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BACTROBAN- mupirocin calcium ointment


  1. Patient Information
  2. Advise The Patient To Administer Bactroban Nasal Ointment As Follows:
  3. Do Not Use Bactroban Nasal Ointment If:
  4. Before Using Bactroban Nasal Ointment, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You:
  5. How Should I Use Bactroban Nasal Ointment?
  6. Bactroban Nasal Ointment May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Bactroban Nasal Ointment Include:
  8. How Should I Store Bactroban Nasal Ointment?
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Usual Dosage:
  12. Revised: 5/2017document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise The Patient To Administer Bactroban Nasal Ointment As Follows: 

Use BACTROBAN nasal ointment only as directed by the healthcare provider. Avoid contact of BACTROBAN nasal ointment with the eyes. If BACTROBAN nasal ointment gets in or near the eyes, rinse thoroughly with water.
Wash your hands before and after applying BACTROBAN nasal ointment.
Apply approximately one half of the BACTROBAN nasal ointment from the single use tube directly into 1 nostril and the other half into the other nostril.
Press the sides of the nose together and gently massage after application to spread the ointment throughout the inside of the nostrils.
Discard the tube after using. Do not re-use.
Report to the healthcare provider any signs of local adverse reactions. BACTROBAN nasal ointment should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.
Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur [

BACTROBAN nasal ointment is a prescription medicine used to reduce the amount of methicillin-resistantStaphylococcus aureus(MRSA) bacteria in your nose.

It is not known if BACTROBAN nasal ointment is safe and effective in children under 12 years of age.

Do Not Use Bactroban Nasal Ointment If: 

you are allergic to mupirocin or any of the ingredients in BACTROBAN nasal ointment.

Before Using Bactroban Nasal Ointment, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You: 

are pregnant or plan to become pregnant. It is not known if BACTROBAN nasal ointment will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if BACTROBAN nasal ointment passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN nasal ointment while breastfeeding.

Tell your healthcare provider about all of the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix BACTROBAN nasal ointment with other intranasal products.

How Should I Use Bactroban Nasal Ointment? 

BACTROBAN nasal ointment is for use in the nose (intranasal).Do not get BACTROBAN in your eyes or mouth.
Use BACTROBAN nasal ointment exactly as your healthcare provider tells you to use it.
Apply approximately one-half of the BACTROBAN nasal ointment from a single-use tube to the inside surface at the front of each nostril 2 times a day for 5 days.
Press the sides of your nose together and gently rub between your finger and thumb for about 1 minute. This spreads the BACTROBAN nasal ointment around the nose.
It is important that you take the full course of BACTROBAN nasal ointment. Do not stop early because the amount of bacteria in your nose may not be reduced.
Wash your handsbefore and afterapplying BACTROBAN nasal ointment.

Bactroban Nasal Ointment May Cause Serious Side Effects, Including: 

severe allergic reactions.Stop using BACTROBAN nasal ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:

hives trouble breathing or wheezing

swelling of your face, lips, mouth, or tongue dizziness, fast heartbeat or pounding in your chest

a rash over your whole body

eye irritation.Do not get BACTROBAN nasal ointment in your eyes. If BACTROBAN nasal ointment gets in your eyes, rinse your eyes well with water.
irritation in the area BACTROBAN nasal ointment is used.Stop using BACTROBAN nasal ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using BACTROBAN nasal ointment.
a type of diarrhea calledclostridium difficile-associated diarrhea (CDAD).CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using BACTROBAN nasal ointment.

The Most Common Side Effects Of Bactroban Nasal Ointment Include: 

These are not all the possible side effects of BACTROBAN nasal ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Bactroban Nasal Ointment? 

Store BACTROBAN nasal ointment at room temperature up to 25 C (77 F).
Do not refrigerate BACTROBAN nasal ointment.
Keep BACTROBAN nasal ointment and all medicines out of the reach of children.

General information about the safe and effective use of BACTROBAN nasal ointment.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BACTROBAN nasal ointment for a condition for which it was not prescribed. Do not give BACTROBAN nasal ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BACTROBAN nasal ointment that is written for health professionals.

Active Ingredient: 

mupirocin calcium

Inactive Ingredients: 

paraffin and SOFTISAN649

BACTROBAN is a registered trademark of the GSK group of companies.

SOFTISAN is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

2017 the GSK group of companies. All rights reserved.

GlaxoSmithKline, Research Triangle Park, NC 27709

BBN:3PIL

For more information, call 1-888-825-5249.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: March 2017

PRINCIPAL DISPLAY PANEL

NDC 0029-1526-11

BACTROBAN(mupirocin calcium)

Nasal Ointment, 2%

10 x 1.0 gram Single-Use Tubes

This shrink-wrapped unit represents one 5-day course of therapy.

Store at 20o- 25oC (68o77oF); excursions permitted 15o- 30oC (59o86oF).. Do not refrigerate.

Do not use if seal on tube nozzle is broken.

Usual Dosage: 

For intranasal use only. Apply one-half the contents of a tube in one nostril. Apply other half of tube contents in other nostril. See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

10000000136205 Rev. 8/15
Bactroban Nasal 10 count label
BACTROBAN
mupirocin calcium ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0029-1526
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MUPIROCIN CALCIUM(UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)MUPIROCIN20 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN(UNII: I9O0E3H2ZE)
Product Characteristics
ColorWHITE (white to off-white)Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0029-1526-1110 in 1 PACKAGE04/10/1996
1NDC:0029-1526-031 in 1 CARTON
11 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05070304/10/1996
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 5/2017document Id: 

e68a42a0-bbca-4983-8e74-2aa0f9d0e8caSet id: 8f44a933-1629-4e65-16a6-9ad421329aa6Version: 15Effective Time: 20170508GlaxoSmithKline LLC



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