Valid Ghana · FDA Ghana

ENICARB INJECTION

CARBOXYMALTOSE

FDA/SD.253-030373

What it does

Carboxymaltose is used to treat iron deficiency anemia, a condition where your body doesn't have enough iron.

Commonly used for: iron deficiency anemia, low iron levels

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.253-030373
Registration date
2025-03-04
Expiry date
2028-04-01
Status
Valid
Active ingredient
CARBOXYMALTOSE
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Emcure Pharmaceuticals
Applicant / LTR
OSARIS CHEMIST LTD
Country of origin
-
Manufacturer location
Plot No. P-1 & P-2, IT-BT Park, Phase-II, D.C, M.I, Hinjawadi, Pune, Man, Maharashtra 411057, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:02 · updated 2026-10-20 04:00:12

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Carboxymaltose is used to treat iron deficiency anemia, a condition where your body doesn't have enough iron.

What it treats

  • iron deficiency anemia
  • low iron levels

How it works

Carboxymaltose helps to increase the amount of iron in your body, which is essential for producing healthy red blood cells.

Who it's for

It is for adults and children who need extra iron due to low levels in their body.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: carboxymaltose

Carboxymaltose, also known as iron carboxymaltose or ferric carboxymaltose, is a parenteral iron preparation used for the treatment of iron deficiency anemia, particularly in patients who cannot tolerate oral iron supplements or need rapid iron replenishment. It is characterized by its ability to deliver a high dose of iron in a single infusion, making it useful in various clinical settings.

Indications

  • Iron deficiency anemia
  • Chronic kidney disease
  • Pregnancy-related anemia
  • Post-surgical anemia
  • Anemia in patients with inflammatory bowel disease

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines in pediatric populations.

Adults: Refer to the BNF for specific dosing information, as doses may vary based on the severity of iron deficiency and clinical condition.

Mechanism of action

Carboxymaltose is a carbohydrate-coated iron complex. Upon administration, it dissociates in the body, releasing ferric ions that are subsequently taken up by transferrin, a plasma protein that transports iron in the bloodstream. This mechanism facilitates iron delivery to erythroid precursors in the bone marrow, promoting hemoglobin synthesis and red blood cell production.

Pharmacodynamics

The pharmacodynamic effects of carboxymaltose are primarily centered on its role in correcting iron deficiency and improving hemoglobin levels. Following administration, the iron is incorporated into hemoglobin, leading to increased oxygen-carrying capacity of the blood, reduced symptoms of anemia, and overall improvement in physical performance and exercise tolerance.

Pharmacokinetics

Carboxymaltose is administered intravenously, allowing for rapid absorption and onset of action. The distribution half-life is relatively short, while the elimination half-life can vary based on individual patient factors. Iron from carboxymaltose is gradually released into the bloodstream, with a portion of the iron stored in ferritin, the body's iron storage protein. The total iron content and the patient's iron status will influence the pharmacokinetic profile, including the duration of action and the need for subsequent doses.

Contra-indications

  • Hypersensitivity to carboxymaltose or any component of the formulation
  • Severe anemia not due to iron deficiency
  • Conditions associated with iron overload or disturbances in iron utilization

Adverse effects

  • Hypotension
  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Dizziness
  • Allergic reactions including rash and anaphylaxis

Interactions

  • May interact with oral iron supplements, reducing their absorption and effectiveness
  • Concomitant use with other intravenous iron preparations should be approached with caution

Precautions

  • Monitor iron levels and signs of iron overload in patients receiving multiple doses
  • Use with caution in patients with a history of allergic reactions to iron preparations
  • Consider cardiovascular status in patients with underlying heart disease

Pregnancy

Carboxymaltose is generally considered safe during pregnancy, but should be used only if clearly needed and after assessing risks versus benefits.

Breast-feeding

Carboxymaltose is excreted in breast milk, but is unlikely to affect the breastfeeding infant when used in therapeutic doses.

Storage

Store in a cool, dry place away from light. Do not freeze. Keep out of reach of children.

Formulations

  • Intravenous infusion solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.