GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
B. Atovaquone and Proguanil Hydrochloride Tablet (62.5mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
Each film-coated tablet contains:
Atovaquone …………………250mg
Proguanil Hydrochloride ………100mg
Excipients……………………………. q.s.
Colour: Titanium Dioxide


B. Atovaquone and Proguanil Hydrochloride Tablet (62.5mg+25mg)
Each film-coated tablet contains:
Atovaquone …………………62.5mg
Proguanil Hydrochloride ………25mg
Excipients……………………………. q.s.
Colour: Lake Indigo Carmine

THERAPEUTIC INDICATIONS:

Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN
*Not suitable for children under 5 years.

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place.
Do not store in bathroom.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.
Note: One tablet is taken 1-2 days before entering the endemic area (area affected with malaria). Then continued as a ONCE DAILY dose which in that area. Once you leave the area with malaria you must continue the ONCE DAILY regime for a further 7 days.

Atovaquone and Proguanil Hydrochloride Tablets (250mg+100mg) Technical Specification:

Product Name:Atovaquone and Proguanil Hydrochloride Tablets (250mg+100mg)
Brand Name:Generics
Strength:Pediatric: 62.5mg+25mg
Adult: 250mg+100mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:12s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antimalarials
Indication: Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.
Storage:Store in in cool & Dry place. Do not store in bathroom.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atovaquone and Proguanil Hydrochloride Tablets (250mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atovaquone and Proguanil Hydrochloride Tablets (250mg+100mg)
    Each film-coated tablet contains:
    Atovaquone …………………250mg
    Proguanil Hydrochloride ………100mg
    Excipients……………………………. q.s.
    Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
*Not suitable for children under 5 years.
Read enclosed leaflet before use.

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place. Do not store in bathroom.

Dosage: As Directed by the Physician.

Note: One tablet is taken 1-2 days before entering the endemic area (area affected with malaria). Then continued as a ONCE DAILY dose which in that area. Once you leave the area with malaria you must continue the ONCE DAILY regime for a further 7 days.

Why Taj Pharmaceuticals?

Taj Pharma is your premier source for Atovaquone and Proguanil Hydrochloride Tablets, offering you a comprehensive solution for malaria prevention and treatment. Our commitment to quality, safety, and affordability makes us the top choice for healthcare providers and patients alike. With a legacy of pharmaceutical excellence, Taj Pharma’s Atovaquone and Proguanil Hydrochloride Tablets are manufactured to the highest industry standards. Our rigorous quality control processes ensure that you receive a reliable and effective medication that meets all regulatory requirements. At Taj Pharma, your health is our priority. We understand the importance of accessible healthcare, and we strive to make our Atovaquone and Proguanil Hydrochloride Tablets affordable without compromising on quality. Count on us for a cost-effective solution to safeguard against malaria and its potential risks.

Join the countless satisfied customers who trust Taj Pharma for their healthcare needs. Make the smart choice and prioritize your health with Taj Pharma’s Atovaquone and Proguanil Hydrochloride Tablets – the gold standard in malaria prevention and treatment.

What is tovaquone and Proguanil Hydrochloride Tablets and its use?

Atovaquone and Proguanil Hydrochloride Tablets are a combination medication used primarily for the prevention and treatment of malaria, a serious and potentially life-threatening mosquito-borne infectious disease caused by the Plasmodium parasite. Here’s a breakdown of their individual components and their uses:

  • Atovaquone: Atovaquone is an antiparasitic medication that works by interfering with the reproduction and growth of the Plasmodium parasites within the red blood cells. It is effective against both Plasmodium falciparum (the most common and deadly form of malaria) and Plasmodium vivax (another common type of malaria). Atovaquone is also used to treat other parasitic infections, such as Pneumocystis jirovecii pneumonia in individuals with weakened immune systems, like those with HIV/AIDS.
  • Proguanil Hydrochloride: Proguanil, in its hydrochloride form, is another antimalarial medication. It works by inhibiting the development of the Plasmodium parasite within the liver, where the parasites first infect the human host. Proguanil is often used in combination with Atovaquone to provide a synergistic effect against the malaria parasite.
  • Together, Atovaquone and Proguanil Hydrochloride Tablets are prescribed for the following purposes:
  • Malaria Prevention: Travelers going to regions where malaria is prevalent are often prescribed these tablets as a prophylactic measure to prevent malaria infection. The combination is effective against chloroquine-resistant strains of malaria.
  • Malaria Treatment: In cases of confirmed malaria infection, healthcare professionals may prescribe Atovaquone and Proguanil Hydrochloride Tablets for treatment, depending on the specific type and drug sensitivity of the malaria parasite.

It’s important to note that while these tablets are effective for malaria prevention and treatment, they are not a substitute for other preventive measures, such as using mosquito nets, wearing protective clothing, and applying mosquito repellent, especially when traveling to high-risk malaria areas. Additionally, individuals should always consult with a healthcare provider or travel medicine specialist before starting any medication for malaria prevention or treatment, as dosages and treatment durations may vary based on individual factors and the region being visited.

How does Atovaquone and Proguanil Hydrochloride Tablets Work?

Atovaquone and Proguanil Hydrochloride Tablets work through a combination of mechanisms to effectively prevent and treat malaria, a mosquito-borne infectious disease caused by the Plasmodium parasite. Here’s how each component of the medication works:

  • Atovaquone: Atovaquone is a hydroxy-1,4-naphthoquinone compound that primarily targets the Plasmodium parasite’s mitochondria, the energy-producing structures within the parasite’s cells. Its mode of action involves inhibiting the parasite’s ability to generate adenosine triphosphate (ATP), which is essential for its survival and reproduction. By disrupting the mitochondrial electron transport chain, Atovaquone essentially starves the parasite of the energy it needs to thrive and multiply within the human host’s red blood cells.
  • Proguanil Hydrochloride: Proguanil, in its hydrochloride form, is a synthetic compound that is metabolized in the body to form the active compound cycloguanil. Cycloguanil primarily targets the Plasmodium parasite during its liver stage, where the parasite undergoes initial development and multiplication following a mosquito bite. Cycloguanil inhibits the activity of an enzyme called dihydrofolate reductase-thymidylate synthase, which is essential for the parasite’s DNA synthesis and replication. By disrupting this process, cycloguanil effectively inhibits the growth and proliferation of the parasite within the liver.
  • Together, the combination of Atovaquone and Proguanil Hydrochloride in a single tablet offers a synergistic approach to malaria prevention and treatment:
  • Atovaquone acts on the parasites once they have entered the red blood cells, preventing their multiplication and survival within these cells.
  • Proguanil Hydrochloride, through its metabolite cycloguanil, targets the parasites during their initial liver stage, reducing their ability to establish a full-blown infection in the body.

This dual mechanism of action makes Atovaquone and Proguanil Hydrochloride Tablets effective against multiple stages of the Plasmodium parasite’s life cycle, making them valuable tools in the prevention and treatment of malaria, particularly in regions where drug-resistant strains of the parasite are prevalent. However, it’s crucial to follow prescribed dosages and treatment regimens as directed by a healthcare provider to ensure maximum effectiveness and to minimize the risk of developing drug resistance.

Benefits of Atovaquone and Proguanil Hydrochloride Tablets:

  • Effective Malaria Prevention: The primary benefit of Atovaquone and Proguanil Hydrochloride Tablets is their effectiveness in preventing malaria. They are particularly valuable in regions where malaria is prevalent, including areas with chloroquine-resistant strains of the parasite.
  • Convenient Combination: These tablets offer the advantage of combining two different antimalarial drugs with different mechanisms of action in a single tablet. This combination enhances their efficacy against various stages of the Plasmodium parasite’s life cycle, making them more effective than single-drug treatments.
  • Well-Tolerated: Atovaquone and Proguanil Hydrochloride Tablets are generally well-tolerated by most individuals. They often have fewer side effects compared to some other antimalarial medications, making them a suitable option for many travelers.
  • No Need for Booster Doses: Unlike some other antimalarial drugs, Atovaquone and Proguanil Hydrochloride Tablets do not require additional doses upon returning from a malaria-endemic area. This makes them more convenient for travelers who may have difficulty accessing healthcare upon their return.

Side Effects of Atovaquone and Proguanil Hydrochloride Tablets:

While these tablets are generally well-tolerated, they can cause side effects in some individuals. Common side effects may include:

  • Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, and abdominal pain are among the most common side effects. Taking the tablets with food can help reduce these symptoms.
  • Headache: Some individuals may experience mild to moderate headaches while taking the medication.
  • Dizziness: Dizziness or lightheadedness may occur in some cases.
  • Skin Reactions: Skin rashes or itching may rarely occur as a side effect.
  • Sleep Disturbances: Insomnia or unusual dreams have been reported by a small number of users.

It’s important to note that severe side effects with Atovaquone and Proguanil Hydrochloride Tablets are rare. However, if you experience any unusual or severe symptoms while taking this medication, it’s essential to seek medical attention promptly. individuals with certain medical conditions, such as a history of psychiatric disorders, liver disease, or kidney disease, should inform their healthcare provider before starting this medication, as special precautions or dosage adjustments may be necessary.

Ultimately, the benefits of Atovaquone and Proguanil Hydrochloride Tablets in preventing and treating malaria generally outweigh the potential side effects for most people. However, it’s crucial to discuss any concerns or medical history with a healthcare provider before starting this or any other medication.

Frequently asked questions (FAQs) about Atovaquone and Proguanil Hydrochloride Tablets:

  1. What are Atovaquone and Proguanil Hydrochloride Tablets used for?

Atovaquone and Proguanil Hydrochloride Tablets are primarily used for the prevention and treatment of malaria, a mosquito borne infectious disease.

  1. How do Atovaquone and Proguanil Hydrochloride Tablets work?

These tablets work by targeting different stages of the Plasmodium parasite’s life cycle. Atovaquone inhibits the parasite within red blood cells, while Proguanil Hydrochloride targets the liver stage, preventing malaria infection.

  1. Are Atovaquone and Proguanil Hydrochloride Tablets effective against all types of malaria?

They are effective against many strains of the malaria parasite, including chloroquine resistant strains. However, their effectiveness may vary by region, and it’s essential to consult a healthcare provider for guidance.

  1. Can I take these tablets for malaria prevention if I’m pregnant or breastfeeding?

Pregnant and breastfeeding women should consult their healthcare provider before using Atovaquone and Proguanil Hydrochloride Tablets, as the safety of these medications during pregnancy and breastfeeding is not well-established.

  1. When should I start taking these tablets before traveling to a malaria endemic area?

It’s typically recommended to start taking them 12 days before entering a malaria risk area. However, follow the specific guidance provided by your healthcare provider.

  1. Do I need to continue taking the tablets after leaving a malaria endemic area?

Yes, you should continue taking the prescribed tablets for the recommended duration even after leaving the malaria endemic area, as specified by your healthcare provider.

  1. What should I do if I miss a dose of Atovaquone and Proguanil Hydrochloride Tablets?

If you miss a dose, take it as soon as you remember. If it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double dose.

  1. Can these tablets be taken with other medications?

Inform your healthcare provider of all the medications and supplements you are taking to ensure there are no potential interactions. Some medications may interfere with the effectiveness of Atovaquone and Proguanil Hydrochloride Tablets.

  1. What are the common side effects of these tablets?

Common side effects may include nausea, vomiting, diarrhea, headache, dizziness, and skin rashes. If you experience severe or unusual side effects, seek medical attention.

  1. Are there any contraindications or precautions I should be aware of before taking these tablets?

Individuals with certain medical conditions or allergies should inform their healthcare provider. It’s essential to discuss your medical history and any concerns with your healthcare provider before starting this medication.

As Atovaquone and Proguanil Hydrochloride Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Atovaquone and Proguanil Hydrochloride 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

Atovaquone and Proguanil Hydrochloride 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 Atovaquone and Proguanil Hydrochloride 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