URAL EFFERVESCENT GRANULES

Product Information

Registration Status: Active

URAL EFFERVESCENT GRANULES is approved to be sold in Singapore with effective from 2013-06-26. It is marketed by ABBOTT LABORATORIES (SINGAPORE ) PTE LTD, with the registration number of SIN14374P.

This product contains Citric Acid 0.72g,Sodium Bicarbonate 1.76g,Sodium Citrate 0.63g, and Tartaric Acid 0.89g in the form of GRANULE, EFFERVESCENT. It is approved for ORAL use.

This product is manufactured by Aspen Pharma Pty Ltd in AUSTRALIA.

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

Citric Acid
Sodium Bicarbonate
Sodium Citrate
Tartaric Acid

Description

A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.

Toxicity

ORAL (LD50): Acute: 5040 mg/kg [Mouse]. 3000 mg/kg [Rat].

Active Ingredient/Synonyms

2-Hydroxytricarballylic acid | 3-Carboxy-3-hydroxypentane-1,5-dioic acid | Citric Acid, Anhydrous | Citronensäure | Citric 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

Sodium bicarbonate is a white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

Indication

Sodium bicarbonate is used for the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturateprotein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.

Mechanism of Action

Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

Active Ingredient/Synonyms

Baking soda | Bicarbonate of soda | Carbonic acid monosodium salt | e 500 | e-500 | e500 | NaHCO3 | Natriumhydrogenkarbonat | Sodium acid carbonate | Sodium bicarbonate | Sodium hydrogen carbonate | Sodium hydrogencarbonate | Sodium bicarbonate |


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 citrate is the sodium salt of citric acid. It is white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely soluble in water, practically insoluble in alcohol. Like citric acid, it has a sour taste. From the medical point of view, it is used as alkalinizing agent. It works by neutralizing excess acid in the blood and urine. It has been indicated for the treatment of metabolic acidosis.

Indication

Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine [FDA Label] [L788] [L789].

Mechanism of Action

Citrate chelates free calcium ions preventing them from forming a complex with tissue factor and coagulation factor VIIa to promote the activation of coagulation factor X [A19410] [A19411]. This inhibits the extrinsic initiation of the coagulation cascade. Citrate may also exert an anticoagulant effect via a so far unknown mechanism as restoration of calcium concentration does not fully reverse the effect of citrate [A19410]. Citrate is a weak base and so reacts with hydrochloric acid in the stomach to raise the pH. It it further metabolized to bicarbonate which then acts as a systemic alkalizing agent, raising the pH of the blood and urine [L790]. It also acts as a diuretic and increases the urinary excretion of calcium.

Pharmacokinetics

Absorption
Tmax of 98-130min [A19414].
Distribution
19-39L [A19414].
Metabolism
Citrate is metabolized to bicarbonate in the liver and plays a role as an intermediate in the citric acid cycle [A19419] [L795].
Elimination

Clearance

Total clearance of 313-1107mL/min [A19414].

Toxicity

Overdose toxicity is mainly due to alkalosis as well as tetany or depressed heart function due to lack of free calcium [L790].

Active Ingredient/Synonyms

Sodium citrate anhydrous | Sodium citrate, anhydrous | trisodium citrate anhydrous | Trisodium citrate, anhydrous | Sodium Citrate |


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

Tartaric acid is a white crystalline organic acid that occurs naturally in many plants, most notably in grapes.Tartaric is an alpha-hydroxy-carboxylic acid, is diprotic and aldaric in acid characteristics, and is a dihydroxyl derivative of succinic acid.

Indication

Tartaric Acid is primarily indicated in conditions like Antiscorbutic, Antiseptic.

Pharmacokinetics

Absorption
Oral or parenteral doses of monosodium 14C-L(+)-tartrate (400 mg/kg) are rapidly excreted by rats and a proportion completely metabolized to CO2. The oral dose was well-absorbed.
Distribution
Metabolism
Most tartarate that is consumed by humans is metabolized by bacteria in the gastrointestinal tract , primarily in the large instestine.
Elimination

Toxicity

Routes of Entry: Inhalation. Ingestion. Toxicity to Animals: Lowest Published Lethal Dose: LDL [Rat - Route: oral; Dose: 7500 mg/kg LDL [Rabbit] - Route: Oral; Dose: 5000 mg/kg LDL [Dog] - Rout: Oral; Dose: 5000 mg/kg Lethal Dose/Conc 50% kill: LD50 [Mouse] - Route: Intravenous; Dose: 485 mg/kg Other Toxic Effects on Humans: Acute Potential Health Effects: Skin: Causes skin irritation Eyes: Causes eye irritation Inhalation: Causes respiratory tract irritation Ingestion: Causes gastrointestinal tract irritation with nausea, vomiting and diarrhea. May affect kidneys (kidney damage), blood, and behavior (convulsions, somnolence), and respiration. Chronic Potential Health Effects: Ingestion: Repeated or prolonged ingestion may cause lesions of the mouth, gastric ulcers, gastrointestinal hyperacidity, and symptoms similar to those of metal fume fever - flu-like condition with fever, chills, sweats, nausea, vomiting, muscle aches, pains, and weakness. Skin: Repeated or prolonged skin contact may cause skin ulcerations or lesions.

Active Ingredient/Synonyms

Tartaric acid | Tartaric 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.

References

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