Labetalol 200mg Tablets

Labetalol is a selective alpha-1 adrenergic blocker and a non-selective beta-adrenergic blocker. It competitively blocks alpha-1 receptors in vascular smooth muscle, leading to vasodilation and reduced peripheral vascular resistance. It also non-selectively blocks beta-1 and beta-2 adrenergic receptors, leading to decreased heart rate, myocardial contractility, and renin release. The combined alpha and beta blockade results in a reduction in blood pressure without reflex tachycardia, and with preservation of cerebral blood flow.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Slow heartbeat
Abnormal burning, numbness, or tingling sensations
Erectile dysfunction
Heart failure or worsening of existing heart failure, characterized by:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ New or worsening swelling in the arms or legs
Liver problems, which may be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

If you have a history of heart disease, inform your doctor, as this medication may increase the risk of heart failure.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention if they bother you or persist:

Dizziness
Fatigue
Weakness
Upset stomach
Tingling sensation on the scalp
* Stuffy nose

This is not an exhaustive list of potential side effects. If you have questions or concerns, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have low blood pressure.
If you have any of the following health conditions:
+ Respiratory problems, such as asthma or COPD (chronic obstructive pulmonary disease)
+ Heart block
+ Heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
If you are currently taking diltiazem or verapamil.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work and other laboratory tests done as directed by your doctor.

Interference with Lab Tests
This medication may affect certain laboratory tests. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.

Risk of Low Blood Sugar
This medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This risk is higher in people with diabetes, children, and individuals who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, discuss them with your doctor.

Diabetes Management
If you have high blood sugar (diabetes), it is crucial to closely monitor your blood sugar levels while taking this medication.

Stopping the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even a heart attack, especially if you have certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Allergic Reactions
If you have a history of severe allergic reactions, consult your doctor, as you may be at risk of an even more severe reaction. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as this medication may reduce the effectiveness of epinephrine.

Eye Procedures
If you are scheduled to undergo cataract surgery or other eye procedures, inform your doctor.

Over-the-Counter Medications
Before taking any over-the-counter products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor.

Special Considerations for Older Adults
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

• Bronchial asthma or history of obstructive airway disease
• Overt cardiac failure
• Greater than first-degree heart block
• Cardiogenic shock
• Severe bradycardia
• Severe hepatic impairment

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and heart failure.
• MAO inhibitors: Potentiation of hypotensive effects.
• Tricyclic antidepressants: Increased risk of tremor.
• Cimetidine: Increases labetalol bioavailability, leading to increased effects.
• General anesthetics (e.g., halothane, cyclopropane): Potentiation of hypotensive effects and myocardial depression.
• Clonidine: Abrupt withdrawal of clonidine while on labetalol can lead to rebound hypertension.

• NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of labetalol.
• Alpha-1 agonists (e.g., phenylephrine, pseudoephedrine): May cause severe hypertension due to unopposed alpha-stimulation.
• Insulin and oral hypoglycemics: Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
• Digoxin: Increased risk of bradycardia.
• Ergot alkaloids: Increased risk of peripheral vasoconstriction.

• Alcohol: May enhance hypotensive effects.
• Antacids: May reduce labetalol absorption (separate administration).

• Dizziness
• Lightheadedness
• Fatigue
• Nausea
• Headache
• Bradycardia (slow heart rate)
• Orthostatic hypotension (dizziness upon standing)
• Shortness of breath or wheezing (especially in patients with underlying respiratory conditions)
• Peripheral edema
• Signs of liver injury (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)

Labetalol is often used for hypertension in pregnancy, particularly for pre-eclampsia/eclampsia, due to its relatively favorable safety profile compared to other antihypertensives. However, it is classified as Pregnancy Category C. There have been reports of adverse effects on the fetus/neonate (e.g., bradycardia, hypoglycemia, respiratory depression) when used during late pregnancy, especially close to delivery. Close monitoring of the neonate for 24-48 hours after birth is recommended.

Labetalol is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2 - Safer). Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding).

Safety and efficacy have not been established in pediatric patients. Use is generally off-label for severe hypertension in children, with dosing based on weight and close monitoring. Not recommended for routine use.

Use with caution in elderly patients, starting with lower doses and titrating slowly, due to increased sensitivity to hypotensive effects and potential for reduced hepatic function. Monitor closely for adverse effects, especially orthostatic hypotension and bradycardia.

• Labetalol offers both alpha-1 and non-selective beta-blockade, providing a unique hemodynamic profile that can be beneficial in certain hypertensive emergencies or in pregnancy-induced hypertension.
• Unlike pure beta-blockers, labetalol typically does not cause reflex tachycardia due to its alpha-1 blocking properties.
• Oral labetalol should not be stopped abruptly, especially in patients with ischemic heart disease, as it can exacerbate angina or precipitate myocardial infarction due to beta-blocker withdrawal syndrome.
• Patients should be advised to take labetalol with food to enhance its bioavailability and reduce variability in absorption.
• Caution is advised in patients with a history of bronchospastic disease (e.g., asthma, COPD) due to its non-selective beta-blocking activity, although it may be used cautiously if no safer alternative exists.
• Monitor for orthostatic hypotension, especially during initial dosing and dose escalations.

• Other Beta-blockers (e.g., Metoprolol, Atenolol, Carvedilol)
• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine, Diltiazem, Verapamil)
• Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• Alpha-1 Blockers (e.g., Prazosin, Terazosin)
• Direct Vasodilators (e.g., Hydralazine, Minoxidil)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.