Inactive Ingredients: Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&C Red # 28, FD&C Blue # 1 and FD&C Red # 40.

The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, propylene glycol and shellac glaze.

structural-formula

CLINICAL PHARMACOLOGY

About 90% of a therapeutic dose of Ursodiol is absorbed in the small bowel after oral administration. After absorption, Ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large “first-pass” effect) where it is conjugated with either glycine or taurine and is then secreted into the hepatic bile ducts. Ursodiol in bile is concentrated in the gallbladder and expelled into the duodenum in gallbladder bile via the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating. Only small quantities of Ursodiol appear in the systemic circulation and very small amounts are excreted into urine. The sites of the drug’s therapeutic actions are in the liver, bile, and gut lumen.

Beyond conjugation, Ursodiol is not altered or catabolized appreciably by the liver or intestinal mucosa. A small proportion of orally administered drug undergoes bacterial degradation with each cycle of enterohepatic circulation. Ursodiol can be both oxidized and reduced at the 7-carbon, yielding either 7-keto-lithocholic acid or lithocholic acid, respectively. Further, there is some bacterially catalyzed deconjugation of glyco- and tauro-ursodeoxycholic acid in the small bowel. Free Ursodiol, 7-keto-lithocholic acid, and lithocholic acid are relatively insoluble in aqueous media and larger proportions of these compounds are lost from the distal gut into the feces. Reabsorbed free Ursodiol is reconjugated by the liver. Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces. Absorbed 7-keto-lithocholic acid is stereospecifically reduced in the liver to chenodiol.

Lithocholic acid causes cholestatic liver injury and can cause death from liver failure in certain species unable to form sulfate conjugates. Lithocholic acid is formed by 7-dehydroxylation of the dihydroxy bile acids (ursodiol and chenodiol) in the gut lumen. The 7-dehydroxylation reaction appears to be alpha-specific, i.e., chenodiol is more efficiently 7-dehydroxylated than Ursodiol and, for equimolar doses of Ursodiol and chenodiol, levels of lithocholic acid appearing in bile are lower with the former. Man has the capacity to sulfate lithocholic acid. Although liver injury has not been associated with Ursodiol therapy, a reduced capacity to sulfate may exist in some individuals, but such a deficiency has not yet been clearly demonstrated.

Pharmacodynamics

Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also inhibits intestinal absorption of cholesterol. It appears to have little inhibitory effect on synthesis and secretion into bile of endogenous bile acids, and does not appear to affect secretion of phospholipids into bile.

With repeated dosing, bile Ursodiol concentrations reach a steady state in about 3 weeks. Although insoluble in aqueous media, cholesterol can be solubilized in at least two different ways in the presence of dihydroxy bile acids. In addition to solubilizing cholesterol in micelles, Ursodiol acts by an apparently unique mechanism to cause dispersion of cholesterol as liquid crystals in aqueous media. Thus, even though administration of high doses does not result in a concentration of Ursodiol higher than 60% of the total bile acid pool, ursodiol-rich bile effectively solubilizes cholesterol. The overall effect of Ursodiol is to increase the concentration level at which saturation of cholesterol occurs.

The various actions of Ursodiol combine to change the bile of patients with gallstones from cholesterol-precipitating to cholesterolsolubilizing, thus resulting in bile conducive to cholesterol stone dissolution.

After Ursodiol dosing is stopped, the concentration of the bile acid in bile falls exponentially, declining to about 5% - 10% of its steady state level in about 1 week.

SPL UNCLASSIFIED SECTION

Clinical Results

advertisement

SPL UNCLASSIFIED SECTION

Gallstone Dissolution

On the basis of clinical trial results in a total of 868 patients with radiolucent gallstones treated in 8 studies for periods ranging from 6 - 78 months with Ursodiol doses ranging from about 5 - 20 mg/kg/day, an Ursodiol dose of about 8 - 10 mg/kg/day appeared to be the best dose.

With an Ursodiol dose of about 10 mg/kg/day, complete stone dissolution can be anticipated in about 30% of unselected patients with uncalcified gallstones < 20 mm in maximal diameter treated for up to 2 years. Patients with calcified gallstones prior to treatment, or patients who develop stone calcification or gallbladder nonvisualization on treatment, and patients with stones > 20 mm in maximal diameter rarely dissolve their stones. The chance of gallstone dissolution is increased up to 50% in patients with floating or floatable stones (i.e., those with high cholesterol content), and is inversely related to stone size for those < 20 mm in maximal diameter.

Complete dissolution was observed in 81% of patients with stones up to 5 mm in diameter. Age, sex, weight, degree of obesity, and serum cholesterol level are not related to the chance of stone dissolution with Ursodiol.

A nonvisualizing gallbladder by oral cholecystogram prior to the initiation of therapy is not a contraindication to Ursodiol therapy (the group of patients with nonvisualizing gallbladders in the Ursodiol studies had complete stone dissolution rates similar to the group of patients with visualizing gallbladders). However, gallbladder nonvisualization developing during Ursodiol treatment predicts failure of complete stone dissolution and in such cases therapy should be discontinued. Partial stone dissolution occurring within 6 months of beginning therapy with Ursodiol appears to be associated with a > 70% chance of eventual complete stone dissolution with further treatment; partial dissolution observed within 1 year of starting therapy indicates a 40% probability of complete dissolution. Stone recurrence after dissolution with Ursodiol therapy was seen within 2 years in 8/27 (30%) of patients in the U.K. studies. Of 16 patients in the U.K. study whose stones had previously dissolved on chenodiol but later recurred, 11 had complete dissolution on Ursodiol. Stone recurrence has been observed in up to 50% of patients within 5 years of complete stone dissolution on Ursodiol therapy. Serial ultrasonographic examinations should be obtained to monitor for recurrence of stones, bearing in mind that radiolucency of the stones should be established before another course of Ursodiol is instituted. A prophylactic dose of Ursodiol has not been established.

advertisement

SPL UNCLASSIFIED SECTION

Gallstone Prevention

Two placebo-controlled, multicenter, double-blind, randomized, parallel group trials in a total of 1,316 obese patients were undertaken to evaluate Ursodiol in the prevention of gallstone formation in obese patients undergoing rapid weight loss. The first trial consisted of 1,004 obese patients with a body mass index ≥ 38 who underwent weight loss induced by means of a very low calorie diet for a period of 16 weeks. An intent-to-treat analysis of this trial showed that gallstone formation occurred in 23% of the placebo group, while those patients on 300, 600, or 1200 mg/day of Ursodiol experienced a 6%, 3%, and 2% incidence of gallstone formation, respectively. The mean weight loss for this 16-week trial was 47 lb for the placebo group, and 47, 48, and 50 lb for the 300, 600, and 1200 mg/day Ursodiol groups, respectively.

The second trial consisted of 312 obese patients (BMI ≥ 40) who underwent rapid weight loss through gastric bypass surgery. The trial drug treatment period was for 6 months following this surgery. Results of this trial showed that gallstone formation occurred in 23% of the placebo group, while those patients on 300, 600, or 1200 mg/day of Ursodiol experienced a 9%, 1%, and 5% incidence of gallstone formation, respectively. The mean weight loss for this 6-month trial was 64 lb for the placebo group, and 67, 74, and 72 lb for the 300, 600, and 1200 mg/day Ursodiol groups, respectively.

SPL UNCLASSIFIED SECTION

ALTERNATIVE THERAPIES

SPL UNCLASSIFIED SECTION

Watchful Waiting

Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7% - 27% in 5 years. Presumably the rate is higher for patients already having symptoms.

advertisement

SPL UNCLASSIFIED SECTION

Cholecystectomy

For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.

Mortality Rates for Cholecystectomy in the U.S.

27,600 Cholecystectomies

(Smoothed Rates)

Deaths/1000 Operations***

Ursodiol

Rating: 3.3 - 3 review(s)
advertisement
How old is patient?

Ursodiol uses


SPL UNCLASSIFIED SECTION

Prescribing Information

SPECIAL NOTE

Gallbladder stone dissolution with Ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with Ursodiol, and alternative therapies should be considered.

DESCRIPTION

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration.

Ursodiol, USP, is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. 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 392.57. Its structure is shown below:

Ursodiol Structural Formula
Figure 1
Mortality Rates for Cholecystectomy in the US

Low Risk Patients*


Age (yrs)


Cholecystectomy


Cholecystectomy Common Duct Exploration


Women


0-49


.54


2.13


50-69


2.80


10.10


Men


0-49


1.04


4.12


50-69


5.41


19.23


High Risk Patients**


Women


0-49


12.66


47.62


50-69


17.24


58.82


Men


0-49


24.39


90.91


50-69


33.33


111.11


* In good health or with moderate systemic disease.

** With severe or extreme systemic disease.

*** Includes both elective and emergency surgery.

Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.

INDICATIONS AND USAGE

1.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. 2.Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

CONTRAINDICATIONS

1.Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for Ursodiol therapy. 2.Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for Ursodiol therapy. 3.Allergy to bile acids.

PRECAUTIONS

advertisement

SPL UNCLASSIFIED SECTION

Liver Tests

Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in the gut from Ursodiol less efficiently and in smaller amounts than that seen from chenodiol. Lithocholic acid is detoxified in the liver by sulfation and, although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage.

Abnormalities in liver enzymes have not been associated with Ursodiol therapy and, in fact, Ursodiol has been shown to decrease liver enzyme levels in liver disease. However, patients given Ursodiol should have SGOT and SGPT (ALT) measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.

SPL UNCLASSIFIED SECTION

Drug Interactions

Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of Ursodiol by reducing its absorption. Aluminum-based antacids have been shown to absorb bile acids in vitro and may be expected to interfere with Ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of Ursodiol.

SPL UNCLASSIFIED SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ursodiol was tested in 2-year oral carcinogenicity studies in CD-1 mice and Sprague-Dawley rats at daily doses of 50, 250, and 1000 mg/kg/day. It was not tumorigenic in mice. In the rat study, it produced statistically significant dose-related increased incidences of pheochromocytomas of adrenal medulla in males and females (p=0.004, Peto trend test). A 78-week rat study employing intrarectal instillation of lithocholic acid and tauro-deoxycholic acid, metabolites of Ursodiol and chenodiol, has been conducted. These bile acids alone did not produce any tumors. A tumor-promoting effect of both metabolites was observed when they were co-administered with a carcinogenic agent. Results of epidemiologic studies suggest that bile acids might be involved in the pathogenesis of human colon cancer in patients who had undergone a cholecystectomy, but direct evidence is lacking. Ursodiol is not mutagenic in the Ames test. Dietary administration of lithocholic acid to chickens is reported to cause hepatic adenomatous hyperplasia.

SPL UNCLASSIFIED SECTION

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with Ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose in rabbits. Studies employing 100- to 200-fold the human dose in rats have shown some reduction in fertility rate and litter size. There have been no adequate and well-controlled studies of the use of Ursodiol in pregnant women, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the Ursodiol trials led to no evidence of effects on the fetus or newborn baby. Although it seems unlikely, the possibility that Ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.

SPL UNCLASSIFIED SECTION

Nursing Mothers

It is not known whether Ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodiol is administered to a nursing mother.

SPL UNCLASSIFIED SECTION

Pediatric Use

The safety and effectiveness of Ursodiol in pediatric patients have not been established.

SPL UNCLASSIFIED SECTION

Geriatric Use

In worldwide clinical studies of Ursodiol, approximately 14% of subjects were over 65 years of age. In a subgroup analysis of existing clinical trials, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age-related differences in safety and effectiveness were found. Other reported clinical experience has not identified differences in response in elderly and younger patients. However, small differences in efficacy and greater sensitivity of some elderly individuals taking Ursodiol cannot be ruled out. Therefore, it is recommended that dosing proceed with caution in this population.

ADVERSE REACTIONS

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

Figure 2
Gallstone Dissolution In Ursodiol and Placebo Patients

GALLSTONE DISSOLUTION


Ursodiol

8 - 10 mg/kg/day

(N=155)


Placebo

(N=159)


N


(%)


N


(%)


Body as a Whole


Allergy


8


(5.2)


7


(4.4)


Chest Pain


5


(3.2)


10


(6.3)


Fatigue


7


(4.5)


8


(5.0)


Infection Viral


30


(19.4)


41


(25.8)


Digestive System


Abdominal Pain


67


(43.2)


70


(44.0)


Cholecystitis


8


(5.2)


7


(4.4)


Constipation


15


(9.7)


14


(8.8)


Diarrhea


42


(27.1)


34


(21.4)


Dyspepsia


26


(16.8)


18


(11.3)


Flatulence


12


(7.7)


12


(7.5)


Gastrointestinal Disorder


6


(3.9)


8


(5.0)


Nausea


22


(14.2)


27


(17.0)


Vomiting


15


(9.7)


11


(6.9)


Musculoskeletal System


Arthralgia


12


(7.7)


24


(15.1)


Arthritis


9


(5.8)


4


(2.5)


Back Pain


11


(7.1)


18


(11.3)


Myalgia


9


(5.8)


9


(5.7)


Nervous System


Headache


28


(18.1)


34


(21.4)


Insomnia


3


(1.9)


8


(5.0)


Respiratory System


Bronchitis


10


(6.5)


6


(3.8)


Coughing


11


(7.1)


7


(4.4)


Pharyngitis


13


(8.4)


5


(3.1)


Rhinitis


8


(5.2)


11


(6.9)


Sinusitis


17


(11.0)


18


(11.3)


Upper Respiratory Tract Infection


24


(15.5)


21


(13.2)


Urogenital System


Urinary Tract Infection


10


(6.5)


7


(4.4)

Figure 3
Gallstone Prevention in Ursodiol and Placebo-Treated Patients

GALLSTONE PREVENTION


Ursodiol

600 mg

(N=322)


Placebo

(N=325)


N


(%)


N


(%)


Body as a Whole


Fatigue


25


(7.8)


33


(10.2)


Infection Viral


29


(9.0)


29


(8.9)


Influenza-like Symptoms


21


(6.5)


19


(5.8)


Digestive System


Abdominal Pain


20


(6.2)


39


(12.0)


Constipation


85


(26.4)


72


(22.2)


Diarrhea


81


(25.2)


68


(20.9)


Flatulence


15


(4.7)


24


(7.4)


Nausea


56


(17.4)


43


(13.2)


Vomiting


44


(13.7)


44


(13.5)


Musculoskeletal System


Back Pain


38


(11.8)


21


(6.5)


Musculoskeletal Pain


19


(5.9)


15


(4.6)


Nervous System


Dizziness


53


(16.5)


42


(12.9)


Headache


80


(24.8)


78


(24.0)


Respiratory System


Pharyngitis


10


(3.1)


19


(5.8)


Sinusitis


17


(5.3)


18


(5.5)


Upper Respiratory Tract Infection


40


(12.4)


35


(10.8)


Skin and Appendages


Alopecia


17


(5.3)


8


(2.5)


Urogenital System


Dysmenorrhea


18


(5.6)


19


(5.8)

OVERDOSAGE

Neither accidental nor intentional overdosing with Ursodiol has been reported. Doses of Ursodiol in the range of 16 - 20 mg/kg/day have been tolerated for 6 - 37 months without symptoms by 7 patients. The LD50 for Ursodiol in rats is over 5000 mg/kg given over 7 - 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with Ursodiol would probably be diarrhea, which should be treated symptomatically.

DOSAGE AND ADMINISTRATION

SPL UNCLASSIFIED SECTION

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 reevaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.

SPL UNCLASSIFIED SECTION

Gallstone Prevention

The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.

HOW SUPPLIED

Ursodiol Capsules USP, 300 mg are #0 capsules with a pink opaque cap, white opaque body, imprinted “Є503” in black ink on cap and body, filled with white powder. They are supplied in bottles of 100 and 1000.

Store at 20° - 25°C (68° - 77°F). Dispense contents in a tight, light-resistant container as defined in the USP.

Keep out of reach of children.


Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Manufactured in USA

Revised February 2016

MF503REV02/16

OE1105

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg

Ursodiol Capsules USP, 300 mg

Rx Only

100 Capsules

ursodiol-300mg-100-count-rev-02-16

Ursodiol pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Ursodiol available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Ursodiol destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Ursodiol Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Ursodiol pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


advertisement

References

  1. Dailymed."URSODIOL CAPSULE [EPIC PHARMA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."URSODIOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "URSODEOXYCHOLIC ACID". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ursodiol?

Depending on the reaction of the Ursodiol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ursodiol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Ursodiol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sdrugs.com conducted a study on Ursodiol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ursodiol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Ursodiol useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

One visitor reported side effects

Did you get side effects while taking the Ursodiol drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Ursodiol medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Ursodiol is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 22 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2021 "sdrugs.com". All Rights Reserved