Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Cholbam
Overview
What is Cholbam?
Cholic acid is a bile acid produced by the liver where it is synthesized from cholesterol. The chemical formula is CHO, the molecular weight is 408.57 and the chemical structure is:
Cholic acid is a white to off-white powder. It is practically insoluble in water and in 0.1 M HCl at 20°C and is sparingly soluble in 0.1 M NaOH at 20°C. It is soluble in glacial acetic acid, alcohols and acetone. A saturated solution in water at 20°C has a pH of 4.4.
CHOLBAM capsules contain 50 mg or 250 mg of cholic acid as the active ingredient in size 2 Swedish orange or size 0 white opaque gelatin capsules, respectively. Inactive ingredients in CHOLBAM include silicified microcrystalline cellulose, magnesium stearate and hard gelatin capsules. The size 2 shells contain gelatin, red iron oxide and titanium dioxide and the size 0 shells contain gelatin and titanium dioxide. CHOLBAM is administered orally.
What does Cholbam look like?
What are the available doses of Cholbam?
Capsules: 50 mg, 250 mg ()
What should I talk to my health care provider before I take Cholbam?
How should I use Cholbam?
CHOLBAM is indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs)
The recommended dosage of CHOLBAM is 10 to 15 mg/kg administered orally once daily, or in two divided doses, in pediatric patients and in adults.
Tables 1 and 2 show the number of capsules that should be administered daily to approximate a 10 mg/kg/day and 15 mg/kg/day dosage, respectively, using the available 50 mg and 250 mg capsules alone or in combination.
Patients with newly diagnosed, or a family history of, familial hypertriglyceridemia may have poor absorption of CHOLBAM from the intestine and require a 10% increase in the recommended dosage to account for losses due to malabsorption. The recommended dosage of CHOLBAM in patients with concomitant familial hypertriglyceridemia is 11 to 17 mg/kg orally once daily, or in two divided doses. Adequacy of the dosage regimen can be determined by monitoring of patients' clinical response including steatorrhea, and laboratory values including transaminases, bilirubin and PT/INR.
What interacts with Cholbam?
Sorry No Records found
What are the warnings of Cholbam?
Sorry No Records found
What are the precautions of Cholbam?
Sorry No Records found
What are the side effects of Cholbam?
Sorry No records found
What should I look out for while using Cholbam?
None.
What might happen if I take too much Cholbam?
Concurrent elevations of serum gamma glutamyltransferase (GGT) and serum alanine aminotransferase (ALT) may indicate CHOLBAM overdose. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline
In the event of overdose the patient should be monitored and treated symptomatically.
How should I store and handle Cholbam?
Storage and HandlingStore at 20–25°C (69-77°F), excursions permitted between 15-30°C (59-86°F). [see USP Controlled Room Temperature].Storage and HandlingStore at 20–25°C (69-77°F), excursions permitted between 15-30°C (59-86°F). [see USP Controlled Room Temperature].KYNAMRO is supplied in single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium. KYNAMRO is available in cartons containing 1 or 4 pre-filled syringes.Pack of 1 pre-filled syringe: NDC 58468-0191-1Pack of 4 pre-filled syringe: NDC 58468-0191-2Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.KYNAMRO is supplied in single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium. KYNAMRO is available in cartons containing 1 or 4 pre-filled syringes.Pack of 1 pre-filled syringe: NDC 58468-0191-1Pack of 4 pre-filled syringe: NDC 58468-0191-2Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.KYNAMRO is supplied in single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium. KYNAMRO is available in cartons containing 1 or 4 pre-filled syringes.Pack of 1 pre-filled syringe: NDC 58468-0191-1Pack of 4 pre-filled syringe: NDC 58468-0191-2Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.KYNAMRO is supplied in single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium. KYNAMRO is available in cartons containing 1 or 4 pre-filled syringes.Pack of 1 pre-filled syringe: NDC 58468-0191-1Pack of 4 pre-filled syringe: NDC 58468-0191-2Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.KYNAMRO is supplied in single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium. KYNAMRO is available in cartons containing 1 or 4 pre-filled syringes.Pack of 1 pre-filled syringe: NDC 58468-0191-1Pack of 4 pre-filled syringe: NDC 58468-0191-2Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to SEDs in the biosynthetic pathway, and in PDs including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles, and facilitate absorption of fat-soluble vitamins in the intestine.
Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.
Non-Clinical Toxicology
None.Potential for Sulfamethoxazole and Trimethoprim to Affect Other Drugs
In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.
It has been reported that sulfamethoxazole and trimethoprim may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when sulfamethoxazole and trimethoprim is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed. Sulfamethoxazole and trimethoprim may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate).
Sulfamethoxazole and trimethoprim, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.
Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations.
There have been reports of marked but reversible nephrotoxicity with coadministration of sulfamethoxazole and trimethoprim and cyclosporine in renal transplant recipients.
Increased digoxin blood levels can occur with concomitant sulfamethoxazole and trimethoprim therapy, especially in elderly patients. Serum digoxin levels should be monitored.
Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin.
Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if sulfamethoxazole and trimethoprim is prescribed.
The efficacy of tricyclic antidepressants can decrease when coadministered with sulfamethoxazole and trimethoprim.
Sulfamethoxazole and trimethoprim potentiates the effect of oral hypoglycemics that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted.
In the literature, a single case of toxic delirium has been reported after concomitant intake of sulfamethoxazole/trimethoprim and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported.
In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of sulfamethoxazole/trimethoprim and an angiotensin converting enzyme inhibitor.
Monitor liver function and discontinue CHOLBAM in patients who develop worsening of liver function while on treatment. Concurrent elevations of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) may indicate CHOLBAM overdose. Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis.
Evidence of liver impairment was present before treatment with CHOLBAM in approximately 86% (44/51) of patients with bile acid synthesis disorders due to SEDs and in approximately 50% (14/28) of patients with PDs including Zellweger spectrum disorders. Five of the patients (3 SED and 2 PD) with liver impairment at baseline experienced worsening serum transaminases, elevated bilirubin values, or worsening cholestasis on liver biopsy following treatment. An additional 5 patients (2 SED and 3 PD) who did not have baseline cholestasis experienced an exacerbation of their liver disease while on treatment. Exacerbation of liver impairment by CHOLBAM in these patients cannot be ruled out.
Six patients with single enzyme defects underwent liver transplant, including four patients diagnosed with AKR1D1 deficiency, one with 3β-HSD deficiency, and one with CYP7A1 deficiency.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).