Doripenem Injection 500 mg
Doripenem Injection IH 500 mg
Therapeutic Class: Anti-Infectives
Dosage Forms: Injectables
Brand Name: Doripenem Injection IH 500 mg™
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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