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Cidofovir Intravitreous Solution 8.1 mg/mL

in Extemporaneous Formulations
Authors:
Rita K. Jew
,
Winson Soo-Hoo
,
Elham Amiri
, and
Jamie M. Gomes
Free access

INGREDIENTS:

Cidofovir 75 mg/mL injection5.4 mL
Sodium chloride 0.9% injectionQSAD: 50 mL

EQUIPMENT AND SUPPLIES:

Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), 2 × 18-G needles, 1 × 10-mL syringe, 1 × 60-mL syringe, 1 × 0.22-µm filter needle

PREPARATION DETAILS:

Caution: Hazardous Drug—Non-antineoplastic hazards: Must be prepared in compliance with USP <800>.

  1. Withdraw volume of injectable solution using a 10-mL syringe.

  2. Withdraw volume of sodium chloride 0.9% injection using a 60-mL syringe.

  3. Add injectable solution into the syringe containing sodium chloride 0.9% injection.

  4. Cap 60-mL syringe and mix well.

  5. Change to a 0.22-µm filter needle.

  6. Transfer the solution into an empty Viaflex bag.

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. Caution: hazardous drug. For ophthalmic use only. Store in refrigerator.

Storage Conditions/Stability — Refrigerate. Stable for 5 days.

STABILITY STUDY DETAILS:

Study Container Type — Polyvinyl chloride or ethylene-propylene copolymer bag

Referenced Manufacturers — Cidofovir injection (Gilead Sciences, Inc); sodium chloride 0.9% injection (Abbott Laboratories; Baxter Healthcare Corp; McGaw, Inc).

Stability-Indicating Study — No

REFERENCE

1.

Ennis RD, Dahl TC. Stability of cidofovir in 0.9% sodium chloride injection for five days. Am J Health Syst Pharm. 1997;54(19):22042206.