Trandate

DRUG DESCRIPTION

Trandate (labetalol) Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.

Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure:

TRANDATE® (labetalol hydrochloride) Structural Formula Illustration

Labetalol HCl has the empirical formula C19H24N2O3•HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol.

Labetalol HCl is a white or off-white crystalline powder, soluble in water.

Trandate Tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100- and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.

What are the possible side effects of labetalol (Normodyne, Trandate)?

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:

  • slow or uneven heartbeats;
  • feeling light-headed, fainting;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice...

Read All Potential Side Effects and See Pictures of Trandate »

What are the precautions when taking labetalol (Trandate)?

Before taking labetalol, tell your doctor or pharmacist if you are allergic to it; 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), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: treated stable heart failure, kidney disease, liver disease,...

Read All Potential Precautions of Trandate »


Trandate Consumer (continued)

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness and tiredness may occur. Scalp tingling may also occur as your body adjusts to the medication. 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 drug 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, trouble breathing, 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 confusion, mood swings, depression).

This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but serious side effects, seek immediate medical attention: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

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 labetalol, tell your doctor or pharmacist if you are allergic to it; 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), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: treated stable heart failure, kidney disease, liver disease, overactive thyroid disease (hyperthyroidism), serious allergic reactions including those needing treatment with epinephrine, blood circulation problems (such as Raynaud's disease, peripheral vascular disease), mental/mood disorders (such as depression), a certain muscle disease (myasthenia gravis).

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.

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.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug, including dizziness and lightheadedness.

Labetalol has been used to treat high blood pressure in pregnant women. It is important to control high blood pressure for the health of the mother and unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor the benefits and risks of using this medication during pregnancy. Rarely, babies born to mothers who took labetalol during pregnancy may have symptoms of low blood pressure, slow heartbeat, slow breathing, and low blood sugar (such as shaking, unusual sweating) for a few days after delivery. Tell the doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Trandate Patient Information Including Side Effects

Brand Names: Normodyne, Trandate

Generic Name: labetalol (Pronunciation: la BAY ta lol)

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

What is labetalol (Trandate)?

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

Labetalol is used to treat hypertension (high blood pressure).

Labetalol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of labetalol (Trandate)?

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:

  • slow or uneven heartbeats;
  • feeling light-headed, fainting;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • depression; or
  • cold feeling in your hands and feet.

Other less serious side effects are more likely to occur, such as:

  • decreased sex drive, impotence, or difficulty having an orgasm;
  • sleep problems (insomnia);
  • tired feeling; or
  • anxiety, nervousness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about labetalol (Trandate)?

Do not stop taking labetalol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need to have any type of surgery, you may need to temporarily stop using labetalol. Be sure the surgeon knows ahead of time that you are using labetalol.

Labetalol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking labetalol.

Labetalol 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.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

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