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Uses
- Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established.
- Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
History
There is currently no drug history available for this drug.
Other Information
Ursodiol is a bile acid available as 300-mg capsules suitable for oral administration.
Ursodiol is ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structure is shown below:
Inactive Ingredients. Pregelatinized Starch, Colloidal Silicon Dioxide, Magnesium Stearate. The capsule shell consists of FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol, and Methanol.
Sources
Ursodiol Manufacturers
- Major Pharmaceuticals
Ursodiol | Major Pharmaceuticals
Gallstone Dissolution
The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- American Health Packaging
- American Health Packaging
Ursodiol | American Health Packaging
Gallstone Dissolution
The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Actavis Pharma, Inc.
Ursodiol | Actavis Pharma, Inc.
2.1 General Dosing InformationThe recommended adult dosage for ursodiol tablets, USP 250 mg and 500 mg in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablets, USP 500 mgThe ursodiol tablets, USP 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol tablets, USP 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
2.1 General Dosing InformationThe recommended adult dosage for ursodiol tablets, USP 250 mg and 500 mg in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablets, USP 500 mgThe ursodiol tablets, USP 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol tablets, USP 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
- Prasco Laboratories
Ursodiol | Prasco Laboratories
The recommended adult dosage for Ursodiol Tablets, USP in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.
The Ursodiol Tablets, USP 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break Ursodiol Tablets, USP 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately.
Half-tablets (scored Ursodiol Tablets, USP 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 25°C (77°F).
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. - Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Ursodiol | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Udl Laboratories, Inc.
Ursodiol | Udl Laboratories, Inc.
Gallstone DissolutionThe recommended dose for ursodiol capsules treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol capsules therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol capsules therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol capsules therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol capsules for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Watson Laboratories, Inc.
Ursodiol | Watson Laboratories, Inc.
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Stat Rx Usa Llc
Ursodiol | Stat Rx Usa Llc
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Tagi Pharma, Inc.
Ursodiol | Tagi Pharma, Inc.
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 - 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- American Health Packaging
Ursodiol | American Health Packaging
Gallstone Dissolution
The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Rising Pharmaceuticals, Inc.
Ursodiol | Rising Pharmaceuticals, Inc.
Gallstone DissolutionThe recommended dose for ursodiol capsule treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol capsules for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Physicians Total Care, Inc.
Ursodiol | Physicians Total Care, Inc.
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Avpak
Ursodiol | Avpak
Gallstone Dissolution
The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Golden State Medical Supply, Inc.
Ursodiol | Golden State Medical Supply, Inc.
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Major Pharmaceuticals
Ursodiol | Major Pharmaceuticals
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Avpak
Ursodiol | Avpak
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Epic Pharma, Llc
Ursodiol | Epic Pharma, Llc
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Lannett Company, Inc.
Ursodiol | Lannett Company, Inc.
Gallstone Dissolution
The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
- Par Pharmaceutical Companies, Inc.
Ursodiol | Par Pharmaceutical Companies, Inc.
2.1 General Dosing InformationThe recommended adult dosage for ursodiol in the treatment of PBC is 13 to 15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver Function Tests (y-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for the three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol 500 mg TabletThe ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
- Bluepoint Laboratories
Ursodiol | Bluepoint Laboratories
2.1 General Dosing InformationThe recommended adult dosage for ursodiol in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablet USP, 500 mgThe ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)]. - Glenmark Generics Inc.,usa
Ursodiol | Glenmark Generics Inc.,usa
2.1 General Dosing InformationThe recommended adult dosage for ursodiol tablets USP, 250 mg and 500 mg in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablet USP, 500 mgThe ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break the ursodiol 500 mg scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
- Actavis Pharma, Inc.
Ursodiol | Actavis Pharma, Inc.
2.1 General Dosing InformationThe recommended adult dosage for ursodiol in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablet USP, 500 mg.The ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)]. - Cardinal Health
Ursodiol | Major Pharmaceuticals
There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.
To determine the initial dosage, consideration should be given to the patient’s age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.
Clinical experience suggests the following recommendations:
Oral Administration Initial Dosage Range Adults Moderate Symptomatology 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology 3 mg to 5 mg b.i.d. or t.i.d.To achieve prompt control, higher doses may be required in some cases.
Geriatric or Debilitated Patients 0.5 mg to 2 mg b.i.d. or t.i.d. Chronic or Resistant Patients 3 mg to 5 mg b.i.d. or t.i.d. Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. ChildrenThe following recommendations apply to children between the ages of 3 and 12 years (weight range 15 to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.)
The total dose may be divided, to be given b.i.d. or t.i.d.
Psychotic Disorders 0.05 mg/kg/day to 0.15 mg/kg/day Non-Psychotic Behavior Disorders and Tourette’s Disorder 0.05 mg/kg/day to 0.075 mg/kg/day Severely disturbed psychotic children may require higher doses. In severely disturbed, non-psychotic children or in hyperactive children with accompanying conduct disorders, who have failed to respond to psychotherapy or medications other than antipsychotics, it should be noted that since these behaviors may be short-lived, short-term administration of haloperidol may suffice. There is no evidence establishing a maximum effective dosage. There is little evidence that behavior improvement is further enhanced in dosages beyond 6 mg per day. Maintenance DosageUpon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.
Switchover ProcedureThe oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms, the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12-24 hours following the last parenteral dose.
- Avkare, Inc.
- Global Pharmaceuticals, Division Of Impax Laboratories, Inc.
Ursodiol | Global Pharmaceuticals, Division Of Impax Laboratories, Inc.
2.1 General Dosing InformationThe recommended adult dosage for ursodiol in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablet USP, 500 mgThe ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
- Carilion Materials Management
Ursodiol | Carilion Materials Management
Gallstone DissolutionThe recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone PreventionThe recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
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