Ferric maltol
What is Ferric maltol?[edit | edit source]
Ferric maltol (ACCRUFER) is an iron replacement product indicated for the treatment of iron deficiency in adults.
What are the uses of this medicine?[edit | edit source]
- This medicine is used for the treatment of iron deficiency in adults.
How does this medicine work?[edit | edit source]
- ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients with:
- Hypersensitivity to the active substance or to any of the excipients
- Hemochromatosis and other iron overload syndromes
- Receiving repeated blood transfusions
What drug interactions can this medicine cause?[edit | edit source]
- Concomitant use of some drugs may reduce the bioavailability of iron after administration of ACCRUFER. Separate the administration of ACCRUFER from these drugs.
- Avoid concomitant use of ACCRUFER with dimercaprol.
- Concomitant use of ACCRUFER may decrease the bioavailability of some drugs. Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate.
- Some medicines may need to be taken at least 4 hours before or 4 hours after you have taken your ACCRUFER dose. Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines.
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2019.
How should this medicine be used?[edit | edit source]
Recommended Dosage
- The recommended dosage of ACCRUFER is 30 mg twice daily, taken 1 hour before or 2 hours after a meal.
Administration
- Take ACCRUFER exactly as your healthcare provider tells you to.
- Take ACCRUFER 2 times a day on an empty stomach 1 hour before or 2 hours after meals.
- Swallow ACCRUFER capsules whole. Do not open, break, or chew ACCRUFER capsules.
- In case of accidental overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Capsules: 30 mg
This medicine is available in fallowing brand namesː
- ACCRUFER
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- flatulence
- diarrhea
- constipation
- feces discolored
- abdominal pain
- nausea
- vomiting
- abdominal discomfort/distension
ACCRUFER may cause serious side effects, including:
- Increased risk of inflammatory bowel disease (IBD) flare
- Too much iron stored in your body (iron overload)
- Risk of overdose in children due to accidental swallowing
What special precautions should I follow?[edit | edit source]
- Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.
- Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron. Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy.
- Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
What to do in case of emergency/overdose?[edit | edit source]
- Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal.
- Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity.
- Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis.
Can this medicine be used in pregnancy?[edit | edit source]
- It is not known if ACCRUFER will harm your unborn baby.
- An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness of ACCRUFER have not been established in pediatric patients.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient: ferric maltol Inactive ingredients: Capsule: colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate, sodium lauryl sulfate Capsule Shell: FD&C Blue No. 1 FD&C Red No. 40, FD&C Yellow 6, hypromellose, titanium dioxide. Ink: ammonium hydroxide, ethanol, iron oxide black, propylene glycol
Who manufactures and distributes this medicine?[edit | edit source]
- Distributed by Shield Therapeutics Inc
What should I know about storage and disposal of this medication?[edit | edit source]
- Store ACCRUFER at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ACCRUFER and all medicines out of reach of children.
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