Each 5 mL syrup contains: Inosiplex 250 mg.
Each tablet contains: Inosiplex 500 mg.
Pharmacology: Pharmacodynamics: Inosiplex is used in the treatment of a variety of viral infections. It acts by modifying or stimulating cell-mediated immune processes rather than acting directly on the virus.
In vitro exposure of cells to inosiplex induces T-lymphocyte differentiation and potentiation of induced lymphoproliferative responses. The drug modulates T-lymphocyte and natural killer cell cytotoxicity, suppressor and helper cell functions. It also increases the number of IgG and complement surface markers. Interleukin-1 and -2 production, and neutrophil, monocyte and macrophage chemotaxis and phagocytosis are also potentiated by inosiplex.
In vivo antiviral and possible antitumor activity of inosiplex is believed to result from enhancement of host immune responses. The drug does not by itself stimulate resting lymphocytes but augments immunological processes by lymphocytes once they have been triggered by mitogens or viral agents.
Pharmacokinetics: Inosiplex is rapidly and completely absorbed (≥90%) from the gastrointestinal tract with peak plasma concentrations occurring 1 hr after an oral dose. It is also rapidly metabolized with a plasma half-life (t½) of 50 min. The inosine portion of the complex yields uric acid and the other components undergo oxidation and glucuronidation. The metabolites are excreted in the urine.
As an immunomodulator for the management of patients with immunodepression suffering from viral infections such as subacute sclerosing panencephalitis (SSPE), varicella, herpes simplex Type 1 and 2.
In the management of recurrent herpes simplex Type 1 and 2.
As an adjunct in the treatment of genital warts.
Usual Pediatric Dose:
50 mg/kg body weight per day, up to a maximum of 100 mg/kg body weight per day, given in divided doses every 4 to 6 hours.
Usual Adult Dose:
50 mg/kg body weight per day, up to a maximum of 4 g/day, given in divided doses every 6 to 8 hours.
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Inosiplex Tablet: Adult Dose:
2 tablets every 6 hours for 5 to 14 days.
Dosing Schedule for Specific Indications: In Adults and Children: SSPE:
50-100 mg/kg body weight/day in divided doses every 4 hours continuously, with regular monitoring to evaluate patient status and requirement for extended treatment.
In Adults: Herpes simplex:
1 g every 6 hours, for 7 to 14 days.
1 g every 8 hours, for 14 to 28 days, as an adjunct to standard topical (podophyllin) or surgical (carbon dioxide laser) treatment.
Or, as prescribed by a physician.
Known hypersensitivity to any component of the product.
Patients suffering from gout or elevated uric acid blood levels.
Inosiplex may cause a transient increase of baseline serum and urine concentrations of uric acid, particularly in men and in the elderly, because of the catabolic metabolism of the inosine content of inosiplex to uric acid in humans. It is not due to a fundamental drug-induced alteration of enzyme or renal clearance function. Therefore, inosiplex should be used with caution in patients with a history of gout, hyperuricemia, urolithiasis, nephrolithiasis, or in those with renal impairment. The uric acid levels of these patients should be monitored closely during inosiplex therapy.
If administered continuously for 3 months or longer, the serum and urine concentrations of uric acid, blood count, liver and renal functions should be monitored regularly in all patients.
Carcinogenicity, Mutagenicity, Impairment of Fertility: Standard mutagenicity assays and in vivo studies in mice and rats and in vitro studies in human peripheral blood lymphocytes revealed no aberrant properties.
Long-term toxicology studies in mice and rats have shown no indication of carcinogenic properties of inosiplex.
Reproduction studies in mice, rats and rabbits at continuous parenteral dosing of up to 20 times the maximum therapeutically recommended human dose (20 x 100 mg/kg/day) have shown no evidence of perinatal toxicity, embryotoxicity, teratogenicity or impaired reproductive function due to inosiplex.
Use in pregnancy: Since more are no adequate studies in pregnant women, inosiplex should be used during pregnancy only when the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known if inosiplex is excreted in human milk; thus, it should be used with caution in breastfeeding women.
The only consistently observed drug-related side effect is transient elevation (usually remaining within normal range) of urine and serum uric acid levels, which usually returns to baseline values a few days after the end of treatment.
Additional adverse effects that have been reported infrequently/rarely during clinical and post-marketing surveillance studies include: Gastrointestinal:
Nausea with or without vomiting, abdominal pain, epigastric discomfort, diarrhea, constipation.
Pruritus/itching, skin rashes, exacerbation of allergic rash.
Headache, vertigo, fatigue, malaise, nervousness, drowsiness, insomnia/sleeplessness.
Elevation of transaminases, alkaline phosphatase or blood urea nitrogen (BUN) levels, There is some evidence that doses of 8 g/day may produce hepatotoxicity.
Other Adverse Effects:
Arthralgia, cold-like reaction (sinusitis).
Concurrent administration with zidovudine increases plasma levels of zidovudine and prolongs gastrointestinal.
Inosiplex should be used with caution with xanthine oxidase inhibitors or uricosuric agents, including diuretics.
Store in a dry place at temperatures not exceeding 30°C, in a dry place. Protect from light.
J05AX05 - inosine pranobex ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
Tab 500 mg (yellow to yellow-white, ½" round, flat, bevel-edged layered, bisected on one side and plain on the other side) x 24's. Syr 250 mg/5 mL (clear, red-orange in color and strawberry flavored) x 60 mL.