Medication-info.com Search Menu

Lofexidine (Lucemyra): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
0.2 mg
Brand names:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Lofexidine

What is the most important information I should know about lofexidine tablets and discontinuing opioid drugs?

Lofexidine tablets can cause serious side effects, including low blood pressure (hypotension), slow heart rate (bradycardia), and fainting.

If you have any of the following signs or symptoms, tell your healthcare provider right away:

  • low blood pressure
  • lightheadedness
  • slow heartbeat
  • feeling faint at rest or when standing up
  • dizziness

If you take lofexidine tablets at home and have any of these signs and symptoms, do not take your next dose of lofexidine tablets until you have talked to your healthcare provider. You should avoid becoming dehydrated or overheated during treatment with lofexidine tablets, which may increase your risk of low blood pressure and fainting. You should also be careful not to stand up too suddenly from lying down or sitting.

When your treatment is complete you will need to stop taking lofexidine tablets gradually or your blood pressure could increase.

For more information about side effects, see “What are the possible side effects of lofexidine tablets?”

Increased risk of opioid overdose. After a period of time of not using opioids drugs, you can become more sensitive to the effects of opioids if you start using opioids again. This may increase your risk of overdose and death.

What are lofexidine tablets?

Lofexidine tablets are a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly.

Lofexidine tablets will not completely prevent the symptoms of opioid withdrawal, which may include feeling sick, stomach cramps, muscle spasms or twitching, feeling of cold, heart pounding, muscular tension, aches and pains, yawning, runny eyes and sleep problems (insomnia).

Lofexidine tablets are not a treatment for opioid use disorder. If you have been diagnosed with opioid use disorder (opioid addiction), your healthcare provider may prescribe lofexidine tablets as part of a complete treatment program for your opioid use disorder (opioid addiction).

It is not known if lofexidine tablets are safe and effective in children.

Before taking lofexidine tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have low blood pressure
  • have a slow heart rate
  • have any heart problems, including history of heart attack or a condition called long QT syndrome
  • have liver or kidney problems
  • drink alcohol

  • are pregnant or plan to become pregnant. It is not known if lofexidine tablets can harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if lofexidine pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with lofexidine tablets.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any medications you may take for the individual symptoms of opioid withdrawal (such as pain relievers or medications for upset stomach).

Especially tell your healthcare provider if you take benzodiazepines, barbiturates, tranquilizers, or sleeping pills. Taking lofexidine tablets with these medicines can cause serious side effects. Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines.

How should I take lofexidine tablets?

  • Take lofexidine tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose if needed.
  • Do not change your dose or stop taking lofexidine tablets without talking to your healthcare provider.

  • Take lofexidine tablets with or without food.

  • If you take too much lofexidine tablets, go to the nearest hospital emergency room right away.

What should I avoid while taking lofexidine tablets?

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how lofexidine tablets affect you.

What are the possible side effects of lofexidine tablets?

The most common side effects of lofexidine tablets include:

  • low blood pressure or symptoms of low blood pressure such as lightheadedness
  • dizziness
  • slow heart rate
  • sleepiness
  • dry mouth

These are not all the possible side effects of lofexidine tablets.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to novadoz at 1-855-668-2369.

How should I store lofexidine tablets?

  • Store lofexidine tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep lofexidine tablets in its original container.
  • Keep lofexidine tablets away from heat and moisture.
  • Lofexidine tablets bottles contain desiccant packs to help keep the tablets dry. Do not remove the desiccant packs until all the tablets are used.

Keep lofexidine tablets and all medicines out of the reach of children.

General information about the safe and effective use of lofexidine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use lofexidine tablets for a condition for which it was not prescribed. Do not give lofexidine tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about lofexidine tablets that is written for health professionals.

What are the ingredients of lofexidine tablets?

Active ingredient: lofexidine.

Inactive ingredients: calcium stearate, citric acid anhydrous, lactose anhydrous, microcrystalline cellulose, povidone, sodium lauryl sulfate, and Opadry OY S 9480 (contains hydroxypropyl cellulose, titanium dioxide, propylene glycol, indigo carmine and sunset yellow).

Manufactured by:

MSN Laboratories Private Limited

Telangana – 509 228,

INDIA

Distributed by:

Novadoz Pharmaceuticals LLC

Piscataway, NJ 08854-3714

For more information, go to www.novadozpharma.com or call 1-855-668-2369.

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 11/2024

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 218699 · View the label on DailyMed

Revision date stated in the text: November 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lofexidine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Lofexidine hydrochloride 0.2 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) MSN
FDA approval ANDA 218699Abbreviated New Drug Application (ANDA) – generic drug Approved February 24, 2025
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Lucemyra with the same TE code
Manufacturers 6 labelers list this drug on DailyMed
Packages (NDC)
Package
0.2 mg – 36 in 1 bottle / 1 in 1 carton NDC 72205-246-42
0.2 mg – 96 in 1 bottle / 1 in 1 carton NDC 72205-246-43

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.