DrugindexOnline^{2nd edition}

Generic name: Labetalol hydrochloride
Brand names: Trandate, Normodyne

Why is Labetalol hydrochloride prescribed?

Normodyne is used in the treatment of high blood pressure. It is effective when used alone or in combination with other high blood pressure medications, especially thiazide diuretics such as HydroDIURIL and "loop" diuretics such as Lasix.

Most important fact about Labetalol hydrochloride

You must take Normodyne regularly for it to be effective. Since blood pressure declines gradually, it may be several weeks before you get the full benefit of Normodyne; and you must continue taking it even if you are feeling well. Normodyne does not cure high blood pressure; it merely keeps it under control.

How should you take Labetalol hydrochloride?

Normodyne can be taken with or without food. The amount of Normodyne absorbed into your bloodstream is actually increased by food.

This medication should be taken exactly as prescribed by your doctor, even if your symptoms have disappeared.

Try not to miss any doses. If Normodyne is not taken regularly, your condition may worsen.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Normodyne.

• More common side effects may include:
  Dizziness, fatigue, indigestion, nausea, stuffy nose

Why should Labetalol hydrochloride not be prescribed?

You should not take Normodyne if you suffer from an obstructive airway disease such as bronchial asthma, congestive heart failure, heart block (a heart irregularity), inadequate blood supply to the circulatory system (cardiogenic shock), a severely slow heartbeat, or any other condition that causes severe and continued low blood pressure.

If you are sensitive to or have ever had an allergic reaction to Normodyne or any of its ingredients you should not take Labetalol hydrochloride.

Special warnings about Labetalol hydrochloride

Normodyne has caused severe liver damage in some people. Although this is a rare occurrence, if you develop any symptoms of abnormal liver function--itching, dark urine, continuing loss of appetite, yellow eyes and skin, or unexplained "flu-like" symptoms--contact your doctor immediately.

If you have a history of congestive heart failure, or kidney or liver disease, Normodyne should be used with caution.

Normodyne should not be stopped suddenly. This can cause chest pain and heart attack. Dosage should be gradually reduced.

If you suffer from asthma, chronic bronchitis, emphysema, or other bronchial diseases, Normodyne should be used cautiously.

This medication may mask the symptoms of low blood sugar or alter blood sugar levels. If you are diabetic, discuss this with your doctor.

Notify your doctor or dentist that you are taking Normodyne if you have a medical emergency, and before you have surgery or dental treatment.

Possible food and drug interactions when taking Labetalol hydrochloride

If Normodyne is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before taking Normodyne with the following:

Airway opening drugs such as Proventil and Ventolin
Antidepressant medications such as Elavil
Cimetidine (Tagamet)
Diabetes drugs such as Micronase
Epinephrine (EpiPen)
Insulin
Nitroglycerin products such as Transderm-Nitro
Nonsteroidal anti-inflammatory drugs such as Advil and Motrin
Ritodrine (Yutopar)
Verapamil (Calan)

Special information if you are pregnant or breastfeeding

The effects of Normodyne during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Normodyne appears in breast milk and could affect a nursing infant. If Labetalol hydrochloride is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

Recommended dosage

ADULTS

Your doctor will adjust the dosages to fit your needs. Your doctor may observe the drug's effect in his or her office over a 1- to 3-hour period after you begin taking it, and then check your pressure again at regular office visits (12 hours after a dose) to make sure that the medicine is effective.

The usual starting dose is 100 milligrams, 2 times per day, alone or with a diuretic drug. After 2 to 3 days of checking your blood pressure, your doctor may begin increasing your dose by 100 milligrams, 2 times per day, at intervals of 2 to 3 days.

The regular dose ranges from 200 to 400 milligrams, 2 times per day. Some people may require total daily dosage of as much as 1,200 to 2,400 milligrams, either alone or with a thiazide diuretic. In these cases, your doctor will observe the drug's effect and adjust your dose accordingly.

CHILDREN

The safety and effectiveness of Labetalol hydrochloride in children have not been established.

OLDER ADULTS

The usual starting dose is the same as younger people's--100 milligrams twice a day. Your doctor may increase the dose, but usually to no more than 200 milligrams twice a day.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical treatment immediately.

• Symptoms of Normodyne overdose may include:
  Dizziness when standing up, severely low blood pressure, severely slow heartbeat