L-arginie + Proanthocyanidin + Folic Acid + Zinc

Approved and Clinically Accepted Indications

Obstetrics & Gynecology:

• Preeclampsia and gestational hypertension
• Intrauterine Growth Restriction (IUGR)
• Oligohydramnios
• Recurrent pregnancy loss due to impaired placental perfusion
• Luteal phase defects
• Poor ovarian reserve
• Support during assisted reproductive technologies (ART)

Andrology & Urology:

• Erectile dysfunction (vascular origin)
• Male infertility (low sperm count or motility, oxidative stress-induced)

Other Off-label Uses:

• Endothelial dysfunction
• Peripheral vascular disease
• Hypertension in pregnancy
• Enhancement of endometrial blood flow and receptivity

Route of Administration: Oral
General Instructions: May be taken with or without food. Sachets should be dissolved in a glass of water and consumed immediately.

Adults:

In Pregnancy-Associated Vascular Complications:

• L-Arginine: 3 g to 6 g per day in divided doses
• Proanthocyanidin: 75 mg to 150 mg daily
• Folic Acid: 0.4 mg to 0.8 mg daily
• Zinc: 10 mg to 30 mg daily
  Usual Dose: 1 sachet or 1 tablet twice daily or as directed by the physician

In Male Infertility or Erectile Dysfunction:

• L-Arginine: 3 g to 5 g daily
• Zinc: 15–30 mg daily
• Folic Acid and Proanthocyanidin: as per standard combination product
  Duration: Minimum 3 months for spermatogenic benefit

Pediatrics:

• Not routinely used. If prescribed, dosage should be determined by a specialist.

Renal Impairment:

• Use cautiously. Avoid high doses in patients with moderate to severe renal impairment.

Hepatic Impairment:

• No established dose adjustment, but clinical caution is advised.

L-Arginine serves as a substrate for endothelial nitric oxide synthase (eNOS), leading to increased nitric oxide (NO) production, which promotes vasodilation and improves microcirculation in the placenta, reproductive organs, and endometrium. Proanthocyanidins, potent polyphenolic antioxidants, protect vascular endothelium by reducing oxidative stress and improving capillary strength. Folic acid contributes to DNA synthesis, cellular division, and homocysteine metabolism, essential for fetal neural development and placental function. Zinc plays a vital role in hormone metabolism, gametogenesis, and supports antioxidant enzymes. The combination enhances reproductive health by improving vascular tone, antioxidant status, and fertility.

L-Arginine:

• Absorption: Rapidly absorbed from the GI tract
• Peak Plasma Time: 2–3 hours
• Bioavailability: Variable due to hepatic metabolism
• Metabolism: Liver and kidney (urea cycle)
• Elimination: Renal
• Half-life: ~1 hour

Proanthocyanidin:

• Absorption: Moderate; improved with food
• Metabolism: Hepatic (glucuronidation and sulfation)
• Elimination: Biliary and renal
• Half-life: 6–12 hours

Folic Acid:

• Absorption: Near complete in fasting conditions
• Metabolism: Hepatic reduction to tetrahydrofolate
• Elimination: Renal
• Half-life: 3–4 hours

Zinc:

• Absorption: Occurs in the small intestine (jejunum)
• Bioavailability: 20%–40%
• Metabolism: Minimal hepatic processing
• Elimination: Primarily fecal; minor renal excretion
• Half-life: Variable (~1–2 days)

Pregnancy:

• L-Arginine, Folic Acid, and Zinc are generally considered safe and beneficial during pregnancy.
• Proanthocyanidin has no defined pregnancy category but is considered low-risk at standard doses.
• Use under medical supervision is recommended.

Lactation:

• All components are either naturally present in or compatible with breast milk.
• No known harmful effects reported in breastfed infants.
• Monitor infants for rare signs of intolerance such as rash or diarrhea.

• Primary Class: Maternal Vasodilator and Antioxidant Support
• Subclass:
• L-Arginine: Nitric Oxide Precursor / Endothelial Modulator
• Proanthocyanidin: Polyphenol Antioxidant
• Folic Acid: Water-Soluble Vitamin (Vitamin B9)
• Zinc: Essential Trace Mineral

• Hypersensitivity to any component of the formulation
• Severe renal impairment or dialysis patients (due to risk of nitrogen overload from L-Arginine)
• Active peptic ulcer or gastrointestinal bleeding
• Wilson's disease (Zinc may interfere with copper metabolism)
• Hypotension (uncontrolled)

• Use with caution in patients with impaired renal or hepatic function.
• L-Arginine may lower blood pressure; monitor in hypertensive patients.
• Long-term high-dose zinc may lead to copper deficiency and immune dysfunction.
• Proanthocyanidins are well tolerated but should be used with caution due to limited data in pregnancy.
• Not a replacement for medical treatment in severe reproductive or placental disorders.

Common Adverse Effects:

• Gastrointestinal: Abdominal discomfort, bloating, diarrhea, nausea
• Neurological: Headache, dizziness
• Others: Metallic taste (zinc), flushing (L-Arginine)

Serious or Rare Adverse Effects:

• Hypotension
• Copper deficiency (with prolonged high-dose zinc)
• Allergic reactions (rash, itching)
• Electrolyte imbalance (very rarely with high-dose L-Arginine)

Timing: Usually within days of initiation; side effects are generally mild and transient.
Severity: Mostly mild; serious adverse effects are rare and dose-dependent.

• Antihypertensives or Nitrates: May cause additive hypotension with L-Arginine
• Tetracyclines and Quinolones: Zinc reduces their absorption; separate administration times
• Penicillamine: Zinc reduces its absorption
• Methotrexate and Sulfasalazine: May reduce folate levels—monitor folic acid status
• Copper Supplements: May be antagonized by chronic zinc use
• Enzyme Involvement: Minimal involvement of cytochrome P450; interactions are mainly absorption-related or functional.

• WHO and national obstetric guidelines support the use of folic acid and zinc as standard antenatal supplements.
• L-Arginine and Proanthocyanidins are increasingly used in the supportive management of IUGR and preeclampsia.
• Male fertility protocols now commonly include zinc + folic acid to improve sperm quality.
• Recent literature supports L-Arginine's role in improving endometrial blood flow during fertility treatments.

• Temperature: Store below 25°C
• Humidity: Keep in a dry environment; avoid high humidity
• Light: Store in a cool, dark place away from direct sunlight
• Handling:
• Sachets: Use immediately after reconstitution
• Do not freeze
• Keep out of reach of children