Erybac tablets

Erybac

  • Active Ingredient: Erythromycin
  • 500 mg, 250 mg
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What is Erybac?

The active ingredient of Erybac brand is erythromycin. Erythromycin is a macrolide antibiotic. Erythromycin fights bacteria in the body.

Used for

Erybac is used to treat diseases such as: Bacterial Endocarditis Prevention, Bartonellosis, Bowel Preparation, Bronchitis, Bullous Pemphigoid, Campylobacter Gastroenteritis, Chancroid, Chlamydia Infection, Dental Abscess, Legionella Pneumonia, Lyme Disease, Lymphogranuloma Venereum, Mycoplasma Pneumonia, Nongonococcal Urethritis, Ocular Rosacea, Otitis Media, Pemphigoid, Pertussis, Pharyngitis, Pneumonia, Rheumatic Fever Prophylaxis, Skin or Soft Tissue Infection, Strep Throat, Syphilis, Early, Upper Respiratory Tract Infection.

Side Effect

Possible side effects of Erybac include: skin rash; Abdominal or stomach pain; greatly decreased frequency of urination or amount of urine; joint or muscle pain; bloody or cloudy urine; chills.

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DOSAGE AND ADMINISTRATION

Optimal blood levels are obtained when Erybac Base Filmtab (Erybac tablets) tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).

Adults: The usual dosage of Erybac Base Filmtab (Erybac tablets) is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.

Children: Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of Erybac should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of Erybac orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides. 3

Conjunctivitis of the newborn caused by Chlamydia trachomatis: Oral Erybac suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks. 3

Pneumonia of infancy caused by Chlamydia trachomatis: Although the optimal duration of therapy has not been established, the recommended therapy is oral Erybac suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital infections during pregnancy due to Chlamydia trachomatis: Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of Erybac by mouth four times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one Erybac 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days. 5

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated: 500 mg of Erybac by mouth four times a day for at least 7 days. 5

For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated: 500 mg of Erybac by mouth four times a day for at least seven days. 5

Primary syphilis: 30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute pelvic inflammatory disease caused by N. gonorrhoeae: 500 mg Erythrocin® Lactobionate-I.V. (Erybac lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of Erybac base orally every 12 hours for 7 days.

Intestinal amebiasis: Adults: 500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days. Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days.

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

Legionnaires' Disease: Although optimal dosage has not been 4 g daily in divided doses.

Erybac Ophthalmic S >

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Erybac ophthalmic and call your doctor at once if you have:

  • severe burning, stinging, or irritation after using this medicine; or
  • signs of eye infection--pain, swelling, severe discomfort, crusting or drainage, eyes more sensitive to light.

Common side effects may include:

  • eye redness; or
  • mild eye irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

1. About Erybac

Erybac is an antibiotic.

Erybac is used in children, often to treat ear infections or chest infections.

The medicine is available on prescription as tablets, capsules, or a liquid that you drink.

It's also available as a skin solution to treat skin infections like acne. It can be given by injection, but this is usually only done in hospital.

Erybac Ophthalmic Interactions

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Do not use other eye medications unless your doctor tells you to.

Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Erybac

Erybac , a natural product isolated from Saccharopolyspora erythraea (formerly Streptomyces) in 1949, was first approved for clinical use in 1952. Erybac is degraded by gastric acid, and has long been associated with stimulation of motilin receptors in the stomach and possibly in the colon, leading to adverse gastrointestinal side effects, including cramping and diarrhea. 68,69 Many preparations have attempted to bypass exposure of Erybac to gastric acid, thereby avoiding products of macrolide hydrolysis. These preparations include enteric coating of orally administered tablets, delayed-release formulations, polymer coating of beads, and various formulations of salts and esters. 70 The lactobionate salt used for intravenous administration of Erybac can cause phlebitis at the site of injection.

Erybac is used for the treatment of group A streptococcal infections in children who are penicillin-allergic. Erybac is an alternative treatment for both streptococcal pharyngitis and streptococcal or staphylococcal impetigo. The usefulness of Erybac for respiratory tract infections caused by S. pneumoniae has been greatly diminished by the development of widespread resistance to the macrolides. 42 Macrolide therapy of upper respiratory tract infections (otitis media and sinusitis) or lower respiratory tract infections (pneumonia) potentially caused by S. pneumoniae has a relatively high likelihood of failure, particularly in younger children who are at highest risk of infections caused by antibiotic-resistant strains. For upper respiratory tract infections, Erybac has inadequate activity against H. influenzae, and must be paired with another agent such as a sulfonamide for empiric therapy. Macrolides are effective therapy for pneumonia caused by Mycoplasma pneumoniae, Chlamydophila pneumoniae, or Legionella pneumophila.

Erybac and azithromycin are the preferred antibiotics for treatment of Campylobacter gastroenteritis. Erybac also remains the most appropriate therapy for diphtheria (Corynebacterium diphtheriae). Erybac, clarithromycin, or azithromycin is recommended for treatment or prophylaxis of pertussis (Bordetella pertussis). 71 Azithromycin is preferred for treatment or prophylaxis for pertussis in neonates, based on concerns for the development of pyloric stenosis. 71 Efficacy of Erybac also has been demonstrated in infections caused by Chlamydophila pneumoniae and Chlamydia trachomatis, including neonatal conjunctivitis and pneumonia, as well as urogenital infections during pregnancy. Erybac is active in vitro against Ureaplasma urealyticum, but its role in the treatment of neonatal infections associated with this organism is not well defined. 72

Adverse effects

Erybacs are often associated with gastrointestinal distress, which can be minimized if the drugs are taken with food. The estolate salt of Erybac may cause cholestatic hepatitis, characterized by elevated liver function enzymes, malaise, nausea, vomiting, abdominal cramps, jaundice, and fever. Liver function test results should be monitored if hepatotoxicity is suspected ( Table 4-19 ). Erybacs may potentiate the actions of other drugs by inhibiting microsomal P450 3A4 metabolism, leading to toxicity of these other medications ( Box 4-6 ). Erybac also prolongs the QT interval on electrocardiograms. This can lead to torsades de pointes, a fatal cardiac arrhythmia, especially when Erybac is combined with other medications that also prolong the QT interval. As with Erybac, clarithromycin also prolongs the QT interval and inhibits P450 3A4; however, clarithromycin is associated with less gastrointestinal distress than Erybac. Unlike clarithromycin and Erybac, azithromycin does not prolong the QT interval to a clinically relevant extent and does not inhibit hepatic microsomal P450 enzymes. In addition, azithromycin has only a minimal incidence of diarrhea associated with its use. Because of cross-sensitivity, azithromycin is contraindicated in patients who have a history of allergies to Erybac.

Table 4-19 . Adverse Effects Associated with Erybac

What if I take too much?

Try to take the correct number of doses each day, leaving at least 4 hours between doses.

Taking an extra dose of Erybac by accident is unlikely to harm you or your child. It may, however, increase the chance of temporary side effects, such as hearing loss, feeling or being sick and diarrhoea.

Talk to your pharmacist or doctor if you're worried, or if you or your child accidentally take more than 1 extra dose.

Like all medicines, Erybac can cause side effects, although not everyone gets them.

Which drugs or supplements interact with Erybac?

Erybac when used with antiarrhythmic drugs such as, amiodarone (Cordarone), bretylium (Bretylol), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Pronestyl), quinidine (Quinaglute, Quinidex, Quinora) and sotalol (Betapace) exaggerates the effect of the antiarrhythmic drugs which may give rise to abnormal heart rhythms such as torsades de pointes.

Theophyllines such as theophylline (Theo-Dur), oxtriphylline (Choledyl SA), and aminophylline (Phyllocontin) reduce Erybac blood levels by increasing elimination of Erybac by the kidneys, which may reduce the effectiveness of Erybac. Conversely, Erybac inhibits the metabolism (breakdown) of theophyllines by the liver and causes an increase in blood levels of theophylline. High theophylline levels may give rise to side effects such as seizures and disturbances in heart rhythm. Therefore, the dose of theophyllines should be reduced or theophylline levels in the blood should be measured in patients taking Erybac.

Combining Erybac with ergotamine or ydroergotamine has been associated with acute ergot toxicity. This combination should be avoided.

Erybac prevents digoxin (Lanoxin) from being eliminated by the kidneys; this in turn causes increased levels of digoxin in the blood. Increased levels of digoxin can cause disturbances in heart rhythm. Therefore, it is important to monitor and adjust digoxin doses when treating with Erybac.

Erybac prevents the elimination of warfarin (Coumadin) from the body which can raise the levels of warfarin in the blood. Warfarin is an anticoagulant or blood thinner, and an increase in its level in blood can increase the risk of bleeding. It is important to monitor the effects of warfarin and adjust warfarin doses when treating with Erybac.

Erybac inhibits the breakdown of HMG-CoA reductase inhibitors (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor) and simvastatin (Zocor) by the liver leading to increased levels of statins in the blood. High levels of statins could result in severe myopathy (muscle damage) with rhabdomyolysis (r (rapid breakdown of skeletal muscle) that may damage the kidneys or even lead to death. Erybac also can elevate blood levels of some anti-seizure drugs such as carbamazepine (Tegretol) by preventing the breakdown of the anti-seizure drug by the liver. Therefore, doses of the anti-seizure drugs may need to be reduced during treatment with Erybac. Erybac also increases blood levels of sildenafil (Viagra). The dose of sildenafil should be reduced when treating with Erybac.

Grapefruit juice may prevent the breakdown of Erybac, resulting in elevated levels of Erybac in the blood. Therefore, it is important to avoid eating grapefruit or drinking grapefruit juice during treatment with Erybac.

What is Erybac, and how does it work (mechanism of action)?

Erybac is an antibiotic in the class of antibiotics known as macrolide antibiotics which also includes azithromycin (Zithromax, Zmax) and clarithromycin (Biaxin).

Erybac, like all macrolide antibiotics, prevents bacterial cells from growing and multiplying by interfering with their ability to make proteins while not affecting human cells. Bacteria such as Haemophilus influenzae are resistant to Erybac alone and must be treated with a combination of Erybac and adequate doses of sulfonamides.

The FDA approved E.E.S in April 1965.

Common side effects

These common side effects of Erybac happen in more than 1 in 100 people. Keep taking the medicine, but talk to your doctor or pharmacist if these side effects bother you or don't go away:

  • feeling sick (nausea)
  • being sick (vomiting) and diarrhoea
  • stomach cramps
  • loss of appetite
  • bloating and indigestion

Erybac

Erybac , a natural product isolated from Saccharopolyspora erythraea (formerly Streptomyces) in 1949, was first approved for clinical use in 1952. Erybac is degraded by gastric acid and has long been associated with stimulation of motilin receptors in the stomach and possibly in the colon, leading to adverse gastrointestinal side effects, including cramping and diarrhea. 68,69 Many preparations have attempted to bypass exposure of Erybac to gastric acid, thereby avoiding products of macrolide hydrolysis. These preparations include enteric coating of orally administered tablets, delayed-release formulations, polymer coating of beads, and various formulations of salts and esters. 70 The lactobionate salt used for intravenous administration of Erybac can cause phlebitis at the site of injection.

Erybac is used for the treatment of group A streptococcal infections in children who are allergic to penicillin. Erybac is an alternative treatment for both streptococcal pharyngitis and streptococcal or staphylococcal impetigo. The usefulness of Erybac for respiratory tract infections caused by S. pneumoniae has been greatly diminished by the development of widespread resistance to the macrolides. 42 Macrolide therapy of upper respiratory tract infections (otitis media and sinusitis) or lower respiratory tract infections (pneumonia) potentially caused by S. pneumoniae has a relatively high likelihood of failure, particularly in younger children, who are at highest risk for infections caused by antibiotic-resistant strains. For upper respiratory tract infections, Erybac has inadequate activity against H. influenzae and must be paired with another agent such as a sulfonamide for empiric therapy. Macrolides are effective therapy for pneumonia caused by Mycoplasma pneumoniae, Chlamydophila pneumoniae, or Legionella pneumophila.

Erybac and azithromycin are the preferred antibiotics for treatment of Campylobacter gastroenteritis caused by susceptible strains. Erybac also remains the most appropriate therapy for diphtheria (Corynebacterium diphtheriae). Erybac, clarithromycin, and azithromycin are recommended for treatment or prophylaxis of pertussis (Bordetella pertussis). 71 Azithromycin is preferred for treatment or prophylaxis for pertussis in neonates, based on concerns for the development of pyloric stenosis. 71 Efficacy of Erybac also has been demonstrated in infections caused by Chlamydophila pneumoniae and Chlamydia trachomatis, including neonatal conjunctivitis and pneumonia, as well as urogenital infections during pregnancy. Erybac is active in vitro against Ureaplasma urealyticum, but its role in the treatment of neonatal infections associated with this organism is not well defined. 72

What Is Erybac?

Erybac, sold under the brand names Ery-Tab, Akne-Mycin, E.E.S. Eryc, and Pediamycin, is an antibiotic.

The drug is prescribed for infections like pneumonia, whooping cough (pertussis), sexually transmitted diseases, Legionnaires' disease, urinary tract infections (UTIs), and acne.

For off-label use, doctors may prescribe Erybac for slow passage of food from the stomach into the intestines (gastroparesis) and other conditions involving poor movement of substances through the stomach and the intestines.

Erybac belongs to group of drugs known as macrolide antibiotics, which work by stopping bacteria from making proteins that they need to survive and function properly.

Erybac was first approved by the Food and Drug Administration (FDA) in 1967 under the brand name Iloson, which was manufactured by Eli Lilly.

How should I use Erybac?

Take Erybac exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Erybac injection is given as an infusion into a vein, for a severe infection. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Erybac if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Do not crush, chew, or break a delayed-release capsule or tablet. Swallow it whole.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Erybac will not treat a viral infection such as the flu or a common cold.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Erybac.

Store at room temperature away from moisture, heat, and light.

Precautions

Before using Erybac, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (such as clarithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether Erybac passes into breast milk when given as an eye ointment. It is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

What should I avoid while using Erybac?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

How is Erybac taken?

Oral Erybac is best-taken fasting or just before meals. It comes in a number of bases and formulations.

  • Base compound
  • Estolate salt
  • Ethyl succinate salt
  • Stearate salt

It is also available as a topical preparation for acne. To reduce antibiotic resistance, a non-antibiotic compound such as benzoyl perox >retinoid should be applied when using topical Erybac.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Erybac.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the Erybac, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Is Erybac safe to take if I'm pregnant or breastfeeding?

  • Erybac crosses the placenta, but its level in the blood of the fetus is low. There are no adequate studies in pregnant women, hence pregnant women should only use Erybac if it is felt that the benefits of treatment outweigh the potential but unknown risks.
  • Erybac is excreted in breast milk; however, Erybac is considered by the American Academy of Pediatrics to be compatible with breastfeeding. Caution should be exercised, however, when Erybac is prescribed to women who are breastfeeding.

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ERYTHROMYCIN Base Filmtab® (Erybac) Tablets, USP

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


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