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Rx Item-Ditropan XL 10Mg Tab 100 By J O M Pharma

NDC 50458-0810-01 UPC/GTIN No.3-50458-81001-1 Mfg.Part No.81001BRAND: DITROPAN  NDC: 50458-0810-01,50458081001 UPC: 3-50458-81001-1,350458810011 J/O/M Pharma ServicesOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Ditropan XL 10Mg Tab 100 By J O M Pharma

$763.34$693.55

Item No.:RX396887 NDC No.50458081001 UPC No.:350458810011 NDC No. 50458-0810-01 UPC/GTIN No. 3-50458-81001-1 MPN 81001 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx396887 Ditropan XL 10mg Tab 100 by J/O/M Pharma Item No. 3396887 NDC No. 50458081001 UPC No. 350458810011 Other Name Oxybutynin,Di

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DITROPAN XL- oxybutynin chloride tablet, extended release
Janssen Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

DITROPAN XL� (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

DITROPAN XL� is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

2 DOSAGE AND ADMINISTRATION

DITROPAN XL� must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.



DITROPAN XL� may be administered with or without food.

2.1 Adults
The recommended starting dose of DITROPAN XL� is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.

2.2 Pediatric Patients Aged 6 Years of Age and Older
The recommended starting dose of DITROPAN XL� is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).

3 DOSAGE FORMS AND STRENGTHS

DITROPAN XL� extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:

5 mg: Pale yellow, round, tablet with �5 XL" printed on one side with black ink.

10 mg: Pink, round, tablet with �10 XL" printed on one side with black ink.

15 mg: Gray, round, tablet with �15 XL" printed on one side with black ink.

4 CONTRAINDICATIONS

DITROPAN XL� is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.

DITROPAN XL� is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema.

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema
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.

5.2 Central Nervous System Effects
Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6)]. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL� affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

DITROPAN XL� should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

DITROPAN XL� should be used with caution in patients with Parkinson�s disease due to the risk of aggravation of symptoms.

5.3 Worsening of Symptoms of Myasthenia Gravis
DITROPAN XL� should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.

5.4 Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy
DITROPAN XL� should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.

5.5 Urinary Retention
DITROPAN XL� should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)].

5.6 Gastrointestinal Adverse Reactions
DITROPAN XL� should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4)].

DITROPAN XL� , like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.

DITROPAN XL� should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

As with any other nondeformable material, caution should be used when administering DITROPAN XL� to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety and efficacy of DITROPAN XL� (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Ditropan IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ? 1% of subjects are shown in Table 1.

NDC 50458-0810-01 UPC/GTIN No.3-50458-81001-1 Mfg.Part No.81001
RX ITEM-Ditropan XL 10Mg Tab 100 By J O
NDC 50458-0810-01 UPC/GTIN No.3-50458-81001-1 Mfg.Part No.81001

BRAND: DITROPAN  NDC: 50458-0810-01,50458081001 UPC: 3-50458-81001-1,350458810011 J/O/M Pharma Services
Ditropan XL 10Mg Tab 100 By J O M Pharma
BRAND: DITROPAN NDC: 50458-0810-01,50458081001 UPC: 3-50458-81001-1,350458810011 J/O/M Pharma Services

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
OXYBUTYNIN CHLORIDE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.