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Product Name
:
SODIUM CHLORIDE ( IV ) ELSaad
Chemical Name
:
Sodium Chlodide
Therapeutic Category
:
Fluids and Electrolytes
Pharmacologic Category
:
Electrolyte Supplement, Parenteral
Pharmaceutical Form
:
Ampoule
Composition
:
Sodium Chlodide 0.45 % / 0.9%
Lactation
Dosing
 
Dosing: Adult
Refractory elevated ICP due to various etiologies (eg, subarachnoid hemorrhage, trauma, neoplasm), transtentorial herniation syndromes (unlabeled use): I.V.: Hypertonic saline: 23.4% (30-60 mL) given over 2-20 minutes administered via central venous access only (Koenig, 2008; Suarez, 1998; Ware, 2005)
Subarachnoid hemorrhage with hyponatremia (ie, ≤135 mEq/L) to enhance cerebral perfusion (unlabeled use): I.V.: Hypertonic saline: 3% sodium chloride/acetate (50:50 mixture) 100-200 mL/hour administered via central venous catheter; titrate to clinical response up to a maximum serum sodium between 150-160 mEq/L (achieved at a rate of 0.5-1 mEq/L/hour) (Suarez, 1999)
Traumatic brain injury with elevated ICP (unlabeled use): I.V.: Hypertonic saline: Note: Optimal dose has not been established; due to insufficient evidence, the Brain Trauma Foundation guidelines (Bratton, 2007) do not make specific recommendations on the use of hypertonic saline for the treatment of traumatic intracranial hypertension. Clinical trials are small; few are prospective. Some concentrations may not be commercially available; administer via central venous catheter; protocols include:
3%: 300 mL administered over 20 minutes when ICP values exceed 20 mm Hg (Huang, 2006)
7.2%: 1.5 mL/kg administered over 15 minutes when ICP values exceed 15 mm Hg (Munar, 2000)
7.5%: 2 mL/kg administered over 20 minutes when ICP values exceed 25 mm Hg (Vialet, 2003)
23.4%: 30 mL administered over 2 minutes (Ware, 2005) or over >30 minutes when ICP values exceed 20 mm Hg (Kerwin, 2009)
GU irrigant: Irrigation: 1-3 L/day by intermittent irrigation
Replacement: I.V.: Determined by laboratory determinations mEq
Hyponatremia: Sodium deficiency (mEq/kg) = [% dehydration (L/kg)/100 x 70 (mEq/L)] + [0.6 (L/kg) x (140 - serum sodium) (mEq/L)]
To correct acute, serious hyponatremia: mEq sodium = [desired sodium (mEq/L) - actual sodium (mEq/L)] x [0.6 x wt (kg)]; for acute correction use 125 mEq/L as the desired serum sodium; acutely correct serum sodium in 5 mEq/L/dose increments; more gradual correction in increments of 10 mEq/L/day is indicated in the asymptomatic patient

Approximate Deficits of Water and Electrolytes in Moderately Severe Dehydration1

Condition
Water
(mL/kg)
Sodium
(mEq/kg)

1A negative deficit indicates total body excess prior to treatment.

Adapted from Behrman RE, Kleigman RM, Nelson WE, et al, eds, Nelson Textbook of Pediatrics, 14th ed, WB Saunders Co, 1992.

Fasting and thirsting
100-120
5-7
Diarrhea


Isonatremic
100-120
8-10
Hypernatremic
100-120
2-4
Hyponatremic
100-120
10-12
Pyloric stenosis
100-120
8-10
Diabetic acidosis
100-120
9-10

Dosing: Pediatric
Hyponatremia: I.V.: Children: Hypertonic solutions (>0.9%) should only be used for the initial treatment of acute serious symptomatic hyponatremia or increased intracranial pressure in the setting of traumatic brain injury.
Maintenance: 3-4 mEq/kg/day; maximum: 100-150 mEq/day; dosage varies widely depending on clinical condition
Replacement: Determined by laboratory determinations mEq
Sodium deficiency (mEq/kg) = [% dehydration (L/kg)/100 x 70 (mEq/L)] + [0.6 (L/kg) x (140 - serum sodium) (mEq/L)]
Increased intracranial pressure (unlabeled use): Hypertonic saline (3%): 0.1-1 mL/kg/hour continuous infusion titrated to maintain ICP <20 mm Hg (Addleson, 2003)

Dosing: Geriatric

Refer to adult dosing.
Use
 
Parenteral: Hypertonic saline: Refractory elevated intracranial pressure (ICP) due to various etiologies (eg, subarachnoid hemorrhage, neoplasm); transtentorial herniation syndrome; traumatic brain injury with elevated ICP. Note: May be used in patients in whom mannitol may not be recommended (eg, renal failure).
Adverse Reactions
 
Frequency not defined.
Cardiovascular: Congestive heart failure, transient hypotension (especially with administration of 23.4% NaCl)
Central nervous system: Central pontine myelinolysis (due to rapid correction of hyponatremia)
Endocrine & metabolic: Dilution of serum electrolytes, extravasation, hypernatremia, hypervolemia, hypokalemia, overhydration
Local: Thrombosis, phlebitis, extravasation
Respiratory: Pulmonary edema
Contraindications
 
Hypersensitivity to sodium chloride or any component of the formulation; hypertonic uterus, hypernatremia, fluid retention
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Hyponatremia: Administration of low sodium or sodium-free I.V. solutions may result in significant hyponatremia or water intoxication in pediatric patients; monitor serum sodium concentration.
• Sodium toxicity: Is almost exclusively related to how fast a sodium deficit is corrected; both rate and magnitude are extremely important.
Disease-related concerns:
• Cirrhosis: Use with caution in patients with cirrhosis.
• Edema: Use with caution in patients with edema.
• Heart failure: Use with caution in patients with heart failure.
• Hypertension: Use with caution in patients with hypertension.
• Renal impairment: Use with caution in patients with renal impairment; may cause sodium retention.
Dosage form specific issues:
• Bacteriostatic sodium chloride: Do not use bacteriostatic sodium chloride in newborns since benzyl alcohol preservatives have been associated with toxicity.
• Irrigants: For external use only; not for parenteral use. Do not use during electrosurgical procedures. Irrigating fluids may be absorbed into systemic circulation; monitor for fluid or solute overload.
• Wound Wash Saline™: For single-patient use only.
Interactions
 
Lithium: Sodium Chloride may increase the excretion of Lithium. Risk C: Monitor therapy
Tolvaptan: Sodium Chloride may enhance the adverse/toxic effect of Tolvaptan. Specifically, Hypertonic Saline may increase the risk for too rapid of an increase in serum sodium concentrations. Management: This interaction is specific to Hypertonic Saline. Avoid concurrent use of Hypertonic Saline with Tolvaptan. Risk X: Avoid combination
Pregnancy
 
C
Monitoring Parameters
 
Serum sodium, potassium, chloride, and bicarbonate concentrations; I & O, weight
Reference Range
Serum/plasma sodium concentration:
Neonates:
Full-term: 133-142 mEq/L
Premature: 132-140 mEq/L
Children ≥2 months to Adults: 135-145 mEq/L
Mechanism of Action
 
Principal extracellular cation; functions in fluid and electrolyte balance, osmotic pressure control, and water distribution
Pharmacodynamics / Kinetics
 
Distribution: Widely distributed
Excretion: Primarily urine; also sweat, tears, saliva
 
   
 
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