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Potassium citrate
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- Active ingredient
- Potassium Citrate 540–1080 mg
- Other brand names
- Potassium Citrate (by Actavis Pharma, Inc.)
- Potassium Citrate (by Ani Pharmaceuticals, Inc.)
- Potassium Citrate (by Ascent Pharmaceuticals Inc)
- Potassium Citrate (by Biocomp Pharma, Inc.)
- Potassium Citrate (by Camber Pharmaceuticals, Inc)
- Potassium Citrate (by Remedyrepack Inc.)
- Potassium Citrate (by Remedyrepack Inc.)
- Potassium Citrate (by Strides Pharma Inc.)
- Potassium Citrate (by Upsher-Smith Laboratories, Llc)
- Potassium Citrate (by Xlcare Pharmaceuticals, Inc.)
- Potassium Citrate (by Zydus Lifesciences Limited)
- Potassium Citrate (by Zydus Pharmaceuticals (usa) Inc.)
- Potassium-Cit (by Eywa Pharma Inc)
- Urocit-K (by Mission Pharmacal Company)
- View full label-group details →
- Drug classes
- Anti-coagulant, Calculi Dissolution Agent
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- January 20, 2026
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Potassium Citrate 540–1080 mg
- Other brand names
- Potassium Citrate (by Actavis Pharma, Inc.)
- Potassium Citrate (by Ani Pharmaceuticals, Inc.)
- Potassium Citrate (by Ascent Pharmaceuticals Inc)
- Potassium Citrate (by Biocomp Pharma, Inc.)
- Potassium Citrate (by Camber Pharmaceuticals, Inc)
- Potassium Citrate (by Remedyrepack Inc.)
- Potassium Citrate (by Remedyrepack Inc.)
- Potassium Citrate (by Strides Pharma Inc.)
- Potassium Citrate (by Upsher-Smith Laboratories, Llc)
- Potassium Citrate (by Xlcare Pharmaceuticals, Inc.)
- Potassium Citrate (by Zydus Lifesciences Limited)
- Potassium Citrate (by Zydus Pharmaceuticals (usa) Inc.)
- Potassium-Cit (by Eywa Pharma Inc)
- Urocit-K (by Mission Pharmacal Company)
- View full label-group details →
- Drug classes
- Anti-coagulant, Calculi Dissolution Agent
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- January 20, 2026
- Manufacturer
- Rising Pharma Holdings, Inc.
- Registration number
- ANDA077440
- NDC roots
- 16571-864, 16571-865
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Potassium citrate is a medication that belongs to a group of compounds known as citrate salts of potassium. It is primarily used to help manage certain kidney conditions, including renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis (a type of kidney stone), and uric acid lithiasis (kidney stones) with or without calcium stones.
This medication works by increasing the levels of citrate in the urine, which can help prevent the formation of certain types of kidney stones. Potassium citrate is available in extended-release tablet form, with each tablet containing either 5 mEq (540 mg) or 10 mEq (1080 mg) of potassium citrate.
Uses
Potassium citrate is a medication used to help manage certain kidney-related conditions. If you have renal tubular acidosis (RTA) with calcium stones, this medication can assist in your treatment. It is also effective for those dealing with hypocitraturic calcium oxalate nephrolithiasis, which refers to the formation of kidney stones due to low levels of citrate in the urine, regardless of the underlying cause. Additionally, potassium citrate can be beneficial for managing uric acid stones, whether or not you also have calcium stones.
This medication works by helping to balance the levels of certain substances in your urine, which can prevent the formation of these types of stones. If you have any of these conditions, potassium citrate may be an important part of your treatment plan.
Dosage and Administration
If you have been diagnosed with severe hypocitraturia (a condition where your urine has low levels of citrate), your treatment will start with a daily dose of 60 mEq (milliequivalents). You can take this as 30 mEq twice a day or 20 mEq three times a day. It's important to take these doses with meals, within 30 minutes after eating, or during a bedtime snack to help your body absorb the medication effectively.
For those with mild to moderate hypocitraturia (where your urine has slightly higher citrate levels), the initial dose will be lower, starting at 30 mEq per day. You can take this as 15 mEq twice a day or 10 mEq three times a day, also with meals or shortly after eating, or at bedtime. Following these guidelines will help ensure that you get the most benefit from your treatment.
What to Avoid
It's important to be aware of certain conditions that may prevent you from safely using this medication. You should not take it if you have hyperkalemia (high potassium levels) or any conditions that could lead to it, such as chronic kidney failure, uncontrolled diabetes, or adrenal insufficiency. Additionally, if you have issues that could delay the passage of the tablet through your digestive system—like delayed gastric emptying, esophageal compression, or intestinal obstruction—you should avoid this medication.
You should also refrain from using it if you have peptic ulcer disease, an active urinary tract infection, or renal insufficiency (a significantly reduced ability of your kidneys to filter waste). Always consult your healthcare provider if you have any of these conditions to ensure your safety.
Side Effects
You may experience some common side effects while taking potassium citrate, including minor gastrointestinal issues like abdominal discomfort, nausea, vomiting, diarrhea, or loose bowel movements. However, there are also serious risks to be aware of. For instance, if you have difficulty excreting potassium, potassium citrate can lead to hyperkalemia (high potassium levels), which can be life-threatening and may occur without noticeable symptoms.
If you experience severe vomiting, abdominal pain, or gastrointestinal bleeding, it’s important to stop taking potassium citrate immediately and seek medical attention, as these could indicate serious complications like bowel perforation or obstruction. Additionally, certain conditions, such as chronic kidney disease, uncontrolled diabetes, or peptic ulcer disease, may increase your risk of adverse reactions. Always consult your healthcare provider if you have any concerns or pre-existing conditions before starting this medication.
Warnings and Precautions
You should be aware that taking potassium citrate can lead to serious health issues, especially if you have conditions that affect how your body removes potassium, such as chronic kidney failure or severe heart problems. This can result in dangerously high potassium levels (hyperkalemia), which may occur quickly and without noticeable symptoms, potentially leading to cardiac arrest.
If you experience severe vomiting, abdominal pain, or gastrointestinal bleeding while using potassium citrate, stop taking it right away and contact your doctor. It's important to investigate these symptoms further, as they could indicate serious complications like bowel perforation or obstruction. Always prioritize your health and seek medical advice if you have concerns.
Overdose
If you suspect an overdose, it’s important to be aware of the potential for a condition called hyperkalemia, which is an elevated level of potassium in the blood. This can happen quickly and may not show any symptoms at first, but it can lead to serious issues like cardiac arrest (when the heart stops beating). Signs of overdose can include irregular heartbeats and changes in electrolyte levels, so close monitoring is essential.
If you or someone you know is experiencing an overdose, it’s crucial to eliminate any medications that contain potassium and avoid foods high in potassium, such as bananas, potatoes, and spinach. Treatment may involve administering intravenous calcium gluconate if there’s no risk of digitalis toxicity (a condition caused by too much digitalis medication). In severe cases, procedures like hemodialysis may be necessary to remove excess potassium from the body. Always seek immediate medical help if you suspect an overdose, as timely intervention can be life-saving.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to be cautious with medications. Currently, there have been no studies on how potassium citrate affects animal reproduction, and we do not know if it can harm a developing fetus or impact your ability to have children. Therefore, potassium citrate should only be used during pregnancy if it is clearly necessary and prescribed by your healthcare provider. Always discuss any medications with your doctor to ensure the safety of you and your baby.
Lactation Use
When breastfeeding, it's important to be mindful of what you take, as it can affect your milk. Human milk typically contains about 13 mEq/L of potassium ions, but it's unclear whether potassium citrate (a supplement that may affect potassium levels) influences this amount.
If you are considering using potassium citrate while breastfeeding, it should only be done if it is clearly necessary. Always consult with your healthcare provider to ensure the safety of both you and your baby.
Pediatric Use
When considering this medication for your child, it's important to know that its safety and effectiveness in children have not been established. This means that there isn't enough research to confirm how well it works or how safe it is for kids. Always consult with your child's healthcare provider to discuss any concerns and to explore the best treatment options for their specific needs.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments or safety concerns. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to be cautious with potassium citrate, as it can lead to a serious condition called hyperkalemia (high potassium levels in the blood). This can happen quickly and may not show any symptoms, but it can be life-threatening and even cause cardiac arrest (a sudden stop of the heart). Therefore, if you have chronic kidney failure or other conditions that affect your ability to excrete potassium, such as severe heart damage or heart failure, you should avoid using potassium citrate altogether.
Always consult your healthcare provider for guidance tailored to your specific health needs, especially regarding any medications you may be considering. Your safety is the top priority.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.
Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to be aware of certain medications that can interact with your treatment. For instance, if you are taking potassium-sparing diuretics, you should avoid using them together, as this can lead to dangerously high levels of potassium in your blood (hyperkalemia). Additionally, medications that slow down how quickly food moves through your digestive system, like anticholinergics, may increase irritation in your stomach when combined with potassium salts.
You should also be cautious if you're using renin-angiotensin-aldosterone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs), as these can also raise your potassium levels. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it within the recommended limits. Make sure to keep the product in a tight container, as specified by the United States Pharmacopeia (USP), to protect it from moisture and contamination.
When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.
Additional Information
No further information is available.
FAQ
What is potassium citrate?
Potassium citrate is a citrate salt of potassium, indicated for managing conditions like renal tubular acidosis and hypocitraturic calcium oxalate nephrolithiasis.
What are the common side effects of potassium citrate?
Common side effects include minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, and nausea.
What serious reactions can occur with potassium citrate?
Serious reactions include hyperkalemia, which can lead to cardiac arrest, and gastrointestinal lesions if severe vomiting or abdominal pain occurs.
Who should not take potassium citrate?
Potassium citrate is contraindicated in patients with hyperkalemia, gastrointestinal obstruction, peptic ulcer disease, active urinary tract infections, and renal insufficiency.
What should I do if I experience severe vomiting or abdominal pain while taking potassium citrate?
You should discontinue potassium citrate immediately and consult your doctor.
Is potassium citrate safe during pregnancy?
Potassium citrate should only be given to a pregnant woman if clearly needed, as its effects on fetal harm are not well established.
Can potassium citrate be used while breastfeeding?
Potassium citrate should be given to a breastfeeding woman only if clearly needed, as its effects on breast milk potassium content are unknown.
What is the recommended dosage for severe hypocitraturia?
For severe hypocitraturia, therapy should start at 60 mEq per day, with doses of 30 mEq twice daily or 20 mEq three times daily.
What is the recommended dosage for mild to moderate hypocitraturia?
For mild to moderate hypocitraturia, therapy should start at 30 mEq per day, with doses of 15 mEq twice daily or 10 mEq three times daily.
How should potassium citrate be stored?
Store potassium citrate at 20° to 25°C (68° to 77°F) in a tight container, with excursions permitted to 15° to 30°C (59° to 86°F).
Packaging Info
The table below lists all NDC Code configurations of Potassium Citrate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Extended Release | 540 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Extended Release | 1080 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Potassium Citrate, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Potassium citrate USP (tripotassium citrate monohydrate) is a citrate salt of potassium with the empirical formula K3C6H5O7 • H2O. Potassium citrate extended-release tablets USP are pale yellow colored, oral wax-matrix tablets. Each tablet contains 5 mEq (540 mg) of potassium citrate and 10 mEq (1080 mg) of potassium citrate. Inactive ingredients include carnauba wax, magnesium stearate, and stearic acid.
Uses and Indications
Potassium citrate is indicated for the management of renal tubular acidosis (RTA) associated with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis, with or without the presence of calcium stones.
There are no teratogenic or nonteratogenic effects associated with the use of potassium citrate.
Dosage and Administration
For patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq per day. This can be administered as 30 mEq two times per day or 20 mEq three times per day. Doses should be taken with meals, within 30 minutes after meals, or at bedtime snack to optimize absorption.
In cases of mild to moderate hypocitraturia (urinary citrate > 150 mg/day), therapy should commence at a dosage of 30 mEq per day. This can be given as 15 mEq two times per day or 10 mEq three times per day, also with meals, within 30 minutes after meals, or at bedtime snack.
It is essential to adhere to these dosing schedules to ensure effective management of hypocitraturia.
Contraindications
Use of this product is contraindicated in the following situations:
Patients with hyperkalemia or conditions predisposing to hyperkalemia, including chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown, due to the risk of exacerbating elevated potassium levels.
Patients with gastrointestinal conditions that may cause arrest or delay in tablet passage, such as delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture, as these conditions may hinder proper absorption.
Patients with peptic ulcer disease, as the product may exacerbate gastrointestinal irritation.
Patients with active urinary tract infections, due to the potential for worsening the infection.
Patients with renal insufficiency, specifically those with a glomerular filtration rate of less than 0.7 ml/kg/min, as this may lead to accumulation of the product and increased risk of adverse effects.
Warnings and Precautions
Patients receiving potassium citrate should be closely monitored for the development of hyperkalemia, particularly in those with compromised renal function or conditions that impair potassium excretion, such as severe myocardial damage or heart failure. The administration of potassium citrate in these populations poses a significant risk of hyperkalemia, which can lead to cardiac arrest. It is crucial to recognize that hyperkalemia may develop rapidly and can be asymptomatic, necessitating vigilant monitoring of serum potassium levels.
In the event of severe gastrointestinal symptoms, including vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate should be discontinued immediately. These symptoms may indicate serious underlying conditions such as bowel perforation or obstruction, which require prompt investigation and management.
Healthcare professionals are advised to remain alert to these potential complications and to ensure appropriate monitoring and intervention strategies are in place for patients receiving potassium citrate.
Side Effects
Patients may experience a range of adverse reactions associated with potassium citrate administration. Common adverse reactions include minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements, and nausea.
Serious adverse reactions have been reported, including hyperkalemia, particularly in patients with impaired mechanisms for excreting potassium. This condition can lead to cardiac arrest and may develop rapidly and asymptomatically, posing a potentially fatal risk. In cases of severe vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate should be discontinued immediately, and the possibility of bowel perforation or obstruction should be investigated.
Additional considerations include patients with pre-existing hyperkalemia or conditions that predispose them to hyperkalemia, such as chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown. Furthermore, caution is advised in patients who may experience delays in tablet passage through the gastrointestinal tract, including those with delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture. Patients with peptic ulcer disease, active urinary tract infections, or renal insufficiency (with a glomerular filtration rate of less than 0.7 ml/kg/min) should also be closely monitored.
Drug Interactions
Concomitant administration of potassium-sparing diuretics is contraindicated due to the potential for severe hyperkalemia. The use of these agents alongside potassium salts should be avoided to prevent this serious adverse effect.
Drugs that slow gastrointestinal transit time, such as anticholinergics, may exacerbate gastrointestinal irritation when used in conjunction with potassium salts. Caution is advised when these medications are co-administered.
For patients receiving renin-angiotensin-aldosterone inhibitors, it is essential to monitor serum potassium levels regularly to detect any signs of hyperkalemia.
Similarly, when nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed, healthcare providers should also monitor for hyperkalemia, as these medications can influence potassium levels. Regular assessment of potassium levels is recommended to ensure patient safety.
Packaging & NDC
The table below lists all NDC Code configurations of Potassium Citrate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Extended Release | 540 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Extended Release | 1080 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Therefore, the use of this medication in children is not recommended until further data is available to support its use in this population.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments or safety concerns. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.
Pregnancy
Pregnant patients should be aware that animal reproduction studies have not been conducted with potassium citrate. Therefore, it is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Given the lack of data, potassium citrate should be prescribed to pregnant women only if clearly needed, weighing the potential benefits against any unknown risks. Healthcare professionals are advised to exercise caution and consider alternative treatments when appropriate.
Lactation
The normal potassium ion content of human milk is approximately 13 mEq/L. It is currently unknown whether potassium citrate affects this potassium content in breast milk. Therefore, potassium citrate should be administered to lactating mothers only if clearly needed.
Renal Impairment
Patients with impaired mechanisms for excreting potassium are at an increased risk of hyperkalemia when administered potassium citrate. This condition can lead to cardiac arrest and may develop rapidly, often without symptoms. Therefore, the use of potassium citrate is contraindicated in patients with chronic renal failure or any other conditions that significantly impair potassium excretion, such as severe myocardial damage or heart failure. Careful consideration and monitoring are essential in this patient population to prevent potentially fatal outcomes.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
Hyperkalemia is a potential consequence of overdosage that can develop rapidly and may be asymptomatic, particularly in patients with compromised mechanisms for potassium excretion. This condition poses a significant risk, as it can lead to cardiac arrest if not promptly addressed.
Management of Hyperkalemia
In the event of hyperkalemia, immediate treatment measures should include close monitoring for arrhythmias and electrolyte changes. It is essential to eliminate any medications that contain potassium, as well as potassium-sparing agents, to mitigate the risk of further complications. Additionally, dietary modifications are necessary; patients should avoid foods high in potassium, such as almonds, apricots, bananas, beans, cantaloupe, carrot juice, figs, grapefruit juice, halibut, milk, oat bran, potatoes, salmon, spinach, and tuna.
For patients at low or no risk of developing digitalis toxicity, intravenous calcium gluconate may be administered as part of the treatment protocol. Furthermore, a dextrose solution can be utilized, with a recommended administration of 300 to 500 mL/hr of a 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
If acidosis is present, correction can be achieved through the administration of intravenous sodium bicarbonate. In severe cases of hyperkalemia, hemodialysis or peritoneal dialysis may be required to effectively lower potassium levels. It is crucial to note that lowering potassium levels too rapidly in patients who are taking digitalis can lead to digitalis toxicity, necessitating careful management throughout the treatment process.
Nonclinical Toxicology
Animal reproduction studies have not been conducted to evaluate the teratogenic potential of potassium citrate. Therefore, it is unknown whether potassium citrate can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Potassium citrate should be administered to pregnant women only if clearly needed.
Regarding non-teratogenic effects, the normal potassium ion concentration in human milk is approximately 13 mEq/L. However, it is not known if potassium citrate influences this concentration. Consequently, potassium citrate should be given to breastfeeding women only if clearly needed.
No specific details are available regarding nonclinical toxicology or animal pharmacology and toxicology in the provided insert.
Postmarketing Experience
No postmarketing experience details are available in the provided text.
Patient Counseling
Patients should be advised to take each dose of the medication without crushing, chewing, or sucking the tablet to ensure proper absorption and effectiveness. It is crucial for patients to take this medicine only as directed, particularly if they are also using diuretics and digitalis preparations, as this can affect the medication's efficacy and safety.
Patients should be encouraged to communicate with their healthcare provider if they experience any difficulty swallowing the tablets or if they notice that the tablet seems to stick in their throat. Additionally, patients must be instructed to seek immediate medical attention if they observe tarry stools or any other signs of gastrointestinal bleeding, as these may indicate serious side effects.
Healthcare providers should inform patients that regular blood tests and electrocardiograms will be performed by their doctor to monitor their health and ensure the safety of the treatment. This ongoing assessment is essential for managing any potential risks associated with the medication.
Storage and Handling
The product is supplied in a tight container as defined by the United States Pharmacopeia (USP). It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F) in accordance with USP Controlled Room Temperature guidelines.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Potassium Citrate as submitted by Rising Pharma Holdings, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.