Brand Name

Trandate {Prometheus Pharma}

Generic Name

labetalol, pronounced la BAY ta lol

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Trandate?

Trandate is a medication that is used to treat hypertension, also known as high blood pressure. Trandate is in a class of medications called beta blockers, and works to help the blood flow through your arteries and veins. Trandate may be used for purposes not indicated in this medication guide.

Key Facts About Trandate

Trandate is a part of a complete program that your doctor has prescribed for you. This program includes diet, exercise, weight control, and possibly other medications. Follow your diet, medication, and exercise routines closely.

PREGNANCY/BREASTFEEDING: We do not know if Trandate can harm an unborn baby. Tell your doctor if you are pregnant or if you plan to become pregnant before taking Trandate. Trandate passes into breast milk and could cause harm to a nursing baby. You should not breast-feed while you are taking Trandate.

SURGERY: Trandate is a medication that may need to be stopped before surgery. Talk to your doctor if you are having surgery and carry a medical alert card for emergencies. If you are having cataract surgery you should be aware that Trandate can affect your pupils. Tell your eye surgeon ahead of time that you are using this medication.

While you are taking Trandate be careful when doing anything that requires you to be alert, such as driving. Trandate may impair your thinking and reaction time.

Never skip doses of Trandate or stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems, like severe chest pain or a heart attack. Your doctor may need to taper you off Trandate slowly if you wish to stop taking Trandate.

Before You Take Trandate

You should not take Trandate if you are allergic to labetalol.

If you have asthma or chronic obstructive pulmonary disease (COPD) you should not take Trandate.

If you have a serious heart condition like “AV block”, slow heart rhythm or a condition that causes low blood pressure you should not take Trandate.

Tell your doctor if you have liver disease, kidney disease, diabetes, sleep apnea, bronchitis or emphysema. You may need to have dose adjustments and frequent blood tests while using Trandate.

Before taking Trandate, tell your doctor if you have congestive heart failure or a breathing problem.

Let your doctor know if you a pheochromocytoma (tumor of the adrenal gland) before starting treatment with Trandate.

You will need to have your blood pressure checked regularly while taking Trandate. Continue using Trandate even if you feel well. High blood pressure often has no symptoms. You may need to use Trandate or another blood pressure medication for the rest of your life.

Trandate Drug Interactions

You should inform your doctor if you are taking any of the following:

• antidepressants like amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin, Zyban), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), paroxetine (Paxil), and sertraline (Zoloft)
• asthma or other breathing disorder medications like albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl)
• cimetidine (Tagamet)
• digoxin (digitalis, Lanoxin)
• diuretics
• heart or blood pressure medications like amlodipine
• Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia) and verapamil (Calan, Covera, Isoptin, Verelan)
• insulin or oral diabetes medications
• nitroglycerin (Nitro-Dur, Nitrolingual, Nitrostat, Transderm-Nitro)

Other drugs you take that are not listed may interact with Trandate. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Trandate

You should follow the instructions on your prescription label and not take Trandate for longer than recommended by your doctor, or in larger or smaller doses.

Trandate can be taken with or without food.

Trandate is only a part of a regimen that your doctor may have prescribed for you. This regimen might include diet, exercise and weight management for healthy living. Be sure to follow your doctor’s instructions.

If you need surgery be sure to tell the surgeon and staff that you are taking Trandate.

Trandate should be stored at room temperature, and away from both moisture and heat.

If you miss a dose of Trandate you should attempt to take the missed dose as soon as you remember, but only if your next dose is less than 8 hours away. Do not take the missed dose in addition to your regular dose.

Trandate Side Effects

Seek emergency help it

you experience any of the following adverse effects.

• v allergic reaction such as breathing difficulties, hives and swelling of your face, lips, throat or tongue
• v faint feeling like you might pass out
• v nausea with upper stomach pain, itching, jaundice, appetite loss, clay colored stools and dark urine
• v shortness of breath, even with mild exertion
• v slow or uneven heartbeats
• v swelling with rapid weight gain

Less serious Trandate side effects may include:

• difficulty having an orgasm
• dizziness or spinning sensation
• drowsiness
• nausea
• tingly feeling on scalp
• tired feeling
• upset stomach

It should be noted that this is not a complete list of possible side effects of Trandate. You should contact your physician for a complete list and medical advice regarding these effects.

Trandate Description and Dosing

Trandate tablets are available as 100 mg, 200 mg and 300 mg. The 100 mg tablets are light orange, round, scored, film-coated and engraved on one side with “Trandate 100”. The 200 mg tablets are white, round, scored, film-coated and engraved on one side with “Trandate 200”. The 300 mg tablets are mid-orange, round, scored, film-coated and engraved on one side with “Trandate 300”.

Consult your doctor for specific dosing pertaining to you. You should take Trandate exactly as your doctor prescribes you to. Do not attempt to alter or change your dose without your physician’s consent.

If you believe you may have overdosed with Trandate seek emergency medical help immediately.

Ingredients in Trandate:

Trandate contains the active ingredient labetalol HCl. Additional inactive ingredients include 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.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.