Namzaric (memantine and donepezil hydrochlorides) Extended-release
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Anesthesia
Cardiovascular Conditions
donepezil hydrochloride, (addition of an active... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Jardiance (empagliflozin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Ketoacidosis (addition of the following sentence)
Fatal cases of ketoacidosis have been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Humulin R U-500 (insulin human injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with the Vial Presentation
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Glyxambi (empagliflozin and linagliptin) & nbsp;
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Ketoacidosis (addition of the following sentence in first paragraph)
Fatal cases of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Epivir (lamivudine) Tablets and Oral Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Eliquis (apixaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Bleeding
Reversal of Anticoagulant Effect
A specific antidote for ELIQUIS is not... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Aromasin (exemestane)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
2 subsections added:
Use in Premenopausal Women
AROMASIN is not indicated for the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Acetadote (acetylcysteine) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions replaces Anaphylactoid subheading (subsection revised)
Serious... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Prismasol and Phoxillum Renal Replacement Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS
PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Mirvaso (brimonidine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS
MIRVASO topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lamprene (clofazimine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
PLR Conversion; refer to label.
CONTRAINDICATIONS (addition)
LAMPRENE is contraindicated in patients with known... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Isoniazid Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS (updated)
Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS
HICON is contraindicated in:
Patients with vomiting and diarrhea
Pregnancy
Lactation
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Evotaz (atazanavir/cobicistat)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS
Table 1: Drugs that are Contraindicated with EVOTAZ
Anticonvulsants Drug Class added to table... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Synjardy (empagliflozin and metformin hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
BOX WARNING (revised as below)
WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
