Aquasol A

Vitamin A Palmitate

Casper Pharma Llc
Human Prescription Drug
NDC 70199-026

Aquasol A also known as Vitamin A Palmitate is a human prescription drug labeled by 'Casper Pharma Llc'. National Drug Code (NDC) number for Aquasol A is 70199-026. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Aquasol A drug includes Vitamin A Palmitate - 15 mg/mL . The currest status of Aquasol A drug is Active.

Drug Information:

Drug NDC:	70199-026
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Aquasol A
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Vitamin A Palmitate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Casper Pharma Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	VITAMIN A PALMITATE - 15 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAMUSCULAR
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Oct, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA006823
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Casper Pharma LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	210972 313650
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	1D1K0N0VVC
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
70199-026-11	1 VIAL, SINGLE-DOSE in 1 CARTON (70199-026-11) / 2 mL in 1 VIAL, SINGLE-DOSE	01 Oct, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Aquasol A

Vitamin A Palmitate

Injection, Solution
Casper Pharma LLC
NDC: 70199-026

Product Elements:

Aquasol a vitamin a palmitate vitamin a palmitate retinol chlorobutanol polysorbate 80 citric acid monohydrate sodium hydroxide

Indications and Usage:

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.

Warnings:

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.

Dosage and Administration:

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.

Contraindications:

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.

Adverse Reactions:

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 tm parenteral including one case of an anaphylactoid type reaction.

Overdosage:

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 â single dose (25,000 units/kg body weight) infant: 350,000 units adult: over 2 million units chronic 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.

Description:

Description aquasol a tm parenteral (water-miscible vitamin a palmitate) provides 50,000 usp units of vitamin a per ml as retinol (c 20 h 30 o) 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. structural formula for aquasol

Clinical Pharmacology:

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 80â300 units per 100 ml (plasma range is 30â70 mcg per dl) and for carotenoids 270â� Read more...

�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.

How Supplied:

How supplied aquasol a tm parenteral (water-miscible vitamin a palmitate) is available as: unit of sale concentration each ndc 70199-026-11 carton of 1 50,000 usp units/ml (15 mg retinol/ml) ndc 70199-026-11 2 ml single-dose vial store at 2â8Â°c (36â46Â°f). do not freeze. pib02611-01 revised:10/2019

Package Label Principal Display Panel:

Principal display panel - 2 ml vial label 2 ml single-dose rx only ndc 70199-026-11 aquasol aâ¢ parenteral water-miscible vitamin a palmitate 50,000 usp units/ml (15 mg retinol) for intramuscular use. sterile aquasol-vial-label

Principal display panel - 2 ml vial carton 2 ml single-dose vials sterile ndc 70199-026-11 rx only aquasol aâ¢ parenteral water-miscible vitamin a palmitate 50,000 usp units/ml (15 mg retinol) for intramuscular use. aquasol-vial-carton

Comments/ Reviews:

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