Rx Item-Northera- Droxidopa Capsule 200Mg 90

These highlights do not include all the information needed to use NORTHERA� safely and effectively. See full prescribing information for NORTHERA. NORTHERA� (droxidopa) capsules, for oral use Initial U.S. Approval: 2014 WARNING: SUPINE HYPERTENSION See full prescribing information for complete boxed warning. Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA [see Warnings and Precautions (5.1)]. RECENT MAJOR CHANGES Contraindications (4) 10/2016 Warnings and Precautions, Supine Hypertension (5.1) 02/2017 Warnings and Precautions, Hyperpyrexia and Confusion (5.2) 10/2016 Warnings and Precautions, Allergic Reactions (5.4) 10/2016 INDICATIONS AND USAGE NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the �feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically (1). DOSAGE AND ADMINISTRATION Starting dose is 100 mg three times during the day (2.1) Titrate by 100 mg three times daily, up to a maximum dose of 600 mg three times daily (2.1) Take consistently with or without food (2.1) To reduce the potential for supine hypertension, elevate the head of the bed and give the last dose at least 3 hours prior to bedtime (2.1) Take NORTHERA capsule whole (2.1) DOSAGE FORMS AND STRENGTHS 100 mg, 200 mg, and 300 mg capsules (3) CONTRAINDICATIONS History of hypersensitivity to the drug or its ingredients (4) WARNINGS AND PRECAUTIONS NORTHERA may cause supine hypertension and may increase cardiovascular risk if supine hypertension is not well-managed (5.1). Hyperpyrexia and confusion (5.2) May exacerbate symptoms in patients with existing ischemic heart disease, arrhythmias, and congestive heart failure (5.3) Allergic reactions (5.4) ADVERSE REACTIONS The most common adverse reactions (>5% and ?3% compared to placebo) are headache, dizziness, nausea, and hypertension (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Use of DOPA decarboxylase inhibitors may require dose adjustments for NORTHERA (7.2) USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended (8.2) Patients with Renal Impairment: Dosing recommendations cannot be provided for patients with GFR less than 30 mL/min (8.6) See 17 for PATIENT COUNSELING INFORMATION.

RX ITEM-Northera- Droxidopa Capsule 200M
NDC Code(s): 67386-820-19, 67386-821-19, 67386-822-19 Packager: Lundbeck Pharmaceuticals LLC Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: New Drug Application

Northera- Droxidopa Capsule 200Mg 90
BRAND: NORTHERA NDC: RX67386-0821-19 ,RX67386082119 UPC: 367386-821194,367386821194 NDC Code(s): 67386-820-19, 67386-821-19, 67386-822-19 Packager: Lundbeck Pharmaceuticals LLC Category: HUMAN P

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