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Inosine pranobex (United States: Not available): Drug information

Inosine pranobex (United States: Not available): Drug information
(For additional information see "Inosine pranobex (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Imunovir
Pharmacologic Category
  • Antiviral Agent
Dosing: Adult
Subacute sclerosing panencephalitis

Subacute sclerosing panencephalitis: Oral: 50 mg/kg/day in 3 to 4 equally divided doses (maximum: 3 g daily).

Dosing: Kidney Impairment: Adult

There is no dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There is no dosage adjustment provided in manufacturer’s labeling.

Dosing: Pediatric
Subacute sclerosing panencephalitis

Subacute sclerosing panencephalitis (SSPE): Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There is no dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There is no dosage adjustment provided in manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Imunovir: 500 mg

Product Availability

Not available in the US

Administration: Adult

Oral: Administer orally in 3 to 4 equally divided doses while awake.

Administration: Pediatric

Oral: Administer orally in 3 to 4 equally divided doses while awake.

Use: Labeled Indications

Note: Not approved in the US.

Treatment of slowly progressive subacute sclerosing panencephalitis; may delay neurologic deterioration and prolong life expectancy.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Dizziness, fatigue, headache, insomnia, nervousness

Dermatologic: Pruritus, skin rash

Endocrine & metabolic: Hyperuricemia

Gastrointestinal: Constipation, diarrhea, gastric distress

Genitourinary: Increased urine output

Neuromuscular & skeletal: Arthralgia

Contraindications

There are no contraindications listed in the manufacturer’s product monograph.

Warnings/Precautions

Concerns related to adverse effects:

• Uric acid: Inosine undergoes rapid metabolism to uric acid. Use with caution in patients with a history of gout, urolithiasis, nephrolithiasis, or kidney impairment. Uricosuric agents (eg, probenecid) or antihyperuricemic therapy (eg, allopurinol) may be necessary for extremely elevated serum uric acid levels.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse effects to the fetus were not observed in animal reproduction studies. Due to the altered immune status of patients who are pregnant, subacute sclerosing panencephalitis may be exacerbated during pregnancy and may progress rapidly. Because this condition is rare, use of inosine pranobex in pregnancy is limited to case reports (Cole 2007).

Monitoring Parameters

Uric acid (serum and urine)

Mechanism of Action

Exact mechanism has not been fully elucidated; may possess antiviral and immunomodulating effects by potentiating T-lymphocyte and macrophage cell function and by influencing cytokine production (Milano, 1991; Petrova, 2010; Wybran, 1978).

Pharmacokinetics

Metabolism: Rapid to uric acid; also undergoes glucuronidation and oxidation

Half-life elimination: ~50 minutes (Campoli-Richards, 1986)

Time to peak: 1 hour (Campoli-Richards, 1986)

Excretion: Urine (as uric acid, glucuronide and oxide metabolites, and unchanged drug)

Brand Names: International
  • Groprinosin (UA);
  • Imin (SG, TW);
  • Imunovir (GB, IE);
  • Isoprinosine (AE, BE, BG, CL, CR, CZ, DE, DO, EG, FR, GR, GT, HN, HR, LT, LU, LV, NI, PA, PH, RO, RU, SK, SV, UA);
  • Isprinol (ID);
  • Neosine (PL);
  • Noviron (UA);
  • Prinol (ID);
  • Prinosine (KR);
  • Pronovir (ID);
  • Qualiprinol (HK);
  • Soprinol (TW);
  • Virux (TW)


For country code abbreviations (show table)
  1. Campoli-Richards, Sorkin EM, and Heel RC, “Inosine Pranobex. A Preliminary Review of Its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Efficacy,” Drugs, 1986, 32(5):383-424. [PubMed 2431857]
  2. Chang TW and Weinstein L, “Antiviral activity of Isoprinosine in vitro and in vivo,” Am J Med Sci, 1973, 265(2):143-6. [PubMed 4350802]
  3. Cole AJ, Henson JW, Roehrl MH, et al. Case records of the Massachusetts General Hospital. Case 24-2007. A 20-year-old pregnant woman with altered mental status. N Engl J Med. 2007;357(6):589-600. [PubMed 17687135]
  4. Imunovir (inosine pranobex) [product monograph]. Swords, Co Dublin, Ireland: KoRa Healthcare; October 2012.
  5. Milano S, Dieli M, Millott S, et al, “Effect of Isoprinosine on IL-2, IFN-ϒ and IL-4 Production in vivo and in vitro,” Int J Immunopharmacol, 1991, 13(7):1013-8. [PubMed 1722191]
  6. Ohnishi H, Kosuzume H, Inaba H, et al, “The Immunomodulatory Action of Inosiplex in Relation to its Effects in Experimental Viral Infections,” Int J Immunopharmacol, 1983, 5(3):181-96. [PubMed 6194125]
  7. Petrova M, Jelev D, Ivanova A, et al, “Isoprinosine Affects Serum Cytokine Levels in Healthy Adults,” J Interferon Cytokine Res, 2010, 30(4):223-8. [PubMed 20038210]
  8. Wybran J, Govaerts A, and Appelboom T, “Inosiplex, a Stimulating Agent for Normal Human T Cells and Human Leukocytes,” J Immunol, 1978, 121(3):1184-7. [PubMed 80429]
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