Nicosit

A. Reproductive and Gynecological Disorders

• Polycystic Ovary Syndrome (PCOS):
  Improves menstrual regularity, enhances ovulation, reduces insulin resistance, and lowers androgen levels in women with PCOS.
• Ovulation Support in Assisted Reproductive Technology (ART):
  Enhances oocyte quality and improves clinical pregnancy outcomes.
• Prevention of Gestational Diabetes Mellitus (GDM):
  Reduces the risk of GDM in high-risk pregnant women.

B. Metabolic and Endocrine Conditions

• Insulin Resistance and Metabolic Syndrome:
  Improves insulin sensitivity and metabolic parameters.
• Type 2 Diabetes Mellitus (Adjunctive):
  Used off-label to improve glycemic control and reduce insulin requirements.

C. Psychiatric and Neurologic Disorders (Off-label Uses)

• Obsessive-Compulsive Disorder (OCD)
• Panic Disorder
• Major Depressive Disorder (Adjunctive)
• Bipolar Disorder (Depressive Phase):
  May support neurotransmitter modulation in resistant cases.

D. Dermatologic Conditions

• Acne Related to PCOS:
  Helps reduce acne by lowering serum androgens and sebum production.

Route of Administration: Oral
Available Forms in Bangladesh: 500 mg, 600 mg, and 1000 mg powders or tablets (verified on Medex.com.bd)

Adults:

• PCOS: 2000 mg twice daily (total 4000 mg/day), often combined with D-chiro-inositol in a 40:1 ratio.
• Ovulation Support (IVF): 2000 mg twice daily, starting 2–3 months prior to treatment.
• Insulin Resistance & Metabolic Syndrome: 2000–4000 mg daily in divided doses.
• Prevention of GDM: 2000 mg twice daily from the first trimester.

Off-label Psychiatric Use:

• OCD, Panic Disorder, Depression: 12–18 g/day in divided doses (clinical research doses only; medical supervision required).

Pediatrics:

• Not routinely recommended. Use only under specialist supervision.

Elderly:

• Same adult dose. Assess renal and hepatic function before use.

Renal/Hepatic Impairment:

• Use with caution. No standardized dose adjustments; monitor closely.

Administration Tips:

• Can be taken with or without food.
• Powder should be dissolved in water or juice immediately before use.

Myo-inositol acts as a precursor to inositol phosphates, including inositol triphosphate (IP3), which function as second messengers in various cellular processes. It enhances insulin signal transduction, promoting glucose uptake and glycogen synthesis. In ovarian tissue, Myo-inositol improves follicle-stimulating hormone (FSH) signaling and oocyte maturation. In the central nervous system, it modulates neurotransmitter systems, including serotonin and dopamine, contributing to its anxiolytic and mood-stabilizing effects.

• Absorption: Rapidly and efficiently absorbed from the gastrointestinal tract.
• Bioavailability: >99%
• Distribution: Widely distributed, including in the brain, liver, and reproductive organs.
• Metabolism: Minimal metabolism; most of the dose remains unchanged.
• Half-life: Approximately 2–3 hours.
• Excretion: Primarily eliminated via renal excretion as unchanged drug.

• Pregnancy:
  Not formally classified by the FDA. However, clinical data suggest it is safe in pregnancy, particularly in women with PCOS or at high risk of gestational diabetes.
• Lactation:
  Excreted in small quantities into breast milk. Considered safe during breastfeeding, with no reported adverse effects on infants.
• Caution:
  High doses should only be used under medical supervision during pregnancy or lactation.

• Primary Class: Nutraceutical / Vitamin-like compound
• Pharmacologic Category: Insulin sensitizer and second messenger precursor
• Subclass: Inositol isomer (Myo-inositol); often used with D-chiro-inositol

• Known hypersensitivity to Myo-inositol or formulation components
• Severe renal impairment (due to risk of drug accumulation)
• Use in children without clinical justification or supervision

• High-dose psychiatric use (≥12 g/day): May cause gastrointestinal discomfort; monitor electrolytes if used long-term.
• Renal impairment: Use cautiously, as excretion is renal.
• Thyroid dysfunction: Myo-inositol may influence thyroid hormone levels; monitor in patients with hypothyroidism or autoimmune thyroiditis.
• Fertility: Can restore ovulation; women of reproductive age not planning pregnancy should use contraception.

Common:

• Gastrointestinal: Nausea, bloating, flatulence, diarrhea
• Neurological: Headache, dizziness (rare)

Less Common:

• Dermatologic: Mild rash or itching
• Metabolic: Occasional hypoglycemia in insulin-sensitive individuals

High-dose Use (>12 g/day):

• Loose stools, abdominal cramps, fatigue

Serious/Rare:

• No serious adverse effects well-documented

• Major Drug-Drug Interactions: None known
• Enhances effects of insulin and insulin sensitizers (e.g., metformin): Monitor blood glucose
• Drug-Food Interactions: None significant
• Drug-Alcohol Interactions: None known
• Enzymatic Pathways: Not a substrate or inhibitor of CYP450 enzymes

• Endocrine Society and ESHRE Guidelines (2023–2024):
  Recommend Myo-inositol as a safe, effective adjunct in PCOS management.
• Research Trends:
  Growing support for Myo-inositol combined with D-chiro-inositol in a 40:1 physiological ratio.
• Clinical Trials:
  Ongoing studies on Myo-inositol for GDM prevention, psychiatric use, and IVF outcomes.

• Temperature: Store below 25°C (77°F)
• Humidity: Store in a dry place
• Light Protection: Keep in original packaging; protect from direct sunlight
• Handling Instructions:
• Powder: Reseal sachet tightly after use
• Do not freeze
• No refrigeration needed unless reconstituted