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Lindex®
Composition
Lindex® 250 Capsule: Each capsule contains Cephradine BP 250 mg.
Lindex® 500 Capsule: Each capsule contains Cephradine BP 500 mg.
Lindex® Granules for Suspension: When reconstituted each 5 ml of suspension contains
Cephradine BP 125 mg.
Lindex® DS Granules for Suspension: When reconstituted each 5 ml of suspension contains
Cephradine BP 250 mg.
Lindex® Granules for Paediatric Drops: When reconstituted each 1.25 ml of drops contains
Cephradine BP 125 mg.
Lindex® 500 mg Injection: Each vial contains Cephradine with L-Arginine sterile powder
equivalent to Cephradine BP 500 mg.
Lindex® 1g Injection: Each vial contains Cephradine with L-Arginine sterile powder equivalent
to Cephradine BP 1 g.
Indication and Use
Lindex® (Cephradine) is used in the treatment of following infections caused by sensitive
organisms. Upper respiratory tract infections: Pharyngitis, sinusitis, otitis media, tonsillitis,
laryngo-tracheo bronchitis. Lower respiratory tract infections: Acute & chronic bronchitis, lobar
and bronchopneumonia. Urinary tract infections: Cystitis, urethritis, pyelonephritis. Skin and soft
tissue infections: Abscess, cellulitis, furunculosis, impetigo. Lindex® is also used in the
prophylaxis of infections during surgical procedure.
Dosage and Administration
The dosage may be given without regard to meals. Adult: Oral: The usual dose is 1 to 2 gm daily
in 2 to 4 divided doses. In severe and chronic infection, the dose can be increased up to 4 gm
daily, which should be given in equally divided doses. Injection: The usual dose is 2 to 4 gm
daily in 3 to 4 equally divided doses by deep intramuscular or intravenous route. Dose may be
increased to 8 gm daily in severe infections e.g. septicaemia and endocarditis. Special dose: In
urinary tract infection, the usual dose is 500 mg every 12 hours. In respiratory tract and skin &
skin structure infection, the usual dose is 250 mg every 6 hours or 500 mg every 12 hours. In
lobar pneumonia, the usual dose is 500 mg every 6 hours or 1 gm every 12 hours. Children:
Oral: The usual dose is 25 to 50 mg/kg/day, up to 100 mg/kg daily in severe infection, in 2 to 4
equally divided doses. Injection: The usual dose is 50 to 100 mg/kg/day in 4 equally divided
doses. Dose may be increased up to 200-300 mg/Kg/day in severe infection. Surgical
Prophylaxis: Recommended dose is 1 to 2 gm by intramuscular or intravenous (over 3 to 5
minutes) route. Subsequent parenteral or oral doses can be administered as appropriate. Therapy
should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or
evidence of bacterial eradication has been obtained. Patients with renal impairment: The
following initial dosage schedule is suggested as a guideline based on creatinine clearance.
Further modification in the dosage schedule may be required because of individual variations in
absorption.
Directions for use
Granules for Suspension: Shake the bottle well before adding water. Then add 65 ml of boiled
and cool water (with the help of the provided measuring cup) to the bottle. For ease of
preparation, add water to the bottle in two portions. Then continue shaking the bottle gently until
the granules are mixed properly. Shake the bottle well before each use. Granules for Paediatric
Drops: Shake the bottle well before adding water. Then add 10 ml of boiled and cool water (with
the help of the provided measuring cup) to the bottle. Then continue shaking the bottle gently
until the granules are mixed properly. Shake the bottle well before each use. Intramuscular
Injection: Add 2 ml of Water for Injection to 500 mg vial and 4 ml of Water for Injection to 1
gm vial and shake. Intravenous Injection: Add 5 ml of Water for Injection to 500 mg vial and 10
ml of Water for Injection to 1 gm vial and shake. The solution should be slowly injected directly
into a vein over a 3 to 5 minutes period.
Contraindication
It is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Use in Pregnancy and Lactation
Pregnancy: The safety of cephradine in pregnancy has not been established. The drug should be
prescribed during pregnancy only when clearly indicated. Lactation: Cephradine is excreted into
breast milk in small amount and should be used with caution in lactating mother.
Side Effect
Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Allergic reactions
including skin rashes, urticaria, eosinophilia, angioedema and anaphylaxis may occur and
elevation of hepatic enzyme values have been noted. Neutropenia has been reported.
Superinfection with resistant microorganisms, particularly candida, may follow the treatment.
There is also a possibility of development of pseudomembranous colitis.
Drug Interaction
When administered concurrently, the following drugs may interact with Cephradine.
Bacteriostat: It may interfere with the bactericidal action of cephalosporins in acute infection.
Diuretics: Enhanced possibility for renal toxicity. Probenecid: Increased and prolonged blood
levels of cephalosporins, resulting in increased risk of nephrotoxicity.
Precaution
It should be used with caution in the presence of markedly impaired renal function. Prolonged
use of Cephradine 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. Cephradine should be prescribed with caution in individuals with
history of gastrointestinal diseases particularly colitis.
Warning
Before therapy with Cephradine, careful inquiry should be made to determine whether the patient
has had previous hypersensitivity reactions to Cephradine, Cephalosporins, Penicillins, or other
drugs. Discontinue the drug, if an allergic reaction to Cephradine occurs.
Storage Condition
Capsule: Store at room temperature. Suspension and Drops: Store in a cool and dry place. After
reconstitution, suspension and drops should be stored in a cool and dry place preferably in a
refrigerator (2°- 8°c) and used within 7 days of preparation. Injection: Reconstituted injections
retain their physical and chemical stability for 2 hours at room temperature and for 12 hours at
5°C. Generally, the injection should be used immediately after preparation.
Packaging Quantity
Lindex® 250 Capsule: Box containing 5 x 4 capsules in alu-alu pack.
Lindex® 500 Capsule: Box containing 5 x 4 capsules in alu-alu pack.
Lindex® Granules for Suspension: Bottle containing granules to produce 100 ml of suspension
when reconstituted.
Lindex® DS Granules for Suspension: Bottle containing granules to produce 100 ml of
suspension when reconstituted.
Lindex® Granules for Paediatric Drops: Bottle containing granules to produce 15 ml of drops
when reconstituted.
Lindex® 500 mg Injection: Each box contains 5 blister pack. Each blister pack contains 1 vial
and 1 ampoule of 5 ml Water for Injection USP.
Lindex® 1 g Injection: Each box contains 1 blister pack, a sterile disposable syringe (10 ml) with
an extra needle, an alcohol prep pad and a strip bandage. Each blister pack contains 1 vial and 1
ampoule of 10 ml Water for Injection USP.