GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amikacin Sulphate Injection IP 100mg/2ml
B. Amikacin Sulphate Injection IP 250mg/2ml
C. Amikacin Sulphate Injection IP 500mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amikacin Sulphate Injection IP 100mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………100mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.


B. Amikacin Sulphate Injection IP 250mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………250mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.

C. Amikacin Sulphate Injection IP 500mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………500mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.

THERAPEUTIC INDICATIONS:

Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.

DIRECTION OF USE:

For IV/IM use only.
See insert for detailed dosage, directions for use and precautions.

CAUTION AND SCHEDULE:

CAUTION: Do not use if solution is not clear or having suspended matter/particles and ask for replacement.
Discard any unused product immediately after use.
SCHEDULE: SCHEDULE H DRUG: WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store in a cool, dry & dark place.
Do not allow to freeze.
Dosage: As directed by physician.

Amikacin Sulphate Injection IP 100mg/2ml Technical Specification:

Product Name:Amikacin Sulphate Injection IP (100mg/2mL)
Brand Name:Amikataj
Strength:(100mg/2mL), (250mg/2mL), (500mg/2mL)
Dosage Form:Liquid Injection (Vial)
Packing:2mL
Route of Administration:For IV/IM use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antibiotics (aminoglycoside)
Indication: Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.
Storage:Store in a cool, dry & dark place. Do not allow to freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amikacin Sulphate Injection IP 100mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amikacin Sulphate Injection IP 100mg/2ml
    Each 2ml contains:
    Amikacin Sulphate I.P.
    Eq. to Amikacin ……………100mg
    Methylparaben I.P. …….0.08%w/v
    (As Preservative)
    Propylparaben I.P. ……0.02%w/v
    (As Preservative)
    Water for Injection I.P. ………q.s.

THERAPEUTIC INDICATION:

Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.

DIRECTION OF USE:

For IV/IM use only.

See insert for detailed dosage, directions for use and precautions.

CAUTION & schedule:

CAUTION:  Do not use if solution is not clear or having suspended matter/particles and ask for replacement.

Discard any unused product immediately after use.

schedule: schedule H DRUG: Warning: Not to be sold by retail without the prescription of Registered Medical Practitioner.   

Discard Unused portion.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store in a cool, dry & dark place. Do not allow to freeze.

Dosage:  As directed by physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a preferred choice for Amikacin Sulphate Injection due to several compelling reasons. Their commitment to maintaining high-quality standards in pharmaceutical manufacturing ensures the efficacy and safety of the medication, instilling confidence in healthcare providers and patients. With extensive pharmaceutical expertise, Taj Pharmaceuticals offers valuable knowledge in producing a wide range of pharmaceutical products, making them a trusted and dependable supplier. Their strict adherence to regulatory standards and robust quality control procedures enhances patient safety. Taj Pharmaceuticals’ global presence and distribution network guarantee the availability of Amikacin Sulphate Injection worldwide, ensuring patient access on a global scale. Investment in research and development demonstrates their commitment to innovation, potentially leading to improved formulations of Amikacin. Affordability is a key focus, making Amikacin Sulphate Injection accessible to a wider range of patients. Taj Pharmaceuticals’ dedication to a patient-centric approach, emphasizing well-being and safety, aligns seamlessly with the importance of antibiotics. This commitment reinforces trust in their products among healthcare providers and patients, ultimately contributing to enhanced patient care and outcomes globally. In summary, Taj Pharmaceuticals’ dedication to quality, compliance, research, affordability, and patient support positions them as a reliable supplier for Amikacin Sulphate Injection, benefiting healthcare providers and patients alike.

What is Amikacin Sulphate Injection and its uses?

Amikacin Sulphate Injection is a pharmaceutical medication that contains the active ingredient amikacin sulfate. It is a type of antibiotic and belongs to the aminoglycoside class of antibiotics. Amikacin is primarily used to treat serious bacterial infections caused by susceptible bacteria. Here are some key uses and indications for Amikacin Sulphate Injection:

  • Severe Bacterial Infections: Amikacin is often reserved for the treatment of severe bacterial infections where other antibiotics may not be effective. These infections can affect various parts of the body, including the respiratory tract, urinary tract, skin, and soft tissues.
  • Hospital-Acquired Infections: Amikacin may be used to treat hospital-acquired infections, including those caused by multidrug-resistant bacteria. It is commonly employed in the hospital setting when treating critically ill patients.
  • Respiratory Tract Infections: It can be used to treat respiratory tract infections, including pneumonia, when the causative bacteria are susceptible to amikacin.
  • Urinary Tract Infections (UTIs): Amikacin is effective against certain urinary tract infections, particularly when they are caused by bacteria that are resistant to other antibiotics.
  • Intra-Abdominal Infections: In some cases, amikacin may be used as part of a combination therapy to treat intra-abdominal infections.
  • Bone and Joint Infections: Amikacin may be considered for the treatment of bone and joint infections when other antibiotics are not suitable or when the causative bacteria are susceptible to amikacin.
  • Skin and Soft Tissue Infections: It may be used in the treatment of skin and soft tissue infections, particularly if the bacteria are known to be susceptible to amikacin.
  • Sepsis and Septicemia: Amikacin can be an important component of treatment when severe infections lead to sepsis or septicemia.

How Does Amikacin Sulphate Injection work?

Amikacin Sulphate Injection works as an antibiotic by targeting and inhibiting the growth of susceptible bacteria. It belongs to the aminoglycoside class of antibiotics and exerts its bactericidal (bacteria-killing) effects through a specific mechanism of action. Here’s how Amikacin works:

  • Disruption of Protein Synthesis: Bacterial cells require protein synthesis to function and reproduce. They rely on ribosomes, cellular structures responsible for assembling proteins. Amikacin disrupts this process by binding to the bacterial ribosomes, particularly the 30S subunit of the bacterial ribosome.
  • Inhibition of Translation: When Amikacin binds to the ribosome, it interferes with the normal reading and translation of the genetic code (mRNA) into functional proteins. This interference disrupts the synthesis of essential bacterial proteins, including those involved in cell wall formation, energy production, and other vital functions.
  • Faulty Protein Production: The disruption caused by Amikacin leads to the production of faulty or incomplete proteins within the bacterial cells. These defective proteins are unable to perform their intended functions.
  • Cellular Damage and Death: As a result of the defective protein production, the bacterial cells undergo significant damage and stress. This damage ultimately leads to cell death. The bactericidal action of Amikacin means that it kills the bacteria rather than merely inhibiting their growth.
  • Selective Action: Importantly, Amikacin exhibits a selective action against bacterial ribosomes and protein synthesis, which makes it highly effective against a wide range of Gram-negative bacteria. It is less effective against Gram-positive bacteria due to differences in ribosome structure.

Benefits of Amikacin Sulphate Injection:

  • Effective Against Resistant Bacteria: Amikacin is particularly valuable in treating infections caused by bacteria that have become resistant to other antibiotics. It is often used as a last resort when dealing with multidrug-resistant bacterial infections.
  • Broad-Spectrum Activity: Amikacin has a broad spectrum of activity against a wide range of Gram-negative bacteria, including those causing severe respiratory, urinary, and intra-abdominal infections.
  • Rapid Onset of Action: When administered via injection, Amikacin quickly reaches therapeutic concentrations in the bloodstream, allowing for a rapid onset of action. This is important in treating severe or life-threatening infections.
  • Bactericidal Action: Amikacin is bactericidal, meaning it kills bacteria rather than merely inhibiting their growth. This property is essential in effectively eradicating infections.
  • Clinically Proven: Amikacin has a long history of successful use in clinical settings, making it a trusted choice for healthcare providers when dealing with serious bacterial infections.

Common Side Effects of Amikacin Sulphate Injection:

  • Kidney and Ear Toxicity: Amikacin can potentially cause kidney and ear (ototoxic) toxicity, especially when administered at high doses or for prolonged periods. Regular monitoring of kidney function and hearing is essential during treatment.
  • Nephrotoxicity: Kidney toxicity may manifest as increased serum creatinine levels, reduced urine output, or kidney damage. Hydration and careful dosing are used to minimize this risk.
  • Ototoxicity: Ear toxicity can lead to hearing loss, balance issues, or ringing in the ears (tinnitus). Patients should report any changes in hearing or balance promptly.
  • Neurotoxicity: In rare cases, Amikacin may cause neurotoxicity, leading to muscle weakness, numbness, or tingling. This effect is more likely with high doses.
  • Injection Site Reactions: Localized pain, swelling, or irritation at the injection site may occur.
  • Allergic Reactions: Some individuals may experience allergic reactions, including rash, itching, swelling, or difficulty breathing. Allergic reactions are rare but require immediate medical attention if they occur.
  • Gastrointestinal Disturbances: Nausea, vomiting, and diarrhea are possible but less common side effects.
  • Blood Disorders: Amikacin may affect blood cell counts, leading to changes in white blood cell, red blood cell, or platelet counts.
  • Liver Enzyme Elevation: Elevated liver enzymes may occur in some patients.

Frequently Asked Questions About Amikacin Sulphate Injection:

Certainly, here are some frequently asked questions (FAQs) about Amikacin Sulphate Injection:

  1. What is Amikacin Sulphate Injection used for?

Amikacin Sulphate Injection is used to treat severe bacterial infections caused by susceptible Gram-negative bacteria. It is often reserved for infections that are unresponsive to other antibiotics or when bacteria are resistant to multiple antibiotics.

  1. How is Amikacin Sulphate Injection administered?

Amikacin Sulphate is administered through intramuscular (IM) or intravenous (IV) injection. The choice of administration route depends on the specific infection, its severity, and the patient’s condition.

  1. What types of infections can be treated with Amikacin?

Amikacin is effective against a wide range of infections, including respiratory tract infections, urinary tract infections, sepsis, intraabdominal infections, bone and joint infections, and more. It is particularly useful when dealing with multidrug resistant bacteria.

  1. How does Amikacin work to treat infections?

Amikacin works by interfering with bacterial protein synthesis, leading to the production of faulty proteins within bacterial cells. This disrupts their normal function and ultimately leads to bacterial cell death.

  1. What is the recommended dosage and duration of treatment with Amikacin?

The dosage and duration of treatment with Amikacin vary depending on the type and severity of the infection, the patient’s age, weight, and kidney function. Healthcare providers carefully determine the appropriate dosing regimen.

  1. Are there any side effects associated with Amikacin Sulphate Injection?

Yes, Amikacin can cause side effects, including kidney toxicity, ear toxicity (ototoxicity), and, less commonly, neurotoxicity. Patients may also experience injection site reactions, gastrointestinal disturbances, and allergic reactions.

  1. How is kidney function monitored during Amikacin treatment?

Kidney function is monitored by measuring serum creatinine levels and assessing urine output. Regular kidney function tests are essential during treatment to detect any signs of kidney toxicity.

  1. Can Amikacin be used during pregnancy or breastfeeding?

Amikacin should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks. It is crucial for healthcare providers to carefully consider the situation and risks before prescribing it in such cases.

  1. Can Amikacin interact with other medications or supplements?

Amikacin can interact with other medications, including certain diuretics and drugs that affect neuromuscular transmission. Inform your healthcare provider about all medications and supplements you are taking to assess potential interactions.

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

If you miss a dose, it’s essential to inform your healthcare provider or nurse promptly. They will determine the best course of action, which may include adjusting the dosing schedule.

Patients should always follow their healthcare provider’s instructions and report any unusual or severe side effects while taking Amikacin Sulphate Injection.

As Amikacin Sulphate Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Amikacin Sulphate 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

Amikacin Sulphate 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 Amikacin Sulphate 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
Fax No: +91 22 2634 1274