Cyclosporine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Organ Transplant - Rejection Prophylaxis

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

Usual Adult Dose for Rheumatoid Arthritis

cyclosporine formulation for emulsion: 5 mg/kg/day orally divided in 2 doses. If possible, anti-inflammatory drugs should be discontinued to help avoid renal toxicity. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg orally twice a day.
Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, cyclosporine capsules USP modified therapy should be discontinued. Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension elevations in serum creatinine (30% above the patient's pretreatment level) or clinically significant laboratory abnormalities.
If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued. The same initial dose and dosage range should be used if cyclosporine capsules USP modified is combined with the recommended dose of methotrexate. Most patients can be treated with cyclosporine capsules USP modified doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.
There is limited long-term treatment data. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.

Usual Adult Dose for Ulcerative Colitis - Active

When refractory to corticosteroids: 4 mg/kg/day via continuous IV infusion. The dose should be titrated gradually to achieve clinical efficacy while avoiding unacceptable toxicity. Therapy should be continued for 7 to 14 days. In successful treatments, oral therapy should be instituted after 14 days of IV therapy and continued for 3 to 6 months.

Some clinicians have found a dose of 2 mg/kg/day via continuous IV infusion to be equally effective to the 4 mg/kg/day dosage regimen.

Usual Adult Dose for Psoriasis

Refractory plaque-type psoriasis: cyclosporine formulation for emulsion: 2.5 mg/kg/day orally in 2 equally divided doses. The dose should be titrated gradually to achieve clinical efficacy while avoiding excessive toxicity. The incidence of serious toxicity increases with time thus limiting the duration of therapy. Disease relapse may occur after discontinuation or reduction in dose. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg twice a day.
Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not occurred in patients by that time, the patient's dosage should be increased at 2 week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4 mg/kg/day.
Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension, elevations in serum creatinine (25% above the patient's pretreatment level), or clinically significant laboratory abnormalities. If dose reduction is not effective in controlling abnormalities, or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued.
Patients generally show some improvement in the clinical manifestations of psoriasis in 2 weeks. Satisfactory control and stabilization of the disease may take 12 to 16 weeks to achieve. Treatment should be discontinued if satisfactory response cannot be achieved after 6 weeks at 4 mg/kg/day or the patient's maximum tolerated dose. Once a patient is adequately controlled and appears stable the dose of cyclosporine capsules USP modified should be lowered, and the patient treated with the lowest dose that maintains an adequate response. Doses below 2.5 mg/kg/day may also be equally effective.
Upon stopping treatment with cyclosporine, relapse will occur in approximately 6 weeks (50% of the patients) to 16 weeks (75% of the patients). In the majority of patients rebound does not occur after cessation of treatment with cyclosporine. Long-term experience with cyclosporine capsules USP modified in psoriasis patients is limited and continuous treatment for extended periods greater than one year is not recommended. Alternation with other forms of treatment should be considered in the long-term management of patients with this lifelong disease.

Usual Pediatric Dose for Organ Transplant - Rejection Prophylaxis

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

Renal Dose Adjustments

Careful monitoring of cyclosporine blood or plasma concentrations is necessary to avoid exacerbation of renal impairment.

Liver Dose Adjustments

Due to decreased cyclosporine plasma clearance in patients with liver disease, plasma or blood concentrations should be monitored closely and dose adjustments made as necessary. Many clinicians suggest to start with one-half of the normally recommended dose when liver function tests exceed 2 to 3 times the normal values.

Dose Adjustments

An oral microemulsion form is available. The initial dose of this product should be the same as for regular oral formulations. However, the bioavailability may be higher, especially in patients with open T-tubes following liver transplantation. Therefore, close observation for clinical and laboratory evidence of cyclosporine toxicity is particularly appropriate if this formulation is used.

Precautions

In general, steady state trough concentrations are measured every day for the first 2 weeks after transplantation or until the patient is stable. Thereafter, concentrations are measured once a week for the first month and then monthly for the first 12 months after transplantation.

Cyclosporine capsules USP modified has increased bioavailability in comparison to Sandimmune (cyclosporine capsules USP). Cyclosporine capsules USP modified and Sandimmune (cyclosporine capsules USP) are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with cyclosporine capsules USP modified than with Sandimmune (cyclosporine capsules USP).

Dialysis

A supplemental dose is not necessary with hemodialysis or peritoneal dialysis.

Cyclosporine is not removed by hemodialysis.

Other Comments

Adjunct therapy with adrenal corticosteroids is recommended initially for organ rejection prophylaxis.

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