According to IQVIA, US sales of Thiamine Hydrochloride Injection, USP, 200mg/2mL, were approximately $33 million in the 12 months … Natural sources of thiamine include brewer’s yeast, legumes, beef, pork, milk, liver, nuts, whole grains, enriched flour, and cereals. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine Hydrochloride 100mg Tablets are a thiamine (vitamin B1)- containing monovitamin product. Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s. pH adjusted with hydrochloric acid.View Manufacturer and/or Label Information: Thiamine HC... Read More. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy. 0000029433 00000 n They are absorbed in man by both diffusion and active transport mechanisms. pregnancy, upcoming surgery, etc. 0000001951 00000 n Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS). Last updated on Oct 1, 2020. 0000025891 00000 n Request a Demo 14 Day Free Trial Buy Now. Thiamine is available under the following different brand names: vitamin B1. Parenteral doses of 100 to 500 mg singly have been administered without toxic effects. Thiamine Hydrochloride 67-03-8 100 mg/mL Monothioglycerol 96-27-5 0.5 % Chlorobutanol 57-15-8 0.5 % Water for Injection 7732-18-5 Quantity Sufficient Thiamine Hydrochloride Injection, USP Fresenius Kabi USA, LLC Revision: 06/01/2015 Page 1 of 5 Page 1 of 5 0000025347 00000 n Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV. ©2020 Sagent Pharmaceuticals, Inc. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label, ferrous sulfate, folic acid, ergocalciferol, thiamine, Zinc, Vitamin B1. Thiamine Hydrochloride offers a supplemental thiamine source. injection therapy. Before using Lennon Thiamine Hydrochloride Injection, inform your doctor about your current list of medications, over the counter products (e.g. Official Long Descriptor. 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. 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. 0000026303 00000 n Thiamine Hydrochloride Injection, USP is indicated for the treatment of thiamine deficiency or beriberi. 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. It is a water-soluble vitamin used for dogs and cats to treat thiamine deficiency. As the intake of thiamine is further increased, it appears unchanged in the urine. Data sources include IBM Watson Micromedex (updated 1 Apr 2021), Cerner Multum™ (updated 5 Apr 2021), ASHP (updated 6 Apr 2021) and others. Thiamine hydrochloride is a hydrochloride obtained by combining thiamine chloride with one molar equivalent of hydrochloric acid. Subscribe to Codify and get the code details in a flash. Serious thiamine deficiency can lead to nerve damage, heart failure, and mental/mood conditions (e.g., confusion, psychosis). 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. 0000005876 00000 n Pregnancy Category A–Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy. 0 0000004901 00000 n Tissue loading may occur at even lower rates of administration. endstream endobj 53 0 obj<. 0000000016 00000 n (�����n����`P�+NV��A���?���v�#��M�� 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: The water soluble vitamins are widely distributed in both plants and animals. Thiamine is distributed in all tissues. However, dosages exceeding 30 mg three times a day are not utilized effectively. 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. 0000001588 00000 n Tablets. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). How does Thiamine Hydrochloride 500 mg/ml, 100 ml work? Each mL contains: Thiamine hydrochloride 100 mg; chlororbutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; Water for Injection q.s. 0000001808 00000 n Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Thiamine is a B vitamin that helps your body to use carbohydrates for energy. 0000028152 00000 n Thiamine is indicated in the treatment or prevention of thiamine deficiency states. 0000008396 00000 n Each ml contains 500 mg thiamine HCl, 0.01% disodium edetate, 1.5% benzyl alcohol and water for injection. Therapeutic Category: Vitamin. 0000012661 00000 n Because studies cannot rule out the possibility of harm, thiamine should be used during pregnancy Thiamine taken by mouth (oral) is available without a prescription. Body depletion of vitamin B1 can occur after approximately three weeks of total absence of thiamine in the diet. 0000011748 00000 n It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; Water for Injection q.s. Thiamine Hydrochloride Injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given. Select one or more newsletters to continue. 2005 Mar;114(1-2):266-77. doi: 10.1016/j.pain.2004.12.027. The requirement for thiamine is greater when the carbohydrate content of the diet is raised. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine, or Vitamin B1, supports the intestines, stomach, heart, muscles, brain, and nervous system, thus playing a pivotal role in many of the body's functions. 0000028355 00000 n Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Healthcare providers give thiamine shots for a memory disorder called Wernicke's encephalopathy syndrome, other thiamine deficiency syndromes in critically ill people, alcohol withdrawal, and coma. Thiamine Hydrochloride Injection is given as an injection, usually into a large muscle, or it may be given by infusion (slow injection) into a vein in your arm. Mfd. Key facts. It is a thiamine and … Excipient (s) with known effect: This product contains lactose monohydrate, see section 4.4. Functions as an essential coenzyme in carbohydrate metabolism. It is used to treat both the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. You'll usually take thiamine once a day if you have a mild vitamin B1 deficiency. 0000007222 00000 n When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. ).Some health conditions may make you more susceptible to the side-effects of the drug. vitamins, herbal supplements, etc. 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. 0000017703 00000 n Medically reviewed by Drugs.com. 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. HOW TO USE: This medication is given by injection into a muscle or vein as directed by your doctor. In the treatment of Wernicke-Korsakoff syndrome, Thiamine Hydrochloride Injection 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. Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; Water for Injection q.s. The water soluble vitamins are widely distributed in both plants and animals. 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. 0000009724 00000 n 0000003917 00000 n Detection: examine in ultraviolet light at 254 nm. Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Application:10µl. In the treatment of beriberi, 10 to 20 mg of Thiamine Hydrochloride Injection are given IM three times daily for as long as two weeks. THIAMINE Hydrochloride Injection, USP. It is reasonably stable to heat in acid solution. 0000027081 00000 n It is also important for normal function of your heart, muscles, and nervous system. Absorption of thiamine following IM administration is rapid and complete. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernickes encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting i… 0000003033 00000 n (See WARNINGS regarding repeated injections of thiamine.). Retain in carton until time of use. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed. Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as cocarboxylase, a coenzyme. Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image; Acti-thiamine Caplet 100mg: Tablet: Oral: Acti Form Ltd. 1991-12-31: 2005-03-21: Canada: <<8E1DE7D61392144A83AD917BBD499A07>]>> Thiamine is widely distributed. Drying:inair. ), allergies, pre-existing diseases, and current health conditions (e.g. The medication is indicated for the treatment of thiamine deficiency or beriberi. 0000025557 00000 n 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. B���� ���Q�����e��n�RF"z�6���x�X�R+f��71�)! Development:over2/3oftheplate. Thiamine is administered orally and by intramuscular or intravenous injection. A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. [See USP Controlled Room Temperature.]. Thiamine combines with ATP to form thiamine pyrophosphate, a coenzyme in carbohydrate metabolism and transketolation reactions. If intake is insufficient, tissues become depleted of their vitamin content. Thiamine HCL injection is used as a supplemental source of thiamine in dogs, cats, and horses. Use only if solution is clear and seal intact. 3. Thiamine may also be used for other conditions as determined by your health care professional. Some tenderness and induration may follow IM use (see WARNINGS). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. WARNING: This product contains aluminum that may be toxic. Pregnancy: Studies in pregnant women have not shown that thiamine HCl increases the risk of fetal abnormalities if administered during pregnancy. Prescription Required. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. 0000026084 00000 n 0000001629 00000 n Dosages of Thiamine: Adults and Pediatric Dosages. 0000021063 00000 n Metabolism is rapid, and the excess is excreted in the urine.Thiamine is distributed in all tissues. Sterile, Nonpyrogenic. Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. It is not known whether this drug is excreted in human milk. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000005953 00000 n Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg Thiamine Hydrochloride Injection in each of the first few liters of IV fluid to avoid precipitating heart failure. 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 Injection IM daily. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). 0000020864 00000 n 50 mg; 100 mg; 250 mg; Capsule Made in India To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Increased levels of pyruvic acid in the blood indicate vitamin B1 deficiency. 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. Sodium hydroxide may have �yDI�c���Pb��� �K���}QX �1\3��@�O���l�N���֨B}�%��SW��G�R�TJ�,X�V������J��>�M�a�`��4��1�O������
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