Putomani is an anti tuberculosis prescription drug, please note that it must be purchased with a physician's prescription and self medication is strictly prohibited.

1、 Drug name

1. Common name: Pretomanid

2. Product Name: PretomanidTablets

2、 Indications

1. As part of the combination treatment scheme, it is used in combination with bedaquiline and linezolid to treat adult lung extensively drug-resistant tuberculosis (XDR-TB) or multi drug resistant tuberculosis (MDR-TB) that is intolerant/unresponsive to standard therapy.

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

3、 Specifications and characteristics

1. Specification: Each tablet contains 200mg of Protomani.

2. Appearance: Tablets.

4、 Main components

1. Active ingredient: Protomani.

2. Accessories: Colloidal silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, sodium dodecyl sulfate, sodium starch glycolate [11].

5、 Usage and dosage

1. Combination therapy requirement: Must be used in combination with bedaquiline and linezolid.

2. Specific plan:

(1.) Putomani: 200mg orally, once daily, for 26 consecutive weeks.

(2.) Bedaquiline: 400mg once a day for the first 2 weeks, and 200mg three times a week for the next 24 weeks (with an interval of ≥ 48 hours).

(3.) Linezolid: Start at 1200mg once daily, adjust the dosage according to toxicity (can be reduced to 600mg or 300mg).

(4.) Medication method: Swallow the whole tablet and take it with food.

6、 Dose adjustment

1. Omission treatment: The dosage of the combination therapy missed due to safety reasons can be supplemented at the end of treatment; The missed dose due to adverse reactions of linezolid does not require supplementation.

2. Interruption of treatment: If bedaquiline or propranolib is discontinued, the entire combination regimen must be discontinued; If linezolid is discontinued in the first 4 weeks, all drugs need to be discontinued. After 4 weeks, linezolid can continue to be used with bedaquiline and propranolib.

7、 Medication precautions

1. Dietary requirements: It should be taken together with food to improve absorption.

2. Monitoring requirements:

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

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

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

3. Vomiting treatment: If vomiting occurs after taking medication, there is no need to take additional medication, and medication should continue according to the original plan.

8、 Medication for special populations

1. Pregnancy: No human data available, animal experiments show that high doses may increase the risk of miscarriage. We need to weigh the pros and cons.

2. Breastfeeding: Avoid breastfeeding as the drug concentration in rat milk is higher than in plasma.

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

4. Liver and kidney dysfunction: Safety is not clear, caution is needed.

9、 Adverse reactions

Common (≥ 10%) conditions include peripheral neuropathy (81%), acne (39%), anemia (37%), nausea (37%), vomiting (34%), headache (28%), elevated transaminase levels (28%), etc.

10、 Contraindications

Prohibited for individuals with contraindications to bedaquiline or linezolid.

11、 Drug interactions

1. CYP3A4 inducers (such as rifampicin and efavirenz): Avoid combination therapy as it may lower the blood concentration of propofol.

2. OAT3 substrate drugs (such as methotrexate): Monitor for adverse reactions and adjust dosage if necessary.

12、 Storage method

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

2. Keep the original packaging sealed.

pretomanidinformation