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TEVA-CEPHALEXIN is a brand name for Cephalexin (also known as Cefalexin), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Of 12,917 patients treated with cephalexin in formal clinical trials, 771(6%) reported adverse events, of which 385 (3%) were judged to be drug related(8) . 6% reacted. The incidence of reported side effects is shown in Table 1. I. 2 Other adverse reactions experienced less frequently include: glossitis/stomatitis, oral moniliasis, pruritus ani, gastroenteritis, fever, pruritus, a positive direct Coombs', allergy/anaphylaxis, intertrigo, angioedema, dizziness, paresthesia, somnolence, visual hallucination/diplopia, insomnia, tremor, leucorrhea, dysuria, malaise/fatigue, super infection, myalgia/back pain, nuchal swelling, dyspnea, cardiac arrhythmia and vasodilatation.
3%) had abnormal laboratory values. There was no consistent pattern of abnormality and only 2 patients were withdrawn from studies as a result of these findings. 4 Biochemical Elev. Alk Phosphatase. 2 Elev. 3 Elev. 2 Renal Elev. 1 Other abnormal values reported less frequently included: elevated creatinine, bilirubin and cholesterol; decreased platelets, hemoglobin and/or hematocrit.
The following adverse reactions have been reported during postmarketing experience: Gastrointestinal: Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported.
The most frequent side effect has been diarrhea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.
Hypersensitivity:
Allergic reactions in the form of rash, urticaria, angioedema, 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, eosinophilia, neutropenia, leukopenia, thrombocytopenia, and slight elevations in SGOT and SGPT have been reported. Vertigo, tinnitus, hearing loss and behavioural changes in young children have been reported with cephalexin use.
OVERDOSAGE Activated charcoal may be administered to aid in the removal of unabsorbed drug. General supportive measures are recommended.
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.
TEVA-CEPHALEXIN (cephalexin) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. WARNINGS Before therapy with TEVA-CEPHALEXIN (cephalexin) is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
TEVA-CEPHALEXIN should be given only with caution to penicillin-sensitive patients. There is some evidence of cross-allergenicity between the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both.
Antibiotics including TEVA-CEPHALEXIN should be administered with caution, and then only when absolutely necessary, to any patient who has demonstrated some form of allergy, particularly to drugs. Of 12,917 clinical trial patients, 462 had histories of penicillin allergy (8).
6 percent) were among those in whom possible allergic reactions to cephalexin were observed. Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment.
When SCAR is suspected, TEVA-CEPHALEXIN should be discontinued and appropriate therapy and/or measures should be taken. Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including cephalexin.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment:
Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary. 7 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.
For management of a suspected drug overdose, contact your regional Poison Control Centre Immediately. DOSAGE AND ADMINISTRATION TEVA-CEPHALEXIN (cephalexin) is administered orally. The adult dosage ranges from 1 to 4 g daily in divided doses.
The usual adult dose is 1 g/day in divided doses every 6 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of TEVA-CEPHALEXIN greater than 4 g are required, parenteral cephalosporins, in appropriate doses should be considered.
The recommended daily dosage for children is 25 to 50 mg/kg/day in divided doses every 6 hours. For the treatment of bacterial pharyngitis caused by Streptococcus pyogenes group A, and, acute cystitis, the daily dosage may be divided into two and given every 12 hours.
TEVA-CEPHALEXIN SUSPENSION CHILD’S WEIGHT 125 mg/5 mL 250 mg/5 mL 10 kg (22 lb) 1/2 to 1 tsp. d. -- 20 kg (44 lb) 1 to 2 tsp. d. 1/2 to 1 tsp. d. 40 kg (88 lb) 2 to 4 tsp. d. 1 to 2 tsp. d. OR 10 kg (22 lb) 1 to 2 tsp. d. - 20 kg (44 lb) 2 to 4 tsp.
d. 1 to 2 tsp. d. 40 kg (88 lb) 4 to 8 tsp. d. 2 to 4 tsp. d In severe infections, the dosage may be doubled. In the treatment of beta hemolytic streptococcal infections, TEVA-CEPHALEXIN therapy […]
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an 4 antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe case (see ADVERSE REACTIONS).
Susceptibility/Resistance Development of Drug-Resistant Bacteria Prescribing TEVA-CEPHALEXIN in the absence of' a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
PRECAUTIONS As is the case with all drugs, patients should be followed carefully so that adverse reactions or unusual manifestations of drug idiosyncrasy may be detected. , epinephrine or other pressor amines, antihistamines, or corticosteroids).
Prolonged use of cephalexin may result in overgrowth of non susceptible organisms. Careful observation of the patient is essential. If super infection occurs during therapy, appropriate measures should be taken. TEVA-CEPHALEXIN should be administered with caution in the presence of markedly impaired renal function.
Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended. If TEVA-CEPHALEXIN is to be used for long term therapy, periodic monitoring of hematology, renal and hepatic functions should be done.
, the incision and drainage of abscesses. Safety of this product for use during pregnancy has not been established. 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.
In patients being treated with TEVA-CEPHALEXIN, a false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with Clinitest tablets, but not with Tes- Tape® (Glucose Enzymatic Test Strip, USP).
5 ADVERSE REACTIONS Of 12,917 patients treated with cephalexin in formal clinical trials, 771(6%) reported adverse events, of which 385 (3%) were judged to be drug related(8) . 6% reacted. The incidence of reported side effects is shown in Table 1.
I. 2 Other adverse reactions experienced less […]