TRANDATE INJ (LABETALOL)

Labetalol HCl injection is a unique beta-blocker that exhibits both selective alpha-adrenergic receptor blocking activity and non-selective beta-adrenergic receptor blocking activity. It acts by competitively blocking the binding of catecholamines, such as adrenaline and noradrenaline, to these receptors. Specifically, labetalol binds to beta1-adrenergic receptors in the heart, reducing heart rate and cardiac contractility, which results in decreased cardiac output and blood pressure. Additionally, its alpha-blocking effect leads to vasodilation by inhibiting the constrictive influence of adrenaline and noradrenaline on alpha-adrenergic receptors in blood vessels, further contributing to the reduction of blood pressure. This dual mechanism of action makes labetalol particularly effective in the rapid control of hypertension and the management of hypertensive emergencies.

Labetalol HCl

Beta-blocker.

Injection

The following are the uses of Labetalol HCl Injection:

• Used for treating high blood pressure in emergency situations, quickly reducing blood pressure during a hypertensive crisis.
• Used for controlling blood pressure during and after surgery, ensuring stable vital signs.
• Used for managing hypertension in pregnancy, as it is relatively safe for both mother and fetus.
• Used for treating severe hypertension, offering a rapid and effective solution.
• Used for preventing and managing complications of high blood pressure, such as heart failure and kidney disease.
• Used for long-term management of hypertension when oral medications are not feasible or effective.
• Used for reducing the risk of cardiovascular events in high-risk patients with hypertension.

In the case of an overdose of Labetalol HCl Injection, prompt medical attention is necessary. Symptoms may include severe hypotension, bradycardia, dizziness, and even loss of consciousness. Treatment should focus on managing these symptoms and maintaining vital signs. This may involve discontinuing the medication, providing cardiovascular support, and monitoring vital signs until the patient stabilizes. It is crucial to seek medical assistance promptly to ensure appropriate management of the overdose.

In the case of a missed dose of Labetalol HCl Injection, it is important to administer the medication as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Avoid doubling the dose to make up for a missed one, as this may increase the risk of side effects. If you miss multiple doses, consult your healthcare professional for guidance on how to safely resume the medication. Always store the medication properly and handle it with care to ensure its effectiveness.

To administer Labetalol HCl Injection, ensure the solution is clear and free of particles, then using a sterile syringe, draw the prescribed dose, and inject it slowly into the intravenous line or as directed by your healthcare professional, following the recommended dosage and administration guidelines provided.

Following are the conditions/situations when Labetalol HCl Injection should not be administered:

• Must not be used in patients with a known allergy or hypersensitivity to Labetalol or any other beta-blockers.
• Contraindicated in patients with severe bradycardia (very slow heart rate).
• Should not be given to patients with cardiogenic shock, which is a condition where the heart cannot pump enough blood to meet the body's needs.
• Not recommended for individuals with severe heart block (a type of heart rhythm problem).
• Contraindicated in patients with severe hypotension (very low blood pressure).
• Should not be used in patients with severe respiratory failure or asthma, as it may worsen breathing difficulties.
• Must not be administered to patients with severe peripheral arterial disease.
• Contraindicated during severe forms of Raynaud's syndrome (a condition affecting blood vessels in fingers and toes).
• Not suitable for patients with a history of severe depression, especially when associated with beta-blocker use.

The side effects of Labetalol HCl Injection may include:

• Fatigue or weakness
• Dizziness or lightheadedness
• Headache
• Gastrointestinal issues such as nausea, vomiting, or diarrhea
• Decreased heart rate (bradycardia)
• Shortness of breath or wheezing
• Skin rashes or itching
• Cold extremities

Following are the precautions and warnings for Labetalol HCl Injection:

• Labetalol should be used with caution in patients with a history of asthma or other obstructive pulmonary diseases, as it may cause bronchospasm.
• It should be avoided in patients with severe bradycardia, heart block greater than first degree, or cardiogenic shock, as it may exacerbate these conditions.
• Use with caution in patients with a history of heart failure, as it may worsen symptoms, especially in those with decompensated heart failure.
• Monitor blood pressure and heart rate closely during administration, especially in patients with existing hypertension or cardiac conditions.
• Labetalol can cause orthostatic hypotension, especially during the initial stages of treatment. Patients should be advised to rise slowly from sitting or lying positions to prevent dizziness or fainting.
• Use with caution in patients with diabetes, as it may mask symptoms of hypoglycemia, such as tachycardia.
• Patients with liver impairment should be monitored closely, as labetalol is metabolized in the liver, and dosage adjustments may be necessary.
• Caution is advised when using labetalol in pregnant or breastfeeding women. It should only be used if the benefits outweigh the risks and under the supervision of a healthcare provider.
• Labetalol may interact with other antihypertensive drugs, antiarrhythmics, or medications that affect heart rate or blood pressure, so close monitoring is necessary when used in combination.
• In case of overdose, symptoms may include severe bradycardia, hypotension, and heart block. Seek immediate medical attention if these symptoms occur.
• Discontinuing labetalol abruptly may lead to rebound hypertension; therefore, it should be tapered gradually under the supervision of a healthcare provider.
• Monitor for signs of adverse effects such as dizziness, fatigue, or swelling, and report any unusual symptoms promptly to a healthcare provider.

Following are the drug interactions for Labetalol HCl Injection:

• Concomitant use with calcium channel blockers, nitrates, or other beta-blockers can lead to excessive blood pressure reduction.
• May enhance the effects of insulin and oral hypoglycemic agents, increasing the risk of hypoglycemia.
• Labetalol may increase the plasma concentrations of lidocaine and tocainide.
• Beta-blockers can reduce the effectiveness of certain asthma medications, such as beta-agonists.
• The hypotensive effects of Labetalol can be additive with other antihypertensive drugs.
• May reduce the elimination of certain medications like chlorpromazine and imipramine, leading to increased plasma levels.
• Concomitant use with clonidine may enhance the risk of rebound hypertension if either drug is discontinued abruptly.

Following are the food interactions to be aware of when taking Labetalol HCl Injection:

• Avoid consuming large amounts of grapefruit or grapefruit juice as it can interfere with the metabolism of Labetalol, potentially leading to increased blood levels of the medication.
• Alcohol consumption should be limited as it may enhance the hypotensive effects of Labetalol, causing excessive dizziness or lightheadedness.
• Caffeine intake from coffee, tea, or energy drinks should be monitored as it can counteract the blood pressure-lowering effects of Labetalol, making the medication less effective.
• High-sodium foods should be consumed in moderation as they can reduce the antihypertensive effects of Labetalol, making blood pressure control more challenging.
• A balanced diet rich in fruits, vegetables, and whole grains is recommended to support overall cardiovascular health during Labetalol treatment.
• Stay well-hydrated by drinking adequate water to maintain blood volume and ensure proper circulation, especially when Labetalol is administered intravenously.
• Avoid excessive consumption of high-fat meals as they may affect the absorption and distribution of Labetalol, potentially altering its effectiveness.
• Consult a healthcare professional for personalized dietary advice and monitoring, especially if you have pre-existing conditions like diabetes or heart disease.

Labetalol HCl Injection should be stored in a controlled environment, preferably in a cool and dry place, away from direct sunlight and moisture. The recommended storage temperature is between 20°C and 25°C (68°F to 77°F). It is crucial to keep the injection in its original packaging, tightly sealed, to maintain its sterility and integrity. Do not use the injection if the seal is broken or if there are any signs of tampering. When disposing of Labetalol HCl Injection, follow local regulations and guidelines for pharmaceutical waste disposal. Do not dispose of it in regular household trash or pour it down the drain. Contact your healthcare provider or pharmacist for guidance on proper disposal methods to ensure environmental safety. Keep this medication securely stored and out of the reach of children and pets.

Following are the quick tips for Labetalol HCl Injection:

• Ensure the injection is administered by a trained healthcare professional.
• Labetalol HCl Injection is typically given intravenously, follow the prescribed dosage and administration guidelines.
• Inform your doctor about any allergies or medical conditions before receiving the injection.
• Stay under medical observation during and after the injection for any immediate reactions.
• Avoid driving or operating heavy machinery until you know how the medication affects you.
• Report any persistent or severe side effects to your doctor promptly.
• Store the injection as directed, away from direct sunlight and extreme temperatures.