NORTHERA Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Lundbeck Pharmaceuticals LLC

Λέξεις κλειδιά

67386-820 67386-821 67386-822

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BOXED WARNING SECTION

WARNING: SUPINE HYPERTENSION 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, ...

1. 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) ...

2. Dosage and Administration

2.1 Dosing Information The recommended starting dose of NORTHERA is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime ...

3. Dosage Forms and Strengths

NORTHERA capsules are available in 100 mg, 200 mg, and 300 mg strengths as specified below. 100 mg: Hard gelatin capsules with Northera on the white body and 100 on the light blue cap 200 mg: Hard gelatin ...

4. Contraindications

NORTHERA is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions (5.4)].

5. Warnings and Precautions

5.1 Supine Hypertension NORTHERA therapy may cause or exacerbate supine hypertension in patients with nOH. Patients should be advised to elevate the head of the bed when resting or sleeping. Monitor blood ...

6. Adverse Reactions

The following adverse reactions with NORTHERA are included in more detail in the Warnings and Precautions section of the label: Supine Hypertension [see Warnings and Precautions (5.1)] Hyperpyrexia ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NORTHERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs that Increase Blood Pressure Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected ...

8.1. Pregnancy

Risk Summary There are no available data on use of NORTHERA in pregnant women and risk of major birth defects or miscarriage. NORTHERA did not produce significant reproductive toxicity in pregnant female ...

8.2. Lactation

Risk Summary There is no information regarding the presence of NORTHERA or its active metabolite(s) in human milk, the effects of NORTHERA on the breastfed child, nor the effects of NORTHERA on milk production/excretion. ...

8.4. Pediatric Use

The safety and effectiveness of NORTHERA in pediatric patients have not been established.

8.5. Geriatric Use

A total of 197 patients with symptomatic nOH aged 75 years or above were included in the NORTHERA clinical program. No overall differences in safety or effectiveness were observed between these patients ...

8.6. Renal Impairment

NORTHERA and its metabolites are primarily cleared renally. Patients with mild or moderate renal impairment (GFR greater than 30 mL/min) were included in clinical trials and did not have a higher frequency ...

10. Overdosage

10.1 Symptoms There have been cases of overdose reported during postmarketing surveillance. A patient ingested 7,700 mg of droxidopa and experienced a hypertensive crisis that resolved promptly with treatment. ...

11. Description

NORTHERA capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the ...

12.1. Mechanism of Action

The exact mechanism of action of NORTHERA in the treatment of neurogenic orthostatic hypotension is unknown. NORTHERA is a synthetic amino acid analog that is directly metabolized to norepinephrine by ...

12.2. Pharmacodynamics

Peak droxidopa plasma concentrations are associated with increases in systolic and diastolic blood pressures. Droxidopa has no clinically significant effect on standing or supine heart rates in patients ...

12.3. Pharmacokinetics

Absorption Peak plasma concentrations (Cmax) of droxidopa were reached by 1 to 4 hours post-dose (mean of approximately 2 hours) in healthy volunteers. High-fat meals have a moderate impact ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies have been conducted at dosages up to 1,000 mg/kg/day in mice and up to 100 mg/kg/day in rats with no indication of carcinogenic effects. Based on dose per unit body surface area, these ...

13.2. Animal Toxicology and/or Pharmacology

In long-term chronic toxicity studies, rats and mice treated for 52 and 80 weeks, respectively, at doses up to 300 mg/kg/day in rats and 1,000 mg/kg/day in mice had increased incidences of renal and cardiac ...

14. Clinical Studies

14.1 Studies in Neurogenic Orthostatic Hypotension Clinical studies (described below) examined the efficacy of NORTHERA in the short-term (1 to 2 weeks) and over longer-term periods (8 weeks; 3 months). ...

16.1. How Supplied

NORTHERA capsules are supplied in the following dosage strengths: 100 mg: Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with Northera on body and ...

16.2. Storage and Handling

NORTHERA capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Elevations in Blood Pressure Counsel patients that NORTHERA causes elevations in blood pressure and increases the risk of supine hypertension, which could lead to strokes, heart attacks, and death. Instruct ...