Sodium Acetate 2meq/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 replacement; pH modifier
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Pharmacologic Class
Sodium salt; Acetate source; Alkalinizing agent
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Pregnancy Category
Not available
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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 an intravenous (IV) medication given to patients who need extra sodium or to help correct the acid-base balance in their blood. It provides sodium, which is important for body fluids and nerve function, and also helps the body produce bicarbonate, which acts as a buffer to keep the blood from becoming too acidic.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided to you. It is essential to follow all instructions closely. 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 immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • This medication is administered in a hospital or clinical setting. No specific lifestyle modifications are typically required by the patient related to this medication itself.
  • Fluid and dietary restrictions, if any, will be determined by your doctor based on your overall medical condition.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's clinical condition, electrolyte and acid-base status. Administered as an additive to intravenous fluids.
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Pediatric Dosing

Neonatal: Highly individualized based on patient's clinical condition, electrolyte and acid-base status. Administered as an additive to intravenous fluids.
Infant: Highly individualized based on patient's clinical condition, electrolyte and acid-base status. Administered as an additive to intravenous fluids.
Child: Highly individualized based on patient's clinical condition, electrolyte and acid-base status. Administered as an additive to intravenous fluids.
Adolescent: Highly individualized based on patient's clinical condition, electrolyte and acid-base status. Administered as an additive to intravenous fluids.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor sodium and acid-base status.
Moderate: Use with caution; monitor sodium and acid-base status closely. Dosage adjustment may be required.
Severe: Contraindicated in severe renal impairment unless closely monitored and indicated for specific electrolyte imbalances. Risk of hypernatremia and fluid overload.
Dialysis: Use with extreme caution; dosage must be carefully adjusted based on dialysis regimen and patient's electrolyte status.

Hepatic Impairment:

Mild: Generally no specific adjustment needed, but monitor acid-base status.
Moderate: Use with caution; acetate metabolism to bicarbonate may be impaired, potentially reducing alkalinizing effect. Monitor acid-base status closely.
Severe: Use with caution; significant impairment of acetate metabolism may occur. Monitor acid-base status closely.

Pharmacology

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Mechanism of Action

Sodium Acetate provides a source of sodium ions (Na+) and acetate ions (CH3COO-). Sodium is the principal cation of the extracellular fluid and plays a major role in fluid and electrolyte balance, nerve function, and muscle contraction. Acetate is a precursor of bicarbonate (HCO3-), which is metabolized in the liver and other tissues to bicarbonate, thus acting as an alkalinizing agent to correct metabolic acidosis.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Distributes throughout the extracellular fluid space.
ProteinBinding: Not significantly protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Sodium: Regulated by renal excretion. Acetate: Rapidly metabolized, half-life is very short (minutes).
Clearance: Sodium: Primarily renal. Acetate: Metabolic clearance.
ExcretionRoute: Sodium: Renal. Acetate: Metabolized to CO2 (exhaled) and H2O, with bicarbonate regulated by renal excretion.
Unchanged: Sodium: Variable, depends on renal function and intake. Acetate: Negligible amount excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV administration for electrolyte effect; alkalinizing effect depends on metabolic conversion of acetate).
PeakEffect: Within minutes to hours, depending on dose and patient's metabolic state.
DurationOfAction: Variable, depends on patient's metabolic needs and renal function.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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
+ Changes 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 for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, talk to 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 high sodium)
  • Swelling in your hands, ankles, or feet (fluid retention)
  • Shortness of breath or difficulty breathing (fluid in lungs)
  • Muscle weakness, cramps, or twitching (electrolyte imbalance)
  • Confusion, dizziness, or unusual tiredness
  • 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 high 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, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in conjunction with your other treatments.

Remember, do not start, stop, 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 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. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Hypernatremia (excess sodium): thirst, lethargy, confusion, seizures, coma
  • Metabolic Alkalosis (excess bicarbonate): muscle weakness, cramps, tetany, hypoventilation, arrhythmias
  • Fluid Overload: edema, dyspnea, crackles, jugular venous distension, hypertension

What to Do:

Overdose requires immediate medical attention. Treatment involves discontinuing the infusion, administering diuretics to promote sodium and fluid excretion, and correcting severe electrolyte or acid-base imbalances. In severe cases, dialysis may be necessary. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Major Interactions

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

  • Diuretics (e.g., Thiazides, Loop diuretics): May alter sodium and fluid balance, requiring careful monitoring.
  • Lithium: Sodium levels can affect lithium excretion; changes in sodium intake or administration may alter lithium levels.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Rationale: To assess baseline electrolyte status and guide initial dosing.

Timing: Prior to initiation of therapy.

Arterial or Venous Blood Gases (ABG/VBG)

Rationale: To assess baseline acid-base status (pH, pCO2, HCO3) and determine need for alkalinizing agent.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete sodium and regulate acid-base balance.

Timing: Prior to initiation of therapy.

Fluid Balance (Intake/Output, Weight)

Rationale: To assess hydration status and prevent fluid overload.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Frequency: Every 4-12 hours initially, then daily or as clinically indicated.

Target: Sodium: 135-145 mEq/L; Bicarbonate: 22-28 mEq/L

Action Threshold: Sodium >145 mEq/L or <135 mEq/L; Bicarbonate >30 mEq/L or <20 mEq/L; significant changes from baseline.

Arterial or Venous Blood Gases (ABG/VBG)

Frequency: As clinically indicated, especially with significant acid-base disturbances.

Target: pH: 7.35-7.45; pCO2: 35-45 mmHg; HCO3: 22-28 mEq/L

Action Threshold: pH <7.35 or >7.45; pCO2 or HCO3 outside target range.

Fluid Balance (Intake/Output, Daily Weight)

Frequency: Daily or more frequently if fluid status is unstable.

Target: Stable weight, balanced I/O.

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

Clinical Assessment (Vital Signs, Edema, Mental Status)

Frequency: Regularly, as per hospital protocol and patient condition.

Target: Normal vital signs, no signs of fluid overload or neurological changes.

Action Threshold: Hypertension, tachycardia, peripheral/pulmonary edema, altered mental status.

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Symptom Monitoring

  • Signs of hypernatremia (thirst, lethargy, confusion, seizures, coma)
  • Signs of metabolic alkalosis (muscle weakness, cramps, tetany, hypoventilation, arrhythmias)
  • Signs of fluid overload (edema, dyspnea, crackles, jugular venous distension, weight gain)
  • Signs of hypokalemia (muscle weakness, fatigue, cardiac arrhythmias) - can occur with severe alkalosis

Special Patient Groups

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Pregnancy

Sodium acetate is an essential electrolyte. When used for appropriate clinical indications (e.g., electrolyte replacement, acid-base correction) in pregnant women, it is generally considered safe. The benefits of correcting severe electrolyte or acid-base imbalances typically outweigh potential risks. Use should be guided by clinical need and careful monitoring.

Trimester-Specific Risks:

First Trimester: No specific risks identified when used appropriately for clinical indications.
Second Trimester: No specific risks identified when used appropriately for clinical indications.
Third Trimester: No specific risks identified when used appropriately for clinical indications. Monitor for fluid overload, especially in pre-eclampsia.
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Lactation

Sodium acetate is a normal component of the body and is considered compatible with breastfeeding when used for appropriate clinical indications. The amount transferred into breast milk is unlikely to cause adverse effects in the infant.

Infant Risk: Low risk
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Pediatric Use

Dosing is highly individualized based on the child's weight, age, clinical condition, and specific electrolyte/acid-base deficits. Close monitoring of serum electrolytes, acid-base status, and fluid balance is crucial due to their smaller fluid compartments and immature renal function.

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Geriatric Use

Elderly patients may be more susceptible to fluid overload, hypernatremia, and electrolyte imbalances due to age-related decreases in renal function, cardiac reserve, and thirst perception. Use with caution and monitor closely for signs of fluid overload and electrolyte disturbances.

Clinical Information

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Clinical Pearls

  • Sodium Acetate is a preferred alkalinizing agent over Sodium Bicarbonate in some situations, particularly in patients with lactic acidosis, as it avoids the transient increase in pCO2 and potential for paradoxical intracellular acidosis.
  • Always dilute Sodium Acetate injection before administration. It is typically added to large volume parenteral solutions.
  • Careful calculation of mEq of sodium and acetate is essential to avoid hypernatremia or metabolic alkalosis.
  • Monitor for signs of fluid overload, especially in patients with cardiac or renal impairment.
  • The acetate component is metabolized to bicarbonate, providing a sustained alkalinizing effect compared to direct bicarbonate administration.
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Alternative Therapies

  • For hyponatremia: Hypertonic saline (e.g., 3% NaCl) in severe cases.
  • For metabolic acidosis: Sodium Bicarbonate, Tromethamine (THAM) in specific cases.
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Cost & Coverage

Average Cost: Low cost per 100ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (typically covered as a standard hospital supply)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take medication that has been prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or the medication's instructions. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal methods or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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, as this will be essential for receiving appropriate treatment.