EES

Dosage Form: suspension, granule for oral suspension; tablet
E.E.S.®

(ERYTHROMYCIN ETHYLSUCCINATE)

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of E.E.S. and other antibacterial drugs, E.E.S. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

EES Description

Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is:

E.E.S. Granules are intended for reconstitution with water. Each 5-mL teaspoonful of reconstituted cherry-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin.

The pleasant tasting, fruit-flavored liquids are supplied ready for oral administration.

E.E.S. 200 Liquid: Each 5-mL teaspoonful of fruit-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin.

E.E.S. 400 Liquid: Each 5-mL teaspoonful of orange-flavored suspension contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin.

Granules and ready-made suspensions are intended primarily for pediatric use but can also be used in adults.

E.E.S. 400® Film-coated Tablets: Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin.

The Film-coated tablets are intended primarily for adults or older children.

Inactive Ingredients

E.E.S. 200 Liquid: FD&C Red No. 40, methylparaben, polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum and natural and artificial flavors.

E.E.S. 400 Liquid: D&C Yellow No. 10, FD&C Yellow No. 6, methylparaben, polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum and natural and artificial flavors.

E.E.S. Granules: Citric acid, FD&C Red No. 3, magnesium aluminum silicate, sodium carboxymethylcellulose, sodium citrate, sucrose and artificial flavor.

E.E.S. 400 Film-coated Tablets: Cellulosic polymers, confectioner's sugar (contains corn starch), cornstarch, D&C Red No. 30, D&C Yellow No. 10, FD&C Red No. 40, magnesium stearate, polacrilin potassium, polyethylene glycol, propylene glycol, sodium citrate, sorbic acid, and titanium dioxide.

EES - Clinical Pharmacology

Orally administered erythromycin ethylsuccinate suspensions and Filmtab tablets are readily and reliably absorbed. Comparable serum levels of erythromycin are achieved in the fasting and nonfasting states.

Erythromycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, erythromycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of erythromycin by the liver into the bile is not known. Less than 5 percent of the orally administered dose of erythromycin is excreted in active form in the urine.

Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk.

Microbiology

Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides used concomitantly.

Staphylocci resistant to erythromycin may emerge during a course of therapy.

Erythromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive Organisms

 

Corynebacterium diphtheriae

 

Corynebacterium minutissimum

 

Listeria monocytogenes

 

Staphylococcus aureus (resistant organisms may emerge during treatment)

 

Streptococcus pneumoniae

 

Streptococcus pyogenes

Gram-negative Organisms

 

Bordetella pertussis

 

Legionella pneumophila

 

Neisseria gonorrhoeae

 

Other Microorganisms

 

Chlamydia trachomatis

 

Entamoeba histolytica

 

Mycoplasma pneumoniae

 

Treponema pallidum

 

Ureaplasma urealyticum

The following in vitro data are available, but their clinical significance is unknown.

Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 µg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well controlled clinical trials.

Gram-positive Organisms

 

Viridans group streptococci

Gram-negative Organisms

 

Moraxella catarrhalis

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method1,2 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of erythromycin powder. The MIC values should be interpreted according to the following criteria:

For Staphylococcus spp:

MIC (µg/mL)	Interpretation
≤ 0.5	Susceptible (S)
1-4	Intermediate (I)
≥ 8	Resistant (R)

For Streptococcus spp. and Streptococcus pneumoniae:

MIC (µg/mL)	Interpretation
≤ 0.25	Susceptible (S)
0.5	Intermediate (I)
≥ 1	Resistant (R)

A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard erythromycin powder should provide the following MIC values:

Microorganism	MIC (µg/mL)
* ATCC is a registered trademark of the American Type Culture Collection
S. aureus ATCC* 29213	0.25-1
E. faecalis ATCC 29212	1-4
S. pneumoniae ATCC 49619	0.03-0.12

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15-µg erythromycin to test the susceptibility of microorganisms to erythromycin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15-µg erythromycin disk should be interpreted according to the following criteria:

For Staphylococcus spp:

Zone Diameter (mm)	Interpretation
≥ 23	Susceptible (S)
14-22	Intermediate (I)
≤ 13	Resistant (R)

For Streptococcus spp. and Streptococcus pneumoniae:

Zone Diameter (mm)	Interpretation
≥ 21	Susceptible (S)
16-20	Intermediate (I)
≤ 15	Resistant (R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for erythromycin.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 15-µg erythromycin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism	Zone Diameter (mm)
S. aureus ATCC 25923	22-30
S. pneumoniae ATCC 49619	25-30

Indications and Usage for EES

To reduce the development of drug-resistant bacteria and maintain the effectiveness of E.E.S. and other antibacterial drugs, E.E.S. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

E.E.S. is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes , Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)

Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.

Listeriosis caused by Listeria monocytogenes.

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.

Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever

Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.4 The therapeutic dose should be administered for 10 days.

Prevention of Recurrent Attacks of Rheumatic Fever

Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).4

Contraindications

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.

Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride. (See PRECAUTIONS - Drug Interactions.)

Warnings

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including E.E.S., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

Precautions

General

Prescribing E.E.S. 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.

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS sections.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.5 Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Information for Patients

Patients should be counseled that antibacterial drugs including E.E.S. should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When E.E.S. is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. 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 E.E.S. 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 (with or without stomach cramps and fever) 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.

Drug Interactions

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of erythromycin with various oral anticoagulants may be more pronounced in the elderly.

Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of erythromycin and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving erythromycin.

The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with erythromycin products in post-marketing experience:

Ergotamine/dihydroergotamine

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines

Erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus, may increase the pharmacologic effect of these benzodiazepines.

HMG-CoA Reductase Inhibitors

Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

Sildenafil (Viagra)

Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered. (See Viagra package insert.)

There have been spontaneous or published reports of CYP3A based interactions of erythromycin with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol, vinblastine, and bromocriptine.

Concomitant administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine is contraindicated. (See CONTRAINDICATIONS.)

In addition, there have been reports of interactions of erythromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.

Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias have been observed. (See CONTRAINDICATIONS.) In addition, deaths have been reported rarely with concomitant administration of terfenadine and erythromycin.

There have been post-marketing reports of drug interactions when erythromycin is co-administered with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, most likely due to inhibition of hepatic metabolism of cisapride by erythromycin. Fatalities have been reported. (See CONTRAINDICATIONS.)

Drug/Laboratory Test Interactions

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.

Pregnancy

Teratogenic Effects

Pregnancy Category B

There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation, and through weaning of two successive litters. 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.

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Elderly patients may be more susceptible to the development of torsades de pointes arrhythmias than younger patients. (See ADVERSE REACTIONS).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See PRECAUTIONS - Drug Interactions).

E.E.S.® Granules contains 25.9 mg (1.1 mEq) of sodium per individual dose.

Adverse Reactions

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.)

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Overdosage

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.

Erythromycin is not removed by peritoneal dialysis or hemodialysis.

EES Dosage and Administration

Erythromycin ethylsuccinate suspensions and Film-coated tablets may be administered without regard to meals.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours. For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

The following dosage schedule is suggested for mild to moderate infections:

Body Weight	Total Daily Dose
Under 10 lbs	30-50 mg/kg/day
	15-25 mg/kg/q 12 h
10 to 15 lbs	200 mg
16 to 25 lbs	400 mg
26 to 50 lbs	800 mg
51 to 100 lbs	1200 mg
over 100 lbs	1600 mg

Adults

400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate.

In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.

For Treatment of Urethritis Due to C. trachomatis or U. urealyticum

800 mg three times a day for 7 days.

For Treatment of Primary Syphilis

Adults: 48 to 64 g given in divided doses over a period of 10 to 15 days.

For Intestinal Amebiasis

Adults: 400 mg four times daily for 10 to 14 days.

Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days.

For Use in Pertussis

Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

For Treatment of Legionnaires' Disease

Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1.6 to 4 g daily in divided doses.)

How is EES Supplied

E.E.S. 200 LIQUID (erythromycin ethylsuccinate oral suspension, USP) is supplied in 1 pint bottles (NDC 24338-140-13) and in l00-mL bottles (NDC 24338-142-13).

E.E.S. 400 LIQUID (erythromycin ethylsuccinate oral suspension, USP) is supplied in 1 pint bottles (NDC 24338-144-13) and in l00-mL bottles (NDC 24338-146-13).

E.E.S. GRANULES (erythromycin ethylsuccinate for oral suspension, USP) is supplied in 100-mL (NDC 24338-134-02) and 200-mL (NDC 24338-136-10) size bottles.

E.E.S. 400 Film-coated tablets (erythromycin ethylsuccinate tablets, USP) 400 mg, are supplied as pink tablets imprinted with the

Recommended storage

Store tablets below 86°F (30°C).

Store granules, prior to mixing, below 86°F (30°C).

After mixing, refrigerate and use within 10 days.

REFERENCES

1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 7th ed. Approved Standard, CLSI Document M07-A7, Vol. 26(2). CLSI, Wayne, PA, Jan. 2006.


2. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing, 18th Informational Supplement, CLSI Document M100-S18, Vol 28(1). CLSI, Wayne, PA, Jan. 2008.


3. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests, 9th ed. Approved Standard CLSI Document M02-A9, Vol. 26(1). CLSI, Wayne, PA, Jan. 2006.


4. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.


5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999;354 (9196):2101-5.

Revised: 12/2010 Arbor Pharmaceuticals, Inc.

The

Arbor Pharmaceuticals, Inc.

Raleigh, NC

(Nos. 5729, 6306, 6369, 6373)

03-A425-R1 Rev. Dec, 2010

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 24338-100-13

100 Tablets

E.E.S. 400®

Film-coated Tablets

ERYTHROMYCIN

ETHYLSUCCINATE

TABLETS, USP

400 mg

Erythromycin

activity

Rx only

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Label

NDC 24338-134-02

100 mL (when mixed)

For Oral Suspension

E.E.S.® Granules

ERYTHROMYCIN

ETHYLSUCCINATE FOR

ORAL SUSPENSION, USP

Erythromycin activity

200 mg per 5 mL

when reconstituted

Rx only

arbor™

PHARMACEUTICALS, INC.

www.arborpharma.com

E.E.S   400 erythromycin ethylsuccinate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-100 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Erythromycin Ethylsuccinate (Erythromycin) Erythromycin 400 mg

Inactive Ingredients Ingredient Name Strength Powdered Cellulose   sucrose   starch, corn   D&C Red No. 30   D&C Yellow No. 10   FD&C Red No. 40   magnesium stearate   polacrilin potassium   polyethylene glycols   propylene glycol   sodium citrate   sorbic acid   titanium dioxide

Product Characteristics Color PINK Score no score Shape OVAL Size 19mm Flavor Imprint Code EE Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-100-13 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA061905	05/03/2011

E.E.S  erythromycin ethylsuccinate  granule, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24338-134 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength erythromycin ethylsuccinate (erythromycin) erythromycin 200 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength citric acid monohydrate   sodium citrate   sucrose   carboxymethylcellulose sodium   magnesium aluminum silicate   FD&C Red No. 3

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24338-134-02 100 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050207	04/18/2011

Labeler - Arbor Pharmaceuticals, Inc. (781796417)

Revised: 12/2011Arbor Pharmaceuticals, Inc.

Apo-Salvent Inhaler

Generic Name: albuterol (Oral route)

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.

• Proventil


• Proventil Repetabs


• Ventolin


• Volmax


• VoSpire ER

In Canada

• Apo-Salvent Inhaler

Available Dosage Forms:

• Tablet


• Syrup


• Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Apo-Salvent Inhaler

Albuterol is used to treat bronchospasm or wheezing in patients with reversible obstructive airway disease, such as asthma.

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Before Using Apo-Salvent Inhaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Arotinolol


• Atenolol


• Atomoxetine


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Furazolidone


• Iproniazid


• Isocarboxazid


• Labetalol


• Landiolol


• Lazabemide


• Levobetaxolol


• Levobunolol


• Linezolid


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Nipradilol


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Rasagiline


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., arrhythmia) or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Hypokalemia (low potassium in the blood) or


• Seizure disorders—Use with caution. May make these conditions worse.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Apo-Salvent Inhaler. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of bronchospasm:
  
  • For oral dosage form (syrup, tablets):
    
    • Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
    
    
    • Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
    
    
    • Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
    
    
    • Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Apo-Salvent Inhaler

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Apo-Salvent Inhaler Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Shakiness in the legs, arms, hands, or feet


• trembling or shaking of the hands or feet

Less common

• Fast, irregular, pounding, or racing heartbeat or pulse

Rare

• Cough


• difficulty breathing


• difficulty with swallowing


• hives or welts


• hoarseness


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• noisy breathing


• redness of the skin


• shortness of breath


• skin rash


• slow or irregular breathing


• swelling of the mouth or throat


• tightness in the chest


• wheezing

Incidence not known

• Agitation


• anxiety


• arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• confusion


• convulsions


• extra heartbeats


• fainting


• hallucinations


• headache


• irritability


• lightheadedness


• mood or mental changes


• muscle pain or cramps


• muscle spasm or jerking of all extremities


• nervousness


• nightmares


• pounding in the ears


• restlessness


• sudden loss of consciousness


• sweating


• total body jerking


• unusual feeling of excitement


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dizziness


• feeling of warmth


• irritability


• nausea


• redness of the face, neck, arms, and occasionally, upper chest


• sleeplessness


• trouble with holding or releasing urine


• trouble sleeping


• unable to sleep

Rare

• Sleepiness


• unusual drowsiness

Incidence not known

• Bad, unusual, or unpleasant (after) taste


• change in taste


• feeling of constant movement of self or surroundings


• gagging


• rough, scratchy sound to voice


• sensation of spinning


• tightness in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Apo-Salvent side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Apo-Salvent Inhaler resources

• Apo-Salvent Inhaler Side Effects (in more detail)
• Apo-Salvent Inhaler Use in Pregnancy & Breastfeeding
• Drug Images
• Apo-Salvent Inhaler Drug Interactions
• Apo-Salvent Inhaler Support Group
• 34 Reviews for Apo-Salvent - Add your own review/rating

Compare Apo-Salvent Inhaler with other medications

• Asthma, acute
• Asthma, Maintenance
• Bronchospasm Prophylaxis
• COPD, Acute
• COPD, Maintenance

Ectosone Regular-Lotion

Generic Name: betamethasone valerate (Topical application route)

bay-ta-METH-a-sone VAL-er-ate

Commonly used brand name(s)

In the U.S.

• Betamethacot


• Beta-Val


• Luxiq


• Qualisone


• Valisone

In Canada

• Betacort Scalp Lotion


• Betnovate


• Betnovate-1/2


• Celestoderm-V


• Celestoderm-V/2


• Ectosone Mild-Lotion


• Ectosone Regular-Cream


• Ectosone Regular-Lotion


• Ectosone Scalp Lotion


• Metaderm Mild


• Metaderm Regular


• Novo-Betamet

Available Dosage Forms:

• Gel/Jelly


• Ointment


• Lotion


• Cream


• Foam

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Betamethasone

Uses For Ectosone Regular-Lotion

Betamethasone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. Betamethasone foam is used for scalp problems. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Ectosone Regular-Lotion

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of betamethasone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam form, safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of betamethasone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of betamethasone

This section provides information on the proper use of a number of products that contain betamethasone. It may not be specific to Ectosone Regular-Lotion. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, lotion, or ointment:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use the foam:

• This medicine comes with a patient information insert. Read and follow the instructions carefully.


• Wash your hands with soap and water before and after using this medicine.


• Turn the can upside down and place a small amount of medicine in a saucer or any cool, clean surface. Do not put the foam directly in your hands. This will melt the foam immediately upon contact with warm skin.


• Move the hair away and put a small amount of the foam on the affected areas of the scalp. Massage it in gently until the medicine has dried.


• Do not wash or rinse the treated areas immediately after applying the medicine.


• Do not use this medicine near heat, open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream and ointment):
    
    • Adults—Apply to the affected area of the skin one to three times per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply a few drops to the affected area of the skin two times per day (morning and evening).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For scalp problems:
  
  • For topical dosage form (foam):
    
    • Adults—Apply to the affected area of the scalp two times per day (once in the morning and once at night).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the can of the foam at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using Ectosone Regular-Lotion

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Ectosone Regular-Lotion Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning, itching, or stinging at the application site

Less common

• Hair loss


• thinning of the hair

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acne or pimples


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Ectosone Regular-Lotion resources

• Ectosone Regular-Lotion Use in Pregnancy & Breastfeeding
• Ectosone Regular-Lotion Drug Interactions
• Ectosone Regular-Lotion Support Group
• 13 Reviews for Ectosone Regular-Lotion - Add your own review/rating

Compare Ectosone Regular-Lotion with other medications

• Atopic Dermatitis
• Dermatitis
• Dermatological Disorders
• Lichen Planus
• Lichen Sclerosus

Osteopetrosis Medications

Definition of Osteopetrosis: The formation of abnormally dense bone, as opposed to osteoporosis.

Drugs associated with Osteopetrosis

The following drugs and medications are in some way related to, or used in the treatment of Osteopetrosis. 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:

Actimmune

Felotens XL 5mg Prolonged Release Tablets

1. Name Of The Medicinal Product

Felotens XL 5 mg Prolonged Release Tablets

2. Qualitative And Quantitative Composition

Felotens XL 5 mg Prolonged Release Tablets contain 5mg of felodipine.

3. Pharmaceutical Form

Light pink, round, biconvex, film coated prolonged-release tablets with imprint 5.

4. Clinical Particulars

4.1 Therapeutic Indications

In the management of hypertension and prophylaxis of chronic stable angina pectoris.

4.2 Posology And Method Of Administration

For oral administration

Hypertension:

Adults (including elderly): The dose should be adjusted to the individual requirements of the patient. The recommended starting dose is 5 mg once daily. If necessary the dose may be further increased or another antihypertensive agent added. The usual maintenance dose is 5-10 mg once daily. Doses higher than 20 mg daily are not usually needed. For dose titration purposes a 2.5 mg tablet is available. In elderly patients an initial treatment with 2.5 mg daily should be considered.

Angina pectoris:

Adults: The dose should be adjusted individually. Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily.

Administration: The tablets should regularly be taken in the morning without food or with a light meal. Felotens XL 5 mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.

Children: The safety and efficacy of Felotens XL 5 mg Prolonged Release Tablets in children has not been established.

Felotens XL 5 mg Prolonged Release Tablets can be used in combination with β-blockers, ACE inhibitors or diuretics. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension. In patients with severely impaired liver function the dose of felodipine should be low. The pharmacokinetics are not significantly affected in patients with impaired renal function.

4.3 Contraindications

Unstable angina pectoris.

Pregnancy.

Acute porphyria.

Patient with a previous allergic reaction to Felotens XL 5 mg Prolonged Release Tablets or other dihydropyridines because of the theoretical risk of cross-reactivity.

Felotens XL 5 mg Prolonged Release Tablets should not be used in patients with clinically significant aortic stenosis, uncontrolled heart failure, and during or within one month of a myocardial infarction.

As with other calcium channel blockers, Felotens XL 5 mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock.

4.4 Special Warnings And Precautions For Use

As with other vasodilators, Felotens XL 5 mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia. Withdraw if ischaemic pain occurs or existing pain worsens shortly after initiating treatment.

There is no evidence that Felotens XL 5 mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction.

The efficacy and safety of Felotens XL 5 mg Prolonged Release Tablets in the treatment of malignant hypertension has not been studied.

Felotens XL 5 mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration of substances which interfere with the cytochrome P450 system may affect plasma concentrations of felodipine. Enzyme inhibitors such as cimetidine, erythromycin, itraconazole, ketoconazole and ritonavir impair the elimination of felodipine, and Felotens XL 5 mg Prolonged Release Tablets dosage may need to be reduced when drugs are given concomitantly. Conversely, powerful enzyme inducing agents such as some anticonvulsants (phenytoin, carbamazepine, phenobarbitone) can increase felodipine elimination and higher than normal Felotens XL 5 mg Prolonged Release Tablets doses may be required in patients taking the drugs.

No dosage adjustment is required when Felotens XL 5 mg Prolonged Release Tablets are given concomitantly with digoxin.

Felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs such as warfarin.

Felodipine may increase the concentration of tacrolimus. When used together, the tacrolimus serum concentration should be followed and the tacrolimus dose may need to be adjusted.

Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to an interaction with flavonoids in the fruit juice. This interaction has been seen with other dihydropyridine calcium antagonists and represents a class effect. Therefore grapefruit juice should not be taken together with Felotens XL 5 mg Prolonged Release Tablets.

The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives such as α-blockers (e.g. prazosin) or β-blockers (e.g. atenolol) and general anaesthetics.

4.6 Pregnancy And Lactation

Felodipine should not be given during pregnancy.

In a study on fertility and general reproductive performance in rats, a prolongation of parturition resulting in difficult labour, increased foetal deaths and early postnatal deaths were observed in the medium- and high-dose groups. Reproductive studies in rabbits have shown a dose-related reversible enlargement of the mammary glands of the parent animals and dose-related digital abnormalities in the foetuses when felodipine was administered during stages of early foetal development.

Felodipine has been detected in breast milk, but it is unknown whether it has harmful effects on the new-born.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

As with other calcium antagonists, flushing, headache, palpitations, dizziness and fatigue may occur. These reactions are usually transient and are most likely to occur at the start of treatment or after an increase in dosage.

As with other calcium antagonists ankle swelling, resulting from precapillary vasodilation, may occur. The degree of ankle swelling is dose related.

In patients with gingivitis/periodontitis, mild gingival enlargement has been reported with Felotens XL 5 mg Prolonged Release Tablets, as with other calcium antagonists. The enlargement can be avoided or reversed by careful dental hygiene.

As with other dihydropyridines, aggravation of angina has been reported in a small number of individuals especially after starting treatment. This is more likely to happen in patients with symptomatic ischaemic heart disease.

The following adverse events have been reported from clinical trials and from Post Marketing Surveillance. In the great majority of cases a causal relationship between these events and treatment with felodipine has not been established.

Skin: rarely - rash and/or pruritus, cutaneous vasculitis, very rarely – leucocytoclastic vasculitis and isolated cases of photosensitivity.

Musculoskeletal: in isolated cases arthralgia and myalgia.

Psychiatric: rarely – impotence/sexual dysfunction

Central and peripheral nervous system: headache, dizziness. In isolated cases paraesthesia.

Gastrointestinal: rarely – gum hyperplasia, very rarely – gingivitis, in isolated cases nausea, abdominal pain, vomiting.

Hepatic: in isolated cases increased liver enzymes.

Urinary system: rarely – urinary frequency

Cardiovascular: rarely - tachycardia, palpitations and syncope.

Vascular (extracardiac):peripheral oedema, flush.

Other: rarely – fever, fatigue, in isolated cases hypersensitivity reactions e.g. urticaria, angio-oedema.

4.9 Overdose

Symptoms: Overdosage may cause excessive peripheral vasodilatation with marked hypotension which may sometimes be accompanied by bradycardia.

Management: Activated charcoal, induction of vomiting or gastric lavage, if appropriate or indicated. Severe hypotension should be treated symptomatically, with the patient placed supine and the legs elevated. Bradycardia, if present, should be treated with atropine 0.5-1 mg i.v. If this is not sufficient, plasma volume should be increased by infusion of e.g. glucose, saline or dextran. Sympathomimetic drugs with predominant effect on the (α₁-adrenoceptor may be given e.g. metaraminol or phenylephrine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing peripheral vascular residence. Due to the high degree of selectivity for smooth muscle in the arterioles, felodipine in therapeutic doses has no direct effect on cardiac contractility or conduction.

It can be used as monotherapy or in combination with other antihypertensive drugs, e.g. β-receptor blockers, diuretics or ACE-inhibitors, in order to achieve an increased antihypertensive effect. Felodipine reduces both systolic and diastolic blood pressure and can be used in isolated systolic hypertension. In a study of 12 patients, felodipine maintained its antihypertensive effect during concomitant therapy with indomethacin.

Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension.

Felodipine has anti-anginal and anti-ischaemic effects due to improved myocardial oxygen supply/ demand balance. Coronary vascular resistance is decreased and coronary blood flow as well as myocardial oxygen supply are increased by felodipine due to dilation of both epicardial arteries and arterioles. Felodipine effectively counteracts coronary vasospasm. The reduction in systemic blood pressure caused by felodipine leads to decreased left ventricular afterload.

Felodipine improves exercise tolerance and reduces anginal attacks in patients with stable effort induced angina pectoris. Both symptomatic and silent myocardial ischaemia are reduced by felodipine in patients with vasospastic angina. Felodipine can be used as monotherapy or in combination with β-receptor blockers in patients with stable angina pectoris.

Felodipine possesses a mild natriuretic/diuretic effect and generalised fluid retention does not occur.

In a randomised, double-blind, 3-week, parallel group study in children aged 6-16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35). The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years.

The long-term effects of felodipine on growth, puberty and general development have not been studied. The long-term efficacy of felodipine as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.

Felodipine is well tolerated in patients with concomitant disease such as congestive heart failure well controlled on appropriate therapy, asthma and other obstructive pulmonary diseases, diabetes, gout, hyperlipidemia impaired renal function, renal transplant recipients and Raynaud's disease. Felodipine has no significant effect on bland glucose levels or lipid profiles.

Haemodynamic effects: The primary haemodynamic effect of felodipine is a reduction of total peripheral vascular resistance which leads to a decrease in blood pressure. These effects are dose- dependent. In patients with mild to moderate essential hypertension, a reduction in blood pressure usually occurs 2 hours after the first oral dose and lasts for at least 24 hours with a trough/peak ratio usually above 50%.

Plasma concentration of felodipine and decrease in total peripheral resistance and blood pressure are positively correlated.

Electrophysiological and other cardiac effects: Felodipine in therapeutic doses has no effect on cardiac contractility or atrioventricular conduction or refractoriness.

Renal effects: Felodipine has a natriuretic and diuretic effect. Studies have shown that the tubular reabsorption of filtered sodium is reduced. This counteracts the salt and water retention observed for other vasodilators. Felodipine does not affect the daily potassium excretion. The renal vascular resistance is decreased by felodipine. Normal glomerular filtration rate is unchanged. In patients with impaired renal function glomerular filtration rate may increase.

Felodipine is well tolerated in renal transplant recipients.

Site and mechanism of action: The predominant pharmacodynamic feature of felodipine is its pronounced vascular versus myocardial selectivity. Myogenically active smooth muscles in arterial resistance vessels are particularly sensitive to felodipine.

Felodipine inhibits electrical and contractile activity of vascular smooth muscle cells via an effect on the calcium channels in the cell membrane.

5.2 Pharmacokinetic Properties

Absorption and distribution: Felodipine is completely absorbed from the gastrointestinal tract after administration of felodipine extended release tablets.

The systemic availability of felodipine is approximately 15% in man and is independent of dose in the therapeutic dose range.

With the extended-release tablets the absorption phase is prolonged. This results in even felodipine plasma concentrations within the therapeutic range for 24 hours.

The plasma protein binding of felodipine is approximately 99%. It is bound predominantly to the albumin fraction.

Elimination and metabolism: The average half-life of felodipine in the terminal phase is 25 hours. There is no significant accumulation during long-term treatment. Felodipine is extensively metabolised by the liver and all identified metabolites are inactive. Elderly patients and patients with reduced liver function have an average higher plasma concentration of felodipine than younger patients.

About 70% of a given dose is excreted as metabolites in the urine; the remaining fraction is excreted in the faeces. Less than 0.5% of a dose is recovered unchanged in the urine.

The kinetics of felodipine are not changed in patients with renal impairment.

In a single dose (felodipine extended release 5 mg) pharmacokinetic study in twelve children aged between 6 and 16 years there was no apparent relationship between age and AUC, C_max or half-life of felodipine

5.3 Preclinical Safety Data

Felodipine is a calcium antagonist and lowers arterial blood pressure by decreasing vascular resistance. In general a reduction in blood pressure is evident 2 hours after the first oral dose and at steady state lasts for at least 24 hours after dose.

Felodipine exhibits a high degree of selectivity for smooth muscles in the arterioles and in therapeutic doses has no direct effect on cardiac contractility. Felodipine does not affect venous smooth muscle and adrenergic vasomotor control.

Electrophysiological studies have shown that felodipine has no direct effect on conduction in the specialised conducting system of the heart and no effect on the AV nodal refractories.

Felotens XL 5 mg Prolonged Release Tablets possess a mild natriuretic/diuretic effect and does not produce general fluid retention, nor affect daily potassium excretion. Felotens XL 5 mg Prolonged Release Tablets are well tolerated in patients with congestive heart failure.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose monohydrate, Cellulose microcristalline, Hypromellose, Povidone, Propyl gallate, Silica colloidal anhydrous, Magnesium stearate, Ferric oxide yellow (E172), Ferric oxide red (E172), Titanium dioxide (E171), Talc, Propylene glycol.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Do not store above 25 °C. Store in the original package.

6.5 Nature And Contents Of Container

PVC/PE/PVDC Aluminium Blisters.

A single pack contains 10, 20, 28, 30, 50, 56 or 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Genus Pharmaceuticals Limited

T/A Genus Pharmaceuticals

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN

8. Marketing Authorisation Number(S)

PL06831/0226

9. Date Of First Authorisation/Renewal Of The Authorisation

02-07-2002/23-02-2009

10. Date Of Revision Of The Text

14/12/2009