lampit
Pharmaranks rates Lampit 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lampit (Nifurtimox) is a medication supplied as a tablet, film coated.
Nifurtimox · by Bayer Pharms
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Nifurtimox
- Form
- Tablet
- Strength
- Nifurtimox 120MG · Nifurtimox 30MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bayer Pharms
- FDA application
- NDA213464
What is Lampit?
From the FDA label:LAMPIT contains nifurtimox, an antiprotozoal. The chemical name is (E)-N-(3-Methyl-1,1-dioxidothiomorpholin-4-yl)-1-(5-nitro-2-furyl)methanimine. The molecular weight is 287.29 and the molecular formula is C 10 H 13 N 3 O 5 S. The structural formula is: LAMPIT (nifurtimox) tablets are yellow round, biconvex tablets, each containing 30 mg or 120 mg of nifurtimox, intended for oral use. The 30 mg tablets are functionally scored on one side and marked with ‘30’ on the other side. The 120 mg tablets are functionally scored on one side and marked with ‘120’ on the other side. The inactive ingredients of the tablets are as follows: calcium hydrogen phosphate dihydrate, magnesium stearate, maize starch, silica colloidal anhydrous and sodium lauryl sulfate. Chemical Structure
How to use
LAMPIT tablets must be taken with food ( 2.1 ) Dosage of LAMPIT in Pediatric Patients (birth a to less than 18 years of age) (2.2) Body Weight Group Total Daily Dose of nifurtimox (mg/kg) 41 kg or greater 8 to 10 Less than 41 kg 10 to 20 a Term newborn with body weight greater than or equal to 2.5 kg • Administer LAMPIT tablets orally, three times daily with food for 60 days. ( 2.2 ) • Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT ( 2.3 , 8.3 ) . • See Full Prescribing Information for additional important administration instructions. ( 2.1 , 2.2 , 2.4, 2.5 ) 2.1 Important Administration Instructions • LAMPIT (30 mg and 120 mg) tablets are for oral use and must be taken with food. • LAMPIT tablets are dosed by body weight of the patient [see Dosage and Administration ( 2.2 )] . • LAMPIT (30 mg and 120 mg) tablets are functionally scored tablets which can be split into one-half (15 mg and 60 mg respectively) at the scored lines by hand. Do not break LAMPIT tablets mechanically with a tablet splitting device [see Dosage and Administration ( 2.4 ) and Instructions for Use] . • LAMPIT 30 mg and 120 mg tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablets [see Dosage and Administration ( 2.5 )] . • Discontinue consumption of alcohol during treatment with LAMPIT…
Side effects
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Potential for Genotoxicity, Carcinogenicity, and Mutagenicity [see Warnings and Precautions ( 5.1 )] • Worsening of Neurological and Psychiatric Conditions [see Warnings and Precautions ( 5.3 )] • Hypersensitivity [see Warnings and Precautions ( 5.4 )] • Decreased Appetite and Weight Loss [see Warnings and Precautions ( 5.5 )] • Porphyria [see Warnings and Precautions ( 5.6 )] The most frequently reported adverse reactions (≥5%) are vomiting, abdominal pain, headache, decreased appetite, nausea, pyrexia, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure to LAMPIT in one prospective, randomized, double-blind trial (Trial 1). 330 pediatric patients with serologic evidence of T. cruzi infection and without Chagas disease-related cardiac or gastrointestinal symptoms were randomly assigned in a 2:1 fashion to a 60-day…
Warnings
Important safety information
Potential for Genotoxicity and Carcinogenicity. ( 5.1 ) • Embryo-Fetal Toxicity: May cause fetal harm. Pregnancy testing is recommended for females of reproductive potential. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise males to use condoms with female partners of reproductive potential. ( 2.3 , 5.2 , 8.1 , 8.3 ) • Worsening Neurological and Psychiatric Conditions: Patients with a history of brain injury, seizures, psychiatric disease, serious behavioral alterations may experience worsening of their conditions when receiving LAMPIT. Administer LAMPIT under close medical supervision in these patients or if neurological disturbances or psychiatric drug reactions occur. ( 5.3 ) • Hypersensitivity: Hypersensitivity reactions including hypotension, angioedema, dyspnea, pruritus, rash or other severe skin reactions have been reported with the use of nifurtimox, discontinuation of treatment is recommended. ( 5.4 ) • Decreased Appetite and Weight Loss: Check body weight every 14 days as dosage may need to be adjusted. ( 5.5 ) • Porphyria: Treatment with nitrofuran derivatives, such as LAMPIT, may precipitate acute attacks of porphyria. Administer LAMPIT under close medical supervision in patients with porphyria. ( 5.6 ) 5.1 Potential for Genotoxicity and Carcinogenicity Genotoxicity Genotoxicity of LAMPIT has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodents [see Nonclinical Toxicology ( 13.1 )] . A study evaluating the cytogenetic effect of nifurtimox in pediatric patients ranging from 7 months to 14 years of age with Chagas disease demonstrated a 13-fold increase in chromosomal aberrations. Carcinogenicity Carcinogenicity has been observed in mice and rats treated chronically with nitrofuran agents which are structurally similar to nifurtimox. Similar data have not been reported for LAMPIT [see Nonclinical Toxicology ( 13.1 )] . It is not known whether LAMPIT is associated with carcinogenicity in humans. 5.2 Embryo-Fetal Toxicity Based on findings from animal studies, LAMPIT can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, nifurtimox administered orally to pregnant rats, and rabbits during organogenesis was associated with reduced maternal body weights in rats, and abortions, fetal death, and smaller litter sizes in rabbits at doses approximately equivalent to and 2-times, respectively, the maximum recommended human dose (MRHD) of 10 mg/kg/day. Fetal malformations were observed in pregnant rabbits administered nifurtimox doses less than the MRHD [see Use in Specific Populations ( 8.1 )]. Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with LAMPIT [see Dosage and Administration ( 2.3 )] . Advise females of reproductive potential to use effective contraception during treatment with LAMPIT and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the last dose of LAMPIT [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.3 )]. 5.3 Worsening of Neurological and Psychiatric Conditions Patients with a history of brain injury, seizures, psychiatric disease, or serious behavioral alterations may experience worsening of their conditions when receiving LAMPIT. Administer LAMPIT under close medical supervision in these patients and in patients who develop neurological disturbances or psychiatric drug reactions. 5.4 Hypersensitivity Cases of hypersensitivity have been reported in patients receiving therapy with nifurtimox. The hypersensitivity could be a reaction induced by nifurtimox or an immune response triggered by Chagas disease during treatment. Hypersensitivity reactions could be accompanied by hypotension, angioedema (including laryngeal or facial edema), dyspnea, pruritus, rash or other severe skin reactions. At the first sign of serious hypersensitivity, discontinue treatment with LAMPIT [see Contraindications ( 4 )]. 5.5 Decreased Appetite and Weight Loss Decreased appetite and weight loss were reported in patients treated with LAMPIT in the clinical trials. During treatment with LAMPIT, patients can lose their appetite or experience nausea/vomiting which can result in weight loss. Check body weight every 14 days, as the dosage may have to be adjusted [see Dosage and Administration ( 2.2 )]. 5.6 Porphyria Treatment with nitrofuran derivatives, such as LAMPIT, may precipitate acute attacks of porphyria. Administer LAMPIT tablets under close medical supervision in patients with porphyria.
Who should not take Lampit
LAMPIT tablets are contraindicated in: • Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT [see Warnings and Precautions ( 5.4 )]. • Patients who consume alcohol during treatment [see Drug Interactions ( 7 )] • Known hypersensitivity to nifurtimox or to any of the excipients in LAMPIT. ( 4 ) • Alcohol consumption during treatment. (4)
Interactions
Concomitant use of LAMPIT with alcohol may increase the incidence and severity of undesirable effects similar to other nitrofurans and nitroheterocyclic compounds. LAMPIT is contraindicated in patients who consume alcohol during treatment [see Dosage and Administration ( 2.2 ) Contraindications ( 4 )].
Storing Lampit, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store LAMPIT tablets in the original bottle with child-resistant closures and do not remove the desiccant.”
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Use copay cards
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Frequently asked questions
- How is Lampit rated?
- pharmaranks gives Lampit a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Lampit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lampit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lampit?
- Lampit is marketed by Bayer Pharms. You can see Bayer Pharms's full profile, rating, and other products on pharmaranks.
- Is Lampit a brand-name or generic drug?
- Lampit is a brand-name product with the active ingredient Nifurtimox.
- Is Lampit available over the counter?
- No. Lampit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lampit come in?
- Lampit is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Lampit FDA-registered?
- Lampit is on record with the U.S. FDA under application number NDA213464. You can verify this on its official FDA label.
- Has Lampit been recalled by the FDA?
- Lampit has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lampit safe?
- There's no single safe-or-not verdict. pharmaranks gives Lampit a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lampit?
- Lampit's side effects are taken directly from its FDA label. From the label: The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Potential for Genotoxicity, Carcinogenicity, and Mutagenicity [see Warnings and Precautions ( 5.1 )] • Worsening of Neurological and Psychiatric Conditions [see Warnings and Precautions ( 5.3 )]… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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lampit
68/100