Componentes:
Método de ação:
Opção de tratamento:
Medicamente revisado por Oliinyk Elizabeth Ivanovna, Farmácia Última atualização em 19.03.2022
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20 principais medicamentos com os mesmos componentes:
Sorbitol: Gastrointestinal stenosis, intestinal ischemia and its complications (necrosis and perforation) may occur in patients treated with polystyrene sulfonate, especially in patients using sorbitol.8 Undesirable effects).
Hypokalaemia: The possibility of severe potassium depletion should be considered, and adequate clinical and biochemical control is essential during treatment, especially in patients on digitalis. Administration of the resin should be stopped when the serum potassium falls to 5mmol/litre.
Other electrolyte disturbances: Because the resin may bind calcium and magnesium ions, deficiencies of these electrolytes may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances.
Other risks: In the event of clinically significant constipation, treatment should be discontinued until normal bowel movement has resumed. Magnesium-containing laxatives should not be used.
The patient should be positioned carefully when ingesting the resin, in order to avoid aspiration, which may lead to bronchopulmonary complications.
Children and neonates: In neonates, sodium polystyrene sulfonate should not be given by the oral route. In children and neonates particular care is needed with rectal administration as excessive dosage or inadequate dilution could result in impaction of the resin. Due to the risk of digestive haemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.
Patients at risk from an increase in sodium load: Care should be taken when administering to patients in whom an increase in sodium load may be detrimental (i.e. congestive heart failure, hypertension, renal damage or oedema). In such instances, adequate clinical and biochemical control is essential. The calcium form of the resin may have advantages in this situation.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Intestinal Necrosis
Cases of intestinal necrosis, some fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Resincalcio use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended.
- Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.
- Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction). Discontinue use in patients who develop constipation.
Electrolyte Disturbances
Monitor serum potassium during therapy because severe hypokalemia may occur.
Resincalcio is not totally selective for potassium, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Monitor calcium and magnesium in patients receiving Resincalcio.
Fluid Overload In Patients Sensitive To High Sodium Intake
Each 15 g dose of Resincalcio contains 1500 mg (60 mEq) of sodium. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, edema) for signs of fluid overload. Adjustment of other sources of sodium may be required.
Risk Of Aspiration
Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles have been reported. Patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. Administer Resincalcio with the patient in an upright position.
Binding To Other Orally Administered Medications
Resincalcio may bind orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 3 hours before or 3 hours after Resincalcio. Patients with gastroparesis may require a 6 hour separation..
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies have not been performed.
Use In Specific Populations
Pregnancy
Risk Summary
Resincalcio is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.
Lactation
Risk Summary
Resincalcio is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.
Pediatric Use
Studies of safety and efficacy have not been conducted in pediatric patients.
In pediatric patients, as in adults, Resincalcio is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin.
In neonates, Resincalcio should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with Resincalcio. use.