Toprelin Special Precautions



T. O. Chemicals


T. O. Chemicals
Full Prescribing Info
Special Precautions
Should not use in patients with rare hereditary problem of galactose intolerance, the Lapp lactose deficiency, or galactose malabsorption.
Use with caution in patients with diabetes because pregabalin may cause weight gain. Some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycemic mediations.
Should be immediately discontinued in patients with hypersensitivity reaction i.e., skin redness, blisters, hives, rash, dyspnea, wheezing.
Use with caution in patients who have had a previous episode of angioedema. Specific symptoms included swelling of the face, mouth (e.g., tongue, lips, gums) and neck (e.g., throat, larynx). In addition, patients who are using other drugs associated with angioedema (e.g., angiotensin-converting enzymes (ACE) inhibitors) may be at increased risk of developing angioedema. Pregabalin should be immediately discontinued in patient with these symptoms.
Avoid driving or operating machinery while taking pregabalin until experience is gained with the drug's effects. Pregabalin may cause dizziness, somnolence, blurred vision, and neuropsychiatric effects.
Inform the clinician if changes in vision occur (i.e., blurred vision, decreased visual acuity, visual field changes). If visual disturbance persists, consider further assessment. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
There are insufficient data for the withdrawal of concomitant antiepileptic drugs, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Should withdraw pregabalin gradually and reduce dosage slowly over at least 1 week because abrupt or rapid discontinuance of pregabalin has been associated with insomnia, nausea, headache, or diarrhea.
Use with caution in elderly and patients with renal impairment. The dosage of pregabalin should be adjusted according to the degree of renal impairment.
Use with caution in patients with New York Heart Association (NYHA) class III or IV congestive heart failure because there are limited data on these patients.
Concomitant administration with a thiazolidinedione antidiabetic agent should be used with caution because co-administration increases risk of edema and weight gain and, particularly in patients with pre-existing cardiac conditions, risk of heart failure.
Inform clinicians promptly of the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm because the increased risk of suicidal thoughts or behavior with pregabalin or other antiepileptic drugs (AEDs) may be observed as early as 1 week after starting drug treatment with AEDs.
Inform clinicians promptly of any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated CK (CPK) concentrations occur.
Pregabalin may decrease platelet count.
Pregabalin may cause PR interval prolongation.
Effects on Ability to Drive and Use Machine: Pregabalin may cause dizziness and somnolence. Pregabalin-related dizziness and somnolence may impair abilities to perform tasks such as driving or operating machinery.
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