Fasiclor

Uses

Oticlor is used for the treatment of the following infections:

Otitis media

Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis

Upper respiratory tract infections, including pharyngitis and tonsillitis

Urinary tract infections, including pyelonephritis and cystitis

Skin and soft tissue infections

Sinusitis

Fasiclor is also used to associated treatment for these conditions: Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenza, Acute Exacerbations of Chronic Bronchitis caused by Moraxella catarrhalis, Bacterial Infections, Bacterial Urinary Tract Infections, Lower respiratory tract infection bacterial, Staphylococcal Skin Infections, Streptococcal Pharyngitis, Streptococcal tonsillitis, Bacterial otitis media, Streptococcus pyogenes skin infection, Susceptible Bacterial Infections

How Fasiclor works

Fasiclor, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits 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 cefaclor interferes with an autolysin inhibitor.

Dosage

Fasiclor dosage

Fasiclor Monohydrate is administered orally.

Children: The usual recommended dosage for children is 20 mg/kg/day in divided doses every 8 hours. The dose of Oticlor suspension and paediatric drops for children is given in the following:

Age Fasiclor Monohydrate suspension , Fasiclor MonohydratePaediatric Drops

1 month - 1 year 2.5 ml t.i.d. 0.625 ml t.i.d

1 year - 5 year 5 ml t.i.d. 1.25 ml t.i.d

over 5 years 10 ml t.i.d 2.5 ml t.i.d

In more serious infections, such as otitis media, or those caused by less susceptible organisms, 40 mg/kg/day is recommended, with a maximum dosage of 1 gm/day. Safety and efficacy have not been established for use in infants aged less than 1 month.

Adults: The usual adult dose is 250 mg every 8 hours. For bronchitis, the dosage is 250 mg administered 3 times daily. A dosage of 250 mg administered 3 times daily for 10 days is recommended for sinusitis. For more severe infections, such as pneumonia, or those caused by less susceptible organisms, dose may be doubled.

Fasiclor may be administered safely in the presence of impaired renal function. Under such conditions, dosage is usually unchanged.

Side Effects

Most adverse effects reported with Fasiclor are similar to those reported with other oral cephalosporins. The most frequent adverse effects reported include gastrointestinal effects (nausea, vomiting, diarrhea) headache and rash. Rarely, Serum sickness-like reactions consisting of erythema multiforme, urticaria accompanied by arthritis, arthralgia, irritability and fever have been reported.

Toxicity

Symptoms of overdose include diarrhea, nausea, stomach upset, and vomiting.

Precaution

Fasiclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.

Interaction

There have been reports of increased anticoagulant effect when Fasiclor and oral anticoagulants were administered concomitantly. The renal excretion of Fasiclor is inhibited by probenecid.

Direction for reconstitution of suspension

For 100 ml suspension: Add 60 ml (12 measuring spoonful) of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Paediatric drops: Add 10 ml (2 measuring spoonful) of boiled and cooled water to the bottle and shake vigorously.

Note: Shake the suspension and paediatric drop well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator. The made up suspension can be used within 7 days if it is stored at room temperature and 14 days if it is kept in refrigerator.

Food Interaction

• Take with or without food.

Fasiclor Drug Interaction

Unknown: aspirin, aspirin, amoxicillin / clavulanate, amoxicillin / clavulanate, ciprofloxacin, ciprofloxacin, ginkgo, ginkgo, acetaminophen, acetaminophen, thiamine, thiamine, cyanocobalamin, cyanocobalamin, pyridoxine, pyridoxine, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol

Fasiclor Disease Interaction

Major: colitisModerate: renal dysfunction, dialysis, liver disease, seizure disorders

Elimination Route

Well absorbed after oral administration, independent of food intake.

Half Life

0.6-0.9 hour

Elimination Route

Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours.

Pregnancy & Breastfeeding use

Pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when prescribing for the pregnant women.Lactation: Small amount of Fasiclor have been detected in breast milk following administration of single 500 mg dose. As the effect on nursing infants is not known, caution should be exercised when Fasiclor is administered to a nursing woman.

Contraindication

Fasiclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Acute Overdose

The symptoms following an overdose of Fasiclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity of the epigastric distress and diarrhea is dose related.

Unless 5 times the normal dose of Fasiclor has been ingested, gastrointestinal lavage will not be necessary.

Storage Condition

Store in a cool and dry place. Protect from light.

Innovators Monograph

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