Product Packing: 10X1X10
Product Composition: Ursodeoxycholic acid 300 mg
Product Price: MRP : 0
URSOCALM-300 is
a prescription formulation containing Ursodeoxycholic
Acid 300 mg. Ursodeoxycholic acid (ursodiol) is a hydrophilic
bile acid used in selected hepatobiliary conditions according to approved
indications and individual clinical assessment.
Ursodeoxycholic acid modifies the composition and
flow of bile and can reduce the relative concentration of more hydrophobic bile
acids. Treatment selection, dose and duration depend on the specific diagnosis
and should follow the approved product label and qualified medical advice.
Each tablet contains:
·
Ursodeoxycholic Acid - 300 mg
·
Excipients - q.s.
Dosage form: Tablet
Uses of URSOCALM-300
URSOCALM-300 may
be prescribed for selected hepatobiliary conditions where Ursodeoxycholic Acid
therapy is approved and clinically appropriate.
·
Management
of selected cholestatic liver conditions according to approved prescribing
information
·
Dissolution
of selected cholesterol gallstones in appropriately assessed patients where
indicated
·
Support
of bile flow and modification of bile composition in approved clinical settings
·
Other
approved uses of Ursodeoxycholic Acid as determined by the treating clinician
How
URSOCALM-300 Works
URSOCALM-300 contains Ursodeoxycholic Acid, a hydrophilic bile acid:
Bile composition: Ursodeoxycholic Acid can
reduce the relative proportion of more hydrophobic bile acids and modify the
bile-acid pool.
Cholesterol handling: It can reduce cholesterol
saturation of bile, an action relevant to selected cholesterol gallstones.
Clinical response depends on the underlying condition, dose, duration
and individual patient factors.
Dose
selection and treatment duration must follow the approved product label and
prescribing clinician's advice.
Dosage
and Direction for Use
Use URSOCALM-300 exactly as prescribed. The required dose and
duration vary according to the indication, body weight, clinical response and
other patient factors.
Swallow
the tablet with water and take it at the time and frequency directed by the
prescriber. Follow label instructions regarding administration with meals.
Long-term therapy may require periodic clinical and laboratory
monitoring according to the indication and approved prescribing information.
Possible
Side Effects
Possible
unwanted effects may include:
·
Diarrhoea or loose stools
·
Abdominal discomfort, nausea or other gastrointestinal symptoms
·
Headache, dizziness or other less common symptoms may occur
·
Rare hypersensitivity or other clinically significant adverse effects
may occur
Report persistent or troublesome adverse effects to the treating
healthcare professional.
Precautions
and Contraindications
Before
using URSOCALM-300, the prescriber should
review the diagnosis, biliary anatomy, liver status and concomitant medicines.
Important precautions include:
Do
not use in patients with known hypersensitivity to Ursodeoxycholic Acid or
formulation ingredients.
·
Certain obstructive biliary conditions, acute inflammation of the
gallbladder or biliary tract, or other contraindicated hepatobiliary conditions
require specialist assessment and may make treatment unsuitable.
·
For gallstone-related treatment, suitability depends on stone type,
size, gallbladder function and other clinical factors.
·
Liver-function monitoring may be required during therapy depending on
the indication and clinical situation.
·
Some bile-acid binding agents or aluminium-containing antacids can
reduce absorption and may require dose separation according to professional
advice.
·
Pregnancy, breastfeeding, children, older adults and patients with
significant liver or biliary disease require individualized professional
guidance.
·
Drug Interaction Considerations
·
Ursodeoxycholic Acid absorption may be reduced by bile-acid sequestrants
such as cholestyramine or colestipol and by some aluminium-containing antacids.
Other clinically relevant interactions depend on the patient's medicines and
condition.
Business
Growth Opportunity with URSOCALM-300
URSOCALM-300 offers pharmaceutical distributors and healthcare entrepreneurs an
opportunity to add an Ursodeoxycholic Acid 300 mg prescription tablet to their
gastro-hepatology product portfolio.
Key Business Advantages
·
Single-ingredient hepatobiliary formulation
·
Ursodeoxycholic Acid 300 mg
·
Established hydrophilic bile-acid molecule
·
Convenient tablet dosage form
·
Suitable addition to gastroenterology and hepatology prescription
portfolios
PCD
Pharma Franchise Opportunity for URSOCALM-300
Ethics Medinova Private Limited offers PCD Pharma Franchise
opportunities for URSOCALM-300 in selected territories across India, subject to availability,
applicable regulations and mutually agreed business terms.
Franchise Support May Include
·
Monopoly-based territory opportunities, subject to availability
·
Promotional materials and visual aids
·
Product information and marketing support
·
Reliable supply coordination
·
Access to a growing pharmaceutical product portfolio
·
Professional partner assistance
Third-Party
Manufacturing Support for Ursodeoxycholic Acid 300 mg Tablets
Ethics
Medinova also supports eligible businesses exploring third-party
manufacturing of formulations similar to URSOCALM-300 under their own
brand, subject to applicable licensing, prescription-drug, regulatory and
manufacturing requirements.
Our
third-party manufacturing support may include:
·
Customized product and pack requirements, subject to regulatory
feasibility
·
Private-label manufacturing opportunities
·
Customized packaging and branding support
·
Product label and pack configuration assistance
·
Manufacturing coordination through suitable licensed facilities
·
Support for documentation and applicable regulatory requirements
1. What is URSOCALM-300?
2. What is URSOCALM-300 used for?
3. How should URSOCALM-300 be taken?
4. Can URSOCALM-300 cause diarrhoea?
5. Does Ursodeoxycholic Acid require
monitoring?
6. Can URSOCALM-300 be used for every type of gallstone?
7. Is a PCD Pharma Franchise available
for URSOCALM-300?
8. Can this formulation be manufactured
under my own brand?
Disclaimer
