Brand
Gengraf
Manufacturer
AVET PHARMACEUTICALS
Strength
25MG
Size
30.0
Color
BLUE/GRAY OPAQUE
Shape
OVAL
Flavor
BOXED WARNING (What is this?)
WARNING
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules, (modified). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Cyclosporine capsules, (modified), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients cyclosporine capsules, (modified) may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients. Cyclosporine capsules, (modified) have increased bioavailability in comparison to Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) [NON-MODIFIED]. Cyclosporine capsules, (modified) and Sandimmune® are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with cyclosporine capsules, (modified) than with Sandimmune®. If a patient who is receiving exceptionally high doses of Sandimmune® is converted to cyclosporine capsules, (modified), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking cyclosporine capsules, (modified) to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.
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BOXED WARNING (What is this?)
For Psoriasis Patients (See also BOXED WARNING above)
Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cyclosporine capsules, (modified).
Cyclosporine, the active ingredient in cyclosporine capsules, (modified), in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.
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DESCRIPTION
Cyclosporine capsules, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, USP the active principle in ...
CLINICAL PHARMACOLOGY
Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and ...
CLINICAL TRIALS
Rheumatoid Arthritis - The effectiveness of Sandimmune® and cyclosporine capsules (modified) in the treatment of severe rheumatoid arthritis was evaluated in 5 clinical studies involving a ...
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation - Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants ...
CONTRAINDICATIONS
General - Cyclosporine capsules (modified) is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid ...
WARNINGS
(See also BOXED WARNING) All Patients - Cyclosporine, the active ingredient of cyclosporine capsules, (modified), can cause nephrotoxicity and hepatotoxicity. The risk increases with ...
PRECAUTIONS
General - Hypertension - Cyclosporine is the active ingredient of cyclosporine capsules, (modified). Hypertension is a common side effect of cyclosporine therapy which may persist. (See ADVERSE ...
Laboratory Tests
In all patients treated with cyclosporine, renal and liver functions should be assessed repeatedly by measurement of serum creatinine, BUN, serum bilirubin, and liver enzymes. Serum lipids ...
DRUG INTERACTIONS
A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety - All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition ...
Pregnancy
Animal studies have shown reproductive toxicity in rats and rabbits. Cyclosporine gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up ...
Nursing Mothers
Cyclosporine is present in breast milk. Because of the potential for serious adverse drug reactions in nursing infants from cyclosporine capsules, (modified), a decision should be made whether to ...
Pediatric Use
Although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received cyclosporine capsules (modified) with no unusual ...
Geriatric Use
In rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. These patients were more likely to develop systolic hypertension on therapy, and more likely to ...
ADVERSE REACTIONS
Kidney, Liver, and Heart Transplantation - The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum ...
OVERDOSAGE
There is a minimal experience with cyclosporine overdosage. Forced emesis and gastric lavage can be of value up to 2 hours after administration of cyclosporine capsules, (modified). Transient ...
DOSAGE & ADMINISTRATION
Cyclosporine capsules (modified) has increased bioavailability in comparison to Sandimmune®. Cyclosporine capsules (modified) and Sandimmune® are not bioequivalent and cannot be used ...
HOW SUPPLIED
Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) 25 mg - Blue gray colored opaque oval shaped soft gelatin capsule imprinted as 'S 25" in red color ink, containing clear to cloudy ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
20 mg - 50 mg - 100 mg
INGREDIENTS AND APPEARANCE
Product Information
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