Iron polymaltose


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intramuscular
Iron deficiency anaemia
Adult: In cases when oral preparations are contraindicated, enteric absorption of Fe is defective, the patient is non-compliant, or when persistent gastrointestinal intolerance makes oral treatment impractical: As solution for inj containing 318 mg iron polymaltose/2 mL equivalent to 100 mg elemental iron: Dosage is individualised according to Hb level and body weight (refer to local product information for detailed dosage table). Alternatively, the dosage is calculated based on a formula. Total Fe dose (mg) = body weight (kg) x (target Hb - actual Hb in g/L) x 0.24 + Fe depot. For body weight ≤34 kg: Fe depot is calculated as 15 mg/kg (Max: 500 mg); for body weight >34 kg: Fe depot is 500 mg. May give 2 mL every other day until the total Fe dose is attained, or 4 mL at longer intervals. Administer doses via ventro-gluteal inj based on Hochstetter technique. Max single daily dose: >10-45 kg: 100 mg (2 mL); >45 kg: 200 mg (4 mL). Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).
Child: In cases when oral preparations are contraindicated, enteric absorption of Fe is defective, the patient is non-compliant, or when persistent gastrointestinal intolerance makes oral treatment impractical: As solution for inj containing 318 mg iron polymaltose/2 mL equivalent to 100 mg elemental iron: Dosage is individualised according to Hb level and body weight (refer to local product information for detailed dosage table). Alternatively, the dosage is calculated based on a formula. Total Fe dose (mg) = body weight (kg) x (target Hb - actual Hb in g/L) x 0.24 + Fe depot. For body weight ≤34 kg: Fe depot is calculated as 15 mg/kg (Max: 500 mg); for body weight >34 kg: Fe depot is 500 mg. Administer doses every other day until the total Fe dose is attained via ventro-gluteal inj based on Hochstetter technique. Max single daily dose: Infants weighing up to 5 kg: 25 mg (0.5 mL); children weighing 5-10 kg: 50 mg (1 mL); >10 kg: Same as adult dose. Dosage recommendations may vary among countries or individual products (refer local to specific product guidelines).

Intravenous
Iron deficiency anaemia
Adult: In cases when oral preparations are contraindicated, enteric absorption of Fe is defective, the patient is non-compliant, or when persistent gastrointestinal intolerance makes oral treatment impractical: As solution for inj containing 318 mg iron polymaltose/2 mL equivalent to 100 mg elemental iron: Dosage is individualised according to Hb level and body weight (refer to local product information for detailed dosage table). Alternatively, the dosage is calculated based on a formula. Total Fe dose (mg) = body weight (kg) x (target Hb - actual Hb in g/L) x 0.24 + Fe depot. For body weight ≤34 kg: Fe depot is calculated as 15 mg/kg (Max: 500 mg); for body weight >34 kg: Fe depot is 500 mg. Infuse the 1st 50 mL slowly (5-10 drops/minute) and closely observe the patient. If well tolerated may increase the rate to 30 drops/minute (based on drop volume of 0.067 mL). Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).

Oral
Iron deficiency without anaemia
Adult: Dosage and treatment duration are individualised according to the extent of Fe deficiency. As elemental iron: 50-100 mg daily. In pregnant women: 100 mg daily. All doses may be taken as a single dose or in divided doses. Therapy duration: 1-2 months. Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).
Child: Dosage and treatment duration are individualised according to the extent of Fe deficiency. As elemental iron: Infants <1 year As drops: 15-25 mg daily; 1-12 years As drops/syr: 25-50 mg daily; >12 years As drops/syr/tab/chew tab: Same as adult dose. All doses may be taken as a single dose or in divided doses. Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).

Oral
Iron deficiency anaemia
Adult: Dosage and treatment duration are individualised according to the extent of Fe deficiency. As elemental iron: Treatment: 100-300 mg daily as a single dose or in divided doses for approx 3-5 months until normalisation of Hb level is attained. Afterwards, continue with 100 mg daily for several weeks. Treatment in pregnant women: 200-300 mg daily as a single dose or in divided doses until target Hb is achieved. Thereafter, continue with 100 mg daily at least until the end of pregnancy. Prevention in high-risk patients: 100 mg daily as a single dose or in divided doses. Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).
Child: Dosage and treatment duration are individualised according to the extent of Fe deficiency. As elemental iron: Treatment: Infants <1 year As drops/syr: 25-50 mg daily; 1-12 years As drops/syr: 50-100 mg daily; >12 years As drops/syr/tab/chew tab: Same adult dose. All doses may be taken as a single dose or in divided doses. Prevention in high-risk patients: >12 years Same as adult dose. Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).

Oral
Prophylaxis of iron deficiency in pregnancy
Adult: Dosage and treatment duration are individualised according to the extent of Fe deficiency. As elemental iron: 50-100 mg daily as a single dose or in divided doses. Dosage recommendations may vary among countries or individual products (refer to local specific product guidelines).
Hướng dẫn pha thuốc
IV infusion: Dilute the calculated total dose in 500 mL of 0.9% NaCl solution (up to 2,500 mg in 500 mL).
Tương kỵ
IV/IM: Toxic Fe compounds may be liberated from the compound when mixed with acidic substances or substances with a strong reducing effect.
Chống chỉ định
Hypersensitivity. Anaemia not caused by simple Fe deficiency (e.g. megaloblastic anaemia secondary to vitamin B12 deficiency, haemolytic anaemia, disturbances in erythropoiesis, hypoplasia of the marrow), Fe overload (e.g. haemochromatosis, haemosiderosis); disturbances in Fe utilisation such as anaemia from lead poisoning, sideroblastic anaemia, and thalassaemia (oral); Osler-Rendu-Weber syndrome, chronic polyarthritis, bronchial asthma, uncontrolled hyperparathyroidism, infectious renal complaints in the acute phase, decompensated hepatic cirrhosis, infectious hepatitis, severe kidney or liver inflammation (IV/IM). IV/IM: Pregnancy (1st trimester).
Thận trọng
Patient with paroxysmal nocturnal haemoglobinuria; infection or tumour, gastrointestinal disorders (e.g. chronic ulcerative colitis, regional colitis, peptic ulcers); CV disease, inflammatory disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, SLE), refractory anaemia and/or haemoglobinopathies, low Fe binding capacity, folic acid deficiency, history of allergic disorders. IV infusion is only recommended for use in hospitals when the IM route is impractical or when tests show that the bone marrow has no stored Fe. Renal and hepatic impairment. Children. Pregnancy (oral; IV/IM [2nd-3rd trimester]) and lactation.
Tác dụng không mong muốn
Significant: Hypersensitivity reaction which may lead to Kounis syndrome, exogenous haemosiderosis (IV/IM); may increase pathogenicity of certain bacteria.
Blood and lymphatic system disorders: Generalised lymphadenopathy (IV/IM).
Cardiac disorders: Chest pain, tachycardia (IV/IM).
Gastrointestinal disorders: Nausea, vomiting; constipation, dark (black) faecal discolouration, diarrhoea, abdominal pain, dyspepsia, tooth discolouration, gastritis (oral).
General disorders and administration site conditions: Chills, fever; inj site reactions such as pain, local inflammation with inguinal lymphadenopathy, or lower quadrant abdominal pain (IM inj).
Musculoskeletal and connective tissue disorders: Back pain, myalgia, arthralgia, stiffness of the arms, legs or face (IV/IM).
Nervous system disorders: Headache; dizziness (IV/IM).
Respiratory, thoracic and mediastinal disorders: Bronchospasm with dyspnoea (IV/IM).
Skin and subcutaneous tissue disorders: Rash, urticaria, erythema, pruritus, diaphoresis.
Vascular disorders: Flushing, syncope, hypotension (IV/IM).
Potentially Fatal: IV/IM: Hypersensitivity reactions, including anaphylactoid reactions.
Chỉ số theo dõi
Monitor Hb and haematocrit regularly; serum Fe levels and Fe studies in 3 weeks post-therapy. Assess for signs and symptoms of hypersensitivity reaction (during and for at least 30 minutes after each administration of IV infusion).
Quá liều
Symptoms: Nausea, vomiting, diarrhoea, abdominal pain, lack of appetite, bloating, and headache. Haemosiderosis may also occur with consequent liver cirrhosis, diabetes and heart failure. Management: Supportive treatment. May administer Fe chelating agent if required. May monitor serum ferritin to recognise deleterious, progressive accumulation of Fe.
Tương tác
Co-administration of parenteral and oral Fe may reduce the absorption of oral Fe preparations. IV/IM: Increased incidence of adverse effects (e.g. nausea, vomiting, abdominal cramps, erythema, hypotension) when given with ACE inhibitors.
Ảnh hưởng đến kết quả xét nghiệm
IV/IM: May cause falsely increased serum bilirubin, falsely reduced serum Ca levels, or false-positive orthotolidine test results. May interfere with bone scans and/or imaging that utilise technetium Tc 99m diphosphonate. May cause decreased uptake of Ga-67 gallium citrate during tumour and/or abscess imaging.
Tác dụng
Description: Iron polymaltose is a complex of ferric hydroxide and isomaltose. It is absorbed into reticuloendothelial system cells where it is ionised to ferric ions. The majority of ferric ions are transported via transferrin into the bone marrow where it is incorporated into haemoglobin, while the remainder is incorporated into myoglobin or haeme-containing enzymes or contained within storage forms, haemosiderin and ferritin.
Synonyms: ferric polymaltose, ferric hydroxide-polymaltose complex, iron (III) hydroxide polymaltose complex, iron polymaltose complex.
Pharmacokinetics:
Absorption: Oral: Rapidly absorbed in the small intestine. Time to peak plasma concentration: 24 hours (IM); 0.75 hours (IV).
Excretion: Via faeces (as unabsorbed Fe). Elimination half-life: 22.4 hours (IV infusion).
Bảo quản
Tab/syr/drops: Store below 30°C. Protect from light. Chew tab: Store below 25°C, in the original container. Solution for inj: Store below 25°C. Do not freeze. Protect from light.
Phân loại MIMS
Vitamin & khoáng chất (trước & sau sinh)/Thuốc trị thiếu máu
Tài liệu tham khảo
Anon. Ferric Hydroxide Polymaltose Complex. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/09/2021.

Buckingham R (ed). Iron Polymaltose. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/09/2021.

Ferrum Hausmann Chewable Tablets (Vifor [International] Inc. [Switzerland]). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 30/09/2021.

Ferrum Hausmann Drops (Vifor [International] Inc. [Switzerland]). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 30/09/2021.

Ferrum Hausmann Syrup (Vifor [International] Inc. [Switzerland]). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 30/09/2021.

Maltofer Drops (Vifor Pharma Asia Pacific Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 30/09/2021.

Maltofer Film-Coated Tablets 100 mg (Vifor Pharma Asia Pacific Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 19/10/2021.

Maltofer Syrup (Vifor Pharma Asia Pacific Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 30/09/2021.

Multichem NZ Ltd. Ferrosig, Solution for Injection, 50 mg/mL data sheet 22 Dec 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 30/09/2021.

Pharmacy Retailing (trading as Healthcare Logistics). Maltofer 100 mg Tablets and 50 mg/5 mL Syrup data sheet 19 July 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 30/09/2021.

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  • Fe-max
  • Hemopoly
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