K-LOR™ trăng tròn mEq (potassium chloride) Extended-release Capsules for Oral Administration
DESCRIPTION
Potassium chloride extended-release capsules are an oraldosage khung of microencapsulated potassium chloride containing 600 mg và 750mg of potassium chloride, USP, equivalent khổng lồ 8 mEq & 10 mEq of potassium,respectively.
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The chemical name of the active ingredient is potassiumchloride and the structural formula is KCl. It has a molecular mass of 74.55.Potassium chloride, USP, occurs as a trắng granular powder or as colorlesscrystals. It is odorless và has a saline taste. Its solutions are neutral khổng lồ litmus.It is freely soluble in water & insoluble in alcohol.
Inactive ingredients: edible ink, ethylcellulose,FD&C xanh No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesiumstearate, sodium lauryl sulfate, titanium dioxide. May contain FD&C Red No.40 & FD&C Yellow No. 6 aluminum lakes.
Indications & Dosage
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INDICATIONS
Potassium chloride extended-release capsules areindicated for the treatment và prophylaxis of hypokalemia in adults andchildren with or without metabolic alkalosis, in patients for whom dietarymanagement with potassium-rich foods or diuretic dose reduction isinsufficient.
DOSAGE & ADMINISTRATION
Administration và MonitoringIf serum potassium concentration is Monitoring
Monitor serum potassium và adjust dosages accordingly.Monitor serum potassium periodically during maintenance therapy to ensurepotassium remains in desired range.
The treatment of potassium depletion, particularly in thepresence of cardiac disease, renal disease, or acidosis requires carefulattention khổng lồ acid-base balance, volume status, electrolytes, includingmagnesium, sodium, chloride, phosphate, & calcium, electrocardiograms & theclinical status of the patient. Correct volume status, acid-base balance andelectrolyte deficits as appropriate.
AdministrationTake with meals và with a full glass of water or otherliquid. Vày not take on an empty stomach because of the potential for gastricirritation
Patients who have difficulty swallowing capsules maysprinkle the contents of the capsule onto a spoonful of soft food. The softfood, such as applesauce or pudding, should be swallowed immediately withoutchewing and followed with a glass of water or juice to lớn ensure complete swallowingof the microcapsules. Do not added to lớn hot foods. Any microcapsule/food mixture shouldbe used immediately và not stored for future use.
Adult DosingDosage must be adjusted to lớn the individual needs of eachpatient. Dosages greater than 40 mEq per day should be divided such that nomore than 40 mEq is given in a single dose.
Treatment of hypokalemia:Typical dose range is40-100 mEq per day.
Maintenance or Prophylaxis: Typical dose is đôi mươi mEqper day.
Pediatric DosingPediatric patients aged birth khổng lồ 16 years old: Dosagemust be adjusted to lớn the individual needs of each patient. Bởi not exceed as asingle dose 1 mEq/kg or đôi mươi mEq, whichever is lower.
Treatment of hypokalemia: The recommended initialdose is 2 lớn 4 mEq/kg/day in divided doses. If deficits are severe or ongoinglosses are great, consider intravenous therapy.
Maintenance or Prophylaxis: Typical dose is 1mEq/kg/day.
HOW SUPPLIED
Dosage Forms và Strengths600 mg (8 mEq): Opaque pale orange capsules imprinted inblack ink “002” on the cap và “002” on the body
750 mg (10 mEq ): Opaque pale orange/opaque whitecapsules imprinted in đen ink “001” on the cap và “001” on the body
Storage và HandlingPotassium chloride extended-release capsules contain 600mg và 750 mg mg of potassium chloride (equivalent to 8 mEq and 10 mEq,respectively).
Table 1: How Supplied
Dose Color Printing NDC#: 68382-xxx-xx Bottle Count 100 500 600 mg (8 mEq) orange “002” - body 702-01 702-05 “002” - cap 750 mg (10 mEq) white “001” - body 701-01 701-05 “001” - cap
Store at 20°-25°C (68°-77°F); excursions are permitted to15° khổng lồ 20°C (59°-86°F)
Dispense in tight, light-resistant container as definedin the USP, with a child-resistant closure.
Manufactured và Distributed By: Nesher PharmaceuticalsUSA LLC., St. Louis, MO 63044. Distributed By: Zydus Pharmaceuticals USA Inc., Pennington,NJ 08534, Part #: RA-SUB2. Revised: Apr 2018
SIDE EFFECTS
The following adverse reactions have been identified withuse of oral potassium salts. Because these reactions are reported voluntarilyfrom a population of uncertain size, it is not always possible lớn reliablyestimate their frequency or establish a causal relationship lớn drug exposure.
The most common adverse reactions lớn oral potassium saltsare nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.
There have been reports of hyperkalemia và of upper andlower gastrointestinal conditions including, obstruction, bleeding, ulceration,and perforation.
Skin rash has been reported rarely.
DRUG INTERACTIONS
Amiloride and TriamtereneUse with triamterene or amiloride can produce severehyperkalemia. Concomitant use is contraindicated
Drugs that inhibit the renin-angiotensin-aldosternonesystem (RAAS) including angiotensin converting enzyme (ACE) inhibitors,angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskirenproduces potassium retention by inhibiting aldosterone production. Closelymonitor potassium in patients taking drugs that inhibit RAAS.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)NSAIDs may produce potassium retention by reducing renalsynthesis of prostaglandin E & impairing the renin-angiotensin system.Closely monitor potassium in patients taking NSAIDS.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Gastrointestinal Adverse ReactionsSolid oral dosage forms of potassium chloride can produceulcerative and/or stenotic lesions of the gastrointestinal tract, particularlyif the drug is in tương tác with the gastrointestinal mucosa for a prolongedperiod of time. Consider the use of liquid potassium in patients withdysphagia, swallowing disorders, or severe gastrointestinal motility disorders.
If severe vomiting, abdominal pain, distention, orgastrointestinal bleeding occurs, discontinue potassium chlorideextended-release capsules và consider possibility of ulceration, obstruction orperforation.
Potassium chloride extended-release capsules should notbe taken on an empty stomach because of its potential for gastric irritation
There are no human data related lớn use of potassiumchloride extended-release capsules during pregnancy and animal reproductivestudies have not been conducted. Potassium supplementation that does not leadto hyperkalemia is not expected to lớn cause fetal harm.
The background risk for major birth defects andmiscarriage in the indicated population is unknown. All pregnancies have abackground risk of birth defect, loss, or other adverse outcomes. In the U.S.general population, the estimated background risk of major birth defects andmiscarriage in clinically recognized pregnancies is 2-4% & 15-20%,respectively.
LactationRisk SummaryThe normal potassium ion content of human milk is about13 mEq per liter. Since oral potassium becomes part of the toàn thân potassium pool,as long as body potassium is not excessive, the contribution of potassiumchloride supplementation should have little or no effect on the màn chơi in humanmilk.
Pediatric UseClinical trial data from published literature havedemonstrated the safety & effectiveness of potassium chloride in childrenwith diarrhea & malnutrition from birth lớn 18 years.
Geriatric UseClinical studies of potassium chloride did not includesufficient numbers of subjects aged 65 & over to lớn determine whether theyrespond differently from younger subjects. Other reported clinical experiencehas not identified differences in responses between the elderly and younger patients.In general, dose selection for an elderly patient should be cautious, usuallystarting at the low kết thúc of the dosing range, reflecting the greater frequencyof decreased hepatic, renal, or cardiac function, & of concomitant disease orother drug therapy.
This drug is known to be substantially excreted by thekidney, & the risk of toxic reactions to lớn this drug may be greater in patientswith impaired renal function. Because elderly patients are more likely lớn havedecreased renal function, care should be taken in dose selection, & it may beuseful to lớn monitor renal function.
CirrhoticsBased on publish literature, the baseline corrected serumconcentrations of potassium measured over 3 hours after administration incirrhotic subjects who received an oral potassium load rose to approximatelytwice that of normal subjects who received the same load. Patients with cirrhosisshould usually be started at the low end of the dosing range, and the serumpotassium level should be monitored frequently
Patients with renal impairment have reduced urinaryexcretion of potassium và are at substantially increased risk of hyperkalemia.Patients with impaired renal function, particularly if the patient is on RAASinhibitors or nonsteroidal anti-inflammatory drugs, should usually be startedat the low over of the dosing range because of the potential for development of hyperkalemia
OVERDOSE
SymptomsThe administration of oral potassium salts to lớn personswith normal excretory mechanisms for potassium rarely causes serioushyperkalemia. However, if excretory mechanisms are impaired, potentially fatalhyperkalemia can result.
Hyperkalemia is usually asymptomatic và may bemanifested only by an increased serum potassium concentration (6.5-8.0 mEq/L)and characteristic electrocardiographic changes (peaking of T-waves, loss ofP-waves, depression of S-T segment, and prolongation of the QTinterval). Latemanifestations include muscle paralysis and cardiovascular collapse fromcardiac arrest (9-12 mEq/L).
TreatmentTreatment measures for hyperkalemia include thefollowing:
Eliminate foods and medications containing potassium & any agents with potassiumsparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, và many others. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.In patients who have been stabilized on digitalis, toorapid a lowering of the serum potassium concentration can produce digitalistoxicity.
The extended-release feature means that absorption andtoxic effects may be delayed for hours. Consider standard measures to lớn removeany unabsorbed drug.
CONTRAINDICATIONS
Potassium chloride extended-release capsules arecontraindicated in patients on amiloride or triamterene.
CLINICAL PHARMACOLOGY
Mechanism Of ActionThe potassium ion (K+) is the principal intracellularcation of most body toàn thân tissues. Potassium ions participate in a number ofessential physiological processes, including the maintenance of intracellulartonicity; the transmission of nerve impulses; the contraction of cardiac,skeletal, và smooth muscle; and the maintenance of normal renal function.
The intracellular concentration of potassium isapproximately 150 to 160 mEq per liter. The normal adult plasma concentrationis 3.5 lớn 5 mEq per liter. An active ion transport system maintains thisgradient across the plasma membrane.
Potassium is a normal dietary constituent and understeady-state conditions the amount of potassium absorbed from thegastrointestinal tract is equal to the amount excreted in the urine. The usualdietary intake of potassium is 50 lớn 100 mEq per day.
PharmacokineticsEach crystal of KCl is microencapsulated and allows forthe controlled release of potassium & chloride ions over an eight- toten-hour period.
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Based on publish literature, the baseline corrected serumconcentrations of potassium measured over 3 hours after administration incirrhotic subjects who received an oral potassium load rose to lớn approximatelytwice that of normal subjects who received the same load.