Oracit Solution
It is used to treat high acid levels in the blood.It is used to lower acid levels in the urine.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Systemic alkalinizer; Urinary alkalinizer
Pharmacologic Class
Alkalinizing agent; Electrolyte
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oracit Solution is a liquid medicine that helps make your urine less acidic (more alkaline). This can help prevent certain kidney stones from forming or help dissolve existing ones. It can also help correct too much acid in your blood.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication after meals and at bedtime, or as directed by your doctor.
Important Administration Instructions
Do not take aluminum products, such as antacids, at the same time as your medication. Consult with your doctor if you have any questions.
Shake the medication well before use.
If you are taking a liquid form of the medication, mix it with water as instructed by your doctor before drinking.
Measure liquid doses carefully using the measuring device provided with the medication. If no device is provided, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat sources.
Keep the lid tightly closed to maintain the medication's potency.
Do not freeze your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication after meals and at bedtime, or as directed by your doctor.
Important Administration Instructions
Do not take aluminum products, such as antacids, at the same time as your medication. Consult with your doctor if you have any questions.
Shake the medication well before use.
If you are taking a liquid form of the medication, mix it with water as instructed by your doctor before drinking.
Measure liquid doses carefully using the measuring device provided with the medication. If no device is provided, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat sources.
Keep the lid tightly closed to maintain the medication's potency.
Do not freeze your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Always dilute the medicine in water or juice before taking it to prevent stomach upset and protect tooth enamel.
- Take the medicine after meals and at bedtime to minimize stomach irritation.
- Drink plenty of fluids throughout the day as directed by your doctor to help prevent kidney stones.
- Avoid foods high in sodium if you are on a sodium-restricted diet.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10-30 mL (equivalent to 10-30 mEq bicarbonate), diluted in water, 4 times daily after meals and at bedtime.
Dose Range:
10 - 30 mg
Condition-Specific Dosing:
urinaryAlkalinization:
10-30 mL, 4 times daily, adjusted to maintain urine pH between 6.0-7.0.
metabolicAcidosis:
10-30 mL, 4 times daily, adjusted based on acid-base balance and clinical response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5-15 mL, 4 times daily, adjusted to maintain desired urine pH or acid-base balance. Dosing should be individualized based on weight and clinical need.
Adolescent:
Same as adult dosing, 10-30 mL, 4 times daily, adjusted to maintain desired urine pH or acid-base balance.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor electrolytes and acid-base status closely.
Moderate:
Use with caution; consider reduced dosage and frequent monitoring of electrolytes and acid-base status. Risk of hypernatremia and metabolic alkalosis increased.
Severe:
Contraindicated due to risk of hypernatremia, metabolic alkalosis, and fluid overload.
Dialysis:
Contraindicated. Not recommended for patients on dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor for signs of metabolic alkalosis.
Moderate:
No specific adjustment recommended, but monitor for signs of metabolic alkalosis.
Severe:
No specific adjustment recommended, but monitor for signs of metabolic alkalosis. Citrate metabolism may be impaired in severe liver disease, potentially reducing efficacy or increasing risk of accumulation.
Pharmacology
Mechanism of Action
Sodium citrate and citric acid are metabolized to bicarbonate. The bicarbonate ions increase the plasma bicarbonate concentration, buffering excess hydrogen ions and raising systemic pH. In the kidneys, the increased bicarbonate load leads to increased excretion of bicarbonate, which raises urinary pH. This alkalinization of urine helps to dissolve uric acid and cystine stones and prevents the formation of new stones.
Pharmacokinetics
Absorption:
Bioavailability:
High (well absorbed orally)
Tmax:
Approximately 1-2 hours (for systemic pH effect)
FoodEffect:
Administered after meals to minimize gastrointestinal upset and improve absorption.
Distribution:
Vd:
Not specifically quantified for citrate/citric acid as a whole, but bicarbonate distributes throughout extracellular fluid.
ProteinBinding:
Not significantly protein bound.
CnssPenetration:
Limited (bicarbonate does not readily cross the blood-brain barrier)
Elimination:
HalfLife:
Short (citrate is rapidly metabolized; bicarbonate half-life is regulated by renal excretion)
Clearance:
Renal (of bicarbonate)
ExcretionRoute:
Renal (as bicarbonate and other ions)
Unchanged:
Minimal (citrate is largely metabolized)
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes (for urinary pH change)
PeakEffect:
1-2 hours (for urinary pH change)
DurationOfAction:
4-6 hours (requiring multiple daily doses)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Diarrhea
- Upset stomach
- Vomiting
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Diarrhea
- Upset stomach
- Vomiting
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain or diarrhea
- Muscle weakness or cramps
- Numbness or tingling in hands or feet
- Swelling of ankles or feet
- Unusual tiredness or confusion
- Irregular heartbeat
- Difficulty breathing
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heat cramps
+ High potassium levels
+ Adynamia episodica hereditaria, a condition that causes periodic muscle weakness
+ Kidney disease
+ Heart disease
+ Inability to urinate
+ Untreated Addison's disease
If you are following a low-sodium or sodium-free diet
If you are taking any of the following medications:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene
* If you are taking or have recently taken any of the following medications:
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril
Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Dehydration (fluid loss)
+ Heat cramps
+ High potassium levels
+ Adynamia episodica hereditaria, a condition that causes periodic muscle weakness
+ Kidney disease
+ Heart disease
+ Inability to urinate
+ Untreated Addison's disease
If you are following a low-sodium or sodium-free diet
If you are taking any of the following medications:
+ Amiloride
+ Eplerenone
+ Spironolactone
+ Triamterene
* If you are taking or have recently taken any of the following medications:
+ Benazepril
+ Captopril
+ Enalapril
+ Fosinopril
+ Lisinopril
+ Moexipril
+ Perindopril
+ Quinapril
+ Ramipril
+ Trandolapril
Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. Be sure to discuss any concerns or questions with your doctor.
Some formulations of this medication may contain benzyl alcohol. Due to the risk of serious side effects, it is recommended to avoid products containing benzyl alcohol in newborns and infants, especially when combined with other medications that also contain benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential alternatives.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to 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.
Some formulations of this medication may contain benzyl alcohol. Due to the risk of serious side effects, it is recommended to avoid products containing benzyl alcohol in newborns and infants, especially when combined with other medications that also contain benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol and to discuss potential alternatives.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to 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.
Overdose Information
Overdose Symptoms:
- Metabolic alkalosis (e.g., muscle twitching, tetany, hyperreflexia, confusion, arrhythmias)
- Hypernatremia (e.g., thirst, lethargy, confusion, seizures, coma)
- Fluid overload (e.g., edema, dyspnea, weight gain)
- Gastrointestinal irritation
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive, including correction of fluid and electrolyte imbalances.
Drug Interactions
Contraindicated Interactions
- Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) - risk of hyperkalemia if patient has underlying renal impairment or is on potassium-containing citrate products, though Oracit is sodium-based, caution is still advised due to potential for electrolyte imbalance.
- Severe renal impairment (anuria, oliguria, azotemia)
Major Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide) - increased absorption of aluminum, leading to aluminum toxicity, especially in renal impairment.
- Tetracyclines (e.g., doxycycline, minocycline) - decreased absorption of tetracyclines due to chelation.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - decreased absorption of fluoroquinolones due to chelation.
Moderate Interactions
- Salicylates (e.g., aspirin) - increased renal excretion of salicylates due to urinary alkalinization, potentially reducing their efficacy.
- Quinidine - decreased renal excretion of quinidine due to urinary alkalinization, potentially increasing quinidine levels and toxicity.
- Amphetamines - decreased renal excretion of amphetamines due to urinary alkalinization, potentially increasing amphetamine levels and toxicity.
- Lithium - increased renal excretion of lithium due to sodium load, potentially decreasing lithium levels.
- Methenamine (e.g., methenamine hippurate, methenamine mandelate) - urinary alkalinization inhibits the antibacterial action of methenamine, which requires acidic urine for activation.
Monitoring
Baseline Monitoring
Serum Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)
Rationale: To establish baseline electrolyte balance and identify pre-existing imbalances.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Creatinine, eGFR)
Rationale: To assess kidney function, as severe renal impairment is a contraindication and affects drug elimination.
Timing: Prior to initiation of therapy.
Urine pH
Rationale: To establish baseline urinary acidity and guide initial dosing for urinary alkalinization.
Timing: Prior to initiation of therapy.
Routine Monitoring
Urine pH
Frequency: Daily, or several times a day initially, then periodically (e.g., weekly) once stable.
Target: 6.0-7.0 (for uric acid/cystine stones); individualized for other conditions.
Action Threshold: If pH is outside target range, adjust dose. If persistently low, increase dose; if persistently high, decrease dose.
Serum Electrolytes (Sodium, Potassium, Bicarbonate)
Frequency: Weekly initially, then monthly or as clinically indicated, especially in patients with renal impairment or other comorbidities.
Target: Within normal physiological limits.
Action Threshold: Significant deviations (e.g., hypernatremia, metabolic alkalosis, hypokalemia) require dose adjustment or discontinuation and corrective measures.
Renal Function (BUN, Creatinine)
Frequency: Periodically, especially in long-term therapy or if renal function changes are suspected.
Target: Within normal limits.
Action Threshold: Significant decline in renal function may necessitate dose reduction or discontinuation.
Symptom Monitoring
- Signs of metabolic alkalosis (e.g., muscle weakness, tetany, hyperreflexia, confusion, arrhythmias)
- Signs of hypernatremia (e.g., thirst, lethargy, confusion, seizures)
- Signs of fluid overload (e.g., edema, dyspnea, weight gain)
- Gastrointestinal upset (e.g., nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. While not expected to cause major birth defects or miscarriage, close monitoring of maternal fluid and electrolyte balance is crucial. Category C indicates animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk of malformations identified, but maintain careful electrolyte balance.
Second Trimester:
Maintain careful electrolyte balance; monitor for fluid retention.
Third Trimester:
Maintain careful electrolyte balance; monitor for fluid retention and potential for metabolic alkalosis in mother.
Lactation
Considered safe for use during breastfeeding. Sodium citrate and citric acid are natural components of the body and breast milk. Minimal excretion into breast milk is expected, and adverse effects on the infant are unlikely. Monitor infant for any signs of electrolyte imbalance if maternal doses are very high.
Infant Risk:
Low risk
Pediatric Use
Dosing must be carefully individualized based on weight, age, and clinical condition. Close monitoring of fluid and electrolyte balance, as well as acid-base status, is essential due to higher susceptibility to imbalances in children.
Geriatric Use
Use with caution in elderly patients, who may have age-related decline in renal function or pre-existing cardiovascular disease. Start with lower doses and titrate slowly. Close monitoring of fluid status, electrolytes, and renal function is crucial to prevent hypernatremia, metabolic alkalosis, and fluid overload.
Clinical Information
Clinical Pearls
- Always dilute Oracit Solution in at least 4-8 ounces of water or juice to prevent gastrointestinal irritation and protect tooth enamel. Rinse mouth after administration.
- Administer after meals and at bedtime to minimize laxative effect and stomach upset.
- Monitor urine pH regularly (e.g., with pH paper) to ensure therapeutic efficacy and prevent over-alkalinization.
- Patients should be advised to report any signs of muscle weakness, numbness, or swelling immediately.
- This product contains a significant amount of sodium; caution is advised in patients on sodium-restricted diets or with conditions exacerbated by sodium intake (e.g., heart failure, hypertension).
Alternative Therapies
- Potassium Citrate (e.g., Urocit-K, K-Lyte) - used for urinary alkalinization, especially when potassium supplementation is also desired or sodium restriction is necessary.
- Sodium Bicarbonate - another systemic alkalinizer, available in tablet or intravenous forms.
- Potassium Bicarbonate
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 473 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to 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. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.