Thiamine
Thiamine Hydrochloride
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-013Thiamine also known as Thiamine Hydrochloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Thiamine is 63323-013. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Thiamine drug includes Thiamine Hydrochloride - 100 mg/mL . The currest status of Thiamine drug is Active.
Drug Information:
| Drug NDC: | 63323-013 |
| 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: | Thiamine |
| 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: | Thiamine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, 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: | THIAMINE HYDROCHLORIDE - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
|
| 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: | ANDA |
| 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 Sep, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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: | ANDA080556 |
| 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: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313324
|
| 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. |
| UPC: | 0363323013219
|
| UPC stands for Universal Product Code. |
| UNII: | M572600E5P
|
| 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 |
|---|
| 63323-013-09 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-09) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-21) | 01 Sep, 2000 | 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. |
Product Elements:
Thiamine thiamine hydrochloride chlorobutanol monothioglycerol sodium hydroxide thiamine hydrochloride thiamine ion
Indications and Usage:
Indications and usage 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 wernickeâs 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 absorp
Read more...tion, because multiple vitamins should usually be given.
Warnings:
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 w
Read more...ho 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.
Dosage and Administration:
Dosage and administration âwetâ 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-kors
Read more...akoff 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.
Contraindications:
Contraindications a history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (see warnings for further information.)
Adverse Reactions:
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:
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.
Description:
Rx only
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: thiamine structure
Clinical Pharmacology:
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 decarboxylati
Read more...on 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.
How Supplied:
How supplied thiamine hydrochloride injection, usp is supplied as follows: product code unit of sale strength each np1302 ndc 63323-013-09 unit of 25 200 mg per 2 ml (100 mg per ml) ndc 63323-013-21 2 ml multiple dose vial 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. novaplus is a registered trademark of vizient, inc.
Package Label Principal Display Panel:
Package label - principal display - thiamine 2 ml multiple dose vial label ndc 63323-013-21 np1302 thiamine hcl injection, usp 200 mg per 2 ml (100 mg per ml) for im or iv use rx only protect from light. 2 ml multiple dose vial package label - principal display - thiamine 2 ml multiple dose vial tray label ndc 63323-013-09 np1302 thiamine hcl injection, usp 200 mg per 2 ml (100 mg per ml) for im or iv use 2 ml multiple dose vial 25 vials rx only np1302-vial np1302-tray