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Is Amlodipine safe while breastfeeding?

In the pharmaceutical industry, Amlodipine is a dihydropyridine Calcium Channel Blocker (CCB). As a pharmacist and manufacturer, I classify this as a “Low-Risk” medication for breastfeeding.

Clinical data indicates that Amlodipine passes into breast milk in very small amounts, which are generally considered insufficient to affect the nursing infant. However, at your WHO-GMP facility in Mumbai, we maintain a cautious stance by recommending clinical monitoring for any infant whose mother is on chronic therapy.

Safety Profile & Pharmacokinetics

Parameter Value / Status Clinical Significance
Relative Infant Dose (RID) < 4.2% Significantly below the 10% safety threshold used by pediatricians.
Milk-to-Plasma Ratio ~0.15 Indicates very low penetration of the drug into the breast milk.
Protein Binding 93% – 98% High protein binding limits the amount of “free” drug available to enter the milk.
Infant Safety Generally Safe No adverse effects have been reported in infants exposed via breast milk.

Mechanism: Selective Transport & Bioavailability

The safety of Amlodipine during breastfeeding is rooted in its molecular behavior.

  • Molecular Size & Ionization: Amlodipine molecules are relatively large and highly protein-bound in the mother’s blood. This makes it difficult for them to cross the biological membranes of the mammary glands.

  • Low Concentration: Studies have shown that the median concentration in breast milk is approximately $11.5\text{ mcg/L}$. For a 5kg infant, this represents an extremely negligible dose.

  • Infant Monitoring: While safe, as a pharmacist, you should advise B2B clients to instruct patients to monitor the infant for signs of low blood pressure, such as unusual lethargy or poor feeding.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai, here is how to position Amlodipine for your digital platforms:

  • Marketing Accuracy: When listing Amlodipine 2.5mg, 5mg, or 10mg tablets on your digital platforms, the “Lactation” section should reflect that it is a preferred CCB for breastfeeding mothers, alongside Nifedipine. This evidence-based positioning builds high trust with international medical distributors.

  • Stability & Packaging: Amlodipine is highly sensitive to light (photolabile). We utilize Alu-Alu blister packaging to ensure a 36-month shelf life. This is a critical selling point for export to Zone IVb tropical climates where light and humidity are high.

  • Dossier Readiness: Since Amlodipine is a staple in maternal health clinics for postpartum hypertension, we maintain full CTD/eCTD Dossiers to help your firm bid for national health and maternal-care tenders.

  • Bioequivalence: Highlight that your Amlodipine achieves bioequivalence with the innovator (Norvasc), ensuring international-grade safety and efficacy for both the mother and the infant.

Amlodipine Tablet