Duricef

cefadroxil

Dosage Form: powder, for suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Duricef® and other antibacterial drugs, Duricef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Duricef Description

Duricef is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate[6R-[6α,7β(R*)]]-. It has the formula C16H17N3O5S • H2O and the molecular weight of 381.40. It has the following structural formula:

Duricef film-coated tablets, 1 g, contain the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, simethicone emulsion, and titanium dioxide.

Duricef for Oral Suspension contains the following inactive ingredients: FD&C Yellow No. 6, flavors (natural and artificial), polysorbate 80, sodium benzoate, sucrose, and xanthan gum.

Duricef capsules contain the following inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

Duricef - Clinical Pharmacology

Duricef is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 μg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 μg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a proportionate increase in Duricef (cefadroxil monohydrate, USP) urinary concentration. The urine antibiotic concentration, following a 1 g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.

Microbiology

In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE):

Beta-hemolytic streptococci

Staphylococci, including penicillinase-producing strains

Streptococcus (Diplococcus) pneumoniae

Escherichia coli

Proteus mirabilis

Klebsiella species

Moraxella (Branhamella) catarrhalis

Note: Most strains of Enterococcus faecalis (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium) are resistant to Duricef. It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species).

Susceptibility tests: Diffusion techniques

The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility. One such standard procedure1 which has been recommended for use with disks to test susceptibility of organisms to cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefadroxil.

Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 μg cephalothin disk should be interpreted according to the following criteria:

Zone diameter (mm)	Interpretation
≥ 18	(S) Susceptible
15–17	(I) Intermediate
≤ 14	(R) Resistant

 

A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “intermediate susceptibility” suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of “Resistant’’ indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30 μg cephalothin disk should give the following zone diameters:

Organism	Zone Diameter (mm)
Staphylococcus aureus ATCC 25923	29–37
Escherichia coli ATCC 25922	17–22

 

Dilution Techniques

When using the NCCLS agar dilution or broth dilution (including microdilution) method2 or equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 μg/mL or less. Organisms are considered resistant if the MIC is 32 μg/mL or greater. Organisms with an MIC value of less than 32 μg/mL but greater than 8 μg/mL are intermediate.

As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 μg/mL and 0.5 μg/mL for Staphylococcus aureus ATCC 29213. For Escherichia coli ATCC 25922, the MIC range should be between 4.0 μg/mL and 16.0 μg/mL. For Streptococcus faecalis ATCC 29212, the MIC range should be between 8.0 and 32.0 μg/mL.

Indications and Usage for Duricef

Duricef is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.

Skin and skin structure infections caused by staphylococci and/or streptococci.

Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).

Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Duricef is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of Duricef for the prophylaxis of subsequent rheumatic fever are not available.

Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Duricef and other antibacterial drugs, Duricef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

Duricef is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Warnings

BEFORE THERAPY WITH Duricef IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.

IF AN ALLERGIC REACTION TO Duricef OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Duricef, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

General

Duricef should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 M2). (See DOSAGE AND ADMINISTRATION.) In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.

Prescribing Duricef in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Prolonged use of Duricef may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Duricef should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis.

Information for Patients

Patients should be counseled that antibacterial drugs including Duricef should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Duricef is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Duricef or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug/Laboratory Test Interactions

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug.

Carcinogenesis, Mutagenesis and Impairment of Fertility

No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.

Pregnancy: Pregnancy Category B

Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil monohydrate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Duricef has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.

Pediatric Use

(See DOSAGE AND ADMINISTRATION.)

Geriatric Use

Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of cefadroxil for the treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION: Renal Impairment). 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.

Adverse Reactions

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred.

Hypersensitivity

Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.

Other

Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported.

In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Overdosage

A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.

In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6–8 hour hemodialysis session.

Duricef Dosage and Administration

Duricef is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

Adults

Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).

Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis—1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

Children

For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of Duricef should be administered for at least 10 days.

See chart for total daily dosage for children.

DAILY DOSAGE OF Duricef® SUSPENSION

CHILD'S WEIGHT
lbs kg		260 mg/5 mL	500 mg/5 mL
10	4.5	½ tsp
20	9.1	1 tsp
30	13.6	1½ tsp
40	18.2	2 tsp	1 tsp
50	22.7	2½ tsp	1¼ tsp
60	27.3	3 tsp	1½ tsp
70 & above	31.8+	—	2 tsp

 

Renal Impairment

In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of Duricef and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M2]) is 500 mg at the time intervals listed below.

Creatinine Clearances	Dosage Interval
0­10 mL/min	36 hours
10­25 mL/min	24 hours
25­50 mL/min	12 hours

 

Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

Reconstitution Directions for Oral Suspension

Bottle Size	Reconstitution Directions
100 mL	Suspend in a total of 67 mL water. Method: Tap bottle lightly to loosen powder. Add 67 mL of water in two portions. Shake well after each addition.
75 mL	Suspend in a total of 51 mL water. Method: Tap bottle lightly to loosen powder. Add 51 mL of water in two portions. Shake well after each addition.
50 mL	Suspend in a total of 34 mL water. Method: Tap bottle lightly to loosen powder. Add 34 mL of water in two portions. Shake well after each addition.
After reconstitution, store in refrigerator. Shake well before using. Keep container tightly closed. Discard unused portion after 14 days.

 

How is Duricef Supplied

Duricef® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with “PPP’’ and “784’’ on one end and with “Duricef’’ and “500 mg’’ on the other end.

Capsules are supplied as follows:

N 0430-0780-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

Duricef® 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with “PPP’’ on one side of the bisect and “785’’ on the other side of the bisect. Tablets are supplied as follows:

N 0430-0781-19 Bottle of 50

Store at controlled room temperature 15°–30° C (59°–86° F).

Duricef® for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

250 mg/5 mL N 0430-2782-15  50 mL Bottle

N 0430-2782-17 100 mL Bottle

500 mg/5 mL N 0430-2783-16  75 mL Bottle

N 0430-2783-17 100 mL Bottle

Prior to reconstitution: Store at controlled room temperature 15°–30° C (59°–86° F).

REFERENCES

1. National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test, 4th Edition, Vol. 10 (7): M2-A4, Villanova, PA, April, 1990.

2. National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990.

Manufactured by Bristol-Myers Squibb Co.

Princeton, NJ 08543

For Warner Chilcott Company, Inc.

Fajardo, PR 00738

Marketed by Warner Chilcott, Inc.

Rockaway, NJ 07866

2782G073

Revised April 2007

Duricef  cefadroxil  powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0430-2782 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength cefadroxil (cefadroxil) Active 250 MILLIGRAM  In 5 MILLILITER FDC Yellow No. 6 Inactive   flavors (natural and artificial) Inactive   polysorbate 80 Inactive   sodium benzoate Inactive   sucrose Inactive   xanthan gum Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0430-2782-15 50 mL (MILLILITER) In 1 BOTTLE None 2 0430-2782-17 100 mL (MILLILITER) In 1 BOTTLE None 3 0430-2782-95 10 mL (MILLILITER) In 1 BOTTLE None

Duricef  cefadroxil  powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0430-2783 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength cefadroxil (cefadroxil) Active 500 MILLIGRAM  In 5 MILLILITER FDC Yellow No. 6 Inactive   flavors (natural and artificial) Inactive   polysorbate 80 Inactive   sodium benzoate Inactive   sucrose Inactive   xanthan gum Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0430-2783-16 75 mL (MILLILITER) In 1 BOTTLE None 2 0430-2783-17 100 mL (MILLILITER) In 1 BOTTLE None 3 0430-2783-95 10 mL (MILLILITER) In 1 BOTTLE None

Duricef  cefadroxil  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0430-0781 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength cefadroxil (cefadroxil) Active 1 GRAM  In 1 TABLET microcrystalline cellulose Inactive   hydroxypropyl methylcellulose Inactive   magnesium stearate Inactive   polyethylene glycol Inactive   polysorbate 80 Inactive   simethicone emulsion Inactive   titanium dioxide Inactive

Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape OVAL (OVAL) Size 21mm Flavor Imprint Code PPP;785 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0430-0781-19 50 TABLET In 1 BOTTLE None

Duricef  cefadroxil  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0430-0780 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength cefadroxil (cefadroxil) Active 500 MILLIGRAM  In 1 CAPSULE DC Red No. 28 Inactive   FDC Blue No. 1 Inactive   FDC Red No. 40 Inactive   gelatin Inactive   magnesium stearate Inactive   titanium dioxide Inactive

Product Characteristics Color WHITE (WHITE) , RED (MAROON) Score no score Shape CAPSULE (CAPSULE) Size 21mm Flavor Imprint Code PPP;784;Duricef;500 Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0430-0780-19 50 CAPSULE In 1 BOTTLE None

Revised: 05/2007Warner Chilcott, Inc.

More Duricef resources

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Compare Duricef with other medications

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Diuril

chlorothiazide

Dosage Form: oral suspension

Diuril Description

Diuril* (Chlorothiazide) is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:

It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.

Diuril Oral Suspension contains 250 mg of chlorothiazide per 5 mL, alcohol 0.5 percent, with methylparaben 0.12 percent, propylparaben 0.02 percent, and benzoic acid 0.1 percent added as preservatives. The inactive ingredients are D&C Yellow 10, flavors, glycerin, purified water, sodium saccharin, sucrose and tragacanth.

Diuril - Clinical Pharmacology

The mechanism of the antihypertensive effect of thiazides is unknown. Diuril does not usually affect normal blood pressure.

Diuril affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy.

Diuril increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.

After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours.

Pharmacokinetics and Metabolism

Diuril is not metabolized but is eliminated rapidly by the kidney. The plasma half-life of chlorothiazide is 45-120 minutes. After oral doses, 10-15 percent of the dose is excreted unchanged in the urine. Chlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

Indications and Usage for Diuril

Diuril is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

Diuril has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Diuril is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.

Contraindications

Anuria.

Hypersensitivity to this product or to other sulfonamide-derived drugs.

Warnings

Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Thiazides may add to or potentiate the action of other antihypertensive drugs.

Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions).

Precautions

General

All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present or after prolonged therapy.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmias and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Hypokalemia may be avoided or treated by use of potassium-sparing diuretics or potassium supplements such as foods with a high potassium content.

Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.

Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazides.

In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

If progressive renal impairment becomes evident, consider withholding or discontinuing diuretic therapy.

Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals.

Drug Interactions

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur.

Antidiabetic drugs (oral agents and insulin) - dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs - additive effect or potentiation.

Cholestyramine and colestipol resins - Both cholestyramine and colestipol resins have the potential of binding thiazide diuretics and reducing diuretic absorption from the gastrointestinal tract.

Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia.

Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant.

Lithium - generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with Diuril.

Non-steroidal Anti-inflammatory Drugs Including Selective Cyclooxygenase-2 (COX-2) Inhibitors - In some patients, the administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Diuril and non-steroidal anti-inflammatory agents or selective COX-2 inhibitors are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

In some patients with compromised renal function (e.g., elderly patients or patients who are volume-depleted, including those on diuretic therapy) who are being treated with non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors, the co-administration of angiotensin II receptor antagonists or ACE inhibitors may result in a further deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

These interactions should be considered in patients taking NSAIDs including selective COX-2 inhibitors concomitantly with diuretics and angiotensin II antagonists or ACE inhibitors. Therefore, the combination should be administered with caution, especially in the elderly.

Drug/Laboratory Test Interactions

Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with chlorothiazide.

Chlorothiazide was not mutagenic in vitro in the Ames microbial mutagen test (using a maximum concentration of 5mg/plate and Salmonella typhimurium strains TA98 and TA100) and was not mutagenic and did not induce mitotic nondisjunction in diploid-strains of Aspergillus nidulans.

Chlorothiazide had no adverse effects on fertility in female rats at doses up to 60mg/kg/day and no adverse effects on fertility in male rats at doses up to 40mg/kg/day. These doses are 1.5 and 1 times 1  the recommended maximum human dose, respectively, when compared on a body weight basis.

1

  Calculations based on a human body weight of 50 kg

Pregnancy

Teratogenic Effects - Pregnancy Category C: Although reproduction studies performed with chlorothiazide doses of 50 mg/kg/day in rabbits, 60 mg/kg/day in rats and 500 mg/kg/day in mice revealed no external abnormalities of the fetus or impairment of growth and survival of the fetus due to chlorothiazide, such studies did not include complete examinations for visceral and skeletal abnormalities. It is not known whether chlorothiazide can cause fetal harm when administered to a pregnant woman; however, thiazides cross the placental barrier and appear in cord blood. Diuril should be used during pregnancy only if clearly needed (see INDICATIONS AND USAGE).

Nonteratogenic Effects: Chlorothiazide may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from Diuril, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

There are no well-controlled clinical trials in pediatric patients. Information on dosing in this age group is supported by evidence from empiric use in pediatric patients and published literature regarding the treatment of hypertension in such patients. (See DOSAGE AND ADMINISTRATION, Infants and Children.)

Geriatric Use

Clinical studies of Diuril did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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 WARNINGS).

Adverse Reactions

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

Body as a Whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm.

Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis. (See WARNINGS.)

Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia.

Special Senses: Transient blurred vision, xanthopsia.

Urogenital: Impotence.

Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Overdosage

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment.

The degree to which chlorothiazide sodium is removed by hemodialysis has not been established.

The oral LD50 of chlorothiazide is 8.5 g/kg, greater than 10 g/kg, and greater than 1 g/kg, in the mouse, rat and dog respectively.

Diuril Dosage and Administration

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Adults

For Edema

The usual adult dosage is 500 mg to 1000 mg (10 mL to 20 mL) once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension

The usual adult starting dosage is 500 mg to1000 mg (10 mL to 20 mL) a day as a single or divided dose. Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2000 mg (40 mL) a day in divided doses.

Infants and Children

For Diuresis and For Control of Hypertension

The usual pediatric dosage is 5 mg to 10 mg per pound (10 mg/kg to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day (2.5 mL to 7.5 mL or ½ to 1½ teaspoonfuls of the oral suspension daily) in infants up to 2 years of age or 1000 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use.)

How is Diuril Supplied

Diuril Oral Suspension, 250 mg of chlorothiazide per 5 mL, is a yellow, creamy suspension, and is supplied as follows:

NDC 65649-311-12 bottles of 237 mL.

Storage

Diuril Oral Suspension: Keep container tightly closed. Protect from freezing, –20°C (–4°F) and store at room temperature, 15-30°C (59-86°F).

Manufactured by:

Paddock Laboratories, Inc.

Minneapolis, MN  55427

For:

Salix Pharmaceuticals, Inc.

Morrisville, NC  27560

VENART-100-1/April 2010

Package Label - Principal Display Panel 

NDC 65649-311-12 bottles of 237 mL.

Diuril®

(CHLOROTHIAZIDE) ORAL SUSPENSION

250 mg/5ml

Manufactured by:

Paddock Laboratories, Inc.

Minneapolis, MN  55427

For:

Salix Pharmaceuticals, Inc.

Morrisville, NC  27560

Diuril  chlorothiazide  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65649-311 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROTHIAZIDE (chlorothiazide) chlorothiazide 250 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   METHYLPARABEN   PROPYLPARABEN   BENZOIC ACID   D&C YELLOW NO. 10   GLYCERIN   WATER   SUCROSE   TRAGACANTH

Product Characteristics Color YELLOW (YELLOW) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65649-311-12 237 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011870	02/15/1962

Labeler - Salix Pharmaceuticals, Inc (793108036)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories		251086799	MANUFACTURE

Revised: 12/2010Salix Pharmaceuticals, Inc

More Diuril resources

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

• Diuril Concise Consumer Information (Cerner Multum)


• Diuril Monograph (AHFS DI)


• Diuril MedFacts Consumer Leaflet (Wolters Kluwer)


• Diuril Advanced Consumer (Micromedex) - Includes Dosage Information


• Chlorothiazide Professional Patient Advice (Wolters Kluwer)


• Diuril Sodium Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Diuril with other medications

• Edema
• High Blood Pressure

Deconsal II

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Deconsal II (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Deconsal II (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Deconsal II (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  circulation problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  enlarged prostate or problems with urination.

  
  

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Deconsal II (guaifenesin and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Deconsal II (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Deconsal II (guaifenesin and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  vomiting, upset stomach;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  dizziness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Deconsal II (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Deconsal II resources

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

• Crantex Prescribing Information (FDA)


• Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)


• Guiatex PE Prescribing Information (FDA)


• Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Deconsal II with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Deconsal II side effects (in more detail)

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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More Depakote resources

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

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