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MedsAcross

Molecule

Lofexidine

Also known as lofexidine hydrochloride
Available on requestNeurology
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Lofexidine is a prescription medicine indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. It is available as tablets for oral use. MedsAcross supplies Lofexidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
N07BC04 Lofexidine · Other nervous system medicines, subgroup N07B, subgroup N07BC
US FDA first approval
16 May 2018
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII UI82K0T627RxCUI 28863CAS 31036-80-3DrugBank DB04948Q3836403

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

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

Source: US FDA prescribing information

Dosing overview

The usual Lofexidine tablets dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals. Lofexidine tablets treatment may be continued for up to 14 days with dosing guided by symptoms. Discontinue Lofexidine tablets with a gradual dose reduction over 2 to 4 days. Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment.

Source: US FDA prescribing information

Warnings and precautions

Risk of Hypotension, Bradycardia, and Syncope: May cause a decrease in blood pressure, a decrease in pulse, and syncope. Monitor vital signs before dosing and advise patients on how to minimize the risk of these cardiovascular effects and manage symptoms, should they occur. Monitor symptoms related to bradycardia and orthostasis. When using in outpatients, ensure that patients are capable of self-monitoring for signs and symptoms. Avoid use in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal failure, as well as in patients with marked bradycardia. Risk of QT Prolongation: Lofexidine tablets prolong the QT interval. Avoid use in patients with congenital long QT syndrome.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in labeling: Hypotension, Bradycardia, and Syncope QT Prolongation Central Nervous System Depression Opioid Overdose Discontinuation Symptoms Most common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. or www.fda.gov/ medwatch

Source: US FDA prescribing information

Interactions

Methadone: Methadone and Lofexidine tablets both prolong the QT interval. ECG monitoring is recommended when used concomitantly. Oral Naltrexone: Concomitant use may reduce efficacy of oral naltrexone. CYP2D6 Inhibitors: Concomitant use of paroxetine resulted in increased plasma levels of Lofexidine tablets. Monitor for symptoms of orthostasis and bradycardia with concomitant use of a CYP2D6 inhibitor.

Source: US FDA prescribing information

Storage

Storage 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).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Lofexidine, sorted by availability.

MedicineManufacturerRegisterAvailability
Lofexidine 0.18 mg tabletOralGeneric name—US FDAAvailable on request
Lofexidine 0.2 mg tabletOralGeneric name—US FDAAvailable on request
Lucemyra 0.2 mg tabletOralBioCorRx PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 May 2018Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Lofexidine available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Lofexidine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lofexidine have?

The catalogue lists 1 brand names for Lofexidine, including Lucemyra.

Is Lofexidine approved by the US FDA?

Yes. The US FDA first approved Lofexidine on 16 May 2018, according to Drugs@FDA.

Does Lofexidine need cold chain shipping?

No listed presentation of Lofexidine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Lofexidine in?

Lofexidine is classified under ATC code N07BC04 (Lofexidine).

References

  1. LOFEXIDINE prescribing information (BioCorRx Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 22 October 2026

Request Lofexidine for export supply

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