding, 70% renal excretion and long half-life, nadolol presents a high risk for accumulation in infants, especially neonates. It is estimated that a fully breastfed infant would receive about 5.1% of the maternal weight-adjusted dosage of nadolol.[2]

Maternal Levels. One mother received nadolol 20 mg daily during gestation for hypertension, with the last dose taken 20 hours before delivery. A single sample of breastmilk obtained 38 hours postpartum (58 hours after the last dose) was 146 mcg/L.[3]

After oral doses of 80 mg daily in 12 women, peak nadolol levels occurred in milk at an average of 6 hours after the dose, compared to peak serum levels at 2.7 hours. Serum and milk half-lives were both about 22 hours. Steady-state milk levels occurred after 3 days of therapy; peak milk levels averaged 443 mcg/L and the mean milk levels averaged 357 mcg/L. None of the infants were breastfed.[4][5]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information on nadolol was not found as of the revision date. A study of mothers taking beta-blockers during nursing found a numerically, but not statistically significant increased number of adverse reactions in those taking any beta-blocker. Although the ages of infants were matched to control infants, the ages of the affected infants were not stated. None of the mothers were taking nadolol.[6]

Effects on Lactation and Breastmilk

Relevant published information on the effects of beta-blockade or nadolol during normal lactation was not found as of the revision date. A study in 6 patients with hyperprolactinemia and galactorrhea found no changes in serum prolactin levels following beta-adrenergic blockade with propranolol.[7]

Alternate Drugs to Consider

Propranolol, Labetalol, Metoprolol

References

1. Riant P, Urien S, Albengres E et al. High plasma protein binding as a parameter in the selection of betablockers for lactating women. Biochem Pharmacol. 1986;35:4579-81. PMID: 2878668

2. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk. Clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988;14:217-40. PMID: 3292101

3. Fox RE, Marx C, Stark AR. Neonatal effects of maternal nadolol therapy. Am J Obstet Gynecol. 1985;152:1045-6. PMID: 4025452

4. Devlin RG, Fleiss PM. Nadolol excretion in human milk. Clin Pharmacol Ther. 1981;29:240. Abstract. DOI: doi:10.1038/clpt.1981.37

5. Devlin RG, Duchin KL, Fleiss PM. Nadolol in human serum and breast milk. Br J Clin Pharmacol. 1981;12:393-6. PMID: 6117304

6. Ho TK, Moretti ME, Schaeffer JK et al. Maternal beta-blocker usage and breast feeding in the neonate. Pediatr Res. 1999;45:67A. Abstract 385.

7. Board JA, Fierro RJ, Wasserman AJ et al. Effects of alpha- and beta-adrenergic blocking agents on serum prolactin levels in women with hyperprolactinemia and galactorrhea. Am J Obstet Gynecol. 1977;127:285-7. PMID: 556882

Substance Name

Nadolol

CAS Registry Number

42200-33-9

Drug Class

Antihypertensive Agents

Adrenergic Beta-Antagonists

Antiarrhythmics