Emrosi
Pronunciation: em-ROH-see
Generic name: minocycline hydrochloride
Dosage form: extended-release capsule, for oral use
Drug class: Tetracyclines
What is Emrosi?
Emrosi is used to treat rosacea in adults and is a low-dose, modified-release form of the antibiotic, minocycline. Emrosi relieves inflammatory lesions caused by rosacea, such as pimples and bumps.
- It is not known if Emrosi is safe and effective for the treatment of infections or for children under the age of 18 years.
Emrosi’s mechanism of action is unknown but may be associated with reducing bacterial by-products that contribute to inflammation, promoting skin barrier repair. Emrosi belongs to the drug class known as tetracycline antibiotics.
Emrosi gained FDA approval on November 4, 2024. Minocycline has been approved since 1971.
Emrosi side effects
The most common side effects of Emrosi are:
- stomach upset
- burning (dyspepsia) after eating or drinking.
Serious side effects and warnings
Emrosi may cause the following serious side effects.
Serious skin and allergic reactions have happened during treatment with minocycline. Emrosi may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking Emrosi and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including:
- skin redness, rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue, or throat
- trouble swallowing or breathing
- blood in your urine
- fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine
- pain on the right side of the stomach area (abdominal pain)
- chest pain or abnormal heartbeats
- swelling in your legs, ankles, and feet.
Permanent tooth discoloration and problems with tooth enamel. Emrosi may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Emrosi may cause tooth enamel to not develop properly. You should not use Emrosi during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. Emrosi is not FDA approved for children.
Slow bone growth. Emrosi may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with Emrosi.
Diarrhea (antibiotic-associated colitis). Antibiotic-associated colitis can happen with most antibiotics, including Emrosi. This type of diarrhea may be caused by an infection (Clostridioides difficile) in your intestines and can be severe and lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.
Liver problems. Emrosi may cause serious liver problems that can lead to death. Stop taking Emrosi and call your healthcare provider right away if you get any of the following symptoms of liver problems:
- loss of appetite
- tiredness
- diarrhea
- yellowing of your skin or the whites of your eyes
- unexplained bleeding or bleeding easily than normal
- confusion
- sleepiness.
Central nervous system effects such as light-headedness, dizziness, and a spinning feeling (vertigo) may occur when beginning Emrosi but may go away during your treatment or if treatment is stopped.
Increased pressure around the brain (idiopathic intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking Emrosi and tell your healthcare provider right away if you have unusual headaches, blurred vision, double vision, and vision loss.
Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using Emrosi for a long time to treat acne may cause immune system reactions. Stop taking Emrosi and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.
Sensitivity to sunlight (photosensitivity). Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with Emrosi. Emrosi can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment.
Discoloration (tissue hyperpigmentation). Emrosi may cause darkening of your nails, bone, skin, eyes, teeth, gums, scars, and internal organs.
Your healthcare provider may do blood tests and check you for side effects during treatment with Emrosi and may stop treatment if you develop certain side effects.
These are not all the side effects with Emrosi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Journey Medical Corporation at 1-855-531-1859.
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Before taking
Do not take Emrosi if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Before taking Emrosi, tell your healthcare provider about all of your medical conditions, including if you:
- have diarrhea or watery stools
- have liver problems
- have kidney problems
- have had increased pressure around your brain that may have cause vision problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Emrosi may harm your unborn baby. Taking Emrosi while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking Emrosi and call your healthcare provider right away if you become pregnant during treatment.
Breastfeeding
Emrosi passes into your milk and may harm your baby. Do not breastfeed during treatment with Emrosi and for 4 days after your final dose.
How should I take Emrosi?
Take Emrosi exactly as your healthcare provider tells you.
Take Emrosi 1 time per day with or without food. Taking Emrosi with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
Swallow Emrosi whole. Do not chew or crush the capsules.
Emrosi dosing
The recommended dosage of Emrosi for rosacea is 40 mg orally, once daily.
What happens if I take too much Emrosi?
If you take too much Emrosi, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room away.
What should I avoid while taking Emrosi?
You should not drive or operate dangerous machinery until you know how Emrosi affects you. Emrosi may cause you to feel dizzy or lightheaded or have a spinning feeling (vertigo).
Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with Emrosi. Emrosi can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment.
Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with Emrosi.
What other drugs will affect Emrosi?
Tell your healthcare provider about all the other medicines you take, including prescription and over-the counter medicines, vitamins and herbal supplements.
Emrosi and other medicines may affect each other and cause serious side effects. Emrosi may affect the way other medicines work, and other medicines may affect how Emrosi works.
Especially tell your healthcare provider if you take:
- a blood thinner medicine
- penicillin antibiotic medicine
- antacids that contain aluminum, calcium, or magnesium or iron-containing medicines
- an acne medicine that contains isotretinoin.
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
Emrosi Storage
Store Emrosi at room temperature between 68°F to 77°F (20°C to 25°C).
Emrosi comes in a child-resistant package which should be kept tightly closed.
Keep away from light, moisture, and excessive heat.
Do not eat the desiccant in the container.
Keep out of the reach of children
Emrosi ingredients
Active ingredient: minocycline hydrochloride 43.19 mg (equivalent to 40 mg of minocycline)
Inactive ingredients: ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry clear, polyethylene glycol, triethyl citrate, and talc.
Available as Emrosi 40 mg extended-release capsules.
Who makes Emrosi?
Journey Medical Corporation manufactures Emrosi.
Popular FAQ
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References
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