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SANDOZ APREMILAST is a brand name for Apremilast, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................4 WARNINGS AND PRECAUTIONS.............................................................................4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Sandoz Apremilast has not been evaluated and is therefore not indicated in combination with potent immunosuppressants or biological therapeutics for psoriasis, psoriatic arthritis or Behçet’s disease such as tumor necrosis factor (TNF) antagonists and anti-IL-12/23 p40 antibodies (see INDICATIONS AND CLINICAL USE, Limitations of Use).
In Behçet’s disease, Sandoz Apremilast should be used by physicians who have knowledge of Behçet’s disease and who have fully familiarized themselves with the efficacy and safety profile of Sandoz Apremilast. Recommended Dose and Dosage Adjustment Recommended adult dose (≥ 18 years of age and older): The recommended dose of Sandoz Apremilast is 30 mg twice daily.
Sandoz Apremilast tablets can be taken with or without food. An initial titration schedule is required, as shown below in Table 4, to reduce the risk of gastrointestinal symptoms. Table 4. Dose Titration Schedule Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg Special Populations Pediatrics (< 18 years of age) The safety and effectiveness of apremilast in pediatric patients have not been established.
Therefore, apremilast should not be used in this patient population. Geriatrics (≥ 65 years of age) No dosage adjustment is necessary for elderly patients (≥ 65 years of age). Due to limited data available in very elderly patients (≥ 75 years of age), Sandoz Apremilast should be used with caution in this patient population.
Hepatic Impairment No dosage adjustment is necessary in patients with moderate and severe hepatic impairment. Renal Impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment. The safety and efficacy of apremilast have not been evaluated in patients with severe renal Sandoz Apremilast Product Monograph Page 15 of 37 impairment.
The maximal recommended dose of Sandoz Apremilast is 30 mg once daily in patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockroft–Gault equation). For initial dosage titration, titrate using only the morning dose (AM dose) in Table 4 and skip the afternoon dose (PM dose).
Continue thereafter at 30 mg once daily (see WARNINGS AND PRECAUTIONS, Renal). Missed Dose Patients should be advised that if they miss a dose of Sandoz Apremilast, they should continue with the next tablet at the usual time. Patients should not take a double dose to make up for a missed dose.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Apremilast in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Administration Sandoz Apremilast tablets should be swallowed whole. The tablets should not be crushed, split or chewed. OVERDOSAGE In case of overdose, patients should seek immediate medical help. Patients should be managed by symptomatic and supportive care.
For management of a suspected drug overdose, contact your regional poison control centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Apremilast, a small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators.
Phosphodiesterase 4 inhibition elevates intracellular cAMP levels, thereby reducing the inflammatory response by modulating the expression of tumor necrosis factor-α (TNF-α), interleukin-23 (IL-23), IL-17 and IL-10. Pharmacodynamics In clinical trials in patients with psoriasis, apremilast decreased lesional skin epidermal thickness, inflammatory cell infiltration, and expression of pro-inflammatory genes, including those for inducible nitric oxide synthase (iNOS), IL-12/IL-23p40, IL-23p19, IL- 17A, IL-22 and IL-8.
Cardiac Electrophysiology A double-blind, placebo- and positive-controlled, randomized, multiple-dose, four period Sandoz Apremilast Product Monograph Page 16 of 37 crossover study was performed to investigate the effects of apremilast on ECG interval parameters in healthy male volunteers (N=60).
Apremilast was tested at a therapeutic dose (30 mg BID on days 1-4 and 30 mg QD on day 5) and a supratherapeutic dose (50 mg BID on days 1-4 and 50 mg QD on day 5). Apremilast 30 mg and 50 mg did not have noteworthy effects on the QTc, QRS, or PR intervals on day 5 of treatment.
6) at 2 h. 6) at 3 h (see WARNINGS AND PRECAUTIONS, Cardiovascular). Pharmacokinetics Table 5. 1) Legend: AUC= Area under curve; BID = Twice daily; Cmax = Maximum concentration; CL/F = apparent clearance; t1/2 = terminal half-life; V/F = apparent volume of distribution Note: Values are displayed as geometric mean (coefficient of variation [%]).
5 hours. Apremilast pharmacokinetics are linear, with a doseproportional increase in systemic exposure and less than dose proportional increase in Cmax between the dose range of 10 to 100 mg daily in healthy volunteers. 75 hour; therefore, apremilast can be administered with or without food.
Distribution:
Human plasma protein binding of […]