Xeridon
Generic Name
Roflumilast
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xeridon 10 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Xeridon 10 mg Tablet contains Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, used for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations. It helps reduce the frequency of COPD flare-ups.
Uses & Indications
Dosage
Adults
10 mg once daily, orally, with or without food.
Elderly
No specific dosage adjustment required based on age.
Renal_impairment
No dosage adjustment required for renal impairment.
How to Take
Take the tablet orally once daily, with or without food. Swallow the tablet whole with water; do not chew, crush, or break it.
Mechanism of Action
Roflumilast inhibits phosphodiesterase-4 (PDE4), an enzyme that metabolizes cyclic adenosine monophosphate (cAMP). By inhibiting PDE4, roflumilast increases intracellular cAMP levels in inflammatory and immune cells, leading to anti-inflammatory effects and bronchodilation. This mechanism reduces inflammation in the lungs and airway smooth muscle contraction, thereby improving airflow and reducing COPD exacerbations.
Pharmacokinetics
Onset
Not immediately for acute relief; therapeutic effects for COPD exacerbation reduction are seen over weeks of continuous treatment.
Excretion
Excreted primarily in the urine as metabolites.
Half life
Approximately 17 hours for roflumilast and 30 hours for its active N-oxide metabolite.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically reached within 1 hour for roflumilast and 8 hours for its active N-oxide metabolite.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 enzymes (CYP3A4 and CYP1A2) to its active N-oxide metabolite, which is pharmacologically more potent.
Side Effects
Contraindications
- Hypersensitivity to Roflumilast or any components of the tablet.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
Drug Interactions
Oral Contraceptives
Concomitant use with oral contraceptives containing ethinyl estradiol and gestodene did not show significant interactions.
CYP450 Inducers (e.g., Rifampicin, Phenobarbital, Phenytoin, Carbamazepine)
May decrease the efficacy of Roflumilast by significantly reducing its plasma concentrations. Concomitant use is not recommended.
CYP450 Inhibitors (e.g., Cimetidine, Erythromycin, Ketoconazole, Fluvoxamine)
May increase Roflumilast exposure, potentially leading to increased side effects. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are mainly extensions of known side effects, such as headache, nausea, diarrhea, abdominal pain, and vomiting. Treatment is symptomatic and supportive; no specific antidote is available. Hemodialysis is unlikely to be effective.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Roflumilast is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Roflumilast or any components of the tablet.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
Drug Interactions
Oral Contraceptives
Concomitant use with oral contraceptives containing ethinyl estradiol and gestodene did not show significant interactions.
CYP450 Inducers (e.g., Rifampicin, Phenobarbital, Phenytoin, Carbamazepine)
May decrease the efficacy of Roflumilast by significantly reducing its plasma concentrations. Concomitant use is not recommended.
CYP450 Inhibitors (e.g., Cimetidine, Erythromycin, Ketoconazole, Fluvoxamine)
May increase Roflumilast exposure, potentially leading to increased side effects. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are mainly extensions of known side effects, such as headache, nausea, diarrhea, abdominal pain, and vomiting. Treatment is symptomatic and supportive; no specific antidote is available. Hemodialysis is unlikely to be effective.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Roflumilast is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Patent expired in many regions, generic versions available
Clinical Trials
Roflumilast demonstrated efficacy in several pivotal placebo-controlled trials (e.g., M2-124, M2-125) in reducing COPD exacerbations in patients with severe COPD and chronic bronchitis.
Lab Monitoring
- No routine laboratory monitoring specific to Roflumilast is generally required. However, monitoring of weight is recommended due to potential weight loss.
- Liver function tests may be considered in patients with pre-existing hepatic conditions.
Doctor Notes
- Emphasize that Roflumilast is a maintenance therapy, not for acute symptom relief.
- Counsel patients on potential GI side effects and weight loss.
- Monitor for psychiatric symptoms, especially in patients with a history of depression.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Report any significant mood changes, depression, or suicidal thoughts to your doctor immediately.
- Do not use for acute bronchospasm relief; it is a maintenance treatment.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or insomnia. Patients should be advised to exercise caution before driving or operating machinery until they know how Xeridon affects them.
Lifestyle Advice
- Avoid smoking, as it worsens COPD and may reduce drug efficacy.
- Engage in regular physical activity as tolerated.
- Maintain a healthy diet.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Xeridon Brand
Other medicines available under the same brand name
