Arsenor

Arsenor10 mg

Tablet

Apremilast

Beacon Pharmaceuticals PLC

Product Code : 1374
MRP 250.00
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Medicine overview

Indications of Arsenor 10 mg

Arsenor 10 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

Arsenor 10 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, Arsenor 10 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 Arsenor 10 mg

The recommended initial dosage titration of Arsenor 10 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. Arsenor 10 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. Arsenor 10 mg dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Arsenor 10 mg be titrated using only the morning schedule and the evening doses be skipped.

Dosage of Arsenor 10 mg

The recommended initial dosage titration of Arsenor 10 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. Arsenor 10 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. Arsenor 10 mg dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Arsenor 10 mg be titrated using only the morning schedule and the evening doses be skipped.

Interaction of Arsenor 10 mg

Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Arsenor 10 mg.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Arsenor 10 mg is not recommended.

Contraindications

Arsenor 10 mg is contraindicated in patients with a known hypersensitivity to Arsenor 10 mg or to any of the excipients in the formulation.

Side Effects of Arsenor 10 mg

The most frequently occurring side effects of Arsenor 10 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 Arsenor 10 mg or its metabolites are present in human milk; however, Arsenor 10 mg was detected in milk of lactating mice. Caution should be exercised when Arsenor 10 mg is administered to a nursing woman.

Precautions & Warnings

Treatment with Arsenor 10 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 Arsenor 10 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 Arsenor 10 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 Arsenor 10 mg in paediatric patients less than 18 years of age have not been established.

Drug Classes

Disease-modifying antirheumatic drugs (DMARDs)

Mode Of Action

Arsenor 10 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, Arsenor 10 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 Arsenor 10 mg or its metabolites are present in human milk; however, Arsenor 10 mg was detected in milk of lactating mice. Caution should be exercised when Arsenor 10 mg is administered to a nursing woman.

Pediatric Uses

Use in Paediatric patient: The safety and effectiveness of Arsenor 10 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.