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Cyproterone acetate

Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosp.

Checked against the official label · Updated

Prescription medicine Oral Safety alerts on record

How to use Cyproterone acetate

Lo que dice el prospecto oficial. Si te lo recetó un médico, sigue la receta. Si el prospecto de tu caja es distinto, manda el de tu caja.

Para quién es

Calcium 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 )

Cómo tomarlo y con qué frecuencia
  • The recommended initial dose of calcium 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 3-4 capsules with each meal
  • Starting dose is 2 capsules with each meal
  • Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached
  • Most patients require 3-4 capsules with each meal
Fortalezas en las que viene

Capsule: 667 mg calcium acetate per capsule. Capsule: 667 mg calcium acetate capsules. ( 3 )

Infancia
  • Safety and effectiveness
  • In pediatric patients have not been established
Older adults

Clinical studies of calcium 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. …

While you are taking it
  • Inform patients to take calcium acetate with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids
  • Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions and Adverse Reactions ]
  • 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 calcium acetate
  • Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace, Doral, FL 33172 Manufactured for: Cipla USA, Inc. …
Talk to a doctor first if
  • Patients with hypercalcemia
  • Hypercalcemia
Medicines it may not mix with

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 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. …

Warnings

Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 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. …

Posibles efectos secundarios

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 Cipla Ltd. at 1-866-604-3268 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. …

Pregnancy and breastfeeding

8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ] . …

If you take too much

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].

Si olvidas una dosis

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2021-06-01.

Marcas en todo el mundo

Products with Cyproterone acetate as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Cyproterone AcetateCYPROTERONE ACETATE 1 g/g · Powder · Farmabios S.p.A.
NDC 46439-8720Label

Nigeria (NAFDAC)

NAFDACCyprodiol Tablet B4-5475NAFDACDianofem Tablets 2 mg/0.035 mg B4-8904

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724U.S. FDA Class II
15 Mar 2021 · Cardinal Health Inc. · TerminatedCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02U.S. FDA Class III
13 Feb 2018 · Nostrum Laboratories Inc · TerminatedPresence of Foreign Tablets/Capsules
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02U.S. FDA Class II
14 Apr 2014 · Fresenius Medical Care Holdings, Inc. · TerminatedCross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepres
CALCIUM ACETATE, Tablet, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00574011302.U.S. FDA Class II
2 Jul 2013 · Aidapak Services, LLC · TerminatedLabeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014; HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Cyproterone acetate

Type the registration number on the pack, or scan it with your camera.

O haz fotos de la caja
Te quedan 3 verificaciones gratis hoy Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Cyproterone acetate

What is Cyproterone acetate used for?

Calcium 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 ) (From the official U.S. FDA label.)

How do I take Cyproterone acetate?

Follow your prescription or the leaflet in your pack. The official label says: The recommended initial dose of calcium 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 3-4 capsules with each meal. Starting dose is 2 capsules with each meal. (2) Titrate the dose every 2-3 weeks until acceptab…

Do I need a prescription for Cyproterone acetate?

Usually yes. Cyproterone acetate is a prescription medicine in most countries. Rules differ by country.

What brands contain Cyproterone acetate?

Cyproterone acetate is sold under names such as Calcium Acetate. Brand names differ between countries.

What are the side effects of Cyproterone acetate?

The official label lists: 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 Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fd… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Cyproterone acetate?

Safety and effectiveness in pediatric patients have not been established. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Cyproterone acetate when pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions… Ask your doctor or midwife first.

What medicines interact with Cyproterone acetate?

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 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.… Use the free interaction checker before combining medicines.

What happens if I take too much Cyproterone acetate?

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ]. Get medical help right away.

How can I check that my Cyproterone acetate is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.