Oxyfer
Generic Name
Ferric Carboxymaltose
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| oxyfer 1 gm injection | ৳ 1,300.00 | N/A |
Description
Overview of the medicine
Oxyfer 1 gm Injection contains Ferric Carboxymaltose, an iron carbohydrate complex used for intravenous iron replacement. It is indicated for the treatment of iron deficiency anemia in adult patients when oral iron preparations are ineffective or cannot be used, or when there is a clinical need for rapid iron repletion.
Uses & Indications
Dosage
Adults
The usual cumulative dose is 1000 mg of iron, given as a single infusion of 1000 mg or as two infusions of 500 mg separated by at least 7 days. Maximum single dose: 1000 mg of iron (20 ml) not to exceed 1000 mg/week. Administer as an intravenous infusion (diluted in up to 250 ml of 0.9% NaCl solution) over a minimum of 15 minutes.
Elderly
No specific dose adjustment is generally required for elderly patients, but caution should be exercised.
Renal_impairment
No dose adjustment is typically required in patients with renal impairment, but caution is advised in patients with severe kidney disease.
How to Take
Oxyfer 1 gm Injection is for intravenous use only. It must be administered as a slow intravenous infusion. It should be diluted in sterile 0.9% sodium chloride solution prior to infusion. The diluted solution should be inspected visually for particulate matter and discoloration before administration. Do not administer if particulate matter or discoloration is present.
Mechanism of Action
Ferric Carboxymaltose delivers iron directly to the body. After intravenous administration, the iron-carbohydrate complex is taken up by the reticuloendothelial system (RES) cells, primarily in the liver, spleen, and bone marrow. The iron is then gradually released from the complex and becomes available for binding to transferrin and incorporation into hemoglobin in erythroid precursor cells, as well as for storage in ferritin.
Pharmacokinetics
Onset
Iron becomes available to the erythroid precursor cells within hours. Clinical effects (e.g., hemoglobin increase) are typically observed within a few weeks.
Excretion
Minimal urinary excretion of intact Ferric Carboxymaltose occurs. Iron is mainly utilized by the body or stored, with very limited excretion.
Half life
Elimination half-life of total iron is approximately 7-12 hours.
Absorption
Following intravenous administration, Ferric Carboxymaltose is directly absorbed into the systemic circulation, leading to 100% bioavailability. The iron-carbohydrate complex is rapidly distributed.
Metabolism
The complex is taken up by the reticuloendothelial system and subsequently metabolized to elemental iron and carbohydrate. The iron is released from the complex and either used for erythropoiesis or stored as ferritin.
Side Effects
Contraindications
- Hypersensitivity to Ferric Carboxymaltose or to any of the excipients.
- Anemia not attributed to iron deficiency (e.g., other types of anemia).
- Evidence of iron overload or disturbances in iron utilization.
- First trimester of pregnancy.
Drug Interactions
Oral Iron Preparations
Parenteral iron preparations should not be administered concomitantly with oral iron preparations as the absorption of oral iron might be reduced. Oral iron therapy should be started at least 5 days after the last injection of Ferric Carboxymaltose.
Storage
Store below 30°C. Do not freeze. Protect from light. Keep out of the reach of children. Use immediately after dilution.
Overdose
Overdose of Ferric Carboxymaltose may lead to accumulation of iron in storage sites, potentially causing hemosiderosis. Treatment should be supportive and may include chelating agents (e.g., deferoxamine) if severe iron overload is confirmed.
Pregnancy & Lactation
Pregnancy Category C. Use in the second and third trimesters only if the potential benefit justifies the potential risk to the fetus. Avoid use in the first trimester. Breastfeeding: It is not known whether Ferric Carboxymaltose is excreted in human milk. Exercise caution when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Ferric Carboxymaltose or to any of the excipients.
- Anemia not attributed to iron deficiency (e.g., other types of anemia).
- Evidence of iron overload or disturbances in iron utilization.
- First trimester of pregnancy.
Drug Interactions
Oral Iron Preparations
Parenteral iron preparations should not be administered concomitantly with oral iron preparations as the absorption of oral iron might be reduced. Oral iron therapy should be started at least 5 days after the last injection of Ferric Carboxymaltose.
Storage
Store below 30°C. Do not freeze. Protect from light. Keep out of the reach of children. Use immediately after dilution.
Overdose
Overdose of Ferric Carboxymaltose may lead to accumulation of iron in storage sites, potentially causing hemosiderosis. Treatment should be supportive and may include chelating agents (e.g., deferoxamine) if severe iron overload is confirmed.
Pregnancy & Lactation
Pregnancy Category C. Use in the second and third trimesters only if the potential benefit justifies the potential risk to the fetus. Avoid use in the first trimester. Breastfeeding: It is not known whether Ferric Carboxymaltose is excreted in human milk. Exercise caution when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, specific to manufacturer's specifications.
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved by relevant health authorities (e.g., DGDA, FDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ferric Carboxymaltose has been evaluated in numerous clinical trials demonstrating its efficacy and safety in various populations with iron deficiency anemia, including patients with chronic kidney disease, inflammatory bowel disease, and postpartum anemia. Key studies include the FERinject trials and comparative studies against oral iron.
Lab Monitoring
- Hemoglobin (Hb) levels before treatment and at least 4 weeks after the last infusion.
- Serum ferritin and transferrin saturation (TSAT) to assess iron stores and response.
- Complete Blood Count (CBC).
Doctor Notes
- Administer slowly and monitor for hypersensitivity reactions during and after infusion.
- Ensure proper diagnostic work-up for iron deficiency anemia before initiating treatment.
- Patients with liver impairment should be monitored closely as iron metabolism may be affected.
Patient Guidelines
- Inform your doctor about all existing medical conditions, especially liver or kidney disease, or any allergies.
- Report any signs of an allergic reaction (e.g., rash, itching, difficulty breathing, swelling) immediately during or after infusion.
- Ensure proper hydration before and after infusion as instructed by your healthcare provider.
- Do not take oral iron supplements simultaneously without consulting your doctor.
Missed Dose Advice
As this medicine is typically administered in a clinical setting by a healthcare professional, a missed dose is unlikely. If a dose is missed, consult your doctor to reschedule the treatment.
Driving Precautions
This medicine may cause dizziness, lightheadedness, or blurred vision. If you experience these symptoms, avoid driving or operating machinery until you feel well.
Lifestyle Advice
- Maintain a balanced diet rich in iron-containing foods (e.g., red meat, leafy greens, fortified cereals) to support long-term iron levels.
- Identify and address the underlying cause of iron deficiency with your doctor to prevent recurrence.
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