Trade Name: Oxybutynin Chloride

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Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 5 mg/1

Storage and handling

OXYBUTYNIN CHLORIDE Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is Cn n n Hn n n NOn n n u2022HCl. The structural formula appears below:n nn
  • Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis.
  • Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.
  • Oxybutynin chloride tablets, USP are for oral administration.
  • Therapeutic Category: Antispasmodic, anticholinergic. n n n n Meets USP Dissolution Test 2.n nn
  • Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride 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 chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.
  • Antimuscarinic activity resides predominately in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in n n n studies.n nn
  • u00a0
  • Absorption
  • Following oral administration of oxybutynin chloride tablets, oxybutynin is rapidly absorbed achieving Cn n n within an hour, following which plasma concentration decreases with an effective half-life of approximately 2 to 3 hours. The absolute bioavailability of oxybutynin is reported to be about 6% (range 1.6 to 10.9%) for the tablets. Wide interindividual variation in pharmacokinetic parameters is evident following oral administration of oxybutynin. n nn
  • The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in n n n . The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; n n n shows the profile for R-oxybutynin. n nn
  • Table 1
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Figure 1
  • u00a0
  • Oxybutynin chloride steady-state pharmacokinetics were also studied in 11 pediatric patients with detrusor overactivity associated with a neurological condition (e.g., spina bifida). These pediatric patients were on oxybutynin chloride tablets with total daily dose ranging from 7.5 mg to 15 mg (0.22 to 0.53 mg/kg). Overall, most patients (86.9%) were taking a total daily oxybutynin chloride dose between 10 mg and 15 mg. Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg twice daily oxybutynin chloride, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in n n n . The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; n n n shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg twice daily. n nn
  • Table 2u00a0u00a0u00a0
  • All Available Data Normalized to an Equivalent of Oxybutynin Chloride Tablets 5 mg BID or TID at Steady State
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • *Reflects Cn n n for pooled data n nn
  • Figure 2
  • Food Effects
  • Data in the literature suggests that oxybutynin solution co-administered with food resulted in a slight delay in absorption and an increase in its bioavailability by 25% (n=18).n n n n
  • Distribution
  • Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of oxybutynin are highly bound (>99%) to plasma proteins. Both enantiomers of desethyloxybutynin are also highly bound (>97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein.
  • Metabolism
  • Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active.
  • Excretion
  • u00a0Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin
  • Oxybutynin chloride was well tolerated in patients administered the drug in controlled studies of 30 daysu2019 duration and in uncontrolled studies in which some of the patients received the drug for 2 years.
  • Oxybutynin chloride tablets, USP 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).
  • Oxybutynin chloride tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.
  • Oxybutynin chloride tablets are u00a0also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
  • Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
  • No data
  • The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.
  • Table 3 u00a0u00a0
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.
  • In addition, the following adverse events were reported by 1 to <5% of patients using oxybutynin chloride (5 to 20 mg/day) in all studies.
  • Infections and Infestationsn- Metabolism and Nutrition Disordersn- Psychiatric Disordersn- Nervous System Disordersn- Eye Disordersn- Cardiac Disordersn- Vascular Disordersn- Respiratory, thoracic and Mediastinal Disordersn- Gastrointestinal Disordersn- Skin and Subcutaneous Tissue Disordersn- Musculoskeletal and Connective Tissue Disordersn- Renal and Urinary Disordersn- General Disorders and Administration Site Conditionsn- Investigationsn- Injury, Poisoning, and Procedural Complications
  • Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with oral oxybutynin chloride: n n n : psychotic disorder, agitation, hallucinations, memory impairment; n n n : convulsions; n n n : cycloplegia, mydriasis, glaucoma; n n n : tachycardia, QT interval prolongation, chest discomfort; n n n : decreased gastrointestinal motility, frequent bowel movements; n n n : rash, decreased sweating; n n n : impotence;u00a0 n n n : Suppression of lactation; n n n hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment; n n n : anorexia; n n n : dysphonia.n nn
  • Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered.
  • Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma.
  • u00a0Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.
  • Adults
  • The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose ofu00a0 2.5 mg two or three times a day is recommended for the frail elderly.
  • Pediatric patients over 5 years of age
  • The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.
  • Oxybutynin Chloride Tablets, USP 5 mg are white, round, biconvex tablets debossed with n005 on one side and bisect on the other side. They are supplied as follows:
  • NDC 66267-642-30 BOTTLES OF 30
  • Pharmacist: Dispense in tight, light-resistant container as defined in the USP.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • u00a0n n n Yong C et al. Effect of Food on the Pharmacokinetics of Oxybutynin in normal subjects. n n n 1991; 8 (Suppl.): S-320. n nn
  • Xenobiotica
  • J. Urol.
  • Drugs & Aging.
  • Manufactured by:
  • Novitium Pharma LLC
  • 70 Lake Drive
  • East Windsor, New Jersey 08520
  • u00a0
  • Revised:
  • LB4018-01
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Oxybutynin Chloride (Oxybutynin Chloride) which is also known as Oxybutynin Chloride and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 5 mg/1.

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