"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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Tigan® (trimethobenzamide hydrochloride injectable) is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
DOSAGE AND ADMINISTRATION
Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
Patients with Renal Impairment
In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
INJECTABLE, 100 mg/mL (Not for use in pediatric patients)
Usual Adult Dosage
2 mL (200 mg) t.i.d. or q.i.d. intramuscularly.
NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use.
Intramuscular administration may cause pain, stinging, burning, redness and swelling at the site of injection. Such effects may be minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.
Store at 25°C (77°F).
Excursions permitted to 15-30°C (59-86°F).
[See USP Controlled Room Temperature]
Single-Dose Vials, 2 mL, trays of 25
NDC 42023-119-25 100 mg/mL in 2 mL Single-Dose Vials
Multi-Dose Vials, 20 mL
NDC 42023-118-01 100 mg/mL in 20 mL Multi-Dose Vials
Prescribing Information as of January 2008. Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307. FDA Rev date: 04/18/08
Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.
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