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Oxybutynin Chloride

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Overview

What is Oxybutynin Chloride?

Oxybutynin chloride is a white crystalline solid, readily soluble in water and acids, but relatively insoluble in alkalis. Chemically, it is the d,i-(racemic) form of 4-diethyl-amino-2-butynyl phenylcyclohexylglycolate hydrochloride with the following formula:

CHClNO M.W. 393.9

Each tablet for oral administration contains oxybutynin chloride, USP 5 mg.

Inactive ingredients include calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1.



What does Oxybutynin Chloride look like?



What are the available doses of Oxybutynin Chloride?

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What should I talk to my health care provider before I take Oxybutynin Chloride?

Sorry No records found

How should I use Oxybutynin Chloride?

Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Adults:

Children over 5 years of age:


What interacts with Oxybutynin Chloride?

Oxybutynin chloride is contraindicated in patients with untreated angle closure glaucoma and in patients with untreated narrow anterior chamber angles since anticholinergic drugs may aggravate these conditions. It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute hemorrhage.


Oxybutynin chloride is contraindicated in patients who have demonstrated hypersensitivity to the product.



What are the warnings of Oxybutynin Chloride?

Cases of tinnitus and reversible or irreversible hearing impairment have been reported. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used).

Oxybutynin chloride, when administered in the presence of high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with oxybutynin chloride would be inappropriate and possibly harmful.

Oxybutynin chloride may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin.


What are the precautions of Oxybutynin Chloride?

Oxybutynin chloride should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Oxybutynin may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, and prostatic hypertrophy.

Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at dosages up to approximately 400 times the recommended human dosage showed no evidence of carcinogenicity.

Oxybutynin showed no increase in mutagenic activity when tested in , , and test symptoms. Reproduction studies in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility.

Pregnancy

Category B:

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride is administered to a nursing woman.

Pediatric Use

The safety and efficacy of oxybutynin chloride administration have been demonstrated for children 5 years of age and older (see ). However, as there is insufficient clinical data for children under age 5, oxybutynin is not recommended for this age group.


What are the side effects of Oxybutynin Chloride?

Following administration of oxybutynin chloride, the symptoms that can be associated with the use of other anticholinergic drugs may occur:

Cardiovascular:

Dermatologic:

Gastrointestinal/Genitourinary:

Nervous System:

Ophthalmic:

Other:


What should I look out for while using Oxybutynin Chloride?

Oxybutynin chloride is contraindicated in patients with untreated angle closure glaucoma and in patients with untreated narrow anterior chamber angles since anticholinergic drugs may aggravate these conditions. It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute hemorrhage.

Oxybutynin chloride is contraindicated in patients who have demonstrated hypersensitivity to the product.

Oxybutynin chloride, when administered in the presence of high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with oxybutynin chloride would be inappropriate and possibly harmful.

Oxybutynin chloride may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin.


What might happen if I take too much Oxybutynin Chloride?

The symptoms of overdosage with oxybutynin chloride may be any of those seen with other anticholinergic agents. Symptoms may include signs of central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, nausea, vomiting, tachycardia, hypotension or hypertension, respiratory failure, paralysis, or coma.

In the event of an overdose or exaggerated response, treatment should be symptomatic and supportive. Maintain respiration and induce emesis or perform gastric lavage (emesis is contraindicated in precomatose, convulsive, or psychotic state). Activated charcoal may be administered as well as a cathartic. Physostigmine may be considered to reverse symptoms of anticholinergic intoxication.

Hyperpyrexia may be treated symptomatically with ice bags or other cold applications and alcohol sponges.


How should I store and handle Oxybutynin Chloride?

Store below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central PharmacyOxybutynin Chloride Tablets, USP:5 mg — Very pale blue, round, scored tablets.Debossed: PLIVA 456They are supplied by as follows:Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Manufactured by:PLIVA®, Inc.East Hanover, NJ  07936This Product was Repackaged By:State of Florida DOH Central Pharmacy


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Oxybutynin chloride exerts direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. It exhibits only one-fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Oxybutynin relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.

Oxybutynin chloride was well tolerated in patients administered the drug in controlled studies of 30 days duration and in uncontrolled studies in which some of the patients received the drug for two years. Pharmacokinetic information is not currently available.

Non-Clinical Toxicology
Oxybutynin chloride is contraindicated in patients with untreated angle closure glaucoma and in patients with untreated narrow anterior chamber angles since anticholinergic drugs may aggravate these conditions. It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute hemorrhage.

Oxybutynin chloride is contraindicated in patients who have demonstrated hypersensitivity to the product.

Oxybutynin chloride, when administered in the presence of high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with oxybutynin chloride would be inappropriate and possibly harmful.

Oxybutynin chloride may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin.

Oxybutynin chloride should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Oxybutynin may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, and prostatic hypertrophy.

Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.

Following administration of oxybutynin chloride, the symptoms that can be associated with the use of other anticholinergic drugs may occur:

Cardiovascular:

Dermatologic:

Gastrointestinal/Genitourinary:

Nervous System:

Ophthalmic:

Other:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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