NDC 70199-026 Aquasol A

Vitamin A Palmitate

NDC Product Information

Aquasol A with NDC 70199-026 is a a human prescription drug product labeled by Casper Pharma Llc. The generic name of Aquasol A is vitamin a palmitate. The product's dosage form is injection, solution and is administered via intramuscular form.

Labeler Name: Casper Pharma Llc

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aquasol A Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • VITAMIN A PALMITATE 15 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intramuscular - Administration within a muscle.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Casper Pharma Llc
Labeler Code: 70199
FDA Application Number: NDA006823 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Aquasol A Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Water-miscible vitamin A Palmitate 50,000 USP Units (15 mg retinol/mL)                                                                                                  Rx onlyTHIS IS A STERILE PRODUCT FOR INTRAMUSCULAR INJECTION

Description

AQUASOL ATM Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C20H30O) in the form of vitamin A 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 vitamin A 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.

Clinical Pharmacology

Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation. Vitamin A prevents retardation of growth and preserves the epithelial cells' integrity. Normal adult liver storage is sufficient to satisfy two years' requirements of vitamin A.Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chylomicron fraction of the lymph. Vitamin A is stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80–300 Units per 100 mL (plasma range is 30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL. The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.*Oil-soluble vitamin A water solubilized with polysorbate 80.

Indications

Vitamin A 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.

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.

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.

Precautions

General: Protect from light. Prolonged daily dose administration over 25,000 Units vitamin A should be under close supervision. Blood level assays are not a direct measure of liver storage. Liver storage should be adequate before discontinuing therapy. Single vitamin A deficiency is rare. Multiple vitamin deficiency is expected in any dietary deficiency.Drug Interactions: Women on oral contraceptives have shown a significant increase in plasma vitamin A levels.Carcinogenesis: There are no studies that show that administration of vitamin A will cause or prevent cancer.Pregnancy: See CONTRAINDICATIONS section.Nursing Mothers: The U.S. Recommended Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.

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 ATM Parenteral including one case of an anaphylactoid type reaction.

Overdosage

  • The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration.Acute toxicity — single dose (25,000 Units/kg body weight)   Infant: 350,000 Units   Adult: Over 2 million UnitsChronic toxicity (4,000 Units/kg body weight for 6 to 15 months)   Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.   Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months.Hypervitaminosis A Syndrome:1.General manifestations:Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.2.Specific manifestations: a. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children.b. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthalmos.c. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation.d. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, vitamin A plasma level over 1,200 Units/100 mL.The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.

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 vitamin A 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.

How Supplied

AQUASOL ATM Parenteral (water-miscible vitamin A Palmitate) is available as:Unit of SaleConcentrationEachNDC 70199-026-11Carton of 150,000 USP units/mL (15 mg retinol/mL)NDC 70199-026-11 2 mL Single-dose vialStore at 2–8°C (36–46°F). Do not freeze. PIB02611-01 Revised:10/2019

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