Safdroxil

Uses

Safdroxil Monohydrate (Safdroxil Monohydrate) is used for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

*Upper respiratory tract infections caused by Streptococcus pyogenes (Group A beta-hemolytic Streptococci) and Streptococcus pneumoniae.

* Urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species.

* Skin and soft tissue infections caused by Staphylococci (including penicillinase producing strains) and Streptococci.

Safdroxil is also used to associated treatment for these conditions: Bacterial Infections, Infection and inflammatory reaction due to internal prosthetic device, implant, and graft, Skin and Subcutaneous Tissue Bacterial Infections, Streptococcal Pharyngitis, Streptococcal tonsillitis, Urinary Tract Infection

How Safdroxil works

Like all beta-lactam antibiotics, cefadroxil binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefadroxil interferes with an autolysin inhibitor.

Dosage

Safdroxil dosage

The bioavailability and consequent chemotherapeutic effects of Safdroxil are unaffected by foods. It may, therefore, be taken with meals or on an empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.IndicationAdult (dose)Children (Dose)

Upper respiratory tract Infections

1 gm per day in single (q.d.) or divided doses (b.i.d.) for 10 days 12 hourly

30 mg/kg/day in a single or in equally divided doses every 12 hours

Urinary Tract Infections

1 or 2 gm per day in single (q.d.) or divided doses (b.i.d.)

30 mg/kg/day in equally divided doses every 12 hours

For all other UTIs

2 gm per day in divided doses (b.i.d)

30 mg/kg/day in equally divided doses every 12 hours

Skin & soft tissue Infections

1 gm per day in single (q.d.) or divided doses (b.i.d.)

30 mg/kg/day in equally divided doses every 12 hours

Prophylaxis against bacterial endocarditis

2 gm 1 hour prior to the procedure

50 mg/kg 1 hour prior to the procedure

Direction for Reconstitution of suspension

For 100 ml suspension and 100 ml DS suspension: Add 65 ml (13 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

For 60 ml suspension: Add 40 ml (8 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Paediatric Drops: Add 10 ml (2 measuring spoonful) to the bottle and shake vigorously.

Note: Shake both oral suspension and paediatric drops well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Side Effects

Generally cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena. Side effects including nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, fever, dizziness, headache, arthralgia may also occur.

Toxicity

Nausea, vomiting, diarrhoea, allergic rashes may occur

Precaution

History of hypersensitivity to penicillins or any other β-lactam drugs. History of GI disease (particularly colitis), severe allergies or asthma. Renal impairment. Pregnancy and lactation.

Interaction

There is no known clinically important drug interactions with Safdroxil.

Food Interaction

• Take with or without food. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

Safdroxil Drug Interaction

Unknown: diphenhydramine, diphenhydramine, atorvastatin, atorvastatin, polyethylene glycol 3350, polyethylene glycol 3350, acetaminophen, acetaminophen, levothyroxine, levothyroxine, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, sertraline, sertraline

Safdroxil Disease Interaction

Major: colitisModerate: renal dysfunction, dialysis, seizure disorders

Elimination Route

Safdroxil is well absorbed on oral administration; food does not interfere with its absorption.

Half Life

1.5 hours

Elimination Route

Over 90% of the drug is excreted unchanged in the urine within 24 hours. Safdroxil was detected in the placenta and breast milk.

Pregnancy & Breastfeeding use

Safdroxil (Safdroxil Monohydrate) is widely used as a first-line oral antibiotic for the treatment of uncomplicated urinary tract infections in pregnant women.

Contraindication

Safdroxil is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Acute Overdose

If amounts >250 mg/kg is ingested, gastric lavage or simulation of vomiting is appropriate.

Storage Condition

Store between 20-25°C. Reconstituted powder for suspension: Store between 2-8°C.

Innovators Monograph

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