Pronunciation:

e-rith-roe-MYE-sin, BEN-zoe-il per-OX-ide

Brand Names:

• Benzamycin Pak

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Antiacne

Chemical—

Macrolide

Uses of This Medicine:

Erythromycin and benzoyl peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of erythromycin and benzoyl peroxide combination in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of erythromycin and benzoyl peroxide combination in geriatric patients.

Other 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Dihydroergotamine
• Dronedarone
• Eliglustat
• Ergotamine
• Flibanserin
• Fluconazole
• Grepafloxacin
• Levoketoconazole
• Levomethadyl
• Lomitapide
• Lovastatin
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Abametapir
• Acalabrutinib
• Acecainide
• Adagrasib
• Afatinib
• Ajmaline
• Alfentanil
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Ascorbic Acid
• Asenapine
• Atazanavir
• Atorvastatin
• Avapritinib
• Azimilide
• Azithromycin
• Bedaquiline
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Cerivastatin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clindamycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daridorexant
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dibenzepin
• Digoxin
• Dihydrocodeine
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Edoxaban
• Efavirenz
• Elacestrant
• Elexacaftor
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Eplerenone
• Escitalopram
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Ifosfamide
• Iloperidone
• Imipramine
• Infigratinib
• Inotuzumab Ozogamicin
• Isoflurane
• Isradipine
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Lofexidine
• Lopinavir
• Lorcainide
• Lumacaftor
• Lumateperone
• Lumefantrine
• Lurasidone
• Lurbinectedin
• Macimorelin
• Mavacamten
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitapivat
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Naloxegol
• Neratinib
• Netupitant
• Nilotinib
• Nirmatrelvir
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Palovarotene
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentamidine
• Pentazocine
• Pexidartinib
• Pimavanserin
• Pirmenol
• Pitavastatin
• Pitolisant
• Pixantrone
• Ponesimod
• Prajmaline
• Pralsetinib
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rimegepant
• Risperidone
• Ritonavir
• Rivaroxaban
• Selpercatinib
• Selumetinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tadalafil
• Tazemetostat
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tenofovir Alafenamide
• Tetrabenazine
• Tezacaftor
• Theophylline
• Tolvaptan
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Troleandomycin
• Ubrogepant
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilanterol
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Voriconazole
• Warfarin
• Zanubrutinib
• Zolmitriptan
• Zolpidem
• Zotepine
• Zuclopenthixol

Using this medicine 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.

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

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea, severe or
• Fungal infections—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed. 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 your skin to become irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

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

To use:

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash the affected area(s) with warm water and mild soap. Rinse well and gently pat dry.
• Apply a small amount of the medicine, using enough to cover the affected area(s) of the skin (e.g., forehead, chin, cheeks, chest, shoulders), and gently rub it in. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves.

Benzamycin® Pak is available in one foil pouch that has two separated compartments. If you are using this brand, open the pouch and mix the contents in the palm of your hand thoroughly. Apply the product right away after mixing. Do not mix or apply the medicine near an open flame.

After washing or shaving, it is best to wait 30 minutes before applying the medicine. The alcohol in the mixed medicine may irritate freshly washed or shaved skin.

Avoid washing the acne-affected area(s) too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin. If you have any questions about this, check with your doctor.

Do not use this medicine after the expiration date on the label. The medicine may not work properly. Get a fresh supply from your pharmacist. Check with your pharmacist if you have any questions about this.

To help keep your acne under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for months or even longer in some cases.

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 topical dosage form (gel):
  • For acne:
    • Adults, teenagers, and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin two times a day (morning and evening), or as directed by your doctor.
    • Children below 12 years of age—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.

Keep the Benzamycin® Pak in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the Benzamycin® topical gel in the refrigerator, away from heat and direct light. Do not freeze. Throw away any unused medicine after 3 months.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause diarrhea, and in some cases it can be severe. 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.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.

If you develop severe swelling, shortness of breath, or any allergic reaction to this medicine, stop using the medicine and check with your doctor right away.

If your acne does not improve within 3 to 4 weeks, or if it becomes worse, check with your doctor. However, treatment of acne may take up to 8 to 12 weeks before you see full improvement.

If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to apply the second medicine at least 1 hour after you apply the first medicine. This may help keep your skin from becoming too irritated. Also, if the medicines are used too close together, they may not work properly.

Mild stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often. Follow your doctor's directions.

You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only ``oil-free'' cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.

Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include skin peeling agents.

Do not apply the medicine to your hair or to any colored fabric. This medicine may cause bleaching.

Side Effects of This Medicine:

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:

Less common or rare

Burning, blistering, crusting, itching, severe redness, or swelling of the skin

dryness or peeling of the skin

eye irritation

feeling of warmth, mild stinging, or redness of the skin

increased sensitivity of the skin to sunlight

oiliness or tenderness of the skin

painful irritation of the skin

redness or other discoloration of the skin

redness, swelling, or itching of the eyelid

severe sunburn

skin rash

swelling of the eyes, face, and nose

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.