Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Extended-Release Tablets, USP are available containing 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq, respectively). The 8 mEq (600 mg) tablets are light brown, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC2 on the other side. They are available as follows: NDC 0378-4560-77 bottles of 90 tablets NDC 0378-4560-05 bottles of 500 tablets The 10 mEq (750 mg) tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC1 on the other side. They are available as follows: NDC 0378-4561-77 bottles of 90 tablets NDC 0378-4561-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.; PRINCIPAL DISPLAY PANEL – 8 mEq NDC 0378-4560-77 Potassium Chloride Extended-Release Tablets, USP* 8 mEq (600 mg) *Meets USP Assay Sample Preparation 2. Rx only 90 Tablets Each film-coated extended-release tablet contains: Potassium chloride, USP 600 mg Usual Dosage: See accompanying prescribing information. Dosage must be adjusted to the individual needs of each patient. For Patient’s Information: Be aware that the expended matrix is not absorbed and may be excreted intact in the stool. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX4560MM3 Keep this and all medication out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Code No.: MH/DRUGS/25/NKD/89 Potassium Chloride Extended-Release Tablets, USP 8mEq Bottle Label; PRINCIPAL DISPLAY PANEL – 10 mEq NDC 0378-4561-77 Potassium Chloride Extended-Release Tablets, USP* 10 mEq (750 mg) *Meets USP Assay Sample Preparation 2. Rx only 90 Tablets Each film-coated extended-release tablet contains: Potassium chloride, USP 750 mg Usual Dosage: See accompanying prescribing information. Dosage must be adjusted to the individual needs of each patient. For Patient’s Information: Be aware that the expended matrix is not absorbed and may be excreted intact in the stool. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX4561MM3 Keep this and all medication out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Code No.: MH/DRUGS/25/NKD/89 Potassium Chloride Extended-Release Tablets, USP 10mEq Bottle Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Extended-Release Tablets, USP are available containing 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq, respectively). The 8 mEq (600 mg) tablets are light brown, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC2 on the other side. They are available as follows: NDC 0378-4560-77 bottles of 90 tablets NDC 0378-4560-05 bottles of 500 tablets The 10 mEq (750 mg) tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and PC1 on the other side. They are available as follows: NDC 0378-4561-77 bottles of 90 tablets NDC 0378-4561-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
- PRINCIPAL DISPLAY PANEL – 8 mEq NDC 0378-4560-77 Potassium Chloride Extended-Release Tablets, USP* 8 mEq (600 mg) *Meets USP Assay Sample Preparation 2. Rx only 90 Tablets Each film-coated extended-release tablet contains: Potassium chloride, USP 600 mg Usual Dosage: See accompanying prescribing information. Dosage must be adjusted to the individual needs of each patient. For Patient’s Information: Be aware that the expended matrix is not absorbed and may be excreted intact in the stool. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX4560MM3 Keep this and all medication out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Code No.: MH/DRUGS/25/NKD/89 Potassium Chloride Extended-Release Tablets, USP 8mEq Bottle Label
- PRINCIPAL DISPLAY PANEL – 10 mEq NDC 0378-4561-77 Potassium Chloride Extended-Release Tablets, USP* 10 mEq (750 mg) *Meets USP Assay Sample Preparation 2. Rx only 90 Tablets Each film-coated extended-release tablet contains: Potassium chloride, USP 750 mg Usual Dosage: See accompanying prescribing information. Dosage must be adjusted to the individual needs of each patient. For Patient’s Information: Be aware that the expended matrix is not absorbed and may be excreted intact in the stool. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX4561MM3 Keep this and all medication out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Code No.: MH/DRUGS/25/NKD/89 Potassium Chloride Extended-Release Tablets, USP 10mEq Bottle Label
Overview
Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a matrix tablet. Potassium Chloride Extended-Release Tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a colorless, elongated, prismatic or cubical crystals, or white granular powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Ethylcellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, red iron oxide, stearic acid, talc, titanium dioxide and yellow iron oxide. Meets USP Assay Sample Preparation 2.
Indications & Usage
Potassium chloride extended-release tablets are 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. Potassium chloride extended-release tablets are 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 & Administration
• Monitor serum potassium and adjust dosages accordingly ( 2.1 ) • If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation ( 2.1 ) • Take with meals and with a glass of water or other liquid. Swallow tablets whole without crushing, chewing or sucking. ( 2.1 ) • Treatment of hypokalemia: Doses range from 40-100 mEq/day in divided doses. Limit doses to 40 mEq per dose. ( 2.2 ) • Prevention of hypokalemia: Typical dose is 20 mEq per day. ( 2.2 ) 2.1 Administration and Monitoring If serum potassium concentration is less than 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 potassium chloride extended-release tablets with meals and with a glass of water or other liquid. Do not take potassium chloride extended-release tablets on an empty stomach because of their potential for gastric irritation [see Warnings and Precautions (5.1) ] . Swallow tablets whole without crushing, chewing or sucking. 2.2 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 40-100 mEq per day. Maintenance or Prophylaxis Typical dose range is 20 mEq per day.
Warnings & Precautions
• Gastrointestinal Irritation: Take with meals ( 5.1 ) 5.1 Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation. Potassium chloride extended-release tablets should not be taken on an empty stomach because of their potential for gastric irritation [see Dosage and Administration (2.1) ] .
Contraindications
Potassium chloride is contraindicated in patients on triamterene and amiloride. • Concomitant use with triamterene and amiloride ( 4 )
Adverse Reactions
The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely. • The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• Triamterene and amiloride: Concomitant use is contraindicated ( 7.1 ) • Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) • Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia ( 7.3 ) 7.1 Triamterene or Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4) ] . 7.2 Renin-angiotensin-aldosterone Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients on concomitant RAAS inhibitors. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
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