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BEDALYTE ORS POWDER (Each sachet contains Sodium Chloride/ Potassium chloride 6.75g/1.30g/1.45g/0.75g/10.25g)

Sodium Chloride/ Potassium chloride

FDA/SD.245-010188 POWDER 6.75g/1.30g/1.45g/0.75g/10.25g

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Registration & product details

Registration no.
FDA/SD.245-010188
Registration date
2024-01-31
Expiry date
2029-02-01
Status
Valid
Active ingredient
Sodium Chloride/ Potassium chloride
Dosage form
POWDER
Strength
6.75g/1.30g/1.45g/0.75g/10.25g
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Phyto-Riker Pharmaceuticals
Country of origin
Ghana
Manufacturer location
Nsawam Road Nsawam Rd, Accra, Ghana

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:57 · updated 2026-10-23 04:00:14

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

Clinical monograph: Sodiumchloride

BNF-referenced

Sodium chloride, commonly known as salt, is an essential electrolyte that plays a crucial role in maintaining fluid balance, blood pressure, and proper cellular function. It consists of sodium (Na+) and chloride (Cl-) ions and is a major component of extracellular fluid. Sodium chloride is used in various clinical settings, including fluid and electrolyte replacement, management of hyponatremia, and as a vehicle for drug delivery in intravenous solutions.

Indications

  • Fluid and electrolyte imbalances
  • Hyponatremia
  • Diabetic ketoacidosis
  • Prophylaxis of sodium chloride deficiency
  • Chronic renal salt wasting
  • Dry eye conditions (as eye drops)

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines based on the child's age and clinical condition.

Adults: Fluid and electrolyte replacement should be individualized based on clinical circumstances. For oral supplementation, adult patients may take 4-8 tablets daily, with a maximum of 20 tablets in severe depletion. For intravenous infusion, the volume of sodium chloride solution required to replace deficits may vary; consult product literature for precise guidance.

Mechanism of action

Sodium and chloride ions function together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid can lead to water balance disorders. Sodium chloride can induce uterine contractions when used in hypertonic solutions, contributing to its abortifacient properties. The precise mechanism may involve prostaglandins released from damaged decidual cells.

Pharmacodynamics

Sodium, as the primary cation in extracellular fluid, is essential for maintaining fluid distribution, osmotic pressure, and overall fluid balance. It works in conjunction with chloride and bicarbonate to regulate the acid-base equilibrium of body fluids. Changes in sodium levels significantly impact water distribution and electrolyte balance within the body.

Pharmacokinetics

Sodium chloride is readily absorbed and distributed in body fluids, influencing extracellular fluid volume and osmotic pressure. It is excreted primarily through the kidneys, with renal function significantly affecting sodium retention and excretion. The pharmacokinetics may vary based on the route of administration (oral or intravenous) and the formulation used.

Adverse effects

  • Abdominal cramps
  • Acidosis
  • Hyperchloraemic diarrhoea
  • Generalised oedema
  • Hypertension
  • Hypotension
  • Irritability
  • Muscle complaints
  • Nausea
  • Vomiting
  • Chills
  • Fever
  • Hypervolemia
  • Local reaction
  • Localized pain
  • Paraesthesia
  • Skin reactions
  • Tremor
  • Vascular irritation
  • Venous thrombosis

Precautions

  • Avoid excessive administration in elderly patients or those with cardiac failure.
  • Monitor for signs of fluid overload, especially in patients with impaired renal function.
  • Consider potential for dilutional hyponatraemia.

Pregnancy

Intra-amniotic instillation of hypertonic sodium chloride can induce abortion and fetal death; caution is advised.

Storage

Store in a cool, dry place, away from direct sunlight. Ensure containers are tightly closed.

Formulations

  • Sodium chloride 0.9% infusion
  • Sodium chloride 5% eye drops
  • Sodium chloride effervescent tablets
BNF 85 (British National Formulary) p.1172 BNF 85 (British National Formulary) p.1303 BNF for Children 2019-2020 p.632 BNF for Children 2019-2020 p.719 BNF for Children 2019-2020 p.750 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Sodiumchloride

PubChem CID 5234

Molecular formula: ClNa

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. Intra-amniotic instillation of 20% sodium chloride injection induces abortion and fetal death. Although the mechanism has not been conclusively determined, some studies indicate that the drug's abortifacient activity may be mediated by prostaglandins released from decidual cells damaged by hypertonic solutions of sodium chloride. Hypertonic sodium chloride-induced uterine contractions are usually sufficient to cause evacuation of both the fetus and placenta; however, abortion may be incomplete in 25-40% of patients. /20% injection/

Pharmacodynamics

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.