Sodium Acetate 4meq/ml Inj 50ml

Manufacturer AMER REGENT 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, 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 an intravenous (IV) medication given to patients who need extra sodium or to help correct the acid-base balance in their body. It's often used when patients are getting nutrition through an IV (like TPN) or when their body is 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 read all the information provided. It's 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 storage method.

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. No specific lifestyle changes are typically required by the patient.
  • Report any unusual symptoms or discomfort during the infusion.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on patient's electrolyte and acid-base status. Typically added to large volume parenteral fluids (e.g., TPN). Common range for sodium supplementation is 1-2 mEq/kg/day, or to correct specific deficits.

Condition-Specific Dosing:

sodium_deficit_correction: Sodium deficit (mEq) = (Desired Na - Actual Na) x Body Weight (kg) x 0.6 (for total body water). Administer a portion of this deficit (e.g., half) over several hours, then reassess.
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Pediatric Dosing

Neonatal: Highly individualized based on weight, gestational age, and electrolyte status. Often 2-4 mEq/kg/day as part of TPN or maintenance fluids.
Infant: Highly individualized based on weight and electrolyte status. Often 2-4 mEq/kg/day as part of TPN or maintenance fluids.
Child: Highly individualized based on weight and electrolyte status. Often 2-4 mEq/kg/day as part of TPN or maintenance fluids.
Adolescent: Highly individualized based on weight and electrolyte status. Often 2-4 mEq/kg/day as part of TPN or maintenance fluids, or adult dosing for deficit correction.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum sodium and fluid balance closely.
Moderate: Use with caution; monitor serum sodium and fluid balance closely. Dosage reduction may be necessary to avoid hypernatremia and fluid overload.
Severe: Contraindicated in severe renal failure or anuria due to risk of hypernatremia, hypervolemia, and metabolic alkalosis. If used, extreme caution and frequent monitoring are required.
Dialysis: Use with extreme caution; dosage must be highly individualized and guided by frequent electrolyte monitoring and dialysis parameters. May be contraindicated.

Hepatic Impairment:

Mild: No specific adjustment typically required, but monitor acid-base status as acetate metabolism to bicarbonate occurs in the liver.
Moderate: Use with caution; monitor acid-base status closely. Impaired acetate metabolism could reduce its alkalinizing effect.
Severe: Use with caution; monitor acid-base status closely. Significant hepatic impairment may reduce the conversion of acetate to bicarbonate, potentially limiting its alkalinizing effect.

Pharmacology

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Mechanism of Action

Sodium Acetate provides 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 bicarbonate precursor; it is metabolized in the liver to bicarbonate (HCO3-), thereby acting as an alkalinizing agent and contributing to the correction of metabolic acidosis.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Distributes primarily in the extracellular fluid compartment (similar to sodium)
ProteinBinding: <1%
CnssPenetration: Limited (sodium does not readily cross the blood-brain barrier, but rapid changes can affect CNS)

Elimination:

HalfLife: Sodium: Not a true half-life, but renal excretion is primary. Acetate: Rapidly metabolized, half-life is minutes.
Clearance: Sodium: Primarily renal clearance. Acetate: Metabolic clearance.
ExcretionRoute: Sodium: Renal. Acetate: Metabolized to bicarbonate and CO2.
Unchanged: Sodium: Varies based on renal function and hydration status. Acetate: Negligible amount excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Immediate (upon intravenous administration)
PeakEffect: Within minutes to hours, depending on infusion rate and patient's metabolic state.
DurationOfAction: Dependent on the patient's metabolic needs and renal function; effects persist as long as infusion continues and for a period thereafter until excess is excreted or metabolized.

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
+ 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. Many people may not experience any side effects or may 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:

  • Excessive thirst
  • Unusual tiredness or weakness
  • Confusion or disorientation
  • Swelling in the ankles, feet, or hands
  • Shortness of breath
  • Muscle cramps or twitching
  • 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 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, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe treatment.

To guarantee your safety, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that this medication can be taken safely in conjunction with your other medications and health conditions.
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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 any concerns or questions you have with your doctor.

This medication may contain aluminum, which can pose a risk of aluminum toxicity with long-term use. This risk is increased 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 (excess sodium): thirst, lethargy, confusion, seizures, coma, respiratory arrest.
  • Fluid overload: edema, pulmonary congestion, hypertension, heart failure.
  • Metabolic alkalosis: muscle weakness, cramps, tetany, hypoventilation, arrhythmias.

What to Do:

Discontinue infusion immediately. Management is supportive, focusing on correcting electrolyte imbalances and fluid status. May involve diuretics, dialysis in severe cases, or administration of acidifying agents for severe alkalosis. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Corticosteroids (may increase sodium retention)
  • Lithium (sodium levels can affect lithium excretion)

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride)

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

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation of therapy.

Acid-Base Status (Arterial Blood Gases or Serum Bicarbonate)

Rationale: To assess baseline acid-base balance, especially if used for alkalinization.

Timing: Prior to initiation of therapy.

Fluid Balance (Intake/Output, Weight)

Rationale: To assess hydration status and risk of fluid overload.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride)

Frequency: Daily or more frequently (e.g., every 4-6 hours) depending on clinical status and infusion rate.

Target: Sodium: 135-145 mEq/L

Action Threshold: Sodium > 145 mEq/L (hypernatremia), Sodium < 135 mEq/L (hyponatremia), significant changes from baseline.

Acid-Base Status (Serum Bicarbonate or ABGs)

Frequency: Daily or as clinically indicated.

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

Action Threshold: Bicarbonate > 28 mEq/L (metabolic alkalosis), pH > 7.45, or persistent acidosis.

Fluid Balance (Intake/Output, Daily Weight)

Frequency: Daily

Target: Stable weight, balanced I/O

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

Renal Function (BUN, Creatinine)

Frequency: Periodically, or as clinically indicated.

Target: Within normal limits for patient

Action Threshold: Significant increase in BUN/Creatinine.

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Symptom Monitoring

  • Signs of hypernatremia (thirst, lethargy, confusion, seizures, coma)
  • Signs of fluid overload (edema, dyspnea, crackles, elevated blood pressure, jugular venous distension)
  • Signs of metabolic alkalosis (muscle weakness, cramps, tetany, hypoventilation, arrhythmias)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Careful monitoring of maternal fluid and electrolyte status is essential.

Trimester-Specific Risks:

First Trimester: No specific data suggesting increased risk of congenital anomalies, but caution advised with any IV fluid/electrolyte administration.
Second Trimester: Monitor maternal fluid and electrolyte balance closely to avoid complications for mother and fetus.
Third Trimester: Monitor maternal fluid and electrolyte balance closely, especially considering increased fluid volume in late pregnancy. Risk of fluid overload or electrolyte imbalance in mother could indirectly affect fetus.
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Lactation

L3 (Moderately Safe). Sodium and acetate are natural components of the body. While sodium is excreted in breast milk, the amount from therapeutic doses is unlikely to cause adverse effects in a healthy, full-term infant. Monitor infant for signs of electrolyte imbalance if large maternal doses are used.

Infant Risk: Low risk for healthy, full-term infants. Potential for electrolyte imbalance if maternal doses are very high or infant has renal impairment.
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Pediatric Use

Use with extreme caution and highly individualized dosing. Pediatric patients, especially neonates and infants, have immature renal function and are more susceptible to fluid and electrolyte imbalances (hypernatremia, hypervolemia, metabolic alkalosis). Frequent and careful monitoring of serum electrolytes, fluid balance, and acid-base status is critical.

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Geriatric Use

Use with caution. Elderly patients may have age-related decreases in renal function, pre-existing cardiovascular disease, or other comorbidities that increase their susceptibility to fluid overload, hypernatremia, and electrolyte imbalances. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Sodium Acetate Injection is a concentrated solution and MUST be diluted prior to intravenous administration. Never administer undiluted.
  • Often used as a component of parenteral nutrition (TPN) solutions to provide sodium and as an alkalinizing agent.
  • Monitor serum sodium, potassium, chloride, bicarbonate, and fluid balance frequently, especially during initiation and dose adjustments.
  • Rapid infusion or excessive doses can lead to hypernatremia, fluid overload, and metabolic alkalosis.
  • Contraindicated in patients with hypernatremia or severe fluid retention.
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Alternative Therapies

  • Oral sodium supplements (for mild hyponatremia in patients who can tolerate oral intake)
  • Other alkalinizing agents (e.g., tromethamine, though rarely used for general acidosis correction)
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Cost & Coverage

Average Cost: Typically <$10 per 50ml 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 the 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, so be sure to check with your pharmacist. 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 call 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.