Omnivit

A. Iron & Micronutrient Deficiency States

• Iron Deficiency Anemia (IDA): Treatment and prevention of anemia resulting from nutritional deficiency, chronic blood loss, or increased physiological needs.
• Anemia in Pregnancy and Lactation: Addresses combined iron and folate deficiency; supports healthy fetal development and reduces maternal anemia risk.
• Anemia in Adolescents and Elderly: Used in nutritionally at-risk populations including teenagers, elderly, and chronically ill individuals.

B. Vitamin Deficiency Syndromes

• Vitamin B-complex Deficiency: Prevention and treatment of deficiencies in thiamine (B1), riboflavin (B2), niacinamide (B3), pyridoxine (B6), and cyanocobalamin (B12), especially in malnourished or alcohol-dependent individuals.
• Vitamin C Deficiency (Scurvy): Corrects deficiency and supports tissue repair, immunity, and iron absorption.

C. Nutritional Supplementation

• Pregnancy, Lactation, and Postpartum Support: Enhances red blood cell formation, neural tube protection, immune support, and overall nutritional balance.
• Recovery After Illness or Surgery: Aids in convalescence, tissue healing, and immune function restoration.
• Supplementation in Chronic Diseases: Useful in patients with chronic infections, gastrointestinal malabsorption, or long-term medication use that impairs nutrient absorption.

Route of Administration: Oral
Dosage Form (Typical Combination):

• Carbonyl Iron 100 mg
• Folic Acid 1.5 mg
• Zinc Sulfate Monohydrate 61.8 mg (equivalent to elemental Zinc 22.5 mg)
• Vitamin B-complex (B1 2 mg, B2 2 mg, B3 20 mg, B6 1 mg, B12 1 mcg)
• Vitamin C 75 mg

A. Adults:

• General supplementation: 1 tablet/capsule once daily.
• Therapeutic use in anemia: 1 tablet/capsule once or twice daily depending on clinical severity and physician judgment.

B. Pregnant and Lactating Women:

• 1 tablet daily, preferably beginning in early pregnancy and continued postpartum.

C. Children (≥12 years):

• 1 tablet daily under medical supervision.
• Children <12 years: Use pediatric-specific formulation; not recommended unless advised by a physician.

D. Geriatric Patients:

• Same as adult dose. Monitor for gastrointestinal effects or altered absorption.

E. Hepatic/Renal Impairment:

• Use cautiously. Monitor serum iron, folate, and vitamin B12 levels during long-term use.

Administration Tips:

• Best taken on an empty stomach for maximum absorption.
• Can be taken with food to minimize gastrointestinal irritation.
• Avoid taking with tea, coffee, milk, antacids, or calcium supplements (they reduce iron absorption).

This combination acts synergistically to correct multiple nutrient deficiencies. Carbonyl Iron provides elemental iron, essential for hemoglobin synthesis and oxygen transport. Folic Acid promotes DNA synthesis and red blood cell formation, especially critical during pregnancy. Zinc functions as a cofactor for over 300 enzymes and supports immune function, wound healing, and protein synthesis. The Vitamin B Complex components facilitate carbohydrate metabolism, neurotransmitter synthesis, and hematopoiesis. Vitamin C enhances non-heme iron absorption from the gut, acts as a potent antioxidant, and supports collagen synthesis. Together, these nutrients restore normal hematological function, correct deficiency states, and support overall metabolic health.

Absorption:

• Iron: Gradually absorbed in the duodenum and upper jejunum.
• Folic Acid: Rapidly absorbed in the proximal small intestine.
• Zinc: Absorbed in the small intestine; phytates and dairy may reduce absorption.
• Vitamin B-complex & C: Water-soluble; rapidly absorbed in the gastrointestinal tract.

Bioavailability:

• Iron (Carbonyl): ~69%
• Folic Acid: ~76%
• Zinc: ~20–30%
• Vitamin B-complex and C: High oral bioavailability, but excess amounts are excreted.

Distribution:

• Iron binds to transferrin; stored in liver, spleen.
• Folic acid and B-complex vitamins distribute to most body tissues.
• Zinc and Vitamin C are widely distributed in intracellular compartments.

Metabolism:

• Iron: Not enzymatically metabolized.
• Folic Acid: Hepatically converted to tetrahydrofolate.
• Vitamin B6, B12: Activated in the liver.
• Vitamin C: Minimal hepatic metabolism.

Elimination:

• Iron: Fecal excretion (mainly unabsorbed).
• Folic Acid, B-complex, and Vitamin C: Excreted via urine.
• Zinc: Eliminated through feces and small amounts in urine/sweat.

Half-life:

• Iron: Variable; dependent on physiological demand.
• Folic Acid: 3–4 hours
• B12: ~6 days
• Zinc: 12–24 hours
• Vitamin C: 8–40 minutes (shorter in smokers and stressed individuals)

• Folic Acid: Category A – Safe and essential during pregnancy.
• Iron, Zinc, B-complex, Vitamin C: No known fetal harm when used at recommended doses.

Lactation:

• Safe for breastfeeding; nutrients support milk quality and infant development.
• Minimal transfer into breast milk; no adverse effects in infants at normal dosages.

Caution:

• Avoid overdosing, especially iron and zinc, as toxicity may occur.
• Ensure B12 status is assessed if using high-dose folic acid.

• Primary Class: Hematinic and Multivitamin Supplement
• Subclass: Iron–Folate–Zinc–B-complex–Vitamin C Combination

• Known hypersensitivity to any ingredient in the formulation.
• Iron overload disorders (e.g., hemochromatosis, hemosiderosis).
• Megaloblastic anemia due to untreated Vitamin B12 deficiency.
• Wilson’s disease (copper-zinc imbalance disorders).
• Severe renal impairment (zinc accumulation risk).

• High-Risk Groups: Elderly, children (risk of overdose), and patients with GI disorders.
• Clinical Monitoring:
• Monitor hemoglobin, serum ferritin, folate, B12, and zinc during long-term therapy.
• Watch for signs of iron or zinc overload.
• Early Signs of Toxicity:
• Iron: Abdominal pain, vomiting, diarrhea, metabolic acidosis (especially in pediatric overdose).
• Zinc: Nausea, vomiting, suppressed immunity if overdosed.
• Folic acid may mask B12 deficiency, delaying neurologic diagnosis.
• Risk of hypersensitivity reactions is low but should be monitored.

Common (≥1%):

• Gastrointestinal: Constipation, nausea, vomiting, abdominal bloating, dark-colored stools.
• Neurological: Headache, dizziness.
• Mucocutaneous: Mild rash, metallic taste (zinc).

Less Common:

• Flatulence, irritability, or allergic rash.

Rare/Serious:

• Iron toxicity (especially in children): May result in shock, acidosis, hepatic injury.
• Long-term high-dose zinc: Copper deficiency, immune suppression.
• Vitamin B6 overdose (very rare): Sensory neuropathy in extreme chronic doses.

• Iron: Reduced absorption with calcium, antacids, dairy, tea, or coffee.
• Decreases absorption of levodopa, methyldopa, tetracyclines, and quinolones.
• Folic Acid: Interacts with methotrexate, trimethoprim, phenytoin, sulfasalazine (antagonists).
• Zinc: Reduced absorption of tetracyclines, ciprofloxacin, penicillamine.
• Vitamin C: Enhances iron absorption. Excessive use may increase risk of oxalate kidney stones.

Enzyme Systems Involved:

• Minimal CYP450 metabolism.
• Interactions primarily occur at the absorption and transport levels.

• WHO & UNICEF: Recommend daily supplementation of iron, folic acid, and vitamin C during pregnancy to prevent anemia and low birth weight.
• NICE Guidelines (UK): Recommend periconceptional folic acid and continued supplementation throughout the first trimester.
• Recent Formulation Additions: Many newer formulations now include B12 to prevent masking of deficiency symptoms and support neurological health.

• Temperature: Store below 25°C (77°F).
• Humidity: Keep away from excessive moisture; store in a dry place.
• Light: Protect from direct sunlight by storing in the original container.
• Handling Precautions:
• Keep out of reach of children due to iron toxicity risk.
• Do not crush or chew sustained-release tablets/capsules.
• Reconstitution Needs: Not applicable unless in liquid form; if in suspension, shake well before use.