Aprila

Aprila30 mg

Tablet

Apremilast

Drug International Ltd.

Product Code : 1209
MRP 51.11
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Medicine overview

Indications of Aprila 30 mg

Aprila 30 mg is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Theropeutic Class

Disease-modifying antirheumatic drugs (DMARDs)

Pharmacology

Aprila 30 mg is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, Aprila 30 mg increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.

Dosage & Administration of Aprila 30 mg

The recommended initial dosage titration of Aprila 30 mg from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Aprila 30 mg can be administered without regard to meals.Day 1: 10 mg in morningDay 2: 10 mg in morning and 10 mg in evening Day 3: 10 mg in morning and 20 mg in evening Day 4: 20 mg in morning and 20 mg in evening Day 5: 20 mg in morning and 30 mg in evening Day 6: 30 mg twice dailyDosage adjustment in patients with severe renal impairment. Aprila 30 mg dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Aprila 30 mg be titrated using only the morning schedule and the evening doses be skipped.

Dosage of Aprila 30 mg

The recommended initial dosage titration of Aprila 30 mg from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Aprila 30 mg can be administered without regard to meals.Day 1: 10 mg in morningDay 2: 10 mg in morning and 10 mg in evening Day 3: 10 mg in morning and 20 mg in evening Day 4: 20 mg in morning and 20 mg in evening Day 5: 20 mg in morning and 30 mg in evening Day 6: 30 mg twice dailyDosage adjustment in patients with severe renal impairment. Aprila 30 mg dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Aprila 30 mg be titrated using only the morning schedule and the evening doses be skipped.

Interaction of Aprila 30 mg

Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Aprila 30 mg.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Aprila 30 mg is not recommended.

Contraindications

Aprila 30 mg is contraindicated in patients with a known hypersensitivity to Aprila 30 mg or to any of the excipients in the formulation.

Side Effects of Aprila 30 mg

The most frequently occurring side effects of Aprila 30 mg are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.

Pregnancy & Lactation

Pregnancy Category C. It is not known whether Aprila 30 mg or its metabolites are present in human milk; however, Aprila 30 mg was detected in milk of lactating mice. Caution should be exercised when Aprila 30 mg is administered to a nursing woman.

Precautions & Warnings

Treatment with Aprila 30 mg is associated with an increase in adverse reactions of depression. Patients, their caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Aprila 30 mg if such events occur.During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Aprila 30 mg 30 mg twice daily compared to 3.3% treated with placebo.

Storage Conditions

Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.

Use In Special Populations

Use in Paediatric patient: The safety and effectiveness of Aprila 30 mg in paediatric patients less than 18 years of age have not been established.

Drug Classes

Disease-modifying antirheumatic drugs (DMARDs)

Mode Of Action

Aprila 30 mg is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, Aprila 30 mg increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.

Pregnancy

Pregnancy Category C. It is not known whether Aprila 30 mg or its metabolites are present in human milk; however, Aprila 30 mg was detected in milk of lactating mice. Caution should be exercised when Aprila 30 mg is administered to a nursing woman.

Pediatric Uses

Use in Paediatric patient: The safety and effectiveness of Aprila 30 mg in paediatric patients less than 18 years of age have not been established.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.