Thiamine Hydrochloride
General Injectables & Vaccines, Inc
Human Prescription Drug
NDC 52584-196Thiamine Hydrochloride is a human prescription drug labeled by 'General Injectables & Vaccines, Inc'. National Drug Code (NDC) number for Thiamine Hydrochloride is 52584-196. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Thiamine Hydrochloride drug includes Thiamine Hydrochloride - 100 mg/mL . The currest status of Thiamine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 52584-196 |
| 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 Hydrochloride |
| 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: | General Injectables & Vaccines, Inc |
| 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: | 21 Aug, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 2023 |
| 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: | ANDA091623 |
| 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: | 21 Dec, 2025 |
| 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: | General Injectables & Vaccines, Inc
|
| 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. |
| 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 |
|---|
| 52584-196-00 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-196-00) / 2 mL in 1 VIAL, MULTI-DOSE | 21 Aug, 2013 | 31 Aug, 2023 | 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 hydrochloride thiamine hydrochloride thiamine hydrochloride thiamine ion monothioglycerol water sodium hydroxide
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 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
Read more..., 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: "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 mg to 20 mg of thiamine hydrochloride are given im 3 times daily for as long as 2 weeks. (see warnings regarding repeated injection of thiamine.) an oral therapeutic multivitamin preparation containing 5 mg 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 mg to 10 mg of thiamine hydrochloride im daily. in the treatment of wernicke-korsakoff sy
Read more...ndrome, thiamine hydrochloride has been administered iv in an initial dose of 100 mg, followed by im doses of 50 mg 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: an occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to thiamine, especially after repeated injection. 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 mg to 500 mg singly have been administered without toxic effects. however, dosages exceeding 30 mg 3 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:
Description: thiamine hydrochloride injection 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; 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 b1, occurs as white cyrstals 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: formula1.jpg
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 2 to 3 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
Read more... pyruvic acid in the blood and a-ketoacids to acetaldehyde and carbon dioxide. increased levels of pyruvic acid in the blood indicate vitamin b1 deficiency. the requirement for thiamine is greater when the carbohydrate content of the diet is raised. body depletion of vitamin b1 can occur after approximately 3 weeks of total absence of thiamine in the diet.
How Supplied:
How supplied thiamine hydrochloride injection, usp, 200 mg/2 ml (100 mg/ml), is available in: ndc 67457-196-02 2 ml (200 mg) multiple-dose vial, packaged 25 vials per carton. 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. preservative free. manufactured for: mylan institutional llc morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland 0941l101 revised: 4/2021 mi:thiaij:r4
Package Label Principal Display Panel:
Sample package label label1.jpg