Rulox Plus Side Effects
Generic Name: aluminum hydroxide / magnesium hydroxide / simethicone
Note: This page contains side effects data for the generic drug aluminum hydroxide / magnesium hydroxide / simethicone. It is possible that some of the dosage forms included below may not apply to the brand name Rulox Plus.
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:
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 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]
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 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]
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]
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 side effects have rarely included formation of renal calculi, most probably due to hypercalciuria, with the use of aluminum hydroxide.[Ref]
Antacids may interfere with drug therapies because of their effect on gastric pH, adsorption or binding to drugs, and changes in urinary pH.[Ref]
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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
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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
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17. Ludwig GD, Kyle CG, de Blanco M ""Tertiary" hyperparathyroidism induced by osteomalacia resulting from phosphorus depletion." Am J Med 43 (1967): 136-40
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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
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It is possible that some side effects of Rulox Plus may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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