Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1328
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Cephalexin (Powder, For Suspension)
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Cephalexin for Oral Suspension, USP is administered orally.<br/>Adults :: The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin for Oral Suspension, USP greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.<br/>Pediatric Patients :: The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours. In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. In the treatment of��-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin for Oral Suspension, USP should be administered for at least 10 days.
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Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-��-Amino-��-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula CHNOS���HO and the molecular weight is 365.41. Cephalexin has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Cephalexin for Oral Suspension, USP is a white to off white granular powder with characteristic flavor, and gives orange colored viscous suspension after reconstitution with water. After mixing, each 5 mL of Cephalexin for Oral Suspension, USP, will contain cephalexin monohydrate equivalent to 125 mg (360 micro mol) or 250 mg (720 micro mol) of anhydrous cephalexin. The suspensions also contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No.6, tutti-frutti flavor, orange flavor, sodium lauryl sulphate, sucrose and xanthan gum.
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Human Pharmacology:: Cephalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL respectively were obtained at 1 hour. Measurable levels were present 6 hours after administration. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250-mg, 500-mg, and 1-g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.<br/>Microbiology:: In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis.Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Aerobes, Gram-positive: Staphylococcus aureus (including penicillinase-producing strains) Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Aerobes, Gram-negative: Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella (Branhamella) catarrhalis Proteus mirabilis Note - Methicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis [formerly Streptococcus faecalis]) are resistant to cephalosporins, including cephalexin. It is not active against most strains of Enterobacter spp., Morganella morganii, and Proteus vulgaris. It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus. Penicillin - resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics.<br/>Susceptibility Tests:
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Cephalexin for Oral Suspension, USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
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Cephalexin for Oral Suspension, USP is a white to off white granular powder with characteristic flavor, and gives orange colored viscous suspension after reconstitution with water. Cephalexin for Oral Suspension, USP, is available in: The 125 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-142-38 200 - mL Bottles NDC 42043-142-58 The 250 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-143-38 200 - mL Bottles NDC 42043-143-58 After mixing store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Prior to mixing, store at 20��to 25��C (68��to 77��F) [see USP Controlled Room Temperature].
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Signs and Symptoms:: Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. If other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication.<br/>Treatment:: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference(PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated. The oral median lethal dose of cephalexin in rats is>5000 mg/kg.
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Cephalexin
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Cephalexin (Powder, For Suspension)
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Gastrointestinal:: Onset of pseudomembranous colitis may occur during or after antibacterial treatment. Nausea and vomiting have been reported rarely. The most frequent side effect has been diarrhea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia, gastritis, and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.<br/>Hypersensitivity:: Allergic reactions in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. In some of these reactions, supportive therapy may be necessary. Anaphylaxis has also been reported. Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in AST and ALT have been reported. In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:<br/>Adverse Reactions:: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction and toxic nephropathy. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced . If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.<br/>Altered Laboratory Tests:: Prolonged prothrombin time, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, pancytopenia, leukopenia, and agranulocytosis.
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Cephalexin for Oral Suspension, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infection, including the prophylaxis of rheumatic fever. Cephalexin for Oral Suspension, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, andKlebsiella pneumoniae 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 Cephalexin for Oral Suspension, USP and other antibacterial drugs, Cephalexin for Oral Suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Whenculture 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.
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Cephalexin
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