calcium acetate
Pharmaranks rates Calcium Acetate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Calcium Acetate is a blood coagulation factor used to treat Hypocalcemia, Chronic Kidney Failure, Postmenopausal Osteoporosis.
Blood Coagulation Factor · by Heritage Pharma
Generic of Phoslo
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Calcium Acetate
- Drug class
- Blood Coagulation Factor
- Form
- Capsule, Tablet
- Strength
- Calcium Acetate 667MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Heritage Pharma
- FDA application
- ANDA202885
What is Calcium Acetate?
From the FDA label:Calcium acetate tablet acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17. Its structural formula is: Each calcium acetate tablet contains 667 mg of calcium acetate, (anhydrous; Ca (CH 3 COO) 2 ; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium. In addition, each tablet contains following inactive ingredients: crospovidone, magnesium stearate and sodium lauryl sulfate. Calcium acetate tablets are administered orally for the control of hyperphosphatemia in end stage renal failure. structure
How to use
Calcium Acetate is sold in more than one form (Capsule and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA202885 — follow the label that came with the product you were actually prescribed.
2 DOSAGE & ADMINISTRATION The recommended initial dose of calcium acetate tablets for the adult dialysis patient is 2 tablets with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 tablets with each meal. Starting dose is 2 tablets with each meal. (2) Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 tablets with each meal. (2)
Side effects
Hypercalcemia is discussed elsewhere [ see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea, and vomiting. (6.1). In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1. Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis Preferred Term Total adverse reactions reported for calcium acetate n = 167 n (%) 3 - mo, open-label study of calcium acetate n = 98 n (%) Double-blind, placebo-controlled, cross over study of calcium acetate n…
Warnings
Important safety information
Treat mild hypercalcemia by reducing or interrupting calcium acetate tablet and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate tablets. (5.1) Hypercalcemia may aggravate digitalis toxicity. (5.2) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate. An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage or discontinue the treatment, depending on the severity of hypercalcemia. More severe hypercalcemia (Ca>12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well. Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined. Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3-month study of a solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment. Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg 2 /dL 2 . 5.2 Concomitant Use with Medications Hypercalcemia may aggravate digitalis toxicity.
Who should not take Calcium Acetate
Patients with hypercalcemia. Hypercalcemia. (4)
Overdose — what happens if you take too much
Administration of calcium acetate tablet in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].
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
The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl and hydroxyl groups). Calcium Acetate Tablet may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism. There are no empirical data on avoiding drug interactions between calcium acetate and most concomitant drugs. When administering an oral medication with calcium acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate. Calcium acetate tablet may decrease the bioavailability of tetracyclines or fluoroquinolones. (7) When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium acetate tablet, or consider monitoring blood levels of the drug. (7) 7.1 Ciprofloxacin In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Capsule and Tablet
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
- What does Calcium Acetate treat?
- Calcium Acetate (Calcium Acetate) may be used to treat hypocalcemia, chronic kidney failure, postmenopausal osteoporosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Calcium Acetate rated?
- pharmaranks gives Calcium Acetate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Calcium Acetate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Calcium Acetate. To pay less, Calcium Acetate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Calcium Acetate?
- Calcium Acetate is marketed by Heritage Pharma. You can see Heritage Pharma's full profile, rating, and other products on pharmaranks.
- Is Calcium Acetate a brand-name or generic drug?
- Calcium Acetate is a generic medication; its active ingredient is Calcium Acetate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Calcium Acetate available over the counter?
- No. Calcium Acetate 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 Calcium Acetate come in?
- Calcium Acetate is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Calcium Acetate?
- Calcium Acetate is classified as blood coagulation factor, phosphate binder, per the FDA's Established Pharmacologic Class.
- Is Calcium Acetate FDA-registered?
- Calcium Acetate is on record with the U.S. FDA under application number ANDA202885. You can verify this on its official FDA label.
- Has Calcium Acetate been recalled by the FDA?
- Calcium Acetate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Calcium Acetate safe?
- There's no single safe-or-not verdict. pharmaranks gives Calcium Acetate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Calcium Acetate?
- Calcium Acetate's side effects are taken directly from its FDA label. From the label: Hypercalcemia is discussed elsewhere [ see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea, and vomiting. (6.1). In clinical studies,… 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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calcium acetate
70/100