Rozex (Topical)

Metronidazole topical gel is used to treat inflammatory lesions (pimples and red bumps) caused by rosacea. Rosacea is a skin condition that leads to redness and pimples on your nose, cheeks, chin, and forehead.

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

It is very important that your doctor checks your progress at regular visits to see if the medicine is working properly and to check for unwanted effects.

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

This medicine may cause nerve problems (e.g., peripheral neuropathy). Check with your doctor right away if you have burning, numbness, tingling, or painful sensations, unsteadiness or awkwardness, or weakness in the arms, hands, legs, or feet.

Skin reactions, including contact dermatitis, may occur while using this medicine. Check with your doctor right away if you have blistering, burning, crusting, dryness, or flaking of the skin or itching, scaling, severe redness, soreness, or swelling of the skin.

This medicine may cause eye irritations. Check with your doctor right away if you have red, sore eyes or tearing of the eyes.

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.

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

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare 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

Studies have not been done to determine how metronidazole topical gel affects children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems for older adults that would limit the use of metronidazole topical gel in this group. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected based on 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.

• Amprenavir
• Bepridil
• Cisapride
• Disulfiram
• Dronabinol
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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

• Acenocoumarol
• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Busulfan
• Capecitabine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxifluridine
• Droperidol
• Ebastine
• Efavirenz
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluorouracil
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Levofloxacin
• Lithium
• Lumefantrine
• Macimorelin
• Mebendazole
• Mefloquine
• Methadone
• Methotrimeprazine
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine Hydrochloride
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pimavanserin
• Pipamperone
• Piperaquine
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tamoxifen
• Tegafur
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Warfarin
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the 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 adjust the dose or how often you use one or both of the medicines.

• Carbamazepine
• Cyclosporine
• Milk Thistle

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used when eating food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Blood disease, history of or
• Nerve problems—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

Less common

• Bladder pain
• blistering, burning, crusting, dryness, or flaking of the skin
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest tightness
• chills
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• itching, scaling, severe redness, soreness, or swelling of the skin
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nausea
• pounding in the ears
• shivering
• slow or fast heartbeat
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Burning, numbness, tingling, or painful sensations
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

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. Your health care professional may also 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:

Rare

• Back pain

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.

In the U.S.

• Metrocream
• Metrogel
• Metrolotion
• Noritate
• Rosadan
• Rosadan Cream Kit
• Rozex
• Vitazol

Available Dosage Forms:

• Gel/Jelly
• Cream
• Lotion

Therapeutic Class: Antiacne Antibacterial

Chemical Class: Nitroimidazole

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 comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

To use the topical gel:

• Wash your hands with soap and water before and after using this medicine.
• Make sure your skin is clean and dry before you apply this medicine.
• Apply a thin layer of this medicine to the affected area of the skin.
• You may apply cosmetics after applying this medicine.

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 rosacea: Adults—Apply to the affected area of the skin once a day. 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

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.