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pretomanid

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Putomani is an anti-tuberculosis prescription drug. Please note when purchasing it: it must be purchased with a doctor’s prescription and self-medication is strictly prohibited.

1. Drug name

1. Common name: Pretomanid

2. Trade name: Pretomanid Tablets

2. Indications < /h2>

1. As part of a combination treatment regimen, combined with bedaquiline and linezolid, for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) or multidrug-resistant tuberculosis (MDR-TB) who are intolerant/unresponsive to standard therapy.

2. Restriction : Not applicable to patients with drug-sensitive tuberculosis, latent tuberculosis infection, extrapulmonary tuberculosis infection, or non-intolerant/unresponsive MDR-TB [1].

3. Specifications and properties of

1. Specifications: Each tablet contains 200 mg of putomanid.

2. Characteristics: Tablets.

IV. Main ingredient

1. Active ingredient: Putomanid.

2. Excipients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate [11].

5. Usage and dosage

1. Requirements for combined use of : Must be used in combination with bedaquiline and linezolid.

2. Specific protocol :

(1.) Putomanib: 200 mg orally, once a day for 26 weeks.

(2.) Bedaquiline: 400 mg once a day for the first 2 weeks, then 200 mg 3 times a week for the next 24 weeks (interval ≥ 48 hours).

(3.) Linezolid: Starting at 1200 mg once a day, adjust the dose according to toxicity (can be reduced to 600 mg or 300 mg).

(4.) How to take : Swallow the whole tablet with food.

VI. Dose adjustment

1. Treatment of missed doses : The dose of the combination regimen that is missed due to safety reasons can be retaken at the end of treatment; the dose missed due to adverse reactions of linezolid does not need to be retaken.

2. Interruption of treatment : If bedaquiline or putomanid is discontinued, the entire combination regimen needs to be stopped; if linezolid is discontinued in the first 4 weeks, all drugs need to be stopped. Bedaquiline and putomanid can be continued after linezolid is discontinued after 4 weeks.

7. Medication precautions

1. Dietary requirements : Need to be taken with food to improve absorption.

2. Monitoring requirements :

Liver function (baseline, after 2 weeks, monthly monitoring).

Blood routine (baseline, after 2 weeks, monthly monitoring).

Electrocardiogram (baseline, weeks 2, 12, and 24).

3. Vomiting treatment : If you vomit after taking the medicine, there is no need to take a supplement and continue taking the medicine as originally planned.

8. Medication for special groups

1. Pregnancy : There is no human data, and animal experiments show that high doses may increase the risk of miscarriage. The pros and cons need to be weighed.

2. Breastfeeding : Avoid breastfeeding. The drug concentration in rat milk is higher than that in plasma.

3. Male fertility : It may cause testicular atrophy and decreased fertility, and the risks need to be informed.

4. Liver and kidney insufficiency : The safety is not clear, so caution is required.

9. Adverse reactions

Common (≥10%) include: Peripheral neuropathy (81%), acne (39%), anemia (37%), nausea (37%), vomiting (34%), headache (28%), elevated transaminases (28%), etc.

10. Contraindications

It is prohibited for those with contraindications to bedaquiline or linezolid.

11. Drug interactions

1. CYP3A4 inducer (such as rifampicin, efavirenz): Avoid combined use, which may reduce the plasma concentration of putomanid.

2. OAT3 substrate drug (such as methotrexate): Monitor adverse reactions and adjust the dose if necessary.

12. Storage method

1. Storage temperature: below 30°C (86°F).

2. Keep the original packaging sealed.