Pregnacare

Approved Indications:

• Iron Deficiency Anemia: Treatment and prevention in adults and children with iron deficiency due to blood loss, poor diet, pregnancy, or chronic disease.
• Megaloblastic Anemia: Due to folic acid and vitamin B-complex deficiencies.
• Nutritional Deficiencies: Correction of combined deficiencies of iron, folic acid, zinc, and B vitamins in malnourished individuals.
• Pregnancy and Lactation: Prevention and treatment of anemia and micronutrient deficiency in pregnant and lactating women.
• Recovery from Surgery or Chronic Illness: To replenish depleted hematologic and nutritional stores.
• Peripheral Neuropathy and Neurotoxicity: Supportive treatment in conditions associated with vitamin B deficiency.

Clinically Accepted Off-label Uses:

• Chronic Alcoholism: To correct vitamin B and micronutrient depletion.
• Elderly Patients: Nutritional supplementation to improve hematologic and neurologic function.
• Immune Support: Zinc and B vitamins enhance immune response in susceptible populations.

Route: Oral (tablet or syrup)

Adults and Adolescents:

• 1 tablet once daily after meals.
• For severe anemia or deficiency, dosage may be increased to 2 tablets daily under physician supervision.
• Duration: Typically 3–6 months or as advised based on clinical response and laboratory values.

Pediatrics (Above 12 years):

• 1 tablet once daily or syrup dosing adjusted by weight.
• Use only under medical guidance.

Elderly:

• Same as adult dosing, with monitoring for tolerability.

Special Populations:

• Renal or Hepatic Impairment: Use cautiously; monitor nutrient levels and adjust dose if needed.
• Pregnancy and Lactation: Recommended dose is 1 tablet daily to meet increased nutritional demands.

Administration Notes:

• Take with food to reduce gastrointestinal discomfort.
• Avoid concurrent intake with antacids, calcium, or tetracycline antibiotics to prevent reduced absorption.
• Shake syrup formulations well before use.

Iron Polymaltose Complex supplies iron in a non-ionic, slowly absorbed form that replenishes body iron stores and supports hemoglobin synthesis, improving oxygen transport capacity. Folic Acid is vital for DNA synthesis and red blood cell maturation, preventing megaloblastic anemia. Zinc acts as a cofactor for numerous enzymes, supporting immune function, wound healing, and cellular metabolism. The Vitamin B-Complex group (including B1, B2, B3, B6, B12) participates in energy metabolism, nerve function, and hematopoiesis. Together, these components synergistically correct anemia, promote neurologic health, and improve overall nutritional status.

• Iron Polymaltose Complex:
  Absorbed slowly in the small intestine with bioavailability around 10–20%, iron is transported bound to transferrin and stored as ferritin. Iron is not metabolized and is lost through normal physiological routes such as desquamation and bleeding.
• Folic Acid:
  Rapidly absorbed in the proximal small intestine with high bioavailability (>85%), metabolized in the liver to active tetrahydrofolate, and excreted mainly via urine.
• Zinc Sulfate:
  Moderately absorbed in the intestine; absorption can be reduced by phytates. Distributed throughout tissues; eliminated mostly via feces.
• Vitamin B-Complex:
  Water-soluble; absorbed primarily in the small intestine; rapid systemic distribution; excess excreted in urine; metabolized variably in the liver depending on specific B vitamin.

• Pregnancy Category:
• Folic Acid: Category A – safe and essential in pregnancy to prevent neural tube defects.
• Iron, Zinc, Vitamin B-Complex: Category B – no evidence of risk in animal studies; widely used during pregnancy.
• Lactation:
  Components are excreted in breast milk in small amounts and considered safe for nursing infants at recommended doses.
• Caution: Excess intake should be avoided.

• Hematinic and Nutritional Supplement
• Iron Preparation (Polymaltose Complex)
• Water-soluble Vitamin (Folic Acid, Vitamin B-Complex)
• Essential Trace Element (Zinc)

• Known hypersensitivity to any component
• Hemochromatosis or iron overload disorders
• Megaloblastic anemia due to vitamin B12 deficiency without B12 supplementation
• Severe renal impairment (relative contraindication for zinc)
• Active peptic ulcer disease (due to iron)

• Monitor iron stores to avoid overload
• Folic acid can mask B12 deficiency; neurological damage may progress if untreated
• Use caution in patients with gastrointestinal disorders
• Long-term zinc supplementation can cause copper deficiency
• Observe for hypersensitivity reactions
• Use under medical supervision in renal or hepatic impairment

Common:

• Gastrointestinal: nausea, constipation, diarrhea, metallic taste, abdominal discomfort
• Dark stools (harmless)

Less Common:

• Headache, dizziness
• Allergic skin reactions (rash, itching)

Rare but Serious:

• Anaphylaxis (very rare)
• Iron toxicity in overdose (especially in children)
• Peripheral neuropathy if B12 deficiency masked

• Iron: Decreased absorption with antacids, calcium, tetracyclines; avoid simultaneous administration
• Folic Acid: Interaction with methotrexate, phenytoin, and sulfasalazine
• Zinc: Interferes with absorption of penicillamine, tetracyclines, quinolones; zinc reduces copper absorption
• Vitamin B-Complex: Phenytoin and isoniazid may reduce B6 efficacy

No significant CYP450 enzyme involvement.

• WHO and national guidelines recommend combined supplementation of iron, folic acid, zinc, and B vitamins in pregnancy and malnutrition.
• Recent emphasis on zinc addition to enhance immune function in vulnerable populations.
• Updated safety guidelines for avoiding iron overdose in children stress child-resistant packaging.
• Recommendations to space iron from calcium and antacids for optimal absorption.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and direct sunlight
• Do not freeze or refrigerate
• Keep tablets in original packaging until use
• Shake syrup formulations well before use
• Keep out of reach of children to avoid accidental overdose