CEPH-1 Dr. Raza Pharma
Drug Category: Cephalosporins.
Generic Name: Cephradine.
Contents: Caps 250mg/500mg: Cephradine 250mg/500mg.
Inj 500mg/1gm: Cephradine 500mg/1gm. Dry Susp 125mg/250mg: Per 5ml: Cephradine 125mg/250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Caps 250mg(018147):20's: 134.30:158.00.
Caps 500mg(018148):20's: 250.75:295.00.
Inj 500mg(027727):Vial: 36.00:42.00.
Inj 1gm(027726):Vial: 65.00:77.00.
Dry Susp 125mg(018158):60ml: 62.05:73.00.
Dry Susp 250mg (018157) :60ml: 96.05:113.00.
Monday, January 28, 2008
CEPH-1 Dr. Raza Pharma
CEPH-1 Dr. Raza Pharma
Drug Category: Cephalosporins.
Generic Name: Cephradine.
Contents: Caps 250mg/500mg: Cephradine 250mg/500mg.
Inj 500mg/1gm: Cephradine 500mg/1gm. Dry Susp 125mg/250mg: Per 5ml: Cephradine 125mg/250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Caps 250mg(018147):20's: 134.30:158.00.
Caps 500mg(018148):20's: 250.75:295.00.
Inj 500mg(027727):Vial: 36.00:42.00.
Inj 1gm(027726):Vial: 65.00:77.00.
Dry Susp 125mg(018158):60ml: 62.05:73.00.
Dry Susp 250mg (018157) :60ml: 96.05:113.00.
Drug Category: Cephalosporins.
Generic Name: Cephradine.
Contents: Caps 250mg/500mg: Cephradine 250mg/500mg.
Inj 500mg/1gm: Cephradine 500mg/1gm. Dry Susp 125mg/250mg: Per 5ml: Cephradine 125mg/250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Caps 250mg(018147):20's: 134.30:158.00.
Caps 500mg(018148):20's: 250.75:295.00.
Inj 500mg(027727):Vial: 36.00:42.00.
Inj 1gm(027726):Vial: 65.00:77.00.
Dry Susp 125mg(018158):60ml: 62.05:73.00.
Dry Susp 250mg (018157) :60ml: 96.05:113.00.
CEPAXIN Epoch
CEPAXIN Epoch
Drug Category: Cephalosporin.
Generic Name: Cephalexin.
Contents: Caps 250mg/500mg: Cephalexin 250mg/500mg.
Syp 125mg/250mg: Per 5ml: Cephalexin 125mg /250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Susp 125mg(031719):60ml: 40.80:48.00.
Susp 250mg(031720):60ml: 67.15:79.00.
Caps 250mg(031721):10's: 57.80:68.00.
Caps 500mg(031722):2x6's: 136.00:160.00.
Drug Category: Cephalosporin.
Generic Name: Cephalexin.
Contents: Caps 250mg/500mg: Cephalexin 250mg/500mg.
Syp 125mg/250mg: Per 5ml: Cephalexin 125mg /250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Susp 125mg(031719):60ml: 40.80:48.00.
Susp 250mg(031720):60ml: 67.15:79.00.
Caps 250mg(031721):10's: 57.80:68.00.
Caps 500mg(031722):2x6's: 136.00:160.00.
CEPAXIN Epoch
CEPAXIN Epoch
Drug Category: Cephalosporin.
Generic Name: Cephalexin.
Contents: Caps 250mg/500mg: Cephalexin 250mg/500mg.
Syp 125mg/250mg: Per 5ml: Cephalexin 125mg /250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Susp 125mg(031719):60ml: 40.80:48.00.
Susp 250mg(031720):60ml: 67.15:79.00.
Caps 250mg(031721):10's: 57.80:68.00.
Caps 500mg(031722):2x6's: 136.00:160.00.
Drug Category: Cephalosporin.
Generic Name: Cephalexin.
Contents: Caps 250mg/500mg: Cephalexin 250mg/500mg.
Syp 125mg/250mg: Per 5ml: Cephalexin 125mg /250mg; after reconstitution as per direction mentioned on the pack.
Regn.No:Pack:Trade Prices:Retail Prices:
Susp 125mg(031719):60ml: 40.80:48.00.
Susp 250mg(031720):60ml: 67.15:79.00.
Caps 250mg(031721):10's: 57.80:68.00.
Caps 500mg(031722):2x6's: 136.00:160.00.
Wednesday, January 23, 2008
Albumin
U.S. BRAND NAMES — Albumarc®; Albuminar®; AlbuRx™; Albutein®; Buminate®; Flexbumin; Plasbumin®
PHARMACOLOGIC CATEGORY Blood Product DerivativePlasma Volume Expander, Colloid
DOSING: ADULTS Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.
Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.
Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.
Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.
DOSING: PEDIATRIC
(For additional information see "Albumin: Pediatric drug information")Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.
Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber] AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Albutein®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Buminate®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber] Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 and potassium 2 mEq/L] Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]
DOSAGE FORMS: CONCISE Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Albutein®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Buminate®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement: 5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia 25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia
Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.
COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.
Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.
Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.
USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment
USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia
Central nervous system: Chills, fever, headache
Dermatologic: Pruritus, rash, urticaria
Gastrointestinal: Nausea, vomiting
Respiratory: Bronchospasm, pulmonary edema
Miscellaneous: Anaphylaxis
CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.
Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.
Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.
DRUG INTERACTIONS — ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/compatible
DIETARY CONSIDERATIONS Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L
Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L
MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms include hypervolemia, congestive heart failure, and pulmonary edema.
CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5
INTERNATIONAL BRAND NAMES — Albapure (ID, TW); Albital (EC); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TZ, UG, ZM, ZW); Albumex (AU, NZ); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminar-25 (TW); Albuminar-5 (TW); Albuminate (ID); Alburaas (TH); Albutein 25% (BR, HK); Biseko 5% (CH); Buminate 25% (HK); Human Albumin "SSI" (DK); Human Albumin (AT, PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (FI, ID); Plasbumin (ID); Plasbumin-25 (CA); Plasbumin-5 (CA); Probialbumin (MX); Seralbumin (CO, CR, DO, GT, HN, NI, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR)
MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space
PHARMACOLOGIC CATEGORY Blood Product DerivativePlasma Volume Expander, Colloid
DOSING: ADULTS Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.
Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.
Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.
Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.
DOSING: PEDIATRIC
(For additional information see "Albumin: Pediatric drug information")Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.
Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber] AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Albutein®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Buminate®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber] Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 and potassium 2 mEq/L] Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]
DOSAGE FORMS: CONCISE Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Albutein®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Buminate®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement: 5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia 25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia
Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.
COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.
Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.
Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.
USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment
USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia
Central nervous system: Chills, fever, headache
Dermatologic: Pruritus, rash, urticaria
Gastrointestinal: Nausea, vomiting
Respiratory: Bronchospasm, pulmonary edema
Miscellaneous: Anaphylaxis
CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.
Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.
Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.
DRUG INTERACTIONS — ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/compatible
DIETARY CONSIDERATIONS Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L
Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L
MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms include hypervolemia, congestive heart failure, and pulmonary edema.
CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5
INTERNATIONAL BRAND NAMES — Albapure (ID, TW); Albital (EC); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TZ, UG, ZM, ZW); Albumex (AU, NZ); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminar-25 (TW); Albuminar-5 (TW); Albuminate (ID); Alburaas (TH); Albutein 25% (BR, HK); Biseko 5% (CH); Buminate 25% (HK); Human Albumin "SSI" (DK); Human Albumin (AT, PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (FI, ID); Plasbumin (ID); Plasbumin-25 (CA); Plasbumin-5 (CA); Probialbumin (MX); Seralbumin (CO, CR, DO, GT, HN, NI, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR)
MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space
Albumin
U.S. BRAND NAMES — Albumarc®; Albuminar®; AlbuRx™; Albutein®; Buminate®; Flexbumin; Plasbumin®
PHARMACOLOGIC CATEGORY Blood Product DerivativePlasma Volume Expander, Colloid
DOSING: ADULTS Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.
Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.
Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.
Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.
DOSING: PEDIATRIC
(For additional information see "Albumin: Pediatric drug information")Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.
Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber] AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Albutein®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Buminate®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber] Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 and potassium 2 mEq/L] Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]
DOSAGE FORMS: CONCISE Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Albutein®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Buminate®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement: 5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia 25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia
Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.
COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.
Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.
Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.
USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment
USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia
Central nervous system: Chills, fever, headache
Dermatologic: Pruritus, rash, urticaria
Gastrointestinal: Nausea, vomiting
Respiratory: Bronchospasm, pulmonary edema
Miscellaneous: Anaphylaxis
CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.
Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.
Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.
DRUG INTERACTIONS — ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/compatible
DIETARY CONSIDERATIONS Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L
Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L
MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms include hypervolemia, congestive heart failure, and pulmonary edema.
CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5
INTERNATIONAL BRAND NAMES — Albapure (ID, TW); Albital (EC); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TZ, UG, ZM, ZW); Albumex (AU, NZ); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminar-25 (TW); Albuminar-5 (TW); Albuminate (ID); Alburaas (TH); Albutein 25% (BR, HK); Biseko 5% (CH); Buminate 25% (HK); Human Albumin "SSI" (DK); Human Albumin (AT, PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (FI, ID); Plasbumin (ID); Plasbumin-25 (CA); Plasbumin-5 (CA); Probialbumin (MX); Seralbumin (CO, CR, DO, GT, HN, NI, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR)
MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space
PHARMACOLOGIC CATEGORY Blood Product DerivativePlasma Volume Expander, Colloid
DOSING: ADULTS Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.
Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.
Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.
Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.
DOSING: PEDIATRIC
(For additional information see "Albumin: Pediatric drug information")Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.
Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 1 mEq/L; packaging contains dry natural rubber] AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Albutein®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Buminate®: 5% [50 mg/mL] (250 mL, 500 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L; packaging contains dry natural rubber] Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 and potassium 2 mEq/L] Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) [contains sodium 130-160 mEq/L and potassium 2 mEq/L] Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]; 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) [contains sodium ~145 mEq/L and potassium 2 mEq/L]
DOSAGE FORMS: CONCISE Injection, solution [preservative free; human]: Albuminar®: 5% [50 mg/mL] (50 mL, 250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) AlbuRx™: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Albutein®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (50 mL, 100 mL) Buminate®: 5% [50 mg/mL] (250 mL, 500 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL) Flexbumin: 25% [250 mg/mL] (50 mL, 100 mL) Human Albumin Grifols®: 25% [250 mg/mL] (50 mL, 100 mL) Plasbumin®: 5% [50 mg/mL] (50 mL, 250 mL); 25% [250 mg/mL] (20 mL, 50 mL, 100 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement: 5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia 25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia
Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.
COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.
Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.
Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.
USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment
USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia
Central nervous system: Chills, fever, headache
Dermatologic: Pruritus, rash, urticaria
Gastrointestinal: Nausea, vomiting
Respiratory: Bronchospasm, pulmonary edema
Miscellaneous: Anaphylaxis
CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.
Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.
Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.
DRUG INTERACTIONS — ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/compatible
DIETARY CONSIDERATIONS Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L
Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L
MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Symptoms include hypervolemia, congestive heart failure, and pulmonary edema.
CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5
INTERNATIONAL BRAND NAMES — Albapure (ID, TW); Albital (EC); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TZ, UG, ZM, ZW); Albumex (AU, NZ); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminar-25 (TW); Albuminar-5 (TW); Albuminate (ID); Alburaas (TH); Albutein 25% (BR, HK); Biseko 5% (CH); Buminate 25% (HK); Human Albumin "SSI" (DK); Human Albumin (AT, PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (FI, ID); Plasbumin (ID); Plasbumin-25 (CA); Plasbumin-5 (CA); Probialbumin (MX); Seralbumin (CO, CR, DO, GT, HN, NI, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR)
MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space
Albendazole
U.S. BRAND NAMES — Albenza®
PHARMACOLOGIC CATEGORY Anthelmintic
DOSING: ADULTS Neurocysticercosis: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30 days 60 kg: 400 mg twice daily for 8-30 days Note: Give concurrent anticonvulsant and steroid therapy during first week.
Hydatid: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) 60 kg: 400 mg twice daily Note: Administer dose for three 28-day cycles with a 14-day drug-free interval in between.
Ancylostoma caninum, Ascaris lumbricoides(roundworm), Ancylostoma duodenale, and Necator americanus(hookworms) (unlabeled use): Oral: 400 mg as a single dose
Clonorchis sinensis(Chinese liver fluke) (unlabeled use): Oral: 10 mg/kg for 7 days
Cutaneous larva migrans (unlabeled use): Oral: 400 mg once daily for 3 days
Enterobius vermicularis(pinworm) (unlabeled use): Oral: 400 mg as a single dose; may repeat in 2 weeks
Gnathostoma spinigerum (unlabeled use): Oral: 400 mg twice daily for 21 days
Gongylonemiasis (unlabeled use): Oral: 10 mg/kg/day for 3 days
Mansonella perstans(unlabeled use): Oral: 400 mg twice daily for 10 days
Visceral larva migrans (toxocariasis) (unlabeled use): Oral: 400 mg twice daily for 5 days
Cysticercus cellulosae(unlabeled use): Oral: 400 mg twice daily for 8-30 days; may be repeated as necessary
Disseminated microsporidiosis (unlabeled use): Oral: 400 mg twice daily
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 400 mg twice daily for 1-6 months
Intestinal microsporidiosis (unlabeled use): Oral: 400 mg twice daily for 21 days
Ocular microsporidiosis (unlabeled use): Oral: 400 mg twice daily, in combination with fumagillin
DOSING: PEDIATRIC
(For additional information see "Albendazole: Pediatric drug information")Neurocysticercosis: Oral: Refer to adult dosing.
Hydatid: Oral: Refer to adult dosing.
Cysticercus cellulosae(unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8-30 days; may be repeated as necessary
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months
For the following unlabeled uses, refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale, Clonorchis sinensis, (Chinese liver fluke), cutaneous larva migrans, Enterobius vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis, Mansonella perstans, Necator americanus (hookworms), visceral larva migrans (toxocariasis)
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: 200 mg
DOSAGE FORMS: CONCISE Tablet: Albenza®: 200 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer with meals. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy.
USE — Treatment of parenchymal neurocysticercosis caused by Taenia solium and cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus granulosus
USE - UNLABELED / INVESTIGATIONAL — Albendazole has activity against Ascaris lumbricoides (roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis (pinworm); Gnathostoma spinigerum; Gongylonema sp; Hymenolepis nana sp (tapeworms); Mansonella perstans (filariasis); Opisthorchis sinensis and Opisthorchis viverrini (liver flukes); Strongyloides stercoralis and Trichuris trichiura (whipworm); visceral larva migrans (toxocariasis); activity has also been shown against the liver fluke Clonorchis sinensis, Giardia lamblia, Cysticercus cellulosae, and Echinococcus multilocularis. Albendazole has also been used for the treatment of intestinal microsporidiosis (Encephalitozoon intestinalis), disseminated microsporidiosis (E. hellem, E. cuniculi, E. intestinalis, Pleistophora sp, Trachipleistophora sp, Brachiola vesicularum), and ocular microsporidiosis (E. hellem, E. cuniculi, Vittaforma corneae).
ADVERSE REACTIONS SIGNIFICANT N = Neurocysticercosis; H = Hydatid disease
>10%: Central nervous system: Headache (11% - N; 1% - H) Hepatic: LFTs increased (~15% - H; <1% - N)
1% to 10%: Central nervous system: Dizziness, vertigo, fever (1%), intracranial pressure increased (1% - N), meningeal signs (1% - N) Dermatologic: Alopecia (2% - H; <1% - N) Gastrointestinal: Abdominal pain (6% - H; 0% - N), nausea/vomiting (3% to 6%) Hematologic: Leukopenia (reversible) (<1%) Miscellaneous: Allergic reactions (<1%)
<1% (Limited to important or life-threatening): Acute renal failure, agranulocytopenia, allergic reaction, granulocytopenia, pancytopenia, rash, thrombocytopenia, urticaria
CONTRAINDICATIONS — Hypersensitivity to albendazole or any component of the formulation
WARNINGS / PRECAUTIONS — Discontinue therapy if LFT elevations are significant; may restart treatment when decreased to pretreatment values. Becoming pregnant within 1 month following therapy is not advised.
Neurocysticercosis: Corticosteroids should be administered 1-2 days before albendazole therapy to minimize inflammatory reactions. Steroid and anticonvulsant therapy should be used concurrently during the first week of therapy to prevent cerebral hypertension. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced changes to the retinal lesion vs benefit of disease treatment.
DRUG INTERACTIONS — Substrate (minor) of CYP1A2, 3A4; Inhibits CYP1A2 (weak)
ETHANOL / NUTRITION / HERB INTERACTIONS — Food: Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by 4-5 times).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy, if at all possible. Women should be advised to avoid pregnancy for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.
LACTATION — Excretion in breast milk unknown/not recommended
DIETARY CONSIDERATIONS — Should be taken with a high-fat meal.
PRICING — (data from drugstore.com)Tablets (Albenza) 200 mg (12): $23.59
MONITORING PARAMETERS — Monitor fecal specimens for ova and parasites for 3 weeks after treatment; if positive, retreat; monitor LFTs and clinical signs of hepatotoxicity; CBC at start of each 28-day cycle and every 2 weeks during therapy
INTERNATIONAL BRAND NAMES — Abentel (CN); ABZ (IN); Acure (PK); Adazol (EC); Albatel (TH); Alben (BR); Albendol (MY); Albenzol (EC); Albex (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Albezole (IN); Alfuca (TH); Alminth (IN); Alzental (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SG, SY, YE); Alzol (TH); Bendapar (MX); Bendex-400 (ZA); Borotel (PE); Ceprazol (CL, PE); Champs D-Worm 6 (MY); Ciclopar (CO); Dalben (HR); Emanthal (IN); Eskazole (AT, AU, DE, GB, IL, JP, MX, NL); Fintel (PE); Gascop (MX); Getzol (CO); Helmiben (UY); Labenda (TH); Loveral (MX); Mebenix (BR); Monodox (CO); Mycotel (TH); Nemozole (IN); Pantex (PY); Paranthil (ZA); Rotopar (EC); Sioban (IN); Vastus (AR); Vemizol (MY); Vermin Plus (MX); Xadem (CO); Zeben (TH); Zela (TH); Zentab (TH); Zentel (AE, AN, AU, BB, BF, BG, BH, BJ, BM, BR, BS, BZ, CI, CL, CO, CR, CY, CZ, DO, EC, EG, ET, FR, GH, GM, GN, GR, GT, GY, HN, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, OM, PA, PE, PH, PL, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TT, TZ, UG, VE, YE, ZA, ZM, ZW)
MECHANISM OF ACTION — Active metabolite, albendazole, causes selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and larvae; glycogen is depleted, glucose uptake and cholinesterase secretion are impaired, and desecratory substances accumulate intracellulary. ATP production decreases causing energy depletion, immobilization, and worm death.
PHARMACODYNAMICS / KINETICS Absorption: <5%; may increase up to 4-5 times when administered with a fatty meal
Distribution: Well inside hydatid cysts and CSF
Protein binding: 70%
Metabolism: Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation (major), hydrolysis, and oxidation
Half-life elimination: 8-12 hours
Time to peak, serum: 2-2.4 hours
Excretion: Urine (<1% as active metabolite); feces
PHARMACOLOGIC CATEGORY Anthelmintic
DOSING: ADULTS Neurocysticercosis: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30 days 60 kg: 400 mg twice daily for 8-30 days Note: Give concurrent anticonvulsant and steroid therapy during first week.
Hydatid: Oral: <60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) 60 kg: 400 mg twice daily Note: Administer dose for three 28-day cycles with a 14-day drug-free interval in between.
Ancylostoma caninum, Ascaris lumbricoides(roundworm), Ancylostoma duodenale, and Necator americanus(hookworms) (unlabeled use): Oral: 400 mg as a single dose
Clonorchis sinensis(Chinese liver fluke) (unlabeled use): Oral: 10 mg/kg for 7 days
Cutaneous larva migrans (unlabeled use): Oral: 400 mg once daily for 3 days
Enterobius vermicularis(pinworm) (unlabeled use): Oral: 400 mg as a single dose; may repeat in 2 weeks
Gnathostoma spinigerum (unlabeled use): Oral: 400 mg twice daily for 21 days
Gongylonemiasis (unlabeled use): Oral: 10 mg/kg/day for 3 days
Mansonella perstans(unlabeled use): Oral: 400 mg twice daily for 10 days
Visceral larva migrans (toxocariasis) (unlabeled use): Oral: 400 mg twice daily for 5 days
Cysticercus cellulosae(unlabeled use): Oral: 400 mg twice daily for 8-30 days; may be repeated as necessary
Disseminated microsporidiosis (unlabeled use): Oral: 400 mg twice daily
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 400 mg twice daily for 1-6 months
Intestinal microsporidiosis (unlabeled use): Oral: 400 mg twice daily for 21 days
Ocular microsporidiosis (unlabeled use): Oral: 400 mg twice daily, in combination with fumagillin
DOSING: PEDIATRIC
(For additional information see "Albendazole: Pediatric drug information")Neurocysticercosis: Oral: Refer to adult dosing.
Hydatid: Oral: Refer to adult dosing.
Cysticercus cellulosae(unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8-30 days; may be repeated as necessary
Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months
For the following unlabeled uses, refer to adult dosing: Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale, Clonorchis sinensis, (Chinese liver fluke), cutaneous larva migrans, Enterobius vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis, Mansonella perstans, Necator americanus (hookworms), visceral larva migrans (toxocariasis)
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: 200 mg
DOSAGE FORMS: CONCISE Tablet: Albenza®: 200 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer with meals. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy.
USE — Treatment of parenchymal neurocysticercosis caused by Taenia solium and cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus granulosus
USE - UNLABELED / INVESTIGATIONAL — Albendazole has activity against Ascaris lumbricoides (roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis (pinworm); Gnathostoma spinigerum; Gongylonema sp; Hymenolepis nana sp (tapeworms); Mansonella perstans (filariasis); Opisthorchis sinensis and Opisthorchis viverrini (liver flukes); Strongyloides stercoralis and Trichuris trichiura (whipworm); visceral larva migrans (toxocariasis); activity has also been shown against the liver fluke Clonorchis sinensis, Giardia lamblia, Cysticercus cellulosae, and Echinococcus multilocularis. Albendazole has also been used for the treatment of intestinal microsporidiosis (Encephalitozoon intestinalis), disseminated microsporidiosis (E. hellem, E. cuniculi, E. intestinalis, Pleistophora sp, Trachipleistophora sp, Brachiola vesicularum), and ocular microsporidiosis (E. hellem, E. cuniculi, Vittaforma corneae).
ADVERSE REACTIONS SIGNIFICANT N = Neurocysticercosis; H = Hydatid disease
>10%: Central nervous system: Headache (11% - N; 1% - H) Hepatic: LFTs increased (~15% - H; <1% - N)
1% to 10%: Central nervous system: Dizziness, vertigo, fever (1%), intracranial pressure increased (1% - N), meningeal signs (1% - N) Dermatologic: Alopecia (2% - H; <1% - N) Gastrointestinal: Abdominal pain (6% - H; 0% - N), nausea/vomiting (3% to 6%) Hematologic: Leukopenia (reversible) (<1%) Miscellaneous: Allergic reactions (<1%)
<1% (Limited to important or life-threatening): Acute renal failure, agranulocytopenia, allergic reaction, granulocytopenia, pancytopenia, rash, thrombocytopenia, urticaria
CONTRAINDICATIONS — Hypersensitivity to albendazole or any component of the formulation
WARNINGS / PRECAUTIONS — Discontinue therapy if LFT elevations are significant; may restart treatment when decreased to pretreatment values. Becoming pregnant within 1 month following therapy is not advised.
Neurocysticercosis: Corticosteroids should be administered 1-2 days before albendazole therapy to minimize inflammatory reactions. Steroid and anticonvulsant therapy should be used concurrently during the first week of therapy to prevent cerebral hypertension. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced changes to the retinal lesion vs benefit of disease treatment.
DRUG INTERACTIONS — Substrate (minor) of CYP1A2, 3A4; Inhibits CYP1A2 (weak)
ETHANOL / NUTRITION / HERB INTERACTIONS — Food: Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by 4-5 times).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy, if at all possible. Women should be advised to avoid pregnancy for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.
LACTATION — Excretion in breast milk unknown/not recommended
DIETARY CONSIDERATIONS — Should be taken with a high-fat meal.
PRICING — (data from drugstore.com)Tablets (Albenza) 200 mg (12): $23.59
MONITORING PARAMETERS — Monitor fecal specimens for ova and parasites for 3 weeks after treatment; if positive, retreat; monitor LFTs and clinical signs of hepatotoxicity; CBC at start of each 28-day cycle and every 2 weeks during therapy
INTERNATIONAL BRAND NAMES — Abentel (CN); ABZ (IN); Acure (PK); Adazol (EC); Albatel (TH); Alben (BR); Albendol (MY); Albenzol (EC); Albex (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Albezole (IN); Alfuca (TH); Alminth (IN); Alzental (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SG, SY, YE); Alzol (TH); Bendapar (MX); Bendex-400 (ZA); Borotel (PE); Ceprazol (CL, PE); Champs D-Worm 6 (MY); Ciclopar (CO); Dalben (HR); Emanthal (IN); Eskazole (AT, AU, DE, GB, IL, JP, MX, NL); Fintel (PE); Gascop (MX); Getzol (CO); Helmiben (UY); Labenda (TH); Loveral (MX); Mebenix (BR); Monodox (CO); Mycotel (TH); Nemozole (IN); Pantex (PY); Paranthil (ZA); Rotopar (EC); Sioban (IN); Vastus (AR); Vemizol (MY); Vermin Plus (MX); Xadem (CO); Zeben (TH); Zela (TH); Zentab (TH); Zentel (AE, AN, AU, BB, BF, BG, BH, BJ, BM, BR, BS, BZ, CI, CL, CO, CR, CY, CZ, DO, EC, EG, ET, FR, GH, GM, GN, GR, GT, GY, HN, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, OM, PA, PE, PH, PL, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TT, TZ, UG, VE, YE, ZA, ZM, ZW)
MECHANISM OF ACTION — Active metabolite, albendazole, causes selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and larvae; glycogen is depleted, glucose uptake and cholinesterase secretion are impaired, and desecratory substances accumulate intracellulary. ATP production decreases causing energy depletion, immobilization, and worm death.
PHARMACODYNAMICS / KINETICS Absorption: <5%; may increase up to 4-5 times when administered with a fatty meal
Distribution: Well inside hydatid cysts and CSF
Protein binding: 70%
Metabolism: Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation (major), hydrolysis, and oxidation
Half-life elimination: 8-12 hours
Time to peak, serum: 2-2.4 hours
Excretion: Urine (<1% as active metabolite); feces
Subscribe to:
Posts (Atom)