LUCEMYRA Film-coated tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

US WorldMeds, LLC

Λέξεις κλειδιά

27505-050

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1. Indications and Usage

LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

2. Dosage and Administration

2.1 Dosing Information The usual LUCEMYRA starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last ...

3. Dosage Forms and Strengths

LUCEMYRA is available as round, peach-colored, film-coated tablets, imprinted with LFX on one side and 18 on the other side. Each tablet contains 0.18 mg lofexidine (equivalent to 0.2 mg of lofexidine ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Risk of Hypotension, Bradycardia, and Syncope LUCEMYRA can cause a decrease in blood pressure, a decrease in pulse, and syncope [see Adverse Reactions (6.1), Clinical Pharmacology (12.2)] ...

6. Adverse Reactions

The following serious adverse reactions are described elsewhere in labeling: Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.1)] QT Prolongation [see Warnings and Precautions ...

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 adverse reaction rates observed for ...

6.2. Postmarketing Experience

Lofexidine is marketed in other countries for relief of opioid withdrawal symptoms. The following events have been identified during postmarketing use of lofexidine. Because these reactions are reported ...

7. Drug Interactions

7.1 Methadone LUCEMYRA and methadone both prolong the QT interval. ECG monitoring is recommended in patients receiving methadone and LUCEMYRA [see Warnings and Precautions (5.2), Clinical Pharmacology ...

8. Use in Specific Populations

8.8 CYP2D6 Poor Metabolizers Although the pharmacokinetics of LUCEMYRA have not been systematically evaluated in patients who do not express the drug metabolizing enzyme CYP2D6, it is likely that the exposure ...

8.1. Pregnancy

Risk Summary The safety of LUCEMYRA in pregnant women has not been established. In animal reproduction studies, oral administration of lofexidine during organogenesis to pregnant rats and rabbits caused ...

8.2. Lactation

Risk Summary There is no information regarding the presence of LUCEMYRA or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Caution should be exercised ...

8.3. Females and Males of Reproductive Potential

In animal studies that included some fertility endpoints, lofexidine decreased breeding rate and increased resorptions at exposures below human exposures. The impact of lofexidine on male fertility has ...

8.4. Pediatric Use

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

8.5. Geriatric Use

No studies have been performed to characterize the pharmacokinetics of LUCEMYRA or establish its safety and effectiveness in geriatric patients. Caution should be exercised when it is administered to patients ...

8.6. Hepatic Impairment

Hepatic impairment slows the elimination of LUCEMYRA but exhibits less effect on the peak plasma concentration than on AUC values following a single dose. Dosage adjustments are recommended based on the ...

8.7. Renal Impairment

Renal impairment slows the elimination of LUCEMYRA but exhibits less effect on the peak plasma concentration than on AUC values following a single dose. Dosage adjustments are recommended based on the ...

10. Overdosage

Overdose with LUCEMYRA may manifest as hypotension, bradycardia, and sedation. In the event of acute overdose, perform gastric lavage where appropriate. Dialysis will not remove a substantial portion of ...

11. Description

LUCEMYRA tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1 ...

12.1. Mechanism of Action

Lofexidine is a central alpha-2 adrenergic agonist that binds to receptors on adrenergic neurons. This reduces the release of norepinephrine and decreases sympathetic tone.

12.2. Pharmacodynamics

Cardiac Electrophysiology Single LUCEMYRA doses of 1.44 to 1.8 mg produced maximum mean change from baseline in QTcF (ΔQTcF) of 14.4 msec (upper two-sided 90% CI: 22.3 msec) and 13.6 msec (17.4 msec) for ...

12.3. Pharmacokinetics

Absorption LUCEMYRA is well absorbed and achieves peak plasma concentration 3 to 5 hours after administration of a single dose. LUCEMYRA shows approximately dose-proportional pharmacokinetics. Administration ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenesis No adequate long-term animal studies have been completed to evaluate the carcinogenic potential of lofexidine. Mutagenesis Lofexidine tested positive in the in vitro mouse lymphoma ...

14. Clinical Studies

Two randomized, double-blind, placebo-controlled trials supported the efficacy of LUCEMYRA. Study 1, NCT01863186 Study 1 was a 2-part efficacy, safety, and dose-response study conducted in the United States ...

16.1. How Supplied

Available as 0.18 mg round, convex-shaped, peach colored, film-coated tablets, imprinted with LFX on one side and 18 on the other side; approximately 7 mm in diameter. Bottles of 36 tablets NDC 27505-050-36 ...

16.2. Storage and Handling

Store in original container at controlled room temperature, 25°C (77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep LUCEMYRA away from excess ...

17. Patient Counseling Information

Advise patients to read the FDA-approved patient labeling (Patient Information). LUCEMYRA may mitigate, but not completely prevent, the symptoms associated with opioid withdrawal syndrome, which may include ...