Apremig-ODT
Generic Name
apremig-odt-75-mg-tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| apremig odt 75 mg tablet | ৳ 150.00 | ৳ 600.00 |
Description
Overview of the medicine
Apremig-ODT 75 mg Tablet contains Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor. It is used to treat certain inflammatory conditions like psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet's disease.
Uses & Indications
Dosage
Adults
The recommended maintenance dose of Apremilast is 30 mg orally twice daily (BID), after initial titration. Titration schedule (standard for Apremilast): Day 1: 10 mg in the morning. Day 2: 10 mg in the morning and 10 mg in the evening. Day 3: 10 mg in the morning and 20 mg in the evening. Day 4: 20 mg in the morning and 20 mg in the evening. Day 5: 20 mg in the morning and 30 mg in the evening. Day 6 onwards: 30 mg in the morning and 30 mg in the evening. The 75 mg strength of Apremig-ODT is atypical for standard Apremilast dosing, and specific dosing guidance for this strength would require a physician's discretion.
Elderly
No dosage adjustment is required in elderly patients (>65 years) based on age alone. However, renal function should be considered.
Renal_impairment
For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 30 mg orally once daily. No dosage adjustment is needed for mild or moderate renal impairment.
How to Take
Take Apremig-ODT 75 mg Tablet orally with or without food. The orally disintegrating tablet can be placed on the tongue and allowed to dissolve before swallowing, or swallowed whole with water.
Mechanism of Action
Apremilast inhibits phosphodiesterase 4 (PDE4), an enzyme specific for cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 leads to increased intracellular cAMP levels, which then modulates the expression of pro-inflammatory and anti-inflammatory mediators.
Pharmacokinetics
Onset
Clinical improvement typically observed within 16-24 weeks for psoriasis and psoriatic arthritis, with some patients seeing effects earlier. Onset for Behçet's disease oral ulcers may be faster.
Excretion
Approximately 58% of the dose is excreted in urine and 39% in feces. Apremilast is mainly excreted as metabolites.
Half life
The mean terminal half-life is approximately 6-9 hours.
Absorption
Rapidly absorbed after oral administration. Absolute bioavailability is approximately 73%. Peak plasma concentrations (Tmax) are reached in approximately 2 hours.
Metabolism
Extensively metabolized, primarily via cytochrome P450 (CYP) enzymes, mainly CYP3A4, with minor contributions from CYP1A2 and CYP2A6. Non-CYP mediated hydrolysis is also involved.
Side Effects
Contraindications
- •Hypersensitivity to Apremilast or any component of the formulation.
- •Severe allergic reactions to previous doses.
Drug Interactions
Oral Contraceptives
Apremilast is not expected to affect the efficacy of oral contraceptives.
Strong CYP450 Inducers (e.g., Rifampin, Phenobarbital, Carbamazepine, Phenytoin)
Co-administration with strong CYP450 inducers may decrease Apremilast exposure, leading to reduced efficacy. Concomitant use is not recommended.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Apremilast overdose. In case of overdose, symptomatic and supportive measures should be initiated as appropriate.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies of Apremilast in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Apremilast is excreted in human milk; caution should be exercised when administered to a nursing woman, or consider discontinuing nursing.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, specific to product batch.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA for Apremilast)
Patent Status
Varies by region; active substance (Apremilast) patent may have expired in some regions allowing generics.
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Global Brand Names
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