Lofexidine .18 mg/1
Lofexidine · TABLET, COATED · Indoco Remedies Limited
Lofexidine is a tablet, coated containing lofexidine at .18 mg/1, taken oral. Manufactured by Indoco Remedies Limited.
Key Facts
- Brand Name
- Lofexidine
- Generic Name
- Lofexidine
- NDC Code (Product)
14445-146- Manufacturer
- Indoco Remedies Limited
- Strength
- .18 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218613
- Marketing Start
- 08/21/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. Lofexidine tablets are a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The usual lofexidine tablet dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals. Lofexidine tablet treatment may be continued for up to 14 days with dosing guided by symptoms. ( 2.1 ) Discontinue lofexidine tablets with a gradual dose reduction over 2 to 4 days. ( 2.1 ) Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment. ( 2.2 , 2.3 ) 2.1 Dosing Information The usual lofexidine tablet 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 use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of lofexidine tablets should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets). Lofexidine tablet treatment may be continued for up to 14 days with dosing guided by symptoms. Discontinue lofexidine tablets with a gradual dose reduction over a 2- to 4-day period to mitigate lofexidine tablet withdrawal symptoms (e.g., reducing by 1 tablet per dose every 1 to 2 days) [see War…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Methadone: Methadone and lofexidine both prolong the QT interval. ECG monitoring is recommended when used concomitantly. ( 7.1 ) Oral Naltrexone: Concomitant use may reduce efficacy of oral naltrexone. ( 7.2 ) CYP2D6 Inhibitors: Concomitant use of paroxetine resulted in increased plasma levels of lofexidine. Monitor for symptoms of orthostasis and bradycardia with concomitant use of a CYP2D6 inhibitor. ( 7.4 ) 7.1 Methadone Lofexidine and methadone both prolong the QT interval. ECG monitoring is recommended in patients receiving methadone and lofexidine concomitantly [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3)]. 7.2 Oral Naltrexone Coadministration of lofexidine and oral naltrexone resulted in statistically significant differences in the steady-state pharmacokinetics of naltrexone. It is possible that oral naltrexone efficacy may be reduced if used concomitantly within 2 hours of lofexidine. This interaction is not expected if naltrexone is administered by non-oral routes [see Clinical Pharmacology (12.3)]. 7.3 CNS Depressant Drugs Lofexidine potentiate the CNS depressant effects of benzodiazepines and may potentiate the CNS depressant eff…
Adverse Reactions
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 (5.2)] Central Nervous System Depression [see Warnings and Precautions (5.3)] Opioid Overdose [see Warnings and Precautions (5.4)] Discontinuation Symptoms [see Warnings and Precautions (5.5)] Most common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 another drug and may not reflect the rates observed in practice. The safety of lofexidine was supported by three randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharma…
Frequently Asked Questions
What is Lofexidine used for?
Lofexidine contains Lofexidine. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Lofexidine a controlled substance?
Lofexidine is not classified as a controlled substance by the DEA.
What is the generic name for Lofexidine?
The generic name for Lofexidine is Lofexidine. There are 3 other brand versions of Lofexidine.
What is the NDC code for Lofexidine .18 mg/1?
The NDC (National Drug Code) for Lofexidine .18 mg/1 is 14445-146, listed by Indoco Remedies Limited.