Darifen ER Tablet
Darifenacin
7.5mg
Acme Laboratories Ltd.
| Pack size | 7's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 22.07 AED |
Indications
Darifen ER Tablet is used for:
Urge incontinence, Urinary frequency and urgency, Overactive bladder
Adult Dose
Oral
Overactive bladder
Adult: For symptomatic treatment of urge incontinence, urinary frequency and urgency.
Initial: 7.5 mg once daily; may increase dose to 15 mg once daily if no adequate response after 2 weeks of therapy.
Child Dose
Renal Dose
Administration
May be taken with or without food. Swallow whole, do not chew/crush/divide.
Contra Indications
Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma
Hypersensitivity
Precautions
Heat prostration may occur in the presence of increased environmental temperature
Use caution in patients with decreased GI motility, hiatal hernia, reflux esophagitis, and ulcerative colitis
Administer with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention
Administer with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention; like other anticholinergic drugs, this drug may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis
Use with caution in patients being treated for narrow-angle glaucoma and only where potential benefits outweigh the risk
Angioedema of face, lips, tongue, and/or larynx reported; in some cases angioedema occurred after first dose; angioedema associated with upper airway swelling may be life-threatening; if involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue therapy and provide appropriate therapy and/or measures necessary to ensure a patent airway
Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose.
The daily dose should not exceed 7.5 mg for patients with moderate hepatic impairment (Child-Pugh B); therapy has not been studied in patients with severe hepatic impairment (Child-Pugh C) and therefore is not recommended for use in this patient population
Central nervous system effects
Therapy is associated with anticholinergic central nervous system (CNS) effects; a variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations, and somnolence
Pregnancy-Lactation
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Animal data
In animal studies, the drug was not teratogenic in rats and rabbits at plasma exposures of free drug (via AUC) up to 59 and 28 times the maximum recommended human dose (MRHD) of 15 mg, respectively
Effects on embryofetal development were observed following administration of the drug during pregnancy, including dilated ureter and/or kidney pelvis in rabbits at about 9 times the MRHD, post-implantation loss in rabbits at about 28 times, and delayed ossification in rats at about 59 times
During pregnancy and lactation (developmental delays in rats at about 17 times the MRHD), which was associated with maternal toxicity reported
Dystocia was observed in rat dams at about 17 times the MRHD
Lactation
There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production
The drug is present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for darifenacin and any potential adverse effects on the breastfed child from darifenacin or from the underlying maternal conditions
Interactions
Concurrent use of CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) or CYP2D6 inhibitors (e.g. quinidine, paroxetine) may increase serum levels of Darifenacin.
CYP3A4 inducers (e.g. barbiturates, phenytoin, rifampicin) may likely decrease Darifenacin serum concentrations.
Darifenacin may act as a moderate inhibitor of CYP2D6, caution when used concomitantly with CYP2D6 substrates that have narrow therapeutic index (e.g. flecainide, thioridazine, imipramine).
Concurrent use of another agent with antimuscarinic properties may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to effects on gastrointestinal motility..
Contraindicated (1)
eliglustat
Serious (44)
apalutamide
carbamazepine
chloramphenicol
cimetidine
clarithromycin
dihydroergotamine
dihydroergotamine intranasal
dronedarone
ergotamine
erythromycin base
erythromycin ethylsuccinate
erythromycin lactobionate
erythromycin stearate
everolimus
fexinidazole
glycopyrronium tosylate topical
idelalisib
itraconazole
ivosidenib
ketoconazole
levoketoconazole
lonafarnib
lopinavir
lovastatin
nefazodone
pazopanib
pimozide
pramlintide
ranolazine
revefenacin
ribociclib
rifabutin
rifampin
secretin
silodosin
simvastatin
sirolimus
sofpironium topical
St John's Wort
thioridazine
tolvaptan
tovorafenib
tucatinib
umeclidinium bromide/vilanterol inhaled
Adverse Effects
Side effects of Darifenacin :
>10%
Dry mouth (19-35%),Constipation (15-21%)
1-10%
Abdominal pain (2-4%),Dizziness (2%),Dry eyes (2%),Dyspepsia (3-8%),Nausea (2-4%),UTI (4-5%),Vaginitis (>1%),Back pain (>1%),Rhinitis (>1%),Abnormal vision (>2%),Vomiting (>1%),Weight gain (>1%),Flu-like syndrome (1-3%),Peripheral edema (>1%)
Potentially Fatal: Hypersensitivity reactions, including angioedema.
Mechanism of Action
Darifenacin is a potent, competitive and selective muscarinic receptor antagonist which has greater binding affinity for muscarinic M3 receptors. M3 receptors are involved in the contraction of the detrusor muscle of the bladder, GI smooth muscle, saliva production, and iris sphincter function. Darifenacin may increase volume threshold in patients with involuntary detrusor contraction, thus increase bladder capacity.
Note
Darifen ER 7.5mg Tablet manufactured by Acme Laboratories Ltd.. Its generic name is Darifenacin. Darifen ER is availble in Bangladesh.
Farmaco BD drug index information on Darifen ER Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.