POTASSIUM CHLORIDE capsule, coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

RedPharm Drug, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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%, respectively

Podsumowanie produktu:

Potassium chloride Extended-Release Capsules USP contain 600 mg and 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq of potassium, respectively).   Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature] . Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only  

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, COATED, EXTENDED
RELEASE
REDPHARM DRUG, INC.
----------
POTASSIUM CHLORIDE ER 10MEQ
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 ADMINISTRATION AND MONITORING
If serum potassium concentration is <2.5 mEq/L, use intravenous
potassium instead of
oral supplementation.
Monitoring
Monitor serum potassium and adjust dosages accordingly. Monitor serum
potassium
periodically during maintenance therapy to ensure potassium remains in
desired range.
The treatment of potassium depletion, particularly in the presence of
cardiac disease,
renal disease, or acidosis requires careful attention to acid-base
balance, volume status,
electrolytes, including magnesium, sodium, chloride, phosphate, and
calcium,
electrocardiograms and the clinical status of the patient. Correct
volume status, acid-
base balance and electrolyte deficits as appropriate.
Administration
Take with meals and with a full glass of water or other liquid. Do not
take on an empty
stomach because of the potential for gastric irritation [see Warnings
and Precautions (
5.1)].
Patients who have difficulty swallowing capsules may sprinkle the
contents of the
capsule onto a spoonful of soft food. The soft food, such as
applesauce or pudding,
should be swallowed immediately without chewing and followed with a
glass of water or
juice to ensure complete swallowing of the microcapsules. Do not added
to hot foods.
Any microcapsule/food mixture should be used immediately and not
stored for future
use.
2.2 ADULT DOSING
Dosage must be adjusted to the individual needs of each patient.
Dosages greater than
40 mEq per day should be divided such that no more than 40 mEq is
given in a single
dose.
_Treatment of hypokalemia: _Typical dose range is 40 to