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Mardex 25 Kit

DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE

Manufacturer: Asclemed USA, Inc.

Score: 142.0

Quick Summary

Mardex 25 Kit is used for various medical procedures, including local or regional anesthesia, analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures. The kit contains bupivacaine hydrochloride, an amide local anesthetic, and dexamethasone sodium phosphate, a corticosteroid. Bupivacaine blocks nerve impulses, producing numbness or loss of sensation, while dexamethasone is used to treat various conditions such as endocrine disorders, rheumatic disorders, and allergic states. However, the kit has several warnings and contraindications, including the risk of cardiac arrest, dose-related toxicity, and methemoglobinemia. The recommended dosage varies depending on the procedure, and special considerations are needed for pediatric, geriatric, and pregnant patients.

Key Clinical Findings and Indications

  • Local or regional anesthesia
  • Analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures
  • Treatment of endocrine disorders, rheumatic disorders, and allergic states

Important Safety Information

Warning

Risk of cardiac arrest, dose-related toxicity, and methemoglobinemia

Contraindications

  • Obstetrical paracervical block anesthesia
  • Intravenous regional anesthesia (Bier Block)
  • Patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type

Adverse Reactions

  • Cardiovascular effects, such as hypotension and bradycardia
  • Neurologic effects, such as seizures and respiratory arrest
  • Allergic-type reactions, such as urticaria and angioneurotic edema

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for elderly patients, patients with hepatic or renal impairment, and patients with cardiovascular disease

Local infiltration

Adult Dose

0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose teartop vials

Pediatric Dose

Not recommended for pediatric patients younger than 12 years

Epidural anesthesia

Adult Dose

0.5% (50 mg/10 mL) (5 mg/mL) in single-dose teartop vials

Pediatric Dose

Not recommended for pediatric patients younger than 12 years

Special Population Considerations

Pregnancy

  • Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated for obstetrical paracervical block anesthesia
  • Use in pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

  • Corticosteroids are excreted in breast milk
  • Use with caution in nursing mothers

Pediatric Use

  • Not recommended for pediatric patients younger than 12 years
  • Continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures

Geriatric Use

  • Elderly patients may require lower doses of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection
  • Use with caution in elderly patients with hypertension, as they may be at increased risk for developing hypotension