Ranolazine Extended-Release Tablets 1000mg Technical Specification:

Product Name:Ranolazine Extended-Release Tablets
Brand Name:Rantotaj ER
Strength:500mg, 1000mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antianginal, Cardiovascular
Indication: Ranolazine is used to treat chronic angina (chest pain).
Storage:Store below 30°C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ranolazine Extended-Release Tablets 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Ranolazine Extended-Release Tablets 1000mg
    Each film coated extended-release tablet contains:
    Ranolazine ………………………1000mg
    Excipients……………………………q.s.
    Colours: Lake tartrazine

THERAPEUTIC INDICATIONS:

Ranolazine is used to treat a certain type of chest pain (chronic angina). It decreases how often you may get chest pain and may help to increase your ability to exercise. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (including nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol).

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.

WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store below 30°C.
Protect from Light and moisture.

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharma stands out as the premier provider for Ranolazine Extended-Release Tablets, and here’s why you should opt for us for your cardiovascular health:

  • Proven Quality: Taj Pharma is synonymous with quality in the pharmaceutical industry. Our Ranolazine Extended-Release Tablets undergo stringent quality control measures, ensuring that each tablet meets the highest standards for purity, efficacy, and safety. Your health is our priority, and we take pride in delivering pharmaceutical solutions you can trust.
  • Affordability: We understand the importance of accessible healthcare. Taj Pharma offers Ranolazine at competitive prices, making this vital cardiovascular medication affordable for all. We believe that cost should never be a barrier to your well-being.
  • Patient-Centered Care: At Taj Pharma, we are committed to patient-centric healthcare. Our dedicated team of experts is here to answer your questions, provide support, and ensure a seamless treatment journey. We believe in fostering a partnership with patients for better health outcomes.
  • Experience You Can Count On: With years of experience in the pharmaceutical industry, Taj Pharma has a track record of excellence. You can trust us to deliver reliable, high-quality Ranolazine Extended-Release Tablets for your cardiovascular needs.

What is Ranolazine Extended-Release Tablets and its use?

Ranolazine Extended-Release Tablets are a medication used to treat certain heart conditions, specifically chronic angina pectoris. Chronic angina is a type of chest pain or discomfort that occurs when the heart muscle doesn’t receive enough oxygen-rich blood. Ranolazine is used in combination with other medications and lifestyle changes to help manage and reduce the frequency of angina attacks.

Use of Ranolazine Extended-Release Tablets is to:

  • Manage Chronic Angina: Ranolazine works by improving blood flow to the heart muscle and reducing the workload on the heart, which can help relieve chest pain associated with chronic angina. It does this by blocking certain sodium channels in heart cells, which can help the heart function more efficiently and with reduced oxygen demand.
  • Combination Therapy: Ranolazine is often prescribed in combination with other medications for heart conditions, such as beta-blockers, nitroglycerin, or calcium channel blockers. This combination approach is tailored to the individual patient’s needs and is aimed at achieving optimal symptom control and improving overall heart health.
  • Improved Exercise Tolerance: Ranolazine can help improve exercise tolerance in individuals with chronic angina. This means that patients may be able to engage in physical activities with less discomfort and reduced risk of angina attacks, which can significantly enhance their quality of life.
  • Strict Dosage and Monitoring: The dosage of Ranolazine Extended-Release Tablets is carefully determined by a healthcare provider based on the patient’s specific condition and medical history. Regular monitoring of heart function, including electrocardiograms (ECGs), may be necessary to ensure the medication is effective and safe.
  • Not for Acute Angina Attacks: Ranolazine is not intended for the treatment of acute angina attacks (sudden-onset chest pain). It is a preventative medication that is taken regularly to reduce the frequency and severity of angina episodes over time.
  • Lifestyle Changes: Alongside medication, lifestyle modifications such as dietary changes, smoking cessation, regular exercise, and stress management are often recommended to complement the treatment of chronic angina. These changes can further help improve heart health and reduce angina symptoms.

How does Ranolazine Extended-Release Tablets work?

Ranolazine Extended-Release Tablets work through a mechanism that primarily involves the inhibition of sodium channels in heart cells. This mechanism of action helps improve the oxygen supply and demand balance in the heart, making it a valuable medication for managing chronic angina. Here’s how Ranolazine works:

  • Sodium Channel Blockade: Ranolazine inhibits a specific type of sodium channel, known as the late sodium current (INa). This channel is responsible for allowing sodium ions to flow into cardiac muscle cells during the late phase of the cardiac action potential. By blocking these channels, Ranolazine reduces the influx of sodium ions into the heart cells.
  • Reduction in Sodium Influx: By blocking the late sodium current, Ranolazine decreases the influx of sodium ions into heart cells during the resting phase. This, in turn, reduces the intracellular sodium concentration, which has several beneficial effects on heart function.
  • Decreased Calcium Overload: Reduced sodium influx leads to decreased intracellular calcium levels. This is important because excessive calcium can lead to increased oxygen demand and the potential for abnormal heart rhythms. Ranolazine helps prevent calcium overload in cardiac cells, reducing the risk of arrhythmias.
  • Improved Oxygen Balance: By reducing the oxygen consumption of heart muscle cells and improving the balance between oxygen supply and demand, Ranolazine helps alleviate chest pain (angina) associated with inadequate blood flow and oxygen delivery to the heart.

Ranolazine does not dilate coronary arteries (blood vessels that supply the heart muscle with oxygen) like some other angina medications, such as nitroglycerin or calcium channel blockers. Instead, it works directly on the cellular level to optimize heart muscle function. Ranolazine is typically prescribed as an extended-release tablet, taken regularly, and is most effective when used as part of a comprehensive treatment plan that may include other medications and lifestyle modifications to manage chronic angina effectively. The specific dosage and treatment plan should be determined by a healthcare provider based on the individual patient’s needs and medical history.

Benefits of Ranolazine Extended-Release Tablets:

  • Angina Symptom Relief: The primary benefit of Ranolazine is the relief of angina symptoms. It can help reduce the frequency and severity of angina episodes, allowing individuals to engage in daily activities with less discomfort and improved quality of life.
  • Improved Exercise Tolerance: Ranolazine can enhance exercise tolerance in individuals with chronic angina. This means patients may be able to participate in physical activities with less risk of angina attacks, which can contribute to better overall cardiovascular health.
  • Preventative Approach: Ranolazine is used as a preventative medication for chronic angina, meaning it helps reduce the occurrence of angina episodes over time. It is not intended to treat acute angina attacks but rather to provide ongoing relief and symptom control.
  • Combination Therapy: Ranolazine can be used in combination with other medications for heart conditions, such as beta-blockers or calcium channel blockers, to achieve optimal symptom management and heart health.

Side Effects of Ranolazine Extended-Release Tablets:

  • Dizziness: Some individuals may experience dizziness while taking Ranolazine. It’s essential to use caution when performing activities that require alertness, such as driving, until you know how the medication affects you.
  • Headache: Headaches can be a side effect of Ranolazine for some individuals.
  • Nausea: Nausea is another potential side effect, although it is generally mild.
  • Constipation: Some people may experience constipation as a side effect.
  • QT Prolongation: Ranolazine can prolong the QT interval on an electrocardiogram (ECG). While this usually does not cause issues, in rare cases, it may lead to a potentially serious irregular heart rhythm. Therefore, Ranolazine should be used with caution in individuals with a history of certain heart rhythm disorders.
  • Liver Enzyme Elevations: In some cases, Ranolazine may lead to elevated liver enzymes, which should be monitored by a healthcare provider during treatment.

Frequently asked questions (FAQs) about Ranolazine Extended-Release Tablets:

  1. What is Ranolazine Extended-Release used for?

Ranolazine Extended-Release Tablets are primarily used to treat chronic angina pectoris, a type of chest pain or discomfort that occurs due to inadequate blood flow and oxygen supply to the heart muscle.

  1. How does Ranolazine work to relieve angina symptoms?

Ranolazine works by blocking specific sodium channels in heart cells, reducing the influx of sodium ions and calcium, which can help improve the balance between oxygen supply and demand in the heart muscle.

  1. Is Ranolazine an immediate treatment for acute angina attacks?

No, Ranolazine is not intended for the treatment of acute angina attacks. It is a preventative medication used to reduce the frequency and severity of angina episodes over time.

  1. Can Ranolazine be taken alone or is it used in combination with other medications?

Ranolazine is often used in combination with other medications for heart conditions, such as beta blockers or calcium channel blockers, as part of a comprehensive treatment plan tailored to the individual patient’s needs.

  1. Are there any specific lifestyle changes recommended while taking Ranolazine?

Yes, lifestyle modifications such as a heart healthy diet, regular exercise, smoking cessation, and stress management are typically recommended alongside Ranolazine to improve overall heart health and angina symptom control.

  1. What are the common side effects of Ranolazine Extended-Release Tablets?

Common side effects can include dizziness, headache, nausea, constipation, and QT interval prolongation on an ECG. However, not everyone will experience these side effects.

  1. Is Ranolazine safe for individuals with certain heart rhythm disorders?

Ranolazine should be used with caution in individuals with a history of certain heart rhythm disorders, as it can prolong the QT interval on an ECG, which may rarely lead to irregular heart rhythms.

  1. Can Ranolazine interact with other medications or supplements?

Yes, Ranolazine may interact with other medications, so it’s important to inform your healthcare provider about all the medications and supplements you are taking.

  1. How long should I take Ranolazine Extended-Release Tablets?

The duration of Ranolazine treatment is determined by a healthcare provider based on the individual’s condition. It is typically taken regularly as part of long term angina management.

  1. Can I consume alcohol while taking Ranolazine?

It’s generally advisable to limit alcohol consumption while taking Ranolazine, as alcohol can interact with the medication and may exacerbate side effects such as dizziness.

As Ranolazine Extended-Release Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Ranolazine Extended-Release Tablets 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

Ranolazine Extended-Release Tablets 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 Ranolazine Extended-Release Tablets, 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ranolazine Extended-Release Tablets 500mg
B) Ranolazine Extended-Release Tablets 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ranolazine Extended-Release Tablets 500mg
Each film coated extended-release tablet contains:
Ranolazine ………………………500mg
Excipients……………………………q.s.
Colours: Lake tartrazine

B) Ranolazine Extended-Release Tablets 1000mg
Each film coated extended-release tablet contains:
Ranolazine ………………………1000mg
Excipients……………………………q.s.
Colours: Helen don pink aluminum lake


THERAPEUTIC INDICATIONS:

Ranolazine is used to treat a certain type of chest pain (chronic angina). It decreases how often you may get chest pain and may help to increase your ability to exercise. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (including nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol).

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.