Description
NDC: 81298-8660-3
AK-Fluor (Fluorescein Sodium 10%) Injection, 12 x 5 mL Single-Dose Vials — Long Grove
| Active ingredients | Fluorescein sodium 10% (100 mg/mL) |
| Dosage form | Injection, solution |
| Route | Intravenous |
| Size | 12-pack (500 mg per 5 mL single-dose vials) |
| Manufacturer | Long Grove |
| NDC | 81298-8660-3 |
Indications and Usage
Indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
Dosage and Administration
For adults, 500 mg administered intravenously. For pediatric patients, 7.7 mg/kg intravenously, not to exceed 500 mg. Inject rapidly into the antecubital vein, taking care to avoid extravasation.
Warnings and Precautions
- Serious hypersensitivity and anaphylactic reactions, including rare deaths, may occur; keep resuscitation equipment and trained personnel available
- Extravasation can cause severe local tissue damage, including skin sloughing and nerve injury
- Greater risk in patients with prior reaction or a history of allergy or asthma
- Causes temporary yellow discoloration of the skin and urine
Contraindications
Contraindicated in patients with known hypersensitivity to fluorescein sodium or any component of the product.
Adverse Reactions
Common reactions include nausea, vomiting, gastrointestinal distress, and headache, along with transient yellow discoloration of the skin and urine. Hypotension and syncope may also occur.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); do not freeze and protect from light.
How Supplied
10% injection, 500 mg per 5 mL, in single-dose glass vials supplied in cartons of 12 vials.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
