Cystnil

Approved and Clinically Accepted Indications:

Polycystic Ovary Syndrome (PCOS):

• Restoration of ovulatory cycles in women with PCOS.
• Improvement of menstrual regularity and fertility.
• Reduction of serum androgen levels and hyperandrogenic symptoms (e.g., acne, hirsutism).
• Supportive management of insulin resistance associated with PCOS.

Female Infertility (Ovulation Induction):

• Enhances oocyte quality, maturation, and pregnancy outcomes, particularly in patients undergoing assisted reproductive techniques (e.g., IVF, ICSI).

Metabolic Syndrome and Insulin Resistance:

• Improves insulin sensitivity, reduces fasting insulin and glucose levels, and supports lipid regulation in insulin-resistant individuals.

Prevention of Gestational Diabetes Mellitus (GDM):

• Used in pregnant women at high risk of GDM to improve insulin action and reduce gestational complications (off-label, clinically supported use).

Menstrual Irregularities:

• Regulates cycles in women with oligomenorrhea or amenorrhea due to metabolic-hormonal imbalance.

Mood and Anxiety Disorders in PCOS (Off-label):

• May contribute to improvement in mood, reduce anxiety, and support overall quality of life in women with PCOS-related emotional disturbances.

Adults (PCOS and Fertility Management):

• Myo-inositol 2000 mg + D-chiro-inositol 50 mg, twice daily.
• Total Daily Dose: Myo-inositol 4000 mg + D-chiro-inositol 100 mg (40:1 ratio).
• Duration: At least 3–6 months for reproductive and metabolic benefits.

Pregnancy (GDM Prevention):

• Myo-inositol 2000 mg twice daily (± D-chiro-inositol as directed by a physician), started early in pregnancy under medical supervision.

Route of Administration:

• Oral (available as powder sachets, tablets, or capsules).
• May be taken with or without food.

Pediatric Use:

• Not established. Not routinely recommended in children or adolescents.

Geriatric Use:

• No specific dose adjustment required. Use with caution in patients with renal impairment.

Renal or Hepatic Impairment:

• Limited data available. Use cautiously; clinical monitoring advised.

Myo-inositol and D-chiro-inositol are stereoisomeric compounds that function as secondary messengers in insulin and gonadotropin signaling. Myo-inositol plays a central role in follicle-stimulating hormone (FSH) signaling, cellular glucose uptake, and follicular development, while D-chiro-inositol influences insulin-mediated androgen synthesis and glucose metabolism. In physiological proportions (typically 40:1), the combination restores insulin sensitivity, decreases circulating insulin levels, reduces ovarian androgen production, and promotes the resumption of ovulation and regular menstruation. This dual mechanism helps correct both the metabolic and reproductive dysfunctions seen in PCOS.

Absorption:

• Rapid and effective absorption following oral administration.

Distribution:

• Widely distributed to intracellular compartments, including the central nervous system and ovaries.

Metabolism:

• Myo-inositol is partially converted into D-chiro-inositol by an epimerase enzyme in insulin-sensitive tissues. Both forms are metabolized via inositol phosphate pathways.

Elimination:

• Primarily excreted unchanged via renal pathways.

Bioavailability:

• Myo-inositol shows good oral bioavailability; absorption may vary with dose.

Half-life:

• Myo-inositol: ~5–6 hours; D-chiro-inositol: less clearly defined.

Onset of Action:

• Initial hormonal and metabolic improvements often observed within 4–8 weeks; reproductive effects typically occur after 8–12 weeks of consistent use.

Pregnancy:

• FDA Category: Not officially assigned.
• Clinical data support the use of Myo-inositol (± D-chiro-inositol) for GDM prevention with no evidence of teratogenicity.
• Considered safe when used under medical supervision.

Lactation:

• Myo-inositol is a natural component of human breast milk.
• No harmful effects reported in breastfed infants; supplementation is generally regarded as safe during breastfeeding.

Caution:

• High-dose or long-term use during pregnancy and lactation should be supervised by a healthcare provider.

• Primary Class: Endocrine Modulator / Nutraceutical
• Sub-class: Inositol Derivatives (Insulin Sensitizer and Ovarian Function Support)

• Hypersensitivity to Myo-inositol, D-chiro-inositol, or any formulation components.
• Severe renal impairment (due to potential accumulation and lack of excretion data).
• Known inositol metabolism disorders (extremely rare).

• Diabetes Mellitus (on insulin or sulfonylureas): Monitor for hypoglycemia when combined with insulin-sensitizing therapy.
• Renal Dysfunction: Use cautiously in patients with moderate to severe renal impairment.
• Hormonal Disorders: Evaluate for secondary causes of menstrual irregularities (e.g., thyroid dysfunction, hyperprolactinemia) prior to treatment.
• Pregnancy & Breastfeeding: Ensure proper medical oversight for high-dose or preventive use.
• Dosage Limits: Excessive intake may cause gastrointestinal discomfort.

Common Side Effects:

• Gastrointestinal: Bloating, nausea, flatulence, abdominal discomfort, diarrhea.
• Central Nervous System: Headache, mild dizziness (transient).
• Reproductive System: Occasional temporary changes in cycle length or flow during early treatment.

Less Common/Rare Effects:

• Hypoglycemia (especially when used with other antidiabetics).
• Mild electrolyte imbalance in cases of overuse or poor renal clearance (very rare).

Severity and Timing:

• Mostly mild and dose-dependent.
• Onset typically occurs within the first 1–3 weeks of use and often resolves with continued use or dose reduction.

Drug-Drug Interactions:

• Antidiabetic Agents: May enhance the glucose-lowering effect; monitor for hypoglycemia.
• Clomiphene Citrate: Sometimes co-administered in infertility treatments; no negative interaction, but monitor response.
• Hormonal Contraceptives: No clinically significant interaction documented.

Drug-Food Interactions:

• No major interactions; may be taken with meals to reduce GI discomfort.

Drug-Alcohol Interactions:

• Alcohol may worsen insulin resistance, counteracting therapeutic benefits.

CYP450 Enzyme Interactions:

• Not known to significantly affect or be metabolized by cytochrome P450 enzymes.

• PCOS Treatment Guidelines (2023–2025): Endorsed by various reproductive health societies as a first-line supplement in PCOS alongside lifestyle changes.
• GDM Prevention Studies: Recent trials support the use of Myo-inositol ± D-chiro-inositol in preventing gestational diabetes in high-risk pregnancies.
• Emerging Use Cases: Ongoing studies investigating use in male infertility, adolescent PCOS, and mood disorders associated with metabolic dysfunction.

• Temperature: Store below 25°C (77°F).
• Humidity: Keep in a dry environment; protect from moisture.
• Light: Store away from direct sunlight.
• Handling: Powder sachets should be reconstituted in water and consumed immediately.
• Stability: Do not freeze; do not refrigerate unless otherwise indicated on product label.