Twicef Pediatric Drops 15 ml bottle

DESCRIPTION

TWICEF (Cefadroxil Monohydrate) is an orally active first generation cephalosporin antibiotic which is more effective against rapidly growing organisms forming cell walls. It acts by inhibiting mucopeptide synthesis in the bacterial cell wall, making it defective and osomotically unstable.

TWICEF is bactericidal in vitro against a wide range of

Gram-positive and Gram-negative microorganisms.

Sensitive Gram-positive organisms include: penicillinase and non-penicillinase producing Staphylococci, betahaemolytic Streptococci, Streptococcus pneumoniae and

Streptococcus pyogenes. Sensitive Gram-negative organisms include: E. coli, Klebsiella spp., Proteus mirabilis, Moraxella (Branhamella) catarrhalis and

Bacteroides spp. (excluding Bacteroides fragilis) and some strains of Haemophilus influenzae.

COMPOSITION

TWICEF 500 capsule: Each capsule contains Cefadroxil Monohydrate USP equivalent to Cefadroxil 500 mg.

TWICEF Powder for suspension: After reconstitution each 5 ml of suspension contains Cefadroxil Monohydrate USP equivalent to Cefadroxil 125 mg.

INDICATIONS

Respiratory tract infections: Tonsillitis, pharyngitis, lobar

and bronchopneumonia, acute and chronic bronchitis,

pulmonary abscess, empyema, pleurisy, sinusitis,

laryngitis, otitis media.

Skin and soft tissue infections: Lymphadenitis, abscesses, cellulitis, decubitus ulcers, mastitis, furunculosis, erysipelas.

Genitourinary tract infections: Pyelonephritis, cystitis, urethritis, gynaecological infections.

Other infections: Osteomyelitis, septic arthritis.

DOSAGE AND ADMINISTRATION

TWICEF can be taken with meals or on an empty stomach.

Adults: 500 mg-1g twice a day, depending on the severity of infection. Alternatively, in skin and soft tissue and uncomplicated urinary tract infections, 1g once a day.

Children:

Under 1 year: 25 mg/kg daily in divided doses.

1-6 years: 250 mg twice a day.

Over 6 years: 500 mg twice a day.

Elderly: Same as adult dose. No specific dosage recommendations or precautions for use in the elderly except to monitor those patients with renal impairment.

In the treatment of beta-haemolytic streptococcal infections, TWICEF should be administered for at least 10 days.

Renal impairment : In patients with renal impairment, the initial dose is 1000 mg of TWICEF and the maintenance dose (based on the creatinine clearance rate [ml/min/1.73m2]) is 500 mg at the time intervals listed

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SIDE EFFECTS

Cefadroxil is usually well tolerated. The most commonly reported side effects are gastrointestinal disturbance and hypersensitivity phenomena. Rash, pruritus, urticaria, angioneurotic oedema have been observed infrequently.

Side effects, including nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, fever, dizziness, headache, arthralgia and genital moniliasis may also occur.

CONTRAINDICATION

Cefadroxil is contra indicated in patients with a history of hypersensitivity to Cefadroxil.

PRECAUTIONS

Use in pregnancy and lactation: Cefadroxil is of pregnancy category B. Although there are no adequate and well controlled studies available in pregnant women, the drug can be used in pregnancy only if clearly needed.

Cefadroxil is excreted in breast milk and should be used with caution in lactating mother.

DRUG INTERACTIONS

No significant data are available.

DIRECTION FOR RECONSTITUTION OF SUSPENSION

Add 65 ml (by using the supplied measuring cup) of boiled and cooled water to the dry powder in the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Discard unused portion of suspension after 14 days.

SUPPLY

TWICEF Capsule 500 mg: Each box contains 5 X 4 capsules in alu-alu blister strips.

TWICEF Powder for suspension: Each bottle contains required amount of powder to prepare 100 ml suspension.