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UDWITH-300
Product Composition
Packaging Details
Product Description
UDWITH-300 Tablets – Ursodeoxycholic Acid 300 mg
UDWITH-300 Tablets by Amcare Pharmaceuticals contain Ursodeoxycholic Acid IP 300 mg in an uncoated tablet formulation. Ursodeoxycholic acid (UDCA), also known as ursodiol, is a bile acid medicine used under medical supervision for specific hepatobiliary conditions.
UDCA is an established treatment for primary biliary cholangitis (PBC) and is also used in selected patients for dissolution of certain cholesterol gallstones. The exact indication depends on the patient’s diagnosis and the type of gallbladder stone.
UDWITH-300 Tablets Composition
| Ingredient | Quantity per Tablet |
|---|---|
| Ursodeoxycholic Acid IP | 300 mg |
| Excipients | q.s. |
Active Ingredient
Ursodeoxycholic Acid IP – 300 mg
The supplied product artwork clearly specifies 300 mg per uncoated tablet.
Product Details
| Product Information | Details |
|---|---|
| Brand Name | UDWITH-300 |
| Generic Name | Ursodeoxycholic Acid |
| Strength | 300 mg |
| Dosage Form | Uncoated Tablet |
| Route | Oral |
| Pack Size | 10 × 10 Tablets |
| Category | Bile Acid / Hepatobiliary Medicine |
| Company | Amcare Pharmaceuticals |
What is UDWITH-300 Used For?
UDWITH-300 Tablets contain ursodeoxycholic acid, which is prescribed for specific liver and biliary conditions.
Primary Biliary Cholangitis
Ursodeoxycholic acid is an established treatment for primary biliary cholangitis (PBC). It can help slow liver damage, particularly when treatment is started earlier in the disease course.
Selected Gallstones
Ursodiol can also be used in carefully selected patients for dissolution of certain cholesterol gallstones, particularly radiolucent, non-calcified stones. It is not appropriate for every type of gallstone or every patient.
Important
UDWITH-300 should be marketed as a prescription medicine, not as a general “liver detox” or routine liver-health supplement.
How Does Ursodeoxycholic Acid Work?
Ursodeoxycholic acid is a naturally occurring bile acid.
It changes the composition and properties of bile and can reduce the relative proportion of more harmful bile acids. In appropriate hepatobiliary conditions, these effects can improve the bile environment and support bile flow.
In PBC, UDCA is used to slow the progression of liver damage.
For selected cholesterol gallstones, ursodiol can decrease cholesterol saturation of bile and promote gradual dissolution of suitable stones. Treatment can require prolonged therapy, and not all stones respond.
UDWITH-300 for Primary Biliary Cholangitis
Primary biliary cholangitis is a chronic disease in which the small bile ducts in the liver become damaged, causing bile to accumulate and potentially leading to progressive liver injury.
Ursodeoxycholic acid is the main established treatment for PBC and may help delay liver damage. Patients receiving UDCA generally require medical follow-up and liver-function monitoring.
UDWITH-300 for Gallstones
Ursodeoxycholic acid is not suitable for every type of gallstone.
Selected ursodiol products are indicated for certain radiolucent, non-calcified cholesterol gallstones, while calcified stones, pigment stones and situations requiring urgent surgery are not appropriate for ursodiol treatment.
Therefore, gallstone treatment should only be started after appropriate diagnostic evaluation by a physician.
Dosage and Administration
The appropriate dose of ursodeoxycholic acid depends on the condition being treated, body weight, liver function and clinical response.
For PBC, one current prescribing label specifies 13–15 mg/kg/day, administered in divided doses with food, with the regimen adjusted by the physician.
Important for UDWITH-300
Because this product contains 300 mg per tablet, the number of tablets required cannot be determined from the tablet strength alone.
Take UDWITH-300 exactly as prescribed by your physician. Do not change the dose or stop treatment without medical advice.
For long-term therapy, liver-function tests may be required to monitor treatment.
How to Take UDWITH-300
- Take the tablet orally with water.
- Follow the prescribed dose and schedule.
- If your physician instructs you to take it with food, follow that instruction.
- Take doses at approximately the prescribed times each day.
- Do not double the next dose if you miss one unless specifically instructed.
- Do not discontinue long-term treatment without consulting your physician.
Side Effects of UDWITH-300
Ursodeoxycholic acid is generally well tolerated, but side effects can occur.
Commonly reported effects
- Diarrhea or loose stools
- Nausea
- Abdominal discomfort
- Vomiting in some patients
Diarrhea and nausea are recognized adverse effects of UDCA.
Seek medical attention if
- Severe or persistent abdominal pain develops
- Severe diarrhea occurs
- Symptoms of an allergic reaction appear
- Liver-related symptoms worsen
- There is significant deterioration in general health
Precautions and Warnings
Before starting UDWITH-300, inform your doctor if you have:
- Gallbladder disease
- Biliary obstruction
- Acute inflammation of the gallbladder or bile ducts
- Liver disease
- Pancreatitis associated with gallstones
- Previous intolerance to ursodeoxycholic acid
- Other significant gastrointestinal conditions
Ursodiol is contraindicated in patients with complete biliary obstruction and in people with known hypersensitivity or intolerance to ursodiol or formulation components.
Liver Function Monitoring
Patients receiving ursodiol for PBC may require regular liver-function testing. One current prescribing label recommends monitoring liver tests during treatment.
UDWITH-300 and Drug Interactions
Certain medicines can interfere with ursodeoxycholic acid absorption or activity.
Bile Acid Sequestrants
Medicines such as bile-acid sequestrants can reduce absorption of ursodiol and may interfere with its action.
Aluminium-Based Antacids
Aluminium-containing antacids may interfere with ursodiol absorption.
Other Medicines
Some medicines that affect lipid metabolism or bile flow may interact with ursodiol.
Always tell your doctor or pharmacist about all prescription medicines, OTC medicines and supplements you are taking.
UDWITH-300 During Pregnancy
Ursodeoxycholic acid may be used in certain pregnancy-related liver conditions under specialist medical supervision, but treatment should be based on a physician’s assessment.
Do not start UDWITH-300 during pregnancy without medical advice.
UDWITH-300 During Breastfeeding
If ursodeoxycholic acid is being considered during breastfeeding, consult the treating physician before starting or changing treatment.
Who Should Not Take UDWITH-300 Without Medical Evaluation?
UDWITH-300 should not be self-medicated by people who simply have:
- “Fatty liver”
- Indigestion
- General liver weakness
- Abdominal discomfort of unknown cause
- Suspected gallstones without diagnosis
Ursodeoxycholic acid is a prescription hepatobiliary medicine, and the appropriate treatment depends on the underlying diagnosis.
Key Features of UDWITH-300
1. Ursodeoxycholic Acid 300 mg
Each tablet contains 300 mg Ursodeoxycholic Acid IP.
2. Uncoated Tablet
The product is supplied as an uncoated oral tablet.
3. Hepatobiliary Medicine
UDCA is used for selected liver and biliary conditions under medical supervision.
4. PBC Treatment
Ursodeoxycholic acid is an established treatment for primary biliary cholangitis.
5. Selected Gallstone Applications
Ursodiol can be used for carefully selected cholesterol gallstones where medical dissolution therapy is appropriate.
Why Choose UDWITH-300 by Amcare Pharmaceuticals?
UDWITH-300 Tablets provide:
- Ursodeoxycholic Acid IP
- 300 mg strength
- Uncoated tablet formulation
- Convenient 10 × 10 tablet pack
- Prescription hepatobiliary medicine
- Suitable for physician-directed treatment of appropriate indications
The product should be used according to the patient’s diagnosis and prescribing physician’s instructions.
