Asivit ZI

Approved Indications:

• Iron Deficiency Anemia (IDA):
• Treatment and prevention of mild to moderate iron deficiency anemia in adults and children.
• Especially indicated during pregnancy, lactation, adolescence, menstruation, or post-surgical blood loss.
• Nutritional Deficiencies:
• Supplementation in cases of deficiency or increased demand of Vitamin B complex (e.g., B1, B2, B6, B12, Niacinamide, Folic Acid) and Zinc.
• Prevention and correction of combined micronutrient deficiencies due to malnutrition, chronic illness, alcoholism, gastrointestinal disorders, or prolonged restrictive diets.
• Pregnancy and Lactation Support:
• Supports maternal health and fetal development by preventing neural tube defects (via folic acid), anemia (via iron), and immune compromise (via zinc and B-vitamins).
• Recovery from Illness or Surgery:
• Recommended in convalescence to replenish iron stores and micronutrients necessary for tissue repair, immune defense, and energy metabolism.

Off-label (Clinically Accepted) Uses:

• Adjunctive therapy in Chronic Fatigue Syndrome
• Supportive care in patients with chronic inflammatory conditions
• Hair fall due to micronutrient deficiency (zinc-related)

Route of Administration: Oral only.

Adults (including pregnant and lactating women):

• 1 tablet or capsule once daily, preferably after a meal to reduce gastrointestinal discomfort.
• In severe deficiency, dosage may be increased to 1 tablet twice daily under medical supervision.

Children (over 12 years):

• 1 tablet daily after meals or as prescribed by a physician.

Pediatric (under 12 years):

• Use with caution; pediatric-specific formulations are preferred. Dose should be based on body weight and medical advice.

Elderly:

• Same as adult dose, unless renal or hepatic impairment exists.

Renal Impairment:

• Use with caution. Monitor serum zinc levels and renal function periodically.

Hepatic Impairment:

• Iron overload risk; administer only if clearly indicated. Regular monitoring is advised.

Duration:

• Typically continued for 3–6 months or until iron and vitamin levels normalize.

Administration Advice:

• Best taken with or immediately after food. Avoid taking with tea, coffee, or calcium-rich meals as they reduce iron absorption.

Iron Polymaltose Complex delivers elemental iron in a stable, non-ionic form. It is absorbed in the small intestine via active transport mechanisms and used for hemoglobin synthesis, restoring oxygen-carrying capacity. Vitamin B Complex (including B1, B2, B6, B12, Niacinamide, Folic Acid) functions as coenzymes in carbohydrate, protein, and fat metabolism, DNA/RNA synthesis, erythropoiesis, and nerve conduction. Zinc acts as a cofactor in numerous enzymatic processes, enhances immunity, supports wound healing, and stabilizes cell membranes. Together, these components work synergistically to correct anemia, restore energy metabolism, and improve tissue recovery.

• Iron (Polymaltose Complex):
• Absorption: Slow, steady release; gastrointestinal absorption ~10–20%
• Distribution: Binds to transferrin; stored in liver, spleen, and bone marrow
• Metabolism: Not metabolized; incorporated into hemoglobin and ferritin
• Excretion: Minimal; excess iron excreted via feces
• Vitamin B Complex:
• Absorption: Rapidly absorbed from the GI tract
• Distribution: Widely distributed; crosses placenta and enters breast milk
• Metabolism: Primarily hepatic
• Excretion: Renal (water-soluble vitamins are eliminated in urine)
• Zinc:
• Absorption: ~20–30% absorbed in the jejunum
• Distribution: Binds to albumin and metallothionein
• Metabolism: Not metabolized; involved in over 300 enzyme systems
• Excretion: Primarily through feces; minimal renal elimination

Pregnancy:

• Generally considered safe in pregnancy (no specific FDA category assigned for combinations).
• Folic acid helps prevent neural tube defects. Iron supports increased hematologic demand.
• Should be used under medical supervision to avoid iron overload.

Lactation:

• Safe during breastfeeding.
• Iron and vitamins are excreted in small amounts in breast milk but are not harmful at recommended doses.
• Zinc passes into breast milk; no adverse effects reported at nutritional doses.

Caution:

• Excessive intake should be avoided. No teratogenicity reported at therapeutic doses.

• Primary Class: Hematinic + Multivitamin Supplement
• Sub-class: Iron Polymaltose Complex with B-complex and Zinc; Nutritional Anemia Therapy

• Hypersensitivity to iron, any B vitamins, or zinc
• Hemochromatosis or hemosiderosis (iron overload states)
• Hemolytic anemia (iron not indicated)
• Severe hepatic or renal impairment (without monitoring)
• Patients receiving repeated blood transfusions

• Iron Overload Risk: Monitor serum ferritin and transferrin saturation in long-term use.
• Gastrointestinal Tolerance: May cause GI upset—monitor in patients with peptic ulcers or IBD.
• Pediatric Use: Risk of accidental overdose in children; store safely.
• Neurological Toxicity: Excess vitamin B6 over time may cause peripheral neuropathy.
• Zinc Overdose: Can cause copper deficiency, especially in long-term use.
• Drug Monitoring: Periodic CBC, iron studies, and vitamin levels may be indicated in long-term therapy.

Common Side Effects (usually mild and transient):

• Gastrointestinal: Nausea, constipation, diarrhea, abdominal discomfort, dark stools
• Neurological: Headache, fatigue
• Skin: Mild rash, itching

Less Common:

• Flatulence, metallic taste in mouth

Serious/Rare:

• Hypersensitivity reactions (rash, urticaria, anaphylaxis - rare)
• Vitamin B6-induced neuropathy (prolonged high doses)
• Iron-induced liver toxicity (in overdose)

Note: GI effects are typically dose-related and improve with food intake.

• Chelation Interactions:
• Zinc may reduce absorption of tetracyclines and fluoroquinolones (e.g., ciprofloxacin).
• Iron may interact with levodopa, thyroxine, and bisphosphonates—separate administration by at least 2 hours.
• Absorption Impairment:
• Antacids, calcium supplements, dairy products, tea, and coffee may decrease iron absorption.
• Enzyme Involvement:
• Minimal CYP450 interactions; B-vitamins and zinc generally do not affect hepatic enzymes.
• Alcohol:
• Chronic alcohol intake can impair B-vitamin metabolism and increase toxicity risk.

• WHO Guidelines on Anemia (2024): Endorses combination iron-micronutrient supplementation in high-risk populations including pregnant women and adolescents.
• Updated Safety Advisory (EMA, 2023): Emphasis on cautious use in iron overload disorders; recommended regular monitoring in long-term users.
• New Pediatric Guidance (2022): Pediatric-specific dosing for iron polymaltose is under revised review for safer use under 12 years.

• Storage Temperature: Store below 25°C (77°F)
• Humidity Protection: Keep in a dry place, away from moisture
• Light Sensitivity: Store in original packaging to protect from light
• Handling Instructions:
• Do not freeze
• Keep out of reach of children
• Do not use if tablet color changes or becomes discolored
• Close cap tightly after each use