CALCIUM CHLORIDE SINGLE DOSE LUER-LOCK PREFILLED SYRINGE 10% 100MG/ML
Generic: Calcium Chloride
CALCIUM CHLORIDE SINGLE DOSE LUER-LOCK PREFILLED SYRINGE 10% 100MG/ML
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Identification
Calcium Chloride
Calcium Chloride
International Medication Systems, Limited
HUMAN PRESCRIPTION DRUG
Administration
INJECTION
INTRAVENOUS, INTRAVENTRICULAR
ANDA203477
Active Ingredients
| Ingredient | Strength |
|---|---|
| CALCIUM CHLORIDE | 100 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established. C alcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. (1) Limitations of Use: The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer Calcium Chloride Injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein. ( 2.1 ) • Do not use intramuscularly or subcutaneously. ( 2.1 ) • Do not administer unless solution is clear and seal is intact. ( 2.1 ) • Stop the administration if the patient complains of any administration-related discomfort, it may be resumed when symptoms disappear. ( 2.1 ) • The recommended adult dose is from 200 mg to 1,000 mg. ( 2.2 ) • The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. ( 2.2 ) • Repeated injections may be required because of rapid calcium excretion. ( 2.2 ) • See the full prescribing information for the recommended starting dose in patients with renal impairment. ( 2.3 ) • Do not mix Calcium Chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates. ( 2.4 ) 2.1 Important Administration Instructions Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus [see Warnings and Precautions ( 5.2 , 5.4 )] . The maximum recommended infusion rate is 1 mL/minute (100 mg/minute). Additional important administration instructions regarding Calcium Chloride Injection are as follows: • Do not use intramuscularly or subcutaneously to avoid tissue necrosis calcinosis cutis [see Warnings and Precautions ( 5.4 )] . • Visually inspect for particulate matter and discoloration prior to administration (the solution is clear, and the seal is intact). Do not administer if the solution is unclear or the seal is not intact. • Stop the administration if the patient complains of any administration-related discomfort; administration may be resumed when symptoms disappear. • Discard the unused portion. • If time permits, allow the solution to warm to body temperature. 2.2 Recommended Dosage and Administration The recommended dose range of Calcium Chloride Injection in: • Adults is from 200 mg to 1,000 mg. • Pediatric patients is from 2.7 to 5 mg/kg of calcium chloride. Dosing of this Calcium Chloride Injection product is not possible in patients who require doses less than 200 mg because the recommended dose cannot be achieved with the supplied syringe. For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg. Individualize the dose for a patient within these dose ranges depending on serum ionized calcium level, severity of hypocalcemia symptoms, and the acuity of hypocalcemia onset. Repeated injections may be required because of rapid excretion of calcium. 2.3 Recommended Starting Dose in Patients with Renal Impairment The recommended starting dose of Calcium Chloride Injection in [see Use in Specific Populations ( 8.6 )]: • Adults with renal impairment is 200 mg. • Pediatric patients is 2.7 mg/kg of calcium chloride. 2.4 Drug Incompatibilities Do not mix Calcium Chloride Injection with other drugs simultaneously. Do not mix Calcium Chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates [see Warnings and Precautions ( 5.1 )]: • In neonates (28 days of age or younger), concomitant use of Calcium Chloride Injection and ceftriaxone is contraindicated [see Contraindications ( 4 )] . • In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. 2.1 Important Administration Instructions Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus [see Warnings and Precautions ( 5.2 , 5.4 )] . The maximum recommended infusion rate is 1 mL/minute (100 mg/minute). Additional important administration instructions regarding Calcium Chloride Injection are as follows: • Do not use intramuscularly or subcutaneously to avoid tissue necrosis calcinosis cutis [see Warnings and Precautions ( 5.4 )] . • Visually inspect for particulate matter and discoloration prior to administration (the solution is clear, and the seal is intact). Do not administer if the solution is unclear or the seal is not intact. • Stop the administration if the patient complains of any administration-related discomfort; administration may be resumed when symptoms disappear. • Discard the unused portion. • If time permits, allow the solution to warm to body temperature. 2.2 Recommended Dosage and Administration The recommended dose range of Calcium Chloride Injection in: • Adults is from 200 mg to 1,000 mg. • Pediatric patients is from 2.7 to 5 mg/kg of calcium chloride. Dosing of this Calcium Chloride Injection product is not possible in patients who require doses less than 200 mg because the recommended dose cannot be achieved with the supplied syringe. For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg. Individualize the dose for a patient within these dose ranges depending on serum ionized calcium level, severity of hypocalcemia symptoms, and the acuity of hypocalcemia onset. Repeated injections may be required because of rapid excretion of calcium. 2.3 Recommended Starting Dose in Patients with Renal Impairment The recommended starting dose of Calcium Chloride Injection in [see Use in Specific Populations ( 8.6 )]: • Adults with renal impairment is 200 mg. • Pediatric patients is 2.7 mg/kg of calcium chloride. 2.4 Drug Incompatibilities Do not mix Calcium Chloride Injection with other drugs simultaneously. Do not mix Calcium Chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates [see Warnings and Precautions ( 5.1 )]: • In neonates (28 days of age or younger), concomitant use of Calcium Chloride Injection and ceftriaxone is contraindicated [see Contraindications ( 4 )] . • In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are also described elsewhere in the labeling: • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions ( 5.1 )] • Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration [see Warnings and Precautions ( 5.2 )] • Arrhythmias with Concomitant Digoxin Use [see Warnings and Precautions ( 5.3 )] • Tissue Necrosis and Calcinosis [see Warnings and Precautions ( 5.4 )] • Aluminum toxicity [see Warnings and Precautions ( 5.5 )] The following adverse reactions have been identified in literature and postmarketing reports of calcium chloride. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: • Nervous system disorders: Paraesthesia (upon rapid injection), calcium taste • General disorders and administration site conditions: Sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions • Cardiovascular disorders: Peripheral vasodilatation, decreased blood pressure Adverse reactions have included paraesthesia (upon rapid injection), calcium taste, sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions, peripheral vasodilatation, and decreased blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.