Is tobramycin inhalation solution on the market in China

Tobramycin Inhalation Solution is an inhaled antibiotic preparation specifically used to treat bronchopulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis. It was developed by the Swiss company Novartis and was approved by the US FDA in 1997. The drug is administered through aerosol inhalation and can directly act on the site of respiratory tract infection. At present, the drug is not yet available in mainland China, nor is it included in the scope of medical insurance reimbursement. Patients need to obtain it through special channels.

Is tobramycin inhalation solution available on the domestic market?

Understanding the domestic marketing situation is of great significance to patients who need this drug treatment.

Domestic registration and approval status

As of now, tobramycin inhalation solution has not yet received marketing approval from the China National Medical Products Administration. A query of the drug registration database showed that the product did not appear in the list of approved imported drugs.

Analysis of reasons for non-marketing

Perhaps due to the relatively small number of cystic fibrosis patients in China, pharmaceutical companies have not given priority to registration in China. This drug needs to be used with a special atomizer, which increases the difficulty of clinical application. The lack of competition among similar products in China also reduces the enthusiasm of pharmaceutical companies to apply.

Although it has not yet been launched in China, patients can still obtain the drug through other channels. The specific purchase methods will be introduced below.

Is tobramycin inhalation solution easy to buy?

For patients who are in urgent need of treatment with this drug, it is important to understand the legal purchasing channels.

Formal acquisition channels

Patients can purchase Turkish products through institutions with cross-border medical service qualifications. The international medical departments of some large hospitals may assist in bringing in patients from overseas through legal channels. A complete prescription and proof of diagnosis are required at time of purchase.

Price and authenticity identification

The price of the Turkish version of the product is approximately US$961 per box (300mg/5ml). The price only reflects overseas legal information and does not make any purchase recommendations or price commitments. It is necessary to confirm that the outer packaging of the medicine is complete and the batch number is clear and can be checked. Check that the medicinal solution should be a light yellow clear liquid with no suspended solids or sediment. Purchasing through formal channels can reduce the risk of buying counterfeit medicines.

Understanding the pharmacokinetic properties of the drug will help in its rational use. The relevant properties will be introduced in detail below.

Pharmacokinetics of tobramycin inhalation solution

Understanding the absorption, distribution, metabolism and excretion characteristics of the drug has guiding significance for clinical medication.

Absorption and distribution characteristics

After inhalation administration, the drug directly acts on the respiratory tract and has high lung bioavailability. The half-life of intravenous injection is about 2 hours, and the half-life of inhaled administration is extended to 3 hours, showing that inhaled administration can maintain effective concentrations in the lungs for a longer period of time.

Metabolism and excretion pathways

Tobramycin is almost not metabolized and is mainly excreted unchanged through the kidneys. Patients with renal insufficiency need to adjust the dosage regimen. Similar to other aminoglycosides, blood concentration should be monitored during treatment to avoid accumulation poisoning.

Pregnant women, lactating women and children should use it with special caution. Elderly patients and those with renal insufficiency need to adjust the dosage. If symptoms such as tinnitus and dizziness occur during medication, you should seek medical attention immediately.