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Bivalirudin

Bivalirudin

2.1 Recommended Dose

Bivalirudin is for intravenous administration only.

Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.

For patients who do not have HIT/HITTS

The recommended dose of Bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.

GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.

For patients who have HIT/HITTS

The recommended dose of Bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.

For ongoing treatment post procedure

Continuation of the Bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of Bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.

2.2 Dosing in Renal Impairment

No reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].

2.3 Instructions for Administration

Bivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).

If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1: Dosing Table Weight (kg) Using 5 mg/mLConcentration Using 5 mg/mLConcentration Bolus0.75 mg/kg(mL) Infusion1.75 mg/kg/h(mL/h) SubsequentLow-rate Infusion0.2 mg/kg/h(mL/h) 43-47 7 16 18 48-52 7.5 17.5 20 53-57 8 19 22 58-62 9 21 24 63-67 10 23 26 68-72 10.5 24.5 28 73-77 11 26 30 78-82 12 28 32 83-87 13 30 34 88-92 13.5 31.5 36 93-97 14 33 38 98-102 15 35 40 103-107 16 37 42 108-112 16.5 38.5 44 113-117 17 40 46 118-122 18 42 48 123-127 19 44 50 128-132 19.5 45.5 52 133-137 20 47 54 138-142 21 49 56 143-147 22 51 58 148-152 22.5 52.5 60
Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with Bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with Bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

2.4 Storage after Reconstitution

Do not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
Klor-con Sprinkle

Klor-con Sprinkle

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), Klor-Con® Sprinkle (Potassium Chloride Extended-release Capsules, USP) Capsules 8 mEq and Klor-Con® Sprinkle (Potassium Chloride Extended-release Capsules, USP) Capsules 10 mEq should be taken with meals and with a full glass of water or other liquid.

Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.
Bivalirudin

Bivalirudin

2.1 Recommended Dose

Bivalirudin is for intravenous administration only.

Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.

For patients who do not have HIT/HITTS

The recommended dose of Bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.

GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.

For patients who have HIT/HITTS

The recommended dose of Bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.

For ongoing treatment post procedure

Continuation of the Bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of Bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.

2.2 Dosing in Renal Impairment

No reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].

2.3 Instructions for Administration

Bivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).

If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1: Dosing Table Weight (kg) Using 5 mg/mLConcentration Using 5 mg/mLConcentration Bolus0.75 mg/k(mL) Infusion1.75 mg/kg/h(mL/h) SubsequentLow-rate Infusion0.2 mg/kg/h(mL/h) 43-47 7 16 18 48-52 7.5 17.5 20 53-57 8 19 22 58-62 9 21 24 63-67 10 23 26 68-72 10.5 24.5 28 73-77 11 26 30 78-82 12 28 32 83-87 13 30 34 88-92 13.5 31.5 36 93-97 14 33 38 98-102 15 35 40 103-107 16 37 42 108-112 16.5 38.5 44 113-117 17 40 46 118-122 18 42 48 123-127 19 44 50 128-132 19.5 45.5 52 133-137 20 47 54 138-142 21 49 56 143-147 22 51 58 148-152 22.5 52.5 60
Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with Bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with Bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

2.4 Storage after Reconstitution

Do not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
Mometasone Furoate

Mometasone Furoate

Apply a thin film of Mometasone Furoate Cream USP, 0.1% to the affected skin areas once daily. Mometasone Furoate Cream USP, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate Cream USP, 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended. (See PRECAUTIONS - Pediatric Use section.)

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of Mometasone Furoate Cream USP, 0.1% in pediatric patients for more than 3 weeks of use have not been established.

Mometasone Furoate Cream USP, 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Cream USP, 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Ciclopirox Solution

Ciclopirox Solution

Ciclopirox topical solution, 8% (nail lacquer), should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after ciclopirox topical solution, 8% (nail lacquer), is removed with alcohol.

Ciclopirox topical solution, 8% (nail lacquer), should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The ciclopirox topical solution, 8% (nail lacquer), should be applied evenly over the entire nail plate.

If possible, ciclopirox topical solution, 8% (nail lacquer), should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

The ciclopirox topical solution, 8% (nail lacquer), should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.
Erythromycin And Benzoy...

Erythromycin And Benzoyl Peroxide Kit

Erythromycin and benzoyl peroxide topical gel USP, 3%;5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.

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