Primacap

Approved & Well-Accepted Uses:

• Cyclic Mastalgia (Cyclic Breast Pain): Widely used to help manage cyclical breast tenderness associated with the menstrual cycle when other measures (supportive bras, NSAIDs) fail.
• Premenstrual Syndrome (PMS): Used as an adjunct to relieve mild breast pain, bloating, mood swings, and irritability during the luteal phase. Evidence remains mixed.
• Atopic Dermatitis (Eczema): Occasionally used as a complementary therapy for mild to moderate eczema to reduce dryness and itching; however, major guidelines (e.g., NICE, AAD) note evidence is inconsistent and it is not a first-line option.
• Diabetic Peripheral Neuropathy (Adjunctive): Some data suggest benefit in mild nerve pain and numbness in early diabetic neuropathy.
• Rheumatoid Arthritis (Supportive): May modestly reduce morning stiffness and joint pain when used with standard disease-modifying therapy.
• Off-Label Uses: Sometimes taken for hormonal acne, menopausal hot flashes, or cervix ripening late in pregnancy — but these uses are not strongly supported and require medical supervision.

Adults:

• Cyclic Mastalgia: 3–4 grams daily, divided into 2–3 doses.
• PMS: 500–1,000 mg, 2–3 times daily for 1–2 weeks before menstruation and during the cycle.
• Atopic Dermatitis: 2–6 grams daily in divided doses (clinical benefit is variable).
• Diabetic Neuropathy: 360–480 mg GLA daily, equal to ~2–4 grams EPO.

Pediatrics:

• Generally not recommended routinely. Under dermatology supervision, children with eczema may be given 2–4 grams daily depending on age and weight.

Elderly:

• No specific adjustment needed; use adult doses.

Renal/Hepatic Impairment:

• No formal dose adjustments established; use with caution for long-term administration in hepatic impairment.

Administration:

• Oral softgel capsules or oil; best absorbed with food containing fat.

Duration:

• May require 1–3 months for maximum benefit. Continued if tolerated and effective.

Evening Primrose Oil provides Gamma-Linolenic Acid (GLA), an omega-6 polyunsaturated fatty acid. In the body, GLA is converted to dihomo-gamma-linolenic acid (DGLA), which acts as a precursor for the anti-inflammatory prostaglandin E1 (PGE1). PGE1 modulates immune responses, reduces inflammation, and influences hormonal pathways. This anti-inflammatory and hormone-modulating action explains its use for cyclic breast pain, PMS symptoms, atopic dermatitis, and mild inflammatory joint pain.

• Absorption: GLA is absorbed in the small intestine; bioavailability is increased when taken with meals containing fat.
• Distribution: Incorporated into cell membrane phospholipids and plasma lipids.
• Metabolism: GLA → DGLA → PGE1 via elongation and desaturation in the liver.
• Elimination: Metabolites are excreted mainly in urine and bile. Specific half-life data are not clearly defined due to rapid incorporation into membranes.

• Pregnancy: Not classified by the FDA. Some midwives have historically used EPO for cervical ripening in late pregnancy, but major medical organizations do not recommend this due to insufficient safety evidence and theoretical risks of uterine stimulation. Use in pregnancy is not advised unless supervised by an obstetric provider.
• Lactation: Limited evidence on excretion into breast milk. Generally considered low risk at standard doses, but safety not firmly established — use caution and consult a healthcare provider.

• Primary Class: Nutritional supplement, botanical oil.
• Subclass: Natural source of omega-6 essential fatty acids; prostaglandin precursor.

• Known allergy or hypersensitivity to Oenothera biennis or formulation excipients.
• History of epilepsy or seizure disorder (risk of lowered seizure threshold).
• Active bleeding disorders (e.g., hemophilia) or use with anticoagulants without medical supervision.

• Bleeding Risk: May increase bleeding tendency if taken with anticoagulants (e.g., warfarin, clopidogrel) or high-dose NSAIDs.
• Seizure Risk: May lower seizure threshold, especially in people taking phenothiazine antipsychotics.
• Surgery: Discontinue at least 2 weeks before elective surgery to reduce bleeding risk.
• Not a substitute: Should not replace proven standard therapies for eczema, PMS, neuropathy, or arthritis.
• Pregnancy: Avoid unsupervised use for labor induction or cervical ripening.

Common:

• Mild gastrointestinal discomfort (nausea, bloating, soft stools)
• Headache

Uncommon:

• Skin rash, mild allergic reactions

Rare:

• Increased bruising or bleeding
• Lowered seizure threshold in predisposed individuals

Side effects are generally mild and self-limiting.

• Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, clopidogrel): May increase bleeding risk.
• Phenothiazines (e.g., chlorpromazine, fluphenazine): May increase risk of seizures.
• No major CYP450 enzyme interactions identified at standard doses.

• Major dermatology guidelines (e.g., NICE, American Academy of Dermatology) do not recommend EPO as routine eczema treatment due to inconsistent evidence.
• Remains included in some breast pain management guidelines as an option when conservative measures fail.
• No recent changes by FDA, EMA, or WHO; EPO remains regulated as a dietary supplement, not an approved prescription medication.

• Store at 15°C to 25°C (59°F to 77°F).
• Protect from direct light, heat, and excessive moisture.
• Keep container tightly closed to prevent oxidation.
• Do not freeze.
• Keep out of reach of children.