{"id":672,"date":"2026-04-12T18:10:36","date_gmt":"2026-04-12T18:10:36","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=672"},"modified":"2026-08-30T03:53:26","modified_gmt":"2026-08-30T03:53:26","slug":"lucipret-pretomanid-200-mgx30-tablets","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/ru\/product\/lucipret-pretomanid-200-mgx30-tablets\/","title":{"rendered":"LuciPret"},"content":{"rendered":"

HIGHLIGHTS OF PRESCRIBING INFORMATION <\/strong><\/span><\/p>\n

These highlights do not include all the information needed to use LuciPret safely and effectively. See full prescribing information for LuciPret.<\/strong><\/span><\/p>\n

 <\/span><\/p>\n

INDICATIONS AND USAGE<\/strong><\/strong><\/span><\/p>\n

Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR)  tuberculosis (TB).  Approval of this indication is based on limited clinical safety and efficacy data.  This drug is indicated for use in a limited and specific population of patients.<\/span><\/p>\n

Limitations of Use : <\/span><\/p>\n

\u2022 Pretomanid Tablets are not indicated for patients with: <\/span><\/p>\n

\u2022 Drug-sensitive (DS) tuberculosis  <\/span><\/p>\n

\u2022 Latent infection due to Mycobacterium tuberculosis <\/span><\/p>\n

\u2022 Extra-pulmonary infection due to Mycobacterium tuberculosis <\/span><\/p>\n

\u2022 MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy <\/span><\/p>\n

\u2022 Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.<\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE AND ADMINISTRATION <\/strong><\/strong><\/span><\/p>\n

\u2022 Pretomanid Tablets must be administered only as part of a regimen in combination with bedaquiline and linezolid. <\/span><\/p>\n

\u2022 Administer Pretomanid Tablets in combination with bedaquiline and linezolid as follows:<\/span><\/p>\n

\u2022 Pretomanid Tablet 200 mg orally once daily for 26 weeks. Swallow Pretomanid Tablets whole with water.  <\/span><\/p>\n

\u2022 Bedaquiline 400 mg orally once daily for 2 weeks followed by 200 mg 3 times per week, with at least 48 hours between doses, for 24 weeks for a total of 26 weeks. <\/span><\/p>\n

\u2022 Linezolid (1,200 mg daily orally for up to 26 weeks, with dose adjustments for known linezolid toxicities).   <\/span><\/p>\n

\u2022 Take the combination regimen with food.   <\/span><\/p>\n

\u2022 Doses of the regimen missed for safety reasons can be made up at  the end of treatment; doses of linezolid alone missed due to  linezolid adverse reactions should not be made up. <\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE FORMS AND STRENGTHS <\/strong><\/strong><\/span><\/p>\n

Tablets: 200 mg\u00d730 tablets<\/span><\/p>\n

 <\/span><\/p>\n

CONTRAINDICATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Pretomanid Tablets used in combination with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and\/or linezolid is contraindicated. <\/span><\/p>\n

 <\/span><\/p>\n

WARNINGS AND PRECAUTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Hepatic adverse reactions were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor symptoms and signs and liver-related laboratory tests.  Interrupt treatment with the entire regimen if evidence of liver injury occurs. <\/span><\/p>\n

\u2022 Myelosuppression was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor complete blood counts.  Decrease or interrupt linezolid dosing if significant myelosuppression develops or worsens. <\/span><\/p>\n

\u2022 Peripheral and optic neuropathy were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor visual function.  Obtain an ophthalmologic evaluation if there are symptoms of visual impairment.  Decrease or interrupt linezolid dosing if neuropathy develops or worsens.  <\/span><\/p>\n

\u2022 QT prolongation was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Use with drugs that prolong the QT interval may cause additive QT prolongation.  Monitor ECGs.  Discontinue the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops. <\/span><\/p>\n

\u2022 Reproductive effects: Pretomanid caused testicular atrophy and impaired fertility in male rats.  Advise patients of reproductive toxicities seen in animal studies and that the potential effects on human male fertility have not been adequately evaluated. <\/span><\/p>\n

\u2022 Lactic acidosis was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Consider interrupting linezolid or the entire combination regimen of Pretomanid Tablets, bedaquiline, and linezolid dosing if significant lactic acidosis develops. <\/span><\/p>\n

 <\/span><\/p>\n

ADVERSE REACTIONS <\/strong><\/strong><\/span><\/p>\n

Most common adverse reactions (\u226510%) are peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased transaminases, dyspepsia, decreased appetite, rash, pruritus, abdominal pain, pleuritic pain, increased gamma-glutamyltransferase, lower respiratory tract infection, hyperamylasemia, hemoptysis, back pain, cough, visual impairment, hypoglycemia, abnormal loss of weight, and diarrhea. <\/span><\/p>\n

 <\/span><\/p>\n

DRUG INTERACTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Strong or moderate CYP3A4 inducers such as rifampin or efavirenz: Avoid co-administration.  <\/span><\/p>\n

\u2022 Organic anion transporter-3 (OAT3) substrates: Monitor for OAT3 substrate drug-related adverse reactions and consider dosage reduction for OAT3 substrate drugs, if needed. <\/span><\/p>\n

 <\/span><\/p>\n

USE IN SPECIFIC POPULATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Lactation: Breastfeeding is not recommended. <\/span><\/p>\n

 <\/span><\/p>\n

Storage <\/strong><\/strong><\/span><\/p>\n

Store at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F), excursions permitted between 15\u00b0C and 30\u00b0C (59\u00b0F and 86\u00b0F) [see USP Controlled Room Temperature]. Protect from moisture. <\/span><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.<\/p>","protected":false},"featured_media":2077,"comment_status":"open","ping_status":"closed","template":"","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"jetpack_seo_schema_type":""},"product_brand":[],"product_cat":[36],"product_tag":[],"class_list":["post-672","product","type-product","status-publish","has-post-thumbnail","product_cat-tuberculosis","first","instock","shipping-taxable","purchasable","product-type-simple"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product\/672","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/comments?post=672"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/media\/2077"}],"wp:attachment":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/media?parent=672"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_brand?post=672"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_cat?post=672"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_tag?post=672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}