Ovacyst

Approved and Clinically Accepted Uses:

• Polycystic Ovary Syndrome (PCOS):
  D-chiro-inositol is used as a nutritional supplement in women with PCOS to improve insulin sensitivity, reduce elevated androgen levels, and restore normal ovulatory cycles.
• Insulin Resistance and Type 2 Diabetes Mellitus:
  Administered to improve insulin signaling and glycemic control in individuals with insulin resistance or type 2 diabetes.
• Gestational Diabetes Mellitus (Off-label):
  Used to improve glucose metabolism and reduce the risk of gestational complications in pregnant women with gestational diabetes.
• Oocyte Quality Improvement in IVF (Off-label):
  Used in combination with myo-inositol to improve oocyte maturation and fertilization rates in women undergoing assisted reproductive technology.
• Metabolic Syndrome and Obesity (Supportive role):
  Helps improve lipid metabolism and may assist in weight management as part of a broader metabolic support strategy.

Adults:

• For PCOS: 600 mg to 1200 mg orally once daily. Often used in combination with myo-inositol in a 40:1 ratio (e.g., 2000 mg myo-inositol + 50 mg D-chiro-inositol twice daily).
• For Type 2 Diabetes or Insulin Resistance: 500 mg to 1200 mg orally once daily.
• For Gestational Diabetes: 500 mg orally once or twice daily with folic acid.

Pediatric Use:
Not well-established. Use in adolescents with PCOS should be under medical supervision.

Elderly:
No specific dose adjustments required; monitor glucose and renal function.

Renal or Hepatic Impairment:
No formal guidelines for dose adjustment; use with caution and monitor clinically.

Duration of Use:
Typically continued for at least 3–6 months, depending on clinical response and treatment goals.

D-chiro-inositol is a stereoisomer of inositol that functions as a secondary messenger in insulin signaling. It enhances insulin action by promoting the activity of glycogen synthase and facilitating glucose uptake into cells, particularly in muscle and adipose tissues. In ovarian tissue, D-chiro-inositol reduces the overproduction of androgens by modulating insulin-induced steroidogenesis, which helps restore normal hormonal balance and ovulation in women with PCOS. These combined metabolic and endocrine effects contribute to improved insulin sensitivity and reproductive function.

• Absorption: Readily absorbed after oral administration.
• Distribution: Distributes into intracellular compartments, particularly insulin-sensitive tissues.
• Metabolism: Not extensively metabolized; functions primarily in its native form.
• Excretion: Primarily excreted unchanged through the kidneys.
• Half-life: Approximately 5 to 8 hours.
• Onset of Effect: Clinical benefits, such as improved ovulation or glycemic control, may take 4–8 weeks to appear.

• Pregnancy: No official FDA pregnancy category. Clinical studies suggest D-chiro-inositol may be safe and beneficial in gestational diabetes. Use only when clearly needed under healthcare supervision.
• Lactation: Unknown whether excreted into human breast milk. Due to limited data, use with caution during breastfeeding.
• Caution: In both pregnancy and lactation, benefits must be weighed against unknown risks.

• Primary Class: Nutraceutical / Dietary Supplement
• Subclass: Inositol Isomer / Insulin Sensitizer

• Known hypersensitivity to D-chiro-inositol or any component of the formulation
• Severe renal impairment (due to risk of accumulation)
• Use with caution in patients taking insulin or insulin secretagogues due to potential hypoglycemia

• Hypoglycemia Risk: May enhance effects of insulin or oral hypoglycemic agents.
• Hormonal Regulation: May cause changes in estrogen or testosterone levels; monitor in reproductive-age women.
• Monitoring: Regular follow-up is advised to assess insulin sensitivity, ovulation status, and metabolic parameters.
• Use in Pregnancy and Lactation: Caution advised due to limited human safety data.
• Allergic Reactions: Discontinue use immediately if signs of hypersensitivity occur.

Common Side Effects:

• Gastrointestinal: Nausea, bloating, diarrhea, flatulence
• Neurological: Headache, dizziness

Less Common:

• Mild menstrual irregularities
• Hormonal fluctuations during early treatment

Rare but Serious:

• Hypoglycemia (especially with concurrent antidiabetic medications)
• Allergic reactions (rash, pruritus, angioedema)

Onset and Severity:
Most side effects are mild and transient, usually occurring within the first few weeks of therapy and resolving with continued use or dose adjustment.

• Antidiabetic Agents (e.g., insulin, metformin): Additive hypoglycemic effect; monitor glucose closely.
• Myo-inositol: Synergistic effect in improving ovarian and metabolic outcomes; often co-administered.
• CYP450 Interactions: No significant inhibition or induction of CYP enzymes such as CYP3A4 or CYP2D6.
• Drug-Food: No known interactions with food.
• Drug-Alcohol: No direct interactions; however, alcohol may interfere with metabolic control.

• PCOS Management: Endocrinology and reproductive societies now support the use of D-chiro-inositol, especially in a 40:1 ratio with myo-inositol, as a non-pharmacologic option for insulin-resistant PCOS.
• Gestational Diabetes: Recent studies suggest its use in early pregnancy may reduce insulin need and improve outcomes.
• Regulatory Status: No major regulatory warnings or contraindication changes have been issued recently.

• Temperature: Store below 25°C (77°F).
• Humidity: Keep in a dry place; avoid exposure to moisture.
• Light Protection: Store in the original container, away from direct sunlight.
• Handling Instructions: No need for refrigeration or reconstitution.
• Shelf Life: Refer to manufacturer labeling; usually stable for 24–36 months unopened.