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Aprima 10
Incepta Pharmaceuticals Ltd.
Generic: Apremilast
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Aprima 10. Please consult your doctor.
CONSULT YOUR DOCTOR
Aprima 10 may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Information regarding the use of Aprima 10 during breastfeeding is not available. Please consult your doctor.
SAFE
Aprima 10 does not usually affect your ability to drive.
CAUTION
Aprima 10 should be used with caution in patients with severe kidney disease. Dose adjustment of Aprima 10 may be needed. Please consult your doctor.
SAFE IF PRESCRIBED
Aprima 10 is safe to use in patients with liver disease. No dose adjustment of Aprima 10 is recommended.
Medicine Overview of Aprima 10mg Tablet
Introduction
Aprima 10 is used in the treatment of moderate to severe plaque psoriasis which is a type of skin condition. This medicine is used when other conventional treatments cannot be used or if the patient is not responsive or intolerant to any of these treatments. Aprima 10 can be taken with or without food. Take it regularly and do not stop taking the medicine even if you get better until that doctor tells you it is alright to stop. You may need to monitor your weight regularly while taking the medicine as it may cause weight loss. Using this medicine...
... Show moreUses of Aprima 10
- Plaque psoriasis
Side effects of Aprima 10
Common
- Diarrhea
- Nausea
- Vomiting
How to use Aprima 10
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Aprima 10 may be taken with or without food, but it is better to take it at a fixed time.
How Aprima 10 works
Aprima 10 is a phosphodiesterase 4 (PDE4) inhibitors. It works by blocking the action of certain chemical messengers that are responsible for inflammation associated with psoriatic arthritis and psoriasis, and thereby reduces the signs and symptoms of these conditions.
Quick Tips
- Aprima 10 is a well-tolerated medicine. Mild stomach upset may occur early during the treatment.
- Monitor your weight regularly as Aprima 10 may cause weight loss.
- Your doctor will gradually increase the dose from day 1 to day 6 of treatment, after which it may be kept constant.
- Tell your doctor immediately if you experience new or worsened depression, suicidal thoughts, other mood changes or unexplained weight loss.
Brief Description
Indication
Active psoriatic arthritis, moderate to severe plaque psoriasis
Administration
To reduce risk of GI symptoms associated with initial therapy, titrate to recommended dose (30 mg PO BID) according to the dosage schedules listed above
Can be administered without regard to meals
Swallow tablet whole; do not crush, split, or chew
Adult Dose
Active psoriatic arthritis, moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
To reduce risk of gastrointestinal symptoms, titrate to recommended dose of 30 mg twice daily according to the following schedule:
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
Hepatic impairment: No dosage adjustment required
Renal Dose
Severe renal impairment (CrCl <30 mL/min): Reduce dose to 30 mg PO qDay
Mild-to-moderate renal impairment: No dosage adjustment required
Contraindication
Known hypersensitivity to apremilast.
Mode of Action
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.
Precaution
Apremilast is associated with an increase in adverse reactions of depression. Before using, evaluate patient for history of depression and/or suicidal thoughts or behavior.
Weight decrease of 5-10% of body weight. Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of Apremilast.
Lactation: Unknown if distributed in human breast milk; caution required
Side Effect
1-10%
Diarrhea (7.7-9.3%),Nausea (7.4-8.9%),Headache (4.8-5.9%),Upper respiratory tract infection (0.6-3.9%),Vomiting (0.8-3.2%),Nasopharyngitis (0.2-2.6%),Upper abdominal pain (0.6-2%)
Pregnancy Category Note
Pregnancy Available pharmacovigilance data use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but data are extremely limited Based on findings from animal reproduction studies, may increase the risk for fetal loss Lactation There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production Detected in the milk of lactating mice Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from...
... Show moreInteraction
Coadministration with strong CYP inducers (eg, rifampin, carbamazepine, phenobarbital phenytoin) may occur and result in a loss of efficacy of apremilast; therefore, coadministration is not recommended.
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