Fesotrex 4 ER

Indications

Fesoterodine is used in adults to treat the symptoms of overactive bladder: a sudden, strong need to pass urine (urgency), passing urine more often than usual (frequency), and leaking urine because of urgency (urge incontinence).

How It Works

Fesoterodine is an antimuscarinic medicine. In the body it is changed into an active substance that blocks muscarinic receptors in the bladder wall. This relaxes the bladder muscle, reduces sudden contractions and allows the bladder to hold more urine.

Dosage and Administration

The usual starting dose for adults is 4 mg once daily. The doctor may increase it to 8 mg once daily after assessing the response. Swallow the prolonged-release tablet whole with water, with or without food; do not chew, divide or crush it. The maximum dose is 4 mg once daily in people with severe kidney problems or those taking strong CYP3A4 inhibitors. Benefit may take up to 2 to 8 weeks to become clear.

Interactions

Strong CYP3A4 inhibitors such as Ketoconazole, Itraconazole, Clarithromycin and Ritonavir raise its levels. Rifampicin, Carbamazepine and Phenytoin lower its effect. Other anticholinergic medicines (such as some antihistamines, tricyclic antidepressants or Oxybutynin) add to side effects like dry mouth and constipation. It may reduce the effect of medicines that speed up stomach emptying, such as Metoclopramide.

Contraindications

• Allergy to Fesoterodine, Tolterodine, peanut or soya, or any ingredient.
• Urinary retention (unable to empty the bladder).
• Gastric retention or severe ulcerative colitis or toxic megacolon.
• Uncontrolled narrow-angle glaucoma.
• Myasthenia gravis.
• Severe liver impairment.

Side Effects

The most common side effect is dry mouth. Others include constipation, dry eyes, blurred vision, dizziness, headache, indigestion, trouble passing urine, and urinary tract infection.

Get urgent medical help if you cannot pass urine at all, have swelling of the face, lips, tongue or throat, difficulty breathing, severe stomach pain or bloating, eye pain with blurred vision, or confusion.

Pregnancy and Lactation

Not recommended during pregnancy, as safety has not been established. It is not known whether it passes into breast milk; breastfeeding is not recommended during treatment.

Precautions and Warnings

Use with care in people with an enlarged prostate or other bladder outlet obstruction, slow bowel movement or severe constipation, reflux, kidney or liver disease, heart rhythm problems including long QT, and in older people. It reduces sweating, so avoid overheating in hot weather. It may cause blurred vision or dizziness, so take care when driving.

Overdose

Overdose may cause severe anticholinergic effects: dry mouth, dilated pupils, blurred vision, fast heartbeat, inability to pass urine, flushing, fever, agitation, confusion or hallucinations. Seek emergency medical help.

Therapeutic Class

Urinary antispasmodic, antimuscarinic agent.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.