Toxicity values: |
LD50 mouse iv= 2100mg/kg[1].
LD50 mouse ip = 3020mg/kg[2].
|
Adverse reactions: |
thiopronine produced a significant hypotensive effect at a dose of 12 mmol[3].
Abnormalities developed like proteinuria[4], hyperlipidemia usually subsided after withdrawal of drug[5], [6],
[7], also the side effects observed with MPG disappear when treatment is withdrawn [8], [9]which suggest that the effects are dose-related
and accumulation of the drug in blood might be the reason[10].
A condition called Pemphigus foliaceus occurred in a cystinuria patient treated with MPG[4].
In mice, it is observed that at higher dose levels such as 100, 200,500mg/kg, 2-MPG can damage liver tissue irreversibly[11].
It is reported to induce chronic intrahepatic cholestasis[12].
Rheumatoid arthritis patients treated with tiopronin showed nephritis and dermatitis due to tiopronin[13].
A strong association between B35-Cw4 class I antigens and toxicity due to tiopronin has been disclosed by imunogenetic typing [13],
[14].
Two patients developed thrombocytopenia while on tioprini[15].
2-Mercaptopropionylglycine (2-MPG) has been shown to transform normal red blood cells (RBCs) into paroxysmal nocturnal haemoglobinuria
(PNH)-like RBCs in vitro, depending on the concentration, pH and time of incubation [16].
Pathological conditions observed in mouse liver during 1-14 days after injecting higher dose levels (100, 200 and 500 mg/kg body-weight) of MPG
are Cytoplasmic degranulation and vacuolation, nuclear changes like pyknosis, shrinkage, necrosis, crenation and mild lymphocytic infiltration,
hyperaemia, hypertypic nuclei.
The damages are reversible after administration of drug upto 200mg/kg body-weight for 14 days interval studied; but after the administration of
500 mg /kg body-weight of MPG the damages are irreversible as studied upto 14 days[11].
At a high dose, thiola showed a cytotoxic effect, significantly decreasing the relative proportion of polychromatic erythrocytes of mice
[17].
Long term (for 30 and 60 days) treatment of male rats with 20mg/kg/day thiola adversely affected the reproductive system [18].
Long-term tolerability study of 2-MPG (Acadione) 1gm/day on Rheumatoid Arthritis patients also revealed adverse conditions which led to discontinuation
of treatment [19].
In study of long-term(average 6.3 years) treatment of cystinuria patients with 2-MPG(500 to 2500mg per day), occurrence of irreversible glomerular lesions
is observed[20].
A report on development of tiopronin-induced lichenoid eruptions after 2-years of treatment with tiopronin in a woman suffering from liver cirrhosis
[7].
It has been shown to have acantholytic potential [21].
Induction of severe polymyositis due to tiopronin is reported in a rheumatoid arthritis patient [22].
Tiopronin can induce Myasthenia gravis [23].
In an in vitro study, MPG induced an increasing degradation of DNA in unirradiated cells with increasing concentration and incubation time[24].
Another in vitro study revealed the inhibition of 3H-thymidine incorporation in unstimulated as well as Phytohemagglutinin (PHA) stimulated lymphocytes
with increasing concentrations of alpha-mercaptopropionyl-glycine while low concentration of the drug enhanced spontaneous lymphocyte blastigenesis
[25].
|
Mutagenicity or Carcinogenicity Data: |
Tiopronin has been proved to be free of mutagenic activity [26]. Thiola did not increase the frequency of chromosomal aberration
in human lymphocytes[17]
Suggested to have anti-carcinogenic effect against certain carcinogens [27].
|
Fertility: |
Long-term treatment of this drug to normal adult rat brought about significant decline in circulating levels of testosterone and an increase in
testicular cholesterol content indicating probable inhibition of androgen synthesis.
The data revealed the loss of sperm motility, reduction in fertilizability and survival of spermatozoa in cauda epididymidis[18]
and also histoarchitecture of reproductive organs, level of testosterone, sperm morphology of rats after long term administration (for 30 and 60 days)
of 20 mg/kg body weight/day Thiola[28].
|
Pregnancy: |
It is unknown whether tiopronin crosses the placenta[29].
Pregnancy Risk Category: C [29].
|
Breast Feeding: |
It is unknown whether tiopronin is distributed in breast milk[29].
Orally administrated 2-mercaptopropionyl-glycine was found to be suppressing Puerperal lactation and plasma prolactin levels in women
in puerperium [30].
|
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