U.S. BRAND NAMES — ALternaGel® [OTC]; Dermagran® [OTC]
PHARMACOLOGIC CATEGORY
Antacid
Antidote
Protectant, Topical
DOSING: ADULTS
Hyperphosphatemia: Oral: Initial: 300-600 mg 3 times/day with meals
Hyperacidity: Oral: 600-1200 mg between meals and at bedtime
Skin protectant: Topical: Apply to affected area as needed; reapply at least every 12 hours
DOSING: PEDIATRIC
(For additional information see "Aluminum hydroxide: Pediatric drug information")
Hyperphosphatemia: Oral: 50-150 mg/kg/24 hours in divided doses every 4-6 hours, titrate dosage to maintain serum phosphorus within normal range
Skin protectant: Topical: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Aluminum may accumulate in renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment:
Dermagran®: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL (473 mL)
ALternaGel®: 600 mg/5 mL (360 mL)
DOSAGE FORMS: CONCISE
Ointment:
Dermagran® [OTC]: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL
ALternaGel® [OTC]: 600 mg/5 mL
GENERIC EQUIVALENT AVAILABLE — Yes: Suspension
ADMINISTRATION
Oral: Dose should be followed with water.
Topical: Apply as needed to affected area; reapply at least every 12 hours.
USE — Treatment of hyperacidity; hyperphosphatemia; temporary protection of minor cuts, scrapes, and burns
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Gastrointestinal: Constipation, discoloration of feces (white speckles), fecal impaction, nausea, stomach cramps, vomiting
Endocrine & metabolic: Hypomagnesemia, hypophosphatemia
CONTRAINDICATIONS — Hypersensitivity to aluminum salts or any component of the formulation
WARNINGS / PRECAUTIONS
Dosage form specific issues: Oral: Hypophosphatemia may occur with prolonged administration or large doses; aluminum intoxication and osteomalacia may occur in patients with uremia. Use with caution in patients with HF, renal failure, edema, cirrhosis, and low sodium diets, and patients who have recently suffered gastrointestinal hemorrhage; uremic patients not receiving dialysis may develop osteomalacia and osteoporosis due to phosphate depletion. When used as an antacid in ulcer treatment, consider buffer capacity (mEq/mL) to calculate dose. Elderly may be predisposed to constipation and fecal impaction. Careful evaluation of possible drug interactions must be done. Topical: Not for application over deep wounds, puncture wounds, infected areas, or lacerations. When used for self medication (OTC use), consult with healthcare provider if needed for >7 days or for use in children <6 months of age.
DRUG INTERACTIONS
ACE Inhibitors: Antacids may decrease the serum concentration of ACE Inhibitors. Risk C: Monitor therapy
Allopurinol: Antacids may decrease the absorption of Allopurinol. Risk D: Consider therapy modification
Amphetamines: Antacids may decrease the excretion of Amphetamines. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): Antacids may decrease the serum concentration of Anticonvulsants (Hydantoin). Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): Antacids may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Fluconazole; Miconazole; Voriconazole. Risk D: Consider therapy modification
Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Ascorbic Acid: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Atazanavir: Antacids may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Antacids may decrease the absorption of Bisphosphonate Derivatives. Antacids containing aluminum, calcium, or magnesium are of specific concern. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Risk C: Monitor therapy
Citric Acid Derivatives: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification
CycloSPORINE: Antacids may decrease the serum concentration of CycloSPORINE. Specifically when cyclosporine is administered orally. Risk C: Monitor therapy
Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Antacids may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Deferasirox: Aluminum Hydroxide may diminish the therapeutic effect of Deferasirox. Risk D: Consider therapy modification
Delavirdine: Antacids may decrease the absorption of Delavirdine. Risk D: Consider therapy modification
Eltrombopag: Aluminum Hydroxide may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., aluminum-containing products) by at least 4 hours. Risk D: Consider therapy modification
Erlotinib: Antacids may decrease the serum concentration of Erlotinib. Management: Separate the administration of erlotinib and any antacid by several hours in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification
Ethambutol: Aluminum Hydroxide may decrease the absorption of Ethambutol. Risk D: Consider therapy modification
Fexofenadine: Antacids may decrease the serum concentration of Fexofenadine. Management: No specific recommendations concerning the time required between their administration are provided. Separate administration of each agent by as much time as possible to decrease the risk of an interaction. Risk D: Consider therapy modification
Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Isoniazid: Antacids may decrease the absorption of Isoniazid. Risk D: Consider therapy modification
Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Risk D: Consider therapy modification
Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Risk D: Consider therapy modification
Mycophenolate: Antacids may decrease the absorption of Mycophenolate. Risk D: Consider therapy modification
Penicillamine: Antacids may decrease the serum concentration of Penicillamine. Risk D: Consider therapy modification
Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Risk D: Consider therapy modification
Protease Inhibitors: Antacids may decrease the absorption of Protease Inhibitors. Exceptions: Darunavir. Risk C: Monitor therapy
QuiNINE: Antacids may decrease the serum concentration of QuiNINE. Risk X: Avoid combination
Quinolone Antibiotics: Antacids may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Sodium Polystyrene Sulfonate: May enhance the adverse/toxic effect of Antacids. The combined use of these two agents may result in metabolic alkalosis. Risk D: Consider therapy modification
Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. Risk D: Consider therapy modification
Tocainide: Antacids may increase the serum concentration of Tocainide. Risk C: Monitor therapy
Trientine: Antacids may decrease the absorption of Trientine. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — No data available on clinical effects on the fetus; available evidence suggests safe use during pregnancy and breast-feeding.
LACTATION — Excretion in breast milk unknown
DIETARY CONSIDERATIONS — Should be taken 1-3 hours after meals when used as an antacid. When used to decrease phosphorus, should be taken within 20 minutes of a meal.
MONITORING PARAMETERS — Monitor phosphorus levels periodically when patient is on chronic therapy.
CANADIAN BRAND NAMES — Amphojel®; Basaljel®
INTERNATIONAL BRAND NAMES — Aldrox (BE); Algeldraat (NL); Alu-Cap (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Alu-Tab (AU, HK, PH, SG); Alucol (IT); Aludrox (DE); Alugel (DE, TW); Alumigel (JP); Alutab (MY); Alzinox (PH); Amphogel (KP); Amphojel (ZA); Pepsamar (BF, BJ, BR, CI, CN, CO, ES, ET, GH, GM, GN, GR, KE, LR, MA, ML, MR, MU, MW, NE, NG, PE, PT, SC, SD, SL, SN, TN, TZ, UG, VE, ZA, ZM, ZW); Rocgel (FR); Ulcerin-P (TW)
MECHANISM OF ACTION — Neutralizes hydrochloride in stomach to form Al (Cl)3 salt + H2O
PATIENT INFORMATION — Do not take oral drugs within 1-2 hours of administration; notify prescriber if relief is not obtained or if there are any signs to suggest bleeding from the GI tract
Wednesday, June 16, 2010
Aluminum hydroxide
U.S. BRAND NAMES — ALternaGel® [OTC]; Dermagran® [OTC]
PHARMACOLOGIC CATEGORY
Antacid
Antidote
Protectant, Topical
DOSING: ADULTS
Hyperphosphatemia: Oral: Initial: 300-600 mg 3 times/day with meals
Hyperacidity: Oral: 600-1200 mg between meals and at bedtime
Skin protectant: Topical: Apply to affected area as needed; reapply at least every 12 hours
DOSING: PEDIATRIC
(For additional information see "Aluminum hydroxide: Pediatric drug information")
Hyperphosphatemia: Oral: 50-150 mg/kg/24 hours in divided doses every 4-6 hours, titrate dosage to maintain serum phosphorus within normal range
Skin protectant: Topical: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Aluminum may accumulate in renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment:
Dermagran®: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL (473 mL)
ALternaGel®: 600 mg/5 mL (360 mL)
DOSAGE FORMS: CONCISE
Ointment:
Dermagran® [OTC]: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL
ALternaGel® [OTC]: 600 mg/5 mL
GENERIC EQUIVALENT AVAILABLE — Yes: Suspension
ADMINISTRATION
Oral: Dose should be followed with water.
Topical: Apply as needed to affected area; reapply at least every 12 hours.
USE — Treatment of hyperacidity; hyperphosphatemia; temporary protection of minor cuts, scrapes, and burns
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Gastrointestinal: Constipation, discoloration of feces (white speckles), fecal impaction, nausea, stomach cramps, vomiting
Endocrine & metabolic: Hypomagnesemia, hypophosphatemia
CONTRAINDICATIONS — Hypersensitivity to aluminum salts or any component of the formulation
WARNINGS / PRECAUTIONS
Dosage form specific issues: Oral: Hypophosphatemia may occur with prolonged administration or large doses; aluminum intoxication and osteomalacia may occur in patients with uremia. Use with caution in patients with HF, renal failure, edema, cirrhosis, and low sodium diets, and patients who have recently suffered gastrointestinal hemorrhage; uremic patients not receiving dialysis may develop osteomalacia and osteoporosis due to phosphate depletion. When used as an antacid in ulcer treatment, consider buffer capacity (mEq/mL) to calculate dose. Elderly may be predisposed to constipation and fecal impaction. Careful evaluation of possible drug interactions must be done. Topical: Not for application over deep wounds, puncture wounds, infected areas, or lacerations. When used for self medication (OTC use), consult with healthcare provider if needed for >7 days or for use in children <6 months of age.
DRUG INTERACTIONS
ACE Inhibitors: Antacids may decrease the serum concentration of ACE Inhibitors. Risk C: Monitor therapy
Allopurinol: Antacids may decrease the absorption of Allopurinol. Risk D: Consider therapy modification
Amphetamines: Antacids may decrease the excretion of Amphetamines. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): Antacids may decrease the serum concentration of Anticonvulsants (Hydantoin). Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): Antacids may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Fluconazole; Miconazole; Voriconazole. Risk D: Consider therapy modification
Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Ascorbic Acid: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Atazanavir: Antacids may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Antacids may decrease the absorption of Bisphosphonate Derivatives. Antacids containing aluminum, calcium, or magnesium are of specific concern. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Risk C: Monitor therapy
Citric Acid Derivatives: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification
CycloSPORINE: Antacids may decrease the serum concentration of CycloSPORINE. Specifically when cyclosporine is administered orally. Risk C: Monitor therapy
Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Antacids may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Deferasirox: Aluminum Hydroxide may diminish the therapeutic effect of Deferasirox. Risk D: Consider therapy modification
Delavirdine: Antacids may decrease the absorption of Delavirdine. Risk D: Consider therapy modification
Eltrombopag: Aluminum Hydroxide may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., aluminum-containing products) by at least 4 hours. Risk D: Consider therapy modification
Erlotinib: Antacids may decrease the serum concentration of Erlotinib. Management: Separate the administration of erlotinib and any antacid by several hours in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification
Ethambutol: Aluminum Hydroxide may decrease the absorption of Ethambutol. Risk D: Consider therapy modification
Fexofenadine: Antacids may decrease the serum concentration of Fexofenadine. Management: No specific recommendations concerning the time required between their administration are provided. Separate administration of each agent by as much time as possible to decrease the risk of an interaction. Risk D: Consider therapy modification
Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Isoniazid: Antacids may decrease the absorption of Isoniazid. Risk D: Consider therapy modification
Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Risk D: Consider therapy modification
Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Risk D: Consider therapy modification
Mycophenolate: Antacids may decrease the absorption of Mycophenolate. Risk D: Consider therapy modification
Penicillamine: Antacids may decrease the serum concentration of Penicillamine. Risk D: Consider therapy modification
Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Risk D: Consider therapy modification
Protease Inhibitors: Antacids may decrease the absorption of Protease Inhibitors. Exceptions: Darunavir. Risk C: Monitor therapy
QuiNINE: Antacids may decrease the serum concentration of QuiNINE. Risk X: Avoid combination
Quinolone Antibiotics: Antacids may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Sodium Polystyrene Sulfonate: May enhance the adverse/toxic effect of Antacids. The combined use of these two agents may result in metabolic alkalosis. Risk D: Consider therapy modification
Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. Risk D: Consider therapy modification
Tocainide: Antacids may increase the serum concentration of Tocainide. Risk C: Monitor therapy
Trientine: Antacids may decrease the absorption of Trientine. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — No data available on clinical effects on the fetus; available evidence suggests safe use during pregnancy and breast-feeding.
LACTATION — Excretion in breast milk unknown
DIETARY CONSIDERATIONS — Should be taken 1-3 hours after meals when used as an antacid. When used to decrease phosphorus, should be taken within 20 minutes of a meal.
MONITORING PARAMETERS — Monitor phosphorus levels periodically when patient is on chronic therapy.
CANADIAN BRAND NAMES — Amphojel®; Basaljel®
INTERNATIONAL BRAND NAMES — Aldrox (BE); Algeldraat (NL); Alu-Cap (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Alu-Tab (AU, HK, PH, SG); Alucol (IT); Aludrox (DE); Alugel (DE, TW); Alumigel (JP); Alutab (MY); Alzinox (PH); Amphogel (KP); Amphojel (ZA); Pepsamar (BF, BJ, BR, CI, CN, CO, ES, ET, GH, GM, GN, GR, KE, LR, MA, ML, MR, MU, MW, NE, NG, PE, PT, SC, SD, SL, SN, TN, TZ, UG, VE, ZA, ZM, ZW); Rocgel (FR); Ulcerin-P (TW)
MECHANISM OF ACTION — Neutralizes hydrochloride in stomach to form Al (Cl)3 salt + H2O
PATIENT INFORMATION — Do not take oral drugs within 1-2 hours of administration; notify prescriber if relief is not obtained or if there are any signs to suggest bleeding from the GI tract
PHARMACOLOGIC CATEGORY
Antacid
Antidote
Protectant, Topical
DOSING: ADULTS
Hyperphosphatemia: Oral: Initial: 300-600 mg 3 times/day with meals
Hyperacidity: Oral: 600-1200 mg between meals and at bedtime
Skin protectant: Topical: Apply to affected area as needed; reapply at least every 12 hours
DOSING: PEDIATRIC
(For additional information see "Aluminum hydroxide: Pediatric drug information")
Hyperphosphatemia: Oral: 50-150 mg/kg/24 hours in divided doses every 4-6 hours, titrate dosage to maintain serum phosphorus within normal range
Skin protectant: Topical: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Aluminum may accumulate in renal impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment:
Dermagran®: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL (473 mL)
ALternaGel®: 600 mg/5 mL (360 mL)
DOSAGE FORMS: CONCISE
Ointment:
Dermagran® [OTC]: 0.275% (120 g)
Suspension, oral: 320 mg/5 mL
ALternaGel® [OTC]: 600 mg/5 mL
GENERIC EQUIVALENT AVAILABLE — Yes: Suspension
ADMINISTRATION
Oral: Dose should be followed with water.
Topical: Apply as needed to affected area; reapply at least every 12 hours.
USE — Treatment of hyperacidity; hyperphosphatemia; temporary protection of minor cuts, scrapes, and burns
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Gastrointestinal: Constipation, discoloration of feces (white speckles), fecal impaction, nausea, stomach cramps, vomiting
Endocrine & metabolic: Hypomagnesemia, hypophosphatemia
CONTRAINDICATIONS — Hypersensitivity to aluminum salts or any component of the formulation
WARNINGS / PRECAUTIONS
Dosage form specific issues: Oral: Hypophosphatemia may occur with prolonged administration or large doses; aluminum intoxication and osteomalacia may occur in patients with uremia. Use with caution in patients with HF, renal failure, edema, cirrhosis, and low sodium diets, and patients who have recently suffered gastrointestinal hemorrhage; uremic patients not receiving dialysis may develop osteomalacia and osteoporosis due to phosphate depletion. When used as an antacid in ulcer treatment, consider buffer capacity (mEq/mL) to calculate dose. Elderly may be predisposed to constipation and fecal impaction. Careful evaluation of possible drug interactions must be done. Topical: Not for application over deep wounds, puncture wounds, infected areas, or lacerations. When used for self medication (OTC use), consult with healthcare provider if needed for >7 days or for use in children <6 months of age.
DRUG INTERACTIONS
ACE Inhibitors: Antacids may decrease the serum concentration of ACE Inhibitors. Risk C: Monitor therapy
Allopurinol: Antacids may decrease the absorption of Allopurinol. Risk D: Consider therapy modification
Amphetamines: Antacids may decrease the excretion of Amphetamines. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): Antacids may decrease the serum concentration of Anticonvulsants (Hydantoin). Risk C: Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): Antacids may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Fluconazole; Miconazole; Voriconazole. Risk D: Consider therapy modification
Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Ascorbic Acid: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Atazanavir: Antacids may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Antacids may decrease the absorption of Bisphosphonate Derivatives. Antacids containing aluminum, calcium, or magnesium are of specific concern. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Risk C: Monitor therapy
Citric Acid Derivatives: May increase the absorption of Aluminum Hydroxide. Risk D: Consider therapy modification
Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification
CycloSPORINE: Antacids may decrease the serum concentration of CycloSPORINE. Specifically when cyclosporine is administered orally. Risk C: Monitor therapy
Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Antacids may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Deferasirox: Aluminum Hydroxide may diminish the therapeutic effect of Deferasirox. Risk D: Consider therapy modification
Delavirdine: Antacids may decrease the absorption of Delavirdine. Risk D: Consider therapy modification
Eltrombopag: Aluminum Hydroxide may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., aluminum-containing products) by at least 4 hours. Risk D: Consider therapy modification
Erlotinib: Antacids may decrease the serum concentration of Erlotinib. Management: Separate the administration of erlotinib and any antacid by several hours in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification
Ethambutol: Aluminum Hydroxide may decrease the absorption of Ethambutol. Risk D: Consider therapy modification
Fexofenadine: Antacids may decrease the serum concentration of Fexofenadine. Management: No specific recommendations concerning the time required between their administration are provided. Separate administration of each agent by as much time as possible to decrease the risk of an interaction. Risk D: Consider therapy modification
Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Isoniazid: Antacids may decrease the absorption of Isoniazid. Risk D: Consider therapy modification
Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Risk D: Consider therapy modification
Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Risk D: Consider therapy modification
Mycophenolate: Antacids may decrease the absorption of Mycophenolate. Risk D: Consider therapy modification
Penicillamine: Antacids may decrease the serum concentration of Penicillamine. Risk D: Consider therapy modification
Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Risk D: Consider therapy modification
Protease Inhibitors: Antacids may decrease the absorption of Protease Inhibitors. Exceptions: Darunavir. Risk C: Monitor therapy
QuiNINE: Antacids may decrease the serum concentration of QuiNINE. Risk X: Avoid combination
Quinolone Antibiotics: Antacids may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Sodium Polystyrene Sulfonate: May enhance the adverse/toxic effect of Antacids. The combined use of these two agents may result in metabolic alkalosis. Risk D: Consider therapy modification
Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. Risk D: Consider therapy modification
Tocainide: Antacids may increase the serum concentration of Tocainide. Risk C: Monitor therapy
Trientine: Antacids may decrease the absorption of Trientine. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — No data available on clinical effects on the fetus; available evidence suggests safe use during pregnancy and breast-feeding.
LACTATION — Excretion in breast milk unknown
DIETARY CONSIDERATIONS — Should be taken 1-3 hours after meals when used as an antacid. When used to decrease phosphorus, should be taken within 20 minutes of a meal.
MONITORING PARAMETERS — Monitor phosphorus levels periodically when patient is on chronic therapy.
CANADIAN BRAND NAMES — Amphojel®; Basaljel®
INTERNATIONAL BRAND NAMES — Aldrox (BE); Algeldraat (NL); Alu-Cap (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Alu-Tab (AU, HK, PH, SG); Alucol (IT); Aludrox (DE); Alugel (DE, TW); Alumigel (JP); Alutab (MY); Alzinox (PH); Amphogel (KP); Amphojel (ZA); Pepsamar (BF, BJ, BR, CI, CN, CO, ES, ET, GH, GM, GN, GR, KE, LR, MA, ML, MR, MU, MW, NE, NG, PE, PT, SC, SD, SL, SN, TN, TZ, UG, VE, ZA, ZM, ZW); Rocgel (FR); Ulcerin-P (TW)
MECHANISM OF ACTION — Neutralizes hydrochloride in stomach to form Al (Cl)3 salt + H2O
PATIENT INFORMATION — Do not take oral drugs within 1-2 hours of administration; notify prescriber if relief is not obtained or if there are any signs to suggest bleeding from the GI tract
Aluminum chloride hexahydrate
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Drysol™ may be confused with Drisdol®
U.S. BRAND NAMES — Certain Dri® [OTC]; Drysol™ ; Hypercare™ ; Xerac AC™
PHARMACOLOGIC CATEGORY
Topical Skin Product
DOSING: ADULTS — Hyperhidrosis: Topical: Apply once daily at bedtime; once excessive sweating has stopped, may decrease to once or twice weekly, or as needed. Wash treated area in the morning.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, topical:
Certain Dri®: 12% (36 mL)
Drysol™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Xerac AC™ : 6.25% (35 mL, 60 mL) [contains ethanol 96%]
DOSAGE FORMS: CONCISE
Solution, topical:
Certain Dri® [OTC]: 12% (36 mL)
Drysol™ , Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL)
Xerac AC™ : 6.25% (35 mL, 60 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Topical: Apply to dry skin. Area may be covered with plastic wrap held in place with snug-fitting T-shirt. Do not hold in place with tape.
USE — Astringent in the management of hyperhidrosis
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Dermatologic: Skin irritation
Local: Burning sensation, prickling sensation, transient itching or stinging
CONTRAINDICATIONS — Hypersensitivity to any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Skin irritation: Discontinue if skin irritation occurs.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with eyes. Do not apply to broken or recently shaved skin. May be harmful to certain metals or fabrics.
DRUG INTERACTIONS — There are no known significant interactions.
PRICING — (data from drugstore.com)
Solution (Drysol)
20% (35): $17.99
20% (37.5): $16.99
20% (60): $20.66
Solution (Hypercare)
20% (35): $16.99
20% (37.5): $15.99
20% (60): $18.99
Solution (Xerac AC)
6.25% (35): $16.99
6.25% (60): $18.99
INTERNATIONAL BRAND NAMES — Anhydrol Forte (GB, IE, IL); Driclor (AU, GB, HK, IE, KP, PH, SG); Drysol (CN, MX)
PATIENT INFORMATION — For external use only. Product may discolor clothing if not completely dry. Discontinue if rash develops.
Sound-alike/look-alike issues:
Drysol™ may be confused with Drisdol®
U.S. BRAND NAMES — Certain Dri® [OTC]; Drysol™ ; Hypercare™ ; Xerac AC™
PHARMACOLOGIC CATEGORY
Topical Skin Product
DOSING: ADULTS — Hyperhidrosis: Topical: Apply once daily at bedtime; once excessive sweating has stopped, may decrease to once or twice weekly, or as needed. Wash treated area in the morning.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, topical:
Certain Dri®: 12% (36 mL)
Drysol™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Xerac AC™ : 6.25% (35 mL, 60 mL) [contains ethanol 96%]
DOSAGE FORMS: CONCISE
Solution, topical:
Certain Dri® [OTC]: 12% (36 mL)
Drysol™ , Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL)
Xerac AC™ : 6.25% (35 mL, 60 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Topical: Apply to dry skin. Area may be covered with plastic wrap held in place with snug-fitting T-shirt. Do not hold in place with tape.
USE — Astringent in the management of hyperhidrosis
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Dermatologic: Skin irritation
Local: Burning sensation, prickling sensation, transient itching or stinging
CONTRAINDICATIONS — Hypersensitivity to any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Skin irritation: Discontinue if skin irritation occurs.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with eyes. Do not apply to broken or recently shaved skin. May be harmful to certain metals or fabrics.
DRUG INTERACTIONS — There are no known significant interactions.
PRICING — (data from drugstore.com)
Solution (Drysol)
20% (35): $17.99
20% (37.5): $16.99
20% (60): $20.66
Solution (Hypercare)
20% (35): $16.99
20% (37.5): $15.99
20% (60): $18.99
Solution (Xerac AC)
6.25% (35): $16.99
6.25% (60): $18.99
INTERNATIONAL BRAND NAMES — Anhydrol Forte (GB, IE, IL); Driclor (AU, GB, HK, IE, KP, PH, SG); Drysol (CN, MX)
PATIENT INFORMATION — For external use only. Product may discolor clothing if not completely dry. Discontinue if rash develops.
Aluminum chloride hexahydrate
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Drysol™ may be confused with Drisdol®
U.S. BRAND NAMES — Certain Dri® [OTC]; Drysol™ ; Hypercare™ ; Xerac AC™
PHARMACOLOGIC CATEGORY
Topical Skin Product
DOSING: ADULTS — Hyperhidrosis: Topical: Apply once daily at bedtime; once excessive sweating has stopped, may decrease to once or twice weekly, or as needed. Wash treated area in the morning.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, topical:
Certain Dri®: 12% (36 mL)
Drysol™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Xerac AC™ : 6.25% (35 mL, 60 mL) [contains ethanol 96%]
DOSAGE FORMS: CONCISE
Solution, topical:
Certain Dri® [OTC]: 12% (36 mL)
Drysol™ , Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL)
Xerac AC™ : 6.25% (35 mL, 60 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Topical: Apply to dry skin. Area may be covered with plastic wrap held in place with snug-fitting T-shirt. Do not hold in place with tape.
USE — Astringent in the management of hyperhidrosis
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Dermatologic: Skin irritation
Local: Burning sensation, prickling sensation, transient itching or stinging
CONTRAINDICATIONS — Hypersensitivity to any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Skin irritation: Discontinue if skin irritation occurs.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with eyes. Do not apply to broken or recently shaved skin. May be harmful to certain metals or fabrics.
DRUG INTERACTIONS — There are no known significant interactions.
PRICING — (data from drugstore.com)
Solution (Drysol)
20% (35): $17.99
20% (37.5): $16.99
20% (60): $20.66
Solution (Hypercare)
20% (35): $16.99
20% (37.5): $15.99
20% (60): $18.99
Solution (Xerac AC)
6.25% (35): $16.99
6.25% (60): $18.99
INTERNATIONAL BRAND NAMES — Anhydrol Forte (GB, IE, IL); Driclor (AU, GB, HK, IE, KP, PH, SG); Drysol (CN, MX)
PATIENT INFORMATION — For external use only. Product may discolor clothing if not completely dry. Discontinue if rash develops.
Sound-alike/look-alike issues:
Drysol™ may be confused with Drisdol®
U.S. BRAND NAMES — Certain Dri® [OTC]; Drysol™ ; Hypercare™ ; Xerac AC™
PHARMACOLOGIC CATEGORY
Topical Skin Product
DOSING: ADULTS — Hyperhidrosis: Topical: Apply once daily at bedtime; once excessive sweating has stopped, may decrease to once or twice weekly, or as needed. Wash treated area in the morning.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, topical:
Certain Dri®: 12% (36 mL)
Drysol™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL) [contains ethanol 93%]
Xerac AC™ : 6.25% (35 mL, 60 mL) [contains ethanol 96%]
DOSAGE FORMS: CONCISE
Solution, topical:
Certain Dri® [OTC]: 12% (36 mL)
Drysol™ , Hypercare™ : 20% (35 mL, 37.5 mL, 60 mL)
Xerac AC™ : 6.25% (35 mL, 60 mL)
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Topical: Apply to dry skin. Area may be covered with plastic wrap held in place with snug-fitting T-shirt. Do not hold in place with tape.
USE — Astringent in the management of hyperhidrosis
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Dermatologic: Skin irritation
Local: Burning sensation, prickling sensation, transient itching or stinging
CONTRAINDICATIONS — Hypersensitivity to any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Skin irritation: Discontinue if skin irritation occurs.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with eyes. Do not apply to broken or recently shaved skin. May be harmful to certain metals or fabrics.
DRUG INTERACTIONS — There are no known significant interactions.
PRICING — (data from drugstore.com)
Solution (Drysol)
20% (35): $17.99
20% (37.5): $16.99
20% (60): $20.66
Solution (Hypercare)
20% (35): $16.99
20% (37.5): $15.99
20% (60): $18.99
Solution (Xerac AC)
6.25% (35): $16.99
6.25% (60): $18.99
INTERNATIONAL BRAND NAMES — Anhydrol Forte (GB, IE, IL); Driclor (AU, GB, HK, IE, KP, PH, SG); Drysol (CN, MX)
PATIENT INFORMATION — For external use only. Product may discolor clothing if not completely dry. Discontinue if rash develops.
Aluminum chloride (dental)
U.S. BRAND NAMES — Hemodent™
PHARMACOLOGIC CATEGORY
Astringent
Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Apply retraction cord as directed
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
DOSAGE FORMS: CONCISE
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
GENERIC EQUIVALENT AVAILABLE — No
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS
Other warnings/precautions: Application: Since large amounts of astringents may cause tissue irritation and possible damage, only small amounts should be applied.
DRUG INTERACTIONS — There are no known significant interactions.
MECHANISM OF ACTION — Precipitates tissue and blood proteins causing a mechanical obstruction to hemorrhage from injured blood vessels
PHARMACOLOGIC CATEGORY
Astringent
Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Apply retraction cord as directed
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
DOSAGE FORMS: CONCISE
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
GENERIC EQUIVALENT AVAILABLE — No
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS
Other warnings/precautions: Application: Since large amounts of astringents may cause tissue irritation and possible damage, only small amounts should be applied.
DRUG INTERACTIONS — There are no known significant interactions.
MECHANISM OF ACTION — Precipitates tissue and blood proteins causing a mechanical obstruction to hemorrhage from injured blood vessels
Aluminum chloride (dental)
U.S. BRAND NAMES — Hemodent™
PHARMACOLOGIC CATEGORY
Astringent
Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Apply retraction cord as directed
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
DOSAGE FORMS: CONCISE
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
GENERIC EQUIVALENT AVAILABLE — No
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS
Other warnings/precautions: Application: Since large amounts of astringents may cause tissue irritation and possible damage, only small amounts should be applied.
DRUG INTERACTIONS — There are no known significant interactions.
MECHANISM OF ACTION — Precipitates tissue and blood proteins causing a mechanical obstruction to hemorrhage from injured blood vessels
PHARMACOLOGIC CATEGORY
Astringent
Hemostatic Agent
DOSING: ADULTS — Control of bleeding: Apply retraction cord as directed
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
DOSAGE FORMS: CONCISE
Liquid:
Hemodent™ : 21% (10 mL, 20 mL, 40 mL)
Retraction cord [impregnated with 21% solution]:
Hemodent™ : Braided cord, thin (7 ft); braided cord medium thin (7 ft); twisted cord #3 (7 ft); twisted cord #9 (7ft)
GENERIC EQUIVALENT AVAILABLE — No
USE — Hemostatic
ADVERSE REACTIONS SIGNIFICANT — No data reported.
CONTRAINDICATIONS — No data reported
WARNINGS / PRECAUTIONS
Other warnings/precautions: Application: Since large amounts of astringents may cause tissue irritation and possible damage, only small amounts should be applied.
DRUG INTERACTIONS — There are no known significant interactions.
MECHANISM OF ACTION — Precipitates tissue and blood proteins causing a mechanical obstruction to hemorrhage from injured blood vessels
Altretamine
MEDICATION SAFETY ISSUES
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
International issues:
Hexalen®: Brand name for hexetidine in Greece
U.S. BRAND NAMES — Hexalen®
PHARMACOLOGIC CATEGORY
Antineoplastic Agent, Miscellaneous
DOSING: ADULTS — Refer to individual protocols.
Ovarian cancer: Oral: 260 mg/m2/day in 4 divided doses for 14 or 21 days of a 28-day cycle
Alternatively (unlabeled use): 4-12 mg/kg/day in 3-4 divided doses for 21-90 days
Alternatively (unlabeled use): 240-320 mg/m2/day in 3-4 divided doses for 21 days, repeated every 6 weeks
Alternatively (unlabeled use): 150 mg/m2/day in 3-4 divided doses for 14 days of a 28-day cycle
DOSING: ELDERLY — Refer to adult dosing.
DOSING: ADJUSTMENT FOR TOXICITY — Temporarily withhold for 14 days or longer, and resume dose at 200 mg/m2/day for any of the following:
Platelet count <75,000/mm3
White blood cell count <2000/mm3 or granulocyte count <1000/mm3
Progressive neurotoxicity
Gastrointestinal intolerance not responsive to antiemetic regimens
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gelcap:
Hexalen®: 50 mg
DOSAGE FORMS: CONCISE
Gelcap:
Hexalen®: 50 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer total daily dose as 3-4 divided doses after meals and at bedtime.
USE — Palliative treatment of persistent or recurrent ovarian cancer
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Peripheral sensory neuropathy (31%; moderate-to-severe 9%), neurotoxicity (21%; may be progressive and dose limiting)
Gastrointestinal: Nausea/vomiting (33% to 70%; severe 1%), diarrhea (48%)
Hematologic: Anemia (33%), leukopenia (5% to 15%; grade 4: 1%), neutropenia
1% to 10%:
Central nervous system: Fatigue (1%), seizure (1%)
Gastrointestinal: Stomach cramps, anorexia (1%)
Hematologic: Thrombocytopenia (9%)
Hepatic: Alkaline phosphatase increased (9%)
<1% (Limited to important or life-threatening): Alopecia, ataxia, depression, dizziness, hepatotoxicity, mood disorders, pruritus, rash, tremor, vertigo
CONTRAINDICATIONS — Hypersensitivity to altretamine or any component of the formulation; pre-existing severe bone marrow suppression or severe neurologic toxicity; pregnancy
WARNINGS / PRECAUTIONS
Boxed warnings: Bone marrow suppression: . Experienced physician: . Neurotoxicity: .
Special handling: Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects: Bone marrow suppression: [U.S. Boxed Warning]: Peripheral blood counts should be done routinely before and after drug therapy; bone marrow suppression is common. Use with caution in patients previously treated with other myelosuppressive drugs. Neurotoxicity: [U.S. Boxed Warning]: Neurologic examinations should be done routinely before and after drug therapy; neurotoxicity is common. USe with caution in patients with pre-existing neurotoxicity.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment. Renal impairment: Use with caution in patients with renal impairment.
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.
DRUG INTERACTIONS
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
MAO Inhibitors: Altretamine may enhance the orthostatic effect of MAO Inhibitors. Risk C: Monitor therapy
MAO Inhibitors: May enhance the orthostatic effect of Orthostasis Producing Agents. Risk C: Monitor therapy
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Pyridoxine: May diminish the therapeutic effect of Altretamine. Specifically when altretamine is used in combination with Cisplatin the response duration may be diminished. Risk D: Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Tricyclic Antidepressants: Altretamine may enhance the orthostatic effect of Tricyclic Antidepressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
PREGNANCY RISK FACTOR — D (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were noted in animal studies. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should avoid becoming pregnant while on therapy.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential toxicity in the nursing infant, breast-feeding is not recommended.
DIETARY CONSIDERATIONS — Should be taken after meals at bedtime.
PRICING — (data from drugstore.com)
Capsules (Hexalen)
50 mg (100): $1167.31
MONITORING PARAMETERS — CBC with differential, liver function tests; neurologic examination
CANADIAN BRAND NAMES — Hexalen®
INTERNATIONAL BRAND NAMES — Hexalen (AU, BG, GB, IL, JP, NO, NZ, SE, TH); Hexastat (AR, FR, IT, PT); Hexinawas (ES)
MECHANISM OF ACTION — Although altretamine's clinical antitumor spectrum resembles that of alkylating agents, the drug has demonstrated activity in alkylator-resistant patients. The drug selectively inhibits the incorporation of radioactive thymidine and uridine into DNA and RNA, inhibiting DNA and RNA synthesis; reactive intermediates covalently bind to microsomal proteins and DNA; can spontaneously degrade to demethylated melamines and formaldehyde which are also cytotoxic.
PHARMACODYNAMICS / KINETICS
Absorption: Well absorbed (75% to 89%)
Distribution: Highly concentrated hepatically and renally; low in other organs
Protein binding: 50% to 94%
Metabolism: Hepatic; rapid and extensive demethylation to active metabolites (pentamethylmelamine and tetramethylmelamine)
Half-life elimination: 13 hours
Time to peak, plasma: 0.5-3 hours
Excretion: Urine (90%, <1% as unchanged drug)
PATIENT INFORMATION — Report any numbness or tingling in extremities. Nausea and vomiting may occur.
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
International issues:
Hexalen®: Brand name for hexetidine in Greece
U.S. BRAND NAMES — Hexalen®
PHARMACOLOGIC CATEGORY
Antineoplastic Agent, Miscellaneous
DOSING: ADULTS — Refer to individual protocols.
Ovarian cancer: Oral: 260 mg/m2/day in 4 divided doses for 14 or 21 days of a 28-day cycle
Alternatively (unlabeled use): 4-12 mg/kg/day in 3-4 divided doses for 21-90 days
Alternatively (unlabeled use): 240-320 mg/m2/day in 3-4 divided doses for 21 days, repeated every 6 weeks
Alternatively (unlabeled use): 150 mg/m2/day in 3-4 divided doses for 14 days of a 28-day cycle
DOSING: ELDERLY — Refer to adult dosing.
DOSING: ADJUSTMENT FOR TOXICITY — Temporarily withhold for 14 days or longer, and resume dose at 200 mg/m2/day for any of the following:
Platelet count <75,000/mm3
White blood cell count <2000/mm3 or granulocyte count <1000/mm3
Progressive neurotoxicity
Gastrointestinal intolerance not responsive to antiemetic regimens
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gelcap:
Hexalen®: 50 mg
DOSAGE FORMS: CONCISE
Gelcap:
Hexalen®: 50 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer total daily dose as 3-4 divided doses after meals and at bedtime.
USE — Palliative treatment of persistent or recurrent ovarian cancer
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Peripheral sensory neuropathy (31%; moderate-to-severe 9%), neurotoxicity (21%; may be progressive and dose limiting)
Gastrointestinal: Nausea/vomiting (33% to 70%; severe 1%), diarrhea (48%)
Hematologic: Anemia (33%), leukopenia (5% to 15%; grade 4: 1%), neutropenia
1% to 10%:
Central nervous system: Fatigue (1%), seizure (1%)
Gastrointestinal: Stomach cramps, anorexia (1%)
Hematologic: Thrombocytopenia (9%)
Hepatic: Alkaline phosphatase increased (9%)
<1% (Limited to important or life-threatening): Alopecia, ataxia, depression, dizziness, hepatotoxicity, mood disorders, pruritus, rash, tremor, vertigo
CONTRAINDICATIONS — Hypersensitivity to altretamine or any component of the formulation; pre-existing severe bone marrow suppression or severe neurologic toxicity; pregnancy
WARNINGS / PRECAUTIONS
Boxed warnings: Bone marrow suppression: . Experienced physician: . Neurotoxicity: .
Special handling: Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects: Bone marrow suppression: [U.S. Boxed Warning]: Peripheral blood counts should be done routinely before and after drug therapy; bone marrow suppression is common. Use with caution in patients previously treated with other myelosuppressive drugs. Neurotoxicity: [U.S. Boxed Warning]: Neurologic examinations should be done routinely before and after drug therapy; neurotoxicity is common. USe with caution in patients with pre-existing neurotoxicity.
Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment. Renal impairment: Use with caution in patients with renal impairment.
Special populations: Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.
DRUG INTERACTIONS
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
MAO Inhibitors: Altretamine may enhance the orthostatic effect of MAO Inhibitors. Risk C: Monitor therapy
MAO Inhibitors: May enhance the orthostatic effect of Orthostasis Producing Agents. Risk C: Monitor therapy
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Pyridoxine: May diminish the therapeutic effect of Altretamine. Specifically when altretamine is used in combination with Cisplatin the response duration may be diminished. Risk D: Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Tricyclic Antidepressants: Altretamine may enhance the orthostatic effect of Tricyclic Antidepressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
PREGNANCY RISK FACTOR — D (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were noted in animal studies. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should avoid becoming pregnant while on therapy.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential toxicity in the nursing infant, breast-feeding is not recommended.
DIETARY CONSIDERATIONS — Should be taken after meals at bedtime.
PRICING — (data from drugstore.com)
Capsules (Hexalen)
50 mg (100): $1167.31
MONITORING PARAMETERS — CBC with differential, liver function tests; neurologic examination
CANADIAN BRAND NAMES — Hexalen®
INTERNATIONAL BRAND NAMES — Hexalen (AU, BG, GB, IL, JP, NO, NZ, SE, TH); Hexastat (AR, FR, IT, PT); Hexinawas (ES)
MECHANISM OF ACTION — Although altretamine's clinical antitumor spectrum resembles that of alkylating agents, the drug has demonstrated activity in alkylator-resistant patients. The drug selectively inhibits the incorporation of radioactive thymidine and uridine into DNA and RNA, inhibiting DNA and RNA synthesis; reactive intermediates covalently bind to microsomal proteins and DNA; can spontaneously degrade to demethylated melamines and formaldehyde which are also cytotoxic.
PHARMACODYNAMICS / KINETICS
Absorption: Well absorbed (75% to 89%)
Distribution: Highly concentrated hepatically and renally; low in other organs
Protein binding: 50% to 94%
Metabolism: Hepatic; rapid and extensive demethylation to active metabolites (pentamethylmelamine and tetramethylmelamine)
Half-life elimination: 13 hours
Time to peak, plasma: 0.5-3 hours
Excretion: Urine (90%, <1% as unchanged drug)
PATIENT INFORMATION — Report any numbness or tingling in extremities. Nausea and vomiting may occur.
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