CALCIUM ACETATE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

INN (mednarodno ime):

CALCIUM ACETATE

Sestava:

CALCIUM ACETATE 667 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Calcium Acetate Capsules are supplied as opaque capsules with blue cap and white body. The capsules are imprinted in black ink with "LP" on the cap and "49" on the body. Each capsule contains 667 mg calcium acetate equivalent to 169 mg calcium. NDC 40051-049-01 667 mg, opaque blue / opaque white capsule, bottle of 200 STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled Room Temperature"] .

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
LOTUS PHARMACEUTICAL CO., LTD. NANTOU PLANT
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE
CALCIUM ACETATE (CALCIUM ACETATE) CAPSULES FOR ORAL USE.
INITIAL U.S. APPROVAL:1990
INDICATIONS AND USAGE
Calcium Acetate 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 2-3 weeks until acceptable serum phosphorus
level is reached. Most patients require 3-4
capsules with each meal.( 2 )
DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg calcium acetate capsule. (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 ECI PHARMACEUTICALS,
LLC AT 954-486-8181 X-109 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
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 Calcium Acetate or consider monitoring blood levels of the
drug.( 7 )
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2016
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