Clofazimine (Oral)

Clofazimine is used along with other medicines to treat a type of leprosy (also known as Hansen's disease) called lepromatous leprosy, which includes dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. Lepromatous leprosy is a more serious and contagious type of the disease, characterized by widespread skin bumps and rashes (multibacillary leprosy), numbness, and muscle weakness, and 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 for your doctor to check your progress regularly to ensure this medicine is working properly. Blood and urine tests may be needed to check for side effects.

Using this medicine during pregnancy can harm your unborn baby. It may also cause birth defects if the father is using it when his 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 with female partners should also use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you are pregnant while using this medicine, tell your doctor immediately.

Your doctor will perform a pregnancy test before starting treatment with this medicine to ensure you are not pregnant.

If your symptoms do not improve within 1 to 3 months, or if they worsen, consult your doctor.

This medicine may form crystals that can be stored in various organs of the body (e.g., lymph nodes, bowels, spleen, liver). When stored in the bowels, this can lead to bowel blockage or bleeding in the stomach or bowels. This medicine may also cause splenic infarction, which means the spleen does not get enough oxygen. Contact your doctor immediately if you experience nausea, vomiting, diarrhea, black or bloody stools, stomach pain, or pain that spreads to the left shoulder.

Contact your doctor right away if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you could have a fast, pounding, or irregular heartbeat. Make sure your doctor knows if you have a history of heart rhythm problems, such as QT prolongation.

Clofazimine may cause your skin to change color to orange-pink or brownish-black within a few weeks after starting treatment. This skin discoloration may lead to depression in some patients. It can also cause your sweat, tears, saliva, urine, stools, and the whites of your eyes to turn red or brownish-black. The discoloration will go away after you stop using this medicine, but it may take several months or years for your skin to return to normal. If the skin discoloration makes you feel very depressed or leads to thoughts of suicide, consult your doctor immediately.

Clofazimine may cause your skin to become dry, rough, itchy, or scaly. Using a skin cream, lotion, or oil may help alleviate this issue.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be balanced against the benefits it may provide. This decision should be made between you and your doctor. For this medicine, consider the following:

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 if you have any other allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies to determine how clofazimine affects children. Its safety and effectiveness in 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 the liver, kidneys, or heart, which may require careful monitoring and possible dose adjustments for those taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be needed. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or alter the other medicines you are taking.

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

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change 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 medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. 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

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some situations. 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

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Depression or
• Heart rhythm problems (e.g., QT prolongation) or
• Stomach or bowel problems—Use with caution. May worsen these conditions.

• Kidney disease, severe—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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

Along with its needed effects, Clofazimine (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also 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.