Flavonate tablets

Flavonate

  • Active Ingredient: Flavoxate
  • 200 mg
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What is Flavonate?

The active ingredient of Flavonate brand is flavoxate. Flavoxate reduces muscle spasms of the bladder and urinary tract. Each tablet for oral administration contains 100 mg Flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

Used for

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

Side Effect

Possible side effects of Flavonate include: skin rash or hives; constipation; dizziness (severe); Blurred vision; Clumsiness or unsteadiness; Confusion.

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DESCRIPTION

URISPAS® (Flavonate HC1) tablets contain Flavonate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, Flavonate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of Flavonate hydrochloride is C24H25NO4• HCl. The molecular weight is 427.94. The structural formula appears below.

URISPAS® is supplied in tablets for oral administration. Each round, white, film-coated URISPAS® tablet is debossed with the product name URISPAS® and contains Flavonate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, starch and talc.

Important Information

You should not use Flavonate if you have bleeding or a blockage in your digestive tract (stomach or intestines), a bladder obstruction, or if you are unable to urinate.

5.1 Sol > Flavonate hydrochloride has been found to be a highly stable compound in the solid state. No signs of degradation were noted in dry material stored for more than three years at room temperature . The stress study performed in this laboratory showed that Flavonate hydrochloride remains intact when exposed to elevated temperature (60-80 °C, 4 weeks), UV/visible light (380-770 nm, 650 W/m 2 , 16 hours), or when stored in a high humidity chamber (40 °C/75% relative humidity, 4 weeks).

The drug product (Flavonate hydrochloride 200 mg tablets) is also stable. Even under harsh thermal stress conditions (4 week storage at 80 °C), it undergoes very insignificant degradation resulting in hydrolytic cleavage of the ester moiety to give low levels (0.7-1.5%) of the corresponding degradants (see Scheme 3 ). Not more than 0.1% of known and unknown impurities were detected in light and high humidity stressed tablets. Flavonate hydrochloride tablets should be stored at 15-30 °C, and have an expiration date of 3 years following the date of manufacture .

How to use Flavonate HCL

Take this medication by mouth, usually 3-4 times a day or as directed by your doctor. Take with food if stomach upset occurs.

The dosage is based on your medical condition and response to therapy. Your doctor may lower your dose after your symptoms have improved. The length of treatment depends on the cause of the problem.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of side effects may be increased.

Tell your doctor if your condition persists or worsens.

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Flavonate HC1. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Before taking this medicine

You should not use Flavonate if you are allergic to it, or if you have:

blockage in your digestive tract (stomach or intestines);

stomach or intestinal bleeding; or

bladder obstruction or if you are unable to urinate.

To make sure Flavonate is safe for you, tell your doctor if you have:

Flavonate is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Flavonate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Flavonate is not approved for use by anyone younger than 12 years old.

Pharmacology and toxicology

Atropine, a belladonna-alkaloid, is a classic parasympatholytic, which inhibits the action of acetylcholine by competitively blocking muscarine receptors. With local application (in the eye), systemic availability is negligible when applied properly. l-Atropine is the biologically active enantiomer, and is sometimes encountered under the name hyoscyamine.

Atropine reaches concentrations in the fetus equivalent to those in the mother within a few minutes. Although atropine may alter fetal heart rate or inhibit fetal breathing after systemic application, exposure to this drug during pregnancy has not been associated with adverse developmental effects or significant fetotoxicity at recommended therapeutic dosages.

Atropine-like belladonna-alkaloids and their derivatives are parasympathicolytic agents, used in the relief of visceral spasms of the gastrointestinal tract and of colic of the biliary and genitourinary systems; some of these agents are used in the treatment of peptic ulcer. Mydriasis (for diagnostical purpose), respiratory tract disorders, urinary incontinence and Parkinsonism are other indications.

Atropine-like belladonna alkalo >Flavonate , oxybutynin, tolterodine, cyclopentolate, and tropicam > It is also available as a mydriatic, and as a patch for prevention of motion sickness (see Chapter 2.4 ). Homatropine, cyclopentolate, and tropicamide are available as a mydriatic.

Flavonate, oxybutynin, and tolterodine are smooth-muscle relaxants for the urinary tract or bladder.

The quaternary ammonium derivatives of atropine-like belladonna alkaloids have peripheral effects similar to those of atropine; central (CNS) effects are negligible. With systemic application, peripheral effects similar to those of atropine cannot be ruled out. The quaternary ammonium derivatives are mostly used as spasmolytics and for gastrointestinal disorders. Among them, butylscopolamine is the most widely used spasmolytic. Butylscopolamine is poorly absorbed after oral administration. Two cases of eclamptic seizures after the intravenous administration of butylscopolamine in patients with severe pre-eclampsia were reported ( Kobayashi 2002 ).

Others are clidinium, glycopyrronium, methantheline, methylscopolamine, pipenzolate, pipoxolan, propantheline, and trospium chloride.

There are no detailed studies in humans concerning the use of these anticholinergic drugs during pregnancy. The same applies to the antispasmodics denaverin, hymecromon, mebeverine, papaverine, phenamazide, pinaverium, and tiropramide.

Specific embryotoxic effects in humans have not thus far been observed with the use of the belladonna alkaloids and derivatives mentioned, but documented experience is very limited.

Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and as such a prostaglandin synthetase inhibitor, is used as a spasmolytic in the relief of kidney and biliary colic (see Chapter 2.1 ).

Anticholinergics, including atropine, can be used throughout pregnancy when strongly indicated. Functional effects, i.e. on the fetal heart rate, must be considered with systemic use. Butylscopolamine is the spasmolytic of choice in this group of medications. Diagnostic application of anticholinergics in the eye can be undertaken during pregnancy. Diarrhea should not be treated routinely with anticholinergics.

CLINICAL PHARMACOLOGY

Flavonate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes.

57% of the Flavonate HC1 was excreted in the urine within 24 hours.

Flavonate

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QUESTION

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • nausea, vomiting, dry mouth;
  • headache, dizziness, drowsiness;
  • pounding heartbeats or fluttering in your chest;
  • confusion, nervousness; or
  • rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Urispas (Flavonate HCl)

What should I avoid while taking Flavonate (Urispas)?

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Standard Therapies

General measures to treat detrusor overactivity include the use of a voiding diary to understand the actual voiding habits and objectify the occurrence of frequency, urgency, and incontinent episodes. A diary should also include intake/output volumes to monitor for excess intake. A timed voiding regimen should be prescribed to gradually increase the time between voids.

Pelvic floor exercises (Kegel) to inhibit spontaneous bladder contractions are beneficial. This can be combined with biofeedback to provide visual and auditory clues to reinforce the teaching of pelvic floor exercises.

Cholinergic muscarinic receptor antagonists and musculotropic relaxant medications are mainstays in the therapy of overactive bladder. These agents work by blocking the action of acetylcholine , the neurotransmitter that triggers a detrusor contraction. Examples of such drugs include oxybutynin chloride, propantheline bromide , hyoscyamine sulfate, Flavonate hydrochloride , and tolterodine. All of these medications display typical anticholinergic side effects including dry mouth, constipation , and blurred vision.

Tricyclic antidepressants , such as amitriptyline and imipramine , block both central and peripheral cholinergic muscarinic receptors and inhibit the neuronal reuptake of monoamines, in particular norepinephrine and serotonin.

Surgical options to treat overactive bladder are reserved for those who fail to respond to pharmacotherapy. Augmentation cystoplasty is up to 90% effective for those with neurogenic bladders and hyperreflexia. Percutaneous and extradural sacral nerve stimulators have been successfully used to suppress urgency and frequency by modulating the neural input to the bladder.


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