Hydroxychloroquine Sulfate Tablets USP 200mg Technical Specification: 

Product Name:Hydroxychloroquine Sulfate Tablet
Brand Name:Generic
Strength:100mg, 200mg, 300mg, 400mg
Dosage Form:Tablet (Film-coated)
Packing:10s, 30s, 100s
Route of Administration:Via oral Route
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antimalarial, Anti-inflammatory, Antirheumatic
Indication:Hydroxychloroquine Sulfate Tablets USP 200mg is in a class of drugs called antimalarials. It kills the organisms that cause malaria. Hydroxychloroquine tablet is used in the treatment of discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus). It is also use in the treatment of chronic and acute rheumatoid arthritis. This medication is available only with your physician prescription.
Storage:Protect form moisture at a temperature not exceeding 30° Degrees Celsius. Do not freeze. Keep the container tightly closed in order to protect from humidity.

Hydroxychloroquine Sulfate Tablets 200mg Manufacturers, Suppliers in India

Taj Pharmaceuticals is of the prominent Hydroxychloroquine Sulfate Tablets 200 mg Manufacturers India brings the best- quality products. Out company Taj Pharma carries the rich experience in the niche manufacturing of Hydroxychloroquine Tablets.

Taj Pharmaceuticals is reputed manufacturer and Hydroxychloroquine Tablets 200 mg Suppliers in India prefer Taj Pharma is best known for the top most standards and consistent quality of products.

Taj Pharma is well-known Hydroxy-chloroquine Tablets USP 200 mg Manufacturer in India gives the assurance of high- quality and high standard. The strict quality-control ensure that every batch of the medicine brings a harmonious standard.

Hydroxy-chloroquine Tablets USP 200mg manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply USP quality standards which is considered best in the world. Further, Taj Pharma uses Hydroxychloroquine Sulfate USP grade best active ingredient to manufacture its tablets to comply with international standards of USA and European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxychloroquine Sulfate Tablets USP 100mg
  • Hydroxychloroquine Sulfate Tablets USP 200mg
  • Hydroxychloroquine Sulfate Tablets USP 300mg
  • Hydroxychloroquine Sulfate Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydroxychloroquine Sulfate Tablets USP 100mg
    Each film coated tablet contains:
    Hydroxychloroquine Sulfate USP
    Equivalent to Hydroxychloroquine Base     100mg
    Excipients                                                          s
    Colours: Ponceau 4 R
  • Hydroxychloroquine Sulfate Tablets USP 200mg
    Each film coated tablet contains:
    Hydroxychloroquine Sulfate USP
    Equivalent to Hydroxychloroquine Base     200mg
    Excipients                                                          s
    Colours: Ponceau 4 R
  • Hydroxychloroquine Sulfate Tablets USP 300mg
    Each film coated tablet contains:
    Hydroxychloroquine Sulfate USP
    Equivalent to Hydroxychloroquine Base     300mg
    Excipients                                                          s
    Colours: Ponceau 4 R
  • Hydroxychloroquine Sulfate Tablets USP 400mg
    Each film coated tablet contains:
  • Hydroxychloroquine Sulfate USP
    Equivalent to Hydroxychloroquine Base     400mg
    Excipients                                                          s
    Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Hydroxychloroquine Tablets belong to a class of drugs named antimalarials. It kills the organisms that cause malaria. Hydroxychloroquine Tablets are use in the treatment of discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus) diseases. It is also used in the treatment of acute and chronic rheumatoid arthritis. Hydroxychloroquine sulfate tablets are disease-modifying anti-rheumatic drug (DMARD). Hydroxychloroquine sulfate works by reducing swelling (inflammation) in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake). This medicine should not be sold by retail without the prescription of a registered Medical Practitioner

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 5 years.
Prevent or treat malaria caused by mosquito bites.
Read the enclosed leaflet before use.

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) [see USP Controlled Room Temperature].
Dispense in tight and light-resistant container.

Dosage: As directed by the Physician
Attach dispensing label as per end county.

Why Taj Pharmaceuticals?

When it comes to Hydroxychloroquine Sulfate Tablets, Taj Pharmaceuticals stands out as your top choice. Our unwavering commitment to quality, stemming from decades of pharmaceutical expertise, ensures that you receive a medication you can trust. We prioritize patient well-being above all else, making us the preferred provider for this vital medication.

  • Quality Assurance: At Taj Pharmaceuticals, quality is non-negotiable. Our Hydroxychloroquine Sulfate Tablets meet stringent industry standards, and our manufacturing processes adhere to the highest quality assurance protocols. We understand the critical importance of consistency and reliability when it comes to pharmaceuticals, and we deliver precisely that.
  • Experience Matters: With a rich history in the pharmaceutical industry, Taj Pharmaceuticals has garnered a reputation for excellence. Our team of experts is dedicated to producing medications that enhance and save lives. When you choose us, you’re choosing a partner with the knowledge and experience needed to deliver pharmaceuticals you can depend on.
  • Your Well-Being Matters: Your health is paramount to us. Taj Pharmaceuticals is committed to providing Hydroxychloroquine Sulfate Tablets that you can trust for your well-being. Rest assured that when you choose us, you’re selecting a partner who puts your health first, every step of the way.

Make the right choice for your health. Choose Taj Pharmaceuticals for Hydroxychloroquine Sulfate Tablets and experience the peace of mind that comes from knowing you’re in the hands of a trusted, experienced, and patient-focused pharmaceutical provider. Your health is our priority, and we’re here to support you on your journey to a healthier future.

What are Hydroxychloroquine Tablets and their uses:

Hydroxychloroquine Sulfate Tablets is a medication that contains hydroxychloroquine as the active ingredient. Here’s an overview of what Hydroxychloroquine is and its common uses:

Hydroxychloroquine (HCQ): This is an antimalarial drug that has been used for many years to treat and prevent malaria, a parasitic infection transmitted through mosquito bites. It is derived from quinine and is part of the 4-aminoquinoline class of drugs.

Common Uses:

  • Malaria Prevention: Hydroxychloroquine is used to prevent malaria in individuals traveling to or living in areas where malaria is prevalent. It is often prescribed for travelers, aid workers, and military personnel.
  • Malaria Treatment: It is also used to treat malaria infections. Hydroxychloroquine can help control and clear the parasitic infection from the body when taken as part of a prescribed regimen.
  • Rheumatoid Arthritis: Hydroxychloroquine is used in the treatment of rheumatoid arthritis, an autoimmune disease where the immune system attacks the joints, leading to pain and inflammation. It can help reduce joint pain, swelling, and stiffness in individuals with this condition.
  • Systemic Lupus Erythematosus (SLE): In individuals with systemic lupus erythematosus, an autoimmune disorder that can affect various organs and systems in the body, hydroxychloroquine is used to manage symptoms such as joint pain, skin rashes, and fatigue.
  • Other Autoimmune Diseases: Hydroxychloroquine is sometimes prescribed to treat other autoimmune diseases, such as Sjögren’s syndrome and discoid lupus erythematosus, which can also cause joint pain and skin problems.
  • COVID-19 (Controversial Use): During the COVID-19 pandemic, hydroxychloroquine gained attention as a potential treatment for the virus. However, its efficacy and safety for this use have been a subject of debate and research, and it is not widely recommended for COVID-19 treatment as of my last knowledge update in September 2021.

It’s crucial to note that the use of hydroxychloroquine should be prescribed and monitored by a healthcare professional, as it can have potential side effects and interactions with other medications. The appropriate dosage and duration of treatment will depend on the specific medical condition being treated. Additionally, guidelines and recommendations regarding its use for COVID-19 may have evolved since my last update, so it’s important to consult the latest medical information and guidelines for any potential use in the context of the pandemic.

How do Hydroxychloroquine Tablets work?

Hydroxychloroquine tablets work through several mechanisms, primarily related to their ability to modulate the immune system and affect various cellular processes. While the precise mechanisms of action are not fully understood, here are some of the key ways in which hydroxychloroquine is believed to work:

  • Antimalarial Action: In the context of malaria treatment and prevention, hydroxychloroquine interferes with the life cycle of the malaria parasite within red blood cells. It concentrates in the acidic food vacuoles of the parasite, raising the pH level and disrupting critical enzymatic processes necessary for the parasite’s survival. This action ultimately leads to the death of the parasite.
  • Immunomodulation: Hydroxychloroquine has immunomodulatory properties, which means it can modify the functioning of the immune system. It is thought to reduce the activation of immune cells, particularly T-cells and dendritic cells. By doing so, it can help control immune responses that are overactive, such as in autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus (SLE).
  • Anti-Inflammatory Effects: Hydroxychloroquine has anti-inflammatory properties, which are especially beneficial in the treatment of autoimmune diseases. It can reduce the production of pro-inflammatory cytokines, inhibit certain enzymes involved in inflammation, and interfere with the signaling pathways that promote inflammation in the body. This helps alleviate symptoms like joint pain and swelling in conditions like rheumatoid arthritis and SLE.
  • Effects on Cellular Function: Hydroxychloroquine may affect cellular functions in various ways. For example, it can alter the function of lysosomes, cellular structures responsible for breaking down waste materials and cellular components. This can impact the processing of substances within cells and influence various cellular processes.

Benefits and Side Effects of Hydroxychloroquine Tablets:

Hydroxychloroquine tablets can have both benefits and potential side effects, depending on the specific medical condition they are used to treat. It’s important to note that the use of hydroxychloroquine should always be prescribed and monitored by a healthcare professional. Here’s an overview of the benefits and potential side effects:

Benefits:

  1. Antimalarial Action: Hydroxychloroquine is effective in preventing and treating malaria, a potentially life-threatening parasitic infection transmitted by mosquitoes. It can be used for both prevention (prophylaxis) and treatment.
  2. Treatment of Autoimmune Diseases: Hydroxychloroquine is commonly used to manage autoimmune diseases such as:
  • Rheumatoid Arthritis: It can help reduce joint pain, swelling, and stiffness in individuals with rheumatoid arthritis.
  • Systemic Lupus Erythematosus (SLE): It is used to manage a range of symptoms associated with SLE, including joint pain, skin rashes, and fatigue.
  • Other Autoimmune Diseases: Hydroxychloroquine may also be prescribed for conditions like Sjögren’s syndrome and discoid lupus erythematosus, which can cause joint pain and skin problems.
  1. Immunomodulation: Hydroxychloroquine can modify the functioning of the immune system. It is used to suppress overactive immune responses in autoimmune diseases.
  2. Anti-Inflammatory Effects: The drug has anti-inflammatory properties, making it effective in reducing inflammation and associated symptoms in autoimmune diseases.

Potential Side Effects:

  1. Gastrointestinal Issues: Common side effects include stomach upset, nausea, vomiting, and diarrhea. These symptoms can often be minimized by taking the medication with food.
  2. Skin Reactions: Hydroxychloroquine can cause skin rashes or changes in skin pigmentation in some individuals.
  3. Eye Problems: In rare cases, prolonged use of hydroxychloroquine may lead to eye problems, including retinal damage. Regular eye examinations are essential for individuals on long-term therapy.
  4. Cardiac Effects: There is a risk of heart rhythm disturbances (arrhythmias) associated with hydroxychloroquine, particularly when taken in high doses or for extended periods. This has raised concerns about its use in certain patients.
  5. Blood Disorders: Hydroxychloroquine can affect blood cell counts in some individuals, leading to conditions like anemia or low white blood cell count.
  6. Neuropsychiatric Effects: Rarely, the drug may cause neuropsychiatric side effects, such as mood changes or hallucinations.
  7. Allergic Reactions: Allergic reactions to hydroxychloroquine are rare but can occur. Signs of an allergic reaction include rash, itching, swelling, severe dizziness, or difficulty breathing.
  8. Drug Interactions: Hydroxychloroquine can interact with other medications, potentially affecting their effectiveness or safety. Always inform your healthcare provider of all medications you are taking.
  9. Risk of Retinal Toxicity: Prolonged use at high doses can lead to retinal toxicity, which is why regular eye examinations are crucial for individuals on long-term hydroxychloroquine therapy.

Frequently Asked Questions About Hydroxychloroquine tablets:

Certainly, here are some frequently asked questions (FAQs) about Hydroxychloroquine tablets, along with their answers:

  1. What is Hydroxychloroquine, and how does it work?

Hydroxychloroquine is a medication used to treat malaria and autoimmune diseases. It works by interfering with the life cycle of the malaria parasite and by modulating the immune system’s responses in autoimmune conditions.

  1. What are the common uses of Hydroxychloroquine?

Hydroxychloroquine is commonly used for malaria prevention and treatment. It is also prescribed to manage autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), and others.

  1. Is Hydroxychloroquine effective against COVID-19?

As of my last update in September 2021, the use of Hydroxychloroquine for COVID-19 treatment was a subject of debate and research. However, its efficacy and safety for COVID-19 had not been definitively established, and its use for this purpose was not widely recommended.

  1. What are the potential side effects of Hydroxychloroquine?

Common side effects include gastrointestinal issues (nausea, vomiting, diarrhea), skin reactions, and, rarely, eye problems, cardiac effects, blood disorders, neuropsychiatric effects, and allergic reactions. Long-term use can also lead to retinal toxicity.

  1. Can I take Hydroxychloroquine with other medications?

Hydroxychloroquine can interact with other medications, potentially affecting their effectiveness or safety. Always inform your healthcare provider of all medications you are taking to avoid potential interactions.

  1. How long can I take Hydroxychloroquine?

The duration of Hydroxychloroquine treatment depends on the specific medical condition it is being used to treat. It is crucial to follow your healthcare provider’s instructions regarding the duration and dosage of the medication.

  1. Is Hydroxychloroquine safe during pregnancy and breastfeeding?

It should be used during pregnancy or breastfeeding only when clearly needed and under the guidance of a healthcare provider, as it may have potential risks to the fetus or nursing infant.

  1. How often should I have eye examinations while taking Hydroxychloroquine long-term?

Regular eye examinations are essential for individuals on long-term Hydroxychloroquine therapy to monitor for potential retinal toxicity. The frequency of these exams will be determined by your healthcare provider.

  1. Can I drink alcohol while taking Hydroxychloroquine?

Moderate alcohol consumption is generally considered acceptable while taking Hydroxychloroquine. However, excessive alcohol use should be avoided, as it can increase the risk of side effects.

  1. Can I stop taking Hydroxychloroquine suddenly?

It’s important to follow your healthcare provider’s instructions for discontinuing Hydroxychloroquine, especially if you have been on long-term therapy. Abruptly stopping the medication can have adverse effects, and gradual tapering may be necessary.

Hydroxychloroquine 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 Hydroxychloroquine 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

As Hydroxychloroquine Tablets 200 mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Hydroxychloroquine Tablets 200 mg product in 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, 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

Hydroxychloroquine Tablets 200mg Regulatory Documents:

  1. Certificate of Analysis (COA)
  2. Method of Analysis (MOA)
  3. Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  4. CTD Dossier / ACTD Dossiers / eCTD Dossiers
  5. Certificate of Pharmaceuticals Product (COPP)
  6. Free Sale Certificate (FSC)

Hydroxy-chloroquine 200mg Tablets as prophylaxis for SAR- covid-19

Hydroxy-chloroquine Sulfate tablets 200mg is found to be effective against covid in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from arcinale evidence of benefias treatment and supported by pre-clinical data.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Hydroxychloroquine Sulfate Tablets USP 100mg
Hydroxychloroquine Sulfate Tablets USP 200mg
Hydroxychloroquine Sulfate Tablets USP 300mg
Hydroxychloroquine Sulfate Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Hydroxychloroquine Sulfate Tablets USP 100mg
Each film coated tablet contains:
Hydroxychloroquine Sulfate USP
Equivalent to Hydroxychloroquine Base 100mg
Excipients q.s
Colours: Ponceau 4 R
B) Hydroxychloroquine Sulfate Tablets USP 200mg
Each film coated tablet contains:
Hydroxychloroquine Sulfate USP
Equivalent to Hydroxychloroquine Base 200mg
Excipients q.s
Colours: Ponceau 4 R
C) Hydroxychloroquine Sulfate Tablets USP 300mg
Each film coated tablet contains:
Hydroxychloroquine Sulfate USP
Equivalent to Hydroxychloroquine Base 300mg
Excipients q.s
Colours: Ponceau 4 R
D) Hydroxychloroquine Sulfate Tablets USP 400mg
Each film coated tablet contains:
Hydroxychloroquine Sulfate USP
Equivalent to Hydroxychloroquine Base 400mg
Excipients q.s
Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Hydroxychloroquine Tablets belongs to a class of drugs named antimalarials. It kills the organisms that cause malaria. Hydroxychloroquine Tablets are use in the treatment of discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus) diseases. It is also used in the treatment of acute and chronic rheumatoid arthritis. Hydroxychloroquine sulfate tablets are disease-modifying anti-rheumatic drug (DMARD). Hydroxychloroquine sulfate works by reducing swelling (inflammation) in people with autoimmune diseases (this is where the body's immune system attacks itself by mistake). This medicine should not be sold by retail without the prescription of registered Medical Practitioner

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 5 years.
Prevent or treat malaria caused by mosquito bites.
Read enclosed leaflet before use.
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) [see USP Controlled Room Temperature].
Dispense in tight and light resistant container.
Dosage: As directed by the Physician
Attach dispensing label as per end county.