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NORMODYNE
LABETALOL - INJECTION

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

LABETALOL - INJECTION

(luh-BET-uh-lol)

COMMON BRAND NAME(S): Normodyne, Trandate

Uses

This medication is used to treat severe high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

OTHER

Uses

This drug may also be used to decrease blood pressure during surgery, which can help decrease surgical bleeding.

How To Use

This medication is given slowly into a vein (IV) as repeated injections, or is given continuously as a diluted liquid (IV infusion). The dosage is based on your medical condition and response to the medication. Follow all instructions in the product package for proper dilution with the correct IV fluids. Consult your pharmacist for more details. You should remain lying down while this drug is being given and for 3 hours after a dose. The maximum blood pressure effect of labetalol usually occurs within 5 minutes of each injection. The maximum dosage of labetalol is 300 mg. Before using, visually check this product and diluted solutions of the drug for particles or discoloration. If either is present, do not use the liquid. Blood pressure must be monitored closely during and after drug administration. Rapid, excessive lowering of blood pressure should be avoided.

Side Effects

Fatigue, nausea, or tingling of the scalp/skin may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if this potentially serious side effect occurs: dizziness. Tell your doctor immediately if these unlikely but serious side effects occur: fainting, leg pain, increased sweating, increased urination, unusual thirst. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusually slow or irregular heartbeat, persistent loss of appetite, stomach pain, persistent sore throat or fever, easy bleeding or bruising, vision changes, difficulty urinating, mental/mood changes. Rare, but possibly fatal, liver problems have occurred during labetalol use. Seek immediate medical attention if you develop: dark urine, yellowing eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, call your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: liver problems, heart problems (e.g., mild/moderate congestive heart failure), pheochromocytoma, diabetes, any allergies. This medication is not recommended for use if you have the following medical conditions: lung disease (asthma, COPD), certain heart problems (e.g. advanced heart block, severe bradycardia, severe heart failure, post-CABG surgery). This drug may make you dizzy for up to 3 hours after it is given. You should remain lying down during this time period in order to prevent falls. You should get up slowly when rising from a seated or lying position; another person should assist you. Use caution when performing activities that require alertness such as driving or using machinery. Limit alcoholic beverages. If you have a history of severe allergic reactions, consult your doctor or pharmacist. Normal doses of epinephrine may not be as effective while you are using this medication. If you are diabetic, this drug may block certain symptoms of low blood sugar. Increased sweating is a symptom that is not affected. Consult your doctor or pharmacist for more details. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. Labetolol should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use, especially: "water pills" (diuretics such as hydrochlorothiazide), other heart medications (e.g., calcium channel blockers, nitroglycerin), cimetidine, glutethimide, asthma drugs (e.g., beta-agonist bronchodilator drugs such as albuterol), diabetes drugs, other high blood pressure drugs (e.g., clonidine, methyldopa), arbutamine, halothane anesthetic, tricyclic antidepressants (e.g., amitriptyline, desipramine). Alkaline medications (such as sodium bicarbonate or furosemide) must not be given in the same IV line as labetalol (a white precipitate may form). Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. This product can affect the results of certain lab tests (e.g., amphetamine). Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, call your local poison control center or emergency room immediately. Symptoms of overdose may include: severe dizziness, unusually slow heartbeat, fainting.

Notes

Laboratory and/or medical tests (e.g., liver function) may be performed to monitor your progress.

Missed Dose

If the dose is interrupted, contact the doctor immediately to re-establish dosing.

Storage

Store the vials at room temperature between 36 and 86 degrees F (2 to 30 degrees C) and away from light. Do not freeze. After dilution in the correct IV fluids, this product is stable for 24 hours refrigerated or at room temperature. Discard any unused liquid.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).