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calcium chloride injection, USP - ANYSYR Use in Specific Populations



8.1 Pregnancy

Risk Summary

Administration of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy (see Clinical Considerations). Animal reproduction studies have not been conducted with Calcium Chloride Injection.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated Maternal and/or Embryo/Fetal/Neonatal Risk

Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can develop fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures.

8.2 Lactation

Risk Summary

Calcium is present in human milk. Administration of the approved recommended dose of Calcium Chloride Injection to the mother is not expected to cause harm to a breastfed infant. There is no information on the effects of Calcium Chloride Injection on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Calcium Chloride Injection and any potential adverse effects on the breastfed infant from Calcium Chloride Injection or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia have been established in pediatric patients.

The use of Calcium Chloride Injection is contraindicated in newborns 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) and Warnings and Precautions (5.1)].

In pediatric 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.

Calcium Chloride Injection contains aluminum that may be associated with central nervous system and bone toxicity. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Calcium Chloride Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.2)].

8.5 Geriatric Use

Clinical studies of Calcium Chloride Injection did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

8.6 Renal Impairment

The use of Calcium Chloride Injection in patients with renal impairment may increase the risk of a higher calcium-phosphorus product. For patients with renal impairment, initiate Calcium Chloride Injection at the lowest recommended dose within the recommended dose range [see Dosage and Administration (2.2)]. Monitor serum calcium levels frequently based on the severity of the renal impairment and the risk of a high calcium-phosphorus product (e.g., every 4 hours).

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