Clinical Pharmacology & Safety Knowledge Base

Medication Safety & WHO AWaRe Antibiotic Framework

Structured pharmacology monographs detailing indications, contraindications, renal/hepatic rules, black-box safety warnings, and WHO AWaRe stewardship categories without hallucinated doses.

Prescribing Guardrail: Reficio is an intelligence and safety reference platform — not an automated prescription generator. All medication choices, dosages, and contraindications require verification by qualified clinicians.
Standard Clinical Indications:
  • First-line oral pharmacotherapy for Type 2 Diabetes Mellitus
  • Prediabetes in high-risk individuals with lifestyle failure
  • Polycystic Ovary Syndrome (PCOS) insulin resistance
Contraindications
  • Severe renal impairment with eGFR < 30 mL/min/1.73m²
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis (DKA)
  • Severe acute heart failure, cardiogenic shock, or acute myocardial infarction
  • Severe hepatic dysfunction or acute alcohol intoxication
Organ-Specific Considerations
Renal: Contraindicated if eGFR < 30 mL/min. If eGFR is 30 to 44 mL/min, maximum recommended dose is 1,000 mg/day with frequent renal monitoring. Initiate with caution if eGFR is 45 to 59 mL/min.
Hepatic: Avoid use in patients with clinical or laboratory evidence of hepatic disease due to impaired lactate clearance capacity.
Pregnancy & Lactation:

Pregnancy: Can be continued during pregnancy under specialist endocrinology supervision if non-pharmacologic interventions are insufficient; Insulin remains standard first-line in GDM.

Breastfeeding: Excreted into human breast milk in low concentrations; considered compatible with breastfeeding with infant monitoring for hypoglycemia.

Mandatory Safety Monitoring:
  • Baseline and at least annual serum creatinine / eGFR (every 3 to 6 months if eGFR < 60 mL/min)
  • Baseline and periodic Hematology (Vitamin B12 levels every 2 to 3 years due to potential absorption inhibition)
  • HbA1c every 3 to 6 months
Source: World Health Organization (WHO) Model List of Essential MedicinesView Official Source