FROLET FCM – Ferric Carboxymaltose 500mg/10ml | IV Iron Injection

Description

ROLET FCM – Ferric Carboxymaltose 500mg/10ml Injection

(Rapid IV Iron Replacement for Severe Deficiency)

Category: Parenteral Iron Preparation
Pack Size: 1 Single-Dose Vial (10ml)
Active Ingredient: Ferric Carboxymaltose IP 500mg elemental iron per 10ml

🟢 Key Benefits

✔ High-dose iron repletion in just 15-30 minutes
✔ Stable complex (minimal free iron toxicity risk)
✔ Single-dose administration up to 1000mg iron
✔ No test dose required (unlike dextran formulations)

🩺 Approved Indications

• Iron-deficiency anemia (Hb ≤10 g/dL)

• Chronic kidney disease (pre-dialysis)

• Postpartum anemia

• GI malabsorption syndromes (IBD, bariatric surgery)

💉 Dosage & Administration

Adult Dosing (Weight-Based):

• <50kg: 500mg single dose

• ≥50kg: 1000mg (2 vials) as single infusion

Infusion Protocol:

1. Dilute in 100-250ml NS

2. Infuse over 15-30 minutes

3. Max 1000mg per session

Pediatric Use: Not recommended below 14 years

⚠️ Critical Warnings

❌ Contraindications:

• Non-iron deficiency anemia

• Iron overload disorders

• 1st trimester pregnancy

⚠️ Monitoring Required:

• Hypophosphatemia (common)

• Transient hypertension during infusion

🛄 Storage Conditions

• Store at 2-8°C (refrigerate)

• Do not freeze

• Use immediately after dilution

📊 Regulatory Status

• WHO Essential Medicine

• FDA/EMA Approved

• Schedule H (India)