Idarubicin Hydrochloride

Idarubicin Hydrochloride Manufacturers

• Sandoz Inc
  

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  Idarubicin Hydrochloride | Sandoz Inc

  

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  (See WARNINGS)

  For induction therapy in adult patients with AML the following dose schedule is recommended:

  Idarubicin Hydrochloride Injection 12 mg/m2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m2 daily by continuous infusion for 7 days or as cytarabine 25 mg/m2 intravenous bolus followed by cytarabine 200 mg/m2 daily for 5 days continuous infusion. In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. In patients with hepatic and/or renal impairment, a dose reduction of Idarubicin Hydrochloride Injection should be considered. Idarubicin Hydrochloride Injection should not be administered if the bilirubin level exceeds 5 mg%. (SeeWARNINGS.)

  The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation. (See CLINICAL STUDIES for doses used in U.S. Clinical studies.)

  Preparation and Administration Precautions

  Caution in handling the solution must be exercised as skin reactions associated with Idarubicin Hydrochloride Injection may occur. Skin accidentally exposed to Idarubicin Hydrochloride Injection should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

  Care in the administration of Idarubicin Hydrochloride Injection will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of Idarubicin Hydrochloride Injection extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered.

  Idarubicin Hydrochloride Injection should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP (0.9%) or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.

  Incompatibility

  Unless specific compatibility data are available, Idarubicin Hydrochloride Injection should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.

  Handling and Disposal

  Procedures for handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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• App Pharmaceuticals, Llc
  

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  Idarubicin Hydrochloride | Sam's West Inc

  

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  do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years of age: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

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• Teva Parenteral Medicines, Inc
  

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  Idarubicin Hydrochloride | Amneal Pharmaceuticals Of New York, Llc

  

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  Divalproex sodium extended-release tablets, USP are an extended-release product intended for once-a-day oral administration. Divalproex sodium extended-release tablets, USP should be swallowed whole and should not be crushed or chewed.

  2.1 Mania

  Divalproex sodium extended-release tablets, USP are administered orally. The recommended initial dose is 25 mg/kg/day given once daily. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In a placebo-controlled clinical trial of acute mania or mixed type, patients were dosed to a clinical response with a trough plasma concentration between 85 and 125 mcg/mL. The maximum recommended dosage is 60 mg/kg/day.

  There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during divalproex sodium extended-release tablets, USP treatment of an acute manic episode. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium extended-release tablets, USP in such longer-term treatment (i.e., beyond 3 weeks).

  2.2 Epilepsy

  Divalproex sodium extended-release tablets, USP are administered orally, and must be swallowed whole. As divalproex sodium extended-release tablets, USP dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine and/or phenytoin may be affected [see Drug Interactions (7.2)].

  Complex Partial Seizures

  For adults and children 10 years of age or older.

  Monotherapy (Initial Therapy)

  Divalproex sodium extended-release tablets, USP have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.

  The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.

  Conversion to Monotherapy

  Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.

  Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of divalproex sodium extended-release tablets, USP therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.

  Adjunctive Therapy

  Divalproex sodium extended-release tablets, USP may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.

  In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see Clinical Studies (14.2)]. However, since valproate may interact with these or other concurrently administered AEDs as well as other drugs, periodic plasma concentration determinations of concomitant AEDs are recommended during the early course of therapy [see Drug Interactions (7)].

  Simple and Complex Absence Seizures

  The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day.

  A good correlation has not been established between daily dose, serum concentrations and therapeutic effect. However, therapeutic valproate serum concentration for most patients with absence seizures is considered to range from 50 to 100 mcg/mL. Some patients may be controlled with lower or higher serum concentrations [see Clinical Pharmacology (12.3)].

  As divalproex sodium extended-release tablets, USP dosage is titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see Drug Interactions (7.2)].

  Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.

  2.3 Migraine

  Divalproex sodium extended-release tablets, USP are indicated for prophylaxis of migraine headaches in adults.

  The recommended starting dose is 500 mg once daily for 1 week, thereafter increasing to 1000 mg once daily. Although doses other than 1000 mg once daily of divalproex sodium extended-release tablets, USP have not been evaluated in patients with migraine, the effective dose range of divalproex sodium delayed-release tablets, USP in these patients is 500 to 1000 mg/day. As with other valproate products, doses of divalproex sodium extended-release tablets, USP should be individualized and dose adjustment may be necessary. If a patient requires smaller dose adjustments than that available with divalproex sodium extended-release tablets, USP, divalproex sodium delayed-release tablets, USP should be used instead.

  2.4 Conversion from Divalproex Sodium Delayed-Release Tablets, USP to Divalproex Sodium Extended-Release Tablets, USP

  In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, USP, divalproex sodium extended-release tablets, USP should be administered once-daily using a dose 8% to 20% higher than the total daily dose of divalproex sodium delayed-release tablets, USP (Table 1). For patients whose divalproex sodium delayed-release tablets, USP total daily dose cannot be directly converted to divalproex sodium extended-release tablets, USP, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets, USP total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets, USP.

  Table 1. Dose Conversion

  Divalproex Sodium Delayed-Release Tablets, USP

  Divalproex Sodium Extended-Release Tablets, USP

  Total Daily Dose (mg)

  (mg)

  500* to 625

  750

  750* to 875

  1000

  1000* to 1125

  1250

  1250 to 1375

  1500

  1500 to 1625

  1750

  1750

  2000

  1875 to 2000

  2250

  2125 to 2250

  2500

  2375

  2750

  2500 to 2750

  3000

  2875

  3250

  3000 to 3125

  3500

  * These total daily doses of divalproex sodium delayed-release tablets, USP cannot be directly converted to an 8% to 20% higher total daily dose of divalproex sodium extended-release tablets, USP because the required dosing strengths of divalproex sodium extended-release tablets, USP are not available. Consideration may be given at the clinician's discretion to increase the patient's divalproex sodium delayed-release tablets, USP total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets, USP.

  There is insufficient data to allow a conversion factor recommendation for patients with divalproex sodium delayed-release tablets, USP doses above 3125 mg/day. Plasma valproate Cmin concentrations for divalproex sodium extended-release tablets, USP on average are equivalent to divalproex sodium delayed-release tablets, USP, but may vary across patients after conversion. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL) [see Clinical Pharmacology (12.2)].

  2.5 General Dosing Advice

  Dosing in Elderly Patients

  Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Starting doses in the elderly lower than 250 mg can only be achieved by the use of divalproex sodium delayed-release tablets, USP. Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence and other adverse reactions. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence. The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response [see Warnings and Precautions (5.14), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].

  Dose-Related Adverse Reactions

  The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia) may be dose-related. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males) [see Warnings and Precautions (5.8)]. The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.

  G.I. Irritation

  Patients who experience G.I. irritation may benefit from administration of the drug with food or by slowly building up the dose from an initial low level.

  Compliance

  Patients should be informed to take divalproex sodium extended-release tablets, USP every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.

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• Amneal-agila, Llc
  

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  Idarubicin Hydrochloride | Amneal-agila, Llc

  

  ---

  (See WARNINGS)

  For induction therapy in adult patients with AML the following dose schedule is recommended:

  Idarubicin hydrochloride injection 12 mg/m2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m2 daily by continuous infusion for 7 days or as cytarabine 25 mg/m2 intravenous bolus followed by cytarabine 200 mg/m2 daily for 5 days continuous infusion. In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. In patients with hepatic and/or renal impairment, a dose reduction of idarubicin hydrochloride injection should be considered. Idarubicin hydrochloride injection should not be administered if the bilirubin level exceeds 5 mg%. (See WARNINGS.)

  The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation. (See CLINICAL STUDIES for doses used in U.S. Clinical studies.)

  Preparation and Administration Precautions

  Caution in handling the solution must be exercised as skin reactions associated with idarubicin hydrochloride injection may occur. Skin accidentally exposed to idarubicin hydrochloride injection should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves and protective gowns is recommended during preparation and administration of the drug.

  Care in the administration of idarubicin hydrochloride injection will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of idarubicin hydrochloride injection extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered.

  Idarubicin hydrochloride injection should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP (0.9%) or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.

  Incompatibility

  Unless specific compatibility data are available, idarubicin hydrochloride injection should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.

  Handling and Disposal - Procedures for handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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