SPL UNCLASSIFIED SECTION
Rx only - WARNING - Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Cyclosporine Capsules USP MODIFIED. At doses ...
DESCRIPTION
Cyclosporine Capsules USP MODIFIED are an oral formulation of cyclosporine, USP that immediately forms an emulsion 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 lung ...
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation - Cyclosporine Capsules USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants ...
CONTRAINDICATIONS
General - Cyclosporine Capsules USP MODIFIED are 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 USP MODIFIED, can cause nephrotoxicity and hepatotoxicity. The risk increases with ...
PRECAUTIONS
General - Hypertension - Cyclosporine is the active ingredient of Cyclosporine Capsules USP MODIFIED. Hypertension is a common side effect of cyclosporine therapy which may persist (see ...
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 USP MODIFIED. Transient ...
DOSAGE AND ADMINISTRATION
Cyclosporine Capsules USP MODIFIED, soft gelatin capsules, has increased bioavailability in comparison to Sandimmune (Cyclosporine Capsules USP). Cyclosporine Capsules USP MODIFIED and Sandimmune ...
HOW SUPPLIED
Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “25 mg”, containing ...
Package/Label Display Panel
NDC 0093-5740-65 - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 25 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules USP). DO ...
Package/Label Display Panel
NDC 0093-9018-65 - New NDC - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 25 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules ...
Package/Label Display Panel
NDC 0093-5741-65 - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 50 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules USP). DO ...
Package/Label Display Panel
NDC 0093-9019-65 - New NDC - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 50 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules ...
Package/Label Display Panel
NDC 0093-5742-65 - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 100 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules USP). DO ...
Package/Label Display Panel
NDC 0093-9020-65 - New NDC - CycloSPORINE Capsules USP MODIFIED - (Soft Gelatin Capsules) 100 mg - WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune® (CycloSPORINE Capsules ...
INGREDIENTS AND APPEARANCE
Product Information
