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Aminodihydrophthalazinedione sodium

Immunomodulators (local classification). Russian development.

ATC code: L03AX-GALAVIT

Updated · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Immune support and respiratory infection care

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. Galavit does not replace evidence-based treatment of bacterial complications of a cold. If it has already been prescribed, discuss options with proven efficacy with your doctor.

Sources

  1. Cochrane (Hemila and Chalker): Vitamin C for preventing and treating the common cold (2013)
D

Prevention of recurrent respiratory infections

Not recommended

For recurrent URI prevention in adults and children with frequent infections, galavit is prescribed as sublingual tablets or rectal suppositories in courses. International paediatric guidelines on frequent respiratory infections do not list the drug. Evidence-based prevention: influenza and pneumococcal vaccination, hand hygiene, sleep and nutrition normalisation.

Sources

  1. Cochrane: Echinacea for preventing and treating the common cold (2014)

ICD-10: Z29.9

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

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.

Safety

Contraindications

  • Pregnancy and breastfeeding
  • Hypersensitivity

Serious adverse effects

  • Independent data on serious adverse events are unavailable

Common adverse effects

  • Allergic reactions (rare per label)

Pregnancy: can you take Aminodihydrophthalazinedione sodium?

Contraindicated in pregnancy per label.

Breastfeeding: can you take Aminodihydrophthalazinedione sodium?

Contraindicated during breastfeeding per label.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Galavit is supplied as 25 mg sublingual tablets, 50 and 100 mg rectal suppositories, and lyophilisate for injection. In Russia, the drug is sold over the counter in most pharmacies. Retail price 600–1500 ₽ per pack. Not registered in the US, EU, or UK. Rarely indexed in international literature, primarily in Russian journals.

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Frequently asked

What is Aminodihydrophthalazinedione sodium used for?

Aminodihydrophthalazinedione sodium is evaluated for the following indications with varying evidence strength: Immune support and respiratory infection care (evidence tier D), Prevention of recurrent respiratory infections (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Aminodihydrophthalazinedione sodium?

Common side effects of Aminodihydrophthalazinedione sodium (≥ 1 in 100): Allergic reactions (rare per label). See the Safety section for uncommon and serious reactions.

Is Aminodihydrophthalazinedione sodium safe during pregnancy?

Contraindicated in pregnancy per label.

Is Aminodihydrophthalazinedione sodium compatible with breastfeeding?

Contraindicated during breastfeeding per label.

Who should not take Aminodihydrophthalazinedione sodium?

Aminodihydrophthalazinedione sodium is contraindicated in: Pregnancy and breastfeeding; Hypersensitivity. Full list in the Safety section.

Other drugs in this group

Glucosaminyl muramyl dipeptide, Bacterial lysates OM-85, Azoximer bromide, α-Glutamyl-L-tryptophan, Alloferon (Allokin-alfa), Sodium deoxyribonucleate (Derinat), Interferon α-2b in suppositories, Cat's claw