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
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, stomach cramps, fecal impaction, nausea, vomiting, discoloration of feces (white speckles)

Endocrine & metabolic: Hypophosphatemia, hypomagnesemia

CONTRAINDICATIONS — Hypersensitivity to aluminum salts or any component of the formulation

WARNINGS / PRECAUTIONS — 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 CHF, 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.

Elderly may be predisposed to constipation and fecal impaction. Careful evaluation of possible drug interactions must be done. When used as an antacid in ulcer treatment, consider buffer capacity (mEq/mL) to calculate dose.

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
Decreased effect: Aluminum hydroxide may decrease the absorption of allopurinol, antibiotics (tetracyclines, quinolones, some cephalosporins), bisphosphonate derivatives, corticosteroids, cyclosporine, delavirdine, iron salts, imidazole antifungals, isoniazid, mycophenolate, penicillamine, phosphate supplements, phenytoin, phenothiazines, trientine.

Absorption of aluminum hydroxide may be decreased by citric acid derivatives.

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.

TOXICOLOGY / OVERDOSE COMPREHENSIVE — Aluminum antacids may cause constipation, phosphate depletion, and bezoar or fecalith formation. In patients with renal failure, aluminum may accumulate to toxic levels. Deferoxamine, traditionally used as an iron chelator, has been shown to increase urinary aluminum output. Deferoxamine chelation of aluminum has resulted in improvements of clinical symptoms and bone histology; however, remains an experimental treatment for aluminum poisoning and has a significant potential for adverse effects.

CANADIAN BRAND NAMES — Amphojel®; Basaljel®

INTERNATIONAL BRAND NAMES — Acidex (ZA); Aldrox (BE); Algeldraat (NL); Alu-Cap (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TZ, UG, YE, ZM, ZW); Alu-Tab (HK, PH); Alucol (IT); Aludrox (DE, IE); Alugel (DE, TW); Alugelibys (ES); Alumigel (JP); Alutab (MY, NZ); Alzinox (PH); Amphogel (AU); Amphojel (CA, NZ, ZA); Basaljel (CA); Gastracol (CH); Pepsamar (BF, BJ, BR, CI, CL, CO, ES, ET, GH, GM, GN, GR, KE, LR, MA, ML, MR, MU, MW, NE, NG, PE, PT, SC, SD, SL, SN, TZ, UG, VE, 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

(For additional information see "Aluminum hydroxide: Patient drug information")


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