Cortiment
Generic Name
Budesonide
Manufacturer
Ferring Pharmaceuticals
Country
Denmark
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| cortiment 9 mg tablet | ৳ 430.00 | ৳ 4,300.00 |
Description
Overview of the medicine
Cortiment is an extended-release tablet containing budesonide, a corticosteroid, used to treat mild to moderate active ulcerative colitis in adults.
Uses & Indications
Dosage
Adults
9 mg once daily in the morning for up to 8 weeks for induction of remission. For maintenance, 6 mg once daily.
Elderly
No specific dose adjustment is required, but use with caution due to potential age-related decrease in hepatic function.
Renal_impairment
No specific dose adjustment is required, as renal excretion is a minor pathway for budesonide elimination. Use with caution in severe renal impairment.
How to Take
Swallow the tablet whole once daily in the morning, with or without food. Do not chew, crush, or break the tablet, as this will affect its extended-release properties.
Mechanism of Action
Budesonide is a glucocorticosteroid with potent local anti-inflammatory effects. Its targeted release in the colon minimizes systemic exposure and side effects compared to traditional oral corticosteroids.
Pharmacokinetics
Onset
Clinical improvement typically seen within 2-4 weeks, with full remission in up to 8 weeks.
Excretion
Excreted primarily via urine (60%) and feces (40%) as metabolites.
Half life
Plasma half-life is approximately 2 to 9 hours.
Absorption
Budesonide is well absorbed after oral administration but undergoes extensive first-pass metabolism. The extended-release formulation ensures targeted delivery to the colon.
Metabolism
Extensive first-pass metabolism in the liver via CYP3A4 enzymes (approximately 90%).
Side Effects
Contraindications
- Hypersensitivity to budesonide or any components of the formulation.
- Systemic fungal infections.
Drug Interactions
Oral Contraceptives
May increase the plasma concentrations of budesonide; however, this interaction is generally considered clinically insignificant.
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine, Barbiturates)
May decrease systemic exposure to budesonide, potentially reducing its therapeutic effect.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Grapefruit juice)
Can significantly increase systemic exposure to budesonide, potentially leading to systemic corticosteroid effects.
Storage
Store below 30°C, protected from moisture and light. Keep out of reach of children.
Overdose
Acute overdose with Cortiment is unlikely to lead to severe clinical problems. In case of an overdose, symptomatic and supportive treatment should be initiated.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: Budesonide is excreted in breast milk. Weigh the benefits of breastfeeding against the potential risks of infant exposure.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent expired for generic, formulation specific patents may exist
WHO Essential Medicine
YesClinical Trials
Clinical trials have demonstrated the efficacy of Cortiment 9 mg in inducing and maintaining remission in adult patients with mild to moderate active ulcerative colitis.
Lab Monitoring
- Monitor for signs of adrenal suppression, especially during withdrawal from systemic corticosteroids or prolonged use.
- Routine monitoring of liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Counsel patients on the importance of adhering to the prescribed dosage and administration instructions.
- Advise patients to avoid grapefruit products due to potential drug interactions.
- Monitor for signs of systemic corticosteroid effects, especially in patients transitioning from systemic steroids.
Patient Guidelines
- Do not stop Cortiment abruptly without consulting your doctor, as this can lead to withdrawal symptoms.
- Report any signs of infection, increased thirst, frequent urination, or vision changes to your doctor.
- Avoid grapefruit and grapefruit juice while taking this medication.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Cortiment is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or fatigue, exercise caution.
Lifestyle Advice
- Maintain a healthy diet and lifestyle. Avoid known triggers for ulcerative colitis flare-ups.
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