Amikacin (Cocine) 50mg/ml (100mg/2ml) Solution for Injection (I.M/I.V) Vial 1's

50mg/ml (100mg/2ml) Solution for Injection

ANTIBACTERIAL (AMINOGLYCOSIDE)

Product Description:

Amikacin (Cocine) 50mg/ml Solution for Injection (I.M/I.V) is a broad-spectrum antibiotic belonging to the aminoglycoside class. It is available as a solution for injection and is commonly used to treat serious bacterial infections caused by gram-negative and some gram-positive bacteria. Amikacin works by inhibiting bacterial protein synthesis, which leads to bacterial cell death.

Each vial contains 50mg/ml of Amikacin in a 2ml solution (total of 100mg per vial). The product is primarily administered via intravenous (IV) or intramuscular (IM) injection.

Indications:

Amikacin (Cocine) 50mg/ml is indicated for the treatment of serious bacterial infections caused by susceptible organisms, including:

1. Respiratory Tract Infections:

   • Pneumonia.

   • Bronchitis.

   • Pulmonary infections in immunocompromised patients.

2. Urinary Tract Infections:

   • Pyelonephritis.

   • Cystitis.

   • Complicated urinary tract infections.

3. Abdominal Infections:

   • Peritonitis.

   • Intra-abdominal infections.

4. Sepsis:

   • Bloodstream infections caused by gram-negative bacteria.

5. Skin and Soft Tissue Infections:

   • Cellulitis, abscesses, or wound infections caused by susceptible organisms.

6. Bone and Joint Infections:

   • Osteomyelitis and septic arthritis.

7. Central Nervous System Infections:

   • Meningitis caused by susceptible bacteria.

8. Other Serious Infections:

   • Infections caused by multi-drug resistant organisms (e.g., Klebsiella, Pseudomonas, and Acinetobacter).

Dosage and Administration:

Amikacin (Cocine) is typically administered by intravenous (IV) or intramuscular (IM) injection, with the exact dosage determined by the healthcare provider based on the patient's condition, infection severity, and kidney function.

General Adult Dosage:

• For Serious Infections:

  • IV/IM Administration: The recommended dosage is typically 15 mg/kg body weight/day, divided into two or three doses. For example:

    • Administer 500mg to 1g every 8-12 hours depending on the infection's severity.

• For Severe Infections:

  • Higher doses or more frequent administration may be necessary, but must be determined by the treating physician.

• For Renal Impairment:

  • Dosage adjustments are required for patients with impaired renal function. Dosage intervals may need to be extended, or the dose reduced to prevent accumulation of the drug in the body.

Duration of Treatment:

• Typically, 7 to 10 days depending on the type of infection, although treatment duration may vary.

Side Effects:

While Amikacin (Cocine) is generally well-tolerated, some patients may experience side effects, including:

1. Common Side Effects:

   • Nausea and vomiting.

   • Injection site reactions such as pain, swelling, or redness.

   • Fever or chills.

2. Serious Side Effects:

   • Nephrotoxicity: Kidney damage, which may manifest as increased serum creatinine or decreased urine output.

   • Ototoxicity: Damage to the hearing and balance organs, leading to hearing loss, tinnitus (ringing in the ears), or vertigo. High blood levels or prolonged use increase the risk.

   • Neuromuscular Blockade: Rarely, amikacin can cause muscle weakness, respiratory paralysis, or difficulty breathing, especially in patients receiving other drugs that block neuromuscular transmission.

   • Hypersensitivity Reactions: Includes rash, urticaria, fever, or anaphylaxis (rare).

3. Hematologic Effects:

   • Low blood cell counts: This includes neutropenia (low white blood cells) or thrombocytopenia (low platelets).

Contraindications:

Amikacin (Cocine) 50mg/ml Solution for Injection should not be used in the following situations:

1. Hypersensitivity to amikacin, other aminoglycoside antibiotics (e.g., gentamicin, tobramycin), or any component of the formulation.

2. Pregnancy (especially in the first trimester), unless the potential benefit outweighs the risk. Amikacin can cross the placenta and cause fetal harm, including ototoxicity.

3. Breastfeeding: It is not recommended for use during breastfeeding due to the potential risk of neonatal ototoxicity.

4. Severe Renal Impairment: Amikacin is contraindicated in patients with severe renal dysfunction, especially without appropriate dosage adjustments, as it can cause nephrotoxicity.

5. Pre-existing Hearing Impairment: Caution should be used in patients with pre-existing hearing problems as amikacin can cause ototoxicity, which may worsen pre-existing conditions.

Precautions:

• Renal Function Monitoring: Regular monitoring of kidney function (serum creatinine, urine output) is required, especially for patients with pre-existing renal impairment.

• Hearing Tests: Monitoring of hearing function is recommended during prolonged therapy or in patients with risk factors for ototoxicity.

• Electrolyte Imbalances: Amikacin can cause disturbances in electrolytes such as potassium and magnesium, which may require correction.

• Pregnancy and Lactation: Use only if clearly needed and prescribed by a healthcare provider after assessing the risk to the fetus or infant.

• Neuromuscular Blockade: Caution in patients receiving neuromuscular blocking agents, especially if they are critically ill or have respiratory failure.

• Toxicity in Elderly: Elderly patients may be more susceptible to nephrotoxicity and ototoxicity. Dosage adjustments may be necessary.

Overdose:

Symptoms of overdose may include:

• Severe nephrotoxicity (kidney damage), leading to acute kidney failure.

• Severe ototoxicity (hearing loss, tinnitus, or vertigo).

• Neuromuscular blockade, which may cause respiratory depression.

Management of overdose:

• Discontinue the drug immediately and provide supportive care.

• Dialysis may be considered in severe cases to remove the drug from the bloodstream.

• Monitor kidney and hearing function closely, and manage symptoms appropriately.

Conclusion:

Amikacin (Cocine) 50mg/ml Solution for Injection is a potent aminoglycoside antibiotic used for the treatment of severe bacterial infections. It is particularly effective against gram-negative bacteria and is often used in patients with serious infections where other antibiotics may not be effective. Due to the potential for serious side effects such as nephrotoxicity and ototoxicity, it is important that patients receiving this treatment are closely monitored, especially those with pre-existing conditions that may increase the risk of these side effects. Always follow the prescribed dosage and seek medical guidance in case of adverse reactions.