Cutivate Ointment

DRUG DESCRIPTION

CUTIVATE (fluticasone propionate) Ointment, 0.005% contains fluticasone propionate [(6?,11?,16?,17?)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

CUTIVATE (fluticasone propionate) structural formula illustration

Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.

Each gram of CUTIVATE Ointment contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.

What are the possible side effects of fluticasone topical (Cutivate)?

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

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluticasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • ...

Read All Potential Side Effects and See Pictures of Cutivate Ointment

What are the precautions when taking fluticasone propionate ointment (Cutivate Ointment)?

Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: glaucoma, problems with urination (such as urinary tract blockage, severely enlarged prostate), stomach/intestinal problems (such as chronic constipation, slow gut, intestinal blockage/infection, ulcerative colitis), myasthenia gravis, kidney problems.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are...

Read All Potential Precautions of Cutivate Ointment


Cutivate Ointment Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, dry mouth, stuffy nose, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult the pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

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.

Tell your doctor right away if you have any serious side effects, including: stomach/abdominal bloating or pain, persistent constipation, persistent nausea, vomiting, diarrhea, decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), eye pain, vision changes, difficulty urinating/inability to urinate.

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.

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

PRECAUTIONS: Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: glaucoma, problems with urination (such as urinary tract blockage, severely enlarged prostate), stomach/intestinal problems (such as chronic constipation, slow gut, intestinal blockage/infection, ulcerative colitis), myasthenia gravis, kidney problems.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you sweat less which can increase the risk for heat stroke, a very serious condition. Avoid hot temperatures and activities that might cause you to overheat. Drink plenty of fluids, and dress lightly while in hot areas. If you become overheated, stop activity and promptly seek cooler shelter. Get medical help right away if you develop a fever, dry/hot skin, weakness, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to this drug's side effects, especially drowsiness, confusion, unusual excitement, constipation, and urination problems.

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.


Cutivate Ointment Patient Information Including Side Effects

Brand Names: Cutivate

Generic Name: fluticasone topical (Pronunciation: floo TIK a sone)

  • What is fluticasone topical (Cutivate Ointment)?
  • What are the possible side effects of fluticasone topical (Cutivate Ointment)?
  • What is the most important information I should know about fluticasone topical (Cutivate Ointment)?
  • What should I discuss with my healthcare provider before using fluticasone topical (Cutivate Ointment)?
  • How should I use fluticasone topical (Cutivate Ointment)?
  • What happens if I miss a dose (Cutivate Ointment)?
  • What happens if I overdose (Cutivate Ointment)?
  • What should I avoid while using fluticasone topical (Cutivate Ointment)?
  • What other drugs will affect fluticasone topical (Cutivate Ointment)?
  • Where can I get more information?

What is fluticasone topical (Cutivate Ointment)?

Fluticasone is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluticasone topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Fluticasone topical should not be used to treat rosacea, severe acne, or viral skin infections such as chickenpox or herpes. Fluticasone should not be used on a child younger than 12 years old.

Fluticasone topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluticasone topical (Cutivate Ointment)?

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

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluticasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Less serious side effects may include:

  • mild skin itching, burning, peeling, or dryness;
  • changes in color of treated skin;
  • headache;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • swollen hair follicles;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

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.

What is the most important information I should know about fluticasone topical (Cutivate Ointment)?

Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child younger than 12 years old without the advice of a doctor. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

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