Pidotimod is an immunostimulant that enhances the immune system in immunodeficiency conditions which make a person more prone to frequent infections, especially respiratory tract infections. It is indicated for recurrent upper and lower respiratory tract infections in children and adults, acute respiratory tract infections, asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, rhinitis, sinusitis, pneumonia, and other immunological disorders.

In general, Pidotimod strengthens and stimulates both humoral immunity and cell-mediated immunity involving T lymphocytes. It also enhances macrophage migration, which plays a key role in immune defense by helping phagocytosis and elimination of infectious organisms. Pidotimod provides effective preventive and protective action against infections caused by Gram-positive and Gram-negative bacteria. This effect is not due to direct antimicrobial activity, but due to its immunostimulant properties.

After oral administration, Pidotimod is rapidly absorbed. In tablet form, peak plasma concentration is reached about 1.5 hours after administration in adults. Oral bioavailability is about 42–44%. Food delays absorption and may reduce bioavailability by up to 50%, so it is recommended to take it 2 hours before or 2 hours after meals. It is widely distributed in the body and undergoes minimal liver metabolism with no known active metabolites. Plasma protein binding is very low, reducing drug interactions. The elimination half-life is approximately 4 hours, and it is mainly excreted through urine with a small amount in feces.

Acute Phase:

• Dose in adults: Take 2 tablets of 400 mg or 1 tablet of 800 mg, twice a day, two hours before or two hours after food and for 15 days.
• Dose in the elderly and children: Take 1 tablet of 400 mg, twice a day, two hours before or two hours after food and for 15 days.

Prophylactic Phase:

• Dose in adults: Take 2 tablets of 400 mg or 1 tablet of 800 mg, once a day, two hours before or two hours after food and for 60 days.
• Elderly and children: Take 1 tablet of 400 mg, 1 time a day, two hours before or two hours after food and for 60 days.

Missed Dose: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Pidotimod does not interfere with antibiotics and does not alter their side effects. However, it may interact with drugs that suppress or stimulate lymphocyte activity, such as thymostimulin. It may also affect immune mechanisms related to IgE, including hyper-IgE syndromes. Food intake delays absorption and may reduce bioavailability by up to 50%.

Pidotimod should not be used together with immunosuppressive therapy or in patients with known hypersensitivity to the drug.

It is generally well tolerated. Rarely, diarrhea may occur. At high doses, sedation, ataxia, dyspnea, and cyanosis have been reported.

There are no adequate controlled studies in pregnant women. It is not recommended during the first trimester. It should be used during pregnancy only if clearly needed and under medical supervision. It is not excreted in breast milk.

Patients should inform the doctor if they are allergic to Pidotimod or other medicines. Kidney disease or diabetes should also be reported. All ongoing medications should be disclosed as they may affect drug action. Use with caution in children under 12 years, and dosage may be adjusted by a physician. Alcohol consumption is not recommended. Smoking may worsen symptoms. No evidence of carcinogenic, mutagenic, teratogenic, or fertility effects has been found.

Pediatric Use: Not recommended for children under 3 years. Dosage should be determined by a physician based on age, body weight, and infection severity.
Geriatric Use: Should be used with caution in elderly patients, especially those with kidney impairment.

No clinical data are available for overdose. However, acute toxicity is low. High doses may cause mild sedation, ataxia, dyspnea, and cyanosis, which usually resolve within 24 hours after stopping the drug and supportive treatment such as gastric lavage and activated charcoal.

Cellular immunity mediator

Store below 30°C in a dry place, protected from light. Keep out of reach of children.