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Isoprinosine prescribing information

 



Prescribing information, recommended dosage:

The prescribing physician will ultimately decide about the details of therapy (dosing, duration, etc.). According to dosing information obtained from published references; patients with cancer can take 2000 mg to 3000 mg of Isoprinosine daily for two months (4-6 tabs of 500 mg Isoprinosine per day). Then they may stop taking Isoprinosine for two months, and then resume taking it at the same dose for another two months.

Packing: 50 tablets, 500 mg 150 ml syrop, 50 mg/ml

Dosages: Because of its immunomodulatory properties Dr. Cheney recommends staggering dosages:
First Month:
•Week One: 6 tablets a day (M-F)
•Week Two: 2 tables a day (M-F)
•Week Three: Repeat Week One
•Week Three: Repeat Week Two
Second Month: Repeat first month
Third Month: Stop Isoprinosine
Four Month: Repeat Month 1
Fifth Month: Repeat Month 1
Six Month: Stop Isopoprinosine

Isoprinosine Syrup
A clear viscous oral solution with a mirabelle plum aroma. Dosage is determined on the basis of lean body weight of the patient and the severity of the disease. Daily administration should be divided evenly during waking hours. The normal duration of acute treatment is 5-14 days.

Adults and the Elderly:
50mg/kg of body weight daily, up to a maximum of 4g, (usually, 20ml x 3-4 times a day).

Children over the age of 1 year:
50mg/kg of body weight daily, (10ml per 10 kg up to 20kgs; thereafter, use adult dose).

SSPE Dosage:
100mg/kg of body weight daily, up to a maximum of 3-4g, continuously, with regular monitoring to evaluate patient status and requirement for extended treatment.

Genital Warts Dosage:
3g (20ml x 3 times a day) for a total of 14-28 days, as an adjunct to conventional topical or surgical procedures


J Interferon Cytokine Res. 2010 Apr;30(4):223-8.
Petrova M, Jelev D, Ivanova A, Krastev Z.
Medical Institute Ministry of Interior, Sofia, Bulgaria. mpetrova@gmail.com

Isoprinosine affects serum cytokine levels in healthy adults.

Isoprinosine is a synthetic purine derivative with immunomodulatory and antiviral properties, which result from an apparent in vivo enhancement of host immune responses. To evaluate the serum levels of certain cytokines during and after isoprinosine treatment, we assigned 10 healthy volunteers to receive isoprinosine 1 g, 3 times daily, 5 consecutive days weekly. Both treatment and follow-up phase last 3 weeks. Interferon-gamma (IFN-gamma), interleukin-2 (IL-2), IL-10, and tumor necrosis factor-alpha (TNF-alpha) were measured in serum using commercial ELISA kits at baseline, 7th, 10th, 14th, 21st, 28th, 35th, and 42nd day. We observed an increase in serum levels of all measured cytokines at 7th to 10th day. The levels of IL-2 had another raise at 42nd day after drop to initial values (P < 0.05; P < 0.001, respectively). Those of IL-10 held up enhanced from 7th to 28th day of measurement (P < 0.01). There was a nearly flat line of values of TNF-alpha after initial slight increase at 10th day. We found a moderate negative correlation between IFN-gamma and IL-2, IL-10, and TNF-alpha (Spearman's r: -0.63, -0.62, -0.63; P < 0.05, respectively). We have demonstrated the immunomodulating properties of isoprinosine in healthy adults. It suggests resumption of the research with up-to-date methods to elucidate the mechanisms of action of inosine pranobex and maybe the other inosine compounds in different clinical settings.


No To Hattatsu. 2009 May;41(3):224-8.
Sato K, Nakagawa E, Nonoda Y, Arai A, Sakuma H, Komaki H, Sugai K, Sasaki M.
Department of Child Neurology, National Center Hospital for Neurology and Psychiatry, National Center of Neurology and Psychiatry, Kodaira, Tokyo.

[Serious complications of intraventricular interferon-alpha and ribavirin in the treatment of subacute sclerosing panencephalitis] [Article in Japanese]

We treated three patients with subacute sclerosing panencephalitis with intraventricular interferon-alpha and oral inosiplex, and followed their clinical courses. One patient was also treated with ribavirin. Results were unsatisfactory; no significant clinical improvement was seen in the patients, and a number of serious complications occurred. Malfunction of the Ommaya reservoir, septic meningitis and chemical encephalopathy were observed in the three patients, respectively. The use of intraventricular interferon-alpha and ribavirin therapy has been increasing despite insufficient evidence of its efficacy. A high risk of serious side effects exists with this therapy. Thus it is important to consider not only the effects but also the side effects and complications as described above. We also propose that a standard protocol for the use of interferon-alpha and ribavirin and the cessation of current therapy is necessary.


Nippon Rinsho. 2007 Aug;65(8):1483-6.
Hosoya M.
Department of Pediatrics, Fukushima Medical University School of Medicine.

[Therapy and prognosis in subacute sclerosing panencephalitis] [Article in Japanese]

Subacute sclerosing panencephalitis (SSPE) is a progressive and fatal central nervous system disorder that results from a persistent SSPE virus infection. Compound which inhibits the replication of SSPE virus might be a candidate for the specific drug for SSPE. Out of several compounds which had been tried for the treatment of SSPE, two drugs, i.e., inosiplex and interferon-a were reported to be effective. Those drugs, however, could not cure the disease. Recently, ribavirin therapy has been proposed as novel antiviral chemotherapy for SSPE. By intraventricular administration, ribavirin level in CSF reaches a concentration at which ribavirin could completely inhibit the replication of SSPE virus. Thus, intraventricular ribavirin therapy might eradicate SSPE virus from the CNS and stop the progression of SSPE syndrome. The therapeutic efficacy should be evaluated in the patients who are treated with the therapy at an early stage of SSPE.


Dev Med Child Neurol. 2010 Jun 15. [Epub ahead of print]
Gutierrez J, Issacson RS, Koppel BS.
Department of Neurology, Miller School of Medicine, University of Miami, Miami, FL, USA.

Subacute sclerosing panencephalitis: an update.

Subacute sclerosing panencephalitis (SSPE) is a chronic encephalitis occurring after infection with measles virus. The prevalence of the disease varies depending on uptake of measles vaccination, with the virus disproportionally affecting regions with low vaccination rates. The physiopathology of the disease is not fully understood; however, there is evidence that it involves factors that favour humoral over cellular immune response against the virus. As a result, the virus is able to infect the neurons and to survive in a latent form for years. The clinical manifestations occur, on average, 6 years after measles virus infection. The onset of SSPE is insidious, and psychiatric manifestations are prominent. Subsequently, myoclonic seizures usually lead to a final stage of akinetic mutism. The diagnosis is clinical, supported by periodic complexes on electroencephalography, brain imaging suggestive of demyelination, and immunological evidence of measles infection. Management of the disease includes seizure control and avoidance of secondary complications associated with the progressive disability. Trials of treatment with interferon, ribavirin, and isoprinosine using different methodologies have reported beneficial results. However, the disease shows relentless progression; only 5% of individuals with SSPE undergo spontaneous remission, with the remaining 95% dying within 5 years of diagnosis.


J Interferon Cytokine Res. 2010 Apr;30(4):223-8.
Petrova M, Jelev D, Ivanova A, Krastev Z.
Medical Institute Ministry of Interior, Sofia, Bulgaria.

Isoprinosine affects serum cytokine levels in healthy adults.

Isoprinosine is a synthetic purine derivative with immunomodulatory and antiviral properties, which result from an apparent in vivo enhancement of host immune responses. To evaluate the serum levels of certain cytokines during and after isoprinosine treatment, we assigned 10 healthy volunteers to receive isoprinosine 1 g, 3 times daily, 5 consecutive days weekly. Both treatment and follow-up phase last 3 weeks. Interferon-gamma (IFN-gamma), interleukin-2 (IL-2), IL-10, and tumor necrosis factor-alpha (TNF-alpha) were measured in serum using commercial ELISA kits at baseline, 7th, 10th, 14th, 21st, 28th, 35th, and 42nd day. We observed an increase in serum levels of all measured cytokines at 7th to 10th day. The levels of IL-2 had another raise at 42nd day after drop to initial values (P < 0.05; P < 0.001, respectively). Those of IL-10 held up enhanced from 7th to 28th day of measurement (P < 0.01). There was a nearly flat line of values of TNF-alpha after initial slight increase at 10th day. We found a moderate negative correlation between IFN-gamma and IL-2, IL-10, and TNF-alpha (Spearman's r: -0.63, -0.62, -0.63; P < 0.05, respectively). We have demonstrated the immunomodulating properties of isoprinosine in healthy adults. It suggests resumption of the research with up-to-date methods to elucidate the mechanisms of action of inosine pranobex and maybe the other inosine compounds in different clinical settings.


Pol Merkur Lekarski. 2009 Aug;27(158):129-31.
Hozyasz KK, Gryglicka H, Radomyska B.
Institute of Mother and Child in Warsaw, Department of Pediatrics, Poland.

[Benign acute childhood myositis (BACM)--cases report] [Article in Polish]

Benign acute childhood myositis (BACM) is characterised by sudden calf pain and inability to walk. We analyzed the characteristics of seven boys and two girls with BACM treated in the Pediatric Department from April 2005 to March 2009. The mean age at onset of symptoms was 7 +/- 2 years. Two boys were hospitalized twice for BACM. All cases occurred in winter or spring. 7 out of all admissions were clustered together in one week long periods. Patients demonstrated prodromal symptoms of flu-like illness followed by the sudden onset of difficulty in walking. One girl additionally complained of a painful right hip. Four patients received inosine pranobex for prodromal viral infection before the clinical onset of myositis. In all cases, creatine phosphokinase (CPK; the highest value at 8988 U/l) and aspartate aminotransferase (AST; the highest value at 329 U/l) values were elevated. The serum concentration of myoglobin was elevated in five out of six tested patients (the highest value at 2172 microg/l). The following haematological abnormalities were detected: leucocytopenia (the lowest WBC 1.35 x 10(3)/microl), neutropenia, and trombocytopenia. All patients made a rapid recovery within 1 to 5 days. Pediatricians and emergency medicine specialists must be aware that BACM is a self-limiting disorder with the acute onset of inability to walk, elevated CPK and AST levels, and transient haematological abnormalities. There is no sufficient data from clinical reports on immunostimulant use before the onset of BACM.


Pol J Vet Sci. 2009;12(2):203-7.
Tykałowski B, Stenzel T, Mazur-Lech B, Andrzejewski M, Koncicki A.
Department of Poultry Diseases, Faculty of Veterinary Medicine, University of Warmia and Mazury in Olsztyn, Oczapowskiego 13, 10-719 Olsztyn, Poland.

The influence of methisoprinol applied in ovo upon hatchability and health status of turkeys.

A study was undertaken to determine the effect of a synthetic immunomodulator, i.e. methisoprinol applied in ovo, upon the hatchability of turkey poults under conditions of a standard hatchery as well as on their health status evaluated based on analyses of selected biochemical indices in their blood serum. Experiments were conducted on 5 groups of BUT 9 turkeys at the age of 5 days (35 birds in each group) hatched from eggs to which methisoprinol (VetAgro, Lublin, Poland) was applied in ovo at a dose of 5 mg (group I), 10 mg (group II) or 20 mg per egg (group III) on the 26th day of incubation. Turkeys hatched from eggs to which a physiological solution of NaCl was applied on the same day at a dose of 0.1 ml per egg (group IV) as well as those hatched from eggs without in ovo injection (group V) served as controls. Five hundreds eggs were used in each group. Hatchability was evaluated based on the number of hatched poults in respect of the number of eggs with live embryos transferred from the setting compartment to the hatching compartment, that were subjected to in ovo administration of the preparations according to the experimental design. Blood serum of the 5-day-old turkey poults was analyzed for activities of AST, ALP, LDH-L, CK, lysozyme and ceruloplasmine as well as for total protein and albumin contents. Analyses were also conducted for the immune system organ index - percentage contribution of organs of the immune system (spleen, thymus and the bursa of Fabricius) in the body weight of turkeys. The study demonstrated that methisoprinol administered to turkey embryos in ovo on day 26 of incubation at doses of 5, 10 or 20 mg per embryo did not induce any disturbances in the hatching process or affect its final result. In addition, it was shown not to exert any negative effect on the health status of the reared turkey poults.


Wei Sheng Yan Jiu. 2009 May;38(3):257-9.
Song R, Xiong Y, Chen Q, Zou X.
Key Laboratory of Environment and Gene Related to Diseases, Medical College of Xi'an Jiaotong University, Ministry of Education, Xi'an 710061, China. song-ruixia@126.com

[Expression of PI3K/Akt signal pathway in acute myocardial ischemia] [Article in Chinese]

OBJECTIVE: To explore the influence of the PI3K/Akt-mediated signal pathway in acute myocardial ischemia (AMI) rats, the expression of pAkt, Akt, Caspase3 and p38 in myocardium and somatic muscles of AMI rats were detected. METHODS: The rats model of AMI were established by peritoneal injecting isoprinosine (ISO), and were detected by electrocardiogram and haemodynamics. The expressions of pAkt, Caspase3 and p38 in somatic muscles and cardiac muscles of AMI and normal rats were detected by Dot blot hybridization and Western blot. RESULTS: In contrast with normal rats, electrocardiogram of AMI rats showed a lower displacement of ST segment (> or = 0.1 mv). The expression of pAkt, Caspase3 and p38 were higher than those in normal rats (P < 0.05). No apparent changes were observed in expression of Akt (P = 0.477). CONCLUSION: Expressions of pAkt, Akt and correlated apoptosis molecule Caspase3 and p38 in cardiac and somatic muscles of AMI rats were higher than those in normal rats. No apparent changes were observed in expression of Akt.


J Neurol. 2008 Dec;255(12):1861-71. Epub 2008 Oct 14.
Garg RK.
Department of Neurology, Chhatrapati Shahuji Maharaj Medical University, Uttar Pradesh, Lucknow, India. garg50@yahoo.com

Subacute sclerosing panencephalitis.

Subacute sclerosing panencephalitis (SSPE) is a subacute encephalopathy of childhood and young adolescence. Infrequently, SSPE can occur in adults and pregnant women. It is caused by an aberrant measles virus, known as the SSPE virus. SSPE virus differs from wild-type measles viruses in the form of several mutations affecting the viral genome. The matrix gene is most commonly affected by these mutations. The characteristic clinical manifestations of SSPE include behavioral changes, cognitive decline, myoclonic jerks, seizures, abnormalities in vision, bilateral pyramidal signs and coma. Ocular changes may occur in up to 50% of patients. The most characteristic ophthalmological lesion is necrotizing retinitis. Cortical blindness can be the early feature of SSPE. The diagnosis of SSPE is often difficult in the early stages. In a typical case diagnosis is based on clinical, electroencephalographic, and cerebrospinal fluid findings. At present, there is no effective treatment to completely cure SSPE. Oral isoprinosine and intrathecal or intraventricular alpha-interferon may prolong survival to some extent. Immunization against measles is currently the most effective strategy against SSPE.


J Neurol Sci. 2008 Dec 15;275(1-2):113-6. Epub 2008 Sep 9.
Eroglu E, Gokcil Z, Bek S, Ulas UH, Ozdag MF, Odabasi Z.
GATA Medical Faculty Department of Neurology, Etlik-ANKARA, Turkey. erdale1965@yahoo.com

Long-term follow-up of patients with adult-onset subacute sclerosing panencephalitis.

Subacute sclerosing panencephalitis (SSPE) is a rare infectious central nervous system disease with a poor prognosis. Nineteen patients, 18 males and one female, ranging in age from 18 to 22, mean 19.6+/-1.5 years with SSPE were evaluated. We treated 9 patients with oral isoprinosine and 10 patients with alpha-interferon plus oral isoprinosine and followed up for 16 to 160 months. Of the 9 patients treated with oral isoprinosine, 7 (77.7%) died, one stabilized, and one showed progression. Seven (70%) of 10 patients treated with alpha-interferon plus oral isoprinosine died, one showed progression, and stabilization was observed in two patients. Thus, we suggest that isoprinosine alone or in combination with intraventricular interferon did not change the prognosis in long-term follow-up periods.


Neurol Sci. 2008 Apr;29(2):121-4. Epub 2008 May 16.
Schreurs A, St?lberg EV, Punga AR.
Department of Neurology, University Hospital Gasthuisberg, Leuven, Belgium.

Indication of peripheral nerve hyperexcitability in adult-onset subacute sclerosing panencephalitis (SSPE).


Orv Hetil. 1993 May 9;134(19):1015-9.
P?r A, Ber? T, Brasch G, G?gl A, Kamar?s G, M?hesfalvi E, Ozsv?r Z, Pa?l M, Szip?cs I, Telegdy L.
P?sci Orvostudom?nyi Egyetem I. Belgy?gy?szati Klinika, P?cs.

Isoprinosine therapy in chronic hepatitis C (multicenter placebo-controlled double-blind prospective study)


Int J Oral Maxillofac Surg. 2001 Aug;30(4):318-22
Femiano F, Gombos F, Scully C.
Stomatology Clinic, II University of Medicine and Surgery, Napoli, Italy.

Oral proliferative verrucous leukoplakia (PVL); open trial of surgery compared with combined therapy using surgery and methisoprinol in papillomavirus-related PVL.


J Neurol. 2008 Dec;255(12):1861-71. Epub 2008 Oct 14.
Garg RK.
Department of Neurology, Chhatrapati Shahuji Maharaj Medical University, Uttar Pradesh, Lucknow, India.

Subacute sclerosing panencephalitis.


BJOG. 2006 Sep;113(9):1088-91.
Georgala S, Katoulis AC, Befon A, Georgala C, Rigopoulos D.
First Department of Dermatology and Venereology, 'A. Sygros' Hospital, Athens, Greece.

Oral inosiplex in the treatment of cervical condylomata acuminata: a randomised placebo-controlled trial.


Int Conf AIDS. 1989 Jun 4-9; 5: 219 (abstract no. Th.B.O.46).
Hidovre
Denmark

Isoprinosine reduced clinical progression in HIV infected patients in a double blind placebo controlled study.


J Gastrointestin Liver Dis. 2006 Dec;15(4):389-91.
Krastev Z, Antonov K, Jelev DT.
Clinic of Gastroenterology, St.Ivan Rilsky University Hospital, Medical University, Sofia, Bulgaria

The prevention of an expected hepatic flare in HBe negative patients after lamivudine discontinuation.


Acta Derm Venereol. 2006;86(5):422-4.
Georgala S, Katoulis AC, Befon A, Georgala K, Stavropoulos PG.
1st Department of Dermatology and Venereology,

Inosiplex for Treatment of Alopecia Areata: a Randomized Placebo-controlled Study.


Int J Antimicrob Agents. 2000 Apr;14(3):181-91.
Masihi KN.
Robert Koch Institute, Nordufer 20, D-13353, Berlin, Germany.

Immunomodulatory agents for prophylaxis and therapy of infections.


J Helminthol. 2001 Sep;75(3):251-7.
Lawton P, Walchshofer N, Sarciron ME.
Departement de Parasitologie et Mycologie Medicale, Faculte de Pharmacie, Lyon, France.

In vitro effects of isoprinosine and a dipeptide methyl ester on Echinococcus multilocularis protoscoleces.


Isoprinosine review article...

 

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