Nature's Formula Calcium Phosphate

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Nature's Formula Calcium Phosphate uses


1 INDICATIONS AND USAGE

Nature's Formula Calcium Phosphate acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Nature's Formula Calcium Phosphate acetate for the adult dialysis patient is 2 capsules 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 capsules with each meal.

- Starting dose is 2 capsules 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 capsules with each meal. (2)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Nature's Formula Calcium Phosphate acetate capsule.

- Capsule: 667 mg Nature's Formula Calcium Phosphate acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Nature's Formula Calcium Phosphate acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Nature's Formula Calcium Phosphate acetate.

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Nature's Formula Calcium Phosphate, including Nature's Formula Calcium Phosphate acetate. Avoid the use of Nature's Formula Calcium Phosphate supplements, including Nature's Formula Calcium Phosphate based nonprescription antacids, concurrently with Nature's Formula Calcium Phosphate acetate.

An overdose of Nature's Formula Calcium Phosphate acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Nature's Formula Calcium Phosphate levels twice weekly. Should hypercalcemia develop, reduce the Nature's Formula Calcium Phosphate 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 Nature's Formula Calcium Phosphate 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 Nature's Formula Calcium Phosphate 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 Nature's Formula Calcium Phosphate 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 solid dose formulation of Nature's Formula Calcium Phosphate acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

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6 ADVERSE REACTIONS

Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].

- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)

- In clinical studies, patients have occasionally experienced nausea during Nature's Formula Calcium Phosphate acetate therapy. (6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 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, Nature's Formula Calcium Phosphate acetate has been generally well tolerated.

Nature's Formula Calcium Phosphate acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Nature's Formula Calcium Phosphate acetate was studied 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.


Preferred Term


Total adverse reactions reported for Nature's Formula Calcium Phosphate acetate

N=167

N (%)


3 month, open label study of Nature's Formula Calcium Phosphate acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Nature's Formula Calcium Phosphate acetate

N=69


Nature's Formula Calcium Phosphate acetate

N (%)


Placebo

N (%)


Nausea


6 (3.6)


6 (6.1)


0 (0)


0 (0)


Vomiting


4 (2.4)


4 (4.1)


0 (0)


0 (0)


Hypercalcemia


21 (12.6)


16 (16.3)


5 (7.2)


0 (0)


Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Nature's Formula Calcium Phosphate concentration could reduce the incidence and severity of Nature's Formula Calcium Phosphate acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of Nature's Formula Calcium Phosphate acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Nature's Formula Calcium Phosphate acetate is characterized by the potential of Nature's Formula Calcium Phosphate to bind to drugs with anionic functions. Nature's Formula Calcium Phosphate acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Nature's Formula Calcium Phosphate acetate and most concomitant drugs. When administering an oral medication with Nature's Formula Calcium Phosphate 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 Nature's Formula Calcium Phosphate 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 Nature's Formula Calcium Phosphate acetate.

- Calcium acetate 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 Nature's Formula Calcium Phosphate acetate 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 Nature's Formula Calcium Phosphate acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Nature's Formula Calcium Phosphate acetate capsules contains Nature's Formula Calcium Phosphate acetate. Animal reproduction studies have not been conducted with Nature's Formula Calcium Phosphate acetate, and there are no adequate and well controlled studies of Nature's Formula Calcium Phosphate acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Nature's Formula Calcium Phosphate acetate treatment [see Warnings and Precautions ]. Maintenance of normal serum Nature's Formula Calcium Phosphate levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Nature's Formula Calcium Phosphate acetate treatment, as recommended, is not expected to harm a fetus if maternal Nature's Formula Calcium Phosphate levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Nature's Formula Calcium Phosphate acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Nature's Formula Calcium Phosphate Acetate Capsules contains Nature's Formula Calcium Phosphate acetate and is excreted in human milk. Human milk feeding by a mother receiving Nature's Formula Calcium Phosphate acetate is not expected to harm an infant, provided maternal serum Nature's Formula Calcium Phosphate levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Nature's Formula Calcium Phosphate acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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10 OVERDOSAGE

Administration of Nature's Formula Calcium Phosphate acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Nature's Formula Calcium Phosphate acetate acts as a phosphate binder. Its chemical name is Nature's Formula Calcium Phosphate acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:


Each white opaque/blue opaque capsule contains 667 mg of Nature's Formula Calcium Phosphate acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Nature's Formula Calcium Phosphate, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

Nature's Formula Calcium Phosphate Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Nature's Formula Calcium Phosphate resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Nature's Formula Calcium Phosphate acetate, when taken with meals, combines with dietary phosphate to form an insoluble Nature's Formula Calcium Phosphate phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Nature's Formula Calcium Phosphate acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Nature's Formula Calcium Phosphate acetate.

14 CLINICAL STUDIES

Effectiveness of Nature's Formula Calcium Phosphate acetate in decreasing serum phosphorus has been demonstrated in two studies of the Nature's Formula Calcium Phosphate acetate solid oral dosage form.

Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.

The patients received Nature's Formula Calcium Phosphate acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of Nature's Formula Calcium Phosphate acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Nature's Formula Calcium Phosphate levels are also presented.


* Ninety-one patients completed at least 6 weeks of the study.

ANOVA of difference in values at pre-study and study completion.

‡ Values expressed as mean ± SE.


Parameter


Pre-Study


Week 4*


Week 8


Week 12


p-value†


Phosphorus (mg/dL)‡


7.4 ± 0.17


5.9 ± 0.16


5.6 ± 0.17


5.2 ± 0.17


≤0.01


Nature's Formula Calcium Phosphate (mg/dL)‡


8.9 ± 0.09


9.5 ± 0.10


9.7 ± 0.10


9.7 ± 0.10


≤0.01


There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Nature's Formula Calcium Phosphate increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Nature's Formula Calcium Phosphate acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of Nature's Formula Calcium Phosphate acetate is shown in the Table 3.


* ANOVA of Nature's Formula Calcium Phosphate acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Nature's Formula Calcium Phosphate Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Nature's Formula Calcium Phosphate (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Nature's Formula Calcium Phosphate acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Nature's Formula Calcium Phosphate by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Nature's Formula Calcium Phosphate Acetate Capsules

667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.

NDC 0615-2303-39: Blistercards of 30 Capsules

NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules

STORAGE

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Nature's Formula Calcium Phosphate acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Nature's Formula Calcium Phosphate supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Nature's Formula Calcium Phosphate acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Nature's Formula Calcium Phosphate pharmaceutical active ingredients containing related brand and generic drugs:


Nature's Formula Calcium Phosphate available forms, composition, doses:


Nature's Formula Calcium Phosphate destination | category:


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References

  1. Dailymed."CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Calcium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Calcium". http://www.drugbank.ca/drugs/DB0137... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Nature's Formula Calcium Phosphate?

Depending on the reaction of the Nature's Formula Calcium Phosphate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nature's Formula Calcium Phosphate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Nature's Formula Calcium Phosphate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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sdrugs.com conducted a study on Nature's Formula Calcium Phosphate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Nature's Formula Calcium Phosphate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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