Indication:
Kidney stones
Adverse Reaction:
CNS - Myastenic syndrome in 1 in 50 patients
Dermatologic- pharynigitis, oral ulcers, rash, ecchymosis, pruritus, urticaria, warts,
skin wrinkling, pemphigus, elastosis, perforans serpiginosis in 1in 6 patients
GI - nausea, emesis, or softstools, anorexia, abdominal pain, bloating, or flatus in 1 in 6 patients
Hematologic- increased bleeding, anemia, leukopenia, thrombocytopenia, eosinophillia,
in about 1 in 25 patients
Hepatic - jaundice and abnormal liver function tests have been reported during tioprotin therapy
Hypersensitivity- laryngeal edema, dyspnea, respiratory distress , fever, chills, arthalgia,
weakness, fatigue, myalgia, adenopathy, in about 1 in 25 patients
Pulmonary - bronchiolitis, hemoptysis, pulmonary infiltrates, dyspnea in 1 in 50 patients
Renal - protenuria, nephrotic syndrome, hematuria in about 1 in 20 patients
Special senses- impairment in taste, and smell in about 1 in 25 patients. These reactions are
more likely to occur in patients who had previuosly shown toxicity to
d-penicillamine
Treatment with tioprotin should be stopped if severe toxicity develops.
Contra-Indications:
Use of tioprotin during pregnancy is contraindicated except in severe patients with cystinuria
when the anticipated benefit of inhibited kidney stones formation clearly outweighs the possible
hazards to the patient
Special Precaution-
Tioprotin may potentially cause all the serious advrse reactions reported for d-penicillamine
Though no direct death has been reported as a result directly from tioprotin treatment, a fatal
outcome of from tioprotin is possible as has been reported with d-penicillanase therapy
as aplastic anemia, agranulocytosis, thrombocytopenia
Hematologic effect- leukopenia of the granulocytic series may develop without eosinophillia
Patients should be adviced to report any signs of hematological abnormalities such as fever,
bleeding, or easy bruisability
Proteinuria - sometimes sufficiently severe to cause nephrotic syndrome may develop from
membranous glmerulopathy. A close observation of patients is mandatory
Complications- apperance of myasthenia gravis reqires cessation of treatment . When
pemphigus -type reaction develop tioprotin therapy should be stopped.
Pregnancy- tioprotin should not be used during pregnancy
Lactation- because of potential serious adverse reactions of nursing infants from tioprotin,
mothers taking tioprotin should not nurse their infants
Children- safety and effectiveness below the age 9 years have not been established
Monitoring- to help monitor the following tests are recommended-
peripheral blood counts, direct platelet count, hemoglobin , serum albumin, liver function tests
24 hour urinary protein and routine urine analysis a 3 to 6 month intervals during treatment
Dosages/ Overdosage Etc:
Indication-
Kidney stones
Dosage-
At least 3litre of fluid ( 10 oz. glassfuls should be provided. including 2 glasses with each meal and
bed time.
The patient is expected to awake at night to urinate they should drink 2 more glasses of fluid before
returning to bed.
Additional fluids should be consumed if there is excessive sweating and fluid loss.
A minimum urine output of 2L/.day on a consisistent basis should be sought.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
THYROTROPIN- SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Tyrotropin. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans or animals.
3. Breast-feeding-
It is not known whether thyrotropin passes into breast milk. However,
this medicine has not been reported to cause problems in nursing babies.
4.Children-
This medicine has been tested in a limited number of children and has
not been shown to cause different side effects or problems than it
does in adults.
5.Older adults-
Although there is no specific information comparing use of thyrotropin
in the elderly with use in other age groups, this medicine is not expected
to cause different side effects or problems in older people.
6. Other medicines-
When you are taking thyrotropin, it is important that your doctor should
know if you are taking-
Thyroid hormones- you may not respond as strongly as thyrotropin if you
have been taking thyroid hormones regularly.
7. Other medical problems-
The presence of other medical problems may affect the use of thyrotropin.
Make sure you tell your doctor if you have any other medical problems
especially-
Hardening of the arteries or
Heart disease or
High blood pressure - thyrotropin increase body metabolism and
cause the heart to work harder, which may make the condition
worse
Untreated underactive adrenal gland or
Untreated underactive pitutiary gland- use of thyrotropin may
severely worsen the conditions
Pregnancy and lactation:
Pregnancy-
Tioprotin should not be used during pregnancy
Lactation-
Because of potential serious adverse reactions of nursing infants from tioprotin,
mothers taking tioprotin should not nurse their infants
Children-
Safety and effectiveness below the age 9 years have not been established
Manufacturer Details