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All price changes →Fesotrex ER
Rx4 mg • Tablet (Extended Release)
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Other strengths and forms by Incepta Pharmaceuticals Ltd.
Indications & Uses
Adult Overactive Bladder Fesoterodine Fumarate is used to treat overactive bladder (OAB) in adults who have urge urinary incontinence, urgency and frequency. Pediatric Neurogenic Detrusor Overactivity Fesoterodine Fumarate is also used to treat neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older who weigh more than 25 kg.
Pharmacology
Fesoterodine is a competitive muscarinic receptor antagonist. After you take it by mouth, the body quickly and extensively breaks it down with nonspecific esterases (a group of enzymes) into its active metabolite, 5-hydroxymethyl tolterodine. This metabolite is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in the contractions of the urinary bladder smooth muscle. Blocking these receptors in the bladder is presumed to be how fesoterodine produces its effects.
A urodynamic study was carried out in patients with involuntary detrusor contractions. It assessed what happened to the volume at first detrusor contraction and to bladder capacity after fesoterodine was given. Both the volume at first detrusor contraction and the bladder capacity increased, and the increase depended on the dose. These findings are consistent with an antimuscarinic effect on the bladder.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Overactive bladder in adults: the recommended starting dose of fesoterodine fumarate is 4 mg by mouth once daily. Depending on how the person responds and tolerates it, the dose can be raised to the maximum of 8 mg once daily.
Neurogenic detrusor overactivity in pediatric patients 6 years and older: for pediatric patients weighing greater than 25 kg and up to 35 kg, the recommended dose is 4 mg by mouth once daily. If needed, it may be increased to 8 mg once daily. For pediatric patients weighing greater than 35 kg, the recommended starting dose is 4 mg by mouth once daily, and after one week it is increased to 8 mg once daily.
Administration: swallow whole with liquid. Do not chew, divide, or crush. It can be taken with or without food.
Pediatric use: the safety and effectiveness of Toviaz have been established for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg.
Geriatric use: no dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age.
Side Effects
In adult patients with OAB, the side effects reported most often with Fesoterodine Fumarate (in 4% or more of patients) were dry mouth and constipation. Dry mouth was seen in 7% of patients on placebo, 19% on Fesoterodine Fumarate 4 mg and 35% on Fesoterodine Fumarate 8 mg. Constipation was seen in 2% on placebo, 4% on 4 mg and 6% on 8 mg. In children with NDO, the adverse reactions reported most often (in 2% or more of patients) were diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased and headache.
Cautions & Contraindications
Warnings & Precautions
Angioedema Stop Fesoterodine Fumarate straight away and give appropriate therapy. Urinary Retention It isn't recommended for patients with clinically significant bladder outlet obstruction, because of the risk of urinary retention. Decreased Gastrointestinal Motility It isn't recommended for patients with decreased gastrointestinal motility, such as those with severe constipation. Worsening of Narrow-Angle Glaucoma Use it with caution in patients being treated for narrow-angle glaucoma. Central Nervous System Effects Somnolence has been reported with Fesoterodine Fumarate. Advise patients not to drive or operate heavy machinery until they know how it affects them. Worsening of Myasthenia Gravis Symptoms Use it with caution in patients with myasthenia gravis.
Contraindications
Fesoterodine must not be given to patients who have a known or suspected hypersensitivity to Fesoterodine or to any of its ingredients. The same applies to hypersensitivity to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. Reactions have included angioedema. It is also contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.
Pregnancy & Breastfeeding
There are no data on the use of Fesoterodine in pregnant women and adolescents, so it isn't possible to judge whether the medicine carries a risk of major birth defects, miscarriage or other harmful outcomes for the mother or the baby.
Nothing is known about whether fesoterodine passes into human milk, what effect it has on a breastfed child, or whether it changes milk production. When deciding on Fesoterodine during breastfeeding, the benefits of breastfeeding for the baby's development and health should be weighed against the mother's own clinical need for the medicine. Any possible harmful effects on the breastfed child, either from Fesoterodine or from the mother's underlying condition, should be considered as well.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Fesoterodine Fumarate below 30°C, away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Fesotrex ER 4 mg
What is Fesotrex ER 4 mg Tablet (Extended Release)?
Fesotrex ER 4 mg Tablet (Extended Release) is a medicine that contains Fesoterodine Fumarate. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Other genito-urinary preparations group of medicines.
What is Fesotrex ER used for?
Adult Overactive Bladder Fesoterodine Fumarate is used to treat overactive bladder (OAB) in adults who have urge urinary incontinence, urgency and frequency. Pediatric Neurogenic Detrusor Overactivity Fesoterodine Fumarate is also used to treat neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older who weigh more than 25 kg.
What are the side effects of Fesotrex ER?
In adult patients with OAB, the side effects reported most often with Fesoterodine Fumarate (in 4% or more of patients) were dry mouth and constipation. Dry mouth was seen in 7% of patients on placebo, 19% on Fesoterodine Fumarate 4 mg and 35% on Fesoterodine Fumarate 8 mg.
Can I take Fesotrex ER during pregnancy or while breastfeeding?
There are no data on the use of Fesoterodine in pregnant women and adolescents, so it isn't possible to judge whether the medicine carries a risk of major birth defects, miscarriage or other harmful outcomes for the mother or the baby. Nothing is known about whether fesoterodine passes into human milk, what effect it has on a breastfed child, or whether it changes milk production. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Fesotrex ER?
Store Fesoterodine Fumarate below 30°C, away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Fesotrex ER?
Some medicines can interact with Fesoterodine Fumarate, for example: Clarithromycin, Itraconazole, Ketoconazole, Carbamazepine, Rifampicin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Fesotrex ER is already among the lowest-priced brands of Fesoterodine Fumarate at this strength.
Do I need a prescription for Fesotrex ER?
Fesotrex ER is a prescription (Rx) medicine. Take it as your doctor advises.