Urginol tablets

Urginol

  • Active Ingredient: Tolterodine
  • 4 mg, 2 mg, 1 mg
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What is Urginol?

The active ingredient of Urginol brand is tolterodine. Tolterodine reduces spasms of the bladder muscles.

Used for

Urginol is used to treat diseases such as: Overactive Bladder, Urinary Incontinence.

Side Effect

Possible side effects of Urginol include: sore throat; Being forgetful; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; pain or tenderness around the eyes and cheekbones; chills; belching; bloody or cloudy urine.

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COMMON BRAND(S): Detrol LA

GENERIC NAME(S): Urginol

This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, Urginol improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

Pharmacodynamics

Urginol has a pronounced effect on bladder function. Effects on urodynamic parameters before and 1 and 5 hours after a single 6.4 mg dose of Urginol immediate release were determined in healthy volunteers. The main effects of Urginol at 1 and 5 hours were an increase in residual urine, reflecting an incomplete emptying of the bladder, and a decrease in detrusor pressure. These findings are consistent with an antimuscarinic action on the lower urinary tract.

What should I avo >

Urginol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase some of the side effects of Urginol.

CONTRAINDICATIONS

DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL LA, are metabolized to 5-hydroxymethyl Urginol .

What is the most important information I should know about Urginol?

You should not take this medication if you are allergic to Urginol or fesoterodine (Toviaz), if you have untreated or uncontrolled narrow-angle glaucoma, or if you have a blockage of the urinary tract, stomach, or intestines.

Before you take Urginol, tell your doctor if you have kidney or liver disease, glaucoma, myasthenia gravis, or a personal or family history of "Long QT syndrome."

Do not crush, chew, break, or open a controlled-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Urginol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase some of the side effects of Urginol.

There are many other drugs that can interact with Urginol. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Drug-Laboratory-Test Interactions

Interactions between Urginol and laboratory tests have not been studied.

What Is Urginol and How Does It Work?

Urginol is prescribed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Urginol is available under the following different brand names: Detrol, and Detrol LA.

Dosage Forms and Strengths

Dosage Considerations – Should be Given as Follows:

  • Immediate release: 2 mg orally every 12 hours
  • Extended release: 2-4 mg orally once daily

  • CrCl 10-30 mL/minute: Not to exceed 1 mg orally every 12 hours (immediate release) or 2 mg orally once daily (extended release)
  • CrCl less than 10 mL/minute: Not recommended

  • Mild to moderate (Child-Pugh class A or B): Not to exceed 1 mg orally every 12 hours (immediate release) or 2 mg orally once daily (extended release)
  • Severe (Child-Pugh class C): Not recommended

Strong CYP3A4 inhibitors

  • Not to exceed 1 mg orally every 12 hours (immediate release) or 2 mg orally once daily (extended release)

Not recommended for pediatric use

How is this medicine (Urginol Tablets) best taken?

Use this medicine (Urginol tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take this medicine (Urginol tablets) at the same time of day.
  • Keep taking this medicine (Urginol tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some things I need to know or do while I take Urginol Tablets?

  • Tell all of your health care providers that you take this medicine (Urginol tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine (Urginol tablets) affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • A very bad reaction called angioedema has happened with this medicine (Urginol tablets). Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Urginol tablets) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Potent CYP2D6 Inhibitors

Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of Urginol immediate release in CYP2D6 extensive metabolizers, resulting in a 4.8-fold increase in Urginol AUC. There was a 52% decrease in C and a 20% decrease in AUC of 5-hydroxymethyl Urginol (5-HMT), the pharmacologically active metabolite of Urginol . The sums of unbound serum concentrations of Urginol and 5-HMT are only 25% higher during the interaction. No dose adjustment is required when Urginol and fluoxetine are coadministered .

If you experience any other symptoms which you think may be due to Urginol, please speak with your doctor or pharmacist for further advice.

Is Urginol safe to take if I'm pregnant or breastfeeding?

At doses much greater than those used in humans, Urginol causes fetal abnormalities in animals, but there are no studies with Urginol in pregnant women. Therefore, Urginol should only be given to pregnant women if the benefits are felt to outweigh the potential risks.

Urginol is secreted into breast milk in animals; however, it is not known if Urginol is secreted into the breast milk of women. Therefore, nursing mothers should either not breast feed or discontinue Urginol.

Precautions

Before taking Urginol, tell your doctor or pharmacist if you are allergic to it; or to fesoterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems emptying your bladder (urinary retention, bladder outflow obstruction), severe blockage of stomach/intestines (gastric retention), glaucoma, stomach/intestinal disease (such as ulcerative colitis, slowed movement of stomach/intestines), severe constipation, kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

Urginol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Urginol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Urginol safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Which drugs or supplements interact with Urginol?

Urginol is broken down by liver enzymes before elimination from the body. Drugs that block these liver enzymes may slow the elimination of Urginol, raise Urginol blood levels, and lead to side effects. The list of drugs that may interfere with the elimination of Urginol includes erythromycin, clarithromycin (Biaxin), ketoconazole (Nizoral), itraconazole (Sporanox), cyclosporine, vinblastine, and miconazole (Monistat, Micatin). The dose of Urginol should be reduced to 1 mg twice daily if taken with any of these drugs.


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