Alphauracil

Alphauracil may be available in the countries listed below.

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Fluorouracil

Fluorouracil is reported as an ingredient of Alphauracil in the following countries:

• Germany

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Acido Borico New.Fa.Dem.

Acido Borico New.Fa.Dem. may be available in the countries listed below.

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Boric Acid

Boric Acid is reported as an ingredient of Acido Borico New.Fa.Dem. in the following countries:

• Italy

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Fenactil

Fenactil may be available in the countries listed below.

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Chlorpromazine

Chlorpromazine hydrochloride (a derivative of Chlorpromazine) is reported as an ingredient of Fenactil in the following countries:

• Poland

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Oxytrol

oxybutynin

Dosage Form: patch
Oxytrol®

Oxybutynin Transdermal System

Revised: January 2011

Rx only

Oxytrol Description

Oxytrol, oxybutynin transdermal system, is designed to deliver oxybutynin continuously and consistently over a 3- to 4-day interval after application to intact skin. Oxytrol is available as a 39 cm2 system containing 36 mg of oxybutynin. Oxytrol has a nominal in vivo delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (interindividual variation in skin permeability is approximately 20%).

Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C22H31NO3. Its structural formula is:

Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water.

Transdermal System Components

Oxytrol is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a cast film of acrylic adhesive containing oxybutynin and triacetin, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix system.

Figure 1: Side and top views of the Oxytrol system.

(Not to scale)

Oxytrol - Clinical Pharmacology

The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction. Oxybutynin thus decreases urinary urgency and the frequency of both incontinence episodes and voluntary urination.

Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies.

Pharmacokinetics

Absorption

Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum. The average daily dose of oxybutynin absorbed from the 39 cm2 Oxytrol system is 3.9 mg. The average (SD) nominal dose, 0.10 (0.02) mg oxybutynin per cm2 surface area, was obtained from analysis of residual oxybutynin content of systems worn over a continuous 4-day period during 303 separate occasions in 76 healthy volunteers. Following application of the first Oxytrol 3.9 mg/day system, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4 ng/mL. Thereafter, steady concentrations are maintained for up to 96 hours. Absorption of oxybutynin is bioequivalent when Oxytrol is applied to the abdomen, buttocks, or hip. Average plasma concentrations measured during a randomized, crossover study of the three recommended application sites in 24 healthy men and women are shown in Figure 2.

Figure 2: Average plasma oxybutynin concentrations (Cp) in 24 healthy male and female volunteers during single-dose application of Oxytrol 3.9 mg/day to the abdomen, buttock, and hip (System removal at 96 hours).

Steady-state conditions are reached during the second Oxytrol application. Average steady-state plasma concentrations were 3.1 ng/mL for oxybutynin and 3.8 ng/mL for N-desethyloxybutynin (Figure 3). Table 1 provides a summary of pharmacokinetic parameters of oxybutynin in healthy volunteers after single and multiple applications of Oxytrol.

Figure 3: Average (SEM) steady-state oxybutynin and N-desethyloxybutynin plasma concentrations (Cp) measured in 13 healthy volunteers following the second transdermal system application in a multiple-dose, randomized, crossover study.

Table 1: Mean (SD) oxybutynin pharmacokinetic parameters from single and multiple dose studies in healthy men and women volunteers after application of Oxytrol on the abdomen.

Dosing	Oxybutynin
	Cmax (SD) (ng/mL)	Tmax1 (hr)	Cavg (SD) (ng/mL)	AUC (SD) (ng/mLxh)
Single	3.0 (0.8)	48	—	245 (59) 2
	3.4 (1.1)	36	—	279 (99) 2
Multiple	6.6 (2.4)	10	4.2 (1.1)	408 (108) 3
	4.2 (1.0)	28	3.1 (0.7)	259 (57) 4

1 Tmax given as median

2 AUCinf

3 AUC0-96

4 AUC0-84 Distribution

Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution was estimated to be 193 L after intravenous administration of 5 mg oxybutynin chloride.

Metabolism

Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall. Metabolites include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, which is pharmacologically active.

After oral administration of oxybutynin, pre-systemic first-pass metabolism results in an oral bioavailability of approximately 6% and higher plasma concentration of the N-desethyl metabolite compared to oxybutynin (see Figure 4). The plasma concentration AUC ratio of N-desethyl metabolite to parent compound following a single 5 mg oral dose of oxybutynin chloride was 11.9:1.

Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite (see Figure 4). Only small amounts of CYP3A4 are found in skin, limiting pre-systemic metabolism during transdermal absorption. The resulting plasma concentration AUC ratio of N-desethyl metabolite to parent compound following multiple Oxytrol applications was 1.3:1.

Figure 4: Average plasma concentrations (Cp) measured after a single, 96-hour application of the Oxytrol 3.9 mg/day system (AUCinf/96) and a single, 5 mg, oral immediate-release dose of oxybutynin chloride (AUCinf/8) in 16 healthy male and female volunteers.

Following intravenous administration, the elimination half-life of oxybutynin is approximately 2 hours. Following removal of Oxytrol, plasma concentrations of oxybutynin and N-desethyloxybutynin decline with an apparent half-life of approximately 7 to 8 hours.

Excretion

Oxybutynin 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 N-desethyloxybutynin.

Special Populations

Geriatric: The pharmacokinetics of oxybutynin and N-desethyloxybutynin were similar in all patients studied.

Pediatric: The pharmacokinetics of oxybutynin and N-desethyloxybutynin were not evaluated in individuals younger than 18 years of age. See PRECAUTIONS: Pediatric Use. 

Gender: There were no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following application of Oxytrol.

Race: Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Oxytrol. Japanese volunteers demonstrated a somewhat lower metabolism of oxybutynin to N-desethyloxybutynin compared to Caucasian volunteers.

Renal Insufficiency: There is no experience with the use of Oxytrol in patients with renal insufficiency.

Hepatic Insufficiency: There is no experience with the use of Oxytrol in patients with hepatic insufficiency.

Drug-Drug Interactions: See PRECAUTIONS: Drug Interactions.

Adhesion

Adhesion was periodically evaluated during the Phase 3 studies. Of the 4,746 Oxytrol evaluations in the Phase 3 trials, 20 (0.4%) were observed at clinic visits to have become completely detached and 35 (0.7%) became partially detached during routine clinic use. Similar to the pharmacokinetic studies, > 98% of the systems evaluated in the Phase 3 studies were assessed as being ≥ 75% attached and thus would be expected to perform as anticipated.

Clinical Studies

The efficacy and safety of Oxytrol were evaluated in patients with urge urinary incontinence in two Phase 3 controlled studies and one open-label extension. Study 1 was a Phase 3, placebo controlled study, comparing the safety and efficacy of Oxytrol at dose levels of 1.3, 2.6, and 3.9 mg/day to placebo in 520 patients. Open-label treatment was available for patients completing the study. Study 2 was a Phase 3 study, comparing the safety and efficacy of Oxytrol 3.9 mg/day versus active and placebo controls in 361 patients.

Study 1 was a randomized, double-blind, placebo-controlled, parallel group study of three dose levels of Oxytrol conducted in 520 patients. The 12-week double-blind treatment included Oxytrol doses of 1.3, 2.6, and 3.9 mg/day with matching placebo. An open-label, dose titration treatment extension allowed continued treatment for up to an additional 40 weeks for patients completing the double-blind period. The majority of patients were Caucasian (91%) and female (92%) with a mean age of 61 years (range, 20 to 88 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge), urge incontinence episodes of ≥ 10 per week, and ≥ 8 micturitions per day. The patient’s medical history and a urinary diary during the treatment-free baseline period confirmed the diagnosis of urge incontinence. Approximately 80% of patients had no prior pharmacological treatment for incontinence. Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume between placebo and active treatment groups are summarized in Table 2.

Table 2: Mean and median change from baseline to end of treatment (Week 12 or last observation carried forward) in incontinence episodes, urinary frequency, and urinary void volume in patients treated with Oxytrol 3.9 mg/day or placebo for 12 weeks (Study 1).

Parameter	Placebo (N = 127)		Oxytrol 3.9 mg/day (N = 120)
	Mean (SD)	Median	Mean (SD)	Median
Weekly Incontinence Episodes
Baseline	37.7 (24.0)	30	34.3 (18.2)	31
Reduction	19.2 (21.4)	15	21.0 (17.1)	19
p value vs. placebo	—		0.0265*
Daily Urinary Frequency
Baseline	12.3 (3.5)	11	11.8 (3.1)	11
Reduction	1.6 (3.0)	1	2.2 (2.5)	2
p value vs. placebo	—		0.0313*
Urinary Void Volume (mL)
Baseline	175.9 (69.5)	166.5	171.6 (65.1)	168
Increase	10.5 (56.9)	5.5	31.6 (65.6)	26
p value vs. placebo	—		0.0009**

*Comparison significant if p < 0.05

**Comparison significant if p ≤ 0.0167

Study 2 was a randomized, double-blind, double-dummy, study of Oxytrol 3.9 mg/day versus active and placebo controls conducted in 361 patients. The 12-week double-blind treatment included an Oxytrol dose of 3.9 mg/day, an active comparator, and placebo. The majority of patients were Caucasian (95%) and female (93%) with a mean age of 64 years (range, 18 to 89 years). Entry criteria required that all patients have urge or mixed incontinence (with a predominance of urge) and had achieved a beneficial response from the anticholinergic treatment they were using at the time of study entry. The average duration of prior pharmacological treatment was greater than 2 years. The patient’s medical history and a urinary diary during the treatment-free baseline period confirmed the diagnosis of urge incontinence. Reductions in daily incontinence episodes, urinary frequency, and urinary void volume between placebo and active treatment groups are summarized in Table 3.

Table 3: Mean and median change from baseline to end of treatment (Week 12 or last observation carried forward) in incontinence episodes, urinary frequency, and urinary void volume in patients treated with Oxytrol 3.9 mg/day or placebo for 12 weeks (Study 2).

Parameter	Placebo (N = 117)		Oxytrol 3.9 mg/day (N = 121)
	Mean (SD)	Median	Mean (SD)	Median
Daily Incontinence Episodes
Baseline	5.0 (3.2)	4	4.7 (2.9)	4
Reduction	2.1 (3.0)	2	2.9 (3.0)	3
p value vs. placebo	—		0.0137*
Daily Urinary Frequency
Baseline	12.3 (3.3)	12	12.4 (2.9)	12
Reduction	1.4 (2.7)	1	1.9 (2.7)	2
p value vs. placebo	—		0.1010*
Urinary Void Volume (mL)
Baseline	175.0 (68.0)	171.0	164.8 (62.3)	160
Increase	9.3 (63.1)	5.5	32.0 (55.2)	24
p value vs. placebo	—		0.0010*

*Comparison significant if p < 0.05

Indications and Usage for Oxytrol

Oxytrol is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Contraindications

Oxytrol is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxytrol is also contraindicated in patients who have demonstrated hypersensitivity to oxybutynin or other components of the product.

Warnings

Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, oxybutynin-containing products should be discontinued and appropriate therapy promptly provided.

Precautions

General

Oxytrol should be used with caution in patients with hepatic or renal impairment.

Urinary Retention: Oxytrol should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS).

Gastrointestinal Disorders: Oxytrol should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS).

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

Information for Patients

Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment. Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), dizziness or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.

Patients should be informed that angioedema has been reported with oral oxybutynin use. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience symptoms consistent with angioedema.

Oxytrol should be applied to dry, intact skin on the abdomen, hip, or buttock. A new application site should be selected with each new system to avoid re-application to the same site within 7 days. Details on use of the system are explained in the patient information leaflet that should be dispensed with the product.

Drug Interactions

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents that produce dry mouth, constipation, somnolence, and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. Pharmacokinetic studies have not been performed with patients concomitantly receiving cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g. ketoconazole, itraconazole, and miconazole) or macrolide antibiotics (e.g. erythromycin and clarithromycin). No specific drug-drug interaction studies have been performed with Oxytrol.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at dosages of oxybutynin chloride of 20, 80 and 160 mg/kg showed no evidence of carcinogenicity. These doses are approximately 6, 25 and 50 times the maximum exposure in humans taking an oral dose based on body surface area.

Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems. Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility or harm to the animal fetus. Subcutaneous administration to rats at doses up to 25 mg/kg (approximately 50 times the human exposure based on surface area) and to rabbits at doses up to 0.4 mg/kg (approximately 1 times the human exposure) revealed no evidence of harm to the fetus due to oxybutynin chloride. The safety of Oxytrol administration to women who are or who may become pregnant has not been established. Therefore, Oxytrol should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

Nursing Mothers

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

Pediatric Use

The safety and efficacy of Oxytrol in pediatric patients have not been established.

Geriatric Use

Of the total number of patients in the clinical studies of Oxytrol, 49% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations: Geriatric).

Adverse Reactions

The safety of Oxytrol was evaluated in a total of 417 patients who participated in two Phase 3 clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in Phase 1 and Phase 2 trials. In the two pivotal studies, a total of 246 patients received Oxytrol during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received Oxytrol for at least 24 weeks and at least 36 weeks, respectively.

No deaths were reported during treatment. No serious adverse events related to treatment were reported.

Adverse events reported in the pivotal trials are summarized in Tables 4 and 5 below.

Table 4: Number (%) of adverse events occurring in ≥ 2% of Oxytrol-treated patients and greater in Oxytrol group than in placebo group (Study 1).

Adverse Event*	Placebo (N = 132)		Oxytrol (3.9 mg/day) (N=125)
	N	%	N	%
Application site pruritus	8	6.1%	21	16.8%
Dry mouth	11	8.3%	12	9.6%
Application site erythema	3	2.3%	7	5.6%
Application site vesicles	0	0.0%	4	3.2%
Diarrhea	3	2.3%	4	3.2%
Dysuria	0	0.0%	3	2.4%
*includes adverse events judged by the investigator as possibly, probably or definitely treatment-related.

 

Table 5: Number (%) of adverse events occurring in ≥ 2% of Oxytrol-treated patients and greater in Oxytrol group than in placebo group (Study 2).

Adverse Event*	Placebo (N = 117)		Oxytrol (3.9 mg/day) (N = 121)
	N	%	N	%
Application site pruritus	5	4.3%	17	14.0%
Application site erythema	2	1.7%	10	8.3%
Dry mouth	2	1.7%	5	4.1%
Constipation	0	0.0%	4	3.3%
Application site rash	1	0.9%	4	3.3%
Application site macules	0	0.0%	3	2.5%
Abnormal vision	0	0.0%	3	2.5%
*includes adverse events judged by the investigator as possibly, probably or definitely treatment-related.

Other adverse events reported by > 1% of Oxytrol-treated patients, and judged by the investigator to be possibly, probably or definitely related to treatment include: abdominal pain, nausea, flatulence, fatigue, somnolence, headache, flushing, rash, application site burning and back pain.

Most treatment-related adverse events were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of Oxytrol-treated patients in Study 1 and by 5.0% of Oxytrol-treated patients in Study 2.

Treatment-related adverse events that resulted in discontinuation were reported by 11.2% of Oxytrol-treated patients in Study 1 and 10.7% of Oxytrol-treated patients in Study 2. Most of these were secondary to application site reaction. In the two pivotal studies, no patient discontinued Oxytrol treatment due to dry mouth.

In the open-label extension, the most common treatment-related adverse events were: application site pruritus, application site erythema and dry mouth.

Post Marketing Surveillance

The following event has been reported in association with Oxytrol use in clinical practice: dizziness. Because spontaneously reported events are from worldwide post marketing experiences, the frequency of events and the role of Oxytrol in their causation cannot be reliably determined.

Overdosage

Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in 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 recovered fully with symptomatic treatment.

Oxytrol Dosage and Administration

Oxytrol should be applied to dry, intact skin on the abdomen, hip, or buttock. A new application site should be selected with each new system to avoid re-application to the same site within 7 days.

The dose of Oxytrol is one 3.9 mg/day system applied twice weekly (every 3 to 4 days).

How is Oxytrol Supplied

Oxytrol 3.9 mg/day (oxybutynin transdermal system). Each 39 cm2 system imprinted with Oxytrol 3.9 mg/day contains 36 mg oxybutynin for nominal delivery of 3.9 mg oxybutynin per day when dosed in a twice weekly regimen.

NDC 52544-920-08 Patient Calendar Box of 8 Systems

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture and humidity. Do not store outside the sealed pouch. Apply immediately after removal from the protective pouch. Discard used Oxytrol in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.

Rx only

A subsidiary of Watson Pharmaceuticals, Inc.

Corona, CA 92880 USA

Revised: January 2011

U.S. Patent Nos. 5,601,839; 5,834,010; and 7,179,483

PATIENT INFORMATION

Information for the Patient

Oxytrol® Oxybutynin Transdermal System

Read this information carefully before you begin treatment. Read the information whenever you get more medicine, there may be something new. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Oxytrol, ask your doctor. Only your doctor can determine if Oxytrol is right for you.

What is Oxytrol?

Oxytrol is a transdermal system (skin patch) to treat overactive bladder. It delivers the active ingredient, oxybutynin, through your skin and into your bloodstream. Overactive bladder makes it hard to control when you urinate (pass water). Overactive bladder can make you urinate more often (increased frequency) or make you feel the need to urinate often (urgency). Overactive bladder can also lead to accidental urine loss (leaking or wetting oneself).

The active ingredient in Oxytrol, oxybutynin, is dissolved in the thin layer of adhesive that sticks the patch to your skin. Oxytrol delivers the medicine slowly and constantly through your skin and into your bloodstream for the 3 or 4 days that you wear the patch. Oxytrol contains the same active ingredient as oxybutynin tablets and syrup.

Who should not use Oxytrol?

Do not use Oxytrol if you have the following medical conditions:

• Urinary retention. Your bladder does not empty or does not empty completely when you urinate.


• Gastric retention. Your stomach empties slowly or incompletely after a meal.


• Uncontrolled narrow-angle glaucoma (high pressure in your eye). Tell your doctor if you have glaucoma or a family history of glaucoma.


• Pregnancy or breastfeeding. Tell your doctor if you are pregnant or breastfeeding. Oxytrol may not be right for you.


• Allergy to oxybutynin or the inactive ingredients in Oxytrol. If you need to know the inactive ingredients, ask your doctor or pharmacist. If you have allergies to medical tape products or other skin patches, tell your doctor.

If you have certain other medical conditions, use Oxytrol with caution. Tell your doctor about all your medical conditions, especially if you have any of the following:

• Liver disease


• Kidney disease


• Bladder obstruction (blockage)


• Gastrointestinal obstruction (blockage in the digestive system)


• Ulcerative colitis (inflamed bowels)


• Myasthenia gravis (nerve weakness)


• Gastric reflux disease or esophagitis (inflamed esophagus, the tube between your mouth and stomach)

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and supplements. Some of them may cause problems if you take Oxytrol. Also, Oxytrol may affect how some of them work.

What should I avoid while using Oxytrol?

Do not expose the patch to sunlight. Therefore, wear it under clothing.

What are the possible side effects of Oxytrol?

You may see mild redness at the site when a patch is removed. This redness should disappear within several hours after removing the patch. If uncomfortable irritation or excessive itchiness continues, tell your doctor.

Oxybutynin may cause sleepiness or blurred vision, so be careful when driving or operating machinery. In addition, sleepiness may be increased by drinking alcohol (beer, wine or hard liquor).

Since oxybutynin treatment may decrease sweating, you may overheat or have fever or heat stroke if you are in warm or hot temperatures.

The most common side effects of Oxytrol are skin reactions where the patch is put on. These include itching and redness. Other side effects include dry mouth, constipation, abnormal vision, headache and dizziness. If you take other medicines that cause dry mouth, constipation, sleepiness or dizziness, Oxytrol can increase those effects.

These are not all the side effects of Oxytrol. For a complete list, ask your doctor or pharmacist.

How should I use Oxytrol?

Put on a new patch of Oxytrol 2 times a week (every 3 to 4 days) according to your doctor’s instructions. Wear the patch all the time until it is time to apply a new one. Wear only 1 patch of Oxytrol at a time. Try to change the patch on the same 2 days each week. Your package of Oxytrol has a calendar checklist printed on the back to help you remember your schedule. Mark the schedule you plan to follow. Always change Oxytrol on the 2 days of the week you mark on the calendar.

Put the patch on a clean, dry, and smooth (fold-free) area of skin on your abdomen (stomach area), hips or buttocks (as shown in the picture). Avoid your waistline area, since tight clothing may rub against the patch. The areas you choose should not be oily, damaged (cut or scraped), irritated (rashes) or have any other skin problems. Do not put Oxytrol on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin.

When you put on a new patch, use a different area of skin from the most recent patch site. You may find it useful to change the site from one side of your body to the other. Do not use the same area for the patch for at least 1 week. You may wish to try different locations when using Oxytrol to find the locations that are most comfortable for you and where clothing will not rub against it.

Each patch is sealed in its own protective pouch. When you are ready to put on the Oxytrol patch, tear open the pouch and remove the patch. Apply the patch to your skin right away. Do not keep or store the patch outside the sealed pouch.

The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner. Remove the first piece of the protective liner and place the patch, adhesive face down, firmly onto the skin.

Bend the patch in half and gently roll the remaining part onto your skin using the tips of your fingers. As you roll the patch in place, the second piece of the protective liner should move off the patch. Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. When putting on the patch, avoid touching the sticky adhesive side. Touching the adhesive may cause the patch to fall off early. Throw away the protective liners.

Contact with water when you are bathing, swimming, showering or exercising will not change the way that Oxytrol works. However, try to avoid rubbing the patch area during these activities.

If the patch partly or completely falls off, press it back in place and continue to follow your application schedule. If the patch does not stay on, throw it away. You should then put on a new patch in a different area, but continue to follow your original application schedule. If you forget to change your patch after 3 or 4 days, remove the old patch, put on a new patch in a different area and continue to follow your original application schedule.

When changing Oxytrol, remove the old patch slowly and carefully to avoid damaging the skin. Once off, fold the patch in half with the sticky sides together. Since the patch will still contain some oxybutynin, throw it away so that it cannot be accidentally worn or swallowed by another person, especially a child, or a pet.

Gently washing the application site with warm water and a mild soap should remove any adhesive that stays on your skin after removing the patch. A small amount of baby oil may also be used to remove any excess residue. Rings of adhesive that become dirty may require a medical adhesive removal pad that you can get from your pharmacist. Alcohol or other dissolving liquids (nail polish remover or other solvents) may cause skin irritation and should not be used.

Store at room temperature, 25°C (77°F). Temporary storage between 15 and 30°C (59 to 86°F) is also permitted. Keep Oxytrol and all medications in a safe, secure place and out of the reach of children.

General advice about Oxytrol

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not give Oxytrol to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Oxytrol. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Oxytrol that is written for health professionals. You can get more information about Oxytrol from the product information department at 1-888-OXY-TROL (1-888-699-8765) or by selecting patient information at the Oxytrol Website located at www.Oxytrol.com.

A subsidiary of Watson Pharmaceuticals, Inc.

Corona, CA 92880 USA

Revised: January 2011

©2001 Watson Pharma, Inc.

PRINCIPAL DISPLAY PANEL

Oxytrol® Oxybutynin Transdermal System

3.9 mg/day carton x 8 transdermal systems (outside and inside views below)

NDC 52544-920-08

Oxytrol  oxybutynin  patch

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-920 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN (OXYBUTYNIN) OXYBUTYNIN 3.9 mg  in 1 d

Inactive Ingredients Ingredient Name Strength TRIACETIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-920-08 8 POUCH In 1 BOX contains a POUCH (52544-920-54) 1 52544-920-54 1 PATCH In 1 POUCH This package is contained within the BOX (

Hidrocortisona Northia Medigroup

Hidrocortisona Northia Medigroup may be available in the countries listed below.

Ingredient matches for Hidrocortisona Northia Medigroup

Hydrocortisone

Hydrocortisone is reported as an ingredient of Hidrocortisona Northia Medigroup in the following countries:

• Peru

International Drug Name Search

Kessar

Kessar may be available in the countries listed below.

Ingredient matches for Kessar

Tamoxifen

Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Kessar in the following countries:

• Chile


• Greece


• Italy


• Philippines


• South Africa

International Drug Name Search

Miroptic

Miroptic may be available in the countries listed below.

Ingredient matches for Miroptic

Chloramphenicol

Chloramphenicol is reported as an ingredient of Miroptic in the following countries:

• Colombia


• Peru

International Drug Name Search

Fermid

Fermid may be available in the countries listed below.

Ingredient matches for Fermid

Clomifene

Clomifene citrate (a derivative of Clomifene) is reported as an ingredient of Fermid in the following countries:

• Bangladesh

International Drug Name Search

Will long

Will long may be available in the countries listed below.

Ingredient matches for Will long

Nitroglycerin

Nitroglycerin is reported as an ingredient of Will long in the following countries:

• Luxembourg

International Drug Name Search

Simvastatina Kern Pharma

Simvastatina Kern Pharma may be available in the countries listed below.

Ingredient matches for Simvastatina Kern Pharma

Simvastatin

Simvastatin is reported as an ingredient of Simvastatina Kern Pharma in the following countries:

• Spain

International Drug Name Search

Gynoplix

Gynoplix may be available in the countries listed below.

Ingredient matches for Gynoplix

Metronidazole

Metronidazole is reported as an ingredient of Gynoplix in the following countries:

• Algeria


• Hong Kong

International Drug Name Search

Dermipred

Dermipred may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Dermipred

Prednisolone

Prednisolone is reported as an ingredient of Dermipred in the following countries:

• France

International Drug Name Search

Aspirina Fecofar

Aspirina Fecofar may be available in the countries listed below.

Ingredient matches for Aspirina Fecofar

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Aspirina Fecofar in the following countries:

• Argentina

International Drug Name Search

Frilans

Frilans may be available in the countries listed below.

Ingredient matches for Frilans

Lansoprazole

Lansoprazole is reported as an ingredient of Frilans in the following countries:

• Italy

International Drug Name Search

Idiopathic Immune Hepatitis Medications

There are currently no drugs listed for "Idiopathic Immune Hepatitis". See Autoimmune Hepatitis.

Drug List:

Cefroxadine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J01DB11

CAS registry number (Chemical Abstracts Service)

0051762-05-1

Chemical Formula

C16-H19-N3-O5-S

Molecular Weight

365

Therapeutic Category

Antibacterial: Cephalosporin

Chemical Name

5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[(amino-1,4-cyclohexadien-1-ylacetyl)amino]-3-methoxy-8-oxo-, [6R-[6α,7ß(R*)]]-

Foreign Names

• Cefroxadinum (Latin)
• Cefroxadin (German)
• Céfroxadine (French)
• Cefroxadina (Spanish)

Generic Names

• Cefroxadine (OS: USAN, DCIT)
• Céfroxadine (OS: DCF)
• CGP 9000 (IS)
• Cefroxadine (PH: JP XIV)

Brand Names

• Cefthan
  Medisa Shinyaku, Japan



• Kanzacin
  Choseido Pharmaceutical, Japan



• Oraspor
  Alfresa Pharma Corporation, Japan

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Propionylpromazine

In some countries, this medicine may only be approved for veterinary use.

CAS registry number (Chemical Abstracts Service)

0003568-24-9

Chemical Formula

C20-H24-N2-O-S

Molecular Weight

340

Therapeutic Categories

Sedative agent

Neuroleptic

Agent for premedication

Chemical Names

1-[10-[3-(Dimethylamino)propyl]-10H-phenothiazin-2-yl]-1-propanone

1-[10-[3-Dimethylaminopropyl]phenothiazin-2-yl]propan-1-on (IUPAC)

10-(3-dimethylaminopropyl)-2-propionylphenothiazine

1-Propanone, 1-(10-(3-(dimethylamino)propyl)-10H-phenothiazin-2-yl)- (9CI)

1-Propanone, 1-(10-(3-(dimethylamino)propyl)phenothiazin-2-yl)-

2-Propionylpromazine

3-propionyl-10-(3'-dimethylaminopropyl)phenothiazine

3-propionyl-10-(gamma-dimethylaminopropyl)phenothiazine

Foreign Names

• Propionylpromazin (German)
• Dipropimazine (French)
• Propionilpromazina (Spanish)

Generic Names

• Dipropimazine (OS: DCF)
• 1497CB (IS)
• BAY 188 (IS)
• Bayer 188 (IS)
• EINECS 222-662-1 (IS)
• Propiopromazine (IS)

Brand Name

• Tranvet (veterinary use)
  Fort Dodge Animale Health, United States

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym

Click for further information on drug naming conventions and International Nonproprietary Names.

Ivanes

Ivanes may be available in the countries listed below.

Ingredient matches for Ivanes

Ketamine

Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Ivanes in the following countries:

• Indonesia

International Drug Name Search

Visofid

Visofid may be available in the countries listed below.

Ingredient matches for Visofid

Cyproterone

Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Visofid in the following countries:

• Italy

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Visofid in the following countries:

• Italy

International Drug Name Search

Antiverrugas Isdin

Antiverrugas Isdin may be available in the countries listed below.

Ingredient matches for Antiverrugas Isdin

Lactic Acid

Lactic Acid is reported as an ingredient of Antiverrugas Isdin in the following countries:

• Spain

Salicylic Acid

Salicylic Acid is reported as an ingredient of Antiverrugas Isdin in the following countries:

• Spain

International Drug Name Search

Metoprolol Stada

Metoprolol Stada may be available in the countries listed below.

Ingredient matches for Metoprolol Stada

Metoprolol

Metoprolol is reported as an ingredient of Metoprolol Stada in the following countries:

• Lithuania

Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprolol Stada in the following countries:

• Austria


• Estonia


• Germany


• Latvia


• Serbia

International Drug Name Search

E Z EX

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for E Z EX

Tiabendazole

Tiabendazole is reported as an ingredient of E Z EX in the following countries:

• United States

International Drug Name Search

Metformin Germania

Metformin Germania may be available in the countries listed below.

Ingredient matches for Metformin Germania

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformin Germania in the following countries:

• Austria

International Drug Name Search

Lapol

Lapol may be available in the countries listed below.

Ingredient matches for Lapol

Lansoprazole

Lansoprazole is reported as an ingredient of Lapol in the following countries:

• Portugal

International Drug Name Search

Catapres-TTS

See also: Generic Catapres

Catapres-TTS is a brand name of clonidine, approved by the FDA in the following formulation(s):

CATAPRES-TTS-1 (clonidine - film, extended release; transdermal)

• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: October 10, 1984
  
  Strength(s): 0.1MG/24HR ^[AB]


• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: October 10, 1984
  
  Strength(s): 0.2MG/24HR ^[AB]


• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: October 10, 1984
  
  Strength(s): 0.3MG/24HR ^[RLD][AB]

Has a generic version of Catapres-TTS been approved?

Yes. The following products are equivalent to Catapres-TTS:

clonidine film, extended release; transdermal

• 
  Manufacturer: AVEVA
  
  Approval date: August 18, 2009
  
  Strength(s): 0.1MG/24HR ^[AB], 0.2MG/24HR ^[AB], 0.3MG/24HR ^[AB]


• 
  Manufacturer: BARR
  
  Approval date: August 20, 2010
  
  Strength(s): 0.1MG/24HR ^[AB], 0.2MG/24HR ^[AB], 0.3MG/24HR ^[AB]


• 
  Manufacturer: MYLAN TECHNOLOGIES
  
  Approval date: July 16, 2010
  
  Strength(s): 0.1MG/24HR ^[AB], 0.2MG/24HR ^[AB], 0.3MG/24HR ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Catapres-TTS. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Catapres-TTS.

See also...

• Catapres-TTS Patches Consumer Information (Wolters Kluwer)
• Catapres-TTS-1 transdermal Consumer Information (Cerner Multum)
• Catapres-TTS-2 transdermal Consumer Information (Cerner Multum)
• Catapres-TTS-3 transdermal Consumer Information (Cerner Multum)
• Catapres-TTS-1 Advanced Consumer Information (Micromedex)
• Catapres-TTS-1 Transdermal Advanced Consumer Information (Micromedex)
• Catapres-TTS-2 Advanced Consumer Information (Micromedex)
• Catapres-TTS-2 Transdermal Advanced Consumer Information (Micromedex)
• Catapres-TTS-3 Advanced Consumer Information (Micromedex)
• Catapres-TTS-3 Transdermal Advanced Consumer Information (Micromedex)
• Clonidine Consumer Information (Drugs.com)
• Clonidine Consumer Information (Wolters Kluwer)
• Clonidine Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Clonidine Patches Consumer Information (Wolters Kluwer)
• Clonidine Tablets Consumer Information (Wolters Kluwer)
• Clonidine Consumer Information (Cerner Multum)
• Clonidine transdermal Consumer Information (Cerner Multum)
• Clonidine Epidural Advanced Consumer Information (Micromedex)
• Clonidine Oral, Transdermal Advanced Consumer Information (Micromedex)
• Clonidine Transdermal Advanced Consumer Information (Micromedex)
• Clonidine AHFS DI Monographs (ASHP)

Inflaforte

Inflaforte may be available in the countries listed below.

Ingredient matches for Inflaforte

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Inflaforte in the following countries:

• Greece

International Drug Name Search

Rhonepride

Rhonepride may be available in the countries listed below.

Ingredient matches for Rhonepride

Cisapride

Cisapride is reported as an ingredient of Rhonepride in the following countries:

• India

International Drug Name Search

Meclopram

Meclopram may be available in the countries listed below.

Ingredient matches for Meclopram

Metoclopramide

Metoclopramide is reported as an ingredient of Meclopram in the following countries:

• Ethiopia

International Drug Name Search

Duracan

Duracan may be available in the countries listed below.

Ingredient matches for Duracan

Fluconazole

Fluconazole is reported as an ingredient of Duracan in the following countries:

• Oman

International Drug Name Search

Béclométhasone Teva

Béclométhasone Teva may be available in the countries listed below.

Ingredient matches for Béclométhasone Teva

Beclometasone

Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Béclométhasone Teva in the following countries:

• France

International Drug Name Search

Tetracyclin-Stricker

Tetracyclin-Stricker may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tetracyclin-Stricker

Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetracyclin-Stricker in the following countries:

• Switzerland

International Drug Name Search

Sefaktil

Sefaktil may be available in the countries listed below.

Ingredient matches for Sefaktil

Cefuroxime

Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Sefaktil in the following countries:

• Turkey

International Drug Name Search

Triofan Schnupfen ohne Konservierungsmittel

Triofan Schnupfen ohne Konservierungsmittel may be available in the countries listed below.

Ingredient matches for Triofan Schnupfen ohne Konservierungsmittel

Carbocisteine

Carbocisteine is reported as an ingredient of Triofan Schnupfen ohne Konservierungsmittel in the following countries:

• Switzerland

Xylometazoline

Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Triofan Schnupfen ohne Konservierungsmittel in the following countries:

• Switzerland

International Drug Name Search

Sultanol

Sultanol may be available in the countries listed below.

Ingredient matches for Sultanol

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Sultanol in the following countries:

• Austria


• Germany


• Japan

International Drug Name Search

Candio-Hermal Plus

Candio-Hermal Plus may be available in the countries listed below.

Ingredient matches for Candio-Hermal Plus

Fluprednidene

Fluprednidene 21-acetate (a derivative of Fluprednidene) is reported as an ingredient of Candio-Hermal Plus in the following countries:

• Germany

International Drug Name Search

Remirta

Remirta may be available in the countries listed below.

Ingredient matches for Remirta

Mirtazapine

Mirtazapine is reported as an ingredient of Remirta in the following countries:

• Bulgaria


• Georgia


• Malta


• Poland

International Drug Name Search

Laaven

Laaven may be available in the countries listed below.

Ingredient matches for Laaven

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Laaven in the following countries:

• Croatia (Hrvatska)

Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Laaven in the following countries:

• Croatia (Hrvatska)

International Drug Name Search

Gabapentine Winthrop

Gabapentine Winthrop may be available in the countries listed below.

Ingredient matches for Gabapentine Winthrop

Gabapentin

Gabapentin is reported as an ingredient of Gabapentine Winthrop in the following countries:

• France

International Drug Name Search

Depakote

Generic Name: divalproex sodium (Oral route)

dye-VAL-proe-ex SOE-dee-um

Oral route(Tablet, Enteric Coated;Tablet, Extended Release;Capsule, Delayed Release)

Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproic acid and its derivatives. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity. Monitor patients closely, and perform liver function tests prior to therapy and at frequent intervals thereafter. Valproate can produce teratogenic effects such as neural tube defects (eg, spina bifida). Accordingly, the use of divalproex sodium in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. If pancreatitis is diagnosed, valproate should ordinarily be discontinued .

Commonly used brand name(s)

In the U.S.

• Depakote


• Depakote DR


• Depakote ER


• Depakote Sprinkles

In Canada

• Alti-Valproic

Available Dosage Forms:

• Tablet, Extended Release


• Tablet, Enteric Coated


• Tablet, Delayed Release


• Capsule, Delayed Release


• Syrup

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Valproic Acid

Chemical Class: Valproic Acid

Uses For Depakote

Divalproex sodium is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

Divalproex sodium is also used to treat the manic phase of bipolar disorder (manic-depressive illness), and helps prevent migraine headaches.

This medicine is available only with your doctor's prescription.

Before Using Depakote

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of divalproex sodium in children. However, safety and efficacy have not been established in children below 10 years of age. Because of divalproex sodium's toxicity, use in children below 2 years of age requires extreme caution.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of divalproex sodium in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving divalproex sodium.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doripenem


• Ertapenem


• Imipenem


• Ketorolac


• Lamotrigine


• Meropenem


• Naproxen


• Primidone


• Vorinostat


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acyclovir


• Aspirin


• Betamipron


• Carbamazepine


• Cholestyramine


• Clomipramine


• Erythromycin


• Ethosuximide


• Felbamate


• Fosphenytoin


• Ginkgo


• Lopinavir


• Lorazepam


• Mefloquine


• Nimodipine


• Nortriptyline


• Olanzapine


• Oxcarbazepine


• Panipenem


• Phenobarbital


• Phenytoin


• Rifampin


• Rifapentine


• Risperidone


• Ritonavir


• Rufinamide


• Topiramate


• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease, severe or


• Congenital metabolism disorders (born with a disease that affects metabolism) or


• Mental retardation with severe seizure disorders—Use with caution. May increase risk for more serious side effects.

• Liver disease or


• Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.

• Pancreatitis (inflammation of the pancreas) or


• Thrombocytopenia (low platelet count)—May make these conditions worse.

Proper Use of divalproex sodium

This section provides information on the proper use of a number of products that contain divalproex sodium. It may not be specific to Depakote. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine comes with a medication guide and patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with food to avoid stomach upset.

The sprinkle capsules may be opened and the contents may be sprinkled onto soft food such as applesauce or pudding. This mixture must be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the sprinkles.

Swallow the extended release tablet whole with a full glass of water. Do not split, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (delayed-release tablets):
  
  • For mania:
    
    • Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 milligrams (mg) per kilogram (kg) of body weight a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For migraine:
    
    • Adults—At first, 250 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For seizures:
    
    • Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight a day to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight a day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.
    
    
    • Children below 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (extended release tablets):
  
  • For mania:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 25 milligrams (mg) per kilogram (kg) of body weight once a day to start. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg per kg of body weight a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For migraine:
    
    • Adults—At first, 500 milligrams (mg) once a day for 1 week. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For seizures:
    
    • Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight a day to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight a day.
    
    
    • Children below 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (sprinkle capsules):
  
  • For seizures:
    
    • Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight a day to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight a day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.
    
    
    • Children below 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Depakote

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant (especially during first trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

It is very important to take folic acid before getting pregnant and during early pregnancy to lower chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Divalproex sodium may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Check with your doctor right away if you have unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; confusion; low body temperature; or loss of consciousness while taking this medicine.

This medicine may cause serious allergic reactions that affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have more than one of the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen lymph glands in the neck, armpit, or groin; unusual tiredness; or yellow eyes or skin.

Divalproex sodium may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these adverse effects, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

If you are taking the sprinkle capsules, part of the capsules may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Depakote Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• confusion


• cough or hoarseness


• crying


• delusions


• dementia


• depersonalization


• diarrhea


• difficult or labored breathing


• dysphoria


• euphoria


• fever or chills


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• lower back or side pain


• mental depression


• muscle aches and pains


• nausea


• nervousness


• painful or difficult urination


• paranoia


• pinpoint red spots on the skin


• quick to react or overreact emotionally


• rapid weight gain


• rapidly changing moods


• runny nose


• shakiness in the legs, arms, hands, or feet


• shivering


• shortness of breath


• sleepiness or unusual drowsiness


• sore throat


• sweating


• tightness in the chest


• tingling of the hands or feet


• trembling or shaking of the hands or feet


• trouble with sleeping


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• wheezing

Less common

• Abnormal dreams


• absence of or decrease in body movement


• anxiety


• bloody nose


• bloody or cloudy urine


• blurred vision


• bruising burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in personality


• change in walking and balance


• changes in patterns and rhythms of speech


• chest pain


• chills


• clumsiness or unsteadiness


• cold sweats


• constipation


• darkened urine


• degenerative disease of the joint


• difficulty with moving


• discouragement


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• dry mouth


• excessive muscle tone


• fast, irregular, pounding, or racing heartbeat or pulse


• fear


• feeling of warmth or heat


• feeling sad or empty


• flushing or redness of the skin, especially on the face and neck


• frequent urge to urinate


• heavy non-menstrual vaginal bleeding


• hyperventilation


• increased need to urinate


• indigestion


• irritability


• lack of appetite


• lack of coordination


• large, flat, blue, or purplish patches in the skin


• leg cramps


• lip smacking or puckering


• loss of bladder control


• loss of interest or pleasure


• loss of strength or energy


• multiple swollen and inflamed skin lesions


• muscle pain or stiffness


• muscle tension or tightness


• normal menstrual bleeding occurring earlier, possibly lasting longer than expected


• pains in the stomach, side, or abdomen, possibly radiating to the back


• passing urine more often


• pounding in the ears


• puffing of the cheeks


• rapid or worm-like movements of the tongue


• rapid weight gain


• restlessness


• seeing, hearing, or feeling things that are not there


• shakiness and unsteady walk


• slurred speech


• small red or purple spots on the skin


• sweating


• swollen joints


• tiredness


• trouble with concentrating


• trouble with speaking


• twitching


• uncontrolled chewing movements


• uncontrolled movements of the arms and legs


• unsteadiness, trembling, or other problems with muscle control or coordination


• vomiting of blood or material that looks like coffee grounds


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness


• fainting


• loss of consciousness


• slow or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• body aches or pain


• change in vision


• congestion


• continuing ringing or buzzing or other unexplained noise in the ears


• hair loss or thinning of the hair


• hearing loss


• heartburn


• impaired vision


• lack or loss of strength


• loss of memory


• problems with memory


• rash


• seeing double


• sleeplessness


• tender, swollen glands in the neck


• trouble with swallowing


• unable to sleep


• uncontrolled eye movements


• voice changes


• weight gain


• weight loss

Less common

• Absent, missed, or irregular menstrual periods


• back pain


• burning, dry, or itching eyes


• change in taste or bad unusual or unpleasant (after) taste


• coin-shaped lesions on the skin


• cough producing mucus


• cramps


• dandruff


• discharge or excessive tearing


• dry skin


• earache


• excess air or gas in the stomach or intestines


• eye pain


• feeling of constant movement of self or surroundings


• full feeling


• heavy bleeding


• increased appetite


• itching of the vagina or genital area


• itching skin


• loss of bowel control


• neck pain


• oily skin


• pain


• pain during sexual intercourse


• pain or tenderness around the eyes and cheekbones


• passing gas


• rash with flat lesions or small raised lesions on the skin


• redness or swelling in the ear


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• redness, swelling, or soreness of the tongue


• sensation of spinning


• sneezing


• stiff neck


• stopping of menstrual bleeding


• thick, white vaginal discharge with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Depakote side effects (in more detail)

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• Depakote Side Effects (in more detail)
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• Drug Images
• Depakote Drug Interactions
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• 129 Reviews for Depakote - Add your own review/rating

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