Milantex Side Effects

Generic Name: aluminum hydroxide / magnesium hydroxide / simethicone

Note: This page contains information about the side effects of aluminum hydroxide / magnesium hydroxide / simethicone. Some of the dosage forms included on this document may not apply to the brand name Milantex.

Not all side effects for Milantex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aluminum hydroxide / magnesium hydroxide / simethicone: capsules, chewable tablets, suspension

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur while taking aluminum hydroxide / magnesium hydroxide / simethicone:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

For Healthcare Professionals

Applies to aluminum hydroxide / magnesium hydroxide / simethicone: oral suspension, oral tablet chewable

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included constipation (secondary to aluminum hydroxide therapy) and diarrhea (secondary to magnesium hydroxide therapy). These agents are combined so lower doses may be used and the constipating and diarrheal effects may be balanced out. However, diarrhea appears to be the dominating effect, regardless of the ratio. Rarely, gastrointestinal obstruction has occurred with the use of aluminum hydroxide.[Ref]

General

Sources of aluminum in patients with renal failure have included water used for dialysate solutions, in addition to aluminum hydroxide. Adverse effects of aluminum accumulation in these patients has led to monitoring of water source aluminum content by dialysis units and periodic measurements of serum aluminum in patients undergoing chronic dialysis.

High aluminum concentrations in patients are generally also associated with high daily dosage. One study suggested that increased aluminum concentrations in uremic patients was most significant with daily doses greater than 3 grams of aluminum hydroxide. Age of the patient has also been directly correlated with aluminum concentrations, with younger age groups perhaps demonstrating higher concentrations.

Concurrent administration of aluminum hydroxide with citrate containing products has been associated with unusually high serum concentrations of aluminum and, especially in cases of renal failure, severe toxicity. It was speculated that citrate increases aluminum's solubility and absorption.

Aluminum concentrations during aluminum hydroxide therapy have also been correlated with body iron stores. One study demonstrated a negative correlation between serum aluminum concentrations and serum ferritin levels. It was postulated that high serum ferritin and high transferritin saturation might hamper gut absorption of aluminum.

During long-term use, aluminum has been shown to deposit in bone, joints, and the brain of patients who accumulate aluminum.

Signs and symptoms of hypermagnesemia may include hypotension, nausea, vomiting, EKG changes, respiratory depression, altered mental status, and coma.[Ref]

Although the majority of aluminum ingested is eliminated by the gastrointestinal tract, absorption of aluminum and increases in serum concentrations have been demonstrated. Accumulation of aluminum and resulting toxicity is confined to patients with renal dysfunction and impaired elimination of aluminum.

Magnesium may be systemically absorbed following administration of magnesium hydroxide. In patients with normal renal function, increased magnesium elimination in the urine occurs and no significant changes in serum magnesium levels would be expected. However, magnesium may accumulate in patients with renal insufficiency.[Ref]

Metabolic

Metabolic side effects have included hypophosphatemia with the use of aluminum hydroxide. In patients on long-term aluminum hydroxide therapy, especially in association with poor diets, hypophosphatemia may result in muscle weakness, rhabdomyolysis, hemolysis, and encephalopathy.[Ref]

Aluminum hydroxide complexes with phosphate in the gut to form insoluble aluminum phosphate, thus inhibiting the absorption of dietary phosphate. Aluminum hydroxide is commonly used in patients with renal dysfunction to regulate the accumulation of phosphate due to decreased elimination.

Hypophosphatemia is thought to stimulate the conversion of calcifediol (25-hydroxy vitamin D3) to calcitriol (1,25-dihydroxy vitamin D3), a potent stimulator of calcium and phosphorus intestinal absorption and osteoclastic resorption. Hypercalciuria is generally associated with hypophosphatemia.[Ref]

Musculoskeletal

Aluminum hydroxide associated hypophosphatemia, if severe and chronic, results in decreased bone mineralization and potentially osteomalacia. Hypophosphatemia is also thought to stimulate the conversion of calcifediol (25-hydroxy vitamin D3) to calcitriol (1,25-dihydroxy vitamin D3), a potent stimulator of osteoclastic resorption, contributing to osteomalacia. These patients generally require phosphorus replacement therapy. Symptoms of osteomalacia may take several weeks to resolve.

Osteomalacia due to aluminum deposition in bone is generally only seen in patients with chronic renal failure. Bone formation slows in response to aluminum bone deposits. Aluminum may also deposit in joint tissue, resulting in arthropathy and hydrarthrosis.[Ref]

Musculoskeletal side effects have included osteomalacia, due to aluminum hydroxide, which may occur by two different mechanisms. Osteomalacia may occur due to hypophosphatemia or due to aluminum accumulation in bone. Osteomalacia due to hypophosphatemia is often accompanied by malaise, bone pain, muscular weakness, and bone fractures. Osteomalacia due to aluminum deposition may present in a similar fashion and occurs predominantly in patients with chronic renal failure. Aluminum deposits are seen on bone biopsy.[Ref]

Nervous system

Encephalopathy associated with aluminum accumulation is generally characterized by speech disorders, dysarthria, dyspraxia, dysphasia, tremor, myoclonus, seizures, coma, and death. EEG of patients with aluminum encephalopathy has shown paroxysmal slowing, and diffuse rhythmical bursts of delta activity.

The interval between commencement of aluminum hydroxide therapy and development of encephalopathy in eight reported cases ranged from three weeks to three months. In two of these patients, aluminum serum concentrations ranged from 871 to 2267 mcg/L. These patients were on concomitant sodium citrate therapy. Most chronic dialysis patients develop aluminum encephalopathy slowly over several years.[Ref]

Nervous system side effects have included encephalopathy which has occasionally been reported in patients with renal failure on long-term therapy with aluminum hydroxide. When available, basal and/or deferoxamine stimulated aluminum serum levels reveal high concentrations.[Ref]

Renal

Renal side effects have rarely included formation of renal calculi, most probably due to hypercalciuria, with the use of aluminum hydroxide.[Ref]

Other

Antacids may interfere with drug therapies because of their effect on gastric pH, adsorption or binding to drugs, and changes in urinary pH.[Ref]

References

1. Johansson G, Backman U, Danielson BG, Fellstrom B, Ljunghall S, Wikstrom B "Magnesium metabolism in renal stone formers. Effects of therapy with magnesium hydroxide." Scand J Urol Nephrol Suppl 53 (1980): 125-34

2. Johansson G, Backman U, Danielson BG, Fellstrom B, Ljunghall S, Wikstrom B "Effects of magnesium hydroxide in renal stone disease." J Am Coll Nutr 1 (1982): 179-85

3. "Product Information. Amphojel (aluminum hydroxide)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

4. Girotti MJ, Ruddan J, Cohanim M "Amphojeloma: antacid impaction in a critically ill patient." Can J Surg 27 (1984): 379-80

5. Chanard J, Roujouleh H, Bernieh B, Bindi P, Dion JJ "Long-term use of magnesium hydroxide [Mg (OH)2] as a phosphate binder in patients on hemodialysis." Clin Nephrol 29 (1988): 216-7

6. Weberg R, Berstad A, Aaseth J, Falch JA "Mineral-metabolic side effects of low-dose antacids." Scand J Gastroenterol 20 (1985): 741-6

7. Johansson G, Backman U, Danielson BG, Fellstrom B, Ljunghall S, Wikstrom B "Biochemical and clinical effects of the prophylactic treatment of renal calcium stones with magnesium hydroxide." J Urol 124 (1980): 770-4

8. Fung MC, Weintraub M, Bowen DL "Hypermagnesemia: elderly over-the-counter drug users at risk." Arch Fam Med 4 (1995): 718-23

9. Kirschbaum BB, Schoolwerth AC "Acute aluminum toxicity associated with oral citrate and aluminum- containing antacids." Am J Med Sci 297 (1989): 9-11

10. Ittel TH, Gladziwa U, Muck W, Sieberth HG "Hyperaluminaemia in critically ill patients: role of antacid therapy and impaired renal function." Eur J Clin Invest 21 (1991): 96-102

11. Poisson M, Mashaly R, Lebkiri B "Dialysis encephalopathy: recovery after interruption of aluminium intake." Br Med J 2 (1978): 1610-1

12. Main J, Ward MK "Potentiation of aluminium absorption by effervescent analgesic tablets in a haemodialysis patient." BMJ 304 (1992): 1686

13. Brahm M "Serum-aluminum in nondialyzed chronic uremic patients before and during treatment with aluminum-containing phosphate-binding gels." Clin Nephrol 25 (1986): 231-5

14. Bardhan KD, Hunter JO, Miller JP, Thomson AB, Graham DY, Russell RI, Sontag S, Hines C, Martin T, Gaussen L, et al "Antacid maintenance therapy in the prevention of duodenal ulcer relapse." Gut 29 (1988): 1748-54

15. Bakir AA, Hryhorczuk DO, Ahmed S, Hessl SM, Levy PS, Spengler R, Dunea G "Hyperaluminemia in renal failure: the influence of age and citrate intake." Clin Nephrol 31 (1989): 40-4

16. Huang JY, Huang CC, Lim PS, Wu MS, Leu ML "Effect of body iron stores on serum aluminum level in hemodialysis patients." Nephron 61 (1992): 158-62

17. Ludwig GD, Kyle CG, de Blanco M ""Tertiary" hyperparathyroidism induced by osteomalacia resulting from phosphorus depletion." Am J Med 43 (1967): 136-40

18. Spencer H, Lender M "Adverse effects of aluminum-containing antacids on mineral metabolism." Gastroenterology 76 (1979): 603-6

19. Cooke N, Teitelbaum S, Avioli LV "Antacid-induced osteomalacia and nephrolithiasis." Arch Intern Med 138 (1978): 1007-9

20. Baker LR, Ackrill P, Cattell WR, Stamp TC, Watson L "Iatrogenic osteomalacia and myopathy due to phosphate depletion." Br Med J 3 (1974): 150-2

21. Carmichael KA, Fallon MD, Dalinka M, Kaplan FS, Axel L, Haddad JG "Osteomalacia and osteitis fibrosa in a man ingesting aluminum hydroxide antacid." Am J Med 76 (1984): 1137-43

22. Insogna KL, Bordley DR, Caro JF, Lockwood DH "Osteomalacia and weakness from excessive antacid ingestion." JAMA 244 (1980): 2544-6

23. Heaf JG, Podenphant J, Joffe P, Andersen JR, Fugleberg S, Braendstrup O "The effect of oral aluminium salts on the bone of non-dialysed uremic patients." Scand J Urol Nephrol 21 (1987): 229-33

24. Sherrard DJ, Ott SM, Andress DL "Pseudohyperparathyroidism. Syndrome associated with aluminum intoxication in patients with renal failure." Am J Med 79 (1985): 127-30

25. Netter P, Kessler M, Burnel D, Hutin MF, Delones S, Benoit J, Gaucher A "Aluminum in the joint tissues of chronic renal failure patients treated with regular hemodialysis and aluminum compounds." J Rheumatol 11 (1984): 66-70

26. Kingswood C, Banks RA, Bunker T, Harrison P, Mackenzie C "Fracture osteomalacia." Lancet 1 (1983): 70-1

27. Alfrey AC, LeGendre GR, Kaehny WD "The dialysis encephalopathy syndrome. Possible aluminum intoxication." N Engl J Med 294 (1976): 184-8

28. Masselot JP, Adhemar JP, Jaudon MC, Kleinknecht D, Galli A "Reversible dialysis encephalopathy: role for aluminium-containing gels." Lancet 2 (1978): 1386-7

29. Sideman S, Manor D "The dialysis dementia syndrome and aluminum intoxication." Nephron 31 (1982): 1-10

30. Pillion G, Loirat C, Blum C, Poisson M, Bacri JL, Broyer M, Mathieu H "Aluminium encephalopathy: a potential risk of aluminium gels in children with chronic renal failure." Int J Pediatr Nephrol 2 (1981): 29-32

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