Sodium Acetate 2meq/ml Inj, 50ml

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
Sodium salt; Acetate salt
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Pregnancy Category
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 is a medication given through an IV (into a vein) to help balance the salt and fluid levels in your body. It also helps correct the acid-base balance in your blood, which is important for your body to function properly. It's often used when you're receiving nutrition through an IV.
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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 proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • This medication is administered in a healthcare setting, so specific lifestyle modifications are not typically required by the patient.
  • Report any unusual symptoms or discomfort immediately to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's clinical condition, serum electrolyte levels, acid-base balance, and fluid requirements. Typically administered as an additive to large volume parenteral fluids (e.g., TPN).

Condition-Specific Dosing:

parenteral_nutrition: Typically 20-150 mEq/day of sodium, with acetate providing a portion of the anion requirement, adjusted to maintain electrolyte and acid-base balance.
hyponatremia_correction: Dosing is calculated based on sodium deficit and desired rate of correction, often using hypertonic saline, but sodium acetate may contribute to overall sodium intake in patients requiring acetate.
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Pediatric Dosing

Neonatal: Dosing is highly individualized based on weight, gestational age, clinical condition, and electrolyte/acid-base status. Typically 2-4 mEq/kg/day of sodium, with acetate as part of the anion source in TPN.
Infant: Dosing is highly individualized based on weight, clinical condition, and electrolyte/acid-base status. Typically 2-4 mEq/kg/day of sodium, with acetate as part of the anion source in TPN.
Child: Dosing is highly individualized based on weight, clinical condition, and electrolyte/acid-base status. Typically 2-4 mEq/kg/day of sodium, with acetate as part of the anion source in TPN.
Adolescent: Dosing is highly individualized based on weight, clinical condition, and electrolyte/acid-base status. Similar to adult dosing principles, often 2-4 mEq/kg/day of sodium, with acetate as part of the anion source in TPN.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum sodium and fluid status closely.
Moderate: Use with caution; monitor serum sodium, fluid status, and acid-base balance closely. Dosage adjustments may be necessary to prevent hypernatremia or fluid overload.
Severe: Contraindicated in severe renal impairment or anuria unless closely monitored and managed by a specialist. Significant risk of hypernatremia and fluid overload. Acetate metabolism may be less efficient.
Dialysis: Use with extreme caution; dosage must be highly individualized based on dialysis regimen and patient's electrolyte and fluid status. Consult nephrology.

Hepatic Impairment:

Mild: No specific adjustment typically required, but monitor fluid and electrolyte balance.
Moderate: Use with caution. Acetate metabolism to bicarbonate may be impaired in significant hepatic dysfunction, potentially leading to less alkalinizing effect or accumulation of acetate. Monitor acid-base status.
Severe: Use with caution. Significant impairment of acetate metabolism may occur. Monitor acid-base status (e.g., anion gap) and electrolytes closely. May contribute to metabolic acidosis if acetate is not metabolized.

Pharmacology

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Mechanism of Action

Sodium acetate provides sodium ions (Na+) which are essential for maintaining fluid and electrolyte balance, osmotic pressure, and normal nerve and muscle function. The acetate ion (CH3COO-) is a bicarbonate precursor; it is metabolized by various tissues (e.g., muscle, liver, kidney) to carbon dioxide and water, consuming hydrogen ions in the process, thereby producing bicarbonate (HCO3-). This alkalinizing effect helps to correct or prevent metabolic acidosis.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.2 L/kg (distributes primarily in extracellular fluid)
ProteinBinding: <1%
CnssPenetration: Limited

Elimination:

HalfLife: Sodium: Regulated by renal excretion; Acetate: Rapidly metabolized (minutes)
Clearance: Sodium: Renal clearance; Acetate: Metabolic clearance
ExcretionRoute: Sodium: Renal; Acetate: Metabolized to CO2 and H2O, excreted via lungs and kidneys
Unchanged: Sodium: Variable, depending on renal function and body needs; Acetate: Negligible
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Pharmacodynamics

OnsetOfAction: Immediate (upon IV administration)
PeakEffect: Minutes (for acetate metabolism to bicarbonate)
DurationOfAction: Dependent on patient's metabolic needs and renal function; effects on electrolyte and acid-base balance are sustained as long as infusion continues and metabolism/excretion are normal.

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 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 any 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:

  • Excessive thirst
  • Unusual tiredness or weakness
  • Confusion or changes in mental status
  • Swelling in your ankles, feet, or hands
  • Shortness of breath
  • Muscle cramps or twitching
  • Nausea or vomiting
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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 as a result of the allergy.
If you have elevated sodium levels or swelling, as these conditions may be relevant to your treatment.

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

Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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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 increase the risk of aluminum toxicity with long-term use. This risk is particularly higher if you have kidney problems or if you are a premature infant. Be sure to discuss this potential risk with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to consult with your doctor. You and your doctor will need to weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hypernatremia (high sodium levels): severe thirst, lethargy, confusion, seizures, coma.
  • Fluid overload: edema, dyspnea, pulmonary congestion, hypertension.
  • Metabolic alkalosis: muscle weakness, cramps, tetany, hypoventilation, arrhythmias.
  • Hypokalemia (due to intracellular shift of potassium in alkalosis).

What to Do:

Discontinue infusion immediately. Management is supportive and includes correction of fluid and electrolyte imbalances. In severe cases, dialysis may be required. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Corticosteroids (e.g., Prednisone, Dexamethasone): May increase sodium retention and fluid overload risk.
  • Drugs causing hypernatremia (e.g., certain diuretics, excessive sodium chloride administration): Additive effect on serum sodium.
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Moderate Interactions

  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): May alter sodium excretion, requiring careful monitoring of fluid and electrolyte balance.
  • Lithium: Sodium levels can affect lithium excretion; changes in sodium intake or excretion may alter lithium levels.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Rationale: To establish baseline electrolyte and acid-base status before initiating therapy and to guide initial dosing.

Timing: Prior to initiation of therapy

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete sodium and manage fluid, crucial for safe administration.

Timing: Prior to initiation of therapy

Fluid Status (Weight, Intake/Output, Physical Exam)

Rationale: To assess baseline hydration and prevent fluid overload.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Frequency: Daily or more frequently as clinically indicated, especially during initial therapy or dose adjustments.

Target: Sodium: 135-145 mEq/L; Bicarbonate: 22-28 mEq/L (or target based on clinical need)

Action Threshold: Sodium <130 mEq/L or >150 mEq/L; Bicarbonate <20 mEq/L or >30 mEq/L (adjust dose, investigate cause)

Acid-Base Status (Arterial Blood Gas or Venous Bicarbonate)

Frequency: As clinically indicated, especially in patients with metabolic acidosis or those receiving large doses.

Target: pH 7.35-7.45

Action Threshold: pH <7.30 or >7.50 (adjust dose, investigate cause)

Fluid Balance (Intake/Output, Daily Weight)

Frequency: Daily

Target: Stable weight, balanced I/O (or target based on clinical need)

Action Threshold: Significant weight gain (>2 kg/day) or positive fluid balance (consider fluid restriction, diuretic)

Renal Function (BUN, Creatinine)

Frequency: Periodically, or as clinically indicated.

Target: Stable within patient's baseline

Action Threshold: Significant increase (suggests renal impairment, re-evaluate dose)

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Symptom Monitoring

  • Signs of hypernatremia (e.g., thirst, lethargy, confusion, seizures, coma)
  • Signs of fluid overload (e.g., peripheral edema, dyspnea, crackles, elevated jugular venous pressure)
  • Signs of metabolic alkalosis (e.g., muscle weakness, cramps, tetany, hypoventilation, arrhythmias)
  • Signs of hypokalemia (e.g., muscle weakness, fatigue, constipation, arrhythmias)

Special Patient Groups

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Pregnancy

Sodium acetate is generally considered safe for use during pregnancy when clinically indicated and administered with careful monitoring of fluid and electrolyte balance. It is often a component of parenteral nutrition.

Trimester-Specific Risks:

First Trimester: No specific risks identified beyond general fluid/electrolyte management.
Second Trimester: No specific risks identified beyond general fluid/electrolyte management.
Third Trimester: No specific risks identified beyond general fluid/electrolyte management. Close monitoring of maternal fluid status is important to prevent complications like preeclampsia.
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Lactation

Sodium acetate is generally considered compatible with breastfeeding when clinically indicated. Sodium and acetate are normal components of the body, and therapeutic doses are unlikely to cause adverse effects in the infant.

Infant Risk: Low risk. Monitor infant for any unusual symptoms, though unlikely.
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Pediatric Use

Dosing must be highly individualized based on weight, age, and clinical condition. Neonates and infants have immature renal function and fluid regulation, requiring meticulous monitoring of fluid balance, serum electrolytes, and acid-base status to prevent hypernatremia, fluid overload, or metabolic disturbances.

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Geriatric Use

Elderly patients may have age-related decreases in renal function, pre-existing cardiovascular disease, or other comorbidities that predispose them to fluid overload or electrolyte imbalances. Use with caution, initiate at lower doses, and monitor fluid status, serum electrolytes, and renal function closely.

Clinical Information

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Clinical Pearls

  • Sodium Acetate is primarily used as a source of sodium and as an alkalinizing agent (via acetate metabolism to bicarbonate), particularly in parenteral nutrition formulations.
  • It is crucial to monitor serum electrolytes (especially sodium), fluid balance (intake/output, daily weights), and acid-base status frequently, especially in patients with renal impairment, cardiac dysfunction, or those receiving large volumes of fluid.
  • Avoid rapid infusion, which can lead to hypernatremia, fluid overload, or metabolic alkalosis.
  • The 2 mEq/mL concentration is highly concentrated and must be diluted before administration. It is typically added to larger volumes of IV fluids or TPN solutions.
  • In patients with severe liver dysfunction, acetate metabolism may be impaired, potentially reducing its alkalinizing effect or leading to acetate accumulation; monitor acid-base status closely.
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Alternative Therapies

  • For hyponatremia: Sodium Chloride (various concentrations)
  • For metabolic acidosis: Sodium Bicarbonate, Tromethamine (THAM)
  • For electrolyte maintenance in TPN: Other sodium salts (e.g., sodium chloride, sodium phosphate)
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Cost & Coverage

Average Cost: Inexpensive per 50ml vial
Generic Available: Yes
Insurance Coverage: Generally covered by most insurance plans as it is a generic, essential medication often used in hospital settings.
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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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct 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 amount, and the time it was taken to ensure prompt and effective treatment.