vitamin A, D, and E topical

Generic Name: vitamin A, D, and E (topical) (VYE ta min A, D, and E)

Brand names: A & D, Aloe Grande, Lazer Creme, Vitamin A & D, Topical, ...show all 12 brand names.Vitamin A & D, Topical, Caldesene (obsolete), Lobana Peri-Garde, Lazer Creme (obsolete), Lobana Derm-Ade, A & D, Vita-Ray

What is vitamin A, D, and E topical?

Vitamin A, D, and E topical is a skin protectant. It works by moisturizing and sealing the skin, and aids in skin healing.

This medication is used to treat diaper rash, dry or chafed skin, and minor cuts or burns.

Vitamin A, D, and E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vitamin A, D, and E topical?

Call your doctor if your skin condition does not get better after using this medication regularly for 1 week. Contact your doctor at any time if your symptoms get worse.

Call your doctor at once if you have swelling, redness, itching, pus, or other signs of infection. Tell your doctor if you feel any numbness or tingling while using vitamin A, D, and E topical.

Do not apply vitamin A, D, and E topical over large skin areas. Do not use the medicine to treat a deep cut, an animal bite, or a serious burn. Call your doctor for instructions on how to treat these more severe skin injuries.

Avoid applying other creams, lotions, ointments, or other medicated skin products to the same areas you treat with vitamin A, D, and E topical.

What should I discuss with my health care provider before using vitamin A, D, and E topical?

Call your doctor at once if you have swelling, redness, itching, pus, or other signs of infection. Tell your doctor if you feel any numbness or tingling while using vitamin A, D, and E topical.

Before using vitamin A, D, and E topical, tell your doctor if you are allergic to any medicines or skin products, including soaps, oils, lotions, or creams.

How should I use vitamin A, D, and E topical?

Use this medication exactly as directed on the label, or as your doctor has prescribed it for you. Do not use more of the medication or use it for longer than recommended.

Keep the baby's diaper area as dry as possible. Change wet or soiled diapers immediately to keep wetness and bacteria from irritating the baby's skin. Always put on a new diaper when the baby first wakes up in the morning, and also just before putting the baby to bed each night.

At each diaper changing, clean the baby's skin thoroughly with a disposable baby wipe or clean wet washcloth. Gently wipe inside the skin folds between the thighs and genitals. When cleaning the diaper area of a boy, gently clean under the scrotum and beneath the foreskin of the penis. When cleaning the diaper area of a girl, always wipe from front to back across the vagina.

Call your doctor if your skin condition does not get better after using this medication regularly for 1 week. Contact your doctor at any time if your symptoms get worse.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

It is unlikely that this medication would cause serious problems from an overdose. Do not apply vitamin A, D, and E topical over large skin areas. Call your doctor if you think you have used too much of the medicine.

Call a poison control center if anyone accidentally swallows this medicine.

What should I avoid while using vitamin A, D, and E topical?

Avoid applying other creams, lotions, ointments, or other medicated skin products to the same areas you treat with vitamin A, D, and E topical.

Avoid excessive wetness of the skin areas you are treating. Keep clothing and diapers as dry as possible.

Vitamin A, D, and E topical side effects

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect vitamin A, D, and E topical?

There may be other drugs that can affect vitamin A, D, and E topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More vitamin A, D, and E resources

• Vitamin A, D, and E Support Group
• 0 Reviews for Vitamin A, D, and E - Add your own review/rating

Compare vitamin A, D, and E with other medications

• Diaper Rash

Where can I get more information?

• Your pharmacist can provide more information about vitamin A, D, and E topical.

Hyperlipoproteinemia Type IV, Elevated VLDL Medications

Drugs associated with Hyperlipoproteinemia Type IV, Elevated VLDL

The following drugs and medications are in some way related to, or used in the treatment of Hyperlipoproteinemia Type IV, Elevated VLDL. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Antara

Atromid-S

B-3-50-Nicotinic-Acid

B3-500-Gr-Nicotinic-Acid

Crestor

Fenoglide

Lipitor

Lipofen

Lofibra

Lopid

Niacin-Sr-Nicotinic-Acid

Niacor

Niaspan

Nicotinex

Pravachol

Simcor

Slo-Niacin-Controlled-Release-Capsules

Tricor

Triglide

Zocor

Inocar Plus

Inocar Plus may be available in the countries listed below.

Ingredient matches for Inocar Plus

Cilazapril

Cilazapril monohydrate (a derivative of Cilazapril) is reported as an ingredient of Inocar Plus in the following countries:

• Spain

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Inocar Plus in the following countries:

• Spain

International Drug Name Search

Zylet

loteprednol etabonate and tobramycin

Dosage Form: ophthalmic suspension
Zylet®

loteprednol etabonate 0.5%

and tobramycin 0.3%

ophthalmic suspension

STERILE

DESCRIPTION:

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension), is a sterile, multiple dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.

Loteprednol etabonate:

C24H31ClO7                         Mol. Wt. 466.96

Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate

Tobramycin:

C18H37N5O9                           Mol. Wt. 467.52

Chemical Name:

O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→ 4)-O- [2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl- (1→ 6)] -2-deoxystreptamine

Each mL contains:

Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.7-5.9. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsmol/kg.

CLINICAL PHARMACOLOGY:

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are capable of producing a rise in intraocular pressure.

Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent. It is highly lipid soluble which enhances its penetration into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis,Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Pharmacokinetics:

In a controlled clinical study of ocular penetration, the levels of loteprednol etabonate in the aqueous humor were found to be comparable between Lotemax and Zylet treatment groups.

Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate ophthalmic suspension 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited (<1 ng/mL) systemic absorption occurs with 0.5% loteprednol etabonate.

INDICATIONS AND USAGE:

Zylet is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

CONTRAINDICATIONS:

Zylet, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Zylet is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Sensitivity to topically applied aminoglycosides may occur in some patients. If sensitivity reaction does occur, discontinue use.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

PRECAUTIONS:

General:

For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients (See WARNINGS:).

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Information for Patients:

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using Zylet.

Carcinogenesis, mutagenesis, impairment of fertility:

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate or tobramycin.

Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, a chromosome aberration test in human lymphocytes, or in an in vivo mouse micronucleus assay.

Oral treatment of male and female rats at 50 mg/kg/day and 25mg/kg/day of loteprednol etabonate, respectively, (500 and 250 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at 100 mg/kg/day (1700 times the maximum daily clinical dose).

Pregnancy:

Teratogenic effects

Pregnancy Category C.

Loteprednol etabonate was shown to be teratogenic when administered orally to rats and rabbits during organogenesis at 5 and 3 mg/kg/day, respectively (50 and 30 times the maximum daily clinical dose in rats and rabbits, respectively). An oral dose of loteprednol etabonate in rats at 50 mg/kg/day (500 times the maximum daily clinical dose) during late pregnancy through the weaning period showed a decrease in the growth and survival of pups without dystocia. However, no adverse effect in the pups was observed at 5 mg/kg/day (50 times the maximum daily clinical dose).

Parenteral doses of tobramycin did not show any harm to fetuses up to 100 mg/kg/day (1700 times the maximum daily clinical dose) in rats and rabbits.

There are no adequate and well controlled studies in pregnant women. Zylet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Zylet is administered to a nursing woman.

Pediatric Use:

In a trial to evaluate the safety and efficacy of Zylet in pediatric subjects age zero to six years with lid inflammation, Zylet with warm compresses did not demonstrate efficacy compared to vehicle with warm compresses. Patients received warm compress lid treatment plus Zylet or vehicle for 14 days. The majority of patients in both treatment groups showed reduced lid inflammation. There were no differences in safety assessments between the treatment groups.

Geriatric Use:

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS:

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.

Zylet:

In a 42 day safety study comparing Zylet to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular adverse events reported in approximately 14% of subjects was headache; all other non-ocular events had an incidence of less than 5%.

Loteprednol etabonate ophthalmic suspension 0.2% - 0.5%:

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Tobramycin ophthalmic solution 0.3%:

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

DOSAGE AND ADMINISTRATION:

SHAKE VIGOROUSLY BEFORE USING.

Apply one or two drops of Zylet into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED:

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension) is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes:

2.5 mL (NDC 24208-358-25) in a 7.5 mL bottle

5 mL (NDC 24208-358-05) in a 7.5 mL bottle

10 mL (NDC 24208-358-10) in a 10 mL bottle

USE ONLY IF IMPRINTED NECKBAND IS INTACT.

Storage: Store upright at 15°-25°C (59°-77°F). PROTECT FROM FREEZING.

KEEP OUT OF REACH OF CHILDREN.

Rx only

Revised November 2009

Manufactured by:

Bausch & Lomb Incorporated

Tampa, Florida 33637

©Bausch & Lomb Incorporated

U.S. Patent Numbers: 4,996,335; 5,540,930; 5,747,061

Zylet is a registered trademark of Bausch & Lomb Incorporated

9007702 (FOLDED)

9004402 (FLAT)

Principle Display Panel

NDC 24208-358-10

Bausch & Lomb

Zylet®

loteprednol etabonate 0.5% and tobramycin 0.3%

ophthalmic suspension

Rx only

10 mL

Sterile Ophthalmic Suspension

Zylet  loteprednol etabonate and tobramycin  suspension/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-358 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOTEPREDNOL ETABONATE (LOTEPREDNOL) LOTEPREDNOL ETABONATE 5 mg  in 1 mL TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-358-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-10) 2 24208-358-25 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 2.5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-25) 3 24208-358-05 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 3 5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-358-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050804	12/14/2004

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Revised: 01/2011Bausch & Lomb Incorporated

More Zylet resources

• Zylet Side Effects (in more detail)
• Zylet Dosage
• Zylet Use in Pregnancy & Breastfeeding
• Zylet Drug Interactions
• Zylet Support Group
• 4 Reviews for Zylet - Add your own review/rating

• Zylet Advanced Consumer (Micromedex) - Includes Dosage Information


• Zylet Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Zylet Consumer Overview

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pimecrolimus topical

Generic Name: pimecrolimus topical (pih meh KRA lih muss TOP ik al)

Brand Names: Elidel

What is pimecrolimus topical?

Pimecrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Pimecrolimus topical is used to treat severe atopic dermatitis when other medications have not worked well.

Pimecrolimus may also be used for purposes other than those listed here.

What is the most important information I should know about pimecrolimus topical?

Do not use pimecrolimus topical on a child 2 years of age or younger.

A small number of people have developed skin cancer after using tacrolimus (Protopic) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Pimecrolimus is not for long-term use.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with pimecrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using pimecrolimus topical for 6 weeks.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs or skin products that can affect pimecrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What should I discuss with my healthcare provider before using pimecrolimus topical?

Before using pimecrolimus topical, tell your doctor if you have:

• 
  

  skin cancer or a skin infection (including herpes or chicken pox);

  
  


• 
  

  Netherton's syndrome (a genetic skin disorder);

  
  


• 
  

  a weak immune system (from cancer treatments, HIV/AIDS or certain medicines such as steroids);

  
  


• 
  

  kidney disease; or

  
  


• 
  

  swelling, redness, or irritation of large areas of your skin.

  
  

If you have any of these conditions, you may not be able to use pimecrolimus or you may need a dosage adjustment or special tests during treatment.

Pimecrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use pimecrolimus without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Pimecrolimus passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

A small number of people have developed skin cancer after using pimecrolimus or tacrolimus (Protopic) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

How should I use pimecrolimus topical?

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Pimecrolimus is not for long-term use.

Do not use pimecrolimus topical on a child 2 years of age or younger.

Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.

Wash your hands before and after using pimecrolimus, unless you are using the medication to treat a hand condition.

Apply the medicine only to clean, dry skin. Use the smallest amount needed to apply a thin layer to the skin areas diagnosed with atopic dermatitis. Rub in gently. Do not cover the treated skin with a bandage.

Do not bathe, shower, or swim right after applying pimecrolimus topical. Water may wash off the medicine.

Right after applying pimecrolimus, you may need to rub in a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Talk to your doctor if your skin condition does not improve after using pimecrolimus topical for 6 weeks.

Store pimecrolimus topical at room temperature. Do not freeze. Keep the cap on the cream tube when not in use.

What happens if I miss a dose?

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Pimecrolimus is not expected to cause overdose symptoms.

What should I avoid while using pimecrolimus topical?

Avoid using any other skin product that has not been recommended by your doctor.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with pimecrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to. Avoid drinking alcohol. Drinking alcohol while you are using pimecrolimus topical may cause your skin or face to feel hot and become flushed or red.

Pimecrolimus topical side effects

Stop using pimecrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pimecrolimus and call your doctor if you have:

• 
  

  worsened skin symptoms;

  
  


• 
  

  signs of a skin infection (redness, swelling, itching, oozing);

  
  


• 
  

  swollen glands; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Less serious side effects are more likely to occur. Continue using pimecrolimus and talk with your doctor if you have any of these side effects:

• 
  

  burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);

  
  


• 
  

  swollen hair follicles;

  
  


• 
  

  acne or warts;

  
  


• 
  

  upset stomach;

  
  


• 
  

  muscle pain;

  
  


• 
  

  runny or stuffy nose;

  
  


• 
  

  headache; or

  
  


• 
  

  feeling more sensitive to hot or cold temperatures.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Pimecrolimus topical Dosing Information

Usual Adult Dose for Atopic Dermatitis:

Apply a thin layer to the affected area twice daily and rub in gently and completely.

Usual Pediatric Dose for Atopic Dermatitis:

3 months to 2 years: Not approved by the FDA for use in this age group
>= 2 years: Apply a thin layer to the affected area twice daily and rub in gently and completely

What other drugs will affect pimecrolimus topical?

Before using pimecrolimus topical, tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet).

  
  


• 
  

  erythromycin (Ery-Tab, E-Mycin, E.E.S. and others);

  
  


• 
  

  an antifungal medicine such as ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan); or

  
  


• 
  

  a heart medicine such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene).

  
  

There may be other drugs or skin products that can affect pimecrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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• Elidel Prescribing Information (FDA)


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Where can I get more information?

• Your pharmacist has additional information about pimecrolimus topical written for health professionals that you may read.

See also: pimecrolimus side effects (in more detail)

Cefuroxime Axetil

Class: Second Generation Cephalosporins
Note: This monograph also contains information on Cefuroxime Sodium
Chemical Name: [6R - [6α,7β(Z)]] - 3 - [[(2 - Aminocarbonyl)oxy]methyl] - 7 - [2 - furanyl(methoxyimino)acetyl]amino] - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid monosodium salt
Molecular Formula: C₁₆H₁₆N₄O₈S
CAS Number: 56238-63-2
Brands: Ceftin, Zinacef

Introduction

Antibacterial; β-lactam antibiotic; second generation cephalosporin.^{1 3}

Uses for Cefuroxime Axetil

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or S. pyogenes.^{79 82 88 89 102 110 145 198 199 200 215}

Not a drug of first choice; considered a preferred alternative to amoxicillin or amoxicillin and clavulanate when these drugs are ineffective or cannot be used (e.g., in patients with a history of non-type 1 hypersensitivity reactions to penicillin).^{143 211}

Bone and Joint Infections

Parenteral treatment of bone and joint infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains).¹

Meningitis

Parenteral treatment of meningitis caused by susceptible S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Neisseria meningitidis, or S. aureus (including penicillinase-producing strains).^{7 25 26 43 44 64 159 161}

Not a drug of choice for meningitis;^{58 143 165 217} treatment failures have been reported, especially in meningitis caused by H. influenzae.^{160 162} In addition, bacteriologic response to cefuroxime appears to be slower than that reported with ceftriaxone, which may increase the risk for hearing loss and neurologic sequelae.^{159 161} When a cephalosporin is indicated for the treatment of bacterial meningitis, a parenteral third generation cephalosporin (usually ceftriaxone or cefotaxime) generally recommended.^{58 143 157 158 165}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).^{79 90 91 145 175 215} Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established.^{79 215}

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{45 46 58 143 171 172 173} oral cephalosporins and oral macrolides considered alternatives.^{45 46 58 143 171} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{143 171}

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only).^{79 145 153 164 166 215} Data insufficient to date to establish efficacy for treatment of acute maxillary sinusitis known or suspected to be caused by β-lactamase-producing strains of H. influenzae or M. catarrhalis.^{79 215}

Treatment of secondary bacterial infections of acute bronchitis caused by susceptible S. pneumoniae, H. influenzae (non-β-lactamase-producing strains only), or H. parainfluenzae (non-β-lactamase-producing strains only).^{79 82 92 93 103 124 215}

Treatment of acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae (non-β-lactamase-producing strains only), or H. parainfluenzae (non-β-lactamase-producing strains only).^{79 82 92 93 103 163 215}

Parenteral treatment of lower respiratory tract infections (including pneumonia) caused by susceptible S. pneumoniae, S. aureus (including penicillinase-producing strains), S. pyogenes (group A β-hemolytic streptococci), H. influenzae (including ampicillin-resistant strains), Escherichia coli, or Klebsiella.¹

Treatment of community-acquired pneumonia (CAP).⁵¹ Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae.⁵¹ Also recommended as an alternative in certain combination regimens used for empiric treatment of CAP.⁵¹ Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).⁵¹

For empiric outpatient treatment of CAP when risk factors for drug-resistant S. pneumoniae are present (e.g., comorbidities such as chronic heart, lung, liver, or renal disease, diabetes, alcoholism, malignancies, asplenia, immunosuppression; use of anti-infectives within the last 3 months), ATS and IDSA recommend monotherapy with a fluoroquinolone active against S. pneumoniae (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.⁵¹ Cefuroxime and cefpodoxime may be less active against S. pneumoniae than amoxicillin or ceftriaxone.⁵¹

If a parenteral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend ceftriaxone, cefotaxime or cefuroxime; if an oral cephalosporin is used for treatment of these infections, ATS and IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.⁵¹

Septicemia

Parenteral treatment of septicemia caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains), or Klebsiella.¹

In the treatment of known or suspected sepsis or the treatment of other serious infections when the causative organism is unknown, concomitant therapy with an aminoglycoside may be indicated pending results of in vitro susceptibility tests.^{1 214}

Skin and Skin Structure Infections

Oral treatment of uncomplicated skin and skin structure infections caused by susceptible S. aureus (including β-lactamase-producing strains) or S. pyogenes.^{79 215}

Parenteral treatment of skin and skin structure infections caused by susceptible S. aureus (including β-lactamase-producing strains), S. pyogenes, E. coli, Klebsiella, or Enterobacter.¹

Urinary Tract Infections (UTIs)

Oral treatment of uncomplicated UTIs caused by susceptible E. coli or K. pneumoniae.^{1 79 215}

Parenteral treatment of UTIs caused by susceptible E. coli or K. pneumoniae.^{1 79}

Gonorrhea and Associated Infections

Oral or parenteral treatment of uncomplicated gonorrhea caused by susceptible N. gonorrhoeae.^{1 9 20 79 215 218} May be effective in urethral, endocervical, and rectal gonorrhea;^{125 144 212} not recommended for pharyngeal infections.²¹² Not a drug of choice for treatment of uncomplicated gonococcal infections;^{36 65 143 218} oral cefuroxime may be an alternative for uncomplicated urogenital and anorectal infections when IM ceftriaxone or oral cefixime cannot be used.^{36 218}

Parenteral treatment of disseminated gonococcal infections caused by susceptible N. gonorrhoeae.^{1 9 20} Not included in current CDC recommendations for disseminated gonococcal infections.^{36 218}

Lyme Disease

Treatment of early Lyme disease manifested as erythema migrans.^{50 58 62 79 143 145 147 181 182 183 208 209 210 215} IDSA, AAP, and other clinicians recommend oral doxycycline, oral amoxicillin, or oral cefuroxime axetil as first-line therapy for treatment of early localized or early disseminated Lyme disease associated with erythema migrans, in the absence of specific neurologic involvement or advanced atrioventricular (AV) heart block.^{58 143 182 208 209 210}

Treatment of early neurologic Lyme disease† in patients with cranial nerve palsy alone without evidence of meningitis (i.e., those with normal CSF examinations or those for whom CSF examination is deemed unnecessary because there are no clinical signs of meningitis).^{143 208 209} Parenteral anti-infectives (IV ceftriaxone, IV penicillin G sodium, or IV cefotaxime) recommended for treatment of early Lyme disease when there are acute neurologic manifestations such as meningitis or radiculopathy.^{143 182 208 209}

Treatment of Lyme carditis†.²⁰⁸ IDSA and others state that patients with AV heart block and/or myopericarditis associated with early Lyme disease may be treated with an oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) or a parenteral regimen (IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium).^{143 182 208 209} A parenteral regimen usually recommended for initial treatment of hospitalized patients; an oral regimen can be used to complete therapy and for the treatment of outpatients.^{143 182 208 209}

Treatment of borrelial lymphocytoma†.²⁰⁸ Although experience is limited, IDSA states that available data indicate that borrelial lymphocytoma may be treated with an oral regimen (doxycycline, amoxicillin, or cefuroxime axetil).²⁰⁸

Treatment of uncomplicated Lyme arthritis† without clinical evidence of neurologic disease.^{143 208 209} An oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) can be used,^{143 208 209} but a parenteral regimen (IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium) should be used in those with Lyme arthritis and concomitant neurologic disease.^{143 208} Patients with persistent or recurrent joint swelling after a recommended oral regimen should receive retreatment with the oral regimen or a switch to a parenteral regimen.^{182 208 209} Some clinicians prefer retreatment with an oral regimen for those whose arthritis substantively improved but did not completely resolve; these clinicians reserve parenteral regimens for those patients whose arthritis failed to improve or worsened.²⁰⁸ Allow several months for joint inflammation to resolve after initial treatment before an additional course of anti-infectives is given.²⁰⁸

Perioperative Prophylaxis

Perioperative prophylaxis in patients undergoing noncardiac thoracic or orthopedic surgery.^{71 194} A preferred agent.⁷¹

Has been used for perioperative prophylaxis in patients undergoing cardiac surgery,^{1 66 193 195 196 197 213} GI surgery,^{3 6} or gynecologic or obstetric surgery (e.g., vaginal hysterectomy).^{1 3 6} Other drugs usually preferred.⁷¹

Cefuroxime Axetil Dosage and Administration

Administration

Administer cefuroxime axetil orally.^{79 215} Administer cefuroxime sodium by IV injection or infusion or by deep IM injection.^{1 214}

IV route preferred in patients with septicemia or other severe or life-threatening infections or in patients with lowered resistance, particularly if shock is present.¹

Cefuroxime ADD-Vantage vials,¹ Duplex drug delivery system containing cefuroxime and dextrose injection in separate chambers,²¹⁴ and the commercially available premixed cefuroxime injection (frozen) should be used only for IV infusion.¹

Oral Administration

Oral suspension must be administered with food.⁷⁹

Tablets may be given orally without regard to meals,^{79 215} but administration with food maximizes bioavailability.^{79 81 82 97 99}

Children 3 months to 12 years of age unable to swallow tablets should receive the oral suspension.⁷⁹ Although the tablets have been crushed and mixed with food (e.g., applesauce, ice cream),^{88 110} the crushed tablets have a strong, persistent taste and the manufacturers state that the drug should not be administered in this manner.^{79 215}

Reconstitution

Reconstitute powder for oral suspension at the time of dispensing by adding the amount of water specified on the bottle to provide a suspension containing 125 or 250 mg of cefuroxime per 5 mL of suspension.⁷⁹

Tap the bottle to thoroughly loosen the powder; add the water in a single portion and shake vigorously.⁷⁹ Shake suspension well just prior to each use and replace the cap securely after each opening.⁷⁹

IV Injection

Reconstitution

Reconstitute vials containing 750 mg or 1.5 g of cefuroxime with 8 or 16 mL of sterile water for injection, respectively, to provide solutions containing approximately 90 mg/mL.¹

Rate of Administration

Inject appropriate dose of reconstituted solution directly into a vein over a period of 3–5 minutes or slowly into the tubing of a freely flowing compatible IV solution.¹

IV Infusion

Other IV solutions flowing through a common administration tubing or site should be discontinued while cefuroxime is being infused unless the solutions are known to be compatible and the flow rate is adequately controlled.¹ If an aminoglycoside is administered concomitantly with cefuroxime, the drugs should be administered at separate sites.¹

Reconstitution and Dilution

For intermittent or continuous IV infusion, 100 mL of sterile water for injection, 5% dextrose injection, 0.9% sodium chloride injection, or other compatible IV solution may be added to an infusion pack labeled as containing 750 mg or 1.5 g of cefuroxime to provide solutions containing approximately 7.5 or 15 mg/mL, respectively.¹

Reconstitute 7.5-g pharmacy bulk package according to the manufacturer’s directions and then further dilute in a compatible IV infusion solution.¹

Reconstitute ADD-Vantage vials containing 750 mg or 1.5 g according to the manufacturer's directions.¹

Reconstitute (activate) commercially available Duplex drug delivery system containing 750 mg or 1.5 g of crystalline cefuroxime and 50 mL of dextrose injection in separate chambers according to the manufacturer’s directions.²¹⁴

Thaw the commercially available premixed cefuroxime injection (frozen) at room temperature (25°C) or in a refrigerator (5°C); do not force thaw by immersion in a water bath or by exposure to microwave radiation.¹ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.¹ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.¹ Do not use in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.¹

Rate of Administration

Intermittent IV infusions generally infused over 15–60 minutes.^{41 44}

IM Injection

Administer IM injections deeply into a large muscle mass such as the gluteus or lateral aspect of the thigh.¹ Use aspiration to ensure needle is not in a blood vessel.¹

Reconstitution

Prepare IM injections by reconstituting vial containing 750 mg of cefuroxime with 3 mL of sterile water for injection to provide a suspension containing approximately 220 mg/mL.¹

Shake IM suspension gently prior to administration.¹

Dosage

Available as cefuroxime axetil⁷⁹ or cefuroxime sodium^{1 214} ; dosage expressed in terms of cefuroxime.^{1 79 214}

Tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis.^{79 215}

Pediatric Patients

General Pediatric Dosage

Mild to Moderate Infections

Oral

AAP recommends 20–30 mg/kg daily given in 2 divided doses in children >4 weeks of age.¹⁴³

IV or IM

AAP recommends 75–100 mg/kg daily given in 3 divided doses in children >4 weeks of age.¹⁴³

Manufacturer states 50–100 mg/kg daily given in 3 or 4 equally divided doses has been effective for most infections in children ≥3 months of age.¹

Severe Infections

Oral

Oral route inappropriate for severe infections per AAP.¹⁴³

IV or IM

AAP recommends 100–150 mg/kg daily given in 3 divided doses in children >4 weeks of age.¹⁴³

Manufacturer recommends 100 mg/kg daily given in 3 or 4 equally divided doses for children ≥3 months of age.¹

Acute Otitis Media (AOM)

Children 3 Months to 12 Years of Age

Oral

Tablets (for children able to swallow tablets whole): 250 mg twice daily for 10 days.^{79 215}

Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.^{79 211}

Bone and Joint Infections

Children 3 Months to 12 Years of Age

IV or IM

150 mg/kg daily given in equally divided doses every 8 hours.¹

Meningitis

Children 3 Months to 12 Years of Age

IV or IM

200–240 mg/kg daily given in equally divided doses every 6–8 hours.^{1 19 49 214}

Pharyngitis and Tonsillitis

Children 3 Months to 12 Years of Age

Oral

Oral suspension: 20 mg/kg daily (maximum 500 mg daily) in 2 divided doses for 10 days.⁷⁹

Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹

Respiratory Tract Infections

Acute Sinusitis in Children 3 Months to 12 Years of Age

Oral

Tablets (for children able to swallow tablets whole): 250 mg twice daily for 10 days.^{79 215}

Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.⁷⁹

Acute Sinusitis in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹

Secondary Bacterial Infections of Acute Bronchitis in Adolescents ≥13 Years of Age

Oral

Tablets: 250 or 500 mg twice daily for 5–10 days.⁷⁹

Acute Exacerbations of Chronic Bronchitis in Adolescents ≥13 Years of Age

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹ Efficacy of regimens <10 days has not been established.⁷⁹

Skin and Skin Structure Infections

Impetigo in Children 3 Months to 12 Years of Age

Oral

Oral suspension: 30 mg/kg daily (maximum 1 g daily) in 2 divided doses for 10 days.⁷⁹

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹

Urinary Tract Infections (UTIs)

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 7–10 days.⁷⁹

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea In Adolescents ≥13 Years of Age

Oral

Tablets: 1 g as a single dose.^{79 218}

Lyme Disease

Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans

Oral

Tablets: 500 mg twice daily for 20 days in adolescents ≥13 years of age.⁷⁹

AAP, IDSA, and others recommend 30 mg/kg (maximum 500 mg) administered in 2 divided doses for 14days (range 14–21 days) in children without specific neurologic involvement or advanced AV heart block.^{141 143 181 182 208 209}

Early Neurologic Lyme Disease†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14 days (range 14–21 days) recommended by IDSA for children with cranial nerve palsy alone without clinical evidence of meningitis.²⁰⁸

Lyme Carditis†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

Borrelial Lymphocytoma†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

Lyme Arthritis†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 28 days recommended by IDSA for children with uncomplicated Lyme arthritis without clinical evidence of neurologic disease.²⁰⁸

Perioperative Prophylaxis

Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery

IV

50 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision).²¹³ Some experts suggest additional doses of 50 mg/kg every 8 hours for up to 48–72 hours; others state that prophylaxis for ≤24 hours is appropriate.²¹³

Adults

General Adult Dosage

IV or IM

750–1.5 g every 8 hours for 5–10 days.^{1 214}

Life-threatening Infections or Those Caused by Less Susceptible Organisms

IV or IM

1.5 g every 6 hours.^{1 214}

Bone and Joint Infections

IV or IM

1.5 g every 8 hours.^{1 214}

Meningitis

IV or IM

Up to 3 g every 8 hours.^{1 214}

Pharyngitis and Tonsillitis

Oral

Tablets: 250 mg twice daily for 10 days.^{79 215}

Respiratory Tract Infections

Acute Sinusitis

Oral

Tablets: 250 mg twice daily for 10 days.^{79 215}

Secondary Bacterial Infections of Acute Bronchitis

Oral

Tablets: 250 or 500 mg twice daily for 5–10 days.^{79 215}

Acute Exacerbations of Chronic Bronchitis

Oral

Tablets: 250 or 500 mg twice daily for 10 days.^{79 215} Efficacy of regimens <10 days has not been established.^{79 215}

Pneumonia

Oral

500 mg twice daily recommended by ATS and IDSA for empiric treatment of community-acquired pneumonia† (CAP).⁵¹ Must be used in conjunction with other anti-infectives for empiric treatment of CAP.⁵¹ (See Respiratory Tract Infections under Uses.)

IV or IM

750 mg every 8 hours.^{1 214} For severe or complicated infections, 1.5 g every 8 hours.^{1 214}

Skin and Skin Structure Infections

Uncomplicated Infections

Oral

Tablets: 250 or 500 mg twice daily for 10 days.^{79 215}

IV or IM

750 mg every 8 hours.^{1 214}

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.¹

Urinary Tract Infections (UTIs)

Uncomplicated Infections

Oral

Tablets: 250 mg twice daily for 7–10 days.^{79 215}

IV or IM

750 mg every 8 hours.^{1 214}

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.¹

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

Oral

Tablets: 1 g as a single dose.^{79 125 144 215 218}

IM

1.5 g as a single dose; divide the dose, give at 2 different sites.¹ Given in conjunction with 1 g of oral probenecid.¹

Disseminated Gonococcal Infections

IV or IM

750 mg every 8 hours.¹

Lyme Disease

Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans

Oral

Tablets: 500 mg twice daily for 20 days.^{79 215}

IDSA and others recommend 500 mg twice daily for 14 days (range 14–21 days) in adults without specific neurologic involvement or advanced AV heart block.^{182 208 209}

Early Neurologic Lyme Disease†

Oral

500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA for adults with cranial nerve palsy alone without clinical evidence of meningitis.²⁰⁸

Lyme Carditis†

Oral

500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

Borrelial Lymphocytoma†

Oral

500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

Lyme Arthritis†

Oral

500 mg twice daily for 28 days recommended by IDSA for adults with uncomplicated Lyme arthritis without clinical evidence of neurologic disease.²⁰⁸

Perioperative Prophylaxis

Noncardiac Thoracic or Orthopedic Surgery

IV

Single 1.5-g dose given within 60 minutes before the procedure.⁷¹

If surgery is prolonged >4 hours or major blood loss occurs, give additional doses every 3–4 hours during the procedure.^{71 213} Postoperative doses usually unnecessary and may increase risk of bacterial resistance.^{71 213}

Cardiac Surgery

IV

For open-heart surgery, manufacturers recommend 1.5 g given at the time of induction of anesthesia and 1.5 g every 12 hours thereafter for a total dosage of 6 g.^{1 214}

During prolonged procedures (>4 hours) or if major blood loss occurs, some clinicians state that additional anti-infective doses should be given every 3–4 hours during the procedure.⁷¹ There is some evidence that single-dose anti-infective prophylaxis may be as effective as 48-hour prophylaxis; there is no evidence of benefit beyond 48 hours.⁷¹

For cardiothoracic surgery and heart and/or lung transplantation, some experts suggest additional 1.5-g doses every 12 hours for up to 48–72 hours; others state that prophylaxis for ≤24 hours is appropriate.²¹³ There is no evidence to support continuing prophylaxis until chest and mediastinal drainage tubes are removed.²¹³

Other Surgery

IV or IM

Manufacturer recommends 1.5 g given IV just prior to surgery (approximately 0.5–1 hour prior to initial incision) and, in lengthy operations, 750 mg given IV or IM every 8 hours.¹ Postoperative doses usually unnecessary and may increase risk of bacterial resistance.⁷¹

Special Populations

Renal Impairment

Dosage adjustments of parenteral cefuroxime necessary in patients with Cl_cr ≤20 mL/minute.^{1 112 113 114 115}

Adults with impaired renal function: 750 mg IM or IV every 12 hours in those with Cl_cr 10–20 mL/minute or 750 mg IM or IV every 24 hours in those with Cl_cr <10 mL/minute.^{1 112 113 114}

Patients undergoing hemodialysis: Give a supplemental dose of parenteral cefuroxime after each dialysis period.^{1 3 30 214}

Children with impaired renal function: Make adjustments to dosing frequency for IM or IV cefuroxime similar to those recommended for adults with renal impairment.¹

Safety and efficacy of oral cefuroxime in patients with renal impairment not established.^{79 215}

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.^{1 214} (See Renal Impairment under Dosage and Administration.)

Cautions for Cefuroxime Axetil

Contraindications

• 
  

  Known hypersensitivity to cefuroxime or other cephalosporins.^{1 79 115}

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.^{1 31 79 88 92 101 103 104 105 214} Careful observation of the patient is essential.^{1 79 214} Institute appropriate therapy if superinfection occurs.^{1 79 214}

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{1 79 214} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis.^{1 79 214} Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.^{79 214}

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{1 79 214} Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.^{79 214}

If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile may need to be discontinued.^{79 214} Some mild cases may respond to discontinuance alone.^{1 184 185 186 187 188} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{1 79 184 185 186 187 188 214}

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.^{1 a}

If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^{1 a}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹ Cautious use recommended in individuals hypersensitive to penicillins:^{1 a} avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

History of GI Disease

Used with caution in patients with a history of GI disease, particularly colitis.¹ (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Prolonged PT

Prolonged PT reported with some cephalosporins.¹

Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged therapy, or stabilized on anticoagulant therapy.^{1 79 215} Administer vitamin K when indicated.^{1 79 215}

Renal Effects

Periodically evaluate renal status during therapy, especially in seriously ill patients receiving maximum dosage.¹

Caution if used concomitantly with nephrotoxic drugs (e.g., aminoglycosides, potent diuretics).¹ (See Interactions.)

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefuroxime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^{1 79 214}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{1 79 214} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{1 79 214}

Patients with Meningitis

Mild to moderate hearing loss reported rarely in pediatric patients who received cefuroxime for treatment of meningitis.^{1 214}

Persistence of positive CSF cultures at 18–36 hours reported; clinical importance unknown.^{1 214}

Phenylketonuria

Ceftin oral suspensions containing 125 or 250 mg of cefuroxime/5 mL contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 11.8 or 25.2 mg of phenylalanine/5 mL, respectively.⁷⁹

Sodium Content

Cefuroxime sodium contains approximately 54.2 mg (2.4 mEq) of sodium per g of cefuroxime.^{1 214}

Specific Populations

Pregnancy

Category B.^{1 79 214}

Lactation

Distributed into milk; use with caution.^{1 79 214}

Pediatric Use

Safety and efficacy of oral or parenteral cefuroxime not established in children <3 months of age.^{1 79 214} Other cephalosporins accumulate in neonates resulting in prolonged serum half-life.^{1 214}

Safety and efficacy of oral cefuroxime for treatment of acute bacterial maxillary sinusitis in pediatric patients 3 months to 12 years of age have been established based on safety and efficacy of the drug in adults.⁷⁹ In addition, use of oral cefuroxime in pediatric patients is supported by pharmacokinetic and safety data in adult and pediatric patients, clinical and microbiologic data from adequate and well-controlled studies of the treatment of acute bacterial maxillary sinusitis in adults and acute otitis media with effusion in pediatric patients, and postmarketing surveillance of adverse effects.⁷⁹

Tablets should not be crushed for pediatric administration since the drug has a strong, persistent, bitter taste;^{79 82 99 101} vomiting was induced aversively in some children who received crushed tablets.¹⁰¹ The oral suspension should be used in children who cannot swallow tablets whole.⁷⁹

To avoid overdosage, the commerc

Insuman N

Insuman N may be available in the countries listed below.

Ingredient matches for Insuman N

Insulin, Isophane

Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insuman N in the following countries:

• Argentina


• Colombia


• Costa Rica


• Dominican Republic


• Ecuador


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

International Drug Name Search