Labetalol Hydrochloride Injection USP 100mg/20ml Technical Specification:
Product Name: | Labetalol Hydrochloride Injection USP 100mg/20ml |
Brand Name: | Generic |
Strength: | 5mg/1ml, 20mg/4ml, 100mg/20ml, 200mg/40ml |
Dosage Form: | Liquid Injection (Sterile) |
Packing: | 5mg/1ml (Single Dose Vial/Ampoule) 20mg/4ml (Single Dose Vial/Ampoule) 100mg/20ml (Multi Dose Vial) 200mg/40ml (Multi Dose Vial) |
Route of Administration: | For I.V. use only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Anti-Hypertensive |
Indication: | Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension. |
Storage: | Store at 20°C to 25°C (68°F to 77°F). Store in a cool and dry place. Improper storage may be deteriorate the product. Protect from freezing and light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Labetalol Hydrochloride Injection USP 100mg/20ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………….45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP………………q.s
THERAPEUTIC INDICATIONS:
Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
DIRECTION OF USE:
For Intravenous use only.
See package insert for usual dosage.
CAUTION & Warning:
CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Why Taj pharmaceuticals?
At Taj Pharmaceuticals, our commitment to providing high-quality pharmaceuticals is at the core of our mission. Labetalol Hydrochloride is a medication that plays a crucial role in managing hypertension (high blood pressure) and certain cardiac conditions. We understand the importance of reliable and effective medications in the treatment of cardiovascular issues, and we take our responsibility seriously. Labetalol Hydrochloride is a non-selective beta-blocker that not only helps lower blood pressure but also manages heart conditions such as angina and arrhythmias. By blocking certain receptors in the heart and blood vessels, it reduces the workload on the heart and promotes smoother blood flow, thereby aiding in the control of hypertension.
Our pharmaceutical products, including Labetalol Hydrochloride, undergo rigorous quality control processes to ensure they meet and exceed international standards. We prioritize the safety and well-being of patients, and our commitment to pharmaceutical excellence is reflected in the quality of our medications. Hypertension and heart conditions are significant health concerns worldwide, and we recognize the impact these conditions can have on individuals and their families. By choosing Taj Pharmaceuticals, you choose a partner dedicated to delivering pharmaceutical products that can help improve the lives of those affected by these conditions. With a global presence and a reputation for excellence, Taj Pharmaceuticals is a trusted source for medications like Labetalol Hydrochloride. We invite you to experience the difference in pharmaceutical quality and reliability that we offer. Trust Taj Pharmaceuticals for your medication needs, and join us in our mission to create a healthier world with improved cardiovascular health.
What is Labetalol Hydrochloride and its uses
Labetalol Hydrochloride is a medication primarily used to treat high blood pressure (hypertension) and manage certain heart conditions. It belongs to a class of drugs known as beta-blockers, which work by affecting the response to nerve impulses in the body, particularly in the heart.
Here are the main uses of Labetalol Hydrochloride:
- Hypertension (High Blood Pressure) Management: Labetalol is highly effective in lowering blood pressure. It works by blocking the action of certain chemicals that can increase heart rate and narrow blood vessels. By doing so, it reduces the workload on the heart and helps blood vessels to relax, leading to a decrease in blood pressure. This makes it a valuable medication for individuals with both mild and severe hypertension.
- Angina (Chest Pain) Treatment: Labetalol may be used to manage angina, a condition characterized by chest pain or discomfort that occurs when the heart muscle doesn’t receive enough oxygen-rich blood. By reducing the heart’s workload and demand for oxygen, Labetalol can help alleviate angina symptoms.
- Heart Rhythm Disorders (Arrhythmias): In certain cases, Labetalol may be prescribed to manage irregular heart rhythms or arrhythmias. It helps stabilize the heart rate and rhythm, making it beneficial for individuals with specific types of arrhythmias.
- Hypertensive Emergencies: Labetalol can be used in hypertensive emergencies, which are situations where blood pressure is dangerously high and requires immediate treatment to prevent organ damage. It can be administered intravenously for rapid blood pressure reduction in a controlled medical setting.
- Heart Failure: Labetalol may be considered as part of the treatment plan for heart failure, particularly when high blood pressure is contributing to the condition. It can help improve the heart’s efficiency and reduce the workload on the heart muscle.
It’s important to note that Labetalol Hydrochloride is typically prescribed by a healthcare provider based on an individual’s specific medical condition and needs. The dosage and duration of treatment may vary depending on the severity of the condition and the patient’s response to the medication. Labetalol Hydrochloride can be an essential component of managing hypertension and certain heart conditions, helping individuals maintain better cardiovascular health and reduce the risk of complications associated with high blood pressure.
How does Labetalol Hydrochloride Work?
Labetalol Hydrochloride works primarily as a nonselective betablocker, affecting both beta1 (β1) and beta2 (β2) adrenergic receptors in the body. It also has some alpha1 (α1) adrenergic blocking properties. The combined action on these receptors leads to its therapeutic effects. Here’s how Labetalol Hydrochloride works:
- Beta1 Adrenergic Receptor Blockade: Labetalol selectively blocks beta1 adrenergic receptors found in the heart. These receptors are typically stimulated by the hormone adrenaline (epinephrine) and are responsible for increasing heart rate and the force of heart contractions. By blocking these receptors, Labetalol reduces the heart’s response to adrenaline, leading to the following effects:
- Slower Heart Rate: Labetalol decreases the heart rate, which reduces the workload on the heart muscle. This can help lower blood pressure, especially in cases of rapid or irregular heart rates.
- Reduced Contractility: It decreases the force with which the heart muscle contracts, which, in turn, reduces the heart’s oxygen demand. This is beneficial for individuals with angina or heart failure.
- Alpha1 Adrenergic Receptor Blockade: Labetalol also has alpha1 adrenergic blocking properties. Alpha1 receptors are found in blood vessels, and their stimulation causes blood vessels to constrict or narrow. By blocking alpha1 receptors, Labetalol causes blood vessels to relax and dilate, reducing peripheral resistance. This results in improved blood flow and a reduction in systemic vascular resistance, which contributes to lower blood pressure.
- Dual Action: Labetalol’s unique combination of beta1, beta2, and alpha1 receptor blocking effects makes it effective for the treatment of hypertension and other cardiovascular conditions. It not only lowers blood pressure by reducing cardiac output (heart rate and contractility) but also by relaxing blood vessels, which further reduces blood pressure.
- Blood Pressure Reduction: The overall result of Labetalol’s action is a decrease in blood pressure. This is particularly valuable for individuals with hypertension, as it helps bring their blood pressure within a healthier range, reducing the risk of complications associated with high blood pressure, such as heart attacks and strokes.
Labetalol Hydrochloride is typically administered orally as tablets or intravenously in certain situations, especially during hypertensive emergencies. The specific dosage and treatment plan are determined by a healthcare provider based on the individual’s condition, blood pressure levels, and response to the medication. It’s important for patients to follow their healthcare provider’s instructions carefully when taking Labetalol to achieve optimal results in managing blood pressure and heart conditions.
Benefits of Labetalol Hydrochloride:
- Effective Blood Pressure Control: Labetalol Hydrochloride is highly effective in lowering high blood pressure (hypertension). By blocking beta-1 and alpha-1 adrenergic receptors, it reduces heart rate, cardiac output, and peripheral vascular resistance, leading to a significant decrease in blood pressure.
- Treatment of Hypertensive Emergencies: Labetalol is used in hypertensive emergencies, situations where blood pressure is dangerously high and requires rapid reduction to prevent organ damage. Its intravenous form can provide quick and controlled blood pressure reduction in a clinical setting.
- Management of Angina: Labetalol can be beneficial in managing angina (chest pain) by reducing the heart’s workload and oxygen demand. This can help alleviate symptoms and improve the quality of life for individuals with angina.
- Heart Rhythm Control: In some cases, Labetalol may be prescribed to manage certain irregular heart rhythms or arrhythmias. By stabilizing heart rate and rhythm, it helps maintain normal cardiac function.
- Heart Failure: Labetalol may be used as part of the treatment plan for heart failure, especially when high blood pressure contributes to the condition. It can help improve the heart’s efficiency and reduce the strain on the heart muscle.
Side Effects of Labetalol Hydrochloride:
- Low Blood Pressure: One of the potential side effects of Labetalol is low blood pressure (hypotension). This can lead to dizziness, light-headedness, or fainting, especially when standing up quickly. It’s important to rise slowly from a sitting or lying position to minimize this effect.
- Bradycardia: Labetalol can slow down the heart rate, leading to bradycardia (a heart rate that is too slow). This effect may not be suitable for individuals with pre-existing bradycardia or certain heart conditions.
- Fatigue: Some individuals may experience fatigue or tiredness while taking Labetalol. This side effect can affect daily activities, so caution is needed when driving or operating heavy machinery.
- Gastrointestinal Issues: Gastrointestinal side effects may include nausea, vomiting, diarrhea, or abdominal discomfort. Taking Labetalol with food can help alleviate these symptoms.
- Bronchospasm: Labetalol may exacerbate asthma symptoms in individuals with asthma or chronic obstructive pulmonary disease (COPD). It should be used cautiously in such cases.
It’s essential for individuals taking Labetalol Hydrochloride to communicate any side effects or concerns with their healthcare provider. Dosage adjustments or alternative medications may be considered to minimize side effects and ensure the best treatment outcomes. This information is not exhaustive, and patients should consult their healthcare providers for personalized guidance on Labetalol use.
Frequently Asked Questions About Labetalol Hydrochloride:
Certainly, here are some frequently asked questions (FAQs) about Labetalol Hydrochloride:
- What is Labetalol Hydrochloride used for?
Labetalol Hydrochloride is primarily used to treat high blood pressure (hypertension) and manage certain heart conditions, including angina and certain irregular heart rhythms.
- How does Labetalol Hydrochloride work to lower blood pressure?
Labetalol Hydrochloride lowers blood pressure by blocking certain receptors (beta1 and alpha1 adrenergic receptors) in the heart and blood vessels. This results in a reduced heart rate, decreased cardiac output, and relaxation of blood vessels, leading to lower blood pressure.
- Is Labetalol Hydrochloride safe to use during pregnancy?
Labetalol may be considered safe for use during pregnancy, particularly when the benefits of blood pressure control outweigh the potential risks. However, it should be used under the guidance of a healthcare provider, and close monitoring is essential.
- Can Labetalol Hydrochloride be used in hypertensive emergencies?
Yes, Labetalol can be used to treat hypertensive emergencies, situations where blood pressure is dangerously high and requires rapid reduction to prevent organ damage. Intravenous administration is often used in these cases.
- What are the common side effects of Labetalol Hydrochloride?
Common side effects may include low blood pressure (hypotension), dizziness, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea), and a slowed heart rate (bradycardia).
- Is it necessary to monitor heart rate while taking Labetalol Hydrochloride?
Yes, regular monitoring of heart rate and blood pressure is typically recommended while taking Labetalol. This helps ensure that the medication is effectively controlling blood pressure without causing bradycardia (slow heart rate).
- Can Labetalol Hydrochloride be taken with other medications?
Labetalol may interact with other medications, including other antihypertensive drugs and medications for heart conditions. It’s important to inform your healthcare provider about all the medications and supplements you are taking to prevent potential interactions.
- Can Labetalol Hydrochloride be stopped abruptly?
Abruptly stopping Labetalol can lead to a rebound increase in blood pressure and should be avoided. If discontinuation is necessary, it should be done gradually under the supervision of a healthcare provider.
- Can Labetalol Hydrochloride be used in individuals with asthma or lung conditions?
Labetalol should be used cautiously in individuals with asthma or chronic obstructive pulmonary disease (COPD), as it may worsen their respiratory symptoms.
- Is it safe to consume alcohol while taking Labetalol Hydrochloride?
Alcohol consumption should be limited while taking Labetalol, as it can interact with the medication and may exacerbate side effects such as dizziness and low blood pressure.
Patients should always follow their healthcare provider’s recommendations and guidance regarding the use of Labetalol Hydrochloride, and they should not hesitate to ask questions or seek clarification about their treatment plan.
As Labetalol Hydrochloride Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Labetalol Hydrochloride Injection product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Labetalol Hydrochloride Injection Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Labetalol Hydrochloride Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Labetalol Hydrochloride Injection USP 5mg/1ml
B. Labetalol Hydrochloride Injection USP 20mg/4ml
C. Labetalol Hydrochloride Injection USP 100mg/20ml
D. Labetalol Hydrochloride Injection USP 200mg/40ml
B. Labetalol Hydrochloride Injection USP 20mg/4ml
C. Labetalol Hydrochloride Injection USP 100mg/20ml
D. Labetalol Hydrochloride Injection USP 200mg/40ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Labetalol Hydrochloride Injection USP 5mg/1ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………....45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP…………...q.s
B. Labetalol Hydrochloride Injection USP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP…………….…0.10mg
Methylparaben USP…………………..0.80mg
Propylparaben USP………………......0.10mg
Water for Injection USP……………..q.s
C. Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………...0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP……….….q.s
D. Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP…………….…..0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP…………..q.s
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………....45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP…………...q.s
B. Labetalol Hydrochloride Injection USP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP…………….…0.10mg
Methylparaben USP…………………..0.80mg
Propylparaben USP………………......0.10mg
Water for Injection USP……………..q.s
C. Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………...0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP……….….q.s
D. Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP…………….…..0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP…………..q.s
THERAPEUTIC INDICATIONS:
Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
DIRECTION OF USE:
For Intravenous use only.
See package insert for usual dosage.
See package insert for usual dosage.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.