Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Technical Specification:

Product Name:Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP
Brand Name:Noforge
Strength:(5mg+160mg+12.5mg), (10mg+160mg+12.5mg), (10mg+160mg+25mg), (10mg+320mg+25mg)
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:Antihypertensive
Indication: Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
Storage:Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
  2. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
  3. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
  4. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF

2.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G

3.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 4 R

4.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. 

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Dispense in a tight container with a child-resistant closure.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) ; excursions permitted between 15°C to 30°C (59°F to 86°F).

Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end county.

Why Taj Pharmaceuticals?

Experience the reliability and commitment to health with Taj Pharma’s Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP. We understand the critical nature of cardiovascular health, and our pharmaceutical expertise reflects in every tablet we produce. Our formulation combines Amlodipine, Valsartan, and Hydrochlorothiazide, three potent medications known for their efficacy in managing high blood pressure and related cardiovascular conditions. Taj Pharma’s unwavering dedication to quality ensures that each tablet meets rigorous pharmaceutical standards, assuring you of the highest quality in every dose. Our commitment to patient well-being extends beyond the tablet itself. With Taj Pharma, you can trust in a partner that prioritizes your health, with a track record of producing safe, effective medications. Choose Taj Pharma for Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP, and take a step toward better cardiovascular health today.

What is Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP and its Use?

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP is a combination medication that contains three active ingredients: Amlodipine, Valsartan, and Hydrochlorothiazide. Each of these components has a specific role in managing and treating various cardiovascular conditions. Here’s an overview of their uses:

  1. Amlodipine:
  • Amlodipine is a calcium channel blocker. It works by relaxing and dilating the blood vessels, which helps to lower blood pressure and improve blood flow. It is primarily used to treat high blood pressure (hypertension).
  • Amlodipine can also be used to relieve chest pain (angina) and prevent certain types of heart related problems in individuals with coronary artery disease.
  1. Valsartan:
  • Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking the effects of a hormone called angiotensin II, which constricts blood vessels and raises blood pressure. By doing so, Valsartan helps to lower blood pressure.
  • It is used to treat high blood pressure (hypertension) and may also be prescribed to improve the function of the heart in people with heart failure.
  1. Hydrochlorothiazide:
  • Hydrochlorothiazide is a diuretic or water pill. It works by increasing the removal of excess salt and water from the body through urine, which reduces the volume of blood in the circulatory system and helps lower blood pressure.
  • It is often combined with other medications to treat high blood pressure and edema (fluid retention) associated with various medical conditions.

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP is typically prescribed when single drug therapy is insufficient to control blood pressure effectively. This combination medication provides the benefits of multiple mechanisms of action, helping to achieve better blood pressure control in individuals with hypertension.

How does Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP work?

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP work through a combination of three different active ingredients, each with its specific mechanism of action. This combination is used to effectively manage high blood pressure (hypertension) by addressing various aspects of blood pressure regulation:

  • Amlodipine (Calcium Channel Blocker): Amlodipine works by blocking calcium channels in the smooth muscle cells of blood vessels and in the heart. By inhibiting the entry of calcium ions into these cells, amlodipine relaxes and dilates the blood vessels. This dilation reduces the resistance in the arteries, making it easier for blood to flow through them. As a result, blood pressure decreases, and the heart’s workload is reduced. Amlodipine also helps to improve blood flow to the heart muscle and can be used to relieve chest pain (angina).
  • Valsartan (Angiotensin II Receptor Blocker – ARB): Valsartan works by blocking the effects of a hormone called angiotensin II. Angiotensin II is a potent vasoconstrictor, meaning it causes blood vessels to narrow, increasing blood pressure. By blocking the actions of angiotensin II, valsartan relaxes blood vessels, reducing their constriction. This results in lower blood pressure and decreased strain on the heart. Valsartan is also used to improve heart function in individuals with heart failure.
  • Hydrochlorothiazide (Diuretic – Thiazide): Hydrochlorothiazide increases the removal of sodium and water from the body through urine. This diuretic action helps to reduce the volume of blood circulating through the blood vessels. As the volume of blood decreases, there is less fluid to pump, leading to a reduction in blood pressure. Additionally, hydrochlorothiazide may have a mild blood vessel relaxation effect on its own.

By combining these three different mechanisms of action in Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP, this medication effectively addresses hypertension from multiple angles. It relaxes blood vessels, reduces fluid volume, and blocks the effects of angiotensin II, ultimately resulting in lower blood pressure. It’s important to note that this combination medication should be prescribed and managed by a healthcare provider, as dosages and individual responses may vary, and it may not be suitable for everyone.

Benefits and Side effects of Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP:

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP offer several potential benefits in managing high blood pressure and related cardiovascular conditions. However, like any medication, they may also come with side effects. Here’s an overview of the benefits and possible side effects:

Benefits:

  • Effective Blood Pressure Control: These tablets combine three different classes of medications, each with its own mechanism of action. This combination allows for effective blood pressure control in many individuals with hypertension who may not respond adequately to single-drug therapy.
  • Reduced Risk of Cardiovascular Events: By lowering blood pressure, this medication can reduce the risk of cardiovascular events such as strokes, heart attacks, and heart failure exacerbations.
  • Management of Edema: Hydrochlorothiazide, a diuretic in this combination, can help reduce fluid retention (edema) associated with various medical conditions, including heart failure.
  • Angina Relief: Amlodipine may provide relief from chest pain (angina) by improving blood flow to the heart muscle.

Side Effects:

It’s important to note that not everyone will experience side effects, and the severity and frequency of side effects can vary from person to person. Common side effects of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP may include:

  • Dizziness or Lightheadedness: Especially when standing up quickly, as amlodipine and hydrochlorothiazide can lower blood pressure.
  • Fluid and Electrolyte Imbalances: Hydrochlorothiazide is a diuretic and may lead to increased urination, electrolyte imbalances (low potassium, sodium), and dehydration in some individuals.
  • Headache: This is a relatively common side effect.
  • Swelling of the Ankles, Feet, or Legs: Especially in individuals prone to fluid retention.
  • Cough or Upper Respiratory Infection: Some people may experience a cough as a side effect of valsartan.
  • Fatigue: Feeling tired or lethargic is possible, though it’s not uncommon with many blood pressure medications.
  • Gastrointestinal Upset: Nausea, abdominal pain, and diarrhea are possible side effects.
  • Changes in Blood Glucose Levels: Some individuals may experience changes in blood sugar levels, which is important to monitor, especially in those with diabetes.
  • Allergic Reactions: Although rare, allergic reactions to any of the components can occur. Symptoms may include rash, itching, swelling, severe dizziness, or difficulty breathing.
  • Kidney Function Changes: These medications may affect kidney function, so regular monitoring is often necessary.

It’s crucial to take the medication exactly as prescribed by your healthcare provider and to attend regular follow-up appointments to monitor your blood pressure and assess for potential side effects. Do not stop or adjust the medication without consulting your healthcare provider, as this may lead to uncontrolled hypertension or other health issues. Always communicate any concerning symptoms or side effects to your healthcare provider for appropriate guidance and management.

Frequently Asked Questions about Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP:

Certainly, here are some frequently asked questions (FAQs) about Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP:

  1. What is Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP, and what is it used for?

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP is a combination medication used to treat high blood pressure (hypertension). It contains three active ingredients that work together to lower blood pressure and manage related cardiovascular conditions.

  1. How does this medication work to lower blood pressure?

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP work through different mechanisms: Amlodipine relaxes blood vessels, Valsartan blocks the effects of a hormone that constricts blood vessels, and Hydrochlorothiazide reduces fluid volume. Together, they help lower blood pressure.

  1. Can this medication be used to treat other conditions besides hypertension?

While its primary use is for hypertension, doctors may prescribe it for other conditions or indications, such as relieving chest pain (angina) and managing fluid retention associated with heart failure.

  1. What is the recommended dosage for Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP?

The dosage will vary depending on your specific medical condition and response to treatment. It is essential to follow your healthcare provider’s prescription and dosing instructions carefully.

  1. Are there any potential side effects of this medication?

Yes, there can be side effects, which may include dizziness, headache, changes in potassium levels, increased urination, and more. It’s important to be aware of possible side effects and report them to your healthcare provider.

  1. Can I take this medication if I have other medical conditions or am on other medications?

It’s crucial to inform your healthcare provider about all your medical conditions and medications you are taking to ensure there are no potential interactions or contraindications.

  1. Is it safe to take during pregnancy or while breastfeeding?

This medication is generally not recommended during pregnancy, especially in the second and third trimesters, as it may harm the fetus. It may also pass into breast milk, so consult with your healthcare provider if you are pregnant or breastfeeding.

  1. Can I drink alcohol while taking Amlodipine, Valsartan, and Hydrochlorothiazide Tablets USP?

Alcohol can interact with this medication and may exacerbate certain side effects, such as dizziness. It’s best to consult your healthcare provider about alcohol consumption while on this medication.

  1. How long does it take for this medication to start lowering blood pressure effectively?

The onset of action can vary, but you may start to see a decrease in blood pressure within a few hours to a few days. However, it may take several weeks to reach its full effect.

  1. Can I suddenly stop taking this medication?

No, it is essential to follow your healthcare provider’s guidance regarding when and how to stop or change the medication. Suddenly discontinuing it can lead to rebound hypertension or other health issues.

As Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Amlodipine, Valsartan and Hydrochlorothiazide Tablets 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

Amlodipine, Valsartan and Hydrochlorothiazide Tablets 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 Amlodipine, Valsartan and Hydrochlorothiazide Tablets 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF

B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G

C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Excipients………………………………………………….q.s
Color: Ponceau 4 R


D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………...320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R

THERAPEUTIC INDICATIONS:

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight container with a child-resistant closure.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.