dianeal low calcium w/dextrose 4.25% in plastic container
Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is a combination medicine containing Calcium Chloride, Dextrose, Magnesium Chloride, Sodium Chloride, and Sodium Lactate.
Calcium Chloride and Dextrose and Magnesium Chloride and Sodium Chloride and Sodium Lactate · by Vantive US Hlthcare
Key facts
- Active ingredient
- Calcium Chloride and Dextrose and Magnesium Chloride and Sodium Chloride and Sodium Lactate
- Form
- Injectable
- Strength
- Calcium Chloride 18.3MG/100ML; Dextrose 4.25GM/100ML; Magnesium Chloride 5.08MG/100ML; Sodium Chloride 538MG/100ML; Sodium Lactate 448MG/100ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Vantive US Hlthcare
- What the pharmacy pays
- ~$0.04 per ml — not your price
- FDA application
- NDA017512
What is Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container?
From the FDA label:DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy Composition/100 mL *Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C 3 H 5 NaO 3 ) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O) DIANEAL PD-2 1.5% Dextrose 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 2.5% Dextrose 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 4.25% Dextrose 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy Composition/100 mL *Dextrose, Hydrous Sodium Chloride (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride (CaCl2•2H2O) Magnesium Chloride (MgCl2•6H2O) DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL…
How to use
For intraperitoneal administration only. ( 2 ) 2.1 Basic Dosing Information DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient’s clinical condition, fluid, electrolyte and specific needs. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m 2 for adults. DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation. Product Selection To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths (3) ] . 2.2 Adding Medications If the resealable…
Side effects
The following adverse reactions are discussed elsewhere in the label: Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1) ] Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4) ] To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL peritoneal dialysis solutions. 6.2 Post-Marketing Experience The following adverse experiences have been identified during post-approval use of DIANEAL solutions or in conjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis. INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection METABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia, Hyponatremia, Dehydration, Hypochloremia VASCULAR DISORDERS: Hypotension, Hypertension RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea…
Warnings
Important safety information
Encapsulating peritoneal sclerosis ( 5.1 ) • Peritonitis: Initiate appropriate antimicrobial therapy ( 5.1 ) • Monitor for lactic acidosis in patients at risk ( 5.2 ) • Monitor for electrolyte, fluid, and nutrition imbalances ( 5.4 ) 5.1 Peritonitis and Encapsulating Peritoneal Sclerosis Peritonitis has been associated with DIANEAL peritoneal dialysis solution use. Following use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy. Encapsulating Peritoneal Sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using DIANEAL solutions. 5.2 Lactic Acidosis Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute renal failure, hepatic failure, inborn errors of metabolism, and treatment with drugs such as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions. Use of DIANEAL solutions in patients with severe lactic acidosis is contraindicated [see Contraindications (4) ]. 5.3 Overinfusion Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat overinfusion. 5.4 Electrolyte, Fluid, and Nutrition Imbalances Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, bicarbonate, calcium, and magnesium levels and volume status. Monitor hematology, electrolytes, blood chemistry and fluid status periodically and take appropriate clinical action. Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a concentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion and hypovolemic shock. 5.5 Hyperglycemia DIANEAL solutions contain dextrose and may increase the risk for hyperglycemia in patients with impaired glucose tolerance. Patients may require initiation or modification of antidiabetic therapy during treatment with DIANEAL solutions. Monitor blood glucose.
Who should not take Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container
DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis. • Pre-existing severe lactic acidosis ( 4 )
Overdose — what happens if you take too much
There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary. Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warnings and Precautions (5.5) ] .
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- How much does Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.04 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container?
- Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is marketed by Vantive US Hlthcare. You can see Vantive US Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container a brand-name or generic drug?
- Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is a brand-name product with the active ingredient Calcium Chloride and Dextrose and Magnesium Chloride and Sodium Chloride and Sodium Lactate.
- Is Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container available over the counter?
- No. Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container come in?
- Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container FDA-registered?
- Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container is on record with the U.S. FDA under application number NDA017512. You can verify this on its official FDA label.
- Is Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container?
- Dianeal Low Calcium W/Dextrose 4.25% in Plastic Container's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed elsewhere in the label: Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1) ] Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4) ] To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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