Maxifer 100 mg/5 ml (IV Injection or Infusion)
5 ml ampoule: ৳ 330.00
Medicine Details
Category | Details |
---|---|
Generic | Iron sucrose |
Company | Globe pharmaceuticals ltd |
Indications
- Treatment of Maxifer deficiency in various clinical conditions
- Rapid Maxifer supply in patients with clinical need
- Use in patients unable to tolerate oral Maxifer therapy
- Use in active inflammatory bowel disease
- Use in chronic kidney disease patients
- Treatment of Maxifer deficiency anaemia in surgical patients and blood donors
Pharmacology
- Therapeutic class of Iron Sucrose is haematinic
- Iron Sucrose Injection USP is a brown, sterile, aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose
- Contains approximately 30% Sucrose w/v
- Has a pH of 10.5-11.1
- Dissociates into Iron and Sucrose after intravenous administration
- Iron transferred from blood to a pool of Iron in the liver and bone marrow
- Ferritin binds and sequesters Iron in a nontoxic form
- Iron binds to plasma transferrin and carries Iron within the plasma and extracellular fluid
- Transferrin receptor returns to the cell membrane
- Intracellular Iron becomes haemoglobin in circulating red blood cells (RBCs)
- Elimination half-life is 6 hours
- Total clearance is 1.2 L/h
- Non-steady state apparent volume of distribution is 10.0 L
- Steady state apparent volume of distribution is 7.9 L
Dosage
- Adult dosage: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
- Limited data on dosage for children under study conditions
- Recommendation not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight for children
Administration
- Intravenous injection at recommended rate
- Maximum of 10 ml Iron Sucrose Injection (200 mg Iron) per injection
- Test dose recommended before therapeutic dose in new patients
- Preferably administered by drip infusion to reduce risk of hypotensive episodes
Interaction
- Drug-drug interactions not studied
- Should not be administered concomitantly with oral iron preparations
- Oral Maxifer therapy not recommended until 5 days after last injection
Contraindications
- Contraindicated in patients with evidence of Iron overload
- Contraindicated in patients with known hypersensitivity to Iron Sucrose or its inactive components
- Contraindicated in patients with anaemia not caused by Iron deficiency
- Contraindicated in patients with history of allergic disorders, liver disease, and infections
Side Effects
- Adverse reactions: hypotension, cramps, nausea, headache, vomiting, diarrhea, chest pain, hypertension, hypervolemia, elevated liver enzymes, dizziness, dyspnea, pneumonia, cough, pruritus, hypersensitivity reactions
- Hypersensitivity reactions include mild or moderate symptoms and serious or life-threatening reactions such as anaphylactic shock
Pregnancy & Lactation
- Pregnancy Category-B
- No adequate and well-controlled studies in pregnant women
- Caution advised when administered to nursing women
Precautions & Warnings
- Caution needed to withhold Maxifer administration in presence of evidence of tissue Maxifer overload
- Periodic monitoring of hematologic and haematinic parameters required for patients receiving Maxifer
- Hypersensitivity reactions have been rarely reported in patients receiving Maxifer
- Caution needed to administer Maxifer according to recommended guidelines to prevent hypotension
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- No overall differences in safety observed between elder and younger subjects
- Injection into dialyser is possible
- Specific dosing recommendations for Chronic Kidney Disease Patients
Overdose Effects
- Dosages in excess of Maxifer needs may lead to accumulation of Maxifer in storage sites
- Periodic monitoring of Maxifer parameters recommended to avoid Maxifer overload
- Particular caution needed to avoid Maxifer overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Maxifer deficiency anaemia
Therapeutic Class
- Parenteral Iron Preparations
Storage Conditions
- Store in a cool (15°C-30°C) & dry place
- Protected from light
- Keep out of the reach of children
- Do not freeze
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