Sodium Acetate 4meq/ml Inj, 100ml

Manufacturer WOODWARD PHARMA SERVICES Active Ingredient Sodium Acetate(SOW dee um AS e tate) Pronunciation SOW dee um AS e tate
It is used to treat or prevent low sodium levels.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Electrolyte replenisher; Alkalinizing agent
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Pharmacologic Class
Electrolyte; Acetate source
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sodium Acetate Injection is a sterile solution given into a vein (intravenously) to help balance the body's fluids and electrolytes, especially sodium. It can also help correct conditions where the body has too much acid (metabolic acidosis) by providing a substance that the body converts into bicarbonate, which helps neutralize acid.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time, after being mixed with fluids.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
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Lifestyle & Tips

  • This medication is given in a hospital or clinic setting, so specific lifestyle modifications are not typically applicable during administration.
  • Follow all instructions from your healthcare provider regarding diet and fluid intake, especially if you have kidney or heart conditions.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's electrolyte status, acid-base balance, and nutritional needs. Typically administered as part of a parenteral nutrition solution or IV fluid regimen.
Dose Range: 20 - 160 mg

Condition-Specific Dosing:

electrolyte_replacement: Dose determined by serum sodium levels and fluid balance.
metabolic_acidosis: Dose determined by acid-base status (e.g., base deficit) and patient weight.
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Pediatric Dosing

Neonatal: Dosing is highly individualized based on weight (mEq/kg/day), clinical condition, and electrolyte/acid-base status. Close monitoring is essential.
Infant: Dosing is highly individualized based on weight (mEq/kg/day), clinical condition, and electrolyte/acid-base status. Close monitoring is essential.
Child: Dosing is highly individualized based on weight (mEq/kg/day), clinical condition, and electrolyte/acid-base status. Close monitoring is essential.
Adolescent: Dosing is highly individualized based on weight (mEq/kg/day), clinical condition, and electrolyte/acid-base status. Close monitoring is essential.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum electrolytes and fluid balance closely.
Moderate: Use with caution; monitor serum electrolytes and fluid balance closely. Dose adjustment may be necessary.
Severe: Contraindicated or use with extreme caution; significant risk of hypernatremia and fluid overload. Close monitoring and dose reduction are essential. May require dialysis.
Dialysis: May be used in patients on dialysis, but dose must be carefully adjusted based on dialysis regimen and residual renal function. Risk of sodium accumulation and fluid overload.

Hepatic Impairment:

Mild: No specific adjustment typically required, but monitor for signs of fluid overload.
Moderate: Use with caution; acetate metabolism to bicarbonate may be impaired. Monitor acid-base status and electrolytes.
Severe: Use with caution; significant impairment of acetate metabolism may occur, potentially leading to metabolic acidosis or impaired correction of existing acidosis. Monitor closely.

Pharmacology

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Mechanism of Action

Sodium acetate provides sodium ions (Na+) and acetate ions (CH3COO-). Sodium is the principal cation of extracellular fluid and plays a large part in fluid and electrolyte balance. Acetate is a precursor of bicarbonate (HCO3-). Acetate is metabolized in the liver (and other tissues) to bicarbonate, thus acting as an alkalinizing agent and contributing to the correction of metabolic acidosis.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Not applicable (IV administration, immediate effect)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.2 L/kg (distributes throughout extracellular fluid)
ProteinBinding: Not significantly protein bound
CnssPenetration: Limited

Elimination:

HalfLife: Sodium: Regulated by renal excretion; Acetate: Rapidly metabolized (half-life minutes)
Clearance: Sodium: Renal clearance; Acetate: Metabolic clearance
ExcretionRoute: Sodium: Renal; Acetate: Metabolized to CO2 (exhaled) and H2O
Unchanged: Sodium: Variable, depends on renal function and intake; Acetate: Negligible
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Pharmacodynamics

OnsetOfAction: Rapid (minutes for acid-base effect, immediate for sodium delivery)
PeakEffect: Rapid (within minutes to hours depending on dose and patient status)
DurationOfAction: Depends on the body's homeostatic mechanisms and ongoing electrolyte/acid-base disturbances.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Shortness of breath
Sudden significant weight gain
* Swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor or seek medical help.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Unusual thirst or dry mouth (may indicate too much sodium)
  • Swelling in your ankles, feet, or hands (edema)
  • Shortness of breath or difficulty breathing (signs of fluid overload)
  • Confusion, dizziness, or unusual tiredness
  • Muscle weakness or cramps
  • Fast or irregular heartbeat
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have elevated sodium levels or swelling.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss the details of these tests with your doctor.

This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk of this toxicity is increased if you have kidney problems or if you are a premature infant. It is crucial to discuss this risk with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. Your doctor will help you weigh the benefits and risks of taking this medication during this time, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Hypernatremia (excessively high sodium levels): severe thirst, lethargy, confusion, seizures, coma.
  • Fluid overload: pulmonary edema, peripheral edema, hypertension, heart failure.
  • Metabolic alkalosis: muscle weakness, tetany, hypoventilation.

What to Do:

Immediately discontinue the infusion. Management is supportive and depends on the severity of symptoms. It may include diuretics to promote sodium and fluid excretion, or in severe cases, dialysis. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Corticosteroids (e.g., Prednisone, Dexamethasone): May increase sodium retention and risk of hypernatremia and fluid overload.
  • Drugs causing sodium retention (e.g., NSAIDs): Increased risk of hypernatremia and fluid overload.
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Moderate Interactions

  • Lithium: Sodium administration can increase renal excretion of lithium, potentially decreasing lithium levels and efficacy. Monitor lithium levels.
  • Diuretics (especially loop diuretics): May alter sodium and fluid balance, requiring careful monitoring and adjustment of sodium acetate dose.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Na, K, Cl)

Rationale: To assess baseline sodium status and identify other electrolyte imbalances.

Timing: Prior to initiation of therapy

Acid-Base Status (ABG or VBG)

Rationale: To assess baseline pH, bicarbonate, and identify metabolic acidosis or alkalosis.

Timing: Prior to initiation of therapy

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete sodium and fluid.

Timing: Prior to initiation of therapy

Fluid Status (Weight, I&O, Vital Signs)

Rationale: To assess baseline hydration and identify risk of fluid overload.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Electrolytes (Na, K, Cl)

Frequency: Daily or more frequently as clinically indicated (e.g., every 4-6 hours in unstable patients)

Target: Sodium: 135-145 mEq/L

Action Threshold: Sodium > 145 mEq/L or < 135 mEq/L; significant changes in other electrolytes

Acid-Base Status (ABG or VBG)

Frequency: Daily or as clinically indicated, especially when correcting acidosis

Target: pH: 7.35-7.45; Bicarbonate: 22-28 mEq/L

Action Threshold: pH outside target range; persistent acidosis or development of alkalosis

Fluid Balance (Intake & Output, Daily Weight)

Frequency: Daily

Target: Appropriate fluid balance for patient's condition

Action Threshold: Significant positive fluid balance, rapid weight gain, or signs of fluid overload

Vital Signs (BP, HR, RR)

Frequency: Regularly as per hospital protocol

Target: Within normal limits for patient

Action Threshold: Changes indicative of fluid overload (e.g., hypertension, tachycardia, tachypnea) or dehydration

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Symptom Monitoring

  • Signs of hypernatremia: thirst, lethargy, confusion, weakness, irritability, seizures, coma.
  • Signs of fluid overload: peripheral edema, pulmonary edema (dyspnea, crackles), weight gain, elevated blood pressure, jugular venous distension.
  • Signs of metabolic alkalosis (if overcorrection): muscle weakness, cramps, tetany, hypoventilation.

Special Patient Groups

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Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted. It is an essential electrolyte. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Careful monitoring of maternal fluid and electrolyte status is crucial.

Trimester-Specific Risks:

First Trimester: Risk unknown; use with caution.
Second Trimester: Risk unknown; use with caution.
Third Trimester: Risk unknown; use with caution. Potential for fluid overload or electrolyte imbalance in mother, which could indirectly affect fetus.
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Lactation

Lactation Risk L3 (Moderately safe). Sodium and acetate are natural components of breast milk. While small amounts are expected to pass into breast milk, significant adverse effects on the infant are unlikely with appropriate maternal dosing. However, caution is advised, especially with large doses, and the infant should be monitored for signs of electrolyte imbalance or fluid overload.

Infant Risk: Low to moderate risk; monitor for signs of electrolyte imbalance or fluid overload.
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Pediatric Use

Dosing must be highly individualized based on weight, age, and clinical condition. Pediatric patients, especially neonates and infants, have smaller fluid compartments and immature renal function, making them more susceptible to fluid overload and electrolyte imbalances (hypernatremia). Close monitoring of fluid balance, serum electrolytes, and acid-base status is critical.

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Geriatric Use

Geriatric patients may have age-related decreases in renal function, cardiac reserve, and altered fluid regulation, increasing their susceptibility to hypernatremia and fluid overload. Start with lower doses and monitor fluid balance, serum electrolytes, and renal function closely. Avoid rapid infusion rates.

Clinical Information

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Clinical Pearls

  • Sodium acetate is a valuable component in parenteral nutrition formulations, providing both sodium and a bicarbonate precursor without adding chloride.
  • It is particularly useful for correcting metabolic acidosis in patients who are also hypochloremic or where chloride restriction is desired.
  • Always monitor serum electrolytes (especially sodium) and acid-base status (pH, bicarbonate) closely during administration.
  • Risk of hypernatremia and fluid overload is significant, especially in patients with impaired renal or cardiac function. Administer slowly and with caution.
  • The acetate component is metabolized to bicarbonate, so it contributes to the body's alkali reserve.
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Alternative Therapies

  • For sodium replacement: Sodium Chloride Injection
  • For metabolic acidosis: Sodium Bicarbonate Injection (direct bicarbonate source)
  • For fluid replacement: Various IV fluid solutions (e.g., Dextrose solutions, Saline solutions)
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Cost & Coverage

Average Cost: Inexpensive per 100ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.