Wandara 1gm Injection

✔️ Uses of Wandara 1gm Injection

• Skin and Structure Infection
• Community-acquired pneumonia
• Complicated urinary tract infections
• Acute pelvic infections
• Complicated Intraabdominal Infection

✔️ How does Wandara 1gm Injection work?

Ertapenem works by killing the bacteria that cause infections. It binds to the bacterial cell wall and disrupts the bacterial cell wall synthesis which causes the death of susceptible microorganisms. As a result, it prevents the growth and spreading of the bacteria which therefore controls the severity of the infection.

✔️ Side Effects of Wandara 1gm Injection

Most adverse effects reported in clinical studies are mild to moderate. Common drug-related side effects include:

• Headache
• Infused vein complications (phlebitis/thrombophlebitis)
• Diarrhea
• Nausea and vomiting

Uncommon side effects may include:

• Dizziness
• Somnolence
• Insomnia
• Seizure
• Confusion
• Extravasation
• Hypotension
• Dyspnea
• Oral candidiasis
• Constipation
• C. difficile-associated diarrhea
• Dry mouth
• Dyspepsia
• Anorexia
• Erythema
• Pruritus
• Abdominal pain
• Taste perversion
• Asthenia/fatigue
• Candidiasis
• Edema/swelling
• Fever
• Chest pain
• Vaginal pruritus

✔️ Quick Suggestions:

• Wandara 1gm Injection is usually administered by a qualified healthcare professional in the clinical or hospital setting.
• Carefully follow all the instructions given by your doctor. Consult the doctor if you experience any undesirable side effects.
• It is given by a drip into a vein (intravenous infusion) over 20 to 60 minutes.
• Inform your doctor if you are allergic to penicillin or if you are taking any seizure medication before starting treatment with this medication.
• Do not stop the use of this medicine without consulting your doctor.
• Eating a balanced diet can support your immune system and overall well-being during treatment

✔️ Administration of Wandara 1gm Injection

Preparation for Intravenous Administration:

• Do not mix or co-infuse Ertapenem with other medications.
• Avoid diluents containing Dextrose.
• Reconstitute a 1 g vial of Ertapenem with 10 mL of Water for Injection, 0.9% Sodium Chloride, or Bacteriostatic Water for Injection. Shake well to dissolve, then dilute in 50 mL of normal saline (0.9% Sodium Chloride). Complete the infusion within 6 hours of reconstitution.

Preparation for Intramuscular Administration:

• Reconstitute a 1 g vial with 3.2 mL of 1% Lidocaine HCl. Shake thoroughly to form a solution.
• Withdraw the recommended dose and administer by deep intramuscular injection into a large muscle. The reconstituted solution should be used within 1 hour.

Visual Inspection: Inspect the parenteral drug visually for particulate matter and discoloration before use. Solutions of Ertapenem may range from colorless to pale yellow; variations within this range do not affect potency.

Note: Always adhere to a registered healthcare professional’s advice when using this medication.

✔️ Pharmacology

Ertapenem is the active ingredient in Wandara and is a sterile, synthetic, long-acting parenteral 1-β methyl-carbapenem. It is structurally related to beta-lactam antibiotics like penicillins and cephalosporins, exhibiting activity against a broad range of Gram-positive and Gram-negative aerobic and anaerobic bacteria.

Ertapenem acts bactericidal by binding to and inhibiting bacterial penicillin-binding proteins (PBPs). In Escherichia coli, it shows strong affinity for PBPs 1a, 1b, 2, 3, 4, and 5, particularly PBPs 2 and 3. By binding to these proteins, ertapenem disrupts bacterial cell wall synthesis, ultimately inhibiting cell wall formation.

✔️ Dosage of Wandara 1gm Injection

• Adults (>12 years): 1 g administered once daily.
• Pediatric (3 months to 12 years): 15 mg/kg twice daily (not to exceed 1 g/day).

Ertapenem can be administered via IV infusion or IM injection. For intravenous administration, it should be infused over 30 minutes.

For prophylaxis in adults undergoing elective colorectal surgery, the recommended dosage is 1 g IV administered as a single dose 1 hour before the surgical incision.

Renal Impairment:

• No dosage adjustment is necessary for patients with creatinine clearance >30 mL/min.
• For advanced renal insufficiency (creatinine clearance ≤30 mL/min), the recommended dose is 500 mg daily.

Hemodialysis: If Ertapenem is given at least 6 hours before hemodialysis, no supplementary dose is required. If given within 6 hours of hemodialysis, a supplementary 30% dose is recommended.

Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.

Note: Always follow your doctor's advice regarding medication use.

• Pediatric Use: The safety and efficacy of Wandara in pediatric patients aged 3 months to 17 years are supported by clinical trials in adults and pharmacokinetic data in children.
• Geriatric Use: As Wandara is significantly excreted by the kidneys, the risk of toxic reactions may be greater in elderly patients with renal impairment. Careful dose selection and monitoring of renal function are recommended.
• Renal Impairment: Dosage adjustments are necessary for patients with creatinine clearance of 30 mL/min or less.
• Hepatic Impairment: The pharmacokinetics of Wandara in patients with hepatic impairment have not been established.

No specific information is available regarding the treatment of Wandara overdose. However, intravenous administration of Wandara at a 3 g daily dose for 8 days in healthy volunteers did not result in significant toxicity. In pediatric studies, a single IV dose of 40 mg/kg (up to a maximum of 2 g) did not lead to toxicity.

In case of an overdose, discontinue Wandara and provide general supportive treatment until renal elimination occurs. Wandara can be removed by hemodialysis, but specific information regarding the use of hemodialysis for overdose management is lacking.

✔️ Interaction

When Wandara is administered alongside probenecid, it competes for active tubular secretion, leading to increased elimination half-life and systemic exposure. No dosage adjustment is required with probenecid; however, using probenecid to extend Wandara's half-life is not recommended.

Additionally, decreased serum levels of valproic acid have been reported when co-administered with Wandara, so monitoring serum levels of valproic acid is advisable.

✔️ Contraindications

Ertapenem is contraindicated in individuals with known hypersensitivity to any components of this product or other drugs in the same class. It is also contraindicated in patients with anaphylactic reactions to beta-lactams and those with known hypersensitivity to local anesthetics of the amide type, severe shock, or heart block.

✔️ Pregnancy & Lactation

Ertapenem is classified as pregnancy category B by the FDA. Due to limited studies in pregnant women, it should only be used during pregnancy if the potential benefits justify the potential risks to both mother and fetus. Ertapenem is excreted in human milk, so caution is advised when administering this medication to nursing women.

✔️ Precautions & Warnings

Before starting therapy with Wandara, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactams. Discontinue Wandara immediately if any allergic reaction occurs, and provide emergency treatment for serious anaphylactic reactions.

Prolonged use of Wandara may lead to the overgrowth of non-susceptible organisms, requiring repeated evaluations of the patient's condition. If a superinfection occurs, appropriate measures should be taken.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Wandara. It is important to consider this diagnosis in patients who develop diarrhea after starting antibiotic treatment, as a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis."

✔️ Storage Conditions:

For injection: Store at 2-8°C. Keep away from light and out of reach of children. For auxiliary packaging, do not store above 30°C.