NDC 51662-1523 Thiamine Hcl

Thiamine Hcl

NDC Product Code 51662-1523

NDC CODE: 51662-1523

Proprietary Name: Thiamine Hcl What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Thiamine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat or prevent a lack of thiamine (deficiency) when the form taken by mouth cannot be used or would not work as well as the injection. Thiamine is a B vitamin that helps your body to use carbohydrates for energy. It is also important for normal function of your heart, muscles, and nervous system. Most people get enough thiamine in their diet, but certain health conditions (e.g., alcoholism, poor nutrition, pregnancy, stomach/intestinal diseases) can cause a deficiency in thiamine. Serious thiamine deficiency can lead to nerve damage, heart failure, and mental/mood conditions (e.g., confusion, psychosis).

NDC Code Structure

  • 51662 - Hf Acquisition Co Llc, Dba Healthfirst

NDC 51662-1523-1

Package Description: 2 mL in 1 VIAL, MULTI-DOSE

NDC Product Information

Thiamine Hcl with NDC 51662-1523 is a a human prescription drug product labeled by Hf Acquisition Co Llc, Dba Healthfirst. The generic name of Thiamine Hcl is thiamine hcl. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 313324.

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.

Thiamine Hcl 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.


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.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • MONOTHIOGLYCEROL (UNII: AAO1P0WSXJ)

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.
  • Intravenous - Administration within or into a vein or veins.

Product Labeler Information

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

Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Labeler Code: 51662
FDA Application Number: ANDA080556 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: ANDA - A product marketed under an approved Abbreviated 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: 06-14-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Thiamine Hcl 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

Description

Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration.Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5).Thiamine hydrochloride, or vitamin B 1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution.The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula:C 12H 17CIN 4OS • HCl M.W. 337.27

Clinical Pharmacology

The water soluble vitamins are widely distributed in both plants and animals. They are absorbed in man by both diffusion and active transport mechanisms. These vitamins are structurally diverse (derivatives of sugar, pyridine, purines, pyrimidine, organic acid complexes and nucleotide complex) and act as coenzymes, as oxidation-reduction agents, possibly as mitochondrial agents. Metabolism is rapid, and the excess is excreted in the urine.Thiamine is distributed in all tissues. The highest concentrations occur in liver, brain, kidney and heart. When thiamine intake is greatly in excess of need, tissue stores increase two to three times. If intake is insufficient, tissues become depleted of their vitamin content. Absorption of thiamine following IM administration is rapid and complete.Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as cocarboxylase, a coenzyme. Its role in carbohydrate metabolism is the decarboxylation of pyruvic acid in the blood and α-ketoacids to acetaldehyde and carbon dioxide. Increased levels of pyruvic acid in the blood indicate vitamin B 1 deficiency.The requirement for thiamine is greater when the carbohydrate content of the diet is raised. Body depletion of vitamin B 1 can occur after approximately three weeks of total absence of thiamine in the diet.

Indications

Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.

Contraindications

A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See
WARNINGS for further information.)

Warnings

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see
ADVERSE REACTIONS).
Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection.If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes. If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection. Be prepared to treat anaphylactic reactions regardless of the precautions taken.Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines.

Precautions

GeneralSimple vitamin B 1 deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.Information for PatientsThe patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy.Usage in PregnancyPregnancy Category A–Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed.Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injections. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see
WARNINGS).

Overdosage

Parenteral doses of 100 to 500 mg singly have been administered without toxic effects. However, dosages exceeding 30 mg three times a day are not utilized effectively.When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake of thiamine is further increased, it appears unchanged in the urine.

Dosage & Administration

“Wet” beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation (see
WARNINGS).
In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks. (See
WARNINGS regarding repeated injections of thiamine.) An oral therapeutic multivitamin preparation containing 5 to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation.
Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV.Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily.In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100 mg daily until the patient is consuming a regular, balanced diet. (See
WARNINGS regarding repeated injections of thiamine.)
Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied

Thiamine Hydrochloride Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT.Use only if solution is clear and seal intact.

Other

Lake Zurich, IL 60047

www.fresenius-kabi.com/us
45819HRevised: September 2019

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