Finasterida Davur may be available in the countries listed below.
Ingredient matches for Finasterida Davur
Finasteride
Finasteride is reported as an ingredient of Finasterida Davur in the following countries:
- Spain
International Drug Name Search
Tuesday, January 25, 2011
Saturday, January 22, 2011
Acetic Acid
Scheme
Ph. Eur.
ATC (Anatomical Therapeutic Chemical Classification)
G01AD02,S02AA10
CAS registry number (Chemical Abstracts Service)
0000064-19-7
Chemical Formula
C2-H4-O2
Molecular Weight
60
Chemical Names
Acetic acid (IUPAC)
Acide éthanoïque (DCF)
Ethanoic Acid
Foreign Names
- Acidum aceticum glaciale (Latin)
- Essigsäure 99% (German)
- Acide acétique glacial (French)
- Ácido acético (Spanish)
Generic Names
- Acide acétique (OS: DCF)
- Glacial Acetic Acid (OS: USAN, JAN)
- 4-02-00-00094 (IS: Beilstein)
- Acetyl hydroxide (IS)
- AcOH (IS)
- BRN 0506007 (IS)
- CCRIS 5952 (IS)
- E 260 (IS)
- Eisessig (IS)
- Ethylic acid (IS)
- HAc (IS)
- Hydrogen acetate (IS)
- Methanecarboxylic acid (IS)
- NSC 132953 (IS)
- Vinegar acid (IS)
- Water-free acetic acid (IS)
- Essigsäure 99% (PH: Ph. Eur. 6)
- Glacial Acetic Acid (PH: BP 2010, Ph. Eur. 6, USP 32, JP XV)
Brand Names
- Earcalm
GlaxoSmithKline Consumer Healthcare, United Kingdom - Instaret
Uni-Pharma, Greece - Liberanit
Trommsdorff, Germany
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Ph. Eur. | European Pharmacopoeia |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Oscimin Oral Dispersible Tablet
Generic Name: hyoscyamine sulfate
Dosage Form: tablet, orally disintegrating
Oscimin Oral Dispersible Tablets
DESCRIPTION
Each round, green, peppermint flavored, orally dispersible tablet contains:
Hyoscyamine Sulfate, USP …… 0.125 mg.
Hyoscyamine sulfate is one of the principal anticholinergic/ antispasmodic components of belladonna alkaloids.
Figure 1: Hyoscyamine Sulfate
(C17H23NO3)2 • H2SO4 • 2H2O M.W. = 712.85
INACTIVE INGREDIENTS
Inactive ingredients include: Green LKB #LB-620, lactose monohydrate, magnesium stearate (veg), mannitol USP, peppermint flavor, starch and stearic acid.
CLINICAL PHARMACOLOGY
Hyoscyamine has actions similar to those of atropine, but is more potent in both its central and peripheral effects.
This product inhibits gastrointestinal propulsive motility and decreases gastric acid secretions. This product controls excessive pharyngeal, tracheal, and bronchial secretion.
This product is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, this product disappears rapidly from the blood and is distributed throughout the entire body. The majority of hyoscyamine sulfate is excreted in the urine unchanged within the first 12 hours and only traces of hyoscyamine sulfate are found in the breast milk.
INDICATIONS AND USAGE
This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.
This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.
CONTRAINDICATIONS
Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.
WARNINGS
Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.
PRECAUTIONS
Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate.
Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.
Information for Patients
This medication should be taken 30 minutes to one hour before meals. This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness.
Drug Interactions
Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.
Nursing Mothers
This product is excreted in human milk. This product should not be administered to a nursing mother.
Pediatric Use
This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications’ suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.
Geriatric Use
Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions.
ADVERSE REACTIONS
Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic-antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); and decreased sweating.
OVERDOSAGE
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.
Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a d degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100- 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable.
DOSAGE AND ADMINISTRATION
Usual dosage: Adults and children over 12 years of age: 1 to 2 tablets can be chewed or placed on tongue for disintegration, three or four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
HOW SUPPLIED
Oscimin Oral Dispersible Tablets are supplied as round, green, peppermint flavored tablets with “LL” over “254” debossed on one side. They are available in bottles of 100 tablets, NDC 68047-254-01.
Storage and Handling
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.
Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Manufactured for:
Larken Laboratories, Inc.
Canton, MS 39046
Rev. 06/2011 500415
PRINCIPAL DISPLAY PANEL
Figure 2: Container label
| OSCIMIN hyoscyamine sulfate tablet, orally disintegrating | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 08/03/2011 | ||
| Labeler - Larken Laboratories, Inc. (791043719) |
| Registrant - Larken Laboratories, Inc. (791043719) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE | |
More Oscimin Oral Dispersible Tablet resources
- Oscimin Oral Dispersible Tablet Side Effects (in more detail)
- Oscimin Oral Dispersible Tablet Use in Pregnancy & Breastfeeding
- Drug Images
- Oscimin Oral Dispersible Tablet Drug Interactions
- Oscimin Oral Dispersible Tablet Support Group
- 20 Reviews for Oscimin Oral Dispersible - Add your own review/rating
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Thursday, January 20, 2011
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.
| 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.
| 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
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| Duricef cefadroxil powder, for suspension | |||||||||||||||||||||||||||
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| Duricef cefadroxil tablet | ||||||||||||||||||||||||||||||
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| Duricef cefadroxil capsule | |||||||||||||||||||||||||||
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Revised: 05/2007Warner Chilcott, Inc.
More Duricef resources
- Duricef Side Effects (in more detail)
- Duricef Dosage
- Duricef Use in Pregnancy & Breastfeeding
- Drug Images
- Duricef Drug Interactions
- Duricef Support Group
- 0 Reviews for Duricef - Add your own review/rating
- Duricef Concise Consumer Information (Cerner Multum)
- Duricef MedFacts Consumer Leaflet (Wolters Kluwer)
- Duricef Monograph (AHFS DI)
- Duricef Advanced Consumer (Micromedex) - Includes Dosage Information
- Cefadroxil Professional Patient Advice (Wolters Kluwer)
Compare Duricef with other medications
- Bacterial Endocarditis Prevention
- Impetigo
- Kidney Infections
- Skin and Structure Infection
- Skin Infection
- Tonsillitis/Pharyngitis
- Upper Respiratory Tract Infection
- Urinary Tract Infection
Wednesday, January 12, 2011
Pindololo
Pindololo may be available in the countries listed below.
Ingredient matches for Pindololo
Pindolol
Pindololo (DCIT) is known as Pindolol in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Click for further information on drug naming conventions and International Nonproprietary Names.
Tuesday, January 11, 2011
Cevit
Cevit may be available in the countries listed below.
Ingredient matches for Cevit
Ascorbic Acid
Ascorbic Acid is reported as an ingredient of Cevit in the following countries:
- Venezuela
International Drug Name Search
Friday, January 7, 2011
Polised
Polised may be available in the countries listed below.
Ingredient matches for Polised
Dextromethorphan
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Polised in the following countries:
- Italy
Sulfogaiacol
Sulfogaiacol is reported as an ingredient of Polised in the following countries:
- Italy
International Drug Name Search
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