Immunomodulators (local classification). Russian development.
ATC code: L03AX-GALAVIT (Aminodihydrophthalazinedione sodium (Galavit) – local code)
Galavit is the sodium salt of aminodihydrophthalazinedione. The manufacturer claims modulation of macrophage and neutrophil functional activity with reversible inhibition of excessive pro-inflammatory cytokine synthesis. Developed in Russia in the 1990s. Not present in international circulation. Independent RCTs with infection incidence, length of hospital stay, or mortality endpoints do not exist.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Galavit is marketed in Russia as a universal immunomodulator across a broad range of infections, inflammation, and postoperative rehabilitation. International clinical guidelines (, , ) do not include the drug; the , , and AEMPS have not approved it. No independent international clinical studies exist. If Galavit was recommended, consider seeking a second opinion.
Not recommended
For recurrent URI prevention in adults and children with frequent infections, galavit is prescribed as sublingual tablets or rectal suppositories in courses. and ERS 2023 paediatric guidelines do not list the drug. Evidence-based prevention: influenza and pneumococcal vaccination, hand hygiene, sleep and nutrition normalisation.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Contraindicated in pregnancy per label.
Contraindicated during breastfeeding per label.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Aminodihydrophthalazinedione sodium is evaluated for the following indications with varying evidence strength: Immune support and respiratory infection care (evidence tier F), Prevention of recurrent respiratory infections (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Aminodihydrophthalazinedione sodium (≥ 1 in 100): Allergic reactions (rare per label). See the Safety section for uncommon and serious reactions.
FDA category N. Contraindicated in pregnancy per label.
Contraindicated during breastfeeding per label.
Aminodihydrophthalazinedione sodium is contraindicated in: Pregnancy and breastfeeding; Hypersensitivity. Full list in the Safety section.