Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Calcium chloride injection, USP (clear solution) is supplied in single-dose plastic vials as follows: NDC No. Container Strength Vial Size Carton 75907-223-35 Plastic Vial 10% (1,000 mg/10 mL) 100 mg/mL 10 mL 10 vials The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10% Calcium chloride Injection, USP - NDC 75907-223-10- Carton Label 10% Calcium chloride Injection, USP - NDC 75907-223-35 - Vial Label "Image Description" "Image Description"
- 16 HOW SUPPLIED/STORAGE AND HANDLING Calcium chloride injection, USP (clear solution) is supplied in single-dose plastic vials as follows: NDC No. Container Strength Vial Size Carton 75907-223-35 Plastic Vial 10% (1,000 mg/10 mL) 100 mg/mL 10 mL 10 vials The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10% Calcium chloride Injection, USP - NDC 75907-223-10- Carton Label 10% Calcium chloride Injection, USP - NDC 75907-223-35 - Vial Label "Image Description" "Image Description"
Overview
10% calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca ++ and Cl - ) in water for injection. It is provided in a 10 mL single-dose plastic vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 1.54 to 2.54 mOsmol/mL (calc.). 10% Calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl 2 · 2H 2 O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2) ].
Indications & 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. Calcium 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
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. 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.
Warnings & Precautions
End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: calcium chloride injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment. In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium. ( 5.1 ) Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration: Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope. ( 2.1 , 5.2 ) Arrhythmias with Concomitant Digoxin Use: Avoid use of calcium chloride injection in patients receiving digoxin. Closely monitor ECG and calcium levels if concomitant therapy is necessary. ( 5.3 , 7.1 ) Tissue Necrosis and Calcinosis: Administer calcium chloride injection slowly through a small needle into a large vein to minimize the risk of tissue necrosis, ulceration and calcinosis. Avoid extravasation or accidental injection into perivascular tissues. Immediately discontinue administration should perivascular infiltration occur. ( 2.1 , 5.4 ) Aluminum Toxicity: Risk of toxicity with prolonged administration if kidney function is impaired. Premature neonates are particularly at risk. When prescribing calcium chloride injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day. ( 5.5 ) 5.1 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates The use of calcium chloride injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Contraindications (4) ]. Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have occurred when ceftriaxone and calcium were administered either simultaneously or non-simultaneously and through different intravenous lines. In-vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups. In patients older than 28 days of age, calcium chloride injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, infusion lines are replaced, or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation. Do not mix or administer calcium chloride injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium [see Dosage and Administration (2.4) ] . 5.2 Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration Rapid injection of calcium chloride injection may cause vasodilation, decreased blood pressure, bradycardia, arrhythmias, syncope, and cardiac arrest. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the risk of syncope. Too rapid an injection exceeding 1 mL/minute may lead to hypotension and cardiac syncope [see Dosage and Administration (2.1) ]. 5.3 Arrhythmias with Concomitant Digoxin Use Arrhythmias may occur if calcium chloride injection and digoxin are administered together. Hypercalcemia resulting from an overdose of calcium chloride injection increases the risk of digoxin toxicity. Avoid the use of calcium chloride injection in patients receiving digoxin. If concomitant therapy is necessary, closely monitor ECG and calcium levels [see Drug Interactions (7.1) ] . 5.4 Tissue Necrosis and Calcinosis Administration of calcium chloride injection in patients with local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. Calcinosis cutis can occur with or without extravasation of calcium chloride injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. Tissue necrosis, ulceration, and secondary infection are the most serious complications. To minimize the risk of tissue necrosis, ulceration and calcinosis, administer calcium chloride injection slowly through a small needle into a large vein [see Dosage and Administration (2.1) ]. Avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, immediately discontinue intravenous administration at that site and treat as needed. 5.5 Aluminum Toxicity Calcium chloride injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature (preterm) neonates and preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower amounts of aluminum. Exposure to aluminum from calcium chloride injection at the recommended dose is not more than 10 mcg [see Dosage and Administration (2.2) and Description (11) ]. When prescribing calcium chloride injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day.
Contraindications
Calcium chloride injection is contraindicated in: Patients with ventricular fibrillation Patients with asystole and electromechanical dissociation Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Warnings and Precautions (5.1) ] . Calcium chloride injection is contraindicated in: Patients with ventricular fibrillation. ( 4 ) Patients with asystole and electromechanical dissociation. ( 4 ) Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment, regardless of whether these products would be received at different times or through separate intravenous lines. ( 4 , 5.1 )
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 Dr. Reddy’s Laboratories at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Digoxin: Avoid concomitant use with calcium chloride injection. If concomitant use is unavoidable, monitor ECG closely during administration of calcium chloride injection. ( 5.3 , 7.1 ) Calcium Channel Blockers: Avoid concomitant use with calcium chloride injection. If concomitant use is unavoidable, monitor blood pressure closely during administration of calcium chloride injection. ( 7.2 ) Drugs That Increase the Risk of Hypercalcemia: Increase the frequency of calcium concentration monitoring in patients taking calcium chloride injection concomitantly with other drugs that increase the risk of hypercalcemia. ( 7.3 ) 7.1 Digoxin Avoid the concomitant use of calcium chloride injection with digoxin. If concomitant use is unavoidable, monitor ECG closely during administration of calcium chloride injection. Synergistic arrhythmias may occur with concomitant use. The use of calcium chloride injection may result in hypercalcemia which increases the risk of digoxin toxicity [see Warnings and Precautions (5.3) ] . 7.2 Calcium Channel Blockers Concomitant use of calcium chloride injection and calcium channel blockers may reduce the response to calcium channel blockers. Avoid concomitant use. If concomitant use is unavoidable, monitor blood pressure closely during administration of calcium chloride injection. 7.3 Drugs That Increase the Risk of Hypercalcemia Increase frequency of monitoring of calcium concentrations in patients taking concomitant calcium chloride injection and other drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, lithium, parathyroid hormone, teriparatide, thiazide diuretics, Vitamin A, and Vitamin D).
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