Lamprene

Lamprene is an FDA-registered drug product whose active ingredient is CLOFAZIMINE. It is labelled by Novartis Pharmaceuticals Corporation taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0078-1049, application NDA019500, label effective 20260817. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CLOFAZIMINE are most often described in connection with: lepromatous leprosy, including dapsone-resistant, complicated erythema, nodosum leprosum, development drug-resistance, only part, combination therapy, initial treatment. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. ( 1.2 ) 1.1 Lepromatous Leprosy LAMPRENE is indicated in combination with other anti-leprosy drugs for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum. 1.2 Usage To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy [see Dosage and Administration (2.1)] . For further guidance on the treatment of leprosy, contact the National Hansen’s Disease Clinical Center, Baton Rouge, Louisiana (LA) at (1-800-642-2477) or http://www.hrsa.gov/hansensdisease/clinicalcenter.html .

2 DOSAGE AND ADMINISTRATION For dapsone-sensitive lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals as a part of a combination regimen for at least 2 years is recommended. ( 2.1 ) For dapsone-resistant lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals in combination with one or more other agents for 3 years. ( 2.1 ) For lepromatous leprosy complicated by erythema nodosum leprosum, 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily for up to 3 months. Taper dose to 100 mg (two 50 mg capsules) as quickly as possible. (2.1 ) 2.1 Dosage Dapsone-sensitive Lepromatous (multibacillary) Leprosy Administer 100 mg (two 50 mg capsules) of LAMPRENE daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti-leprosy drug. Dapsone-resistant Lepromatous Leprosy Administer 100 mg (two 50 mg capsules) of LAMPRENE daily with meals in combination with one or more other anti-leprosy drugs for 3 years, followed by monotherapy with 100 mg (two 50 mg capsules) of LAMPRENE daily. Lepromatous Leprosy complicated by Erythema Nodosum Leprosum Reactions Administer LAMPRENE at 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily, in conjunction with baseline anti-leprosy treatment and steroids as clinically indicated. If LAMPRENE is administered at 200 mg (four 50 mg capsules) dose, taper to 100 mg (two 50 mg capsules) as soon as possible after the erythema nodosum reaction is controlled. Doses of LAMPRENE of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision [see Warnings and Precautions (5.1)] . 2.2 Important Pre-test Prior to Administration Sexually-active females of reproductive potential should have a pregnancy test prior to LAMPRENE administration [see Use in Specific Populations (8.3)] .

4 CONTRAINDICATIONS LAMPRENE is contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of LAMPRENE. Known hypersensitivity to clofazimine or to any of the excipients of LAMPRENE. ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Abdominal Obstruction and Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1)] QT Prolongation [see Warnings and Precautions (5.2)] Skin and Body Fluid Discoloration and Other Skin Reactions [see Warnings and Precautions (5.3)] Psychological Effects of Skin Discoloration [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of LAMPRENE were identified. Because these adverse reactions are reported from different studies, these adverse reactions cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Occurring In More Than 1% of Patients Skin : Pigmentation from pink to brownish-black in 75% to 100% of the patients within a few weeks of treatment; ichthyosis and dryness (8% to 28%); rash and pruritus (1% to 5%). Gastrointestinal : Abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance (40% to 50%). Ocular : Diminished vision, conjunctival and corneal pigmentation due to clofazimine crystal deposits; dryness; burning; itching; irritation. Other : Discoloration of urine, feces, sputum, sweat; elevated blood sugar; elevated erythrocyte sedimentation rate (ESR). Adverse Reactions Occurring In Less Than 1% of Patients Skin : Phototoxicity, erythroderma, acneiform eruptions, monilial cheilosis. Gastrointestinal : Bowel obstruction, gastrointestinal bleeding, anorexia, constipation, weight loss, hepatitis, jaundice, eosinophilic enteritis, enlarged liver. Ocular : Maculopathy (bull’s eye retinopathy). Nervous : Dizziness, drowsiness, fatigue, headache, giddiness, neuralgia, taste disorder. Psychiatric : Depression and suicide secondary to skin discoloration. Laboratory : Elevated levels of albumin, serum bilirubin, and aspartate aminotransferase (AST); eosinophilia; hypokalemia. Other : Splenic infarction, thromboembolism, anemia, cystitis, bone pain, edema, fever, lymphadenopathy, vascular pain. Most common adverse reactions reported in 40% to 50% of patients are skin and body fluid discoloration, abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Lamprene used for?
1 INDICATIONS AND USAGE LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. ( 1.2 ) 1.1 …

Who makes Lamprene?
Novartis Pharmaceuticals Corporation is the labeler of record for Lamprene.

What form does Lamprene come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lamprene prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Lamprene been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.