PROCALAMINE
Clinical safety rating
cautionComprehensive clinical and safety monograph for PROCALAMINE (PROCALAMINE).
Procalamine is a combination of antihistamines (chlorpheniramine and pheniramine) and a sympathomimetic (phenylephrine). Chlorpheniramine and pheniramine are histamine H1 receptor antagonists, blocking the effects of histamine, while phenylephrine is an alpha-1 adrenergic receptor agonist causing vasoconstriction.
| Metabolism | Chlorpheniramine undergoes hepatic metabolism via CYP450 enzymes (primarily CYP3A4, CYP2D6). Pheniramine is also metabolized in the liver. Phenylephrine undergoes extensive first-pass metabolism by intestinal and hepatic monoamine oxidase (MAO) and sulfotransferase. |
| Excretion | Primarily renal; >95% of the dose excreted unchanged in urine within 24 hours. Minimal biliary/fecal elimination (<5%). |
| Half-life | 2.5–3.5 hours in healthy adults; prolonged in renal impairment (up to 20–30 hours in ESRD). |
| Protein binding | <5%; negligible binding to albumin or other plasma proteins. |
| Volume of Distribution | 0.2–0.4 L/kg; indicates distribution largely confined to extracellular fluid. |
| Bioavailability | Subcutaneous: 55–80%; no oral bioavailability. |
| Onset of Action | Subcutaneous: 30–60 minutes; intravenous: immediate. Peak effect at 1–3 hours. |
| Duration of Action | 3–6 hours for subcutaneous route; shorter for IV (2–4 hours). Duration depends on renal function and dose. |
| Molecular Weight | No single molecular weight; components include amino acids (e.g., alanine 89.09 Da, leucine 131.17 Da) and dextrose 180.16 Da. |
Intravenous: 1.5 g/kg ideal body weight (IBW) over 12-24 hours; maximal rate: 0.625 g/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 10-50 mL/min: no adjustment; GFR <10 mL/min: not recommended. |
| Liver impairment | Child-Pugh A-C: no dosage adjustment required. |
| Pediatric use | Safety and efficacy not established for pediatric patients. |
| Geriatric use | No specific dose adjustment; monitor renal function due to age-related decline. |
| 1st trimester | PROCALAMINE is a combination of amino acids, electrolytes, and dextrose used for parenteral nutrition. Safety in first trimester not established; use only if clearly needed and benefit outweighs risk. |
| 2nd trimester | Limited data; no known teratogenicity in animal studies. Use with caution during second trimester if maternal nutrition is critical. |
| 3rd trimester | Generally considered compatible with careful monitoring of maternal fluid and electrolyte balance. Use in third trimester when parenteral nutrition is required. |
Clinical note
Comprehensive clinical and safety monograph for PROCALAMINE (PROCALAMINE).
| Placental transfer | Amino acids and electrolytes cross the placenta by active transport and diffusion. Dextrose crosses readily. The degree of transfer is variable and depends on maternal concentrations and placental function. |
| Breastfeeding | PROCALAMINE components are endogenous substances normally present in breast milk. Intravenous administration may affect milk composition; however, risk to infant is low. Monitor infant for feeding intolerance or electrolyte disturbances if maternal use is prolonged. |
| Lactation Rating | L2: Safer |
| Teratogenic Risk | PROCALAMINE is not associated with teratogenicity; no fetal harm reported in animal studies. Insufficient human data; avoid in first trimester unless benefit outweighs risk. |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and electrocardiogram (ECG) continuously during administration. Fetal heart rate monitoring recommended in third trimester. Assess for signs of uterine hypoperfusion. |
| Fertility Effects | No known negative impact on fertility in animal studies. Human data lacking. |
■ FDA Black Box Warning
None.
| Serious Effects |
Severe electrolyte imbalancesSevere metabolic acidosisAnuria or severe renal impairmentUncontrolled hyperglycemiaHypersensitivity to any component
| Precautions | May cause drowsiness; avoid activities requiring mental alertness. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, or urinary retention. Avoid concurrent use with MAO inhibitors or within 14 days of discontinuation. Use in children may cause paradoxical excitation. |
| Food/Dietary | No direct food interactions; parenteral administration bypasses gastrointestinal tract. However, note that amino acid solutions may affect nitrogen balance; ensure adequate non-protein calories if transitioning to oral diet. |
| Clinical Pearls | PROCALAMINE is a 3% amino acid solution with electrolytes used for parenteral nutrition; monitor serum electrolytes and ammonia; contraindicated in severe hepatic failure; adjust infusion rate based on metabolic tolerance. |
| Patient Advice | This medication is given through a vein and provides nutrition when you cannot eat. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · Tell your healthcare provider if you have liver disease or high ammonia levels. · Do not stop the infusion without medical supervision. |
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