Wednesday, June 16, 2010

Aluminum hydroxide, magnesium hydroxide, and simethicon

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Maalox® may be confused with Maox®, Monodox®
Mylanta® may be confused with Mynatal®

Maalox® is a different formulation than Maalox® Total Stomach Relief®

U.S. BRAND NAMES — Alamag Plus [OTC]; Aldroxicon I [OTC]; Aldroxicon II [OTC]; Almacone Double Strength® [OTC]; Almacone® [OTC]; Gelusil® [OTC]; Maalox® Max [OTC]; Maalox® [OTC]; Mi-Acid Maximum Strength [OTC]; Mi-Acid [OTC]; Mintox Extra Strength [OTC]; Mintox Plus [OTC]; Mylanta® Liquid [OTC]; Mylanta® Maximum Strength Liquid [OTC]

PHARMACOLOGIC CATEGORY
Antacid
Antiflatulent

DOSING: ADULTS — Dyspepsia, abdominal bloating: Oral: 10-20 mL or 2-4 tablets 4-6 times/day between meals and at bedtime; may be used every hour for severe symptoms

DOSING: ELDERLY — Refer to adult dosing.

DOSING: RENAL IMPAIRMENT — Aluminum and/or magnesium may accumulate in renal impairment.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Liquid: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (360 mL); aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (360 mL)
Aldroxicon I: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (30 mL)
Aldroxicon II: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (30 mL)
Almacone®: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (360 mL)
Almacone Double Strength®: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (360 mL)
Maalox®: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (360 mL, 770 mL) [lemon and mint flavors]
Maalox® Max: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (360 mL, 770 mL) [cherry, vanilla creme, and wild berry flavors]
Mi-Acid: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (360 mL)
Mi-Acid Maximum Strength: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (360 mL)
Mintox Extra Strength: Aluminum hydroxide 500 mg, magnesium hydroxide 450 mg, and simethicone 40 mg per 5 mL (360 mL) [lemon creme flavor]
Mylanta®: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL (180 mL, 360 mL, 720 mL) [original, cherry, and mint flavors]
Mylanta® Maximum Strength: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL (180 mL, 360 mL, 720 mL) [original, cherry, orange creme, and mint flavors]

Suspension (Alamag Plus): Aluminum hydroxide 225 mg, magnesium hydroxide 200 mg, and simethicone 25 mg per 5 mL (360 mL)

Tablet, chewable: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg
Alamag Plus: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg [cherry flavor]
Almacone®: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg [peppermint flavor]
Gelusil®: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg [peppermint flavor]
Mintox Plus: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg

DOSAGE FORMS: CONCISE
Liquid: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL; aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL
Aldroxicon I [OTC], Almacone® [OTC], Maalox® [OTC], Mi-Acid [OTC], Mylanta® [OTC]: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg per 5 mL
Aldroxicon II [OTC], Almacone Double Strength [OTC], Maalox® Max® [OTC], Mi-Acid Maximum Strength [OTC], Mylanta® Maximum Strength [OTC]: Aluminum hydroxide 400 mg, magnesium hydroxide 400 mg, and simethicone 40 mg per 5 mL
Mintox Extra Strength [OTC]: Aluminum hydroxide 500 mg, magnesium hydroxide 450 mg, and simethicone 40 mg per 5 mL

Suspension:
Alamag Plus [OTC]: Aluminum hydroxide 225 mg, magnesium hydroxide 200 mg, and simethicone 25 mg per 5 mL

Tablet, chewable: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg
Alamag Plus [OTC], Gelusil® [OTC], Mintox Plus [OTC]: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 25 mg
Almacone® [OTC]: Aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, and simethicone 20 mg

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — Administer 1-2 hours apart from oral drugs.

USE — Temporary relief of hyperacidity associated with gas; may also be used for indications associated with other antacids

ADVERSE REACTIONS SIGNIFICANT
>10%: Gastrointestinal: Chalky taste, stomach cramps, constipation, bowel motility decreased, fecal impaction, hemorrhoids

1% to 10%: Gastrointestinal: Nausea, vomiting, discoloration of feces (white speckles)

<1% (Limited to important or life-threatening): Dehydration or fluid restriction, hypomagnesemia, hypophosphatemia

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

Alpha-/Beta-Agonists: Antacids may decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Dipivefrin. Risk C: Monitor therapy

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

Bisphosphonate Derivatives: Magnesium Salts may decrease the absorption of Bisphosphonate Derivatives. Only oral magnesium salts are of concern. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification

Calcitriol: May increase the serum concentration of Magnesium Salts. Risk D: Consider therapy modification

Calcium Channel Blockers: May enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

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

Eltrombopag: Magnesium Salts may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., magnesium-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

Mycophenolate: Magnesium Salts may decrease the absorption of Mycophenolate. This only applies to oral magnesium salts. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Only of concern in patients with increased serum magnesium concentrations. Risk C: Monitor therapy

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

Phosphate Supplements: Magnesium Salts 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

QuiNIDine: Antacids may decrease the excretion of QuiNIDine. 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

Quinolone Antibiotics: Magnesium Salts may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. 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

Tetracycline Derivatives: Magnesium Salts may decrease the absorption of Tetracycline Derivatives. Only applicable to oral preparations of each agent. 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

Trientine: May decrease the serum concentration of Magnesium Salts. Magnesium Salts may decrease the serum concentration of Trientine. Risk D: Consider therapy modification

PREGNANCY RISK FACTOR — C (show table)

DIETARY CONSIDERATIONS — Should be taken 1-3 hours after meals.

PRICING — (data from drugstore.com)
Suspension (Mylanta)
200-200-20 mg/5 mL (355): $7.99
200-200-20 mg/5 mL (355): $9.12
200-200-20 mg/5 mL (710): $8.80

Suspension (Mylanta Double-Strength)
400-400-40 mg/5 mL (355): $7.99
400-400-40 mg/5 mL (710): $10.15

CANADIAN BRAND NAMES — Diovol Plus®; Gelusil®; Mylanta® Double Strength; Mylanta® Extra Strength; Mylanta® Regular Strength

INTERNATIONAL BRAND NAMES — Diovol Plus (CA); Gelusil (CA); Mylanta Double Strength (CA); Mylanta Extra Strength (CA); Mylanta Regular Strength (CA)

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