GENERIC NAME OF MEDICINAL PRODUCT:

(A) Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
(B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Nicardipine Hydrochloride Injection USP 10mg/10ml (1mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..1mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.

B) Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
Each ml contains:
Nicardipine Hydrochloride USP………..2.5mg
Benzoic acid USP ………….3.05mg
Sodium chloride USP………75mg
Water for Injection USP…………q.s.


THERAPEUTIC INDICATION:

Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
Must be diluted before infusion.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Discard the unused portion after use.
Dosage: As directed by Physician.

Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml) Technical Specification:

Product Name:Nicardipine Hydrochloride Injection USP
Brand Name:(GENERICS)
Strength:10mg/10ml (1mg/ml), 25mg/10ml (2.5mg/ml)
Dosage Form:Liquid Injection (Sterile)
Packing:10ml Ampoules, Vial (single-dose)
Route of Administration:For Intravenous Infusion
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-angina, Anti-hypertensive, Calcium channel blocker.
Indication: Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage:Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml)
    Each ml contains:
    Nicardipine Hydrochloride USP………..2.5mg
    Benzoic acid USP ………….3.05mg
    Sodium chloride USP………75mg
    Water for Injection USP…………q.s. 

THERAPEUTIC INDICATION:

Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION: Do not use it if the solution is not clear or has suspended matter.

Must be diluted before infusion. 

KEEP OUT OF REACH OF CHILDREN.

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° to 77°). See USP-controlled room temperature.

Discard the unused portion after use. 

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Elevate your healthcare standards with Taj Pharma’s Nicardipine Hydrochloride Injection USP. As a reputable pharmaceutical company, we prioritize your well-being by offering a dependable and effective cardiovascular treatment option. Our commitment to quality and safety ensures that you receive the best care possible. With decades of experience in the industry, Taj Pharma is a name you can rely on. Our Nicardipine Hydrochloride Injection USP is manufactured with precision and undergoes rigorous quality checks to meet international standards. Whether you’re a healthcare professional looking for a trusted solution or a patient seeking reliable treatment, choose Taj Pharma for peace of mind. Discover how Taj Pharma’s Nicardipine Hydrochloride Injection USP can make a difference in cardiovascular health. Explore our range of pharmaceutical solutions today, backed by our unwavering dedication to your health and well-being. Trust in Taj Pharma for excellence in healthcare.

What are Nicardipine Hydrochloride Injection USP and its use?

Nicardipine Hydrochloride Injection USP is a medication used in the treatment of various cardiovascular conditions. It belongs to a class of drugs known as calcium channel blockers. Nicardipine works by relaxing and dilating the blood vessels, which in turn helps to lower blood pressure and improve blood flow to the heart muscle.

Uses of Nicardipine Hydrochloride Injection USP:

  • Hypertension (High Blood Pressure): Nicardipine is often used in hospital settings to treat severe hypertension or high blood pressure, especially in situations where rapid blood pressure control is needed, such as in hypertensive emergencies.
  • Angina Pectoris: It may also be used to manage stable angina (chest pain) and variant angina (Prinzmetal’s angina) by reducing the workload on the heart and improving blood supply to the heart muscle.
  • Postoperative Hypertension: Nicardipine may be administered after surgery, particularly cardiac surgery, to manage and prevent high blood pressure.
  • Subarachnoid Hemorrhage: In some cases, it can be used to manage blood pressure in patients with subarachnoid hemorrhage, a type of stroke.

Nicardipine is typically administered intravenously (IV) in a hospital or clinical setting, as it requires careful monitoring of blood pressure and heart rate during treatment. The dosage and duration of treatment will be determined by a healthcare provider based on the specific medical condition and the patient’s response to the medication.

How does Nicardipine Hydrochloride Injection USP work?

Nicardipine Hydrochloride Injection USP works by blocking calcium channels in cells, primarily in the smooth muscle cells lining blood vessels and in cardiac muscle cells. This mechanism of action makes it a calcium channel blocker, specifically a dihydropyridine calcium channel blocker. Here’s how it works:

  • Blocking Calcium Influx: Calcium ions play a crucial role in muscle contraction, including the contraction of smooth muscle cells in blood vessel walls and cardiac muscle cells in the heart. By blocking calcium channels, Nicardipine reduces the influx of calcium ions into these muscle cells.
  • Vasodilation: In blood vessels, the reduced influx of calcium ions causes relaxation and dilation of the smooth muscle lining the vessel walls. This dilation leads to an increase in the diameter of the blood vessels, resulting in reduced resistance to blood flow. As a result, blood pressure decreases, making it an effective treatment for hypertension (high blood pressure).
  • Cardiac Effects: Nicardipine also affects the heart by reducing the contractility of cardiac muscle cells. This means that the force with which the heart contracts is decreased. As a result, the heart’s workload is reduced, and it consumes less oxygen. This effect is beneficial in treating conditions like angina (chest pain) and certain types of cardiac arrhythmias (irregular heart rhythms).

By dilating blood vessels and reducing cardiac workload, Nicardipine Hydrochloride Injection USP helps improve blood flow and reduce the workload on the heart. This can be especially useful in conditions where there is an increased demand for oxygen by the heart muscle or when it’s necessary to lower blood pressure quickly, such as in hypertensive emergencies or during certain surgical procedures.

Benefits and Side effects of Nicardipine Hydrochloride Injection USP:

Benefits:

  • Blood Pressure Control: Nicardipine helps lower high blood pressure by relaxing and widening blood vessels. This reduces the workload on the heart and can be particularly beneficial in managing hypertension.
  • Angina Treatment: Nicardipine may also be used to treat angina (chest pain) caused by certain heart conditions, including stable angina and variant angina. By relaxing the coronary arteries, it can improve blood flow to the heart muscle, relieving chest pain.

Side Effects:

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. Common side effects of Nicardipine Hydrochloride Injection USP may include:

  • Flushing: Some people may experience a warm, red, or flushed feeling in their face and neck.
  • Headache: Headaches are a common side effect of nicardipine use.
  • Dizziness or Lightheadedness: Nicardipine can lower blood pressure, leading to dizziness or lightheadedness, especially when standing up quickly.
  • Nausea or Upset Stomach: Gastrointestinal symptoms like nausea or an upset stomach can occur.
  • Swelling in the Ankles or Feet: Fluid retention may lead to swelling in the extremities.
  • Low Blood Pressure: In some cases, nicardipine may cause blood pressure to drop too low, resulting in symptoms like fainting, weakness, or confusion.
  • Abnormal Heartbeat: Although less common, some individuals may experience changes in their heart rhythm while taking this medication.
  • Allergic Reactions: While rare, some people may be allergic to nicardipine and may experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing.
  • Liver Function: In rare cases, nicardipine can affect liver function, leading to elevated liver enzymes. Regular monitoring of liver function may be necessary in some patients.
  • Other Side Effects: Less common side effects may include muscle cramps, nervousness, or a ringing sensation in the ears (tinnitus).

Frequently Asked Questions about Nicardipine Hydrochloride Injection USP:

  • What is Nicardipine Hydrochloride Injection USP used for?

Nicardipine Hydrochloride Injection USP is primarily used to treat high blood pressure (hypertension) and certain heart conditions like angina.

  • How does Nicardipine work?

Nicardipine is a calcium channel blocker that works by relaxing and widening blood vessels, which helps lower blood pressure and improve blood flow to the heart.

  • Is Nicardipine available in other forms, like oral tablets?

Yes, Nicardipine is available in oral tablet form for long-term blood pressure management. The injection form is typically used in situations where rapid blood pressure control is needed, such as in a hospital setting.

  • How is Nicardipine Hydrochloride Injection USP administered?

Nicardipine injection is typically administered intravenously (IV) by a healthcare professional. The dosage and rate of administration will be determined by your healthcare provider.

  • What are the common side effects of Nicardipine Hydrochloride Injection USP?

Common side effects may include flushing, headache, dizziness, nausea, swelling in the ankles or feet, and low blood pressure. However, not everyone will experience these side effects.

  • Can Nicardipine interact with other medications?

Yes, Nicardipine can interact with certain medications, including other blood pressure-lowering drugs, medications that affect heart rhythm, and some antibiotics. It’s important to inform your healthcare provider of all medications and supplements you are taking to avoid potential interactions.

  • Is Nicardipine safe during pregnancy and breastfeeding?

Nicardipine is generally not recommended during pregnancy unless the potential benefits outweigh the risks. It may pass into breast milk, so it’s important to discuss its use with your healthcare provider if you are pregnant or breastfeeding.

  • Can Nicardipine be abruptly stopped?

No, Nicardipine should not be abruptly stopped without consulting your healthcare provider. Sudden discontinuation can lead to rebound high blood pressure or other complications.

  • How should Nicardipine Hydrochloride Injection USP be stored?

It should be stored at room temperature and protected from light. Follow the storage instructions provided by your healthcare provider or on the medication label.

  • What should I do if I miss a dose of Nicardipine?

Since Nicardipine injection is usually administered by a healthcare professional, you are unlikely to miss a dose. However, if you have concerns about your treatment, discuss them with your healthcare provider.

  • Is Nicardipine Hydrochloride Injection USP available as a generic medication?

Yes, generic versions of Nicardipine Hydrochloride Injection USP are available, typically at a lower cost than the brandname version.

As Nicardipine Hydrochloride Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Nicardipine Hydrochloride Injection USP 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

Nicardipine Hydrochloride Injection USP 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 Nicardipine Hydrochloride Injection USP, 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
Fax No: +91 22 2634 1274