Nicardipine Hydrochloride

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Nicardipine hydrochloride injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure should be monitored both during and after the infusion; too rapid or excessive reduction in either systolic or diastolic blood pressure during parenteral treatment should be avoided.

Preparation

WARNING: VIALS MUST BE DILUTED BEFORE IV INFUSION

Dilution:  Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP  

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP  

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP  

Dextrose (5%) with 40 mEq Potassium, USP  

Sodium Chloride (0.45%) Injection, USP  

Sodium Chloride (0.9%) Injection, USP 

Nicardipine hydrochloride injection is NOT compatible with Sodium Bicarbonate (5%) Injection, USP, or Lactated Ringer's Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

Nicardipine HCl injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure should be monitored both during and after the infusion; too rapid or excessive reduction in either systolic or diastolic blood pressure during parenteral treatment should be avoided.

PREPARATION

WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION

Dilution: Nicardipine HCl injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. Each ampul (25 mg)should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL

Nicardipine HCl injection has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP
Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP
Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
Dextrose (5%) with 40 mEq Potassium, USP
Sodium Chloride (0.45%) Injection, USP
Sodium Chloride (0.9%) Injection, USP

Nicardipine HCl injection is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer's Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

Inspection: As with all parenteral drugs, nicardipine HCl injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine HCl injection is normally light yellow in color.

DOSAGE

As a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

For Initiation of Therapy in a Drug Free Patient

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment.

Nicardipine HCl injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes and does not reach final steady state for about 50 hours.

When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for about 50 hours.

Titration: For gradual reduction in blood pressure, initiate therapy at 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

For more rapid blood pressure reduction, initiate therapy at 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal, the infusion rate should be decreased to 30 mL/hr (3 mg/hr).

Maintenance: The rate of infusion should be adjusted as needed to maintain desired response.

CONDITIONS REQUIRING INFUSION ADJUSTMENT

Hypotension or Tachycardia: If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. When blood pressure has stabilized, infusion of nicardipine HCl injection may be restarted at low doses such as 30 - 50 mL/hr (3 - 5 mg/hr) and adjusted to maintain desired blood pressure.

Infusion Site Changes: Nicardipine HCl injection should be continued as long as blood pressure control is needed.  The infusion site should be changed every 12 hours if administered via peripheral vein.

Impaired Cardiac, Hepatic, or Renal Function: Caution is advised when titrating nicardipine HCl injection in patients with congestive heart failure or impaired hepatic or renal function (see "Precautions").

TRANSFER TO ORAL ANTIHYPERTENSIVE AGENTS

If treatment includes transfer to an oral antihypertensive agent other than nicardipine HCl capsules, therapy should generally be initiated upon discontinuation of nicardipine HCl injection.

If nicardipine HCl capsules are to be used, the first dose of a TID regimen should be administered 1 hour prior to discontinuation of the infusion.

2.1 Epilepsy

It is not necessary to monitor topiramate plasma concentrations to optimize topiramate tablets therapy.

On occasion, the addition of topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate tablets may require adjustment of the dose of topiramate tablets.

Because of the bitter taste, tablets should not be broken.

Topiramate tablets can be taken without regard to meals.

Monotherapy Use

Adults and Pediatric Patients 10 Years and Older

The recommended dose for topiramate tablet monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titration according to the following schedule (Table 1):

Children Ages 2 to <10 Years

Dosing of topiramate as initial monotherapy in children 2 to < 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies (14.1)].

Dosing in patients 2 to <10 years is based on weight. During the titration period, the initial dose of topiramate tablets should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). 

Adjunctive Therapy Use

Adults (17 Years of Age and Over) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial onset seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day (600 mg, 800 mg or 1,000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1,600 mg have not been studied.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.1)].

Pediatric Patients (Ages 2 to 16 Years) – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks [see Clinical Studies (14.1)].

2.4 Patients with Renal Impairment

In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

2.5 Geriatric Patients (Ages 65 Years and Over)

Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate <70 mL/min/1.73 m2)) is evident [see Clinical Pharmacology (12.3].

2.6 Patients Undergoing Hemodialysis

Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

2.7 Patients with Hepatic Disease

In hepatically impaired patients, topiramate plasma concentrations may be increased. The mechanism is not well understood.

The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least three days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady state plasma drug concentrations.

Concomitant Use With Other Antianginal Agents

The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy. (See PRECAUTIONS: Blood Pressure, INDICATIONS AND USAGE, CLINICAL PHARMACOLOGY, Effects in Hypertension.) At least three days should be allowed before increasing the nicardipine dose to ensure achievement of steady state plasma drug concentrations.

Concomitant use with other Antihypertensive Agents, Beta-blockers.

(See PRECAUTIONS, Drug Interactions.)

Although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS)

Nicardipine should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See PRECAUTIONS.)

Caution is advised when titrating nicardipine dosage in patients with congestive heart failure. (See WARNINGS.)

Nicardipine hydrochloride injection is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

WARNING: VIALS MUST BE DILUTED BEFORE INFUSION

Dilution: Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

Dextrose (5%) with 40 mEq Potassium, USP

Sodium Chloride (0.45%) Injection, USP

Sodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer's Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

Inspection: As with all parenteral drugs, nicardipine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection  is normally light yellow in color.

Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

Dosage for Initiation of Therapy in a Patient not receiving oral nicardipine

Initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

Discontinuation of infusion is followed by a 50% offset action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of nicardipine hydrochloride injection.

If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

Nicardipine hydrochloride injection is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

WARNING: VIALS MUST BE DILUTED BEFORE INFUSION

Dilution: Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

Dextrose (5%) with 40 mEq Potassium, USP

Sodium Chloride (0.45%) Injection, USP

Sodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer's Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

Inspection: As with all parenteral drugs, nicardipine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection  is normally light yellow in color.

Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

Dosage for Initiation of Therapy in a Patient not receiving oral nicardipine

Initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

Discontinuation of infusion is followed by a 50% offset action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of nicardipine hydrochloride injection.

If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least three days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady state plasma drug concentrations.

Concomitant Use With Other Antianginal Agents

The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy. (See PRECAUTIONS: Blood Pressure, INDICATIONS AND USAGE, CLINICAL PHARMACOLOGY, Effects in Hypertension.) At least three days should be allowed before increasing the nicardipine dose to ensure achievement of steady state plasma drug concentrations.

Concomitant use with other Antihypertensive Agents, Beta-blockers.

(See PRECAUTIONS, Drug Interactions.)

Although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS)

Nicardipine should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See PRECAUTIONS.)

Caution is advised when titrating nicardipine dosage in patients with congestive heart failure. (See WARNINGS.)

The dose should be individually titrated for each patient beginning with 20 mg 3 times daily. Doses in the range of 20 mg to 40 mg 3 times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady-state plasma drug concentrations.

The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg 3 times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg 3 times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy. (See PRECAUTIONS, Blood Pressure; INDICATIONS AND USAGE; CLINICAL PHARMACOLOGY, Effects in Hypertension.) At least 3 days should be allowed before increasing the nicardipine dose to ensure achievement of steady-state plasma drug concentrations.

(See PRECAUTIONS, Drug Interactions.)

Although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS.)

Nicardipine should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See PRECAUTIONS.)

Caution is advised when titrating nicardipine dosage in patients with congestive heart failure. (See WARNINGS.)

Trichomoniasis:

In the Female:

One-day treatment -two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each given in the same day.

Seven-day course of treatment -250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.

The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.

Pregnant patients should not be treated during the first trimester (see CONTRAINDICATIONS). In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).

When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.

In the Male: Treatment should be individualized as for the female.

Amebiasis:

Adults:

For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.

For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.

Pediatric patients

35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.

Anaerobic Bacterial Infections

In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.

The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.

The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

Dosage Adjustments

Patients with Severe Hepatic Impairment

For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients Undergoing Hemodialysis:

Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).

The dose should be individually titrated for each patient beginning with 20 mg 3 times daily. Doses in the range of 20 mg to 40 mg 3 times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady-state plasma drug concentrations.

The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg 3 times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg 3 times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. (See ; ; .) At least 3 days should be allowed before increasing the nicardipine dose to ensure achievement of steady-state plasma drug concentrations. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy.PRECAUTIONS, Blood PressureINDICATIONS AND USAGECLINICAL PHARMACOLOGY, Effects in Hypertension

(See .) PRECAUTIONS, Drug Interactions

Although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See .) PRECAUTIONS

Nicardipine should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See .) PRECAUTIONS

Caution is advised when titrating nicardipine dosage in patients with congestive heart failure. (See .) WARNINGS

The dose should be individually titrated for each patient beginning with 20 mg 3 times daily. Doses in the range of 20 mg to 40 mg 3 times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady-state plasma drug concentrations.

The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg 3 times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg 3 times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. (See ; ; .) At least 3 days should be allowed before increasing the nicardipine dose to ensure achievement of steady-state plasma drug concentrations. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy.PRECAUTIONS, Blood PressureINDICATIONS AND USAGECLINICAL PHARMACOLOGY, Effects in Hypertension

(See .) PRECAUTIONS, Drug Interactions

Although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See .) PRECAUTIONS

Nicardipine should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See .) PRECAUTIONS

Caution is advised when titrating nicardipine dosage in patients with congestive heart failure. (See .) WARNINGS

Nicardipine hydrochloride injection is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

WARNING: VIALS MUST BE DILUTED BEFORE INFUSION.

Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 mg/mL. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

Dextrose (5%) with 40 mEq Potassium, USP

Sodium Chloride (0.45%) Injection, USP

Sodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer’s Injection, USP.

THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE.

As with all parenteral drugs, nicardipine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally light yellow in color.

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

Oral Nicardipine Dose

Equivalent I.V. Infusion Rate

20 mg q8h

0.5 mg/hr = 5 mL/hr

30 mg q8h

1.2 mg/hr = 12 mL/hr

40 mg q8h

2.2 mg/hr = 22 mL/hr

Initiate therapy at 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

Discontinuation of infusion is followed by a 50% offset action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of nicardipine hydrochloride injection.

If oral nicardipine is to be used, administer the first dose one hour prior to discontinuation of the infusion.