CALCIUM ACETATE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)

Sẵn có từ:

LUPIN LIMITED

INN (Tên quốc tế):

CALCIUM ACETATE

Thành phần:

CALCIUM ACETATE 667 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Patients with hypercalcemia. 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) ]. Maintenance of normal serum calcium 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. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. The effects of calcium acetate on labor and delivery are un

Tóm tắt sản phẩm:

Calcium Acetate Capsules are s ize "00" capsules with blue cap and white body, imprinted with "LU" in white ink on the cap and "G41" in blue ink on the body containing white to off white granular powder for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Bottle of 200 capsules NDC 68180-134-15 STORAGE: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP "Controlled Room Temperature"].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CALCIUM ACETATE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE
CAPSULES.
CALCIUM ACETATE CAPSULES FOR ORAL USE.
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium Acetate Capsule is a phosphate binder indicated for the
reduction of serum phosphorus in patients with end
stage renal disease. (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg calcium acetate. (3)
CONTRAINDICATIONS
Hypercalcemia. (4)
WARNINGS AND PRECAUTIONS
Treat mild hypercalcemia by reducing or interrupting calcium acetate
and Vitamin D. Severe hypercalcemia may
require hemodialysis and discontinuation of calcium acetate. (5.1)
Hypercalcemia may aggravate digitalis toxicity. (5.2)
ADVERSE REACTIONS
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 LUPIN PHARMACEUTICALS
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Calcium acetate 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, or consider monitoring blood levels of
the drug. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypercalcemia
5.2 Concomitant Use with