Imipenem & Cilastatin Injection 1gm

Therapeutic Class: Anti-Infectives

Dosage Forms: Injectables

Brand Name: Imipenem & Cilastatin Injection USP 1000 mg

Packaging Available In Alu/PVC Blister

Pack Size: 30x10 Softgels

Best Imipenem & Cilastatin Injection 1 gm Manufacturer, Supplier & Exporter In India

How it works?

Uses of Imipenem & Cilastatin Injection 1gm

Imipenem & Cilastatin Injection 1gm is a powerful antibiotic used to treat serious infections caused by a wide range of bacteria.

Key Actions:
Imipenem kills bacteria by stopping them from building their protective cell walls.

Cilastatin helps imipenem work better by stopping the kidneys from breaking it down too quickly.

Together, they fight both Gram-positive and Gram-negative bacteria, including tough ones like Pseudomonas aeruginosa.

Dosages administration of Imipenem & Cilastatin Injection 1gm

Dosage Instructions for Adults while using Imipenem & Cilastatin Injection 1gm.

  • This medicine is given through a vein (IV infusion).
  • Each dose contains equal parts of imipenem and cilastatin.
  • The dose depends on the type of infection and how well your kidneys are working.

For Patients with Healthy Kidneys (Creatinine Clearance ≥ 90 mL/min)

Dose How to Give It
500 mg Infuse over 20 to 30 minutes
1000 mg Infuse over 40 to 60 minutes
Max per day Do not exceed 4 grams per day

Table 1: Dosage of Imipenem & Cilastatin Injection USP 1000 mg in Adult Patients with Creatinine Clearance Greater than or Equal to 90 mL/min

Suspected or Proven Pathogen Susceptibility Dosage of Imipenem & Cilastatin Injection USP 1000 mg
If the infection is suspected or proven to be due to a susceptible bacterial species 500 mg every 6 hours OR 1000 mg every 8 hours
If the infection is suspected or proven to be due to bacterial species with intermediate susceptibility 1000 mg every 6 hours

Pediatric Dosage Guide

Not Recommended For:

  • Children with brain infections (CNS infections) are at risk of seizures.
  • Children under 30 kg with kidney problems—no safety data available.

General Guidelines:

  • Based on adult studies, the maximum daily dose for children should not exceed 4 grams.
  • This medicine is given through a vein (IV infusion).

The dose depends on the child’s age, weight, and type of infection.

Table 2: Recommended Imipenem & Cilastatin Injection USP 1000 mg Dosage in Pediatric Patients for Non-CNS Infections.

Age Dose (mg/kg) *,† Frequency (hours)

Greater than or equal to 3 Months of Age

15-25 mg/kg Every 6 hours

Less than or equal to 3 months of age (Greater than or equal to 1,500 g body weight)

4 weeks to 3 months of age 25 mg/kg Every 6 hours
1 to 4 weeks of age 25 mg/kg Every 8 hours
Less than 1 week of age 25 mg/kg Every 12 hours

Doses less than or equal to 500 mg should be given by intravenous infusion over 20 to 30 minutes.

Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

Recommend that the maximum total daily dosage not exceed 4 g/day.

Dosage in Adult Patients with Renal Impairment

Patients with creatinine clearance less than 90 mL/min require dosage reduction of IMIPENEM & CILASTATIN INJECTION USP 1000 MG as indicated in the table below. The serum creatinine should represent a steady state of renal function. Use the Cockroft-Gault method described below to calculate the creatinine clearance:

Males =(weight in kg × (140 − age in years)) ÷ (72 × serum creatinine in mg/dL)

Females: (0.85) x (value calculated for males)

Table 3: Dosage of Imipenem & Cilastatin Injection USP 1000 mg for Adult Patients in Various Renal Function Groups Based on Estimated Creatinine Clearance (CLcr)

Creatinine clearance (mL/min)
Greater than or equal to 90 Less than 90 to greater than or equal to 60 Less than 60 to greater than or equal to 30 Less than 30 to greater than or equal to 15
Dosage of IMIPENEM & CILASTATIN INJECTION USP 1000 MG*, 500 mg

every 6 hours

400 mg

every 6 hours

300 mg

every 6 hours

200 mg

every 6 hours

OR
If the infection is suspected or proven to be due to a

susceptible bacterial species:

1000 mg

every 8 hours

500 mg

every 6 hours

500 mg

every 8 hours

500 mg

every 12 hours

Dosage of IMIPENEM & CILASTATIN INJECTION USP 1000 MG*,†

If the infection is suspected or proven to be due to bacterial species with intermediate susceptibility

1000 mg every 6 hours 750 mg every 8 hours 500 mg every 6 hours 500 mg every 12 hours

How to Give This Imipenem & Cilastatin Injection 1gm?

  • If the dose is 500 mg or less, give it slowly over 20 to 30 minutes.
  • If the dose is more than 500 mg, give it slowly over 40 to 60 minutes.
  • If the patient feels nauseous during the infusion, slow down the drip.

Kidney Function and Safety

  • Patients with creatinine clearance between 15 and 30 mL/min have a higher risk of seizures.
  • Patients with creatinine clearance less than 15 mL/min should not receive this medicine unless they are scheduled for hemodialysis within 48 hours.
  • This medicine is not recommended for patients on peritoneal dialysis—there’s not enough safety data.

Dosing for Hemodialysis Patients

  • If the patient is on hemodialysis and has very low kidney function (<15 mL/min):
    • Use the same dose as for patients with 15–30 mL/min clearance.
    • Give the medicine after dialysis, and time the next dose based on when dialysis ends.
    • These patients—especially those with brain or nerve conditions—should be closely monitored.
    • This medicine should only be used if the benefits outweigh the risk of seizures.

What This Medicine Does

Imipenem/Cilastatin is a powerful antibiotic used to treat serious infections caused by a wide range of bacteria.

Key Actions:

  • Imipenem kills bacteria by stopping them from building their protective cell walls.
  • Cilastatin helps imipenem work better by stopping the kidneys from breaking it down too quickly.
  • Together, they fight both Gram-positive and Gram-negative bacteria, including tough ones like Pseudomonas aeruginosa.

How It Works in the Body

Absorption & Distribution

  • Imipenem is not absorbed well by mouth, so it’s given through a vein.
  • After IV injection, it reaches peak levels in the blood in less than an hour.
  • Both drugs spread well through the body and bind moderately to blood proteins.

Metabolism & Elimination

  • Imipenem is broken down in the kidneys unless cilastatin is present to protect it.
  • Cilastatin is partly broken down into another form in the kidneys.
  • Most of the medicine is removed from the body through urine within a few hours.

Special Considerations

Elderly Patients

  • No dose change is needed if kidney function is normal for their age.

Patients with Kidney Problems

  • The medicine stays longer in the body, so dose adjustments are needed.
  • In dialysis patients, the medicine is cleared faster during treatment.

Children

  • The medicine spreads slightly more in children than adults.
  • It is cleared from their bodies within 1 hour (imipenem) and 40 minutes (cilastatin).

 

Side effects of Imipenem & Cilastatin Injection 1gm

Serious Side Effects of  Imipenem & Cilastatin Injection 1 gm

These are rare but can be dangerous:

  • Severe allergic reactions: swelling, skin peeling, serious rashes
  • Kidney failure
  • Severe diarrhea (pseudomembranous colitis)
  • Seizures or convulsions

Infections

  • Rare: Yeast infections (candidosis), unusual bacteria (xanthomonas)

Blood Problems

  • Common: High white blood cells or platelets.
  • Uncommon: low white blood cells, low hemoglobin, slow blood clotting.
  • Rare to very rare: Serious blood disorders like anemia or bone marrow issues.

Immune Reactions

  • Rare: Skin rashes, severe allergic reactions.

Nervous System

  • Uncommon: Muscle jerks, confusion, hallucinations, tingling, sleepiness, dizziness, headaches
  • Rare: Brain inflammation (encephalopathy)

Ear Problems

  • Rare: Hearing loss
  • Unknown: Ringing in ears (tinnitus)

Heart Issues

  • Rare: Low blood pressure
  • Unknown: Fast heartbeat or palpitations

Breathing Problems

  • Very rare: Fast breathing or shortness of breath

Stomach and Gut

  • Uncommon: Nausea, vomiting, diarrhea, tooth/tongue staining
  • Rare: Serious diarrhea, taste changes
  • Unknown: Stomach pain, heartburn, sore throat, increased saliva

People with low white blood cells may feel more sick to their stomach than others.

Liver Issues

  • Common: Mild increase in liver enzymes
  • Rare to very rare: Liver failure or severe hepatitis

Skin Reactions

  • Common: Rash, itching, hives
  • Rare to unknown: Serious skin conditions, flushing, sweating, and skin changes.

Muscle and Joint

  • Very rare: Weakness or worsening of muscle disease.
  • Unknown: Joint pain, chest discomfort.

Kidney and Urine

  • Rare: Peeing too little or too much.
  • Very rare: Kidney failure, changes in urine color (harmless in children)

Injection Site and General Symptoms

  • Uncommon: redness, pain, swelling, and vein inflammation.
  • Rare to unknown: Weakness, fever.

Precautions of Imipenem & Cilastatin Injection 1gm

Important Safety Precautions while taking Imipenem & Cilastatin Injection 1gm.

When to Use

  • This medicine is for serious or complicated infections caused by bacteria that don’t respond to other antibiotics.
  • It should not be used for mild infections.

Allergic Reactions

  • If you’ve ever had an allergy to penicillins or cephalosporins, tell your doctor.
  • Severe allergic reactions like swelling or difficulty breathing can happen.
  • If any allergy symptoms appear, stop the medicine immediately and seek help.

Gut Health Warning

  • This medicine may cause severe diarrhea linked to a condition called pseudomembranous colitis.
  • Be extra cautious if you’ve had colitis or other stomach issues before.
  • Diarrhea during treatment should be checked by a doctor.

Use in Children

  • Not recommended for children under 3 years old.
  • Use with caution in children 3 years and older, especially if they have kidney problems.

Brain and Nerve Effects

  • People with brain disorders or kidney problems may be more likely to have side effects like tremors or seizures.
  • Stick to the exact dose prescribed.
  • If symptoms like shaking or confusion appear, talk to your doctor right away.
  • This medicine is not meant to treat brain infections.

Muscle Weakness

  • If you have myasthenia gravis (a muscle condition), this medicine may make it worse.
  • Contact your doctor if symptoms flare up.

Kidney Problems

  • If your kidney function is very low (<5 mL/min), you should not take this medicine unless you’re scheduled for dialysis within 48 hours.
  • For dialysis patients, this medicine is only used if the benefits outweigh the risks.

Long-Term Use

  • If you’re on this medicine for a long time, your liver, kidneys, and blood should be checked regularly.

Sodium Content

  • Each 500 mg dose contains 37.5 mg of sodium.
  • If you’re on a low-sodium diet, let your doctor know.

Storage instruction of Imipenem & Cilastatin Injection 1gm

Store below 30°C temperature. Protect from light.

Keep the medicine out of reach of children.

Packing details of Imipenem & Cilastatin Injection 1gm

10 ml clear glass vial with bromobutyl rubber stopper, sealed with a flip-off aluminum seal.

Imipenem & Cilastatin Injection  in a glass vial is supplied with a 10 ml plastic ampoule of diluent Sterilized Water for Injections USP in a unit carton with a pack insert.

 

F. A. Q

Frequently Asked Questions

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