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