Micafungin Sodium for Injection 100mg Technical Specification:

Product Name:Micafungin Sodium for Injection 100mg
Brand Name:FungiShield
Strength:50mg, 100mg
Dosage Form:Lyophilised Powder for Injection (Sterile)
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-fungal
Indication: Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis etc.
Storage:Store at a temperature not exceeding between 25°C -30°C. Do not refrigerate.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Micafungin Sodium for Injection 100mg (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Micafungin Sodium for Injection 100 mg
    a)Each vial contains:
    Micafungin Sodium
    equivalent to Micafungin……………………100mg
    Excipients………………………………………………q.s.
    b)Sodium Chloride Injection IP 0.9% w/v (10ml)
    Each ml contains:Sodium Chloride IP……………………………….9mg
    Water for Injection IP…………………………..q.s.

THERAPEUTIC INDICATION:

Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess without meningoencephalitis or ocular dissemination, and esophageal candidiasis.

DIRECTION OF USE:

To be reconstituted with 5 ml/10ml of Sodium Chloride Injection IP 0.9% w/v.

CAUTION AND SCHEDULE:

CAUTION: Do not use the reconstituted solution if it contains any visible.

SCHEDULE: Schedule “H” Drug WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

KEEP OUT OF REACH OF CHILDREN

For dosage and administration please see enclosed leaflet or As directed by an Physician.

DOSAGE: As directed by Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals leads the way in providing Micafungin Sodium for Injection, a crucial medication in combating invasive fungal infections. With a steadfast dedication to quality, safety, and innovation, we ensure that every vial of Micafungin Sodium meets the highest global standards. For decades, Taj Pharmaceuticals has been synonymous with trust in the pharmaceutical industry, delivering life-saving medications to healthcare professionals and patients worldwide. Our commitment to accessibility ensures that individuals in need have access to top-quality pharmaceuticals, including Micafungin Sodium. Our state-of-the-art manufacturing facilities adhere to the most rigorous quality control protocols, guaranteeing the purity and efficacy of every dose. Whether in critical care or routine antifungal therapy, healthcare providers trust Taj Pharmaceuticals for reliable and effective medications. Choose Taj Pharmaceuticals for Micafungin Sodium for Injection and experience pharmaceutical excellence that prioritizes your health and well-being. We are here to support healthcare providers and patients, providing the quality and reliability you deserve in the fight against invasive fungal diseases.

What is Micafungin Sodium for Injection and its uses:

Micafungin Sodium for Injection is a medication used in the treatment of fungal infections. It belongs to a class of antifungal drugs known as echinocandins. Here’s an overview of Micafungin Sodium for Injection and its primary uses:

  • Composition:
    Micafungin is the active ingredient in Micafungin Sodium for Injection.
  • Uses:
    Invasive Candidiasis:
    Micafungin Sodium for Injection is primarily used to treat invasive candidiasis, a serious fungal infection caused by Candida species. Invasive candidiasis can affect various organs and systems in the body and is often seen in individuals with weakened immune systems, such as critically ill patients, transplant recipients, or those receiving chemotherapy.
    Esophageal Candidiasis: It is also indicated for the treatment of esophageal candidiasis, a fungal infection of the esophagus that can cause symptoms like difficulty swallowing and chest pain.
    Prophylaxis: In some cases, it may be used as prophylactic therapy to prevent invasive candidiasis in high-risk patients, such as those undergoing hematopoietic stem cell transplantation.
  • Mechanism of Action:
    Micafungin works by inhibiting the synthesis of a key component of the fungal cell wall called beta1,3Dglucan. This disruption weakens the fungal cell wall, leading to the rupture and death of the fungal cells. Importantly, this mechanism of action is specific to fungi and does not affect human cells, making it a targeted and low-toxicity antifungal therapy.
  • Administration:
    Micafungin Sodium for Injection is administered as an intravenous infusion in a hospital or clinical setting. The dosage and duration of treatment depend on the specific fungal infection and the patient’s response.
  • Clinical Considerations:
    Micafungin is typically used in patients with confirmed or suspected fungal infections, especially when other antifungal medications may not be suitable due to resistance or safety concerns. The decision to use Micafungin is made by healthcare providers based on the patient’s clinical condition and the results of diagnostic tests.
  • Prevention:
    While it is primarily used for the treatment of fungal infections, in some cases, Micafungin may be used to prevent invasive candidiasis in high-risk patients undergoing certain medical procedures or treatments.

Micafungin Sodium for Injection is a valuable tool in the treatment of serious fungal infections, particularly in patients with compromised immune systems or those who are critically ill. The choice of antifungal medication depends on the type of infection, patient specific factors, and potential risks and benefits.

How does Micafungin Sodium for Injection Work?

Micafungin Sodium for Injection is an antifungal medication that works by targeting and disrupting the fungal cell wall. It belongs to a class of antifungal drugs known as echinocandins. Here’s how Micafungin works:

  • Fungal Cell Wall Synthesis:
    Fungi, including Candida species, have a rigid and protective outer layer called the cell wall. The cell wall is essential for their survival and structural integrity.
  • Inhibition of β1,3DGlucan Synthesis:
    Micafungin specifically inhibits the synthesis of a key component of the fungal cell wall called beta1,3Dglucan. Beta1,3Dglucan is crucial for providing structural support and stability to the fungal cell wall.
  • Weakening of Fungal Cell Wall:
    When Micafungin is administered, it interferes with the enzyme (1,3betaDglucan synthase) responsible for building beta1,3Dglucan. This interference disrupts the formation and integrity of the fungal cell wall.
  • Cell Wall Damage and Cell Lysis:
    With the cell wall weakened or incomplete, the fungal cells become structurally compromised. They are unable to maintain their shape and integrity.
  • Cell Lysis and Fungal Death:
    As a result, the fungal cells become susceptible to osmotic stress and eventually rupture or lyse. This leads to the death of the fungal cells.
  • Specificity for Fungi:
    Importantly, Micafungin’s mechanism of action is highly specific to fungi and does not affect human cells. Human cells do not have a beta1,3Dglucan cell wall component, making Micafungin a targeted and low-toxicity antifungal therapy.

By disrupting the synthesis of the fungal cell wall, Micafungin effectively weakens and destroys the fungal cells. This targeted action makes Micafungin a valuable tool in the treatment of invasive fungal infections caused by organisms like Candida species. It is particularly useful in patients with compromised immune systems or those with serious underlying medical conditions where fungal infections can be life-threatening.

Benefits of Micafungin Sodium for Injection:

  • Effective Treatment: Micafungin Sodium for Injection is highly effective in treating invasive fungal infections caused by Candida species. It is particularly valuable in cases where other antifungal medications may not be effective due to resistance or safety concerns.
  • Broad Spectrum: It has a broad spectrum of activity against various Candida species, making it a versatile choice for fungal infections.
  • Low Toxicity: Micafungin has low toxicity to human cells because it specifically targets the fungal cell wall. This specificity reduces the risk of adverse effects on the patient.
  • Rapid Onset: The medication is administered intravenously and often exhibits a rapid onset of action, providing relief to patients with acute fungal infections.
  • Critical Care Use: Micafungin is suitable for use in critical care settings, where rapid and effective treatment of invasive fungal infections is crucial.
  • Well-Tolerated: It is generally well-tolerated by most patients, with fewer side effects compared to some other antifungal medications.

Side Effects of Micafungin Sodium for Injection:

  • Infusion-Related Reactions: Some patients may experience infusion-related reactions, such as fever, chills, headache, and nausea. These reactions are typically mild and can be managed by slowing down the infusion rate.
  • Liver Enzyme Elevation: Micafungin can lead to elevated liver enzymes in some individuals. Healthcare providers may monitor liver function during treatment.
  • Gastrointestinal Symptoms: Patients may experience gastrointestinal symptoms like nausea, vomiting, or diarrhea.
  • Electrolyte Imbalances: In some cases, electrolyte imbalances, particularly hypokalemia (low potassium levels), may occur.
  • Rash and Skin Reactions: Skin reactions, including rash and itching, are possible side effects but are less common.
  • Headache: Some patients may experience headaches during or after Micafungin infusion.
  • Abnormal Laboratory Values: There may be changes in laboratory values, such as alterations in blood counts, which healthcare providers monitor.

It’s important to note that while Micafungin is generally well-tolerated, the decision to use this medication is made by healthcare providers based on the specific fungal infection, the patient’s medical history, and potential risks and benefits. Fungal infections can be serious, and Micafungin plays a crucial role in their treatment, especially in patients with compromised immune systems or life-threatening conditions. Any concerns or side effects should be discussed with healthcare professionals during the course of treatment.

Frequently Asked Questions About Micafungin Sodium for Injection:

Certainly, here are some frequently asked questions (FAQs) about Micafungin Sodium for Injection:

  1. What is Micafungin Sodium for Injection used for?

Micafungin Sodium for Injection is primarily used to treat invasive fungal infections caused by Candida species. This includes infections that affect internal organs and systems.

  1. How is Micafungin administered?

It is administered intravenously (IV) in a hospital or clinical setting. The dosage and duration of treatment depend on the specific fungal infection and the patient’s response.

  1. Is Micafungin the same as other antifungal medications, like fluconazole or amphotericin B?

Micafungin belongs to a different class of antifungal medications called echinocandins. While it has a different mechanism of action, it is used to treat similar fungal infections. The choice of antifungal medication depends on factors like the type of infection and patient-specific considerations.

  1. Is Micafungin safe for use in pregnant or breastfeeding women?

The use of Micafungin during pregnancy or breastfeeding should be discussed with healthcare providers, taking into consideration the potential risks and benefits.

  1. What are the common side effects of Micafungin Sodium for Injection?

Common side effects may include infusion-related reactions (fever, chills, headache), nausea, vomiting, diarrhea, and elevated liver enzymes. Most side effects are mild and manageable.

  1. How long does Micafungin treatment typically last?

The duration of treatment varies depending on the specific fungal infection and the patient’s response. Some infections may require a shorter course of treatment, while others may necessitate a longer duration.

  1. Can Micafungin be used to prevent fungal infections?

Micafungin is primarily used for the treatment of established fungal infections. It is not typically used for prophylaxis (prevention) of fungal infections.

  1. Is Micafungin safe for use in children and infants?

Micafungin is approved for use in pediatric patients, including infants, under the guidance of healthcare professionals.

  1. What should I do if I experience adverse effects during Micafungin treatment?

If you experience any concerning side effects or adverse reactions, it’s important to notify your healthcare provider promptly. They can assess the situation and make necessary adjustments to your treatment plan.

Patients should maintain open communication with their healthcare providers, ask questions, and seek clarification regarding Micafungin treatment to ensure safe and effective management of fungal infections.

As Micafungin Sodium for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Micafungin Sodium for Injection 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

Micafungin Sodium for Injection 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 Micafungin Sodium for Injection, 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Micafungin Sodium for Injection 50mg (FungiShield)
B. Micafungin Sodium for Injection 100mg (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Micafungin Sodium for Injection 50 mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...50mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection IP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................q.s.

B) Micafungin Sodium for Injection 100 mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...100mg
Excipients…………………………….………………. q. s
Sodium Chloride Injection IP 0.9% w/v (10ml)
b) Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................q.s.


THERAPEUTIC INDICATIONS:

Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess without meningoencephalitis or ocular dissemination, and esophageal candidiasis.

DIRECTION OF USE:

To be reconstituted with 5 ml/10ml of Sodium Chloride Injection IP 0.9% w/v.

CAUTION AND SCHEDULE:

CAUTION: Do not use the reconstituted solution if it contains any visible.
SCHEDULE: SCHEDULE “H” DRUG WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
For dosage and administration please see enclosed leaflet or As directed by an Physician.
DOSAGE: As directed by Physician.