AQUASOL A
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AQUASOL A (AQUASOL A).
Vitamin A is essential for vision, epithelial differentiation, bone growth, reproduction, and immune function. It acts as a retinol-binding protein that regulates gene expression through retinoic acid receptors.
| Metabolism | Hepatic metabolism via alcohol/aldehyde dehydrogenases to retinoic acid, which undergoes glucuronidation and excretion. |
| Excretion | Renal: ~60% as metabolites; fecal: ~30% as unchanged drug and metabolites; biliary: ~10%. |
| Half-life | Terminal elimination half-life: 24-48 hours (mean 36 h); prolonged in renal impairment; clinical context: steady-state achieved in ~5-7 days with daily dosing. |
| Protein binding | ≥95% bound to retinol-binding protein (RBP) and albumin. |
| Volume of Distribution | 0.5-0.7 L/kg; large Vd indicates extensive tissue distribution, particularly liver and fat stores. |
| Bioavailability | Oral: 80-90%; IM/SC: 100%. |
| Onset of Action | IM/SC: 24-72 h; Oral: 72-96 h; IV: N/A. |
| Duration of Action | Supplementation: 1-2 months after single dose; deficiency correction: 2-4 weeks with daily therapy; clinical note: hepatic storage extends duration. |
| Action Class | Vitamins |
100,000 to 200,000 IU intramuscularly once monthly for prophylaxis; 50,000 to 100,000 IU intramuscularly daily for 3 days for severe deficiency.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required for renal impairment; monitor for hypervitaminosis A if GFR <30 mL/min. |
| Liver impairment | Contraindicated in Child-Pugh class C cirrhosis; reduce dose by 50% in Child-Pugh class B, maximum 50,000 IU per dose. |
| Pediatric use | 50,000 IU intramuscularly once monthly for prophylaxis; 5,000 to 10,000 IU/kg intramuscularly daily for 5 days for deficiency (max 100,000 IU/day). |
| Geriatric use | Start at 50,000 IU intramuscularly once monthly; monitor for toxicity due to reduced hepatic clearance and increased risk of osteoporosis. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AQUASOL A (AQUASOL A).
| Breastfeeding | Vitamin A is excreted into breast milk. The M/P ratio is not well-defined. Excessive maternal intake (≥10,000 IU/day) may cause hypervitaminosis in the infant. Nursing mothers should limit supplements to RDA (1300 mcg RAE). Single doses up to 200,000 IU for postpartum deficiency are considered acceptable with monitoring. |
| Teratogenic Risk | Oral vitamin A in doses exceeding the recommended daily allowance (RDA) during pregnancy is associated with teratogenic effects, including central nervous system, cardiovascular, and craniofacial defects. The risk is highest in the first trimester (days 15-60 post-conception). Hypervitaminosis A (≥10,000 IU/day) is contraindicated. Second and third trimester excess may lead to fetal growth restriction and preterm birth. RDA: 800 mcg retinol activity equivalents (RAE) daily. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to vitamin A; hypervitaminosis A; pregnancy (high doses).
| Precautions | Hypervitaminosis A with high doses; hepatotoxicity; teratogenicity (avoid pregnancy); use with caution in patients with hepatic or renal impairment. |
| Food/Dietary | Avoid excessive intake of foods rich in vitamin A (e.g., liver, fortified cereals, dairy) to prevent cumulative toxicity. No other known dietary restrictions. |
| Clinical Pearls | AQUASOL A is a water-miscible vitamin A formulation for intramuscular use, indicated when oral therapy is not feasible. Monitor for signs of hypervitaminosis A (e.g., pseudotumor cerebri, hepatotoxicity). Avoid in patients with hypervitaminosis A or hypersensitivity to any component. Use with caution in renal impairment due to potential accumulation. |
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| Fetal Monitoring | Monitor plasma retinol levels if high-dose therapy is used. Assess fetal anatomy via ultrasound in first trimester if exposure to supratherapeutic doses occurred. Observe for signs of hypervitaminosis (headache, hepatomegaly, bone pain) in mother and infant. In third trimester, monitor fetal growth. |
| Fertility Effects | Excessive vitamin A intake may disrupt menstrual cyclicity and impair ovulation due to altered retinoid signaling. Both deficiency and excess can impair spermatogenesis and oogenesis. Recommended intakes support normal fertility. |
| Patient Advice | This medication is given as an injection into a muscle by a healthcare provider. · Do not take any additional vitamin A supplements while using this drug to avoid toxicity. · Report any symptoms such as severe headache, blurred vision, nausea, vomiting, drowsiness, or skin changes to your doctor immediately. · Keep all follow-up appointments for blood tests to monitor vitamin A levels and liver function. |