Tromethamine Hydrochloride

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Tromethamine Hydrochloride uses


INDICATIONS AND USAGE

Tromethamine Hydrochloride Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease:

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CONTRAINDICATIONS

Tromethamine Hydrochloride Solution (tromethamine injection) is contraindicated in uremia and anuria. In neonates it is also contraindicated in chronic respiratory acidosis and salicylate intoxication.

WARNINGS


The intravenous administration of Tromethamine Hydrochloride Solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

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PRECAUTIONS


Do not administer unless solution is clear and seal is intact. Discard unused portion.

Pregnancy Category C:

Animal reproduction studies have not been conducted with Tromethamine Hydrochloride. It is also not known whether Tromethamine Hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tromethamine Hydrochloride should be given to a pregnant woman 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 Tromethamine Hydrochloride Solution is administered to a nursing mother.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with Tromethamine Hydrochloride Solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pediatric Use:

The safety and effectiveness of Tromethamine Hydrochloride Solution in pediatric patients is based on over 30 years’ clinical experience documented in the literature and on safety surveillance. Tromethamine Hydrochloride Solution has been used to treat severe cases of metabolic acidosis with concurrent respiratory acidosis because it does not raise PCO2 as bicarbonate does in neonates and infants with respiratory failure. It has also been used in neonates and infants with hypernatremia and metabolic acidosis to avoid the additional sodium given with the bicarbonate. However, because the osmotic effects of Tromethamine Hydrochloride Solution are greater and large continuous doses are required, bicarbonate is preferred to Tromethamine Hydrochloride Solution in the treatment of acidotic neonates and infants with RDS. Hypoglycemia may occur when this product is used in premature and even full-term neonates. See WARNINGS and ADVERSE REACTIONS.

Geriatric Use:

Clinical studies of Tromethamine Hydrochloride solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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ADVERSE REACTIONS

Generally, side effects have been infrequent.

Respiratory: Although the incidence of ventilatory depression is low, it is important to keep in mind that such depression may occur. Respiratory depression may be more likely to occur in patients who have chronic hypoventilation or those who have been treated with drugs which depress respiration. In patients with associated respiratory acidosis, Tromethamine Hydrochloride should be administered with mechanical assistance to ventilation.

Vascular: Extreme care should be taken to avoid perivascular infiltration. Local tissue damage and subsequent sloughing may occur if extravasation occurs. Chemical phlebitis and venospasm also have been reported.

Hematologic: Transient depression of blood glucose may occur.

Hepatic: Infusion via low-lying umbilical venous catheters has been associated with hepatocellular necrosis.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

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OVERDOSAGE

Too rapid administration and/or excessive amounts of Tromethamine Hydrochloride may cause alkalosis, hypoglycemia, overhydration or solute overload. In the event of overdosage, discontinue the infusion, evaluate the patient and institute appropriate countermeasures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

The LD50 values for the acute intravenous toxicity of Tromethamine Hydrochloride are influenced by the rate of infusion of the dose administered.

Intravenous LD50 Mice = 3500 mg/kg

Intravenous LD50 Rats = 2300 mg/kg

DOSAGE AND ADMINISTRATION

Tromethamine Hydrochloride Solution (tromethamine injection) is administered by slow intravenous infusion, by addition to pump-oxygenator ACD blood or other priming fluid or by injection into the ventricular cavity during cardiac arrest. For infusion by peripheral vein, a large needle should be used in the largest antecubital vein or an indwelling catheter placed in a large vein of an elevated limb to minimize chemical irritation of the alkaline solution during infusion. Catheters are recommended.

Dosage and rate of administration should be carefully supervised to avoid overtreatment (alkalosis). Pretreatment and subsequent determinations of blood values (e.g. pH, PCO2, PO2, glucose and electrolytes) and urinary output should be made as necessary to monitor dosage and progress of treatment. In general, dosage should be limited to an amount sufficient to increase blood pH to normal limits (7.35 to 7.45) and to correct acid-base derangements. The total quantity to be administered during the period of illness will depend upon the severity and progression of the acidosis. The possibility of some retention of Tromethamine Hydrochloride, especially in patients with impaired renal function, should be kept in mind.

The intravenous dosage of Tromethamine Hydrochloride Solution (tromethamine injection) may be estimated from the buffer base deficit of the extracellular fluid in mEq/liter determined by means of the Siggaard-Andersen nomogram. The following formula is intended as a general guide:

Tromethamine Hydrochloride Solution (mL of 0.3 M) Required =

Body Weight (kg) X

Base Deficit (mEq/liter) X 1.1*

Thus, a 70 kg patient with a buffer base deficit (“negative base excess”) of 5 mEq/liter would require 70 x 5 x 1.1 = 385 mL of Tromethamine Hydrochloride Solution containing 13.9 g (115 mEq) of Tromethamine Hydrochloride. The need for administration of additional Tromethamine Hydrochloride Solution is determined by serial determinations of the existing base deficit.

* Factor of 1.1 accounts for an approximate reduction of 10% in buffering capacity due to the presence of sufficient acetic acid to lower pH of the 0.3 M solution to approximately 8.6.

Correction of Metabolic Acidosis Associated with Cardiac Bypass Surgery: An adverse dose of approximately 9.0 mL/kg (324 mg/kg) has been used in clinical studies with Tromethamine Hydrochloride Solution (tromethamine injection). This is equivalent to a total dose of 630 mL (189 mEq) for 70 kg patient. A total single dose of 500 mL (150 mEq) is considered adequate for most adults. Larger single doses (up to 1000 mL) may be required in unusually severe cases.

It is recommended that individual doses should not exceed 500 mg/kg (227 mg/lb) over a period of not less than one hour. Thus, for a 70 kg (154 pound) patient the dose should not exceed a maximum of 35 g per hour (1078 mL of a 0.3 M solution). Repeated determinations of pH and other clinical observations should be used as a guide to the need for repeat doses.

Correction of Acidity of ACD Blood in Cardiac Bypass Surgery: The pH of stored blood ranges from 6.80 to 6.22 depending upon the duration of storage. The amount of Tromethamine Hydrochloride Solution used to correct this acidity ranges from 0.5 to 2.5 g (15 to 77 mL of a 0.3 M solution) added to each 500 mL of ACD blood used for priming the pump-oxygenator. Clinical experience indicates that 2 g (62 mL of a 0.3 M solution) added to 500 mL of ACD blood is usually adequate.

Correction of Metabolic Acidosis Associated with Cardiac Arrest: In the treatment of cardiac arrest, Tromethamine Hydrochloride Solution should be given at the same time that other standard resuscitative measures, including manual systole, are being applied. If the chest is open, Tromethamine Hydrochloride Solution is injected directly into the ventricular cavity. From 2 to 6 g (62 to 185 mL of a 0.3 M solution) should be injected immediately. Do not inject into the cardiac muscle.

If the chest is not open, from 3.6 to 10.8 g (111 to 333 mL of a 0.3 M solution) should be injected immediately into a larger peripheral vein. Additional amounts may be required to control acidosis persisting after cardiac arrest is reversed.

Correction of Metabolic Acidosis Associated with RDS in Neonates and Infants: The initial dose of Tromethamine Hydrochloride Solution should be based on initial pH and birthweight amounting to approximately 1 mL per kg for each pH unit below 7.4. Further doses have been given according to changes in PaO2, pH and PCO2.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.

HOW SUPPLIED

Tromethamine Hydrochloride Solution (tromethamine injection) is supplied in a single-dose 500 mL large volume glass container (List No. 1593).

Store at 20 to 25°C (68 to 77°F).

Protect from freezing.

Revised: October, 2005


©Hospira 2005


EN-1069


Printed in USA


HOSPIRA, INC., LAKE FOREST, IL 60045 USA

RL-2792

Tromethamine Hydrochloride pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


Tromethamine Hydrochloride available forms, composition, doses:

Form 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.


Tromethamine Hydrochloride destination | category:

Destination 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.


Tromethamine Hydrochloride Anatomical Therapeutic Chemical codes:

A 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.


Tromethamine Hydrochloride pharmaceutical companies:

Pharmaceutical 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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Frequently asked Questions

Can i drive or operate heavy machine after consuming Tromethamine Hydrochloride?

Depending on the reaction of the Tromethamine Hydrochloride after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tromethamine Hydrochloride 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 Tromethamine Hydrochloride 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 Tromethamine Hydrochloride, 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 Tromethamine Hydrochloride 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. Rachana Salvi, MD Pharmacology

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