Kalijum hlorid rastvor (Kalii chloridum solutio)

Kalijum hlorid rastvor (Kalii chloridum solutio)

MINERALNI PREPARATI KALIJUM HLORIDA:

RASTVORI KALIJUM HLORIDA 10% – 33% (1,3 – 4,3 mEq/ mL)

Kalii chloridum solutio 10% – 33%

namenjeni za prevenciju hipokalijemije i kod hipokalijemije različite etiologije, antidoti kod trovanja digitalisom, izvori elektrolita.

LISTA ODOBRENIH ZDRAVSTVENIH IZJAVA – EFSA
Kalijum
Kalijum doprinosi održavanju normalnog krvnog pritiska.
Kalijum doprinosi normalnoj funkciji mišića.
Kalijum doprinosi normalnom funkcionisanju nervnog sistema.
Cink
Cink doprinosi normalnom kiselinsko-baznom metabolizmu.
Cink doprinosi normalnoj sintezi DNK.
Cink ima ulogu u procesu deobe ćelija.
Cink doprinosi normalnoj sintezi proteina.
Cink doprinosi normalnom metabolizmu makronutrijenata.
Cink doprinosi normalnom metabolizmu uglјenih hidrata.
Cink doprinosi normalnoj funkciji imunog sistema.
Cink doprinosi normalnoj kognitivnoj funkciji.
Cink doprinosi normalnom metabolizmu masnih kiselina.
Cink doprinosi normalnom metabolizmu vitamina A.
Cink doprinosi održavanju normalnih kostiju.
Cink doprinosi održavanju normalne kose.
Cink doprinosi održavanju normalne kože.
Cink doprinosi održavanju normalnih noktiju.
Cink doprinosi održavanju normalnog vida.
Cink doprinosi normalnoj plodnosti i reprodukciji.
Cink doprinosi održavanju normalnog nivoa testosterona u krvi.
Cink doprinosi zaštiti ćelija od oksidativnog stresa.
Jod
Jod doprinosi normalnoj proizvodnji tiroidnih hormona i normalnoj funkciji štitaste žlezde.
Jod doprinosi normalnom funkcionisanju nervnog sistema.
Jod doprinosi normalnoj kognitivnoj funkciji.
Jod doprinosi održavanju normalnog energetskog metabolizma.
Jod doprinosi održavanju normalne kože.
Jod doprinosi normalnom rastu dece.
Magnezijum
Magnezijum ima ulogu u procesu deobe ćelije.
Magnezijum doprinosi normalnoj psihološkoj funkciji
Magnezijum doprinosi održavanju normalnih kostiju
Magnezijum doprinosi održavanju normalnih zuba.
Magnezijum doprinosi ravnoteži elektrolita
Magnezijum doprinosi normalnoj sintezi proteina.
Magnezijum doprinosi smanjenju umora i iscrplјenosti.
Magnezijum doprinosi normalnom energetskom metabolizmu.
Magnezijum doprinosi normalnoj funkciji mišića.
Magnezijum doprinosi normalnom funkcionisanju nervnog sistema.

MINERALNI PREPARATI KALIJUM HLORIDA:

RASTVORI KALIJUM HLORIDA 10% – 33% (1,3 – 4,3 mEq/ mL)

 

Kalii chloridum solutio 10% – 33%

 

ATC:

A12BA01 – mineralni suplementi kalijum hlorid,

B05XA01 – rastvori elektrolita,

V60AB – homeopatik,

V60B – antropozofik.

 

U skladu sa:

Eu. Ph. 8,  01.07.2015. monografijom:  0185 Kalii chloridum

Pharmacopée française 2002 ANSM:

Kalii chloridum ad praeparationes homoeopathicas

(KALIUM MURIATICUM POUR PRÉPARATIONS HOMÉOPATHIQUES)

 

Mineralni preparati u tečnom obliku (nerazblaženi ili razblaženi) za oralnu upotrebu.

 

a) Kalii chloridum solutio 10% – 33% (Potassium chloride dilution 10% – 33%),

 

Sastav:

a) rastvor(DER 1:10), rastvarač sterilna voda (aqua sterilisata),

b) rastvor(DER 1:5), rastvarač sterilna voda (aqua sterilisata),

c) rastvor(DER 1:2,5), rastvarač sterilna voda (aqua sterilisata),

d) rastvor(DER 1:3), rastvarač sterilna voda (aqua sterilisata).

 

Kalium chloratum  ispoljava  mnogobrojna istražena dejstva.

 

Sadržaj: sadrži kalijum hlorid p.a. (pro analysi – analitičke čistoće 99,9%) MW: 74,551300 g/mol

a) Kalii chloridum dilutio 10%: 1.3 mEq kalijuma/ mL.

b) Kalii chloridum dilutio 20%: 2.6 mEq kalijuma/ mL.

c) Kalii chloridum dilutio 30%: 3.9 mEq kalijuma/ mL.

d) Kalii chloridum dilutio 33%: 4,3 mEq kalijuma/ mL.

 

 

Vrednost kalijuma se izražava jedinicom miliekvivalent po litru (mEq/L).

 

Normalni rezultati su :

3,5 do 5,2 mEq/L za odrasle,

3,4 do 4,7 mEq/L za decu uzrasta od 1 do 18 godina starosti

 

Niska vrednost kalijuma u krvi može biti izazvana:

– gubitkom kalijuma zbog dijareje, znojenja, povraćanja ili

– zbog nedovoljnog unosa kalijuma hranom,

– gubitka kalijuma zbog teških opekotina ili odvodnjavanja rane

– bolestima kao što su cistična fibroza, primarni aldosteronizam ili alkoholizam,

– upotrebom lekova kao što su diuretici ili antibiotici,

– dobijanjem tečnosti IV putem bez dovoljno kalijuma,

– velikim fizičkim naporima (planinari, biciklisti, drvoseče, …).

 

Visoka vrednosti kalijuma u krvi može biti izazvana:

– insuficijencijom bubrega,

– traumama kao što su opekotine, udesi ili operacije,

– nekontrolisanim dijabetesom,

– bolestima kao što su sistemski lupus eritematozus, anemijom srpastih ćelija,

– morbus Addisoni.

 

Indikacije: mineralni preparati su namenjeni poboljšanju opšteg stanja organizma kroz razna naučno dokazana dejstva.

Upotreba kod profilakse hipokalijemije i hipokalijemije, antidot kod trovanja digitalisom.

Ima jako dejstvo kod: hipokalijemije.

Upotrebljava se kao: antidot kod trovanja digitalisom, izvor elektrolita.

 

Doziranje i način primene:

individualno u zavisnosti od godina starosti i stanja organizma

Kalii chloridum solutio 10%: 1.3 mEq kalijuma/ mL.

Kalii chloridum solutio 20%: 2.6 mEq kalijuma/ mL.

Kalii chloridum solutio 30%: 3.9 mEq kalijuma/ mL.

Kalii chloridum solutio 33%: 4.3 mEq kalijuma/ mL.

 

do 2 mL (80 kapi) podeljeno u 2 do 4 doze.

Mineralni  preparati KALIJUM HLORID HSS i TM:

pojedinačna doza: 0,5-1 mL, preporučena dnevna doza (PDD): 2 mL.

Oralna (sat vremena pre obroka) i lokalna primena.

 

Pojedinačna doza ne bi smečla da pređe 40 mEq.

Dnevna doza ne bi smela da pređe 200 mEq u periodu od 24 sata

 

Upotreba na koži: aplicirati na obolelo mesto u tankom sloju ili obliku impregniranog zavoja.

Napraviti pauzu posle 4 nedelje neprekidne upotrebe.

Po preporukama, preparat postiže najbolje efekte pri upotrebi od 8 do 12 nedelja, duža upotreba je bezbedna uz pauze.

 

LD50 >2,5g/ kg

 

Kontraindikacije:

Hiperkalijemija i hiperhloremija, kod smanjene funkcije bubrega, šoka i u stanjima dehidratacije, anurija iliazotemija, Adisonova bolest, toplotni grčevi, preosetljivost na jedinjenja kalijuma.

U većim koncentracijama nadražuje GIT, izaziva proliv, slabost i smetnje kardiovaskularnom sistemu.

 

Čuvanje:

na tamnom, suvom i hladnom mestu do 20˚C, van domašaja dece i izlaganja EM zračenju, u dobro zatvorenoj originalnoj ambalaži.

 

Rok upotrebe:

5 godina, posle prvog otvaranja 6 meseci.

 

Pakovanje: 100 mL ( 3 1/2 fl oz), farmaceutske braon bočice standarno, 250 mL, 500 mL, 1L i 5 L na zahtev.

 

Nutritivne informacije:

KALIJUM HLORID HSS i TM:

energetska vrednost u 100 mL: 0 kJ/ 0 kcal,

u preporučenoj dnevnoj dozi (PDD) 2 mL: 0kJ/ 0 kcal,

suve materije (DR) više od

Kalii chloridum solutio 10% – 33%.

10,0% – 33% (Fr. Ph.).

 

Bez konzervanasa, proteina, masti i ugljenih hidrata.

 

KALIJUM HLORID HSS i TM su rukom rađeni proizvodi. CENOVNIK

U zavisnosti od procenta Kalijum hlorida u rastvoru i veličine pakovanja.

RSD 250/ 50 mL, RSD 300/ 100 mL 33%,  (2 + 0,03 KCl g%).

XXX

For Healthcare Professionals

Applies to potassium chloride: compounding powder, intravenous solution, oral capsule extended release, oral granule extended release, oral liquid, oral powder for reconstitution, oral tablet, oral tablet extended release

Metabolic

Metabolic side effects have been reported rarely and have usually resulted from hyperkalemia. The risk of hyperkalemia is relatively high in patients with preexisting renal insufficiency.[Ref]

Signs of hyperkalemia include muscle weakness, including frank skeletal muscle and diaphragm paralysis, cardiac arrhythmias, and ECG changes. Common ECG changes associated with hypokalemia include loss of P waves, wide QRS complexes, decreased rate, and conduction disturbances. If toxicity is suspected or documented, potassium should be stopped immediately. While monitoring the ECG, a combination of dextrose and insulin in a ratio of 3 g of dextrose for every 1 unit of insulin may be administered. Sodium bicarbonate 50 to 100 mEq and calcium gluconate 10% intravenously may be helpful if acidosis is present. Potassium-binding resins or dialysis may be necessary in serious cases.
A 74-year-old woman receiving chronic intermittent hemodialysis treatment three times a week for 5 months developed cardiopulmonary arrest secondary to severe hyperkalemia on two separate occasions. The patient had a history of nephrolithiasis, hypertension, renal vascular disease, and chronic obstructive pulmonary disease (30-year history of smoking). A potassium-containing salt substitute was a probable cause.
The Boston Collaborative Drug Surveillance Program monitored 16,048 consecutive patients. of whom 4,921 (31%) had received potassium chloride (KCl). Adverse reactions were reported in 5.8%, the most common being hyperkalemia
Hyperkalemia is significantly more likely after intravenous administration and in elderly patients with uremia who receive high doses.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have been reported from orally administered potassium chloride. They have included bad taste or aftertaste, nausea (10% to 30%), abdominal pain (20%), diarrhea (25%), dyspepsia or „heartburn“ (5% to 20%) and GI ulceration. They have rarely included gastric or small bowel obstruction associated with the use of solid preparations.[Ref]

In a large, retrospective study of 104,908 patients, the reported incidence of upper GI tract bleeding was 0.3% to 0.4%, depending on the type of KCl preparation. The risk of GI bleeding was approximately 30% lower with use of a microencapsulated KCl preparation compared with a wax-matrix preparation.
All solid KCl preparations can cause erosive damage to the GI mucosa, especially when they are administered in high doses with an anticholinergic agent. Anticholinergic agents increase GI transit (and potassium-mucosa contact) time.
The incidence of small bowel ulceration associated with encapsulated or wax-matrix KCl is relatively low, averaging less than 1 per 100,000 patient-years. The incidence of small bowel lesions associated with enteric-coated KCl is higher, averaging 40 to 50 per 100,000 patient-years.
Patients at higher risk of GI lesions include the elderly, the immobile and those with scleroderma, diabetes mellitus, mitral valve replacement, cardiomegaly or esophageal stricture. These problems were so much more common with the use of enteric-coated KCl, this form of the drug was withdrawn from the market in 1965.
The pathogenesis of potassium-induced ulceration is not known, but may be direct mucosal injury or induction of local mesenteric vascular insufficiency.
Nearly half of all patients complain of a bad taste or aftertaste.
Liquid KCl may be a better choice for patients with a history of esophageal stenosis or left atrial enlargement.[Ref]

Local

Local side effects related to intravenous administration have included phlebitis or erythema at the injection site and pain with infusion.[Ref]

Local reactions related to intravenous administration of KCl occur in up to 25% of patients. Diluting 40 mEq or less of KCl in 1 liter or more of intravenous solution and administering this concentration in no less than 1 hour is strongly recommended to reduce the likelihood of these problems. If the clinical situation is not critical and the patient’s serum K+ is 2.5 mEq/L or more, an infusion rate not to exceed 10 mEq/hour is recommended.
Limited data show that infusion pain was significantly less common among patients when KCl (in D5W) was infused with 50 mg of lidocaine compared with KCl infusions without lidocaine.[Ref]

Nervous system

A single case of paraplegia following epidural injection of 15 mL of 15% KCl and bupivacaine has been reported. The patient suffered permanent neurologic damage, which was thought to be due to the high extracellular concentration of potassium in the injection. Potassium salts are not routinely used as adjuvants to local anesthetics.[Ref]

Nervous system side effects have included a single report of paraplegia following epidural injection.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported rarely. They have included a single case of contact dermatitis.[Ref]

Dermatologic

Dermatologic side effects have rarely included skin rash.[Ref]

 

References

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  3. Doorenbos CJ, Vermeij CG „Danger of salt substitutes that contain potassium in patients with renal failure.“ BMJ 326 (2003): 35-6
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  39. Lakhani M, Stewart WK „Hazards of potassium chloride solution.“ Lancet 2 (1985): 453
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  42. Javett S „Slow k ulcer.“ S Afr J Surg 13 (1975): 64
  43. Wynn V „Potassium chloride and bowel ulceration.“ Br Med J 5477 (1965): 1546
  44. „Potassium chloride and bowel ulceration.“ Br Med J 5475 (1965): 1383-4
  45. „Small-intestine ulceration and enteric-coated potassium chloride.“ Med Lett Drugs Ther 7 (1965): 57-8
  46. Davies DR, Brightmore T „Idiopathic and drug-induced ulceration of the small intestine.“ Br J Surg 57 (1970): 134-9
  47. Lech Y, Hey H, Jorgensen F, Matzen P, Ostergaard O „Evaluation of the ulcerogenic effect of potassium chloride by endoscopy and fecal blood loss.“ J Clin Pharmacol 27 (1987): 206-9
  48. Rosenthal T, Adar R, Militianu J, Deutsch V „Esophageal ulceration and oral potassium chloride ingestion.“ Chest 65 (1974): 463-5
  49. Dietz MW „Iatrogenic jejunal ulcer.“ Am J Roentgenol Radium Ther Nucl Med 99 (1967): 136-8
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  51. Lambert JR, Newman A „Ulceration and stricture of the esophagus due to oral potassium chloride (slow release tablet) therapy.“ Am J Gastroenterol 73 (1980): 508-11
  52. Sinar DR, Bozymski EM, Blackshear JL „Effects of oral potassium supplements on upper gastrointestinal mucosa: multicenter clinical comparison of three formulations and placebo.“ Clin Ther 8 (1986): 157-63
  53. Strahan J, Sweeney PJ „A case of small bowel perforation.“ Ulster Med J 34 (1965): 22
  54. Brower RA „Jejunal perforation possibly induced by slow-release potassium in a patient with Crohn’s disease.“ Dig Dis Sci 31 (1986): 1387-90
  55. Moore JG, Alsop WR, Freston JW, Tolman KG „The effect of oral potassium chloride on upper gastrointestinal mucosa in healthy subjects: healing of lesions despite continuing treatment.“ Gastrointest Endosc 32 (1986): 210-2
  56. Lofgren RP, Rothe PR, Carlson GJ „Jejunal perforation associated with slow-release potassium chloride therapy.“ South Med J 75 (1982): 1154-5
  57. Lubbe WF, Cadogan ES, Kannemeyer AH „Oesophageal ulceration due to slow-release potassium in the presence of left atrial enlargement.“ N Z Med J 90 (1979): 377-9
  58. McMahon FG, Ryan JR, Akdamar K, Ertan A „Effect of potassium chloride supplements on upper gastrointestinal mucosa.“ Clin Pharmacol Ther 35 (1984): 852-5
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  67. Shuster F, Berg EH „Enteric-coated potassium and bowel obstruction.“ JAMA 194 (1965): 570
  68. Leijonmarck CE, Raf L „Ulceration of the small intestine due to slow-release potassium chloride tablets.“ Acta Chir Scand 151 (1985): 273-8
  69. Reinus FZ, Weinberger HA, Fischer WW „Medication-induced ulceration of the small bowel.“ Am J Surg 112 (1966): 97-101
  70. Hasker W, McCaffrey J „Ulceration of a Meckel’s diverticulum due to a potassium chloride tablet.“ Med J Aust 2 (1972): 261-2
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  72. Trewby PN „Drug-induced peptic ulcer and upper gastrointestinal bleeding.“ Br J Hosp Med 23 (1980): 185-8,190
  73. Farquharson-Roberts MA, Giddings AE, Nunn AJ „Perforation of small bowel due to slow release potassium chloride (slow-K).“ Br Med J 3 (1975): 206
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  75. Eng J, Sabanathan S „Drug-induced esophagitis.“ Am J Gastroenterol 86 (1991): 1127-33
  76. Sandor F „Complications of „slow-K“ therapy.“ J R Coll Gen Pract 26 (1976): 595-8
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  78. Barloon TJ, Moore SA, Mitros FA „A case of stenotic obstruction of the jejunum secondary to slow- release potassium.“ Am J Gastroenterol 81 (1986): 192-4
  79. Bronson DL, Gamelli RL „Jejunal ulceration and stricture due to wax-matrix potassium chloride tablets and amitriptyline.“ J Clin Pharmacol 27 (1987): 788-9
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  84. Mason SJ, O’Meara TF „Drug-induced esophagitis.“ J Clin Gastroenterol 3 (1981): 115-20
  85. Moorhouse RA „Letter: Potassium-induced stricture of the small bowel.“ Lancet 1 (1976): 365
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  87. Henry JG, Shinner JJ, Martino JH, Cimino LE „Fatal esophageal and bronchial artery ulceration caused by solid potassium chloride.“ Pediatr Cardiol 4 (1983): 251-2
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  89. Williams HP „Accidental subcutaneous infiltration of potassium chloride solution causing necrosis.“ Br Med J (Clin Res Ed) 289 (1984): 1742
  90. Pucino F, Danielson BD, Carlson JD, Strommen GL, Walker PR, Beck CL, Thiege DJ, Gill DS „Patient tolerance to intravenous potassium chloride with and without lidocaine.“ Drug Intell Clin Pharm 22 (1988): 676-9
  91. „Product Information. K-Dur (potassium chloride).“ Schering Laboratories, Kenilworth, NJ.
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Izvor: www.drugs.com

X X X X X 

Potassium Chloride Concentrate 20%

Kalium chloratum Bundesanzeiger Nr. 190 a vom 10.10.1985

Monographie BGA/BfArM (Kommission D)












Pakovanje mL/ g:
 10 20 30 50 100 250 500 1000

Količina:
1 2 3 više 

 

vrh