Lamprene (Oral)

Clofazimine is used along with other medicines to treat a type of leprosy (also known as Hansen's disease) called lepromatous leprosy. This includes cases of lepromatous leprosy that are resistant to dapsone, as well as lepromatous leprosy complicated by erythema nodosum leprosum. Lepromatous leprosy is a more serious and contagious form of the disease, with widespread skin bumps and rashes (multibacillary leprosy), numbness, and muscle weakness. It can also affect body organs (for example, the nose, kidneys, and male reproductive organs).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your doctor will give you a pregnancy test before starting treatment with this medicine to make sure you are not pregnant.

If your symptoms do not improve within 1 to 3 months, or if they become worse, check with your doctor.

This medicine may be stored in different organs of the body (eg, lymph nodes, bowels, spleen, liver) as crystals. When stored in the bowels, this may lead to bowel blockage or stomach or bowel bleeding. This medicine may also cause splenic infarction, where the spleen does not get enough oxygen. Check with your doctor right away if you have nausea, vomiting, diarrhea, black or bloody stools, stomach pain, or pain spreading to the left shoulder.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

Clofazimine may cause orange-pink to brownish-black discoloration of the skin within a few weeks after you start using it. Because of the skin discoloration, some patients may become depressed. It may also cause your sweat, tears, spit, urine, stools, and the whites of your eyes to turn red or brownish-black in color. The discoloration will go away when you stop using this medicine. However, it may take several months or years for the skin to clear up completely. If skin discoloration causes you to feel very depressed or to have thoughts of suicide, check with your doctor right away.

Clofazimine may cause dry, rough, itchy, or scaly skin. You may use a skin cream, lotion, or oil to help treat this problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how clofazimine affects children. Its safety and effectiveness for children have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of clofazimine. However, older patients are more likely to have age-related issues with their liver, kidneys, or heart, which may require careful monitoring and possible dose adjustments for patients taking this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is especially important for your healthcare professional to know if you are using any of the following medicines. The following interactions are noteworthy and may not include all possible interactions.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medicine or adjust your other medications.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bosutinib
• Buprenorphine
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clothiapine
• Clozapine
• Colchicine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Elexacaftor
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Mavacamten
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Palovarotene
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tezacaftor
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following may increase the risk of certain side effects, but taking both medications may be the best option for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aluminum Hydroxide
• Amlodipine
• Magnesium Hydroxide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. The following interactions may not include all possible interactions.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Orange Juice

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical problems, especially:

• Depression or
• Heart rhythm issues (e.g., QT prolongation) or
• Stomach or bowel issues—Use with caution. This medicine may worsen these conditions.

• Severe kidney disease—Use with caution. The effects may be heightened due to slower removal of the medicine from your body.

• Liver disease—Avoid using this medicine in patients with this condition, unless the benefits outweigh the risks.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Constipation
• diarrhea
• heartburn
• indigestion
• loss of appetite
• nausea
• pain or discomfort in the chest, upper stomach, or throat
• stomach pain
• vomiting

Less common

• Blurry vision
• dry mouth
• dryness, burning, itching, or irritation of the eye
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• bone pain
• chest pain
• chills
• constipation
• cough
• dark urine
• decreased urine
• decreased vision
• depression and thoughts of suicide secondary to skin discoloration
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• general tiredness and weakness
• irregular heartbeat
• light-colored stools
• mood changes
• muscle pain or cramps
• nerve pain
• numbness or tingling in the hands, feet, or lips
• pain in the chest, groin, or legs, especially the calves
• pain spreading to the left shoulder
• pale skin
• seizures
• severe stomach pain
• severe, sudden headache
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramping
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• swelling
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• troubled breathing with exertion
• unusual bleeding or bruising
• upper right abdominal pain and fullness
• vision changes
• vomiting of blood or material that looks like coffee grounds
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dry, rough, or scaly skin
• pink to brownish black skin discoloration

Less common

• Discoloration of the eye, urine, stool, spit, sweat
• itching, skin rash

Rare

• Bad unusual or unpleasant (after)taste
• change in taste
• dizziness
• drowsiness
• giddiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lamprene

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with meals.

To help clear up your leprosy completely, it is very important that you keep using clofazimine for the full time of treatment, even if you begin to feel better after a few months. You may have to take it every day for as long as 2 to 3 years. If you stop using this medicine too soon, your symptoms may return, worsen, or infect other people.

This medicine is taken together with other medicines (eg, other antileprosy medicines, steroids). Follow your doctor's orders on the right times to take these medicines.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicines, check with your doctor or pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For lepromatous leprosy (dapsone-sensitive): Adults—100 milligrams (mg) in combination with two other antileprosy drugs for at least 2 years. Your doctor may give you an appropriate antileprosy drug after. Children—Use and dose must be determined by your doctor. For lepromatous leprosy (dapsone-resistant): Adults—100 milligrams (mg) in combination with one or more other antileprosy drugs for 3 years. Your doctor may then give you 100 mg of clofazimine once a day. Children—Use and dose must be determined by your doctor. For lepromatous leprosy complicated by erythema nodosum leprosum: Adults—100 to 200 milligrams (mg) once a day for up to 3 months, in combination with other antileprosy drugs and steroids. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.