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Buy Clofazimine (Lamprene) No Prescription 50mg

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Clofazimine: Cautions

Clofazimine generally is well tolerated when given in dosages of 100 mg daily or less. The major adverse effects of the drug involve the skin, eyes, and GI tract. Discoloration of various body tissues and fluids occurs in most patients receiving clofazimine, apparently because clofazimine is a bright-red dye and crystals of the drug are distributed to and accumulate in these tissues and fluids. Although most adverse effects of clofazimine are mild, dose related, and reversible following discontinuance of the drug, severe GI effects, which may be fatal, have been reported rarely.

Dermatologic Effects

Pink to brownish-black discoloration of the skin occurs in up to 75-100% of patients receiving clofazimine. The degree of skin discoloration is dose related and is most pronounced on exposed parts of the body, including the thin, hairless skin of the face (particularly periorbital and perinasal areas) and the thick, hairless, hypopigmented skin of the palms and soles, and in areas where leprosy lesions are located.

Occasionally, patients have described a feeling of tension in succulent, infiltrated lesions of the face accompanying the development of this discoloration. Biopsy of discolored skin has revealed the presence of granulomas, the extent of which appears to be related to the amount of drug deposited. Discoloration is most apparent in light-skinned individuals and may be particularly disturbing to these individuals.

Skin discoloration usually is evident 1-4 weeks after initiation of clofazimine therapy and gradually disappears within 6-12 months after discontinuance of the drug; however, the skin occasionally may retain traces of color for 4 years or longer. In addition to discoloration secondary to drug deposits, melanosis similar to that observed with phenothiazines has been reported in patients receiving clofazimine.

The blue-grey, blackish brown, to black discoloration associated with clofazimine-induced melanosis resolves more gradually following discontinuance of the drug and may persist as circumscribed hyperpigmented areas in some patients.

During therapy with the drug, leprosy nodules may be replaced by scar tissue in the form of shiny, jet black, circular macules. Ichthyosis and dry skin, especially on the legs and forearms, have been reported in 8-38% of patients receiving clofazimine. Clofazimine-induced ichthyosis and dryness generally occur as leprosy resolves and may be relieved by applying oil, petrolatum, or an emollient lotion containing 25% urea to the affected areas.

Desquamation may occur. Pruritus and nonspecific rash (e.g., follicular and papular) have been reported in 1-5%1 and seborrheic dermatitis, erythroderma, erythema multiforme, acneiform eruptions, monilial cheilosis (perleche), and phototoxicity have been reported in less than 1% of patients receiving clofazimine.

Severe exfoliative dermatitis, which appeared to be a hypersensitivity reaction, occurred in at least one patient receiving the drug.

Ocular Effects

Reversible, dose-related, red-brown discoloration of the conjunctiva, cornea, and lacrimal fluid may occur during clofazimine therapy. Conjunctival discoloration has been reported in 38-57% of patients receiving the drug. Bilateral, linear or branched, brownish lines or streaks in the cornea have been reported in some patients receiving clofazimine dosages of 100-400 mg daily for 2 months or longer; these lines slowly disappeared after clofazimine therapy was completed.


Discoloration in the macular areas of the eye and bluish discoloration of the lens have also been reported rarely. Although discoloration of the conjunctiva and other parts of the eye during clofazimine therapy does not appear to affect visual acuity, diminished vision has been reported rarely in patients receiving the drug. Dryness, burning, itching, irritation, and watering of the eye have been reported in 2-32% of patients receiving clofazimine.

GI Effects

GI effects are the major dose-limiting adverse effects of clofazimine. Abdominal and epigastric pain, diarrhea, nausea, vomiting, and GI intolerance have been reported in up to 60% of patients receiving the drug.

Anorexia, weight loss, malabsorption, constipation, bowel congestion or obstruction, GI bleeding, splenic infarction, and eosinophilic enteritis have been reported in less than 1% of patients receiving the drug.

Adverse GI effects appear to be dose related and occur most frequently in patients receiving more than 100 mg of clofazimine daily. In patients who receive usual dosages of the drug, adverse GI effects may occur within a few days or weeks after initiation of clofazimine therapy and apparently are caused by a direct irritant effect of the drug on the intestinal mucosa; GI symptoms in these patients generally subside following a decrease in clofazimine dosage. In patients who receive 300 mg or more of the drug daily, a severe syndrome of crampy or colicky abdominal pain, persistent diarrhea, and weight loss may occur 3 months or longer after initiation of clofazimine therapy; discontinuance of the drug usually is, and hospitalization may be, necessary.

If clofazimine therapy is not discontinued, partial or complete bowel obstruction may occur. Severe abdominal symptoms have necessitated exploratory laparotomies in some patients and several fatalities have been reported. Although the exact cause of this syndrome is unknown, massive deposits of clofazimine crystals in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes have been observed.

Nervous System Effects

Dizziness, drowsiness, fatigue, headache, giddiness, neuralgia, and taste disorder have been reported in less than 1% of patients receiving clofazimine. Depression, secondary to skin discoloration, may occur in some patients receiving clofazimine; this may have contributed to at least 2 suicides in patients receiving the drug.

Other Effects

Reversible, dose-related, red-brown discoloration of sweat, sputum, urine, feces, nasal secretions, semen, and breast milk may occur during clofazimine therapy. Although a causal relationship has not been established, increased blood glucose concentrations have been reported in more than 1% of patients receiving the drug.


Eosinophilia, anemia, hypokalemia, elevated erythrocyte sedimentation rate (ESR), and elevated concentrations of serum albumin, bilirubin, and AST (SGOT) have been reported in less than 1% of patients receiving clofazimine. Thromboembolism, cystitis, bone pain, edema, fever, lymphadenopathy, vascular pain, hepatitis, jaundice, and enlarged liver also have been reported in less than 1% of patients receiving the drug.

Precautions and Contraindications

Clofazimine dosages exceeding 100 mg daily should be used for as short a period as possible and only under close medical supervision. Severe GI effects, including splenic infarction, bowel obstruction, and GI bleeding, have been reported rarely during clofazimine therapy and have been fatal in a few patients.

Clofazimine should be used with caution in patients with GI symptoms such as abdominal pain and diarrhea. If a patient complains of colicky or burning abdominal pain, nausea, vomiting, or diarrhea during clofazimine therapy, dosage of the drug should be reduced and, if necessary, the interval between doses increased, or the drug should be discontinued.

Patients receiving clofazimine should be warned that the drug may cause a pink to brownish-black discoloration of the skin as well as discoloration of the conjunctiva, lacrimal fluid, sweat, sputum, urine, feces, nasal secretions, semen, and breast milk.

Patients should be advised that skin discoloration, although reversible, may take several months or years to disappear after completion of clofazimine therapy. The fact that skin discoloration may result in mental depression in some patients should be considered; depression secondary to skin discoloration may have contributed to at least 2 suicides in patients receiving clofazimine. The manufacturer states that there are no known contraindications to use of clofazimine.

Pediatric Precautions

Safety and efficacy of clofazimine in children 12 years of age or younger have not been established. The drug has been used in a limited number of children.

Mutagenicity and Carcinogenicity

Clofazimine was not mutagenic in the Ames microbial mutagen test with or without metabolic activation. Studies have not been performed to date to evaluate the carcinogenic potential of clofazimine.

Pregnancy, Fertitlity and Lactation

Clofazimine did not appear to be teratogenic in rabbits or rats when given at dosages 8 or 25 times the usual human dosage, respectively. However, in reproduction studies in mice using clofazimine dosages 12-25 times the usual human dosage, the drug caused retardation of fetal skull ossification, an increased incidence of abortions and stillbirths, and impaired neonatal survival. There are no adequate and controlled studies to date using clofazimine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Clofazimine has been used during (including throughout) pregnancy in a limited number of women without evidence of teratogenicity. However, clofazimine does cross the placenta, and the skin of some neonates born to women who received the drug during pregnancy was discolored at birth; the discoloration gradually faded over the first year. Several neonates born to women receiving the drug during pregnancy have died, but a causal relationship to clofazimine has not been established.

Although further study is needed, there is some evidence that estrogen excretion may be decreased in pregnant women receiving clofazimine. In reproduction studies in rats receiving a clofazimine dosage 25 times the usual human dosage, there was some evidence of impaired fertility since the number of offspring was reduced and there was a lower proportion of implantations.

Because clofazimine is distributed into milk, the drug should not be used in nursing women unless clearly indicated since skin discoloration can occur in nursing infants of such women.

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Dosage forms of Clofazimine:
Clofazimine powder

Synonyms of Clofazimine:

Chlofazimine, Clofazimina [INN-Spanish], Clofaziminum [INN-Latin]

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Therapeutic classes of Clofazimine:

Antimycobacterials, Coloring Agents, Dyes, Leprostatic Agents


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