"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Infrequently, large doses of the intranasal formulations of DDAVP (desmopressin acetate tablets) and DDAVP (desmopressin acetate tablets) Injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage.
Central Diabetes Insipidus: In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of DDAVP (desmopressin acetate tablets) Tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of DDAVP (desmopressin acetate tablets) Tablets.
Primary Nocturnal Enuresis: The only adverse event occurring in ≥ 3% of patients in controlled clinical trials with DDAVP (desmopressin acetate tablets) Tablets that was probably, possibly, or remotely related to study drug was headache (4% DDAVP (desmopressin acetate tablets) , 3% placebo).
Other: The following adverse events have been reported; however their relationship to DDAVP (desmopressin acetate tablets) has not been established: abnormal thinking, diarrhea, and edema-weight gain.
See WARNINGS for the possibility of water intoxication and hyponatremia.
Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.
Read the DDAVP (desmopressin acetate tablets) Side Effects Center for a complete guide to possible side effects
Although the pressor activity of DDAVP (desmopressin acetate tablets) is very low compared to its antidiuretic activity, large doses of DDAVP (desmopressin acetate tablets) Tablets should be used with other pressor agents only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Last reviewed on RxList: 2/18/2008
This monograph has been modified to include the generic and brand name in many instances.
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