Trandate

(Labetalol Hydrochloride)

The active ingredient in Normodyne is labetalol hydrochloride. Its pharmacology involves blocking both beta and alpha receptors in the body. This action slows the heart rate, relaxes blood vessels, and lowers blood pressure. By blocking catecholamines (hormones that normally tighten blood vessels and increase heart rate), labetalol reduces the force of the heart’s contractions and the pressure in the arteries, making it easier for the heart to pump and improving blood flow.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Normodyne. However, the following is a synopsis of the general guidelines for the use of Normodyne:

• Take Normodyne exactly as prescribed, usually by mouth in tablet form.
• The usual starting dose for adults with hypertension is 100 mg twice daily. Your doctor may increase this to help you reach your blood pressure goal.
• Normodyne can be taken with or without food.
• If you are switching from another blood pressure medication, your doctor will tell you how to adjust safely.
• Do not stop taking labetalol suddenly, as this can cause your blood pressure to rise and may increase the risk of chest pain (angina) or heart attack.

Some mild or common side effects of Normodyne include:

• Dizziness or lightheadedness, especially when standing up
• Fatigue or unusual tiredness
• Nausea or upset stomach
• Headache
• Sexual side effects like decreased libido
• Stuffy nose

Some individuals may experience serious side effects while using Normodyne. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Very slow heartbeat (bradycardia) or fainting
• Severe hypotension (very low blood pressure) with confusion or extreme weakness
• Signs of allergic reaction, such as swelling of the face, lips, or throat, trouble breathing, or hives
• Worsening heart failure, chest pain, sudden weight gain, or severe shortness of breath
• Signs of liver problems, like loss of appetite, yellowing of skin or eyes

These are not all of the possible side effects of Normodyne. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Normodyne, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Asthma or other bronchospasm‑prone lung disease.
• Slow or irregular heartbeat.
• Heart conduction issues, like heart block.
• Severe heart failure, heart disease, recent heart attack, or cardiogenic shock.
• Very low blood pressure (hypotension).
• Diabetes, as labetalol can mask low blood sugar signs like a fast heartbeat.

Your doctor may adjust your treatment if you have kidney or liver problems, are elderly (geriatric), or have other cardiovascular issues.

• Pheochromocytoma (adrenal gland tumor).

Normodyne should not be used if you have:

• A known allergy to labetalol
• Severe bradycardia
• Heart block beyond first degree
• Decompensated heart failure
• Cardiogenic shock
• Severe hypotension

You will see the effects of labetalol on your blood pressure within hours of a dose, but full therapeutic effects often take several days to weeks as your doctor adjusts the dosage forms and amounts to what works best for you.

When Normodyne is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other blood pressure medications like diltiazem, verapamil, or nitroglycerin, which can increase low blood pressure risk
• Drugs like cimetidine that may change how labetalol is broken down
• Medications for asthma, like albuterol

Labetalol tablets commonly come in 100 mg and 200 mg strengths. Doses are divided across the day based on your blood pressure needs. The total daily dose may reach up to 2,400 mg in some cases.

Store Normodyne (labetalol) at room temperature between about 20°C to 25°C (68°F to 77°F), away from moisture and heat. Keep out of reach of children and do not store outdated medicine.

Normodyne was historically marketed by pharmaceutical manufacturers, but the brand name has been discontinued in the U.S. The generic versions of labetalol are now made by multiple drug manufacturers.

While the original brand name Normodyne is not commonly used now, generic labetalol is available and widely prescribed.

Do not stop labetalol suddenly. Your doctor will usually reduce your dose gradually to avoid rebound high blood pressure, chest pain, or heart rhythm changes.

Labetalol is commonly used to treat high blood pressure in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They can help you weigh benefits and risks, as labetalol does pass into breast milk. They will know or recommend what is best for you.