Pidotimod

Indications

Pidotimod is an immunostimulant that boost up immunity system in immunodeficiency conditions that predispose an individual to frequent infections, specially 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 disorders, chronic bronchitis, rhinitis, sinusitis, pneumonia and immunological disorders.

Pharmacology

In general, Pidotimod reinforces and stimulates both the immunological mechanisms involved in humoral immunity and those of cellular immunity mediated by T lymphocytes. At the same time, it stimulates and increases the migration of the macrophage which is an essential and primordial point in the cellular immune response where it serves the purpose of obtaining an adequate phagocytosis and elimination of the infectious germ. Pidotimod has an effective and efficient prophylactic and protective action against infections by Gram positive and Gram-negative germs that is not due to an intrinsic antimicrobial property of pidotimod but rather to its immunostimulant effect.

Pidotimod is rapidly absorbed following oral administration. For the Pidotimod tablet, the mean peak plasma concentration is achieved 1.5 hours after administration in adults. oral bioavailability was 42-44%. The Administration with food does not affect the extent of absorption of Pidotimod but results in a delay in the absorption of the drug and a reduction in its bioavailability of up to 50%. So, it is recommended to administer Pidotimod two hours before or two hours after food. It is widely distributed throughout the body. Pidotimod is almost completely absorbed when administered orally. It undergoes little metabolism in the liver. No known metabolites. Its binding to plasma proteins is very poor, a fact that represents an advantage, because it does not interfere with other medications. It has a half-life of approximately 4 hours. It is eliminated mainly in the urine and little in the feces.

Dosage & Administration

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.

Interaction

Pidotimod does not interfere with the use of antibiotics nor does it modify the side effects caused by them. pidotimod can interact with drugs that block or stimulate lymphocyte activity, such as thymostimulin. It can also interfere with those mechanisms that are somehow connected to IgE, such as hyper IgE syndromes. The intake of Pidotimod with food results in a delay in the absorption of the drug and a reduction in its bioavailability of up to 50%.

Contraindications

Should not be administered simultaneously with immunosuppressive treatment or in patients with known hypersensitivity to Pidotimod.

Side Effects

It is generally well tolerated, but diarrhea may rarely occur in some patients. At high doses and based on experience, sedation, ataxia, dyspnea, and cyanosis may occur.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. It should not recommend during the first trimester of pregnancy. During pregnancy, Pidotimod should only be used taking into account the risk benefit factor and under medical supervision. It is not excreted by breast milk. Consult your doctor before taking it.

Precautions & Warnings

Inform the doctor if Patients are allergic to Pidotimod or other medicines. Before taking this medicine, let the doctor know if he has kidney disease or diabetes. Doctor should also know about all other medications are taking, as many of these may make this medicine less effective or change how it works. And also, inform the doctor if Patients are pregnant or breastfeeding. Pidotimod to be taken with caution, especially if patients are children below 12. In this case, doctor may adjust your dose depending on patient’s age. Consumption of alcohol with Pidotimod is not advisable as it may cause unpleasant side effects. Do not smoke- it can make patients symptoms worse. does not cause any adverse effect of carcinogenesis. Nor have mutagenic, teratogenic and fertility alterations been found.

Use in Special Populations

Pediatric Use: Pidotimod Tablet is recommended not to be taken by children less than 3 years. It is recommended to consult a doctor before giving it to children so as to decide the required dosage of the medicine on the basis of body mass, age and condition of infection.

Geriatric Use: Pidotimod Tablet should be used with caution in elderly patients especially the ones suffering from kidney diseases. Consult your doctor before using pidotimod Tablet

Overdose Effects

There are no clinical data on overdose when administered at doses higher than those recommended. However, the acute toxicity of Pidotimod is low: In these cases, slight sedation, ataxia, dyspnea, and cyanosis occurred, which disappeared 24 hours after discontinuing treatment and after gastric lavage, activated charcoal, and supportive measures.

Therapeutic Class

Cellular immunity mediated

Storage Conditions

Store below 30ºC & dry place, away from light. Keep out of the reach of children.