Water-Miscible Retinyl Palmitate

Prescription

상품명: AQUASOL A Parenteral

제형

Injection

투여 경로

INTRAMUSCULAR

제조사

Rising Pharma Holdings, Inc.

About This Medication

DESCRIPTION AQUASOL A ® Parenteral (Water-Miscible Retinyl Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C 20 H 30 O) in the form of retinyl palmitate, a light yellow to amber oil. Contains 0.5% chlorobutanol as preservative; 12% polysorbate 80, 0.1% citric acid, and sodium hydroxide to adjust pH. The structural formula of retinol is: Ordinarily oil-soluble, the retinyl palmitate in this product has been water solubilized by special processing* and is available in a water solution for intramuscular injection. One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of betacarotene. *Oil-soluble retinyl palmitate water solubilized with polysorbate 80. aquasol-struc

유효 성분

성분	함량
Vitamin A Palmitate	-

적응증 및 용법

INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population. Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.

용량 및 투여 방법

DOSAGE AND ADMINISTRATION For intramuscular use. I. Adults 100,000 Units daily for three days followed by 50,000 Units daily for two weeks. II. Pediatric patients 1 to 8 years old 17,500 to 35,000 Units daily for 10 days. III. Infants 7,500 to 15,000 Units daily for 10 days. Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants and other pediatric patients under 8 years old, is recommended daily for two months. Low birth-weight infants may require additional retinyl palmitate though the exact dosing in these pediatric patients has not been established. In malabsorption, the parenteral route must be used for an equivalent preparation. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

Side Effects Overview

ADVERSE REACTIONS See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A ® Parenteral including one case of an anaphylactoid type reaction. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

경고 및 주의 사항

WARNINGS Avoid overdosage. Keep out of the reach of children. Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

금기

CONTRAINDICATIONS The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation. Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with overdosage in several species. Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin A in excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin A is used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.

Frequently Asked Questions

INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population. Vitamin A supplementation for deficiency states in this population has been …

DOSAGE AND ADMINISTRATION For intramuscular use. I. Adults 100,000 Units daily for three days followed by 50,000 Units daily for two weeks. II. Pediatric patients 1 to 8 years old 17,500 to 35,000 Units daily for 10 days. III. Infants 7,500 to 15,000 Units daily for 10 days. Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants …

WARNINGS Avoid overdosage. Keep out of the reach of children. Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

CONTRAINDICATIONS The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation. Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with overdosage in several species. Malformations of the central nervous system, the eye, …

Water-Miscible Retinyl Palmitate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Similar Injection Products

Anticoagulant Citrate Dextrose Solution …

Tagraxofusp

Anticoagulant Citrate Phosphate Dextrose …

Vancomycin

Rituximab-Abbs

Technetium Tc-99M Exametazime

Browse all Injection products →

References & Data Sources

• DailyMed — Water-Miscible Retinyl Palmitate drug label (National Library of Medicine)
• openFDA — Water-Miscible Retinyl Palmitate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 210972 (NLM Normalized Drug Names)
• NDC Directory — Water-Miscible Retinyl Palmitate (FDA National Drug Code)

의료 면책 조항

이 페이지의 정보는 교육 목적으로만 제공되며, 전문적인 의학적 조언, 진단 또는 치료를 대체하는 용도로 사용해서는 안 됩니다.

의학적 상태나 의약품에 관한 질문이 있으시면 반드시 의사 또는 자격을 갖춘 의료 전문가에게 조언을 구하시기 바랍니다.

데이터 출처: DailyMed (NLM), openFDA, MFDS