Aprima Tablet

Aprima Tablet is manufactured by Incepta Pharmaceuticals Limited. Aprima Tablet contains 30 mg Apremilast. It is Disease-modifying antirheumatic drugs (DMARDs) class drug.

Aprima is an inhibitor of phosphodiesterase 4 (PDE4) enzyme specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism by which Aprima exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.

Uses

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

Brand Name: Aprima
Generic: Apremilast
Weight: 30 mg
Type: Tablet
Therapeutic Class: Disease-modifying antirheumatic drugs (DMARDs)
Manufacturer: Incepta Pharmaceuticals Limited
Price: 0.00
Last Updated: November 19, 2020 at 6:15 pm

Dosage

Aprima contains Apremilast 30 mg. Aprima Dosage:

The recommended initial dosage titration of Aprima 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. Aprima can be administered without regard to meals.

Day 1: 10 mg in morning

Day 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 and thereafter: 30 mg twice daily

Dosage adjustment in patients with severe renal impairment

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

 

Side Effects

The most frequently occurring side effects of Aprima are nausea, diarrhea, and headache.

Other less frequent side effects are upper respiratory tract infection, vomiting, nasopharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.

Precaution

Treatment with Aprima 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 Aprima 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 Aprima 30 mg twice daily compared to 3.3% treated with placebo.

Aprima

Interaction

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

Pregnancy Lactation use

Pregnancy: Pregnancy Category C.

Nursing mothers: It is not known whether Aprima or its metabolites are present in human milk; however Aprima was detected in milk of lactating mice. Caution should be exercised when Aprima is administered to a nursing woman.

Usage in Pediatric Patients

The safety and effectiveness of Aprima in pediatric patients less than18 years of age have not been established.

Contraindication

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

Special Warning

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

Acute Overdose

 

Interaction with other Medicine

Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of Aprima. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with Aprima is not recommended.

Storage Condition

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