Erythromycin

Benzamycin® Pak contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6- dideoxy-3-C-methyl-3-O-methyl-a- L-ribo-hexopyranosyl)-oxy]-14- ethyl-7,12,13-trihydroxy- 3,5,7,9,11,13-hexa-methyl-6-[ [3,4,6-trideoxy-3-(dimethylamino)-b-D- xylo-hexopyranosyl] oxy]oxacyclotetradecane-2,10- dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is (C37H67NO13).  It has the following structural formula:

Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Benzamycin (erythromycin) ® Pak also contains benzoyl peroxide for topical use. Benzoyl peroxide is an oxidizing agent demonstrating antibacterial activity. Chemically, benzoyl peroxide is (C14H10O4).  It has the following structural formula:

Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of product, as dispensed, contains 30 mg of erythromycin and 50 mg of benzoyl peroxide in a base of SD Alcohol 40B, purified water, hydroxypropyl cellulose, carbomer 934, sodium hydroxide, dioctyl sodium sulfosuccinate 75%. Each Benzamycin (erythromycin) ® Pak contains 0.8 grams of product.

The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug.

Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

Microbiology

Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol and clindamycin.

Benzoyl peroxide is an antibacterial agent which has been shown to be effective against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones. The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen.

Do not use benzoyl peroxide and erythromycin topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid abrasive, harsh, or drying soaps and cleansers while using benzoyl peroxide and erythromycin topical.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.

Do not use benzoyl peroxide and erythromycin topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area at the same time unless directed to do so by your doctor. They may interfere with the effects or absorption of benzoyl peroxide and erythromycin topical.

Do not cover the affected area after applying benzoyl peroxide and erythromycin topical. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the affected area.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Avoid combining PABA-containing sunscreens and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.

Oral:

Oral erythromycin is a prescription medication used to treat infections caused by bacteria, such as respiratory tract infections, intestinal infections, ear infections, urinary tract infections, skin infections, and venereal disease.

Topical:

Topical erythromycin is a prescription medication used to treat acne vulgaris. The ophthalmic ointment is used to treat infections of the eye.

Injectable:

Injectable erythromycin is a prescription medication used to treat infections caused by bacteria, such as respiratory tract infections, intestinal infections, urinary tract infections, skin infections, and venereal disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Other antibiotics
• Anticoagulants, such as warfarin (Coumadin)
• Astemizole (Hismanal)
• Carbamazepine (Tegretol)
• Cisapride (Propulsid)
• Clozapine (Clozaril)
• Colchicine
• Cyclosporine (Neoral, Sandimmune)
• Digoxin (Lanoxin)
• Disopyramide (Norpace)
• Ergotamine
• Felodipine (Plendil)
• Lovastatin (Mevacor)
• Phenytoin (Dilantin)
• Pimozide (Orap)
• Terfenadine (Seldane)
• Theophylline (Theo-Dur)
• Triazolam (Halcion)
• Verapamil (Calan, Verelan)

This is not a complete list of erythromycin drug interactions. Ask your doctor or pharmacist for more information.

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Ilotycin (Erythromycin)

Erythromycin is used to prevent and treat infections in many different parts of the body, including respiratory tract infections, skin infections, diphtheria, intestinal amebiasis, acute pelvic inflammatory disease, Legionnaire's disease, pertussis, and syphilis. erythromycin is also used to prevent recurrent attacks of rheumatic fever in patients who have had an allergic reaction to penicillin or sulfa drugs.

Erythromycin belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth.

erythromycin is available only with your doctor's prescription.

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 erythromycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to erythromycin 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 erythromycin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of erythromycin in the elderly. However, elderly patients are more likely to have erythromycin-induced hearing loss, heart rhythm problems, and bleeding problems.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 erythromycin, 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 erythromycin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Dihydroergotamine
• Dronedarone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Flibanserin
• Fluconazole
• Grepafloxacin
• Levomethadyl
• Lomitapide
• Lovastatin
• Mesoridazine
• Methylergonovine
• Methysergide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using erythromycin 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.

• Acecainide
• Afatinib
• Ajmaline
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Atorvastatin
• Azimilide
• Azithromycin
• Bedaquiline
• Bosutinib
• Bretylium
• Brexpiprazole
• Buserelin
• Carbamazepine
• Ceritinib
• Cerivastatin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clindamycin
• Clomipramine
• Clozapine
• Cobicistat
• Cobimetinib
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Digoxin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Eliglustat
• Encainide
• Enflurane
• Eplerenone
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Fosaprepitant
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Isoflurane
• Isradipine
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Lopinavir
• Lorcainide
• Lumacaftor
• Lumefantrine
• Lurasidone
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Naloxegol
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olaparib
• Ondansetron
• Oxycodone
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pirmenol
• Pitavastatin
• Pitolisant
• Pixantrone
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Risperidone
• Sematilide
• Sertindole
• Sevoflurane
• Simeprevir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tadalafil
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Theophylline
• Tizanidine
• Tolvaptan
• Topotecan
• Toremifene
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Troleandomycin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Venetoclax
• Verapamil
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voriconazole
• Warfarin
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using erythromycin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Anisindione
• Avanafil
• Bexarotene
• Budesonide
• Buspirone
• Cyclosporine
• Diazepam
• Dicumarol
• Methylprednisolone
• Midazolam
• Phenprocoumon
• Roflumilast
• Salmeterol
• Sildenafil
• Sirolimus
• Suvorexant
• Tolterodine
• Triazolam
• Trimetrexate
• Valproic Acid
• Zafirlukast

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Bradycardia (slow heartbeat) or
• Heart rhythm problems (e.g., QT prolongation) or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected—Use is not recommended in patients with these conditions.

• Congestive heart failure—The granules and tablet dosage forms of erythromycin contains sodium, which can make this condition worse.

• Elevated liver enzymes or
• Liver disease (including cholestatic hepatitis) or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

Take erythromycin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take erythromycin with or without food.

Measure the mixed suspension with a marked measuring spoon, oral syringe, or medicine cup.

Keep using the medicine for the full time of treatment, even if you or your child begin to feel better after the first few doses. Your infection may not go away if you stop using the medicine too soon.

Dosing

The dose of erythromycin 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 erythromycin. 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 oral dosage forms (granules for suspension, suspension, and tablets):
  • For treatment of bacterial infections:
    • Adults—400 milligrams (mg) every 6 hours or 800 mg every 12 hours. Depending on the severity of your infection, your doctor may increase your dose as needed up to 4000 mg per day.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided in equal doses and taken every 6 hours. Depending on the severity of your infection, your doctor may increase your dose as needed.

Missed Dose

If you miss a dose of erythromycin, 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

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.

Keep the mixed E.E.S.® suspension in the refrigerator. Throw away any unused medicine within 10 days.

Store the mixed Ery-Ped® suspension at room temperature. Throw away any unused medicine within 35 days.

It is very important that your doctor check the progress of you or your child at regular visits to make sure erythromycin is working properly. Blood and urine tests may be needed to check for unwanted effects. If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Do not use erythromycin if you or your child are also using astemizole (Hismanal®), cisapride (Propulsid®), pimozide (Orap®), or terfenadine (Seldane®). Using these medicines together may increase risk for more serious side effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

erythromycin can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have worsening symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Make sure your doctor knows if you are pregnant or may be pregnant before taking erythromycin.

Erythromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using erythromycin. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are using erythromycin. The results of some tests may be affected by erythromycin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• hearing problems (rare);

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have serious side effects from erythromycin, including hearing loss, or a life-threatening fast heart rate.

Common side effects may include:

• mild diarrhea; or

• nausea, vomiting, stomach pain, loss of appetite.

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.