Potassium-Normin (Tablets) Instructions for Use

Marketing Authorization Holder

ICN Polfa Rzeszow, S.A. (Poland)

Manufactured By

Alkaloida Chemical Company, Ltd. (Hungary)

ATC Code

A12BA01 (Potassium chloride)

Active Substance

Potassium chloride (Ph.Eur.)

Dosage Form

Potassium-Normin

Extended-release tablets 1 g: 30 pcs.

Dosage Form, Packaging, and Composition

Extended-release tablets are slightly convex on both sides, disc-shaped, white with a marbled pattern, with a bitter taste, odorless; white on the break.

Excipients: colloidal anhydrous silicon dioxide (aerosil A200) – 10 mg, polyvinyl butyral (movital B30T) – 57.50 mg, cetyl alcohol – 17 mg, magnesium stearate – 1 mg, talc – 8 mg.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing potassium deficiency in the body

Pharmacotherapeutic Group

Potassium preparation

Pharmacological Action

Potassium reduces myocardial excitability and conductivity, weakens the toxic effect of cardiac glycosides without affecting their positive inotropic action.

In small doses, K⁺ dilates coronary vessels, in large doses it constricts them. It is involved in the process of nerve impulse conduction. It activates many cytoplasmic enzymes, regulates intracellular osmotic pressure, protein synthesis, and amino acid transport. It improves the contraction of skeletal muscles in muscular dystrophy and myasthenia.

Pharmacokinetics

After oral administration, it is easily and almost completely passively absorbed (absorption – 70%) because its concentration (both dietary and released from the dosage form) is higher in the lumen of the small intestine than in the blood. From the retard tablets, it is gradually and slowly released throughout the entire gastrointestinal tract. In the ileum and colon, K⁺ is secreted into the intestinal lumen by the principle of coupled exchange with Na⁺ and is excreted with bile (10%). The distribution of K⁺ in the body continues for about 8 hours from the moment of administration. T_1/2 in the absorption phase is 1.31 hours; the release time from retard tablets is 6 hours.

Indications

• Prevention and treatment of hypokalemia of various origins, including that caused by various conditions and diseases (vomiting, diarrhea) and induced by drug therapy (diuretics, glucocorticosteroids, cardiac glycosides).

ICD codes

Dosage Regimen

Administer orally. Swallow tablets whole with a full glass of water; do not crush or chew.

Determine the dose individually based on the clinical condition and plasma potassium concentration.

For prophylaxis and treatment of hypokalemia, initiate therapy with a dose of 1-2 g per day (calculated as potassium chloride).

If required, increase the daily dose gradually. The maximum daily dose is 6 g.

Divide daily doses exceeding 2 g; administer two or three times per day to minimize gastrointestinal irritation.

Take during or immediately after meals.

Regularly monitor serum potassium levels, ECG, and clinical status during therapy.

Adjust dosage based on laboratory results and patient response. Discontinue immediately if signs of hyperkalemia occur.

Adverse Reactions

From the gastrointestinal tract nausea, vomiting, diarrhea, flatulence, abdominal pain, ulceration of the gastrointestinal mucosa, gastrointestinal bleeding, intestinal perforation and obstruction.

From the nervous system paresthesia, muscle weakness, confusion.

From the cardiovascular system decreased blood pressure, arrhythmias, heart block, cardiac arrest.

Other hyperkalemia, allergic reactions.

Contraindications

• Hyperkalemia;
• Complete AV block;
• Adrenal insufficiency;
• Chronic renal failure;
• Concomitant therapy with potassium-sparing diuretics;
• Metabolic disorders (acidosis, hypovolemia with hyponatremia);
• Erosive and ulcerative lesions of the gastrointestinal tract;
• Pregnancy;
• Breastfeeding;
• Age under 18 years;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

If use during pregnancy is necessary, the expected benefit for the mother should be weighed against the potential risk to the fetus. Breastfeeding should be discontinued during treatment.

Use in Renal Impairment

Contraindicated

• Chronic renal failure.

Pediatric Use

The safety and efficacy of potassium chloride use in children have not been established.

Special Precautions

During treatment, it is necessary to monitor the K⁺ content in the blood serum, ECG, and acid-base balance.

The safety and efficacy of potassium chloride use in children have not been established.

A diet high in sodium chloride increases the excretion of K⁺ from the body.

It should be taken into account that hyperkalemia, which can be fatal, can develop rapidly and be asymptomatic.

Overdose

Symptoms hyperkalemia (muscle hypotonia, paresthesia, slowed AV conduction, arrhythmias, cardiac arrest). Early clinical signs of hyperkalemia usually appear at a serum K⁺ concentration above 6 mEq/L: peaking of the T wave, widening of the QRS complex.

More severe symptoms of hyperkalemia – muscle paralysis and cardiac arrest – develop at a K⁺ concentration of 9-10 mEq/L.

Treatment orally or intravenously – sodium chloride solution; if necessary – hemodialysis and peritoneal dialysis.

Drug Interactions

Potassium-sparing diuretics, potassium preparations, ACE inhibitors, NSAIDs increase the risk of hyperkalemia.

It reduces the side effects of cardiac glycosides.

It enhances the effect of quinidine and the side effects of disopyramide.

Storage Conditions

Store in a dry place at a temperature of 15-30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.