Data from FDA - Curated by EPG Health - Last updated 19 December 2016
CONTRAINDICATIONS The use of THIOLA® during pregnancy is contraindicated, except in those with
THIOLA® should not be begun again in patients with a prior history of developing agranulocytosis, aplastic anemia or thrombocytopenia on this medication.
PRECAUTIONS Patients should be advised of the potential development of
In order to assess effect on stone disease, urinary cystine analysis should be monitored frequently during the first
Abdominal roentogenogram (KUB) is advised on a yearly basis to monitor the size and appearance/disappearance of stone(s).
USE IN PREGNANCY: Pregnancy category C. D-penicillamine has been shown to cause skeletal
A similar teratogenicity might be expected for THIOLA® although
THIOLA® should be used during pregnancy only if the potential
NURSING MOTHERS: Because THIOLA® may be excreted in milk and because of the potential serious
It may be reinstated at a
A generalized rash (erythematous, maculopapular or morbilliform) accompanied by
It may be controlled by antihistamine therapy, typically recedes when
Less commonly, rash may appear late in the course of treatment (of more than 6 months).
Located usually in the trunk, the late rash is associated with
A drug reaction simulating lupus erythematous, manifested by fever,
It may be associated with a
It is believed to be the result of chelation of trace metals by THIOLA™. Hypogeusia is often self-limiting.
Unlike during d-penicillamine therapy, vitamin B6
A multiclinic trial involving 66 cystinuric patients in the United States indicated that THIOLA® is associated with fewer or
Among those who had to stop taking d-penicillamine due to toxicity, 64.7 % could take THIOLA®.
A review of
Despite this apparent
They include: Gastrointestinal side-effects (
These reactions are more likely to
In patients who had previously manifested
Patients should be told to report
The treatment with THIOLA® should be stopped if
A direct cause and effect relationship, based upon these foreign reports, has not been
DOSAGE AND ADMINISTRATION
At least 3 liters of fluid (10-10 oz. glassfuls) should be provided, including two glasses with each meal and at bedtime.
The patients should be expected to awake at night to urinate; they should drink two more glasses of fluids before
In patients who continue to form cystine stones on the above
THIOLA® may also be substituted for d-penicillamine in patients who have
In both situations, the
The dose of THIOLA® should not be
The extent of the
THIOLA® may be begun at a dosage of 800 mg/day in adult patients with cystine stones.
In a multiclinic trial,
In children, initial dosage may be based on 15 mg/kg/day.
Urinary cystine should be measured at 1 month after THIOLA® treatment, and every 3 months thereafter.
THIOLA® dosage should be readjusted depending on the urinary cystine value.
Whenever possible, THIOLA® should be given in divided doses 3 times/day at least one hour before or 2 hours after meals.
In patients who had shown
|Agency product number||C5W04GO61S|
|Date Last Revised||30-11-2012|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Mission Pharmacal Company|