Bisacodyl Tablet Bowel Prep Kit Solution

Pronunciation: POL-ee-ETH-i-leen GLYE-kol/e-LECK-troe-lites/bis-AK-oh-dil
Generic Name: Polyethylene Glycol/Electrolytes
Brand Name: HalfLytely and Bisacodyl Tablet Bowel Prep Kit

Bisacodyl Tablet Bowel Prep Kit Solution is used for:

Cleaning out the bowel before certain medical procedures (eg, colonoscopy). It may also be used for other conditions as determined by your doctor.

Bisacodyl Tablet Bowel Prep Kit Solution is a combination of 2 laxatives. The solution works by changing the amounts of water and electrolytes in the intestines. The tablet works by causing the colon to move contents along more quickly.

Do NOT use Bisacodyl Tablet Bowel Prep Kit Solution if:

• you are allergic to any ingredient in Bisacodyl Tablet Bowel Prep Kit Solution


• you have appendicitis; severe stomach pain; severe constipation; stomach, intestinal, or rectal bleeding; or certain stomach or bowel problems (eg, blockage, problems with the contents of your stomach emptying, opening or hole in the wall of your stomach or bowel, certain types of inflammation, very enlarged bowel)


• you cannot swallow the tablet whole


• you will be having abdominal surgery

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bisacodyl Tablet Bowel Prep Kit Solution:

Some medical conditions may interact with Bisacodyl Tablet Bowel Prep Kit Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a throat (esophagus) disease, reflux problems (GERD), stomach or bowel problems (eg, ulcerative colitis), swallowing problems (eg, history of aspiration or regurgitation), problems with your gag reflex, electrolyte problems (eg, low blood potassium, sodium, calcium, or magnesium levels), kidney problems, or rectal bleeding of unknown cause


• if you have nausea, vomiting, or undiagnosed stomach pain


• if you have a history of heart problems (eg, irregular heartbeat, congestive heart failure, angina) or a recent heart attack


• if you have a history of seizures, alcohol use, or you are currently in withdrawal from alcohol or certain other substances (eg, benzodiazepines)

Some MEDICINES MAY INTERACT with Bisacodyl Tablet Bowel Prep Kit Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Tricyclic antidepressants (eg, amitriptyline) because the risk of seizures may be increased


• Angiotensin converting enzyme (ACE) inhibitors (eg, lisinopril), angiotensin receptor blockers (ARBs) (eg, losartan), diuretics (eg, furosemide, hydrochlorothiazide), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because they may increase the risk of Bisacodyl Tablet Bowel Prep Kit Solution's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bisacodyl Tablet Bowel Prep Kit Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bisacodyl Tablet Bowel Prep Kit Solution:

Use Bisacodyl Tablet Bowel Prep Kit Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Bisacodyl Tablet Bowel Prep Kit Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Bisacodyl Tablet Bowel Prep Kit Solution refilled.


• For best results, do not eat solid food or drink milk on the day that you use Bisacodyl Tablet Bowel Prep Kit Solution. Drink only clear liquids and do not eat any solid foods from the time you start Bisacodyl Tablet Bowel Prep Kit Solution until your procedure is complete.


• Some of these products come with a Flavor Pack. If this product comes with a Flavor Pack and you wish to use it, add the contents of the Flavor Pack into the bottle before you add the water. If you do not use the Flavor Pack, throw it away.


• To mix the solution, fill the container with the amount of water indicated on the package label. Use lukewarm water to mix Bisacodyl Tablet Bowel Prep Kit Solution to help the medicine dissolve faster. Shake well.


• Chilling Bisacodyl Tablet Bowel Prep Kit Solution improves the taste. Do not add sugar, sweetening agents, or other additives to Bisacodyl Tablet Bowel Prep Kit Solution.


• To use the bisacodyl tablet - Swallow the tablet with water unless your doctor instructs you otherwise. Swallow the tablet whole. Do not break, crush, or chew before swallowing.


• Do not take an antacid within 1 hour before you take the tablet.


• The first bowel movement should occur about 1 to 6 hours after you take the tablet.


• Wait until a bowel movement occurs (or a maximum of 6 hours) and then begin drinking the solution, unless your doctor has given you different instructions.


• To use the polyethylene glycol/electrolytes solution - Shake well before each use. Unless your doctor has given you different instructions, drink 8 ounces (240 mL) of the solution every 10 minutes until it is completely gone. It is best to drink each portion quickly rather than sipping it. Rinsing your mouth with mouthwash after each glass of medicine may help get rid of the taste.


• Other medicines taken by mouth within 1 hour of the start of the solution may not be absorbed or be effective. Contact your doctor or pharmacist with any concerns you might have about taking your other medicines.


• If you miss a dose of Bisacodyl Tablet Bowel Prep Kit Solution, take it as soon as you remember. Continue to take it as directed by your doctor. Notify your doctor right away if you are unable to finish taking Bisacodyl Tablet Bowel Prep Kit Solution before your test.

Ask your health care provider any questions you may have about how to use Bisacodyl Tablet Bowel Prep Kit Solution.

Important safety information:

• The first bowel movement usually occurs about 1 hour after you begin drinking Bisacodyl Tablet Bowel Prep Kit Solution.


• If you experience stomach discomfort, pain, or bloating, you may need to stop the solution for a short time or allow a longer time between doses. Check with your doctor or pharmacist for more information. Notify your doctor right away if you are unable to finish taking Bisacodyl Tablet Bowel Prep Kit Solution before your test.


• Keep all doctor and lab appointments while you are taking Bisacodyl Tablet Bowel Prep Kit Solution.


• Do not drink large amounts of water during or after preparation for colonoscopy. Discuss any questions or concerns with your doctor.


• Do not take other laxatives while you are using Bisacodyl Tablet Bowel Prep Kit Solution. Discuss any questions with your doctor or pharmacist.


• Use Bisacodyl Tablet Bowel Prep Kit Solution with caution in patients who are unconscious or partially conscious because they may be at greater risk for vomiting and inhaling Bisacodyl Tablet Bowel Prep Kit Solution.


• Use Bisacodyl Tablet Bowel Prep Kit Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Bisacodyl Tablet Bowel Prep Kit Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bisacodyl Tablet Bowel Prep Kit Solution while you are pregnant. It is not known if Bisacodyl Tablet Bowel Prep Kit Solution is found in breast milk. If you are or will be breast-feeding while you use Bisacodyl Tablet Bowel Prep Kit Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Bisacodyl Tablet Bowel Prep Kit Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; lightheadedness; nausea; rectal irritation; stomach fullness, cramps, or discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; confusion; decreased urination; fainting; muscle weakness or cramping; persistent or severe nausea or vomiting; rectal bleeding; seizures; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; symptoms of dehydration (eg, very dry mouth or eyes, increased thirst, fast heartbeat, dizziness, headache); vomiting of blood.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Bisacodyl Tablet Bowel Prep Kit Solution:

Store the tablet and the powder for solution (before mixing) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. After mixing the solution, store it in the refrigerator in a tightly closed container. Use the solution within 48 hours. Discard any unused portion of Bisacodyl Tablet Bowel Prep Kit Solution. Keep Bisacodyl Tablet Bowel Prep Kit Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Bisacodyl Tablet Bowel Prep Kit Solution, please talk with your doctor, pharmacist, or other health care provider.


• Bisacodyl Tablet Bowel Prep Kit Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bisacodyl Tablet Bowel Prep Kit Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bisacodyl Tablet Bowel Prep Kit resources

• Bisacodyl Tablet Bowel Prep Kit Use in Pregnancy & Breastfeeding
• Bisacodyl Tablet Bowel Prep Kit Drug Interactions
• Bisacodyl Tablet Bowel Prep Kit Support Group
• 2 Reviews for Bisacodyl Bowel Prep - Add your own review/rating

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International Drug Name Search

Desmopressin Tablets

Generic Name: desmopressin acetate

Dosage Form: tablet
DESMOPRESSIN ACETATE TABLETS

Rx only

DESCRIPTION:

Desmopressin acetate are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), is an antidiuretic hormone affecting renal water conservation. It is chemically defined as 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. The structural formula is as follows:

C46H64N14O12S2·C2H4O2·3H20 Molecular Weight: 1183.34

Desmopressin Acetate Tablets contain desmopressin acetate equivalent to either 0.1 mg or 0.2 mg of desmopressin acetate. In addition, each tablet contains the following inactive ingredients: butylated hydroxyanisole, butylated hydroxytoluene, crospovidone, lactose monohydrate, magnesium stearate, povidone and potato starch.

CLINICAL PHARMACOLOGY:

Desmopressin acetate tablets contain as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin.

Central Diabetes Insipidus:

Dose response studies in patients with diabetes insipidus have demonstrated that oral doses of 0.025 mg to 0.4 mg produced clinically significant antidiuretic effects. In most patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours. With doses of 0.4 mg, antidiuretic effects were observed for up to 12 hours; measurements beyond 12 hours were not recorded. Increasing oral doses produced dose dependent increases in the plasma levels of desmopressin acetate.

The plasma half-life of desmopressin acetate followed a monoexponential time course with t1/2 values of 1.5 to 2.5 hours which was independent of dose.

The bioavailability of desmopressin acetate oral tablets is about 5% compared to intranasal desmopressin acetate, and about 0.16% compared to intravenous desmopressin acetate. The time to reach maximum plasma desmopressin acetate levels ranged from 0.9 to 1.5 hours following oral or intranasal administration, respectively. Following administration of desmopressin acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to 7 hours based on the measurement of increased urine osmolality.

The use of desmopressin acetate tablets in patients with an established diagnosis will result in a reduction in urinary output with an accompanying increase in urine osmolality. These effects usually will allow resumption of a more normal life style, with a decrease in urinary frequency and nocturia.

There are reports of an occasional change in response to the intranasal formulations of desmopressin acetate (desmopressin acetate Nasal Spray and desmopressin acetate Rhinal Tube). Usually, the change occurred over a period of time greater than six months. This change may be due to decreased responsiveness, or to shortened duration of effect. There is no evidence that this effect is due to the development of binding antibodies, but may be due to a local inactivation of the peptide. No lessening of effect was observed in the 46 patients who were treated with desmopressin acetate tablets for 12 to 44 months and no serum antibodies to desmopressin were detected.

The change in structure of arginine vasopressin to desmopressin acetate resulted in less vasopressor activity and decreased action on visceral smooth muscle relative to enhanced antidiuretic activity. Consequently, clinically effective antidiuretic doses are usually below the threshold for effects on vascular or visceral smooth muscle. In the four long-term studies of desmopressin acetate tablets, no increases in blood pressure in 46 patients receiving desmopressin acetate tablets for periods of 12 to 44 months were reported.

In one study, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulation were compared during an 8-hour dosing interval at steady state. The doses administered to 36 hydrated (water loaded) healthy male adult volunteers every 8 hours were 0.1, 0.2, 0.4 mg orally and 0.01 mg intranasally by rhinal tube. The results are shown in the following table:

Mean Changes from Baseline (SE) in Pharmacodynamic Parameters in Normal Healthy Adult Volunteers

(SE) = Standard error of the mean
Treatment	Total Urine Volume in mL	Maximum Urine Osmolality in mOsm/kg
0.1 mg PO q8h	-3689.3 (149.6)	514.8 (21.9)
0.2 mg PO q8h	-4429.9 (149.6)	686.3 (21.9)
0.4 mg PO q8h	-4998.8 (149.6)	769.3 (21.9)
0.01 mg IN q8h	-4844.9 (149.6)	754.1 (21.9)

With respect to the mean values of total urine volume decrease and maximum urine osmolality increase from baseline, the 90% confidence limits estimated that the 0.4 mg and 0.2 mg oral dose produced between 95% and 110% and 84% to 99% of pharmacodynamic activity, respectively, when compared to the 0.01 mg intranasal dose.

While both the 0.2 mg and 0.4 mg oral doses are considered pharmacodynamically similar to the 0.01 mg intranasal dose, the pharmacodynamic data on an inter-subject basis was highly variable and, therefore, individual dosing is recommended.

In another study in diabetes insipidus patients, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulations were compared over a 12-hour period. Ten fluid-controlled patients under age 18 were administered tablet doses of 0.2 mg and 0.4 mg, and intranasal doses of 0.01 mg and 0.02 mg.

Mean Peak Pharmacodynamic Parameters (SD) in Pediatric and Adolescent Diabetes Insipidus Patients

(SD) = Standard Deviation
Treatment	Total Urine Volume in mL/min	Maximum Urine Osmolality in mOsm/kg
0.1 mg IN	0.3 (0.15)	717.0 (224.63)
0.2 mg IN	0.3 (0.25)	761.8 (298.82)
0.4 mg PO	0.3 (0.12)	678.3 (147.91)
0.01 mg PO	0.2 (0.15)	787.2 (73.34)

All four dose formulations (0.01 mg IN, 0.02 mg IN, 0.2 mg PO and 0.4 mg PO) have a similar, pronounced pharmacodynamic effect on urine volume and urine osmolality. At two hours after study drug administration, mean urine volume was 4 mL/min and urine osmolality was >500 mOsm/kg. Mean plasma osmolality remained relatively constant over the time course recorded (0 to 12 hours). A statistical separation from baseline did not occur at any dose or time point. In these patients, the 0.2 mg tablets and the 0.01 mg intranasal spray exhibited similar pharmacodynamic profiles as did the 0.4 mg tablets and the 0.02 mg intranasal spray formulation. In another study of adult diabetes insipidus patients previously controlled on desmopressin acetate intranasal spray, after one week of self-titration from spray to tablets, patients’ diuresis was controlled with 0.1 mg desmopressin acetate tablets three times a day.

Primary Nocturnal Enuresis:

Two double-blind, randomized, placebo-controlled studies were conducted in 340 patients with primary nocturnal enuresis. Patients were 5-17 years old, and 72% were males. A total of 329 patients were evaluated for efficacy. Patients were evaluated over a two-week baseline period in which the average number of wet nights was 10 (range 4-14). Patients were then randomized to receive 0.2, 0.4, or 0.6 mg of desmopressin acetate or placebo. The pooled results after two weeks are shown in the following table:

Response to Desmopressin Acetate and Placebo at Two Weeks of Treatment Mean (SE) Number of Wet Nights/2 Weeks

		Placebo (n=85)	0.2 mg/day (n=79)	0.4 mg/day (n=82)	0.6 mg/day (n=83)
Baseline		10 (0.3)	11 (0.3)	10 (0.3)	10(0.3)
Reduction from Baseline		1 (0.3)	3 (0.4)	3 (0.4)	4 (0.4)
Percent Reduction from Baseline		10%	27%	30%	40%
p-value vs. placebo		─	<0.05	<0.05	<0.05

Patients treated with desmopressin acetate tablets showed a statistically significant reduction in the number of wet nights compared to placebo-treated patients. A greater response was observed with increasing doses up to 0.6 mg.

In a six month, open-label extension study, patients completing the placebo-controlled studies were started on 0.2 mg/day desmopressin acetate tablets, and the dose was progressively increased until the optimal response was achieved (maximum dose 0.6 mg/day). A total of 230 patients were evaluated for efficacy; the average number of wet nights/2 weeks during the untreated baseline period was 10 (range 4-14), and the average duration (SD) of treatment was 4.2 (1.8) months. Twenty-five (25) patients (11%) achieved a complete or near complete response (≤2 wet nights/2 weeks) and did not require titration to the 0.6 mg/day dose. The majority of patients (198 of 230, 86%) were titrated to the highest dose. When all dose groups were combined, 128 (56%) showed at least a 50% reduction from baseline in the number of wet nights/2 weeks, while 87 (38%) patients achieved a complete or near complete response.

INDICATIONS AND USAGE:

Central Diabetes Insipidus:

Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate tablets are ineffective for the treatment of nephrogenic diabetes insipidus.

Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.

Primary Nocturnal Enuresis:

Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate tablets may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.

CONTRAINDICATIONS:

Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets.

Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

WARNINGS:

Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.

When desmopressin acetate tablets are administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving desmopressin acetate therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.

Desmopressin acetate should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

PRECAUTIONS:

General:

Intranasal formulations of desmopressin acetate at high doses and desmopressin acetate injection have infrequently produced a slight elevation of blood pressure which disappears with a reduction of dosage. Although this effect has not been observed when single oral doses up to 0.6 mg have been administered, the drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease, because of a possible rise in blood pressure.

Desmopressin acetate should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, since these patients may develop hyponatremia.

Rare severe allergic reactions have been reported with desmopressin acetate. Anaphylaxis has been reported with intravenous and intranasal administration of desmopressin acetate, but not with desmopressin acetate tablets.

Laboratory Tests:

Central Diabetes Insipidus: Laboratory tests for monitoring the patient with central diabetes insipidus or post-surgical or head trauma-related polyuria and polydipsia include urine volume and osmolality. In some cases, measurements of plasma osmolality may be useful.

Drug Interactions:

Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate tablets should be used with other pressor agents only with careful patient monitoring.

Carcinogenicity, Mutagenicity, and Impairment of Fertility:

Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy:

Category B:

Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 µg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to desmopressin acetate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Several publications where desmopressin acetate was used in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established. A fifteen year Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the possible therapeutic advantages against the possible risks in each case.

Nursing Mothers:

There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable desmopressin acetate in breast milk following an intranasal dose of 0.01 mg.

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when desmopressin acetate is administered to nursing mothers.

Pediatric Use:

Central Diabetes Insipidus: Desmopressin acetate tablets have been used safely in pediatric patients, age 4 years and older, with diabetes insipidus for periods up to 44 months. In younger pediatric patients the dose must be individually adjusted in order to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible convulsions; dosing should start at 0.05 mg (1/2 of the 0.1 mg tablet). Use of desmopressin acetate in pediatric patients requires careful fluid intake restrictions to prevent possible hyponatremia and water intoxication.


Primary Nocturnal Enuresis: Desmopressin acetate tablets have been safely used in pediatric patients age 6 years and older with primary nocturnal enuresis for up to 6 months. Some patients respond to a dose of 0.2 mg; however, increasing responses are seen at doses of 0.4 mg and 0.6 mg. No increase in the frequency or severity of adverse reactions or decrease in efficacy was seen with an increased dose or duration. The dose should be individually adjusted to achieve the best results.

ADVERSE REACTIONS:

Infrequently, large doses of the intranasal formulations of desmopressin acetate and desmopressin acetate injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage.

Central Diabetes Insipidus:

In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of desmopressin acetate tablets.

Primary Nocturnal Enuresis:

The only adverse event occurring in ≥ 3% of patients in controlled clinical trials with desmopressin acetate tablets that was probably, possibly, or remotely related to study drug was headache (4% desmopressin acetate, 3% placebo).

Other:

The following adverse events have been reported; however, their relationship to desmopressin acetate has not been established: abnormal thinking, diarrhea, and edema-weight gain.

See WARNINGS for the possibility of water intoxication and hyponatremia.

OVERDOSAGE:

(See ADVERSE REACTIONS.) In case of overdose, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate. The patient should be observed and treated with appropriate symptomatic therapy.

An oral LD50 has not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

DOSAGE AND ADMINISTRATION:

Central Diabetes Insipidus:

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablets therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Adults and Children: It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use:

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Primary Nocturnal Enuresis:

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal desmopressin acetate therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.

HOW SUPPLIED:

Desmopressin Acetate Tablets are available as:

 0.1 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/25 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2464-01

 0.2 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/26 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2465-01

Dispense in a tight, light-resistant container with a child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Avoid exposure to excessive heat or light.

Keep out of the reach of children.

Manufactured by:

Watson Laboratories, Inc.

Corona, CA 92880

Distributed by:

Watson Pharma, Inc.

Corona, CA 92880 USA

Revised: July 2011                                                                     195817-1

PRINCIPAL DISPLAY PANEL

NDC 0591-2464-01

Desmopressin

Acetate Tablets

0.1 mg                       New NDC

Watson       100 Tablets          Rx only

PRINCIPAL DISPLAY PANEL

NDC 0591-2465-01

Desmopressin

Acetate Tablets

0.2 mg                        New NDC

Watson        100 Tablets            Rx Only

DESMOPRESSIN ACETATE  desmopressin acetate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-2464 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.1 mg

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE   BUTYLATED HYDROXYTOLUENE   CROSPOVIDONE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, POTATO   POVIDONE

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code WPI;22;25 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-2464-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076470	08/15/2011

DESMOPRESSIN ACETATE  desmopressin acetate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-2465 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.2 mg

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE   BUTYLATED HYDROXYTOLUENE   CROSPOVIDONE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, POTATO   POVIDONE

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code WPI;22;26 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-2465-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076470	08/15/2011

Labeler - Watson Laboratories, Inc. (966714656)

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc. - Florida		020778751	ANALYSIS, MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc. - Florida		014759176	ANALYSIS, LABEL, PACK

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc. - Florida		129357732	ANALYSIS

Revised: 08/2011Watson Laboratories, Inc.

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Albendazole Makers Lab

Albendazole Makers Lab may be available in the countries listed below.

Ingredient matches for Albendazole Makers Lab

Albendazole

Albendazole is reported as an ingredient of Albendazole Makers Lab in the following countries:

• Myanmar

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Ozid

Ozid may be available in the countries listed below.

Ingredient matches for Ozid

Omeprazole

Omeprazole is reported as an ingredient of Ozid in the following countries:

• Indonesia

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Semduramicin Sodium

Semduramicin Sodium may be available in the countries listed below.

Ingredient matches for Semduramicin Sodium

Semduramicin

Semduramicin Sodium (USAN) is also known as Semduramicin (Rec.INN)

International Drug Name Search

Glossary

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.

Sertralina Ranbaxy

Sertralina Ranbaxy may be available in the countries listed below.

Ingredient matches for Sertralina Ranbaxy

Sertraline

Sertraline is reported as an ingredient of Sertralina Ranbaxy in the following countries:

• Portugal

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralina Ranbaxy in the following countries:

• Italy


• Spain

International Drug Name Search

Solprin

Solprin may be available in the countries listed below.

Ingredient matches for Solprin

Aspirin

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

• Australia


• New Zealand

International Drug Name Search

Vincristine Sulphate Injection

Vincristine Sulphate Injection may be available in the countries listed below.

Ingredient matches for Vincristine Sulphate Injection

Vincristine

Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vincristine Sulphate Injection in the following countries:

• Georgia

International Drug Name Search

Vectan

Vectan may be available in the countries listed below.

Ingredient matches for Vectan

Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Vectan in the following countries:

• Japan

International Drug Name Search

Levocetile

Levocetile may be available in the countries listed below.

Ingredient matches for Levocetile

Acetylcarnitine

Acetylcarnitine is reported as an ingredient of Levocetile in the following countries:

• Vietnam

International Drug Name Search

Coderol

Coderol may be available in the countries listed below.

Ingredient matches for Coderol

Glucosamine

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

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Mevecan

Mevecan may be available in the countries listed below.

Ingredient matches for Mevecan

Cefuroxime

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

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Dalfampridine

Pronunciation: dal-FAM-pri-DEEN
Generic Name: Dalfampridine
Brand Name: Ampyra

Dalfampridine is used for:

Improvement of walking in patients with multiple sclerosis (MS).

Dalfampridine is a potassium channel blocker. Exactly how it works is not known. It is thought to increase nerve function that will improve walking in patients with MS.

Do NOT use Dalfampridine if:

• you are allergic to any ingredient in Dalfampridine


• you have moderate to severe kidney problems


• you have a history of seizures


• you take any other medicines that contain other aminopyridines (eg, 4-AP, fampridine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dalfampridine:

Some medical conditions may interact with Dalfampridine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney problems, kidney or urinary tract infections, or an abnormal electroencephalogram (EEG)

Some MEDICINES MAY INTERACT with Dalfampridine. However, no specific interactions with Dalfampridine are known at this time.

Ask your health care provider if Dalfampridine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dalfampridine:

Use Dalfampridine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dalfampridine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dalfampridine refilled.


• Take Dalfampridine by mouth with or without food.


• Swallow Dalfampridine whole. Do not break, crush, chew, or dissolve before swallowing.


• Dalfampridine works best if it is taken at the same time each day.


• If you miss a dose of Dalfampridine, do not make up the missed dose. Take your next dose at your regular scheduled time. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dalfampridine.

Important safety information:

• Dalfampridine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Dalfampridine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT take more than the recommended dose or take for longer than prescribed without talking with your doctor.


• Dalfampridine may increase your risk of seizures. Contact your doctor right away if you experience a seizure while taking Dalfampridine.


• Lab tests, including kidney function, may be performed while you take Dalfampridine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Dalfampridine with caution in the ELDERLY; they may be more sensitive to its effects.


• Dalfampridine should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Dalfampridine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Dalfampridine while you are pregnant. It is not known if Dalfampridine is found in breast milk. Do not breast-feed while taking Dalfampridine.

Possible side effects of Dalfampridine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; dizziness; headache; nausea; sore throat; stuffy or runny nose; trouble sleeping; upset stomach; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); balance problems; burning, numbness, or tingling; confusion; seizure; symptoms of urinary tract infection (eg, burning or pain while urinating, difficulty urinating, inability to control urination).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dalfampridine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; memory loss; seizure; sweating; tremor.

Proper storage of Dalfampridine:

Store Dalfampridine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dalfampridine out of the reach of children and away from pets.

General information:

• If you have any questions about Dalfampridine, please talk with your doctor, pharmacist, or other health care provider.


• Dalfampridine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dalfampridine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dalfampridine resources

• Dalfampridine Side Effects (in more detail)
• Dalfampridine Use in Pregnancy & Breastfeeding
• Dalfampridine Drug Interactions
• Dalfampridine Support Group
• 17 Reviews for Dalfampridine - Add your own review/rating

• Dalfampridine Professional Patient Advice (Wolters Kluwer)


• Dalfampridine Monograph (AHFS DI)


• dalfampridine Advanced Consumer (Micromedex) - Includes Dosage Information


• Ampyra Prescribing Information (FDA)


• Ampyra Consumer Overview

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