RM CEFALEXIN 100MG DROPS 10ML

Medicine Information

What is this medicine used for?

For the treatment of the following infections by susceptible microorganisms:

• Skin and skin structure infections.
• Bone and joint infections.
• Genitourinary tract infections, including acute prostatic.
• Respiratory tract infections including acute and chronic bronchitis and infected bronchiectasis.
• Ear, nose and throat infections including otitis media, mastoiditis, sinusitis, follicular sinusitis, and pharyngitis.
• Dental infections.

How much and how often should you use this medicine?

Use in Adult: 250mg every 6 hours (Maximum dose: 4g/day)

Usual Pediatric Dose: 25 to 50 mg/kg body weight/day to be given in equally divided doses every 6 hours.

Contraindication:

Known hypersensitivity to cephalosporins, penicillins, or any component of the product.

Warnings and Precautions:

• Careful inquiry should be made prior to cefalexin therapy to determine whether the patient has had previous hypersensitivity reactions to cefalexin, cephalosporins, penicillins, or other drugs.
• Use with caution in patients with penicillin sensitivity since cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of allergy to penicillin.
• In case of an allergic reaction to cefalexin, the drug should be discontinued. Serious acute hypersensitivity reactions may require immediate treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, corticosteroids, pressor amines, and airway management, as clinically indicated.
• Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
• Cephalosporins, including cefalexin, have been associated with the development of seizures, particularly in patients with renal impairment, in whom dosage of drug was not reduced. If seizures due to cefalexin develop, the drug should be discontinued and treatment with an anticonvulsant should be given as clinically indicated.
• Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk include those with renal or hepatic impairment, poor nutritional state, those receiving a prolonged course of antimicrobial therapy, and patients stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk, and exogenous Vitamin K administered as indicated.
• A false-positive Coombs test has been reported during treatment with other cephalosporins. It should be recognized that a positive Coombs test may be due to the drug (e.g., Coombs testing of newborns whose mother has received cephalosporins before parturition or in hematologic studies or in transfusion cross-matching procedures where anti-globulin tests are performed).
• Use with caution in patients with renal impairment. Careful clinical and laboratory monitoring should be done, as the safe dosage may be lower than usually recommended.
• Periodic assessment of organ system function, including renal, hepatic, and hematopoietic, is recommended during prolonged therapy.
• Prescribing cefalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and may increase the risk of antibiotic resistance.
• As with other antibacterial drugs, long-term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.

Undesirable Effects:

• GI: Abdominal cramp/pain, anorexia, CDAD, colitis, diarrhea, dyspepsia, gastritis, gastroenteritis, glossitis/stomatitis, nausea, vomiting.
• Dermatologic: Anaphylaxis, angioedema, eosinophilia, erythema multiforme, fever, genital and anal pruritus, intertrigo, pruritus, rash, serum sickness-like reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
• Hematologic: Decreased hemoglobin and/or hematocrit, hemolytic anemia, reversible leukopenia, neutropenia, decreased platelets, positive direct and indirect antiglobalin test results, thrombocytopenia.
• Renal and Genitourinary: Transient increase in blood urea nitrogen (BUN) and serum creatinine concentrations, dysuria, reversible interstitial nephritis, nephrotoxicity, leukorrhea, pruritus vulvae, vaginal discharges, vulvovaginitis.
• Hepatic: Transient increase in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase concentrations, increased serum bilirubin, transient hepatitis, and cholestatic jaundice.
• Nervous System: Agitation, confusion, diplopia, dizziness, fatigue, headache, hallucinations, insomnia, malaise, paresthesia, somnolence, tremor, toxic paranoid reactions. Vertigo, tinnitus, hearing loss, and behavioral changes in young children have been reported with cefalexin use.
• Other AE: Arthralgia, myalgia, arthritis, joint disorder, back pain, nuchal swelling, cardiac arrhythmia, vasodilation, dyspnea, superinfection, elevated cholesterol.

Interaction with other medicaments:

• Alcohol: Disulfiram-like reactions may occur when alcohol is ingested within 48-72 hours after administration of beta-lactam antibiotics containing an N-methylthiotetrazole side chain. The reactions appear to result from accumulation of acetaldehyde and do not occur if alcohol is ingested prior to the first dose. Alcohol ingestion during 24 to 72 hours after administration of some cephalosporins should be avoided.
• Estrogen or Progestin: Some cephalosporins may reduce the efficacy of oral contraceptives.
• Metformin: When single 500 mg doses of cefalexin and metformin were given to 12 healthy subjects, plasma metformin Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. Information on the interaction between cefalexin and metformin after multiple doses is unavailable. Careful patient monitoring and metformin dose adjustment is recommended during concomitant therapy.
• Nephrotoxic drugs: Concurrent use of nephrotoxic agents such as aminoglycosides, colistin, polymyxin B, or vancomycin may increase the risk of nephrotoxicity with some cephalosporins and should probably be avoided, if possible.
• Diuretics: Concurrent treatment with high doses of cephalosporins and potent diuretics (e.g., furosemide) may adversely affect renal function.

Indication

For the treatment of the following infections caused by susceptible microorganisms

Ingredients

Each ml reconstituted suspension (oral drops) contains: Cefaclor ( as monohydrate) 100mg Flavor: Orange