Buy Actigall Online

Actigall (ursodiol)

THERAPEUTIC CLASS

Bile acid

DEA CLASS

RX

INDICATIONS

Indicated for patients with radiolucent, noncalcified gallbladder stones <20mm in diameter in whom elective cholecystectomy would be undertaken if not for the presence of increased surgical risk or for patients who refuse surgery. Prevention of gallstone formation in obese patients experiencing rapid weight loss.

ADULT DOSAGE

Gallbladder Stones

Use in patients with radiolucent, noncalcified gallbladder stones <20mm in diameter in whom elective cholecystectomy would be undertaken if not for the presence of increased surgical risk or for patients who refuse surgery

Dissolution:

8-10mg/kg/day given bid-tid. Obtain ultrasound at 6-month intervals for 1 yr. Continue therapy after stones have dissolved and confirm with repeat ultrasound within 1-3 months

Prevention of Gallstone Formation in Obese Patients Experiencing Rapid Weight Loss:
600mg/day (300mg bid)

ADMINISTRATION

Oral route

HOW SUPPLIED

Cap: 300mg

CONTRAINDICATIONS

Calcified cholesterol stones, radiopaque stones, compelling reasons for cholecystectomy (radiolucent bile pigment stones, unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula).

WARNINGS/PRECAUTIONS

Monitor SGOT (AST) and SGPT (ALT) at the initiation of therapy and periodically thereafter. Caution in elderly.

ADVERSE REACTIONS

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, N/V, arthralgia, coughing, viral infection, bronchitis, pharyngitis, back pain, myalgia, headache, sinusitis.

DRUG INTERACTIONS

Decreased absorption with bile acid sequestrants and aluminum-based antacids. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) may increase hepatic cholesterol secretion and encourage cholesterol gallstone formation.

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

Bile acid; suppresses hepatic synthesis, cholesterol secretion, and inhibits intestinal cholesterol absorption; actions combine to change bile from cholesterol-precipitating to cholesterol-solubilizing, resulting in bile conducive to cholesterol stone dissolution.

PHARMACOKINETICS

Absorption: Small bowel (90%). Metabolism: Liver (1st pass, conjugation). Elimination: Feces.

ASSESSMENT

Assess for type of bile pigment stones (calcified cholesterol, radiopaque, radiolucent), unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary GI fistula, nursing status, and possible drug interactions. Obtain baseline AST and ALT.

MONITORING

Ultrasound should be taken in 6-month intervals for first year. If appear dissolved, continue therapy and confirm on repeat ultrasound within 1-3 months. If partial dissolution not seen by 12 months, success is greatly reduced. Monitor AST and ALT periodically. Signs/symptoms of hypersensitivity reactions.

PATIENT COUNSELING

Seek medical attention if symptoms of hypersensitivity or allergic reactions occur. Advise patient that gallbladder stone dissolution requires months of therapy.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Dispense in tight container.

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