Cephalexin, 500 mg capsules 16 pcs

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Indications

Active ingredient

Composition

Each capsule contains:

The active substance:

Cephalexin monohydrate (in terms of cephalexin) – 250 mg;

Excipients:

Methylcellulose (metocel A15) – 4.2 mg, calcium stearate monohydrate – 3 mg, potato starch – to the weight of the capsule contents of 300 mg;

Capsule composition: Gelatin – 80.751 mg, glycerol – 0.122 mg, purified water – 13.92 mg, methyl parahydroxybenzoate – 0.35 mg, propyl parahydroxybenzoate – 0.089 mg, titanium dioxide – 0.644 mg, sodium lauryl sulfate – 0.056 mg, sunset yellow dye E110 – 0.013 mg, quinoline yellow dye E104 – 0.055 mg.

How to take, the dosage

Overly, 30-60 minutes before a meal with water.

Adults and children over 12 years of age with a body weight of more than 40 kg are prescribed in a dose of 250 mg 4 times daily (every 6 hours) or 500 mg 2 times daily (every 12 hours).

The daily dose for adults and children over 12 years of age is 1000 mg; in severe course of infection the daily dose can be increased to 4000 mg.

In patients with impaired renal function the daily dose is adjusted taking into account the creatinine clearance: in creatinine clearance of 5-20 ml/min the maximum daily dose is 1500 mg/day; in creatinine clearance less than 5 ml/min – 500 mg/day.

The duration of treatment depends on the nature and severity of the pathological process and is determined by the data of bacteriological studies. Usually the duration of treatment is 7-14 days, but in severe infectious diseases may require longer therapy. In most infectious diseases the treatment continues for at least another 48-72 hours after the disappearance of symptoms of the disease and/or according to the results of bacteriological analysis.

Infections caused by group A beta-haemolytic streptococcus, the minimum duration of treatment is 10 days.

Interaction

Concomitant use with furosemide. etacrynic acid, nephrotoxic antibiotics (e.g., aminoglycosides, polymyxins), phenylbutazone increases the risk of renal damage.

Drugs that reduce tubular secretion increase the concentration of the drug in the blood and slow its excretion.

In case of concomitant use with metformin, it may be necessary to adjust the dose of the latter.

Salicylates and indomethacin slow down excretion of cephalexin.

Decreases prothrombin index, increases the effect of indirect anticoagulants.

Hypokalemia has been described in a patient with leukemia taking cytotoxic drugs when prescribed gentamicin and cephalexin.

Special Instructions

Before initiating treatment with cephalexin, a detailed history of prior hypersensitivity reactions to penicillins, cephalosporins or other agents causing an allergic reaction in the patient should be taken. Patients with a history of allergic reactions to penicillins and carbapenems may have hypersensitivity to cephalosporin antibiotics. If an allergic reaction develops, treatment with the drug should be discontinued and appropriate measures taken.

Pseudomembranous colitis has been described in cases of pseudomembranous colitis when taking antibiotics, the severity of which may vary from mild to life-threatening. Therefore, the differential diagnosis of pseudomembranous colitis should be made in patients with diarrhea that occurs during or after treatment with antibiotics. If diarrhea is prolonged or severe or if the patient experiences abdominal cramps, treatment with the drug should be stopped immediately and the patient should be examined. Medicines which inhibit intestinal peristalsis should not be used.

Cases of acute generalized exanthematous pustulosis have been described during treatment with cephalexin. When prescribing the drug, patients should be informed about the signs and symptoms of acute generalized exanthematous pustulosis and closely monitor the skin reactions. In case of skin reactions characteristic of acute generalized exanthematous pustulosis, treatment with cephalexin should be stopped immediately. A significant proportion of cases of acute generalized exanthematous pustules have been reported during the first week of therapy.

Long-term use of cephalexin may lead to overgrowth of resistant microorganisms. If superinfections develop during treatment, appropriate measures should be taken.

A positive direct Coombs reaction is possible during treatment with cephalexin. False positive results of glucose determination in urine in tests based on reduction of copper ions (with Benedict or Feling solutions or with tablets Clinitest) may be observed during treatment with the drug.

In patients with impaired renal function cumulation is possible (dosing regimen adjustment is required).

In staphylococcal infection there is a cross-resistance between cephalosporins and isoxazolylpenicillins.

Patients should be particularly cautious while using the drug to drive vehicles and engage in other potentially hazardous activities due to possible adverse reactions from the central nervous system, such as dizziness, agitation, seizures, hallucinations.

Contraindications

Hypersensitivity (including to other beta-lactam antibiotics), children under 10 years of age (for this dosage form).

Renal insufficiency, pseudomembranous colitis (history).

Side effects

Allergic reactions: rash, urticaria, Quincke’s edema, erythema multiforme, eosinophilia, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactic shock.

Skin disorders: acute generalized exanthematous pustulosis.

Digestive system disorders: abdominal pain, dry mouth, anorexia, nausea, vomiting, diarrhea, flatulence, gastritis, toxic hepatitis, cholestatic jaundice, increased “liver” transaminases and alkaline phosphatase activity, increased bilirubin concentration, candidiasis of intestine, oral cavity, pseudomembranous colitis.

Nervous system disorders: dizziness, weakness, headache, agitation, hallucinations, seizures.

Urinary system disorders: interstitial nephritis, itching of the genitals and anus, vaginitis, vaginal discharge, candidiasis of the genitals.

Hematopoietic organs: leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

Motor system disorders: arthralgia, arthritis.

Laboratory measures: increase in prothrombin time.

Others: fever.

Overdose

Symptoms: Vomiting, nausea, epigastric pain, diarrhea, hematuria.

Treatment: Activated charcoal, maintenance of airway patency, control of vital functions: blood gas, electrolyte balance.

Pregnancy use

Prenatal use of the drug is possible only when the estimated benefit to the mother exceeds the potential risk to the fetus.

If it is necessary to use the drug during breastfeeding, breastfeeding should be stopped.