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nebivolol
Bystolic Pharmaceutical company:
Forest Pharmaceuticals, Inc.
www.forestpharm.com

Pharmacologic classification: beta blocker
Therapeutic classification:
antihypertensive
Pregnancy risk category:
C


AVAILABLE FORMS
Tablets: 2.5 mg, 5 mg, 10 mg

INDICATIONS AND DOSAGES
Hypertension--
Adults: 5 mg P.O. daily. May be increased at 2-week intervals to a maximum of 40 mg P.O. daily based on patient response.
ADJUST-A-DOSE:
In patients with severe renal impairment (creatinine clearance less than 30 ml/minute), start dosage at 2.5 mg P.O. daily. Adjust slowly with close patient monitoring. In patients with moderate hepatic impairment, start dosage at 2.5 mg P.O. daily. Adjust slowly with close patient monitoring. Drug isn’t recommended with severe hepatic impairment.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients who are hypersensitive to any component of the drug, or who have severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a pacemaker is in place), severe hepatic impairment (Child-Pugh greater than B), or who are breast-feeding.
   Use cautiously in patients with heart failure, bronchospastic diseases, diabetes, hypoglycemia, thyroid dysfunction, renal impairment, hepatic impairment, history of anaphylactic reactions, pheochromocytoma, arterial insufficiency, or who are pregnant or have recently undergone surgery.
   Use caution when discontinuing therapy in patients with coronary artery disease or hyperthyroidism; abrupt discontinuation may exacerbate angina, increase the risk of myocardial infarction and ventricular arrhythmias, worsen the symptoms of hyperthyroidism, or precipitate a thyroid storm.

INTERACTIONS
Drug-drug. Beta blockers: May excessively reduce sympathetic activity. Don’t use together.
Calcium channel blockers (particularly verapamil and diltiazem), antiarrhythmics, digitalis glycosides: May decrease heart rate and impair conduction in the heart if used together. Monitor patient closely and adjust doses as needed.
Catecholamine-depleting drugs (reserpine, guanethidine): May increase the risk of severe suppression of sympathetic activity. Avoid use together; if the combination must be used, monitor patient closely.
Clonidine: May have additive effects if used together. Nebivolol should be discontinued for several days before gradually tapering clonidine.
CYP2D6 inhibitors or inducers (quinidine, propafenone, fluoxetine, paroxetine): May increase the risk of unexpected blood pressure response if used together. Monitor patient response closely and adjust dosage as needed.

ADVERSE REACTIONS
CNS: headache, dizziness, insomnia, asthenia, paresthesia.
CV: chest pain, bradycardia, dysrhythmias, peripheral edema, hypotension.
GI: nausea, diarrhea, abdominal pain.
Metabolic: hypercholesterolemia, hyperuricemia.
Respiratory: dyspnea.
Skin: rash.
Other: fatigue.

Reactions may be common, uncommon, life-threatening, or
COMMON AND LIFE-THREATENING.

     
   

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