Physicians EZ Use M-pred

METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE

Manufacturer: Asclemed USA, Inc.

Score: 146.0

Quick Summary

Physicians EZ Use M-pred is a combination of methylprednisolone acetate, bupivacaine hydrochloride, and povidone-iodine. It is used for various medical conditions including allergic states, dermatologic diseases, endocrine disorders, and more. The key clinical findings and indications include its use in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Important safety information and contraindications include the risk of cardiac arrest with use of bupivacaine hydrochloride in obstetrical anesthesia, and its contraindication in patients with known hypersensitivity to the product and its constituents. The main dosing recommendations include the use of 0.25% to 0.75% concentrations of bupivacaine hydrochloride injection for different types of blocks, and the initial dosage of parenterally administered methylprednisolone acetate injectable suspension will vary from 4 to 120 mg. Special population considerations include the use of the drug during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures
Treatment of allergic states, dermatologic diseases, endocrine disorders, and more
Intra-articular or soft tissue administration for short-term administration in acute gouty arthritis, acute and subacute bursitis, and more

Important Safety Information

Warning

Risk of cardiac arrest with use of bupivacaine hydrochloride in obstetrical anesthesia

Contraindications

Known hypersensitivity to the product and its constituents
Intrathecal administration
Premature infants due to the presence of benzyl alcohol

Adverse Reactions

Cardiovascular reactions such as hypotension and bradycardia
Central nervous system reactions such as seizures and respiratory depression
Allergic reactions such as anaphylaxis and angioedema

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic or renal impairment

Local or regional anesthesia

Adult Dose

0.25% to 0.75% concentrations of bupivacaine hydrochloride injection

Pediatric Dose

Not recommended for use in pediatric patients younger than 12 years

Intra-articular or soft tissue administration

Adult Dose

20 to 80 mg of methylprednisolone acetate injectable suspension

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Corticosteroids have been shown to be teratogenic in many species

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth or cause other untoward effects
A decision should be made whether to continue nursing or discontinue the drug

Pediatric Use

The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids
Pediatric patients should be titrated to the lowest effective dose

Geriatric Use

Patients 65 years and over may be at increased risk for developing hypotension
Dose selection should be cautious, usually starting at the low end of the dosing range