Centany AT Topical

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mupirocin topical in children. However, safety and effectiveness of mupirocin cream have not been established in children younger than 3 months of age, and mupirocin ointment in children younger than 2 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mupirocin topical cream in the elderly.

No information is available on the relationship of age to the effects of mupirocin topical ointment in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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—Use with caution. May make this condition worse.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although uncommon, mild burning or stinging after using this medication may occur. If you have severe burning, stinging, or irritation, stop using this medication and tell your doctor right away.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in a new skin infection caused by fungus or yeast. Tell your doctor right away if you notice signs of a new infection, or if your current infection does not get better or if it gets worse.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using mupirocin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyethylene glycol found in some brands), 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: kidney disease (if you are using a brand of mupirocin that contains polyethylene glycol).

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 unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Applies to mupirocin topical: compounding powder, nasal ointment, topical cream, topical kit, topical ointment

Dermatologic

Nasal Ointment: Cutaneous hypersensitivity reactions have been reported very rarely during postmarketing experience.

Topical Ointment: Cutaneous sensitization reactions to the active component or ointment base have been reported.[Ref]

Nasal Ointment:
-Uncommon (0.1% to 1%): Pruritus/itching
-Frequency not reported: Rash
-Postmarketing reports: Cutaneous hypersensitivity reactions

Topical Cream:
-Common (1% to 10%): Rash, pruritus, cutaneous hypersensitivity reactions
-Frequency not reported: Dry skin, erythema, cellulitis, dermatitis, hives

Topical Ointment:
-Common (1% to 10%): Pruritus/itching, erythema, dry skin/dryness
-Uncommon (0.1% to 1%): Contact dermatitis, furunculosis, exfoliative dermatitis, rash, cutaneous sensitization reactions[Ref]

Gastrointestinal

Frequency not reported: Clostridium difficile-associated diarrhea

Nasal Ointment:
-Frequency not reported: Diarrhea, dry mouth, nausea

Topical Cream:
-Common (1% to 10%): Diarrhea, nausea
-Frequency not reported: Abdominal pain, ulcerative stomatitis

Topical Ointment:
-Frequency not reported: Nausea[Ref]

Hypersensitivity

Postmarketing reports: Systemic allergic reactions (e.g., anaphylaxis, generalized rash, urticaria, angioedema)[Ref]

Systemic allergic reactions have been reported during postmarketing experience very rarely.[Ref]

Local

Nasal Ointment:
-Common (1% to 10%): Burning, irritation, tingling, itching, stinging, soreness, facial pain over maxillae

Topical Cream:
-Common (1% to 10%): Application site reactions, application site burning, application site hypersensitivity reactions (including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash)

Topical Ointment:
-Common (1% to 10%): Burning, stinging, pain/swelling at application site, dryness, itching, erythema
-Frequency not reported: Increased exudate, application site reactions[Ref]

Nervous system

Nasal Ointment:
-Common (1% to 10%): Taste perversion, headache

Topical Cream:
-Common (1% to 10%): Headache
-Frequency not reported: Dizziness[Ref]

Ocular

Nasal Ointment:
-Common (1% to 10%): Conjunctivitis
-Frequency not reported: Blepharitis, burning, tearing[Ref]

Other

Nasal Ointment:
-Common (1% to 10%): Burning/stinging
-Frequency not reported: Ear pain

Topical Cream:
-Frequency not reported: Bleeding or pain secondary to eczema, secondary wound infection

Topical Ointment:
-Common (1% to 10%): Burning/stinging/pain
-Rare (0.01% to 0.1%): Systemic reactions (not otherwise specified)
-Frequency not reported: Tenderness, swelling, increased exudate[Ref]

Respiratory

Nasal Ointment:
-Common (1% to 10%): Postnasal drip, sinusitis, rhinitis, respiratory disorder (including upper respiratory tract congestion), pharyngitis, cough
-Uncommon (0.1% to 1%): Nasal mucosa reactions
-Frequency not reported: Epistaxis[Ref]

Some side effects of Centany AT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.