Miltefosine capsules 50mg (Impataj)

Miltefosine capsules 50mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Miltefosine capsules 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Miltefosine capsules 50mg
  Each Hard Gelatin Capsule contains:
  Miltefosine ………………50mg
  Excipients ……………………. q.s.
  Approved colours are used in empty
  capsule shell: Brilliant Blue FCF

THERAPEUTIC INDICATIONS:

Miltefosine capsules is an antibiotic. It is used in the treatment of kala-azar (a parasitic disease spread by the bite of infected sand files). It inhibits the growth of parasite and kills it, thus relieving your infection.

Miltefosine use to treat a certain infection called leishmaniasis. It works by stopping the growth of certain n parasites.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

Take one tablet by mouth three times daily.

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

EMBRYO-FETAL TOXICITY

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store in a cool, dry & dark place.  Do not store in the bathroom.

Dosage: Adolescent/adult patients aged 12-65 years received Impataj orally for 28 days. Impataj target dose was 2.5 mg/kg/day.

Daily dosage to 150mg (3 capsules).

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is your trusted choice for Miltefosine capsules – a reliable source for quality medication, unparalleled expertise, and a commitment to global health. At Taj Pharmaceuticals, we prioritize your health and well-being above all else. Our Miltefosine capsules are meticulously manufactured in state-of-the-art facilities, adhering to stringent quality standards to guarantee safety and efficacy. With a legacy of pharmaceutical excellence spanning decades, we have earned a reputation for delivering pharmaceutical products that healthcare professionals and patients alike can rely on. What sets us apart is not just our commitment to quality but our dedication to making a positive impact on global health. Taj Pharmaceuticals has a strong history of actively contributing to healthcare initiatives worldwide, ensuring that essential medications like Miltefosine are accessible to those who need them most. When you choose Taj Pharmaceuticals, you’re not only choosing a trusted medication source, but you’re also joining us in our mission to improve healthcare outcomes globally.

Rest assured that Taj Pharmaceuticals is your partner in health, offering Miltefosine capsules with the utmost care, integrity, and expertise. Experience the difference with Taj Pharmaceuticals, where your health is our priority.

What is Miltefosine Capsules and its use?

Miltefosine capsules are a medication used primarily to treat certain parasitic infections and a particular form of skin cancer. Here’s more information about Miltefosine and its common uses:

• Treatment of Visceral Leishmaniasis (Kala-Azar): Miltefosine is most notably used to treat visceral leishmaniasis, a serious parasitic infection caused by various species of the Leishmania parasite. Visceral leishmaniasis, also known as kala-azar, can lead to severe symptoms such as fever, weight loss, anemia, and enlargement of the spleen and liver. Miltefosine is effective in combating this infection by targeting the parasites responsible for the disease.
• Cutaneous Leishmaniasis: Miltefosine may also be used to treat cutaneous leishmaniasis, a less severe form of the disease that affects the skin. This condition often manifests as skin ulcers or lesions.
• Treatment of Free-Living Amoebas: In some cases, Miltefosine can be prescribed to combat infections caused by free-living amoebas, such as Naegleria fowleri, which can cause a rare but often fatal brain infection known as primary amoebic meningoencephalitis (PAM).
• Treatment of Skin Cancer (Off-Label Use): Miltefosine has also been explored as an off-label treatment for certain types of skin cancer, including basal cell carcinoma. However, its use in this context may not be as common or well-established as its use for parasitic infections.

Miltefosine is a prescription medication, and its use should be supervised by a healthcare professional. The dosage and duration of treatment may vary depending on the specific condition being treated, the patient’s age, weight, and overall health, as well as other factors. Patients should follow their healthcare provider’s instructions carefully and report any side effects or concerns during the course of treatment.

How does Miltefosine Capsules Work?

Miltefosine works by disrupting the cell membranes of certain microorganisms, including parasitic organisms, which leads to their destruction. Here’s a more detailed explanation of how Miltefosine capsules work:

• Disruption of Cell Membranes: Miltefosine is a phospholipid compound that has a particular affinity for the cell membranes of microorganisms. Cell membranes are essential for the survival and integrity of these organisms, as they control the flow of nutrients and waste products in and out of the cells.
• Alteration of Membrane Properties: Miltefosine interacts with the lipid components of the cell membranes, causing alterations in their properties. This disruption compromises the structural integrity and function of the membranes.
• Loss of Cellular Homeostasis: As a consequence of these changes, the affected microorganisms experience a loss of cellular homeostasis. Essential molecules and ions can leak out of the cells, while harmful substances may enter, leading to cellular dysfunction.
• Cell Death: Ultimately, the disruption of the cell membrane’s integrity and function results in the death of the microorganisms. In the case of parasitic infections like leishmaniasis, this action targets and kills the parasites responsible for the disease.
• Selective Action: Miltefosine’s mechanism of action is selective, primarily affecting certain microorganisms while sparing human cells. This selectivity is due to differences in the composition and structure of cell membranes between microorganisms and human cells.

It’s important to note that the specific molecular details of Miltefosine’s interaction with cell membranes may vary depending on the type of microorganism it is targeting. In the context of parasitic infections, Miltefosine is particularly effective against Leishmania parasites, leading to its use as a treatment for leishmaniasis.

Benefits and Side effects of Miltefosine Capsules?

Miltefosine capsules can offer significant benefits in treating certain parasitic infections, but like any medication, they also come with potential side effects. Here are the benefits and common side effects associated with Miltefosine:

Benefits:

• Effective Against Leishmaniasis: Miltefosine is highly effective in treating visceral leishmaniasis (kala-azar), a severe parasitic infection caused by Leishmania parasites. It is also used for cutaneous leishmaniasis. Miltefosine helps eradicate the parasites responsible for these infections, leading to symptom relief and a cure.
• Oral Administration: Miltefosine is administered orally in the form of capsules, which makes it more convenient for patients compared to some other treatments that may require intravenous or intramuscular injections.
• Broad-Spectrum Activity: In addition to its primary use against Leishmania parasites, Miltefosine has shown some activity against other microorganisms, including certain free-living amoebas responsible for infections like primary amoebic meningoencephalitis (PAM).

Common Side Effects:

• Gastrointestinal Issues: Mild to moderate gastrointestinal side effects are relatively common with Miltefosine. These may include nausea, vomiting, diarrhea, and abdominal pain. Taking the medication with food can help alleviate these symptoms.
• Headache: Some individuals may experience headaches while taking Miltefosine.
• Elevated Liver Enzymes: Miltefosine can occasionally lead to elevated levels of liver enzymes in the blood. Regular monitoring of liver function is typically recommended during treatment.
• Renal Dysfunction: There have been reports of renal (kidney) dysfunction in rare cases. Monitoring kidney function is essential during treatment.
• Electrolyte Imbalance: Miltefosine can affect electrolyte levels in the body, potentially leading to disturbances like low potassium (hypokalemia) or low sodium (hyponatremia). Regular monitoring is crucial.
• Skin Rashes: Skin rashes or itching may occur in some individuals.
• Pregnancy Considerations: Miltefosine is known to have teratogenic potential (potential to cause birth defects), so it should be avoided during pregnancy or when there’s a possibility of becoming pregnant. Effective contraception is necessary during treatment and for several months afterward.
• Other Possible Side Effects: Less common side effects may include dizziness, fatigue, and changes in taste.

It’s important to remember that not everyone will experience these side effects, and some individuals may tolerate Miltefosine well. Healthcare professionals will carefully weigh the potential benefits of treatment against the risks and closely monitor patients for any adverse reactions during the course of treatment. Patients prescribed Miltefosine should always follow their healthcare provider’s instructions, report any unusual or severe side effects, and attend regular check-ups to ensure the medication’s safety and effectiveness.

Frequently asked questions (FAQs) about Miltefosine Capsules:

1. What is Miltefosine?

Miltefosine is a medication used to treat certain parasitic infections, primarily visceral and cutaneous leishmaniasis, as well as some free living amoeba infections.

2. How does Miltefosine work?

Miltefosine disrupts the cell membranes of microorganisms, leading to their destruction. It alters membrane properties, causing a loss of cellular homeostasis and ultimately cell death in the targeted microorganisms.

3. What are the common uses of Miltefosine?

Miltefosine is primarily used to treat visceral and cutaneous leishmaniasis, but it can also be considered for the treatment of certain free-living amoeba infections. Off label use may include the treatment of some skin cancers.

4. Is Miltefosine available over the counter?

No, Miltefosine is a prescription medication and is not available over the counter. It should only be used under the supervision of a healthcare professional.

5. What are the potential side effects of Miltefosine?

Common side effects may include gastrointestinal issues (nausea, vomiting, diarrhea), headache, elevated liver enzymes, renal dysfunction, electrolyte imbalances, skin rashes, and more. Serious side effects are possible, so regular monitoring is crucial.

6. Can Miltefosine be used during pregnancy?

Miltefosine is known to have teratogenic potential (may cause birth defects). It should be avoided during pregnancy or when there’s a possibility of becoming pregnant. Effective contraception is necessary during treatment and for several months afterward.

7. How is Miltefosine administered?

Miltefosine is typically administered orally in the form of capsules. It’s important to take the medication exactly as prescribed by your healthcare provider.

8. Is Miltefosine safe for children?

The use of Miltefosine in children may be considered in certain cases, but the dosage and treatment plan should be carefully determined by a pediatrician or healthcare professional.

9. Can I drink alcohol while taking Miltefosine?

It’s generally advisable to avoid alcohol while taking Miltefosine, as alcohol may exacerbate certain side effects and interactions with the medication.

10. How long should I take Miltefosine?

The duration of Miltefosine treatment will depend on the specific condition being treated. Your healthcare provider will provide guidance on the length of treatment.

11. What should I do if I miss a dose of Miltefosine?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.

12. Can I take other medications while on Miltefosine?

It’s essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking, as some may interact with Miltefosine.

As Miltefosine Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Miltefosine Capsules 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

Miltefosine Capsules 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 Miltefosine Capsules, 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