Structural Formula

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 pyruvic acid in the blood and α-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.

INDICATIONS AND USAGE

Thiamine hydrochloride injection is effective for the treatment of Thiamine deficiency or beriberi whether of the dry 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.

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

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General

Simple vitamin B1 deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.

Information for Patients

The 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 Pregnancy

SPL UNCLASSIFIED SECTION

Pregnancy 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 Mothers

It 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

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.

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.

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.

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 syndrome, 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.

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).

Protect from light.

Use only if solution is clear and seal intact.

Preservative Free.

Manufactured for:

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

0941L100

Revised: 1/2017

MI:THIAIJ:R3

PRINCIPAL DISPLAY PANEL - 200 mg/2 mL

NDC 67457-196-02

Thiamine

Hydrochloride

Injection, USP

200 mg/2 mL

(100 mg/mL)

For Intramuscular or

Intravenous Use Only

Rx only 25 x 2 mL Multi-Dose Vials

Preservative Free

Sterile. Non-pyrogenic.

Each mL contains: Thiamine HCl, 100 mg; monothioglycerol, 0.5% v/v; water

for injection, q.s. Sodium Hydroxide may have been added for pH adjustment.

Contains no more than 400 mcg/L of aluminum.

Usual

Dosage: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F).

Protect from light.

Use only if solution is clear and seal intact.

Manufactured for:

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

Mylan.com

MI:196:25C:R3

Thiamine Hydrochloride Injection, USP 200 mg/2 mL Carton Label

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Thiamine pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Thiamine available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.

 DRUGS & SUPPLEMENTS

Thiamine

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How often in a day do you take medicine? How many times?

Thiamine uses


DESCRIPTION

Thiamine hydrochloride injection, USP is a sterile solution of Thiamine hydrochloride in Water for Injection for intramuscular 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 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:

C12H17ClN4OS - HCl M.W. 337.27
Price
CVS Pharmacy vitamin b-1 100 mg tablet0.02 USD
Capsules; Oral; Vitamin B1 (Thiamine Hydrochloride) 100 mg / ml
Infuvite pediatric vial2.58 USD
Injectable; Injection; Vitamin B1 (Thiamine Hydrochloride) 100 mg / ml
Injectable; Injection; Vitamin B1 (Thiamine Hydrochloride) 200 mg / ml
Injectable; Injection; Vitamin B1 (Thiamine Hydrochloride) 25 mg / ml
Injectable; Injection; Vitamin B1 (Thiamine Hydrochloride) 50 mg / ml
Injectable; Injection; Vitamin B1 (Thiamine Hydrochloride) 500 mg / ml
Tablets; Oral; Vitamin B1 (Thiamine Hydrochloride) 100 mg
Tablets; Oral; Vitamin B1 (Thiamine Hydrochloride) 25 mg
Tablets; Oral; Vitamin B1 (Thiamine Hydrochloride) 50 mg
Thiamiject 100 mg/ml1.24 USD
Thiamine 100 mg tablet0.21 USD
Thiamine 100 mg/ml vial8.61 USD
Thiamine 250 mg tablet0.03 USD
Thiamine 500 mg tablet0.18 USD
Thiamine Hcl 100 mg/ml1.24 USD
Thiamine hcl 50 mg tablet0.01 USD
Thiamine hcl powder0.73 USD
Vitamin B-1 100 mg/ml1.64 USD
Vitamin b-1 100 mg tablet0.05 USD
Vitamin b-1 250 mg tablet0.06 USD
Vitamin b-1 50 mg tablet0.02 USD

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Thiamine destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Thiamine Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Thiamine pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "thiamine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "thiamine". http://www.drugbank.ca/drugs/DB0015... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Thiamine?

Depending on the reaction of the Thiamine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Thiamine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Thiamine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Thiamine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Thiamine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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