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COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP

Product Information

Registration Status: Active

SIN06281P

COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP is approved to be sold in Singapore with effective from 1991-11-06. It is marketed by LUEN WAH MEDICAL COMPANY (SINGAPORE) PTE LTD, with the registration number of SIN06281P.

This product contains Calcium Chloride 0.027g/100ml,Lactic Acid 0.24ml/100ml,Potassium Chloride 0.04g/100ml,Sodium Chloride 0.6g/100ml, and Sodium Hydroxide 0.115g/100ml in the form of INJECTION. It is approved for INTRAVENOUS use.

This product is manufactured by PT OTSUKA INDONESIA in INDONESIA REP OF, andTHAI OTSUKA PHARMACEUTICAL CO LTD in THAILAND.

It is an Over-the-counter Medicine that can be freely obtained from any retailer

Product Reference
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Description

Calcium chloride is an ionic compound of calcium and chlorine. It is highly soluble in water and it is deliquescent. It is a salt that is solid at room temperature, and it behaves as a typical ionic halide. It has several common applications such as brine for refrigeration plants, ice and dust control on roads, and in cement. It can be produced directly from limestone, but large amounts are also produced as a by-product of the Solvay process. Because of its hygroscopic nature, it must be kept in tightly-sealed containers.

Indication

For the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, for the treatment of magnesium intoxication due to overdosage of magnesium sulfate, and used to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid.

Mechanism of Action

Calcium chloride in water dissociates to provide calcium (Ca2+) and chloride (Cl-) ions. They are normal constituents of the body fluids and are dependent on various physiological mechanisms for maintenance of balance between intake and output. For hyperkalemia, the influx of calcium helps restore the normal gradient between threshold potential and resting membrane potential.

Toxicity

Too rapid injection may produce lowering of blood pressure and cardiac syncope. Persistent hypercalcemia from overdosage of calcium is unlikely because of rapid excretion.

Active Ingredient/Synonyms

Calcium chloride anhydrous | Calcium chloride, anhydrous | calcium(2+) chloride | Calcium Chloride |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed) Sodium lactate is the sodium salt of lactic acid, and has a mild saline taste. It is produced by fermentation of a sugar source, such as corn or beets, and then, by neutralizing the resulting lactic acid to create a compound having the formula NaC3H5O3.

Indication

For use as an alkalinizing agent.

Mechanism of Action

Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Active Ingredient/Synonyms

(±)-2-hydroxypropanoic acid | 2-Hydroxypropanoic acid | 2-Hydroxypropionic acid | Acidum lacticum | DL- lactic acid | DL-Lactic Acid | DL-Milchsäure | Lacticum acidum | Milchsäure | Milk acid | rac-lactic acid | α-hydroxypropanoic acid | α-hydroxypropionic acid | Lactic Acid |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives.

Indication

For use as an electrolyte replenisher and in the treatment of hypokalemia.

Mechanism of Action

Supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.

Pharmacokinetics

Absorption
Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.
Distribution
Metabolism
Elimination

Toxicity

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, of if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Active Ingredient/Synonyms

[KCl] | Chlorid draselny | Chloride of potash | Kaliumchlorid | KCl | Monopotassium chloride | Muriate of potash | Sylvite | Potassium Chloride |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium chloride is the salt most responsible for the salinity of seawater and of the extracellular fluid of many multicellular organisms. It is listed on the World Health Organization Model List of Essential Medicines.

Indication

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

Mechanism of Action

Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.

Pharmacokinetics

Absorption
Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients.
Distribution
The volume of distribution is 0.64 L/kg.
Metabolism
The salt that is taken in to gastro intestinal tract remains for the most part unabsorbed as the liquid contents pass through the stomach and small bowel. On reaching the colon this salt, together with the water is taken in to the blood. As excesses are absorbed the kidney is constantly excreting sodium chloride, so that the chloride level in the blood and tissues remains fairly constant.Further more, if the chloride intake ceases, the kidney ceases to excrete chlorides. Body maintains an equilibrium retaining the 300gm of salt dissolved in the blood and fluid elements of the tissue dissociated into sodium ions and chloride ions.
Elimination

Toxicity

The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension. ( toxnet)

Active Ingredient/Synonyms

Sodium Chloride | Sodium Chloride |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

Sodium hydroxide is also known as _lye_ or _soda_ , or _caustic soda_ [L1971]. At room temperature, sodium hydroxide is a white crystalline odorless solid that absorbs moisture from the air. It is a synthetically manufactured substance. When dissolved in water or neutralized with acid it releases substantial amounts of heat, which may prove sufficient to ignite combustible materials. Sodium hydroxide is highly corrosive [L1965]. Sodium hydroxide is generally used as a solid or a diluted in a 50% solution. This chemical is used to manufacture soaps, rayon, paper, explosives, dyestuffs, and petroleum products [L1965]. It is also used in processing cotton fabric, laundering and bleaching, metal cleaning and processing, oxide coating, electroplating, and electrolytic extracting. It is commonly found in commercial drain/ oven cleaners [L1965]. According to the the FDA, sodium hydroxide is considered a direct food recognized as safe, where it serves as a pH control agent and follows good manufacturing guidelines [L1967]. Interestingly, sodium hydroxide has been studied for its use in the treatment of prion disease (as occurs in mad cow disease and kuru). The use of this compound has been shown to effectively reduce prion levels in an in vitro inactivation assay [A32334].

Indication

Used to destroy or kill the nail matrix (matrixectomies) [L1968].

Mechanism of Action

Because of its high-level alkalinity, sodium hydroxide in aqueous solution directly causes bond breakage in proteins (especially disulfide bridges). Hair and fingernails are found to be dissolved after 20 hours of direct contact with sodium hydroxide at pH values higher than 9.2 [L1975]. Sodium hydroxide has depilatory effects which have been described after accidental contact with solutions in the workplace. The breakage of bonds in proteins may lead to severe necrosis to the application site. The level of corrosion depends on the period of contact with the tissue, and on the concentration of sodium hydroxide [L1975].

Pharmacokinetics

Absorption
There are no quantitative data for the absorption of sodium hydroxide through the skin. Solutions which contain 50 % sodium hydroxide have been shown to be corrosive and lethal when applied dermally to mice [L1977].
Distribution
Metabolism
Elimination

Toxicity

Human poisoning cases indicate that a dose of 10 grams orally is fatal [L1970]. Sodium hydroxide is toxic by oral ingestion [L1965]. Sodium hydroxide is corrosive to all tissues. Concentrated vapors lead to serious damage to the eyes and respiratory system. Oral ingestion of sodium hydroxide, which occurs frequently in children, causes severe tissue necrosis, with stricture formation of the esophagus, often resulting in death. Contact with the skin may result in contact dermatitis, hair loss, as well as necrosis due to severe irritation [L1972]. Increased incidence of esophageal carcinoma after severe intoxication with sodium hydroxide has been reported in man. In animal studies, long-term dermal contact with substances leading to pH changes in the skin causes the development of tumors, as a result of severe tissue irritation and reparative cell growth [L1977]. Mutagenic for mammalian somatic cells. May cause damage to the following organs: mucous membranes, upper respiratory tract, skin, eyes [MSDS]. Tumors are not to be expected if the effects of irritation are prevented [L1977]. To date, there are no relevant studies of the prenatal toxic effects of sodium hydroxide [L1977].

Active Ingredient/Synonyms

caustic soda | lye | soda lye | sodium hydrate | white caustic | Sodium hydroxide |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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