K-TAB Film-coated tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

AbbVie Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

K-TAB is 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 ...

2. Dosage and Administration

2.1 Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose ...

3. Dosage Forms and Strengths

8 mEq (600 mg): Round, yellow, debossed extended-release tablets with K-TAB on one side. 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with 10 on one side and K-TAB ...

4. Contraindications

Potassium chloride is contraindicated in patients on triamterene or amiloride.

5. Warnings and Precautions

5.1 Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains in ...

6. 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 ...

7. Drug Interactions

7.1 Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications (4)]. 7.2 Renin-Angiotensin-Aldosterone System Inhibitors ...

8. Use in Specific Populations

8.6 Cirrhotics Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. Based on published literature, the baseline corrected ...

8.1. Pregnancy

Risk Summary There are no human data related to use of K-TAB during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not ...

8.2. Lactation

Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as K-TAB becomes part of the body potassium pool, as long as body potassium ...

8.4. Pediatric Use

Safety and effectiveness of K-TAB in children have not been established.

8.5. Geriatric Use

Clinical studies of K-TAB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not ...

8.7. Renal Impairment

Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is ...

10. Overdosage

10.1 Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially ...

11. Description

K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 600 mg, 750 mg and 1500 mg of potassium chloride, USP, equivalent to 8 mEq, 10mEq and 20 ...

12.1. Mechanism of Action

The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular ...

12.3. Pharmacokinetics

Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16.1. How Supplied

K-TAB (potassium chloride extended-release tablets, USP) contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 mEq, 10 mEq and 20 mEq of potassium, respectively). K-TAB is provided ...

16.2. Storage and Handling

Recommended Storage: Store at room temperature 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Advise patients to seek medical attention if tarry stools or other ...