Xinc OT

 60 mg Tablet
Eskayef Pharmaceuticals Ltd.

Unit Price: ৳ 5.00 (3 x 10: ৳ 150.00)

Strip Price: ৳ 50.00

Indications

Approved and Widely Recognized Uses:

  • Dietary zinc supplementation: For prevention and treatment of zinc deficiency, especially in populations at risk (e.g., malnourished individuals, chronic diarrhea, elderly, alcoholics).
  • Immune system support: As an adjunct to support immune function during colds, infections, or wound healing.
  • Acne vulgaris and other inflammatory skin conditions: Zinc orotate is sometimes used for its anti-inflammatory and wound-healing properties.
  • Growth and development support: In children and adolescents with inadequate dietary intake or growth delay due to zinc deficiency.
  • Chronic diarrhea in children: Zinc supplementation (regardless of form) is recommended by WHO/UNICEF to reduce duration and severity.

Clinically Accepted Off-label or Nutraceutical Uses:

  • Oral ulcer healing and mucosal repair.
  • Prostate health support in adult males.
  • Cognitive function enhancement in elderly or zinc-deficient individuals.
  • Antioxidant therapy in chronic inflammation-related conditions.

Note: Zinc orotate is often marketed as a “bioavailable” form of zinc, but no major regulatory agencies (FDA, EMA, etc.) officially distinguish orotate over other salts for therapeutic preference.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Dosage & Administration

Adults:

  • Typical dose: 15–30 mg elemental zinc per day.
  • Zinc orotate is usually formulated to provide ~5–20 mg of elemental zinc per tablet or capsule.
  • Taken once daily, preferably with food to minimize GI irritation.

Children:

  • 1–3 years: 3 mg elemental zinc/day
  • 4–8 years: 5 mg/day
  • 9–13 years: 8 mg/day
  • 14–18 years: Boys 11 mg/day, Girls 9 mg/day

Pregnancy & Lactation:

  • Recommended intake increases to 11–12 mg/day depending on age and lactation status.

Zinc Deficiency Treatment:

  • Higher doses may be used temporarily (e.g., 20–40 mg elemental zinc/day) under medical supervision.

Administration Notes:

  • Best taken with meals to reduce nausea.
  • Avoid taking with high-calcium or iron meals (can impair absorption).

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Mechanism of Action (MOA)

Zinc is an essential trace element that functions as a catalytic, structural, and regulatory cofactor in over 300 enzymes and transcription factors. Zinc orotate is a chelate of zinc and orotic acid that facilitates better membrane transport of zinc ions into cells. Once absorbed, zinc contributes to immune function, DNA and RNA synthesis, wound healing, protein metabolism, and cellular growth. It stabilizes cell membranes, exhibits antioxidant activity by superoxide dismutase modulation, and plays a vital role in gene expression and cell-mediated immunity. Orotate may aid zinc absorption and intracellular delivery, though this is still under investigation.

Pharmacokinetics
  • Absorption: Zinc orotate is absorbed in the small intestine, primarily in the jejunum and ileum. The orotate ligand may enhance cellular uptake compared to inorganic salts, but this is not conclusively proven.
  • Bioavailability: Moderate to high; affected by presence of phytates, calcium, and iron in food.
  • Distribution: Widely distributed in tissues, especially in muscle, bone, skin, and liver.
  • Metabolism: Zinc is not metabolized but incorporated into enzymes and proteins.
  • Excretion: Primarily via feces (through bile and pancreatic secretions); smaller amounts via urine and sweat.
  • Half-life: No standard plasma half-life; biological turnover is slow and storage is limited.
Pregnancy Category & Lactation

Pregnancy:

  • Not formally classified under new FDA Pregnancy and Lactation Labeling Rule (PLLR).
  • Zinc is considered safe in pregnancy when used at recommended dietary allowances (RDA: 11–12 mg/day).
  • Higher doses (e.g., >40 mg/day) may pose risks and require medical supervision.

Lactation:

  • Zinc is excreted in breast milk, and supplementation may be needed for lactating women with low zinc intake.
  • Considered safe during breastfeeding when used at dietary levels.
Therapeutic Class
  • Primary: Trace Mineral Supplement
  • Subclass: Zinc Compound (Chelated Form – Orotate Salt)
Contraindications
  • Hypersensitivity to zinc or orotic acid
  • Severe renal failure (due to potential accumulation and reduced excretion)
  • Wilson’s disease (excessive zinc may interfere with copper metabolism)
Warnings & Precautions
  • Zinc overdose risk: Excessive intake (>40 mg/day elemental zinc) may cause copper deficiency, immune dysfunction, or GI symptoms.
  • Impaired absorption with food/phytates: High-fiber diets or cereal-based diets may reduce zinc bioavailability.
  • Copper deficiency risk: Long-term supplementation should be monitored for copper status.
  • Renal impairment: Caution due to risk of metal accumulation.
Side Effects

Common (usually mild and dose-dependent):

  • GI: Nausea, stomach upset, vomiting, abdominal pain, metallic taste
  • CNS: Headache, fatigue (rare)

Serious or Rare:

  • Copper deficiency anemia (with long-term high-dose use)
  • Immunosuppression (with chronic excessive doses)
  • Renal dysfunction (very rare, in high-dose chronic use)

Side effects typically occur at doses exceeding 40 mg/day elemental zinc.

Drug Interactions
  • Reduced zinc absorption with:
    • Iron supplements
    • Calcium supplements
    • Phytates in bran/cereals
  • Reduced absorption of other drugs:
    • Tetracyclines (e.g., doxycycline)
    • Quinolones (e.g., ciprofloxacin)
    • Penicillamine
  • Reduced copper absorption: Long-term zinc therapy may require copper monitoring.
  • No significant CYP enzyme involvement.
Recent Updates or Guidelines
  • WHO & UNICEF guidelines continue to recommend zinc (any bioavailable form) for pediatric diarrhea management.
  • No specific regulatory updates regarding zinc orotate as a preferred salt.
  • Ongoing debates in nutraceutical literature about comparative bioavailability of zinc orotate vs. gluconate/picolinate.
Storage Conditions
  • Temperature: Store at 15–30°C (59–86°F)
  • Humidity: Store in a dry place; protect from moisture
  • Light: Protect from excessive light; store in original container
  • Handling: No reconstitution needed; no refrigeration
  • Capsules/Tablets: Keep tightly closed and away from children
Available Brand Names