What is tromethamine and how does it work. What are the primary uses of tromethamine in medicine. How is tromethamine administered and what are its potential side effects. What precautions should be taken when using tromethamine.

Understanding Tromethamine: An Overview

Tromethamine, also known as THAM or Tris, is a versatile organic compound with significant applications in medicine and biochemistry. Its chemical formula is C4H11NO3, and it functions as an organic amine proton acceptor. This unique property makes tromethamine a valuable tool in various clinical and laboratory settings.

Is tromethamine a new drug? No, tromethamine has been in use for several decades. It was first synthesized in the early 20th century and has since become an essential component in many medical and pharmaceutical applications.

The Chemical Nature of Tromethamine

Tromethamine’s chemical structure is characterized by its three hydroxymethyl groups attached to a central carbon atom, along with an amino group. This configuration gives the compound its ability to act as a buffer and alkalizing agent.

Why is tromethamine’s chemical structure important? The unique arrangement of hydroxymethyl groups and the amino group allows tromethamine to effectively accept protons, making it an excellent buffer in biological systems. This property is crucial for its medical applications, particularly in managing acid-base imbalances.

Key Chemical Properties of Tromethamine:

• Molecular Weight: 121.135 g/mol
• Chemical Formula: C4H11NO3
• Synonyms: THAM, Tris, Trometamol
• Physical State: White crystalline powder
• Solubility: Highly soluble in water

Medical Applications of Tromethamine

Tromethamine’s primary medical use is in the prevention and correction of metabolic acidosis. This condition occurs when there’s an imbalance in the body’s acid-base equilibrium, leading to an excess of acid in the blood and other bodily fluids.

In which medical procedures is tromethamine commonly used? Tromethamine is frequently employed in cardiac bypass surgery to manage acid-base balance. It’s also used in various other clinical scenarios where metabolic acidosis is a concern, such as severe kidney disease, diabetic ketoacidosis, and certain types of poisoning.

Other Medical Uses of Tromethamine Include:

1. As a buffer in medical solutions and blood products
2. In the treatment of respiratory acidosis
3. As a component in some medications to enhance stability or solubility
4. In cardioplegic solutions used during heart surgery

Mechanism of Action: How Tromethamine Works

Tromethamine’s effectiveness in treating metabolic acidosis stems from its ability to accept protons and increase blood pH. When administered, it rapidly distributes throughout the extracellular fluid, where it binds to excess hydrogen ions.

How does tromethamine differ from other buffers? Unlike bicarbonate, which is commonly used to treat acidosis, tromethamine does not produce carbon dioxide as a byproduct. This makes it particularly useful in situations where increased CO2 production could be problematic, such as in patients with respiratory issues.

The Process of pH Regulation by Tromethamine:

1. Tromethamine enters the bloodstream
2. It dissociates into its protonated form and hydroxyl ions
3. The protonated form binds to excess hydrogen ions in the blood
4. This process raises the blood pH, correcting acidosis
5. Excess tromethamine is excreted by the kidneys

Pharmacokinetics and Administration of Tromethamine

Tromethamine is typically administered intravenously as a solution. Its rapid distribution and action make it an effective tool for quickly addressing acute acid-base imbalances.

What factors affect the dosing of tromethamine? The dosage of tromethamine is calculated based on the patient’s body weight and the severity of acidosis. Factors such as renal function and concurrent medications can also influence the appropriate dose.

Key Pharmacokinetic Properties:

• Route of Administration: Primarily intravenous
• Onset of Action: Rapid, within minutes of administration
• Distribution: Throughout extracellular fluid
• Metabolism: Minimal hepatic metabolism
• Excretion: Primarily renal

Potential Side Effects and Precautions

While tromethamine is generally well-tolerated, it can cause side effects, particularly if administered too rapidly or in excessive doses. Healthcare providers must carefully monitor patients receiving tromethamine to ensure safe and effective treatment.

Can tromethamine cause electrolyte imbalances? Yes, one of the potential side effects of tromethamine administration is electrolyte disturbances, particularly hypokalemia (low potassium levels). This is why close monitoring of electrolyte levels is crucial during treatment.

Common Side Effects of Tromethamine:

• Respiratory depression
• Hypoglycemia
• Hypokalemia
• Hyperirritability
• Local irritation at the injection site

Tromethamine in Research and Industry

Beyond its medical applications, tromethamine plays a significant role in various research and industrial settings. Its buffering properties make it valuable in biochemistry and molecular biology laboratories.

How is tromethamine used in laboratory settings? In labs, tromethamine is often used to prepare buffer solutions for various experiments and assays. It’s particularly useful in DNA and RNA studies, as it helps maintain stable pH conditions crucial for these sensitive molecules.

Industrial and Research Applications of Tromethamine:

1. As a component in polymerase chain reaction (PCR) buffers
2. In the production of cosmetics and personal care products
3. As an emulsifying agent in various industrial processes
4. In the formulation of certain cleaning products
5. As a pH adjuster in pharmaceutical preparations

Tromethamine in Pharmaceutical Formulations

Tromethamine’s versatility extends to its use in pharmaceutical formulations. It serves multiple purposes in drug development and manufacturing, contributing to the stability and efficacy of various medications.

Why is tromethamine used in drug formulations? Tromethamine is often included in pharmaceutical preparations to stabilize pH, enhance drug solubility, or improve the compatibility of different ingredients. Its buffering capacity helps maintain the integrity of sensitive drug molecules.

Roles of Tromethamine in Pharmaceuticals:

• pH adjustment in injectable medications
• Solubility enhancement for poorly water-soluble drugs
• Stabilization of sensitive pharmaceutical compounds
• As a counter-ion in salt forms of certain drugs
• In topical formulations as a penetration enhancer

The use of tromethamine in pharmaceuticals highlights its importance beyond its primary medical applications. Its ability to interact with various drug molecules and formulation components makes it a valuable excipient in modern drug development.

Tromethamine in Comparison to Other Buffers

While tromethamine is a powerful and versatile buffer, it’s essential to understand how it compares to other commonly used buffers in medical and laboratory settings. This comparison can help in choosing the most appropriate buffer for specific applications.

How does tromethamine compare to bicarbonate in treating acidosis? Tromethamine offers several advantages over bicarbonate, including its ability to buffer without producing CO2 and its effectiveness in intracellular spaces. However, bicarbonate remains the first-line treatment for many types of acidosis due to its natural presence in the body and well-established safety profile.

Comparison of Tromethamine with Other Common Buffers:

The choice of buffer depends on the specific application, whether it’s for medical treatment, laboratory research, or industrial processes. Each buffer has its unique properties and potential drawbacks that must be considered.

Future Perspectives and Ongoing Research

As our understanding of acid-base physiology and pharmacology continues to evolve, so does the potential for new applications and improvements in the use of tromethamine. Ongoing research is exploring novel uses and formulations of this versatile compound.

What new applications of tromethamine are being investigated? Recent studies have been exploring the potential use of tromethamine in neuroprotection during ischemic events, its role in managing certain types of poisoning, and its possible applications in nanotechnology and drug delivery systems.

Areas of Current Research and Future Potential:

• Neuroprotective effects in stroke and traumatic brain injury
• Enhanced drug delivery systems utilizing tromethamine’s properties
• Novel formulations for improved stability of biological pharmaceuticals
• Potential applications in environmental remediation
• Use in 3D bioprinting as a biocompatible buffer

The ongoing research into tromethamine reflects its continued importance in medicine and science. As new applications are discovered and existing uses are refined, tromethamine is likely to remain a crucial tool in various fields for years to come.

Regulatory Status and Availability of Tromethamine

Understanding the regulatory status and availability of tromethamine is crucial for healthcare providers, researchers, and industry professionals. Its use is governed by various regulatory bodies worldwide, ensuring its safety and efficacy in different applications.

Is tromethamine readily available for medical use? Tromethamine is approved for medical use in many countries and is available as a prescription medication. However, its availability and specific approved indications may vary between regions.

Regulatory Information:

• FDA Status: Approved for medical use in the United States
• EMA Status: Authorized in the European Union
• WHO Essential Medicines List: Not included as of 2021
• Controlled Substance Status: Not a controlled substance

The regulatory landscape for tromethamine ensures its safe and appropriate use in medical settings. Healthcare providers should always consult the most current guidelines and regulations when considering the use of tromethamine in patient care.

Environmental and Safety Considerations

As with any chemical compound, the environmental impact and safety considerations of tromethamine are important aspects to consider. While it’s generally regarded as safe for its intended uses, proper handling and disposal are crucial.

What are the environmental implications of tromethamine use? Tromethamine is considered to have low environmental toxicity. However, like all chemicals, it should be handled and disposed of properly to minimize any potential environmental impact.

Safety and Environmental Aspects:

• Biodegradability: Readily biodegradable
• Aquatic Toxicity: Low to moderate
• Handling Precautions: Use appropriate personal protective equipment
• Disposal: Follow local regulations for chemical waste disposal
• Storage: Store in a cool, dry place away from incompatible materials

Proper understanding and adherence to safety guidelines ensure that tromethamine can be used effectively and responsibly in various settings, from clinical applications to research laboratories and industrial processes.

Tromethamine: Uses, Interactions, Mechanism of Action

Summary

Tromethamine is a proton acceptor used for the prevention and correction of metabolic acidosis associated with various clinical conditions, such as cardiac bypass surgery.

Generic Name

Tromethamine

DrugBank Accession Number

DB03754

Background

An organic amine proton acceptor. It is used in the synthesis of surface-active agents and pharmaceuticals; as an emulsifying agent for cosmetic creams and lotions, mineral oil and paraffin wax emulsions, as a biological buffer, and used as an alkalizer. (From Merck, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p1424)

Type

Small Molecule

Groups

Approved

Structure

Weight

Average: 121.135
Monoisotopic: 121.073893223

Chemical Formula

C₄H₁₁NO₃

Synonyms

• 1,1,1-tris(hydroxymethyl)methanamine
• 2-Amino-2-(hydroxymethyl)-1,3-propanediol
• aminotris(hydroxymethyl)methane
• THAM
• Tris
• Tris(hydroxymethyl)aminomethane
• Trometamol
• Tromethamine

External IDs

• NSC-6365

Indication

For the prevention and correction of metabolic acidosis.

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Associated Conditions

• Metabolic Acidosis

Contraindications & Blackbox Warnings

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Pharmacodynamics

Not Available

Mechanism of action

Target	Actions	Organism
UAmyloid beta A4 protein	inhibitor	Humans

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects

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Toxicity

Not Available

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
Flecainide	The serum concentration of Flecainide can be increased when it is combined with Tromethamine.

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Food Interactions

No interactions found.

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Tham	Injection, solution	3.6 g/100mL	Intravenous	Hospira, Inc.	2020-06-24	Not applicable	US
Tham Solution 36mg/ml	Solution	36 mg / mL	Intravenous	Hospira Healthcare Ulc	1972-12-31	2018-10-03	Canada

Mixture Products

json?group=mixtures” data-total=”1″>

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Sooryehan Hyo Fermented Sun Block	Tromethamine (2.63 mL/100mL) + Amiloxate (1.6 mL/100mL) + Bemotrizinol (1 mL/100mL) + Diethylamino hydroxybenzoyl hexyl benzoate (1 mL/100mL) + Ensulizole (3.9 mL/100mL) + Octinoxate (7 mL/100mL) + Titanium dioxide (2.52 mL/100mL)	Cream	Topical	Lg Household & Health Care Ltd.	2011-09-27	Not applicable	US

ATC Codes

B05XX02 — Trometamol

• B05XX — Other i.v. solution additives
• B05X — I.V. SOLUTION ADDITIVES
• B05 — BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
• B — BLOOD AND BLOOD FORMING ORGANS

B05BB03 — Trometamol

• B05BB — Solutions affecting the electrolyte balance
• B05B — I.V. SOLUTIONS
• B05 — BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
• B — BLOOD AND BLOOD FORMING ORGANS

Drug Categories

• Alcohols
• Blood and Blood Forming Organs
• Blood Substitutes and Perfusion Solutions
• Buffers
• Compounds used in a research, industrial, or household setting
• Excipients
• Glycols
• I. V. Solution Additives
• i.v. Solutions
• Laboratory Chemicals
• Pharmaceutic Aids
• Pharmaceutical Preparations
• Pharmaceutical Vehicles
• Propylene Glycols
• Solutions Affecting the Electrolyte Balance

Chemical TaxonomyProvided by Classyfire

Description

This compound belongs to the class of organic compounds known as 1,2-aminoalcohols. These are organic compounds containing an alkyl chain with an amine group bound to the C1 atom and an alcohol group bound to the C2 atom.

Kingdom

Organic compounds

Super Class

Organic nitrogen compounds

Class

Organonitrogen compounds

Sub Class

Amines

Direct Parent

1,2-aminoalcohols

Alternative Parents

Primary alcohols / Organopnictogen compounds / Monoalkylamines / Hydrocarbon derivatives

Substituents

1,2-aminoalcohol / Alcohol / Aliphatic acyclic compound / Hydrocarbon derivative / Organic oxygen compound / Organooxygen compound / Organopnictogen compound / Primary alcohol / Primary aliphatic amine / Primary amine

Molecular Framework

Aliphatic acyclic compounds

External Descriptors

primary amino compound, triol (CHEBI:9754) / a small molecule (TRIS)

Affected organisms

Not Available

UNII

023C2WHX2V

CAS number

77-86-1

InChI Key

LENZDBCJOHFCAS-UHFFFAOYSA-N

InChI

InChI=1S/C4h21NO3/c5-4(1-6,2-7)3-8/h6-8H,1-3,5h3

IUPAC Name

2-amino-2-(hydroxymethyl)propane-1,3-diol

SMILES

NC(CO)(CO)CO

Synthesis Reference

Jean Bourguignon, Marcel-Xavier Sion, Michel Moreau, “Preparation of tris(hydroxymethyl)aminomethane. ” U.S. Patent US4233245, issued August, 1959.

US4233245

General References

Not Available

External Links

Human Metabolome Database

HMDB0240288

KEGG Drug

D00396

KEGG Compound

C07182

PubChem Compound

6503

PubChem Substance

46506027

ChemSpider

6257

RxNav

10865

ChEBI

9754

ChEMBL

CHEMBL1200391

ZINC

ZINC000000896695

PDBe Ligand

TRS

Wikipedia

Tris

FDA label

Download (88.7 KB)

Clinical Trials

Phase	Status	Purpose	Conditions	Count
3	Active Not Recruiting	Prevention	Respiratory Syncytial Virus (RSV) Infection	1
3	Active Not Recruiting	Treatment	Childhood Atypical Teratoid/Rhabdoid Tumor	1
3	Active Not Recruiting	Treatment	Extraocular Retinoblastoma	1
3	Completed	Treatment	Localized, resectable Neuroblastoma (NB) / Localized, unresectable Neuroblastoma (NB) / Recurrent Neuroblastoma / Regional Neuroblastoma / Stage 4 Neuroblastoma / Stage 4S Neuroblastoma	1
3	Recruiting	Treatment	Acute Lymphoblastic Leukaemias (ALL) / Acute Myeloid Leukemia / Myelodysplastic Syndrome	1
2	Active Not Recruiting	Treatment	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Acute Biphenotypic Leukemia (ABL) / Acute Leukemia of Ambiguous Lineage / Acute Lymphoblastic Leukemia in Remission / Acute myeloid leukaemia (in remission) / Acute Undifferentiated Leukemia (AUL) / Allogeneic Hematopoietic Stem Cell Transplantation Recipient / Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) / Childhood Acute Lymphoblastic Leukemia in Remission / Childhood Acute Myeloid Leukemia in Remission / Donors / Lymphoblastic Lymphoma / Myelodysplastic Syndrome With Excess Blasts / Myelodysplastic Syndrome With Excess Blasts-1 / Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2) / Recurrent Acute Lymphoblastic Leukemia (ALL) / Recurrent Acute Myeloid Leukemia / Recurrent Childhood Acute Lymphoblastic Leukemia / Recurrent Childhood Acute Myeloid Leukemia / Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Refractory Acute Lymphoblastic Leukemia (ALL) / Refractory Acute Myeloid Leukemia (AML)	1
2	Active Not Recruiting	Treatment	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Acute Biphenotypic Leukemia (ABL) / Acute Leukemia of Ambiguous Lineage / Acute Undifferentiated Leukemia (AUL) / Adult Acute Lymphoblastic Leukemia in Remission / Adult Acute Myeloid Leukemia in Remission / Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Childhood Acute Lymphoblastic Leukemia in Remission / Childhood Acute Myeloid Leukemia in Remission / Myelodysplastic Syndrome With Excess Blasts-1 / Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2) / Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML) / Recurrent Adult Acute Lymphoblastic Leukemia (ALL) / Recurrent Adult Acute Myeloid Leukemia / Recurrent Childhood Acute Lymphoblastic Leukemia / Recurrent Childhood Acute Myeloid Leukemia / Refractory Adult Acute Lymphoblastic Leukemia / Refractory Lymphoblastic Leukemia, Acute, Childhood	1
2	Active Not Recruiting	Treatment	Ganglioneuroblastoma / High Risk Neuroblastoma	1
2	Active Not Recruiting	Treatment	Hematopoietic and Lymphoid System Neoplasm / High Risk Acute Myeloid Leukemia / High-risk Myelodysplastic Syndrome (MDS) / Lymphoproliferative Disorders / Myelodysplastic Syndrome / Myeloproliferative/Myelodysplastic Neoplasm / Recurrent Acute Lymphoblastic Leukemia (ALL) / Recurrent Acute Myeloid Leukemia / Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive / Recurrent High Risk Myelodysplastic Syndrome / Recurrent Hodgkin Lymphoma / Recurrent Myelodysplastic Syndrome / Recurrent Non-Hodgkin Lymphoma / Recurrent Plasma Cell Myeloma	1
2	Recruiting	Treatment	Acute Myeloid Leukemia / Chronic Myelomonocytic Leukemia / Myelodysplastic Syndrome	1

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Cream	Topical
Injection, solution	Intravenous	3. 6 g/100mL
Solution	Intravenous	36 mg / mL
Injection, solution	Intravenous; Parenteral	3.6 %
Solution	Intravenous	3.6 %

Prices

Not Available

Patents

Not Available

State

Solid

Experimental Properties

Not Available

Predicted Properties

Property	Value	Source
Water Solubility	695.0 mg/mL	ALOGPS
logP	-2.1	ALOGPS
logP	-2.7	Chemaxon
logS	0.76	ALOGPS
pKa (Strongest Acidic)	14.16	Chemaxon
pKa (Strongest Basic)	8.95	Chemaxon
Physiological Charge	1	Chemaxon
Hydrogen Acceptor Count	4	Chemaxon
Hydrogen Donor Count	4	Chemaxon
Polar Surface Area	86. 71 Å2	Chemaxon
Rotatable Bond Count	3	Chemaxon
Refractivity	28.36 m3·mol-1	Chemaxon
Polarizability	12.02 Å3	Chemaxon
Number of Rings	0	Chemaxon
Bioavailability	1	Chemaxon
Rule of Five	Yes	Chemaxon
Ghose Filter	No	Chemaxon
Veber’s Rule	No	Chemaxon
MDDR-like Rule	No	Chemaxon

Predicted ADMET Features

Property	Value	Probability
Human Intestinal Absorption	+	0.52
Blood Brain Barrier	–	0.6989
Caco-2 permeable	–	0.6613
P-glycoprotein substrate	Non-substrate	0. 6664
P-glycoprotein inhibitor I	Non-inhibitor	0.9749
P-glycoprotein inhibitor II	Non-inhibitor	0.9671
Renal organic cation transporter	Non-inhibitor	0.9239
CYP450 2C9 substrate	Non-substrate	0.8432
CYP450 2D6 substrate	Non-substrate	0.8337
CYP450 3A4 substrate	Non-substrate	0.8096
CYP450 1A2 substrate	Non-inhibitor	0.8179
CYP450 2C9 inhibitor	Non-inhibitor	0.9095
CYP450 2D6 inhibitor	Non-inhibitor	0.9027
CYP450 2C19 inhibitor	Non-inhibitor	0.895
CYP450 3A4 inhibitor	Non-inhibitor	0.9568
CYP450 inhibitory promiscuity	Low CYP Inhibitory Promiscuity	0.9686
Ames test	Non AMES toxic	0. 9257
Carcinogenicity	Non-carcinogens	0.7844
Biodegradation	Ready biodegradable	0.582
Rat acute toxicity	1.5129 LD50, mol/kg	Not applicable
hERG inhibition (predictor I)	Weak inhibitor	0.9739
hERG inhibition (predictor II)	Non-inhibitor	0.9664

ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

Mass Spec (NIST)

Not Available

Spectra

Spectrum	Spectrum Type	Splash Key
Predicted MS/MS Spectrum – 10V, Positive (Annotated)	Predicted LC-MS/MS	Not Available
Predicted MS/MS Spectrum – 20V, Positive (Annotated)	Predicted LC-MS/MS	Not Available
Predicted MS/MS Spectrum – 40V, Positive (Annotated)	Predicted LC-MS/MS	Not Available
Predicted MS/MS Spectrum – 10V, Negative (Annotated)	Predicted LC-MS/MS	Not Available
Predicted MS/MS Spectrum – 20V, Negative (Annotated)	Predicted LC-MS/MS	Not Available
Predicted MS/MS Spectrum – 40V, Negative (Annotated)	Predicted LC-MS/MS	Not Available
LC-MS/MS Spectrum – LC-ESI-QQ , positive	LC-MS/MS	splash20-00di-0900000000-53da6b0f35ab1e8e8a57
LC-MS/MS Spectrum – LC-ESI-QQ , positive	LC-MS/MS	splash20-0pi0-7900000000-244b89c0e2e656701b1d
LC-MS/MS Spectrum – LC-ESI-QQ , positive	LC-MS/MS	splash20-0a4i-9000000000-a468801012da982d3bac
LC-MS/MS Spectrum – LC-ESI-QQ , positive	LC-MS/MS	splash20-0a4i-9000000000-eb66f99d48d2027e0fb2
LC-MS/MS Spectrum – LC-ESI-QQ , positive	LC-MS/MS	splash20-0a4i-9000000000-2983a91b4350760fab44

Targets

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Kind

Protein

Organism

Humans

Pharmacological action

Unknown

Actions

Inhibitor

General Function

Transition metal ion binding

Specific Function

Functions as a cell surface receptor and performs physiological functions on the surface of neurons relevant to neurite growth, neuronal adhesion and axonogenesis. Involved in cell mobility and tra…

Gene Name

APP

Uniprot ID

P05067

Uniprot Name

Amyloid beta A4 protein

Molecular Weight

86942.715 Da

References

1. Arispe N, Rojas E, Pollard HB: Alzheimer disease amyloid beta protein forms calcium channels in bilayer membranes: blockade by tromethamine and aluminum. Proc Natl Acad Sci U S A. 1993 Jan 15;90(2):567-71. doi: 10.1073/pnas.90.2.567. [Article]

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Drug created at June 13, 2005 13:24 / Updated at June 16, 2023 16:10

Tromethamine: Indications, Side Effects, Warnings

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Generic name: Tromethamine [ troe-METH-a-meen ]
Brand name: Tham
Drug classes: Minerals and electrolytes, Miscellaneous genitourinary tract agents

Medically reviewed by Drugs.com. Last updated on Apr 15, 2023.

Uses of Tromethamine:

• It is used to treat or prevent acid problems in the blood.

What do I need to tell my doctor BEFORE I take Tromethamine?

For all patients taking tromethamine:

• If you have an allergy to tromethamine or any other part of tromethamine.
• If you are allergic to tromethamine; any part of tromethamine; or any other drugs, foods, or substances. Tell your doctor about the allergy and
  what signs you had.
• If you are not able to pass urine.

Children:

• This medicine is not for newborns who have any of these problems: High blood carbon dioxide levels or too much salicylate in the body.

This is not a list of all drugs or health problems that interact with tromethamine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check
to make sure that it is safe for you to take tromethamine with all of your drugs and health problems. Do not start, stop, or change the dose of
any drug without checking with your doctor.

What are some things I need to know or do while I take Tromethamine?

For all patients taking tromethamine:

• Tell all of your health care providers that you take tromethamine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tromethamine
  while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

• Use with care in children. Talk with the doctor.

How is this medicine (Tromethamine) best taken?

Use tromethamine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your
doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing;
  tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue,
  or throat.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling
  like passing out; numbness or tingling; or shortness of breath.
• Trouble breathing, slow breathing, or shallow breathing.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Fever.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling,
  blisters, skin sores, or leaking of fluid where the drug is going into your body.

What are some other side effects of Tromethamine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical
help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical
advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

How do I store and/or throw out Tromethamine?

• If you need to store tromethamine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your
  pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tromethamine, please talk
  with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
  taken, how much, and when it happened.

More about tromethamine

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• Side effects
• Dosage information
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• Drug class: minerals and electrolytes

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Medical anti-shock kit – OOO NPF TRANSMEDTECH

tel. : +7 977 777-03-55 street 3rd Post Office, 57k2, microdistrict Gorodok B, Lyubertsy +7 909 656-98-68 Product Specifications To enter the section you need to log in Login Password Authorization Failure Individual wearable first aid kits First aid kits group Related products Case colours: olive, red, black. Case length, mm – – 100±5; Case width, mm – 65±5; Case height, mm – – 25±5; Weight, not more than gr. – 100 Medical anti-shock kit is a case made of impact-resistant polymer, which contains 5 attachments necessary for providing medical self-help and mutual assistance in life-threatening conditions. The set is recommended to be used by trained employees of rescue and special units and persons with medical education in autonomous conditions. The set is used in the absence of qualified medical care during the “golden hour” (up to 40-60 minutes from the onset of a life-threatening condition) and during long-term transportation of the victim to a medical institution. The use of the kit is indicated for such critical conditions as: traumatic, pain, anaphylactic shock, and for the prevention of their development, with serious injuries and wounds, bites of poisonous animals, drowning. The action of the set is due to the drugs included in its composition: ketorolac tromethamine – an anesthetic, cordiamin – a stimulant of the respiratory and vasomotor centers of the brain, dexamethasone – a glucocorticoid hormone with a pronounced anti-inflammatory and anti-shock effect. Perhaps both separate and joint use of drugs. When using, allergic reactions to the drugs included in the anti-shock kit and contraindications to their use should be excluded. For use, it is necessary to have stable skills in intramuscular or subcutaneous injections. The injection is carried out in an unaffected area (limb). Features: Minimum weight and overall dimensions Reliable protection of contents from external influences Affordable price UT CONFIRMED LIST of attachments included in the Antishock Medical Kit: Alcohol wipe – 1 pc – Used to treat the injection site Ketorolac tromethamine solution (ketans) 30mg/ml – 1 – Used as an anesthetic Cordiamin solution 250mg/ml – 1 amp. – Used to stimulate cardiac and respiratory activity Dexamethasone solution 4mg/ml – 1 amp – Used as an anti-inflammatory and anti-shock agent Syringe 5 ml – 1 pc – For injection Composition-description – 1 Case container – 1- To protect the contents from external influences All attachments are not drugs prohibited for circulation by civilians. © 2014 CJSC “NPF TRANSMEDTECH” When using site materials, a hyperlink to the resource is required. All rights reserved.

Ketorol 2% 30.0 g gel (id 89227760)

Ketorol®

Tradename

Ketorol® 90 027

International Nonproprietary Name

Ketorolac

Dosage form

Gel

Composition

1 g of gel contains

active substance – ketorolac tromethamine 20.00 mg tromethamine, purified water, Indian dgeatan, ethanol, glycerol.

Description

Uniform, transparent or almost transparent gel with a characteristic odor.

Pharmacotherapeutic group

Preparations for the treatment of diseases of the musculoskeletal system. Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. Derivatives of acetic acid.

ATX code M01AB15.

Pharmacological properties

Pharmacokinetics

The biological value of ketorolac is approximately 80-100%. The pharmacokinetics of ketorolac is linear over the usual initial dose range. The concentration of the drug in the blood plasma at rest is approximately 50% higher than after a single dose. With regard to other non-steroidal anti-inflammatory drugs, Ketorolac is almost completely bound to plasma proteins (> 99%), resulting in a small apparent volume of distribution (Vd) [<0.3 l/kg]. It is extensively metabolized, primarily by fusion with glucuronic acid, and excreted via the kidneys. Metabolites do not have a significant analgesic effect. The average terminal half-life (t ½ β) of Ketorolac in healthy volunteers was about 5 hours.

Pharmacodynamics

Ketorol® is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory effects. The main mechanism of action of ketorol, like other NSAIDs, is manifested in its pharmacological effect – inhibition of prostaglandin synthesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are most active in the periphery.

Ketorol does not have a sedative or anxiolytic effect, does not affect opioid receptors. Ketorol does not have a depressant effect on the respiratory center and does not increase the respiratory depression and sedation caused by opioid analgesics. Ketorol does not cause drug dependence. After abrupt discontinuation of the drug, withdrawal symptoms do not occur.

Indications for use

– relief of pain in muscles and joints

– post-traumatic pain syndrome

– for soft tissue contusions such as sprains, bursitis, tendonitis, epicondylitis, synovitis, osteoarthritis of superficial joints.

Dosage and administration

For external use.

A small amount of gel (3-5 cm) is applied in a thin layer on the skin of the inflamed or painful area of ​​the body 1-2 times a day, rubbing with fingertips with light massaging movements. The dosage should be selected in accordance with the area of ​​the affected area.

Thoroughly rinse and dry affected areas before applying Ketorol gel. The drug is gently applied to the skin with massage movements, spreading over the affected area, it should not be applied in the area close to the eyes, on mucous membranes or open wounds. Patients are not recommended to use an airtight bandage. Hands should be washed before and after using this drug.

Side effects

Often (more than 3%)

– headache, dizziness, drowsiness

– swelling of the face, legs, ankles, fingers, feet

– weight gain

– nausea, dyspepsia, diarrhea,

9 0008 Less often (1 – 3%)

–skin rash, purpura

–excessive sweating

– constipation, flatulence, stomach fullness, vomiting, stomatitis

– increased blood pressure, palpitations, pallor, syncope, anemia, eosinophilia

– itching, rash

Rarely (less than 1%)

– gastritis, belching, anorexia, increased appetite, dry mouth vertigo, paresthesia, depression, nervousness, thinking disorder, inability to concentrate, hyperkinesias, stupor, excessive thirst, taste disturbance insufficiency, thrombocytopenia, purpura), frequent urination, increase or decrease in urine volume, nephritis, renal edema, hematuria, proteinuria, oliguria, hyponatremia, hyperkalemia, nephritis, renal edema

– hearing loss, ringing in the ears, visual impairment (including blurred vision)

– bronchospasm or dyspnea, rhinitis, larynx and lung edema, cough anemia, eosinophilia, leukopenia

– bleeding from postoperative wound, epistaxis, rectal bleeding

– fever, infection chest, wheezing)

– aseptic meningitis (fever, severe headache, convulsions, neck and/or back stiffness), hallucinations, depression, psychosis

– exfoliative dermatitis (fever with or without chills, redness, induration or skin peeling, swelling and / or soreness of the palatine tonsils), urticaria, Stevens-Johnson syndrome, Lyell’s syndrome

– edema of the tongue, angioedema.

Contraindications

– hypersensitivity to the active substance and other components, acetylsalicylic acid or other NSAIDs

– gastric and duodenal ulcers, gastrointestinal bleeding or perforation of gastric ulcers nasal postures, bronchospasm and Quincke’s edema resulting from aspirin treatment

– peptic ulcers

– hypocoagulation, including hemophilia

– liver and kidney failure

– hemorrhagic stroke

– bleeding, including after surgery

– hematopoietic disorders

– chronic pain

– pregnancy and lactation open wounds

– aspirin triad

– hypovolemia

– dehydration

– children and adolescents up to 18 years of age.

Drug interactions

There are no cases of clinically significant drug interactions with topical Ketorol.

The following cases are incidental interactions with oral treatment with Ketorol, resulting in a slight decrease in the ability of plasma protein to bind warfarin. Laboratory studies show that at a therapeutic concentration of a salt of salicylic acid, the ability to bind Ketorol decreases from approximately 99.2% to 97.5%, representing the possibility of a twofold increase in the levels of Ketorol, unbound by blood plasma. It is reported that the action of Ketorol reduces the diuretic response to furosemide in normovolemic patients by approximately 20%. The concomitant use of Ketorol and probenecid leads to a reduced degree of clearance from Ketorol and a significant increase in the content of Ketorol in the blood plasma (approximately three times), and an approximately two-fold increase in the terminal half-life is also observed. An increase in the concentration of lithium in the blood plasma has been reported as a result of the suppression of the ability to cleanse the kidneys of lithium when taking certain non-steroidal anti-inflammatory drugs. There have also been reports of increased plasma lithium levels with Ketorolac. A possible interaction between Ketorol and curare-like non-depolarizing agents has been reported, leading to apnea. Concomitant use of Ketorol and ACE inhibitors may increase the risk of renal failure, especially in patients with malnourished organism. Several cases of epileptic seizures have been reported with the concomitant use of Ketorol and antiepileptic drugs (phenytoin, carbamazepine). There have been cases of hallucinations with the concomitant use of Ketorol with psychotropic drugs (fluoxetine, thiotexin, alprazolam).

In laboratory testing

Ketorol inhibits platelet aggregation and may prolong bleeding time. Pregnancy and lactation The excretion of Ketorolac tromethamine into breast milk after its systematic use is limited. As a result of a study involving 10 women, it was found that the ratio of milk and plasma in the concentration of ketorolac tromethamine varies from 0.015 to 0.037.

Pediatric Use

Recommended doses and indications for pediatric use of Ketorolac Gel have not yet been established.

Because NSAIDs reduce platelet aggregation, Ketorol should be used with caution in patients with bleeding disorders.

Use in patients with impaired liver function

When taking Ketorol, an increase in the level of hepatic transaminases is possible, therefore it is necessary to prescribe a short course of treatment to patients with liver diseases.

Use in patients with impaired renal function

Ketorol® is administered to patients with impaired renal function with caution under the control of urine tests.

Use in elderly patients

When taking Ketorol, adverse reactions in elderly patients are more common, it is necessary to prescribe low doses of the drug. Maximum doses should not exceed 60 mg and should be taken at intervals of 6 to 8 hours.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Since patients with the appointment of Ketorol develop side effects from the central nervous system (dizziness, drowsiness) and from the senses (hearing loss, tinnitus, visual impairment), it is recommended to avoid performing work that requires increased attention and quick response.