MAGNESIUM: 9,739 Adverse Event Reports & Safety Profile

DESCRIPTION Normosol ® -R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid.

Each

100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R pH 7.4 is a parenteral fluid and electrolyte replenisher.

Sodium

Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Potassium

Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Magnesium

Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl 2

• 6H 2 O) deliquescent crystals very soluble in water.

Sodium

Acetate, USP is chemically designated sodium acetate, anhydrous (C 2 H 3 NaO 2 ), a hygroscopic powder soluble in water. It has the following structural formula: Sodium gluconate is chemically designated C 6 H 11 NaO 7 , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula sodium acetate structural formula sodium gluconate

INDICATIONS AND USAGE Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.

AND ADMINISTRATION Preparation and Administration ( 2.2 )

• Must dilute in water prior to ingestion.
• Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose.
• Must consume additional water after each dose.
• Stop consumption of all fluids at least 2 hours before the colonoscopy.

Recommended

Dosage and Administration

• Split-Dose (two-day) regimen consists of two doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 )
• Recommended sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: o Adults: Two 6-ounce doses. ( 2.3 )
• For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1 , 2.2 , 2.3 )

2.1 Dosage and Administration Overview Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and additional water is required for a complete preparation for colonoscopy. One bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is equivalent to one dose. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is supplied in one dosage strength <span class="opacity-50 text-xs">[see Dosage Forms and Strengths (3) ]</span>. The recommended dosage is:

• Adults: Two 6-ounce doses [see Dosage and Administration (2.3) ]. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.2 Important Preparation and Administration Instructions

• Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Warnings and Precautions (5.1) ]
• Must dilute sodium sulfate, potassium sulfate and magnesium sulfate oral solution in water before ingestion.
• Must consume additional water after each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
• On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth gelatin dessert without fruit). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy.
• Do not eat solid food or drink milk or eat or drink anything colored red or purple.
• Do not drink alcohol.
• Do not take other laxatives while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
• Do not take oral medications within one hour of starting each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
• If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Drug Interactions (7.2) ].
• Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

2.3 Recommended Dosage and Administration in Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults: Dose 1 – On the Day Prior to Colonoscopy:

• May consume a light breakfast, or only clear liquids (no solid food).
• In the evening before the procedure, pour the contents of one bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution into the mixing container provided.
• Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount.
• Drink two additional containers filled with water to the 16-ounce fill line over the next hour.

Dose

2 - Day of Colonoscopy:

• Continue to consume only clear liquids.
• In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution into the mixing container provided.
• Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount.
• Drink two additional containers filled with water to the 16-ounce fill line over the next hour.
• Complete all solution of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and required water at least two hours prior to colonoscopy.

Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions:

• Gastrointestinal obstruction or ileus [see Warnings and Precautions (5.6) ]
• Bowel perforation [see Warnings and Precaution (5.6) ]
• Toxic colitis or toxic megacolon
• Gastric retention
• Hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution
• Gastrointestinal obstruction or ileus ( 4 , 5.6 )
• Bowel perforation ( 4 , 5.6 )
• Toxic colitis or toxic megacolon ( 4 )
• Gastric retention ( 4 )
• Hypersensitivity to any ingredient ( 4 )

REACTIONS The following important adverse reactions for bowel preparations are described elsewhere in the labeling:

• Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions (5.1) ]
• Cardiac Arrhythmias [see Warnings and Precautions (5.2) ]
• Seizures [see Warnings and Precautions (5.3) ]
• Use in Patients with Risk of Renal Injury [see Warnings and Precautions (5.4) ]
• Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions (5.5) ]
• Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.6) ]
• Aspiration [see Warnings and Precautions (5.7) ] Most common adverse reactions are:
• Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Adults

The safety of sodium sulfate, potassium sulfate and magnesium sulfate oral solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies (14) ].

Most Common Adverse Reactions Table

1 shows the most common adverse reactions reported in at least 2% of patients receiving sodium sulfate, potassium sulfate and magnesium sulfate oral solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens.

Table

1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial Symptom Split-Dose (2-Day)

Regimen

Sodium sulfate, potassium sulfate and magnesium sulfate oral solution % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 * reported in at least 2% of patients Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either sodium sulfate, potassium sulfate and magnesium sulfate oral solution or PEG+E administered as a split-dose (2-day) regimen.

Table

2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day)

Regimen

1 Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table. 2 Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest.

Less Common Adverse

Reactions AV Block (1 case) and CK increase.

Adverse

Reactions with Unapproved Use In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with sodium sulfate, potassium sulfate and magnesium sulfate oral solution as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen.

• overall discomfort, abdominal distention, nausea, and vomiting
• total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) Administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in an evening-only (1-day) dosing regimen is not recommended. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

AND PRECAUTIONS

• Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 )
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 )
• Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3 , 7.1 )
• Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 )
• Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ( 4 , 5.6 )
• Patients at risk for aspiration: Observe during administration. ( 5.7 )

5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. If a patient develops significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Use sodium sulfate, potassium sulfate and magnesium sulfate oral solution with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment <span class="opacity-50 text-xs">[see Drug Interactions (7.1) ]</span>. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause temporary elevations in uric acid <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span>. Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering sodium sulfate, potassium sulfate and magnesium sulfate oral solution to patients with gout or other disorders of uric acid metabolism.

5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3 Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia <span class="opacity-50 text-xs">[see Drug Interactions (7.1 )]</span>.

5.4 Use in Patients with Risk of Renal Injury Use sodium sulfate, potassium sulfate and magnesium sulfate oral solution with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) <span class="opacity-50 text-xs">[see Drug Interactions (7.1) ]</span>. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with sodium sulfate, potassium sulfate and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients <span class="opacity-50 text-xs">[see Use in Specific Populations (8.6) ]</span>.

5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and sodium sulfate, potassium sulfate and magnesium sulfate oral solution may increase these risks <span class="opacity-50 text-xs">[see Drug Interactions (7.3) ]</span>. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

5.6 Use in Patients with Significant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering sodium sulfate, potassium sulfate and magnesium sulfate oral solution <span class="opacity-50 text-xs">[see Contraindications (4) ]</span>. Use with caution in patients with severe active ulcerative colitis.

5.7 Aspiration Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Observe these patients during administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Use with caution in these patients.

PRECAUTIONS Patients with Renal Impairment In patients with renal impairment, administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may result in sodium and/or potassium or magnesium retention (see WARNINGS ). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention or magnesium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions Other

Products that Affect Fluid and/or Electrolyte Balance Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Other

Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Lithium

Renal clearance of lithium may be increased during administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use.

Other

Products that Increase the Risk of Hyperkalemia Because of its potassium content, avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations. Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Drug/Laboratory

Test Interactions There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions. These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing PLASMA-LYTE solutions should be interpreted cautiously and confirmed by other diagnostic methods. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Teratogenic Effects

Animal reproduction studies have not been conducted with PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). It is also not known whether PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) should be given to a pregnant woman only if clearly needed.

Nursing

Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is administered to a nursing mother.

Pediatric Use

The use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in pediatric patients is based on clinical practice.

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Consider monitoring renal function in elderly patients.

Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Other

Drugs that Increase the Risk of Hyponatremia Administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Lithium

Renal clearance of lithium may be increased during administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP). Monitor serum lithium concentrations during concomitant use.

Other

Products that Increase the Risk of Hyperkalemia Because of its potassium content, avoid use of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations. Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Drug Facts Active Ingredients: (HPUS*) 25% of each Calcarea carbonica 21X Hypophysis 21X Mag carb 800C Zinc met 18LM *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc.

New

Castle, DE 19720 Rev. 11/23 AA