Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Serum Electrolyte Abnormalities
- …Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of other drugs known to raise serum potassium levels.
- Coadministration of Accuretic with orother drugs that raise serum potassium levels may result hyperkalemia. Monitor serum potassium in such patients…
- Do not co-administer ACCUPRIL with aliskiren in patients with diabetes....added
- ...added... Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
Serum Electrolyte Abnormalities:
- Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. The risk of hyperkalemia may be increased in patients with renal insufficiency, diabetes mellitus or with concomitant use of drugs that raise serum potassium (see Drug Interactions). The risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or with concomitant use of drugs that lower serum potassium. Monitor serum electrolytes periodically.
Other Metabolic Disturbances:
- Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Accuretic.
Potassium Supplements and Potassium-Sparing Diuretics:
- Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, monitor serum potassium frequently.
- Digoxin: Thiazide- induced electrolyte disturbances, i.e. hypokalemia, hypomagnesemia, increase the risk of digoxin toxicity, which may lead to fatal arrhythmic events (See PRECAUTIONS).
- Antidiabetic drugs (e.g., oral agents, insulin): Dosage adjustment of the antidiabetic drug may be required (see Precautions).
- EYE DISORDERS: acute myopia and acute angle closure glaucoma (see Warnings)
- Avoid concomitant use of aliskiren with Accuretic
- Do not co-administer aliskiren with ACCURECTIC in patients with diabetes or in patients with renal impairment (GFR < 60 mL/min/1.73 m2).
Anaphylactoid and Possibly Related Reactions
- Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
- Agents the inhibit mTOR or DPP-IV: Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAS)
- Do not co-administer aliskiren with ACCURETIC in patients with diabetes with renal impairment (GFR <60 mL/min/1.73 m2).
- Non-steroidal Anti-inflammatory Drugs—the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics may be reduced by concurrent administration of nonsteroidal anti-inflammatory agents.
- Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors): In patients who....