Renasistin

RENASISTIN®
Cefadroxil Anhydrate

COMPOSITION
Renasistin® 500 Capsule
Each capsule contains:
Cefadroxil monohydrate equivalent to Cefadroxil anhydrate 500 mg
Renasistin® 250 Dry Syrup
Each 5 mL contains:
Cefadroxil monohydrate equivalent to Cefadroxil anhydrate 250 mg
Renasistin® OD
Each mL contains:
Cefadroxil monohydrate equivalent to Cefadroxil anhydrate 150 mg

PHARMACOLOGY

Cefadroxil is one of the first generation cephalosporins for oral uses. This antibiotic has bactericidal action which depends on ability to reach and bind penicillin-binding protein located in bacterial cytoplasmic membranes, inhibit bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents crosslinkage of peptidoglycan chains which necessary (or bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited and lysis and elongation of susceptible bacteria frequently occur. Rapidly dividing bacteria are those most susceptible to the action of this generation cephalosporins. Its anti bacterial spectra is included most gram - positive (Salmonella, Shigella, Haemophilus influenza etc), and some gram negative bacteria (E-coli, Klebsiela, Proteus mirabilis).

INDICATIONS
Renasistin® is indicated in the treatment of infections caused by Gram-positive and Gram-negative bacteria.

1. Urinary tract infections: Pyelonephritis, cystitis, urethritis.
2. Respiratory tract infections: Tonsilitis, pharyngitis, bronchitis, pneumonia, bronchopneumonia, abscess of lung, sinusitis, laryngitis, otitis media.
3. Skin and skin-structure infections Lymphadenitis, abscess, cellulitis, erysipelas, furunculosis, mastitis.
4. Other infection caused by bacteria which sensitive to Cefadroxil and its derivative.
5. It is not suggested for upside breathing line infection and otitis media which is caused by H. influenzae.

DOSAGE AND ADMINISTRATION
Renasistin® 500 capsule

1. Adult or children with body weight more than 40 kg:
   
   (500 - 1000) mg, twice daily, depend on the condition of disease
2. Children with body weight less than 40 kg:
   
   • Less than 1 year, old: 25 mg/kg body weight daily in divided dose.
   • (1-6) years old: 250 mg twice daily
   • More than 6 years old: 500 mg twice daily

Renasistin® 250 Dry syrup
To make up the 60 mL of the reconstituted syrups, add the water until mark on the bottle. Shake well until all powder is well dispersed before taking each dose.

1. Adult or children with body weight more than 40 kg : 500 - 1000 mg equivalent to 2-4 teaspoons of Renasistin® 250 Dry Syrup, twice daily, depend on the condition of disease.
2. Children with body weight less than 40 kg:
   
   • Less than 1 year old; 25 mg/kg body weight daily in divided dose.
   • (1-6) years old: 250 mg equivalent to 1 teaspoon of Renasistin® 250 Dry Syrup, twice daily
   • More than 6 years old: 500 mg equivalent to 2 teaspoons of Renasistin® 250 Dry Syrup twice daily

Renasistin® OD
To make up the 15 mL of the reconstituted suspension, add 8 mL of water on the bottle. Shake well until all powder is well dispersed before taking each dose.
The recommended daily dosage for children is 25 mg/kg bb per day in divided doses every 12 hours. It should be administered for at least 10 days.

WARNINGS AND PRECAUTIONS

1. This medication should be used carefully:
• In patients who allergy to penicillin; renal function impairment and patients with collitis.
• In pregnant or breast feeding women.
2. In addition can also give positive-false reaction in coomb reaction and glucose test in urine with Benedict & Fehling reaction.
3. However in long term medication can cause the growth of microorganism which nonsensitive to cefadroxil.

SIDE EFFECTS
Incidence rare: abdominal or stomach cramps, pain, bloating, or diarrhoea, nausea or vomiting, skin rash, unusual weight loss (pseudomembranous collitis). Other reactions which are include as a hepatic disfunction such as cholestasis and the increasing of transaminase serum, pruritus genital, monoliasis genital, vaginitis, neutropenia which occur temporary.

CONTRAINDICATIONS
Renasistin® is contraindicated in patients who have hypersensitivity reaction to cephalosporins or penicillins.

DRUG INTERACTIONS
Probenecid may decrease the renal tubular secretion of cefadroxil when being used concurrently, resulting in increased and more prolonged cefadroxil serum concentration and/or toxicity. The risk increasing of nefrotoxicity in the used of cephalosporins with aminoglicoside or poten diuretic such as furosemid.

STORAGE
Store below 30°C. Protect from light

PRESENTATION
Renasistin® 500 Capsule
Box of 3 strips @ 10 capsules
Reg. No. DKL9131503301 B1

Renasistin® 250 Dry Syrup
Box of Bottle @ 60 mL
Reg. No. DKL9231501938B1

Renasistin® OD
Box of Bottle @ 15mL
Reg. No. DKL0831528436A1

ON MEDICAL PRESCRIPTION ONLY HARUS DENGAN RESEP DOKTER

Manufactured by:
PT. PRATAPA NIRMALA
Tangerang - Indonesia

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