Drug Interactions between safinamide and Vilamit MB

MONITOR CLOSELY: The following interaction applies only to products containing sodium biphosphate that are used for bowel cleansing. It does not apply to products containing sodium biphosphate that are used for other, non-laxative related purposes.

Coadministration with agents that affect renal function or perfusion such as diuretics, ACE inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of acute phosphate nephropathy associated with the use of bowel-cleansing phosphate solutions. The risk and/or severity of fluid and electrolyte disturbances may also be increased, which can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment. Acute phosphate nephropathy is a rare adverse event that presents as acute renal failure with minimal proteinuria and a bland urine sediment. Renal biopsy findings are consistent with nephrocalcinosis and include acute and/or chronic renal tubular injury, calcium-phosphate crystal deposition in the distal tubules and collecting ducts, and no other pattern of histological injury. The risk of acute phosphate nephropathy stems from the large phosphate load, fluid shifts, and decreased intravascular volume, which can be exacerbated in the presence of medications that affect renal perfusion or function. In reported cases, acute renal failure was typically diagnosed within two to five months of colonoscopy. These cases often resulted in permanent impairment of renal function, some requiring long-term dialysis.

MANAGEMENT: Caution is advised when bowel-cleansing phosphate preparations are prescribed in patients treated with agents that affect renal function or perfusion, particularly if they are frail or elderly. Bowel-cleansing phosphate preparations should not be used in patients who have impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities. In patients at risk for acute phosphate nephropathy, baseline and postprocedure labs including serum electrolytes, calcium, phosphate, BUN, and creatinine should be performed. Patients should be advised not to exceed the recommended dosage of their bowel-cleansing preparation and to drink sufficient quantities of clear fluids during before, during, and after bowel cleansing. Limited data suggest that administration of an electrolyte rehydration solution may attenuate the electrolyte abnormalities and hypovolemia. Hospitalization and intravenous fluid hydration may be appropriate for frail or elderly patients who may be unable to drink an adequate volume of fluid.

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CONTRAINDICATED: Coadministration of a selective monoamine oxidase B (MAO-B) inhibitor with other MAO inhibitors, selective or nonselective, may increase the risk of a hypertensive crisis. Although selective inhibitors of MAO-B presumably have minimal effect on intestinal and hepatic MAO-A that catabolizes exogenous amines like tyramine, the selectivity may not be absolute even at recommended doses and may diminish with increasing doses. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline. There have also been postmarketing reports of patients who experienced significantly elevated blood pressure, including very rare cases of hypertensive crisis, after ingestion of unknown amounts of tyramine-rich foods while taking recommended doses of rasagiline, despite results from multiple tyramine challenge studies demonstrating selectivity for MAO-B at recommended doses. The combination of a selective MAO-B inhibitor and a nonselective MAO inhibitor can also cause hypotensive reactions including orthostasis. Hypotension, sometimes sudden in onset, has been reported with rasagiline and selegiline, particularly when used with levodopa and during the first two months of treatment.

CONTRAINDICATED: Coadministration of a selective MAO-B inhibitor with other MAO inhibitors may increase the risk of serotonin syndrome, which is a rare but serious and potentially fatal condition thought to result from hyperstimulation of brainstem 5-HT1A and 2A receptors. Symptoms of the serotonin syndrome may include mental status changes such as irritability, altered consciousness, confusion, hallucination, and coma; autonomic dysfunction such as tachycardia, hyperthermia, diaphoresis, shivering, blood pressure lability, and mydriasis; neuromuscular abnormalities such as hyperreflexia, myoclonus, tremor, rigidity, and ataxia; and gastrointestinal symptoms such as abdominal cramping, nausea, vomiting, and diarrhea.

MANAGEMENT: Concurrent use of selective MAO-B inhibitors with other MAO inhibitors is considered contraindicated. At least 14 days should elapse between discontinuation of a nonselective MAO inhibitor and initiation of treatment with a selective MAO inhibitor, and vice versa. The recommended dosages of selective MAO-B inhibitors should not be exceeded, as it can increase the risk of nonselective MAO inhibition and precipitation of a hypertensive crisis.

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