Cefadroxil

What is Cefadroxil?

• Cefadroxil (Duricef; Ultracef) is a semisynthetic cephalosporin antibiotic intended for oral administration used to treat certain infections caused by bacteria such as infections of the skin, throat, tonsils, and urinary tract.

Cefadroxil

Cefadroxil

Cefadroxil V1

What are the uses of this medicine?

Cefadroxil (Duricef; Ultracef) is used for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

• Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
• Skin and skin structure infections caused by staphylococci and/or streptococci.
• Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).

How does this medicine work?

• Cephalosporins are bactericidal because of their inhibition of cell-wall synthesis.

Cefadroxil has been shown to be active against the following organisms:

• Beta-hemolytic streptococci
• Staphylococci, including penicillinase-producing strains
• Streptococcus (Diplococcus) pneumoniae
• Escherichia coli
• Proteus mirabilis
• Klebsiella species
• Moraxella (Branhamella) catarrhalis

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known allergy to the cephalosporin group of antibiotics.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics.

Is this medicine FDA approved?

• It was patented in 1967 and approved for medical use in 1978.

How should this medicine be used?

Recommended dosage: In Adults: Urinary Tract Infections:

• For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single or divided doses.
• For all other urinary tract infections the usual dosage is 2 g per day in divided doses.

Skin and Skin Structure Infections:

• For skin and skin structure infections the usual dosage is 1 g per day in single or divided doses.

Pharyngitis and Tonsillitis:

• Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis— 1 g per day in single or divided doses for 10 days.

In Children: For urinary tract infections:

• The recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours.

For pharyngitis, tonsillitis, and impetigo:

• The recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours.

For other skin and skin structure infections:

• The recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours.

• In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil monohydrate should be administered for at least 10 days.

Administration:

• Cefadroxil comes as a capsule, tablet, and suspension (liquid) to take by mouth.
• It is usually taken with or without food every 12 or 24 hours .
• Take cefadroxil at around the same times every day.
• Take cefadroxil with food to reduce nausea and stomach upset.
• Shake the suspension well before each use to mix the medication evenly.
• You should begin to feel better during the first few days of treatment with cefadroxil.
• Continue to take cefadroxil until you finish the prescription even if you feel better.
• If you stop taking cefadroxil too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule, tablet, and suspension (liquid)

This medicine is available in fallowing brand namesː

• Duricef; Ultracef

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dyspepsia
• nausea and vomiting
• Diarrhea
• Allergies (in the form of rash, urticaria, angioedema, and pruritus)
• cholestasis and elevations in serum transaminase
• genital pruritus
• genital moniliasis
• vaginitis
• moderate transient neutropenia
• fever

Cefadroxil may cause serious side effects which may include:

• Anaphylaxis
• Agranulocytosis
• thrombocytopenia
• idiosyncratic hepatic failure
• erythema multiforme
• Stevens-Johnson syndrome
• serum sickness
• arthralgia

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefadroxil monohydrate, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
• Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• Cefadroxil monohydrate should be used with caution in the presence of markedly impaired renal function. In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.
• Prescribing cefadroxil monohydrate in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Prolonged use of cefadroxil monohydrate 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.
• Cefadroxil monohydrate should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis.
• Patients should be counseled that antibacterial drugs including cefadroxil capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may

(1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefadroxil capsules or other antibacterial drugs in the future.

• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.
• Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• cephalosporins is not associated with significant outcomes.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• No action is required other than general support and observation.
• For amounts greater than 250 mg/kg, induce gastric emptying.
• 63% of a 1 g oral dose is extracted from the body during a 6–8 hour hemodialysis session.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• CEFADROXIL

Inactive Ingredients:

• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN
• CELLULOSE, MICROCRYSTALLINE
• SHELLAC
• POTASSIUM HYDROXIDE
• MAGNESIUM STEARATE
• PROPYLENE GLYCOL
• TITANIUM DIOXIDE
• FERROSOFERRIC OXIDE
• CROSPOVIDONE

Who manufactures and distributes this medicine?

Manufactured by:

• Lupin Limited
• Mandideep
• INDIA

Manufactured for:

• Lupin Pharmaceuticals, Inc.
• Baltimore, Maryland
• United States

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F).

• Dailymed label info on Cefadroxil
• FDA Cefadroxil