Trolovol Overdose

Rating: 5 - 1 review(s)
How do you administer this medicine?
sponsored

What happens if I overdose Trolovol?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Trolovol:

Store Trolovol at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trolovol out of the reach of children and away from pets.

Overdose of Trolovol in details

sponsored

No information provided.

What should I avoid while taking Trolovol?

Avoid taking other medicines at the same time you take Trolovol. If you take an iron supplement, take it at least 2 hours before or 2 hours after you take this medicine. Iron can make it harder for your body to absorb this medicine.

Avoid taking mineral supplements, unless your doctor tells you to.

If you have Wilson's disease, avoid eating nuts, chocolate, molasses, liver, shellfish, mushrooms, broccoli, and cereals that are fortified with copper. Also avoid taking mineral supplements that contain copper. If your drinking water supply contains more than 0.1 mg of copper per liter, you may need to drink distilled or demineralized water.

Trolovol warnings

The use of Trolovol has been associated with fatalities due to certain diseases, such as aplastic anemia, agranulocytosis, thrombocytopenia, Goodpasture’s syndrome, and myasthenia gravis.

Because of the potential for serious hematological and renal adverse reactions to occur at any time, routine urinalysis, white and differential blood cell count, hemoglobin determination, and direct platelet count must be done every two weeks for at least the first six months of Trolovol therapy and monthly thereafter. Patients should be instructed to report promptly the development of signs and symptoms of granulocytopenia and/or thrombocytopenia such as fever, sore throat, chills, bruising, or bleeding. The above laboratory studies should then be promptly repeated.

Leukopenia and thrombocytopenia have been reported to occur in up to five percent of patients during Trolovol therapy. Leukopenia is of the granulocytic series and may or may not be associated with an increase in eosinophils. A confirmed reduction in WBC below 3500 per cubic mL mandates discontinuance of Trolovol therapy. Thrombocytopenia may be on an idiosyncratic basis with decreased or absent megakaryocytes in the marrow, when it is part of an aplastic anemia. In other cases the thrombocytopenia is presumably on an immune basis since the number of megakaryocytes in the marrow has been reported to be normal or sometimes increased. The development of a platelet count below 100,000 per cubic mL, even in the absence of clinical bleeding, requires at least temporary cessation of Trolovol therapy. A progressive fall in either platelet count or WBC in three successive determinations, even though values are still within the normal range, likewise requires at least temporary cessation.

Proteinuria and/or hematuria may develop during therapy and may be warning signs of membranous glomerulopathy which can progress to a nephrotic syndrome. Close observation of these patients is essential. In some patients the proteinuria disappears with continued therapy; in others Trolovol must be discontinued. When a patient develops proteinuria or hematuria the physician must ascertain whether it is a sign of drug-induced glomerulopathy or is unrelated to Trolovol.

Rheumatoid arthritis patients who develop moderate degrees of proteinuria may be continued cautiously on Trolovol therapy, provided that quantitative 24-hour urinary protein determinations are obtained at intervals of one to two weeks. Trolovol dosage should not be increased under these circumstances. Proteinuria which exceeds 1 g/24 hours, or proteinuria which is progressively increasing requires either discontinuance of the drug or a reduction in the dosage. In some patients, proteinuria has been reported to clear following reduction in dosage.

In rheumatoid arthritis patients, Trolovol should be discontinued if unexplained gross hematuria or persistent microscopic hematuria develops.

In patients with Wilson’s disease or cystinuria the risks of continued Trolovol therapy in patients manifesting potentially serious urinary abnormalities must be weighed against the expected therapeutic benefits.

When Trolovol is used in cystinuria, an annual x-ray for renal stones is advised. Cystine stones form rapidly, sometimes in six months.

Up to one year or more may be required for any urinary abnormalities to disappear after Trolovol has been discontinued.

Because of rare reports of intrahepatic cholestasis and toxic hepatitis, liver function tests are recommended every six months for the duration of therapy.

Goodpasture’s syndrome has occurred rarely. The development of abnormal urinary findings associated with hemoptysis and pulmonary infiltrates on x-ray requires immediate cessation of Trolovol.

Obliterative bronchiolitis has been reported rarely. The patient should be cautioned to report immediately pulmonary symptoms such as exertional dyspnea, unexplained cough, or wheezing. Pulmonary function studies should be considered at that time.

Myasthenic syndrome sometimes progressing to myasthenia gravis has been reported. Ptosis and diplopia, with weakness of the extraocular muscles, are often early signs of myasthenia. In the majority of cases, symptoms of myasthenia have receded after withdrawal of Trolovol.

Most of the various forms of pemphigus have occurred during treatment with Trolovol. Pemphigus vulgaris and pemphigus foliaceus are reported most frequently, usually as a late complication of therapy. The seborrhea-like characteristics of pemphigus foliaceus may obscure an early diagnosis. When pemphigus is suspected, Trolovol should be discontinued. Treatment has consisted of high doses of corticosteroids alone or, in some cases, concomitantly with an immunosuppressant. Treatment may be required for only a few weeks or months, but may need to be continued for more than a year.

Once instituted for Wilson’s disease or cystinuria, treatment with Trolovol should, as a rule, be continued on a daily basis. Interruptions for even a few days have been followed by sensitivity reactions after reinstitution of therapy.

Use In Pregnancy - Trolovol has been shown to be teratogenic in rats when given in doses 6 times higher than the highest dose recommended for human use (based on a standard weight of 50 kg). Skeletal defects, cleft palates, and fetal toxicity (resorptions) have been reported.

There are no controlled studies on the use of Trolovol in pregnant women. Although normal outcomes have been reported, characteristic congenital cutis laxa and associated birth defects have been reported in infants born of mothers who received therapy with Trolovol during pregnancy. Trolovol should be used in women of childbearing potential only when the expected benefits outweigh the possible hazards. Women on therapy with Trolovol who are of childbearing potential should be apprised of this risk, advised to report promptly any missed menstrual periods or other indications of possible pregnancy, and followed closely for early recognition of pregnancy.

Wilson’s Disease - Reported experience* shows that continued treatment with Trolovol throughout pregnancy protects the mother against relapse of the Wilson’s disease, and that discontinuation of Trolovol has deleterious effects on the mother.

If Trolovol is administered during pregnancy to patients with Wilson’s disease, it is recommended that the daily dosage be limited to 1 g. If cesarean section is planned, the daily dosage should be limited to 250 mg during the last six weeks of pregnancy and post-operatively until wound healing is complete.

Cystinuria - If possible, Trolovol should not be given during pregnancy to women with cystinuria. There are reports of women with cystinuria on therapy with Trolovol who gave birth to infants with generalized connective tissue defects who died following abdominal surgery. If stones continue to form in these patients, the benefits of therapy to the mother must be evaluated against the risk to the fetus.

Rheumatoid Arthritis - Trolovol should not be administered to rheumatoid arthritis patients who are pregnant and should be discontinued promptly in patients in whom pregnancy is suspected or diagnosed.

There is a report that a woman with rheumatoid arthritis treated with less than one gram a day of Trolovol during pregnancy gave birth (cesarean delivery) to an infant with growth retardation, flattened face with broad nasal bridge, low set ears, short neck with loose skin folds, and unusually lax body skin.

What should I discuss with my healthcare provider before taking Trolovol?

For all patients taking Trolovol (Trolovol):

Rheumatoid arthritis patients:

This is not a list of all drugs or health problems that interact with Trolovol (Trolovol).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Trolovol (Trolovol) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Trolovol precautions

sponsored

Some patients may experience drug fever, a marked febrile response to Trolovol, usually in the second to third week following initiation of therapy. Drug fever may sometimes be accompanied by a macular cutaneous eruption. In the case of drug fever in patients with Wilson's disease or cystinuria, Trolovol should be temporarily discontinued until the reaction subsides. Then Trolovol should be reinstituted with a small dose that is gradually increased until the desired dosage is attained. Systemic steroid therapy may be necessary, and is usually helpful, in such patients in whom drug fever and rash develop several times.

In the case of drug fever in rheumatoid arthritis patients, because other treatments are available, Trolovol should be discontinued and another therapeutic alternative tried since experience indicates that the febrile reaction will recur in a very high percentage of patients upon readministration of Trolovol.

The skin and mucous membranes should be observed for allergic reactions. Early and late rashes have occurred. Early rash occurs during the first few months of treatment and is more common. It is usually a generalized pruritic, erythematous, maculopapular or morbilliform rash and resembles the allergic rash seen with other drugs. Early rash usually disappears within days after stopping Trolovol and seldom recurs when the drug is restarted at a lower dosage. Pruritus and early rash may often be controlled by the concomitant administration of antihistamines. Less commonly, a late rash may be seen, usually after six months or more of treatment, and requires discontinuation of Trolovol. It is usually on the trunk, is accompanied by intense pruritus, and is usually unresponsive to topical corticosteroid therapy. Late rash may take weeks to disappear after Trolovol is stopped and usually recurs if the drug is restarted.

The appearance of a drug eruption accompanied by fever, arthralgia, lymphadenopathy or other allergic manifestations usually requires discontinuation of Trolovol.

Certain patients will develop a positive antinuclear antibody (ANA) test and some of these may show a lupus erythematosus-like syndrome similar to drug-induced lupus associated with other drugs. The lupus erythematosus-like syndrome is not associated with hypocomplementemia and may be present without nephropathy. The development of a positive ANA test does not mandate discontinuance of the drug; however, the physician should be alerted to the possibility that a lupus erythematosus-like syndrome may develop in the future.

Some patients may develop oral ulcerations which in some cases have the appearance of aphthous stomatitis. The stomatitis usually recurs on rechallenge but often clears on a lower dosage. Although rare, cheilosis, glossitis and gingivostomatitis have also been reported. These oral lesions are frequently dose-related and may preclude further increase in Trolovol dosage or require discontinuation of the drug.

Hypogeusia (a blunting or diminution in taste perception) has occurred in some patients. This may last two to three months or more and may develop into a total loss of taste; however, it is usually self-limited despite continued Trolovol treatment. Such taste impairment is rare in patients with Wilson's disease.

Trolovol should not be used in patients who are receiving concurrently gold therapy, antimalarial or cytotoxic drugs, oxyphenbutazone or phenylbutazone because these drugs are also associated with similar serious hematologic and renal adverse reactions.

Patients who have had gold salt therapy discontinued due to a major toxic reaction may be at greater risk of serious adverse reactions with Trolovol but not necessarily of the same type.

Patients who are allergic to penicillin may theoretically have cross-sensitivity to Trolovol. The possibility of reactions from contamination of Trolovol by trace amounts of penicillin has been eliminated now that Trolovol is being produced synthetically rather than as a degradation product of penicillin.

Patients with Wilson's disease or cystinuria should be given 25 mg/day of pyridoxine during therapy, since Trolovol increases the requirement for this vitamin. Patients also may receive benefit from a multivitamin preparation, although there is no evidence that deficiency of any vitamin other than pyridoxine is associated with Trolovol. In Wilson's disease, multivitamin preparations must be copper-free.

Rheumatoid arthritis patients whose nutrition is impaired should also be given a daily supplement of pyridoxine. Mineral supplements should not be given, since they may block the response to Trolovol. Iron deficiency may develop, especially in pediatric patients and in menstruating women. In Wilson's disease, this may be a result of adding the effects of the low copper diet, which is probably also low in iron, and the Trolovol to the effects of blood loss or growth. In cystinuria, a low methionine diet may contribute to iron deficiency, since it is necessarily low in protein. If necessary, iron may be given in short courses, but a period of two hours should elapse between administration of Trolovol and iron, since orally administered iron has been shown to reduce the effects of Trolovol.

Trolovol causes an increase in the amount of soluble collagen. In the rat this results in inhibition of normal healing and also a decrease in tensile strength of intact skin. In man this may be the cause of increased skin friability at sites especially subject to pressure or trauma, such as shoulders, elbows, knees, toes, and buttocks. Extravasations of blood may occur and may appear as purpuric areas, with external bleeding if the skin is broken, or as vesicles containing dark blood. Neither type is progressive. There is no apparent association with bleeding elsewhere in the body and no associated coagulation defect has been found. Therapy with Trolovol may be continued in the presence of these lesions. They may not recur if dosage is reduced. Other reported effects probably due to the action of Trolovol on collagen are excessive wrinkling of the skin and development of small, white papules at venipuncture and surgical sites.

The effects of Trolovol on collagen and elastin make it advisable to consider a reduction in dosage to 250 mg/day, when surgery is contemplated. Reinstitution of full therapy should be delayed until wound healing is complete.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies have not been done with Trolovol. There is a report that five of ten autoimmune disease-prone NZB hybrid mice developed lymphocytic leukemia after 6 months' intraperitoneal treatment with a dose of 400 mg/kg Trolovol 5 days per week.

Trolovol is directly mutagenic to S. typhimurium strain TA92 in the Ames test; mutagenicity is enhanced by kidney postmitochondrial subcellular fraction 9. Trolovol does not induce gene mutations in Chinese hamster V79 cells.

Trolovol induces sister-chromatid exchanges and chromosome aberrations in cultivated mammalian cells. No studies on the effect of Trolovol on fertility are available.

Pregnancy

Pregnancy Category D

Nursing Mothers

Pediatric Use

The efficacy of Trolovol in juvenile rheumatoid arthritis has not been established.

Geriatric Use

Clinical studies of Trolovol are limited in subjects aged 65 and over; they did not include sufficient numbers of elderly subjects aged 65 and over to adequately determine whether they respond differently from younger subjects. Review of reported clinical trials with Trolovol in the elderly suggest greater risk than in younger patients for overall skin rash and abnormality of taste. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drugs.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and careful monitoring of renal function is recommended.

What happens if I miss a dose of Trolovol?

Take the missed dose on an empty stomach as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor. If you have missed several doses in a row, do not take any more doses without first talking to your doctor.


sponsored

Reviews

Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 8 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2024 ndrugs.com All Rights Reserved