Doripenem Injection 500 mg

Doripenem Injection IH 500 mg

Therapeutic Class: Anti-Infectives

Dosage Forms: Injectables

Brand Name: Doripenem Injection IH 500 mg™

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WHO
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How it works?

Uses of Doripenem Injection 500 mg

Doripenem Injection 500 mg is a broad-spectrum carbapenem antibiotic used to treat serious bacterial infections, especially those caused by resistant organisms. It works by inhibiting bacterial cell wall synthesis, leading to cell death.

 

Precautions of Doripenem Injection 500 mg

Precautions for Doripenem Injection 500 mg

Hypersensitivity Reactions

  • Serious and sometimes fatal allergic reactions (anaphylaxis) have occurred with beta-lactam antibiotics like Doripenem.
  • Before starting treatment, inform your doctor if you’ve ever had an allergic reaction to:
    • Doripenem
    • Other carbapenems or cephalosporins
    • Penicillin or other beta-lactam antibiotics
  • If an allergic reaction occurs, stop the medicine immediately and seek emergency care.

Seizure Risk

  • Seizures have been rarely reported with doripenem and other carbapenems.
  • Use with caution in patients with a history of seizures or those taking valproic acid/sodium valproate, as doripenem may reduce its effectiveness.

Diarrhea and Colitis

  • Doripenem may cause Clostridium difficile-associated diarrhea, which can be mild to life-threatening.
  • If you develop severe or persistent diarrhea, contact your doctor immediately.
  • Do not take anti-diarrhea medicines unless advised by your doctor.

Superinfection Risk

  • Prolonged use may lead to overgrowth of resistant bacteria or fungi (e.g., Candida, enterococci).
  • Monitor for signs of new infections during treatment.
  • If superinfection occurs, your doctor may change or stop the antibiotic.

Inhalation Warning

  • Doripenem should not be used via inhalation.
  • Investigational use by this route has caused pneumonitis (lung inflammation).

Pregnancy and Breastfeeding

Pregnancy

  • Limited data available; not recommended unless clearly necessary.
  • Animal studies are insufficient to confirm safety.

Lactation

  • It’s unknown if Doripenem passes into human breast milk.
  • In animal studies, doripenem and its metabolite were found in milk.
  • Your doctor will help weigh the benefits of breastfeeding vs. treatment.

Dosages administration of Doripenem Injection 500 mg

Dosage
The recommended dosage and administration by infection are shown in the following table:

Infection Dosage Frequency Infusion Time
Nosocomial pneumonia, including

ventilator-associated pneumonia

 500 mg every 8 hours 1 or 4 hours*
Complicated intra-abdominal infection 500 mg every 8 hours 1 hour
Complicated UTI, including pyelonephritis 500 mg every 8 hours 1 hour

Adults (≥18 years)

  • Standard dose: 500 mg every 8 hours
  • Route: Intravenous (IV) infusion
  • Infusion time: Over 1 hour
    • For severe infections or less susceptible pathogens, a 4-hour infusion may be more effective
  • Duration of therapy: 5–14 days

May switch to oral antibiotics after at least 3 days of IV therapy once clinical improvement is seen.

Pediatric Patients

  • Not recommended for children under 18 years due to lack of safety and efficacy data.

Renal Impairment

Creatinine Clearance (CrCl) Recommended Dose Frequency
51–79 mL/min (mild) No adjustment needed Every 8 hours
30–50 mL/min (moderate) 250 mg IV Every 8 hours
<30 mL/min (severe) 250 mg IV Every 12 hours
  • Use with caution in severe renal impairment due to increased drug exposure
  • Not recommended for patients on dialysis (insufficient data)

Elderly Patients (≥65 years)

  • No dose adjustment needed, unless there is moderate to severe renal impairment

Hepatic Impairment

  • No dose adjustment required

Preparation & Administration Instructions

  • Reconstitution:
    • Add 10 mL sterile water or normal saline to the 500 mg vial
    • Shake gently to form a suspension (approx. 50 mg/mL)
  • Infusion preparation:
    • Withdraw suspension and add to 100 mL of normal saline or 5% dextrose
    • Shake until clear (final concentration ≈ 4.5 mg/mL)
  • Important:
    • Do not inject the suspension directly.
    • Use aseptic technique.
    • Inspect for particulate matter or discoloration before use.

Side effects of Doripenem Injection 500 mg

Drug Reactions—Doripenem Injection 500 mg

Frequency Categories

  • Very Common: ≥ 1/10
  • Common: ≥ 1/100 to < 1/10
  • Uncommon: ≥ 1/1,000 to < 1/100
  • Not Known: Cannot be estimated from available data.

Infections and Infestations

Frequency Adverse Effects
Common Oral candidiasis, Vulvomycotic infection

Blood and Lymphatic System Disorders

Frequency Adverse Effects
Not Known Neutropenia

Immune System Disorders

Frequency Adverse Effects
Uncommon Hypersensitivity reactions
Not Known Anaphylaxis

Nervous System Disorders

Frequency Adverse Effects
Common Headaches

Vascular Disorders

Frequency Adverse Effects
Common Phlebitis

Gastrointestinal Disorders

Frequency Adverse Effects
Common Nausea, Diarrhoea
Uncommon Clostridium difficile colitis

Hepato-Biliary Disorders

Frequency Adverse Effects
Common Increased liver enzymes

Skin and Subcutaneous Tissue Disorders

Frequency Adverse Effects
Common Pruritus, Rash
Not Known Stevens-Johnson syndrome, Toxic epidermal necrolysis

 

Storage instruction of Doripenem Injection 500 mg

Store below 30°C temperature. Protect from light.

Keep the medicine out of reach of children.

Packing details of Doripenem Injection 500 mg

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

Doripenem Injection IH 500 mg 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.

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