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Levetiracetam injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible.
Levetiracetam injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.
Levetiracetam injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.
Levetiracetam injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.
There is currently no drug history available for this drug.
Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration.
The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
Levetiracetam injection contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.1)].
Perindopril Erbumine Manufacturers
- Marlex Pharmaceuticals Inc
Perindopril Erbumine | West-ward Pharmaceuticals Corp
2.1 Dosing for Partial Onset Seizures
Adults 16 Years and Older
Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
1 Month to < 6 Months
Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.
6 Months to < 4 Years
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.
4 Years to < 16 Years2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.2.3 Dosing for Primary Generalized Tonic-Clonic Seizures
Adults 16 Years and Older
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
Pediatric Patients Ages 6 to <16 Years2.4 Switching from Oral Dosing
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.
When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.2.5 Switching to Oral Dosing
At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.2.6 Preparation and Administration Instructions
Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.
Any unused portion of the levetiracetam injection vial contents should be discarded.
AdultsTable 1: Preparation and Administration of Levetiracetam Injection for Adults Dose Withdraw Volume Volume of Diluent Infusion Time 500 mg 5 mL (5 mL vial) 100 mL 15 minutes 1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes 1500 mg 15 mL (three 5 mL vials) 100 mL 15 minutes
See Table 1 for the recommended preparation and administration of levetiracetam injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.
For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.
When using levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg).
The following calculation should be used to determine the appropriate daily dose of levetiracetam injection for pediatric patients:Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weigh (kg) 100 mg/mL 2.7 Dosage Adjustments in Adult Patients with Renal Impairment
Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. Information is unavailable for dosage adjustments in pediatric patients with renal impairment. In order to calculate the dose recommended for adult patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
CLcr = [140-age (years)] x weight (kg) (x 0.85 for female patients)
72 x serum creatinine (mg/dL)
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (mL/min/1.73m2) = CLcr (mL/min) x 1.73
BSA subject (m2)
Table 2:Dosage Adjustment Regimen for Adult Patients withRenal Impairment
500 to 1,500
Every 12 hours
50 – 80
500 to 1,000
Every 12 hours
30 – 50
250 to 750
Every 12 hours
250 to 500
Every 12 hours
ESRD patients using dialysis
500 to 1,000*
Every 24 hours*2.8 Compatibility and Stability
Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15º to 30°C (59º to 86°F).
Sodium chloride (0.9%) injection, USP
Lactated Ringer’s injection
Dextrose 5% injection, USP
Other Antiepileptic Drugs
There is no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.
- Lupin Pharmaceuticals, Inc
Perindopril Erbumine | Lupin Pharmaceuticals, Inc
Stable Coronary Artery Disease
In patients with stable coronary artery disease, perindopril erbumine tablets should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased as tolerated, to a maintenance dose of 8 mg once daily. In elderly patients (>70 yrs), perindopril erbumine tablets should be given as a 2 mg dose once daily in the first week, followed by 4 mg once daily in the second week and 8 mg once daily for maintenance dose if tolerated.
Use in Uncomplicated Hypertensive Patients: In patients with essential hypertension, the recommended initial dose is 4 mg once a day. The dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled or to a maximum of 16 mg per day. The usual maintenance dose range is 4 to 8 mg administered as a single daily dose. perindopril erbumine tablets may also be administered in two divided doses. When once-daily dosing was compared to twice-daily dosing in clinical studies, the B.I.D. regimen was generally slightly superior, but not by more than about 0.5 to 1.0 mm Hg.
Use in the Elderly Patients: As in younger patients, the recommended initial daily dosage of perindopril erbumine tablets for the elderly (>65 years) is 4 mg daily, given in one or two divided doses. The daily dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled, but experience with perindopril erbumine tablets is limited in the elderly at doses exceeding 8 mg. Dosages above 8 mg should be administered with caution and under close medical supervision. (See PRECAUTIONS: Geriatric Use.)
Use in Concomitant Diuretics: If blood pressure is not adequately controlled with perindopril alone, a diuretic may be added. In patients currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of perindopril. To reduce likelihood of such reaction, the diuretic should, if possible, be discontinued 2 to 3 days prior to the beginning of perindopril erbumine tablets therapy. (See WARNINGS.) Then, if blood pressure is not controlled with perindopril erbumine tablets alone, the diuretic should be resumed.
If the diuretic cannot be discontinued, an initial dose of 2 to 4 mg daily in one or in two divided doses should be used with careful medical supervision for several hours and until blood pressure has stabilized. The dosage should then be titrated as described above. (See WARNINGS and PRECAUTIONS: Drug Interactions.)
After the first dose of perindopril erbumine tablets, the patient should be followed closely for the first two weeks of treatment and whenever the dose of perindopril erbumine tablets and/or diuretics is increased (See WARNINGS and PRECAUTIONS, Drug Interactions.) In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of perindopril erbumine tablets. To reduce the likelihood of hypotension, the dose of diuretic, if possible, can be adjusted which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of perindopril erbumine tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Dose Adjustment in Renal Impairment
Kinetic data indicate that perindoprilat elimination is decreased in renally impaired patients, with a marked increase in accumulation when creatinine clearance drops below 30 mL/min. In such patients (creatinine clearance <30 mL/min), safety and efficacy of perindopril erbumine tablets have not been established. For patients with lesser degrees of impairment (creatinine clearance above 30 mL/min), the initial dosage should be 2 mg/day and dosage should not exceed 8 mg/day due to limited clinical experience. During dialysis, perindopril is removed with the same clearance as in patients with normal renal function.
- Aurobindo Pharma Limited
Perindopril Erbumine | Mylan Pharmaceuticals Inc.
Adults Initiation of Therapy
The usual starting dosage of methyldopa tablets is 250 mg two to three times a day in the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than 2 days, until an adequate response is achieved. To minimize the sedation, start dosage increases in the evening. By adjustment of dosage, morning hypotension may be prevented without sacrificing control of afternoon blood pressure.
When methyldopa tablets are given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When methyldopa tablets are given with anti-hypertensives other than thiazides, the initial dosage of methyldopa tablets should be limited to 500 mg daily in divided doses; when methyldopa tablets are added to a thiazide, the dosage of thiazide need not be changed.Maintenance of Therapy
The usual daily dosage of methyldopa tablets is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 g. Once an effective dosage range is attained, a smooth blood pressure response occurs in most patients in 12 to 24 hours. Since methyldopa has a relatively short duration of action, withdrawal is followed by return of hypertension usually within 48 hours. This is not complicated by an overshoot of blood pressure.
Occasionally tolerance may occur, usually between the second and third month of therapy. Adding a diuretic or increasing the dosage of methyldopa frequently will restore effective control of blood pressure. A thiazide may be added at any time during methyldopa therapy and is recommended if therapy has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2 g of methyldopa daily.
Methyldopa is largely excreted by the kidney and patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.Pediatric Patients
Initial dosage is based on 10 mg/kg of body weight daily in two to four doses. The daily dosage then is increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3 g daily, whichever is less. (See PRECAUTIONS: Pediatric Use.)
- Roxane Laboratories, Inc.
Perindopril Erbumine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age)
The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.2.3 Homozygous Familial Hypercholesterolemia
The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.2.4 Concomitant Lipid-Lowering Therapy
Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].2.5 Dosage in Patients with Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)].2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium tablets and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin calcium tablets should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is employed [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].
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