REGISTRATION NUMBER
P N003610/01
TRADE NAME
Arbidol®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Umifenovir
DOSAGE FORM
Capsules
COMPOSITION PER CAPSULE
Active ingredient: Umifenovir hydrochloride monohydrate – 103.5 mg (equivalent to 100 mg Umifenovir hydrochloride).
Excipients: Potato starch – 30.14 mg, Microcrystalline cellulose 101 – 52.26 mg, Colloidal silicon dioxide – 2.0 mg, Povidone K-25 – 10.1 mg, Calcium stearate – 2.0 mg.
CAPSULE COMPOSITION
Shell: Titanium dioxide (E 171) – 2.0000%, Gelatin – up to 100%.
Cap: Titanium dioxide (E 171) – 1.3333%, Sunset yellow dye (E 110) – 0.0044%, Quinoline yellow dye (E 104) – 0.9197%, Gelatin – up to 100%.
DESCRIPTION
Hard gelatin capsules No. 1, with a white body and yellow cap. The capsule contents are a mixture of granules and powder ranging from white to white with a yellowish or greenish-yellow tint.
PHARMACOLOGICAL GROUP
Antiviral Agent
ATC CODE
J05AX13
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Arbidol® is an antiviral drug that inhibits in vitro influenza A and B viruses, including high-pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other acute respiratory viruses (coronavirus, rhinovirus, adenovirus, respiratory syncytial virus, and parainfluenza virus). Its antiviral mechanism involves hemagglutinin interaction, preventing viral lipid envelope fusion with cell membranes. It has moderate immunomodulatory effects and enhances resistance to viral infections.
Arbidol® induces interferons, with production observed 16 hours post-administration and elevated titers persisting for 48 hours. It stimulates cellular and humoral immunity, increasing blood lymphocytes (particularly T-cells), normalizing the immunoregulatory index, and boosting phagocytic macrophage function and natural killer (NK) cell count.
Therapeutic efficacy is demonstrated by reduced illness duration and severity, diminished complications, and mitigated exacerbations of chronic bacterial diseases. Clinical studies show significant reduction in influenza symptoms and viral RNA detection by Day 4. The drug is low-toxicity (LD50 > 4 g/kg) and well-tolerated at recommended doses.
PHARMACOKINETICS
Arbidol® is rapidly absorbed and distributed in organs and tissues. Maximum plasma concentration is reached within 1.5 hours. It is metabolized in the liver, with a half-life of 17-21 hours. About 40% is excreted unchanged, mainly in bile (38.9%) and minimally by the kidneys (0.12%). Within 24 hours, 90% of the dose is eliminated.
INDICATIONS
- Prevention and treatment of influenza A and B, other acute respiratory viral infections (ARVI).
- Combination therapy for recurrent herpes infections.
- Prevention of postoperative infectious complications.
- Combination therapy for acute rotavirus infections in children over 6 years.
CONTRAINDICATIONS
- Hypersensitivity to Umifenovir or any excipients.
- Children under 6 years.
- First trimester of pregnancy.
- Breastfeeding period.
USE WITH CAUTION
Second and third trimesters of pregnancy.
PREGNANCY AND LACTATION
Animal studies show no harmful effects on pregnancy or fetal development. Use is contraindicated in the first trimester. In the second and third trimesters, it may be used for influenza treatment and prevention if the potential benefit outweighs the risk. Consult a physician for benefit-risk assessment. Unknown if it is excreted in human breast milk; discontinue breastfeeding if use is necessary.
DOSAGE AND ADMINISTRATION
Oral administration before meals.
SINGLE DOSE BASED ON AGE
Children 6-12 years: 100 mg (1 capsule).
Children >12 years and adults: 200 mg (2 capsules).
DOSING SCHEDULE
| Indication | Dosage Schedule |
|---|---|
| Non-specific prevention during epidemics | Single dose 2 times/week for 3 weeks. |
| Post-exposure prevention | Single dose daily for 10-14 days. |
| Treatment of influenza and ARVI | Single dose 4 times/day (every 6 hours) for 5 days. |
| Combination therapy for recurrent herpes | Single dose 4 times/day (every 6 hours) for 5-7 days, then 2 times/week for 4 weeks. |
| Prevention of postoperative infections | Single dose 2 days pre-surgery, then on Day 2 and Day 5 post-surgery. |
| Acute rotavirus infections (children >6 years) | Single dose 4 times/day (every 6 hours) for 5 days. |
SIDE EFFECTS
Generally well-tolerated. Rare side effects include allergic reactions.
Frequency classification (WHO): Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), unknown (not determinable from data).
OVERDOSE
No cases reported.
DRUG INTERACTIONS
No adverse interactions noted with antipyretics, mucolytics, or local vasoconstrictors. Specific clinical studies on interactions are unavailable.
SPECIAL INSTRUCTIONS
Adhere to the prescribed regimen and duration. If a dose is missed, take it as soon as possible and continue as prescribed. Consult a physician if symptoms persist beyond 3 days.
EFFECTS ON DRIVING AND MACHINERY
Does not impair ability to drive or operate machinery.
FORM OF RELEASE
Capsules, 100 mg.
5 or 10 capsules in PVC/aluminum blister packs.
1, 2, or 4 blister packs with instructions in a cardboard box.
STORAGE CONDITIONS
Store at temperatures not exceeding 25°C. Keep out of reach of children.
SHELF LIFE
3 years. Do not use beyond the expiration date.
DISPENSING CONDITIONS
Over-the-counter.
MANUFACTURER
OTCPharm JSC, Russia. https://otcpharm.ru/, https://arbidol.ru/