; Packager: Mylan Institutional Inc. This is a repackaged label. These highlights do not include all the information needed to use zolpidem tartrate tablets See full prescribing information for zolpidem tartrate tablets . Review the zolpidem tartrate tablets Medication Guide with every patient prior to.
Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention. Urogenital System: Frequent: urinary tract infection.
Metabolic and Nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.
at INFO-RX) or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc.
There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem.
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Consideration of consultation responses on review proposal. Review of TA77: Zaleplon, zolpidem and zopiclone for the management of insomnia. This guidance was issued April Mylan (zolpidem, zopiclone). ▫ Ratiopharm UK (zolpidem.