ROMACIN 99.934% POWDER 300G

Indications

Approved Uses

Treatment of hyperkalemia (elevated serum potassium) in adults and children, including in patients with renal impairment; it may be used as adjunctive therapy in severe hyperkalemia (including dialysis patients) but is not limited to anuria/oliguria or dialysis only.

Dosage & Administration

Dosing by Condition

Hyperkalemia-Adults: Oral 15 g 3-4 times daily as a suspension; Rectal 30 g in ~100-200 mL water as a retention enema, repeat as needed based on potassium. Pediatrics: commonly 0.5-1 g/kg/day in divided doses (oral or rectal) with close monitoring.

Initial Dose

15g orally three to four times daily (adults)

Maintenance Dose

15g orally one to three times daily, adjusted based on serum potassium levels

Maximum Dose

60g per day (oral); 30g per enema (rectal)

Children's Dosage

1 g/kg every 6 hours orally or rectally as needed; oral use not recommended in neonates

Dose Adjustment Notes

Titrate to serial serum potassium and stop/hold once potassium is normalized to avoid hypokalemia; monitor and adjust for electrolyte disturbances (calcium/magnesium) and constipation/impaction risk, especially in renal impairment and the elderly.

How to Take

Oral: Do not take the dry powder. Measure the prescribed dose and disperse in water (or another suitable non‑sorbitol vehicle) to form a suspension; administer promptly and follow with additional water. Separate from other oral medicines by at least 3 hours (≥6 hours for narrow‑therapeutic‑index drugs when feasible). Rectal: Prepare an aqueous suspension and administer via rectal catheter as a retention enema; retain as long as possible (commonly 30-60 minutes) then evacuate/irrigate as directed; avoid sorbitol-containing enemas.

How to Prepare

Oral: Suspend each dose in water (typical guidance ~3-4 mL water per gram of resin) and administer promptly. Rectal: Prepare a suspension (commonly 30 g in ~150 mL water or 10% dextrose) for retention enema and use immediately.

Side Effects

Common Side Effects

GI: constipation, nausea, vomiting, diarrhea, anorexia; Electrolytes/metabolic: hypokalemia, hypercalcemia, hypomagnesemia; Rare but serious: intestinal/colonic necrosis (especially with sorbitol), fecal impaction/obstruction.

Side Effect Frequency

Common: Gastrointestinal effects (constipation, nausea, vomiting, diarrhea, anorexia). Important/rare but serious: fecal impaction, intestinal obstruction, GI ulceration/ischemia/necrosis/perforation; electrolyte disturbances including hypokalemia, hypercalcemia, and hypomagnesemia.

Safety & Warnings

Contraindications

Contraindications include: hypersensitivity to calcium polystyrene sulfonate/resin components; hypokalemia (do not use when potassium is low/normal); obstructive bowel disease/ileus or conditions with markedly reduced gut motility (including neonates); and concomitant sorbitol use should be avoided (often treated as a contraindication due to intestinal necrosis risk).

Warnings & Precautions

Avoid concomitant sorbitol due to intestinal necrosis risk; monitor serum electrolytes regularly (K+, Ca2+, Mg2+ and others as clinically indicated) and stop/adjust if hypokalemia or hypercalcemia develops; ensure adequate bowel function and discontinue if significant constipation/impaction occurs; use caution in patients with reduced gut motility or high GI-risk states (post-op, ileus); not for rapid emergency lowering of potassium-use standard acute hyperkalemia measures when needed; avoid aspiration during oral administration.

Age Restriction

Oral administration is contraindicated in neonates; rectal use in neonates/infants is generally avoided and, if ever considered, should be only under specialist supervision with extreme caution due to high risk of GI complications.

Drug Interactions

Drug Interactions

Key interactions: sorbitol (avoid-associated with intestinal necrosis); other oral medicines (reduced absorption-separate administration by several hours); antacids/laxatives containing magnesium or aluminum (and other cations) may increase risk of alkalosis and reduce resin effectiveness; digitalis/digoxin (toxicity risk increased if resin causes hypokalemia); levothyroxine and lithium (reduced absorption).

Interaction Severity

MAJOR: Sorbitol (oral or rectal) due to risk of intestinal necrosis. MODERATE: Other oral medications (reduced absorption-separate by ≥3 hours; longer for narrow-therapeutic-index drugs), Digoxin (toxicity risk if hypokalemia occurs), Levothyroxine (reduced absorption-separate), Lithium (reduced absorption), Magnesium/aluminum-containing antacids/laxatives (electrolyte/metabolic effects and GI risks).

Food Interaction

May be taken with or without food; do not mix/administer with high-potassium liquids/foods (e.g., orange juice) and avoid sorbitol-containing products.

Special Populations

Children

1 g/kg every 6 hours orally or rectally as needed; oral use not recommended in neonates

Kidney Impairment

No formal renal dose adjustment is specified, but use requires close monitoring of electrolytes (especially potassium, calcium, magnesium) and bowel function in renal impairment.

Storage & Patient Advice

Storage Conditions

Store below 30°C in a tightly closed container. After reconstitution/preparation as an oral or rectal suspension: use immediately; do not store for later use unless specifically directed by the manufacturer/pharmacy.

Preparation Instructions

Oral: Suspend each dose in water (typical guidance ~3-4 mL water per gram of resin) and administer promptly. Rectal: Prepare a suspension (commonly 30 g in ~150 mL water or 10% dextrose) for retention enema and use immediately.

Stopping the Medicine

Discontinue once serum potassium has returned to the desired/normal range (i.e., when hyperkalemia is corrected), with continued monitoring to avoid overshoot hypokalemia; do not treat to a fixed threshold of 5 mmol/L for all patients.

Overdose

Overdose may cause severe hypokalemia (weakness, paralysis, arrhythmias), hypercalcemia, and GI complications (constipation, fecal impaction, obstruction); management is to stop the resin, correct electrolytes, provide supportive care, and remove resin from the GI tract (laxatives/enemas as appropriate) with urgent medical evaluation.

Patient Counseling

Mix well with water/syrup and take immediately-never swallow dry powder; separate from other oral medicines by ≥3 hours; avoid sorbitol-containing products and avoid mixing with high-potassium beverages (e.g., orange juice); follow prescribed low-potassium diet; maintain hydration and report constipation, no bowel movement, severe abdominal pain, blood in stool, or muscle weakness; attend scheduled blood tests for potassium and other electrolytes.

Monitoring Requirements

Serum electrolytes (K+, Ca2+, Mg2+, Na+, bicarbonate as clinically indicated) and clinical GI status (bowel movements/constipation, abdominal pain); in severe hyperkalemia monitor ECG and repeat potassium frequently until controlled.

Pharmacology

Mechanism of Action

A non-absorbed cation-exchange resin that exchanges calcium for potassium in the gastrointestinal tract (predominantly the colon), increasing fecal potassium excretion and lowering serum potassium.

Onset of Action

Delayed: typically hours with rectal administration and several hours to >24 hours orally; not reliable for immediate, life-threatening hyperkalemia (use temporizing measures instead).

Duration of Effect

Effect persists while resin remains in the GI tract; potassium-lowering can continue for ~1-2 days after the last dose depending on GI transit and repeat dosing.

Half-Life

Not applicable (not systemically absorbed).

Bioavailability

Not systemically absorbed; acts locally in the gastrointestinal tract (oral/rectal).

Metabolism

Not metabolized.

Excretion

Excreted in feces as resin (including potassium-bound resin).

Protein Binding

Not applicable (not systemically absorbed).

Product Information

Available Dosage Forms

Powder for oral suspension, powder for rectal suspension

Composition per Dose

Each 15g dose (approximately 3 level teaspoons): 15g calcium polystyrene sulfonate 99.934% w/w

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

Hyperkalemia (not kidney stones

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.