Venopex 100 mg/5 ml (IV Injection or Infusion)

Indications

• Treatment of Venopex deficiency in various conditions
• Rapid Venopex supply when clinically needed
• Patients intolerant to oral Venopex therapy
• Patients with active inflammatory bowel disease
• Non-dialysis dependent-chronic kidney disease patients receiving erythropoietin
• Non-dialysis dependent-chronic kidney disease patients not receiving erythropoietin
• Hemodialysis dependent-chronic kidney disease patients receiving erythropoietin
• Peritoneal dialysis dependent-chronic kidney disease patients receiving erythropoietin
• Treatment of Venopex deficiency anaemia in surgical patients
• Treatment of Venopex deficiency anaemia in postpartum patients

Pharmacology

• Therapeutic class: Haematinic
• Iron Sucrose Injection USP is a brown, sterile, aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use
• Contains approximately 30% Sucrose w/v and has a pH of 10.5-11.1
• Dissociates into Iron and Sucrose after intravenous administration
• Iron transfers from blood to liver and bone marrow
• Ferritin binds and sequesters Iron in a nontoxic form
• Iron binds to plasma transferrin for distribution to tissues
• Intracellular Iron becomes haemoglobin in red blood cells

Dosage

• Adult dosage: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
• Limited data for children under study conditions
• Children dosage: Not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week

Administration

• Intravenous injection at recommended rate
• Maximum 10 ml Iron Sucrose Injection (200 mg Iron) per injection
• Test dose before therapeutic dose in new patients
• Preferably administered by drip infusion in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride
• Dilution to take place immediately prior to infusion
• Infusion time varies with Iron dosage
• Test dose before therapeutic dose for new patients

Interaction

• No studied drug-drug interactions with Venopex
• Do not administer concomitantly with oral iron preparations
• Oral Venopex therapy should not be given until 5 days after last injection

Contraindications

• Contraindicated in patients with evidence of Iron overload
• Known hypersensitivity to Iron Sucrose or any of its inactive components
• Anaemia not caused by Iron deficiency
• History of allergic disorders, liver disease, and infections

Side effects

• Adverse reactions include hypotension, cramps, nausea, headache, vomiting, diarrhea
• Body as a whole: fever, pain, asthenia, malaise, accidental injury
• Cardiovascular disorders: chest pain, hypertension, hypervolemia
• Gastrointestinal disorders: abdominal pain, elevated liver enzymes
• Central and peripheral nervous system: dizziness
• Musculoskeletal system: musculoskeletal pain
• Respiratory system: dyspnea, pneumonia, cough
• Skin and appendages: pruritus, application site reaction
• Hypersensitivity reactions: wheezing, dyspnea, anaphylactoid reactions, test dose recommended

Pregnancy and lactation

• Pregnancy Category-B
• Use during pregnancy only if clearly needed
• Not known if excreted in human milk
• Caution in administering to nursing women

Precautions and warnings

• Periodic monitoring of hematologic and haematinic parameters required
• Caution in the presence of evidence of tissue Venopex overload
• Serious hypersensitivity reactions reported
• Frequent hypotension in hemodialysis patients receiving intravenous Venopex
• Adherence to recommended guidelines for administration

Special populations

• Safety and effectiveness not established in pediatric patients
• No overall differences in safety observed between elderly and younger subjects

Overdose effects

• Excess dosage may lead to accumulation in storage sites
• Periodic monitoring of Venopex parameters may assist in recognizing accumulation
• Caution in avoiding Venopex overload
• Symptoms associated with overdosage or rapid infusion include hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, and cardiovascular collapse
• Successful treatment with IV fluids, hydrocortisone, and antihistamines reported

Therapeutic class

• Parenteral Iron Preparations

Storage conditions

• Store in a cool (15°C-30°C) and dry place, protected from light
• Keep out of the reach of children
• Do not freeze

Related Brands

• Salviron 100 mg/5 ml (IV Injection or Infusion) - ethical-drugs-limited