Alfasin XR Tablet
Alfuzosin
10mg
Incepta Pharmaceuticals Ltd.
| Pack size | 24's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10.00 AED |
Indications
Alfasin XR Tablet is used for:
Benign prostatic hyperplasia (BPH)
Adult Dose
Oral
Benign prostatic hyperplasia
Adult: 2.5 mg tid. Max: 10 mg/day. 1st dose should be given before bedtime.
Extended-release: 10 mg once daily.
Child Dose
Renal Dose
Renal Impairment
Initially, 2.5 mg bid. Adjust dose according to response.
Administration
Administration Should be taken with food. Swallow whole.
Extended-Release: Should be taken with food. Take immediately after the same meal each day. Swallow whole, do not chew/crush.
Contra Indications
Moderate or severe hepatic impairment
Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir)
Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients
Precautions
Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates.
Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min).
Use with caution in patients with mild hepatic impairment.
Should not be used in combination with other alpha adrenergic antagonists.
Prostate carcinoma should be ruled out prior to treatment.
Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique.
Discontinue Alfuzosin if symptoms of angina pectoris appear or worsen.
Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval.
Pregnancy-Lactation
Pregnancy
Drug is not indicated for use in women; there are no adequate data on the developmental risks associated with use in pregnant women
Animal data
Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbits, via body surface area
Lactation
Drug is not indicated for use in women; there are no data on the presence in human milk, effect on breastfed child, or on milk production
Interactions
CYP3A4 Inhibitors
Alfuzosin is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir since alfuzosin blood levels are increased
Alpha Adrenergic Antagonists
The pharmacokinetic and pharmacodynamic interactions between Alfuzosin and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and UROXATRAL should not be used in combination with other alpha-adrenergic antagonists
Antihypertensive Medication and Nitrates
There may be an increased risk of hypotension/postural hypotension and syncope when taking Alfuzosin concomitantly with anti-hypertensive medication and nitrates
PDE5 Inhibitors
Caution is advised when alpha adrenergic antagonists, including Alfuzosin, are coadministered with PDE5 inhibitors. Alpha-adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension
Potentially Fatal: Concurrent use w/ potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) increases plasma alfuzosin levels.
Contraindicated (30)
atazanavir
ceritinib
chloramphenicol
cisapride
clarithromycin
cobicistat
darunavir
dronedarone
elvitegravir/cobicistat/emtricitabine/tenofovir DF
fluconazole
fosamprenavir
idelalisib
indinavir
itraconazole
ketoconazole
lefamulin
levoketoconazole
lopinavir
mifepristone
nefazodone
nelfinavir
nirmatrelvir
nirmatrelvir/ritonavir
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
posaconazole
ritonavir
saquinavir
thioridazine
tipranavir
voriconazole
Adverse Effects
Side effects of Alfuzosin :
1-10%
Abdominal pain (1-2%),Back pain (1-2%),Brochitis (1-2%),Constipation (1-2%),Dizziness (5.7%),Dyspepsia (1-2%),Fatigue (2.7%),Headache (3%),Impotence (1-2%),Nausea (1-2%),Pharyngitis (1-2%),URT infection (3%),Sinusitis (1-2%),Upper respiratory infection (3%)
Mechanism of Action
Alfuzosin is a quinazoline derivative which exhibits selectivity for alpha1-adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors causes relaxation of smooth muscle in the bladder neck and prostate, resulting in improvement in urine flow and a reduction in symptoms of benign prostatic hyperplasia (BPH).
Note
Alfasin XR 10mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Alfuzosin. Alfasin XR is availble in Bangladesh.
Farmaco BD drug index information on Alfasin XR Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.