Fexuclue Tab

FEXUCLUE TAB is a medication manufactured by SUN PHARMA-RION DIV, primarily used for treating acid-related disorders.

Name

• Common Name: Fexuprazan
• Brand Name: FEXUCLUE TAB

Composition

Each FEXUCLUE TAB contains 40 mg of Fexuprazan HCl as the active pharmaceutical ingredient. Inactive ingredients include Microcrystalline Cellulose, Magnesium stearate, Opadry Green AMB2 88A610038, Opadry White 03B28796, Croscarmellose Sodium, Yellow Iron Oxide, lactose hydrate, and Yellow No. 4. Fexuprazan is classified as a potassium-competitive acid blocker (P-CAB).

Uses

FEXUCLUE TAB is prescribed for the following conditions:

• Erosive Esophagitis (EE): A condition where the lining of the food pipe is inflamed or damaged due to stomach acid reflux. It promotes rapid healing of the esophageal lining and alleviates symptoms such as burning sensation, chest pain, and difficulty swallowing.
• Acid-Related Disorders: Including gastroesophageal reflux disease (GERD).

Dosage and Administration

For the treatment of erosive esophagitis, the typical dosage for adults is 40 mg, administered orally once a day for 4 weeks. If untreated esophagitis or symptoms persist, an additional 4 weeks of treatment may be administered. The tablet can be taken with or without meals and should be swallowed whole, without chewing, crushing, or breaking.

Side Effects

• Common Side Effects: Indigestion, nausea, abdominal discomfort, stomach inflammation (gastritis), erythema (skin redness), headache, back pain, and diarrhea.
• Less Common Side Effects (incidence <1%): Hiatal hernia, bronchitis, herpes simplex, influenza, contact dermatitis, pruritus, facial edema, chest discomfort, pain, fever, dizziness, dysgeusia, myalgia, musculoskeletal pain, and hypertriglyceridemia.
• Serious Side Effects: Rarely, stiffness, arrhythmia, and seizures have been reported with similar classes of drugs. Hypomagnesemia can also occur with long-term use.

Precautions

• Contraindications: FEXUCLUE TAB is contraindicated in patients with a history of hypersensitivity to its components, pregnant and lactating women, and those taking medications containing atazanavir, nelfinavir, or rilpivirine. Patients with congenital lactose conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid this medicine.
• Use with Caution: Caution is advised for patients with hepatic or renal impairment, as dose adjustments may be necessary. Elderly patients and those with a history of allergy to Yellow 4 Tartrazine should also be monitored carefully.
• General Warnings: The medication may mask symptoms of malignant tumors, potentially delaying diagnosis. There may be a slightly increased risk of gastrointestinal infections by bacteria such as Salmonella, Campylobacter, and Clostridium difficile due to reduced stomach acidity. Increased serum gastrin levels can occur, which might lead to false positive results in diagnostic tests for neuroendocrine tumors.
• Drug Interactions: FEXUCLUE TAB can affect the absorption of other oral drugs whose bioavailability depends on stomach pH, such as atazanavir and nelfinavir.

Storage

Store FEXUCLUE TAB below 30°C. Keep the medication out of reach of children.

FEXUCLUE TAB, containing Fexuprazan, is a potassium-competitive acid blocker (P-CAB) medication used to treat acid-related conditions, primarily erosive esophagitis. It is manufactured by Sun Pharma-Rion Div.

Here are some frequently asked questions about FEXUCLUE TAB:

What is FEXUCLUE TAB used for?

FEXUCLUE TAB is used for the treatment of erosive esophagitis, a condition where the lining of the food pipe becomes inflamed or damaged due to stomach acid reflux. It helps heal the esophageal lining and reduces symptoms like burning sensation, chest pain, and difficulty swallowing. It is also being studied for other acid-related disorders and conditions like gastroesophageal reflux disease (GERD) and the improvement of gastric mucosal lesions in acute or chronic gastritis.

How does FEXUCLUE TAB work?

FEXUCLUE TAB contains Fexuprazan, which is a potassium-competitive acid blocker (P-CAB). It works by directly and reversibly blocking the H⁺/K⁺-ATPase enzyme, also known as the proton pump, in the acid-secreting parietal cells of the stomach. By inhibiting this enzyme, Fexuprazan controls the secretion of gastric acid, thereby reducing acid production at its source and allowing the esophagus to heal.

What is the usual dosage of FEXUCLUE TAB?

For adults, the typical dosage for treating erosive esophagitis is 40 mg administered orally once a day for 4 weeks. If the esophagitis is untreated or symptoms persist, administration may continue for another 4 weeks, totaling up to 8 weeks of treatment. The tablet can be taken with or without meals.

What are the possible side effects of FEXUCLUE TAB?

Common side effects reported include indigestion, nausea, abdominal discomfort, stomach inflammation, erythema (skin redness), headache, and back pain. Other less common side effects can include diarrhea, hiatal hernia, bronchitis, influenza, dizziness, and muscle pain.

Is FEXUCLUE TAB safe during pregnancy or breastfeeding?

FEXUCLUE TAB should generally not be used during pregnancy or while breastfeeding. There are no clinical trial data in pregnant and lactating women, and animal studies have shown that the product passes into breast milk and may have harmful effects on the developing baby. Patients with congenital conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid this medicine.

Can FEXUCLUE TAB be taken with other medications?

FEXUCLUE TAB can interact with other medications. Since it raises the pH in the stomach, it may affect the absorption of oral drugs whose bioavailability depends on gastric pH, such as atazanavir, nelfinavir, or rilpivirine, which are contraindicated with Fexuclue. The medicine is primarily metabolized by CYP3A4, and its plasma concentration may be slightly affected by CYP3A4 inhibitors.

What precautions should be taken when using FEXUCLUE TAB?

Precautions include hypersensitivity to the product or its components, or to Yellow 4 Tartrazine. It should be administered with care in patients with hepatic or renal impairment, and in the elderly. FEXUCLUE TAB may mask symptoms of malignant tumors or delay their diagnosis, so a malignant tumor should be ruled out if suspected. Gastric acid inhibitors like Fexuclue may also slightly increase the risk of gastrointestinal infections by bacteria such as Salmonella, Campylobacter, and Clostridium difficile. Long-term use may lead to increased serum gastrin levels and, in some cases, hypomagnesemia.

What happens if a dose of FEXUCLUE TAB is missed?

Information on what to do if a dose is missed is not explicitly detailed in the provided search results. It is generally advised to consult your doctor or pharmacist for specific guidance if you miss a dose of FEXUCLUE TAB.

How should FEXUCLUE TAB be stored?

FEXUCLUE TAB should be stored at temperatures not exceeding 30°C. It is important to keep the medicine out of reach of children.