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LET (Lidocaine 4%/Racepinephrine 0.225%/Tetracaine 0.5%) Topical Solution

in Extemporaneous Formulations
Free access

INGREDIENTS:

Lidocaine hydrochloride 20% injection10 mL
Racepinephrine hydrochloride 2.25% inhalation solution5 mL
Sodium metabisulfite powder31.5 mg
Tetracaine hydrochloride 2% injection12.5 mL
Sterile water for irrigationQSAD: 50 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, pharmaceutical analytical scale, graduated cylinder

PREPARATION DETAILS:

  1. Measure indicated volume of lidocaine hydrochloride, racepinephrine hydrochloride, tetracaine hydrochloride, and sterile water for irrigation into an amber glass container.

  2. Weigh out sodium metabisulfite and add to the container.

  3. Shake well to mix.

Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).

Labeling Requirements — Extemporaneously compounded preparation. For topical use only. Store at room temperature or refrigerate.

Storage Conditions/Stability — Store at room temperature or refrigerate. Protect from light. Stable for 182 days when refrigerated and 28 days when stored at room temperature.

STABILITY STUDY DETAILS:

Study Container Type — Amber glass bottle with a tight-fitting cap

Referenced Manufacturers — Lidocaine injection pintop vial (Abbott Laboratories); racepinephrine inhalation solution (Nephron Pharmaceuticals Corp); tetracaine injection (Winthrop Laboratories); sodium metabisulfite (Gallipot, Inc); sterile water for irrigation (Abbott Laboratories).

Stability-Indicating Study — No

Footnote — Solution should have a blue tint.

REFERENCE

1.

Larson TA, Uden DL, Schilling CG. Stability of epinephrine hydrochloride in an extemporaneously compounded topical anesthetic solution of lidocaine, racepinephrine, and tetracaine. Am J Health Syst Pharm. 1996;53(6):659662.

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