POTASSIUM CHLORIDE capsule, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

から入手可能:

PD-Rx Pharmaceuticals, Inc.

INN（国際名）:

POTASSIUM CHLORIDE

構図:

POTASSIUM CHLORIDE 750 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene. Risk Summary There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectiv

製品概要:

Potassium chloride extended-release capsules USP, 10 mEq are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 30 (NDC 55289-218-30), bottles of 270 (NDC 55289-218-94), ). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.                                                                                                                     

認証ステータス:

Abbreviated New Drug Application

製品の特徴

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES.
POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium chloride extended-release capsules contain potassium
chloride, a potassium salt indicated for
the treatment and prophylaxis of hypokalemia with or without metabolic
alkalosis, in patients for whom
dietary management with potassium-rich foods or diuretic dose
reduction is insufficient. ( 1)
DOSAGE AND ADMINISTRATION
Monitor serum potassium and adjust dosage accordingly ( 2.1)
If serum potassium concentration is <2.5 mEq/L, use intravenous
potassium instead of oral
supplementation. ( 2.1)
_Treatment of hypokalemia:_
Adults: Typical doses range from 40 to 100 mEq/day in 2 to 5 divided
doses; limit doses to 40 mEq per
dose. ( 2.2)
Pediatric patients: 2 to 4 mEq/kg/day in divided doses not to exceed 1
mEq/kg as a single dose or 20
mEq, whichever is lower; if deficits are severe or ongoing losses are
great, consider intravenous
therapy. ( 2.3)
_Maintenance or Prophylaxis of hypokalemia:_
Adults: Typical dose is 20 mEq per day ( 2.2)
Pediatric patients: Typical dose is 1 mEq/kg/day. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 600 mg (8mEq) and 750 mg (10 mEq)
CONTRAINDICATIONS
Concomitant use with triamterene and amiloride. ( 4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Irritation: Take with meals ( 5.1)
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort, and
diarrhea. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA AT 1-888-838-2872
OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant use is contraindicated ( 7.1)