Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg Technical Specification:

Product Name:Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
Brand Name:Generic
Strength:(50mg+12.5mg), (100mg+12.5mg), (100mg+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: Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Storage:Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 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:

  • Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
    Each film-coated tablet contains:
    Losartan Potassium USP…………………..100mg
    Hydrochlorothiazide USP………………….12.5mg
    Excipients…………………………………………q.s
    Colour: Ponceau 2R

THERAPEUTIC INDICATIONS:

Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.

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, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE.
KEPP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

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 to 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 country.

Why Taj Pharmaceuticals?

At Taj Pharma, we take pride in our unwavering dedication to producing Losartan Potassium and Hydrochlorothiazide Tablets USP of the highest quality. Our commitment to your health and well-being is at the forefront of everything we do. Here’s why you should choose Taj Pharma for your healthcare needs:

  • Quality Assurance: We adhere to the strictest quality standards in the pharmaceutical industry. Our state-of-the-art manufacturing facilities are equipped with cutting-edge technology, ensuring that each tablet is crafted with precision and consistency.
  • Trusted Reputation:With a long-standing history of excellence, Taj Pharma has gained the trust of healthcare professionals and patients worldwide. Our commitment to quality and safety has made us a respected name in the pharmaceutical field.
  • Effective Formulation: Our Losartan Potassium and Hydrochlorothiazide Tablets USP are formulated to provide optimal therapeutic benefits. We prioritize research and development to ensure that our products meet the highest efficacy standards.
  • Patient-Centric Approach: Your health is our top priority. We are dedicated to improving patient outcomes and enhancing the quality of life for those who rely on our medications. Our customer support team is always ready to assist with any questions or concerns you may have.
  • Global Reach: Taj Pharma’s reach extends across the globe, allowing patients from diverse backgrounds to access our high-quality pharmaceuticals. We are committed to making healthcare accessible to all.

When you choose Taj Pharma for Losartan Potassium and Hydrochlorothiazide Tablets USP, you are choosing a partner in your health journey. We are committed to delivering excellence in every tablet we produce, so you can trust that your well-being is in good hands. Discover the Taj Pharma difference today and experience the difference for yourself.

What is Losartan Potassium and Hydrochlorothiazide Tablets USP and its use?

Losartan Potassium and Hydrochlorothiazide Tablets USP is a medication that combines two active ingredients: losartan potassium and hydrochlorothiazide. Each of these components serves a specific purpose in treating certain medical conditions:

  • Losartan Potassium: Losartan is an angiotensin II receptor antagonist, commonly referred to as an angiotensin receptor blocker (ARB). It works by blocking the action of a hormone called angiotensin II, which causes blood vessels to narrow and constrict. By blocking angiotensin II, losartan helps relax blood vessels, reduce blood pressure, and improve blood flow. It is primarily used to treat high blood pressure (hypertension).
  • Hydrochlorothiazide: Hydrochlorothiazide is a diuretic, often referred to as a “water pill.” It works by increasing the removal of excess salt and water from the body through urine. This can help reduce fluid retention and lower blood pressure. Hydrochlorothiazide is often used in combination with other antihypertensive medications to enhance their effectiveness.

Uses:

  • Hypertension (High Blood Pressure): This medication is commonly used to treat high blood pressure in adults. High blood pressure is a significant risk factor for heart disease, stroke, and other cardiovascular problems. By lowering blood pressure, Losartan Potassium and Hydrochlorothiazide Tablets help reduce the risk of these complications.

this medication should only be used under the guidance of a healthcare professional, as the dosage and usage instructions may vary depending on an individual’s specific medical condition and needs. Additionally, it’s essential to follow the prescribed dosage and regularly monitor blood pressure while taking this medication to ensure its effectiveness and safety.

How does Losartan Potassium and Hydrochlorothiazide Tablets USP Work?

Losartan Potassium and Hydrochlorothiazide Tablets USP work through a combination of two active ingredients: losartan potassium and hydrochlorothiazide. Each of these components has its mechanism of action, and together, they provide a synergistic effect in managing hypertension (high blood pressure):

Losartan Potassium (Angiotensin II Receptor Blocker):

Losartan is classified as an angiotensin II receptor antagonist or angiotensin receptor blocker (ARB). It works by targeting the renin-angiotensin-aldosterone system (RAAS), which plays a crucial role in regulating blood pressure and fluid balance.

  • Angiotensin II Constriction: Angiotensin II is a hormone that causes blood vessels to constrict and narrow. This constriction can lead to an increase in blood pressure.
  • ARB Action: Losartan binds to specific receptors (angiotensin II type 1 receptors) in blood vessels and other tissues. By doing so, it blocks the effects of angiotensin II, preventing its ability to constrict blood vessels. As a result, blood vessels relax and dilate, which reduces resistance to blood flow and lowers blood pressure.

Hydrochlorothiazide (Diuretic):

Hydrochlorothiazide is a thiazide diuretic, also known as a “water pill.” Its primary mode of action involves the kidneys and the excretion of sodium and water from the body.

  • Sodium Reabsorption: In the kidneys, hydrochlorothiazide works by inhibiting the reabsorption of sodium and chloride ions from the renal tubules into the bloodstream. When sodium is excreted in urine, it takes water with it, reducing the overall volume of blood in the circulatory system.
  • Volume Reduction: As the volume of blood decreases, there is less pressure on the blood vessel walls, resulting in a decrease in blood pressure.

Together, these two components have a complementary effect on blood pressure regulation. Losartan helps to relax blood vessels and reduce vascular resistance, while hydrochlorothiazide reduces fluid volume by promoting the excretion of sodium and water through urine.

The combination of losartan potassium and hydrochlorothiazide in a single tablet allows for more effective blood pressure control in individuals with hypertension. It’s important to note that this medication should be used as prescribed by a healthcare professional, and regular monitoring of blood pressure is typically recommended to ensure that the treatment is working effectively and safely.

Benefits of Losartan Potassium and Hydrochlorothiazide Tablets USP:

  • Blood Pressure Control: The primary benefit of Losartan Potassium and Hydrochlorothiazide Tablets USP is their effectiveness in lowering high blood pressure (hypertension). By reducing blood pressure, this medication helps lower the risk of complications associated with hypertension, such as heart disease, stroke, kidney problems, and vision issues.
  • Combination Therapy: This medication combines two active ingredients, losartan potassium (an angiotensin receptor blocker) and hydrochlorothiazide (a diuretic). This combination can provide better blood pressure control than using each medication alone in some individuals.
  • Reduction of Fluid Retention: Hydrochlorothiazide, being a diuretic, can help reduce fluid retention, making it beneficial for individuals who have edema (fluid buildup) associated with conditions like heart failure or kidney problems.
  • Prevention of Stroke: In addition to lowering blood pressure, losartan may offer some protection against certain types of strokes, particularly in people with a history of stroke or at high risk for stroke.
  • Kidney Protection: Losartan may be prescribed for individuals with kidney disease, particularly those with diabetes. It can help slow the progression of kidney damage associated with high blood pressure and diabetes.

Side Effects of Losartan Potassium and Hydrochlorothiazide Tablets USP:

  • Dizziness or Lightheadedness: Some people may experience dizziness or a feeling of faintness, especially when standing up quickly. This is more common when starting the medication or with a dose increase.
  • Increased Urination: Hydrochlorothiazide is a diuretic, so it can lead to increased urination. This effect can be particularly noticeable during the early stages of treatment.
  • Electrolyte Imbalance: Diuretics like hydrochlorothiazide can cause imbalances in electrolytes, such as potassium, sodium, and magnesium. Your healthcare provider may monitor your electrolyte levels and adjust your treatment as needed.
  • Elevated Blood Uric Acid Levels: Some individuals may experience an increase in blood uric acid levels, which can potentially lead to gout attacks in susceptible individuals.
  • Allergic Reactions: While rare, allergic reactions to losartan or hydrochlorothiazide can occur and may manifest as skin rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if you experience any signs of an allergic reaction.
  • Kidney Function Changes: In some cases, the use of Losartan Potassium and Hydrochlorothiazide Tablets may lead to changes in kidney function. Your healthcare provider may perform periodic kidney function tests.

It’s essential to discuss any side effects or concerns with your healthcare provider. They can provide guidance on managing side effects and determine whether this medication is suitable for your specific medical condition. Additionally, do not stop taking the medication without consulting your healthcare provider, as abrupt discontinuation can lead to an increase in blood pressure.

Frequently asked questions (FAQs) about Losartan Potassium and Hydrochlorothiazide Tablets USP:

  1. What is Losartan Potassium and Hydrochlorothiazide Tablets USP used for?

This medication is primarily used to treat high blood pressure (hypertension) in adults. It combines two active ingredients, losartan potassium and hydrochlorothiazide, to help lower blood pressure.

  1. How does Losartan Potassium and Hydrochlorothiazide work?

Losartan potassium is an angiotensin II receptor blocker (ARB) that relaxes blood vessels, while hydrochlorothiazide is a diuretic that reduces fluid volume. Together, they work to lower blood pressure by reducing vascular resistance and promoting the excretion of excess salt and water from the body.

  1. Is this medication suitable for everyone with high blood pressure?

Not necessarily. Your healthcare provider will determine if Losartan Potassium and Hydrochlorothiazide Tablets are the right choice for your specific condition. They will consider your medical history, current medications, and individual health needs.

  1. Are there any potential side effects?

Yes, as with any medication, Losartan Potassium and Hydrochlorothiazide Tablets USP can have side effects. Common side effects may include dizziness, increased urination, and electrolyte imbalances. It’s important to discuss any side effects with your healthcare provider.

  1. How often should I take this medication?

The dosing frequency and amount will be determined by your healthcare provider based on your individual needs. It’s important to follow their instructions and take the medication as prescribed.

  1. Can I take Losartan Potassium and Hydrochlorothiazide with other medications?

Your healthcare provider will consider potential drug interactions when prescribing this medication. Inform them of all the medications, supplements, and overthecounter drugs you are taking to ensure there are no adverse interactions.

  1. Can I drink alcohol while taking this medication?

It’s generally advisable to limit alcohol consumption when taking Losartan Potassium and Hydrochlorothiazide, as alcohol can increase blood pressure. Discuss alcohol use with your healthcare provider for personalized guidance.

  1. How long does it take for the medication to start working?

The onset of action can vary, but you may start to see a reduction in blood pressure within a few weeks of starting treatment. However, it’s essential to continue taking the medication as prescribed even if you feel better.

  1. Is it safe to use Losartan Potassium and Hydrochlorothiazide during pregnancy and breastfeeding?

This medication is generally not recommended during pregnancy. It’s crucial to discuss pregnancy plans with your healthcare provider, as they may need to adjust your treatment. It’s also important to consult with your healthcare provider before breastfeeding while taking this medication.

  1. What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.

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

Losartan Potassium 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 Losartan Potassium 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:

1. Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg
2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..50mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Sunset yellow FCF

2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Ponceau 2R


3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….25mg
Excipients…………………………………………q.s
Colour: Ponceau 4R

THERAPEUTIC INDICATIONS:

Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.

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, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE.
KEPP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
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 to 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 country.