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Gralise Generic Name & Formulations
Legal Class
Rx
General Description
Gabapentin 300mg, 600mg; tabs.
How Supplied
Tabs—90; 30-Day Starter pack—78 (9 x 300mg + 69 x 600mg)
Manufacturer
Gralise Indications
Indications
Postherpetic neuralgia.
Gralise Dosage and Administration
Adult
Swallow whole; do not crush, split or chew tabs. Take once daily with the evening meal. ≥18yrs: initially 300mg on Day 1, 600mg on Day 2, 900mg on Days 3–6, 1200mg on Days 7–10, 1500mg on Days 11–14, titrate up to 1800mg on Day 15. Renal impairment: CrCl 30–60mL/min: 600–1800mg. CrCl <30mL/min or on hemodialysis: not recommended.
Children
<18yrs: not established.
Gralise Contraindications
Not Applicable
Gralise Boxed Warnings
Not Applicable
Gralise Warnings/Precautions
Warnings/Precautions
Not interchangeable with other gabapentin products. Epilepsy. Increased risk of suicidal thoughts/behavior. Monitor for worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. Multiorgan hypersensitivity. Renal impairment. Avoid abrupt cessation; if discontinuing, withdraw gradually over 1 week or longer. Elderly. Pregnancy (Cat.C). Nursing mothers.
Gralise Pharmacokinetics
See Literature
Gralise Interactions
Interactions
Increased risk for serious respiratory depression when concomitant CNS depressants, opioids. May affect or be affected by hydrocodone. Potentiated by morphine. Separate dosing of aluminum- or magnesium-containing antacids by at least 2hrs. May cause false (+) results with urine protein tests (eg, Multistix SG).
Gralise Adverse Reactions
Adverse Reactions
Dizziness, somnolence, headache, lethargy, peripheral edema, diarrhea, dry mouth, pain in extremity.
Gralise Clinical Trials
See Literature
Gralise Note
Not Applicable
Gralise Patient Counseling
See Literature
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