KPIC: Sparon Tab. treats acute spastic pain and smooth muscle spasms

Aju Pharm manufactures Sparon Tab., an oral single-agent prescription tablet containing tiropramide hydrochloride, designed to relieve smooth muscle spasms and acute cramp-like pain in the biliary tract, gastrointestinal tract, and kidneys, according to the Korea Pharmaceutical Information Center.

Regulatory Approval History and Insurance Reimbursement Changes

The Ministry of Food and Drug Safety originally approved Sparon Tab. on July 24, 2003, assigning it the item standard code 200300521. Health authorities structured its national health insurance reimbursement at 135 won per tablet starting February 1, 2017, before adjusting the pricing to 115 won per tablet on September 5, 2023. The drug maintains the insurance code 654000570, with reimbursement criteria most recently updated on May 1, 2025. Packaging configurations listed by the Ministry of Food and Drug Safety include 30 tablets per bottle and 300 tablets per bottle.

Aju Pharm maintains manufacturing and marketing responsibilities from its headquarters in Guro-gu, Seoul. The product formulation relies on microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose hydrate, sodium starch glycolate, povidone, and white Tapshield coating material. The company packages the medication in airtight containers kept at controlled room temperatures between 1 and 30 degrees Celsius, following a registration update logged on March 19, 2026.

Clinicians Prescribe Sparon Tab for Acute Spastic Pain

Medical providers prescribe Sparon Tab. for acute spastic pain conditions, including biliary colic, abdominal cramps from various origins, and renal or ureteral colic. It addresses abdominal cramping tied to gastrointestinal dyskinesia, cholelithiasis, cholecystitis, and post-surgical adhesions. The standard dosage protocol for adults dictates taking 100 milligrams of tiropramide hydrochloride orally two to three times daily, subject to adjustment by a clinician based on patient age and symptom severity.

Contraindications restrict administration for patients with mechanical gastrointestinal stenosis, megacolon, collapse, known hypersensitivity to the drug, or severe hepatic failure. Because the tablet contains lactose, patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption must avoid the medication. Physicians must also exercise caution when prescribing the treatment to patients diagnosed with glaucoma or prostatic hyperplasia, even though the compound lacks anticholinergic activity.

Therapeutic equivalence data published by the Korea Pharmaceutical Information Center documents a 2×2 crossover bioequivalence study conducted by Teragen Etex. Researchers administered a single oral dose of the test drug TPM Tab., containing tiropramide hydrochloride produced by Teragen Etex, alongside the reference drug Tyropa Tab., produced by Daewoong Pharmaceutical, to 49 healthy adult volunteers under fasting conditions.

Sparon Tab Causes Dry Mouth and Interacts with Hypotensives

Observed adverse reactions include dry mouth, nausea, vomiting, and constipation. Patients who develop allergic manifestations such as pruritus or erythema must discontinue use immediately. Drug interaction alerts warn that administering high doses of Sparon Tab. alongside blood pressure-lowering medications can intensify the hypotensive response.

Animal testing revealed no adverse reactions in pregnant subjects or fetuses, but regulatory guidelines restrict usage during pregnancy to cases where clear clinical necessity outweighs potential risks, requiring direct supervision by a licensed medical practitioner. Patients experiencing dry mouth during therapy find relief by holding ice cubes in the mouth or consuming sugar-free gum and hard candies.