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ANDROGEL- testosterone gel


  1. Abnormal Sexual Changes:
  2. Behavior Problems:
  3. Signs And Symptoms In Women When They Come In Direct Contact With Androgel 1% May Include:
  4. Do Not Use Androgel 1% If You:
  5. Before Using Androgel 1%, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  6. Androgel 1% Can Cause Serious Side Effects Including:
  7. The Most Common Side Effects Of Androgel 1% Include:
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. 2. How Should Androgel (pump Or Packet) Be Applied?
  11. How To Use The Androgel Pump?
  12. How To Use The Androgel Packets?
  13. Before You Start Using Androgel, Tell Your Healthcare Professional If You :
  14. Tell Your Healthcare Provider About All Of The Medicines You Take, Including Prescription And Non-prescription Medicines, Vitamins And Herbal Supplements. Androgel Can Affect How Your Body Handles Other Drugs. Changes In Your Dose Or Careful Monitoring May Be Needed If You Are Taking Any Of The Following Medications:
  15. Most Common:
  16. Contact Your Healthcare Professional If You Experience Any Of The Following Adverse Reactions:
  17. Prostate Disorders:
  18. Testosterone Transfer:
  19. 6. How Should Androgel Be Stored?
  20. Repackaged By:
  21. Patient Information
  22. What Is The Most Important Information I Should Know About Androgel?
  23. Signs And Symptoms Of Early Puberty In A Child May Include:
  24. Do Not Use Androgel If You:
  25. Before You Use Androgel, Tell Your Healthcare Provider If You:
  26. Especially, Tell Your Healthcare Provider If You Take:
  27. How Should I Use Androgel?
  28. Applying Androgel:
  29. If You Are Using The Androgel Pump:
  30. If You Are Using Androgel Packets:
  31. Androgel Can Cause Serious Side Effects Including:
  32. The Most Common Side Effects Of Androgel Include:
  33. How Should I Store Androgel?
  34. What Are The Ingredients In Androgel?active Ingredient:
  35. Marketed By:
  36. Revised: 12/2011document Id:

Abnormal Sexual Changes: 

  • enlarged penis or clitoris.
  • early growth of hair near the vagina or around the penis (pubic hair).
  • erections or acting out sexual urges (sex drive).

Behavior Problems: 

  • acting aggressively, behaving in an angry or violent way.
Women

Signs And Symptoms In Women When They Come In Direct Contact With Androgel 1% May Include: 

  • changes in body hair.
  • an abnormal increase in pimples (acne).

Stop using ANDROGEL 1% and call your healthcare provider right away if you
ANDROGEL 1% is a prescription medicine that contains testosterone. ANDROGEL 1% is used to treat adult males who have low or no testosterone due to certain medical conditions.

  • Your healthcare provider will test your blood before you start and while you are using ANDROGEL 1%.
  • It is not known if ANDROGEL 1% is safe or effective to treat men who have low testosterone due to aging.
  • It is not known if ANDROGEL 1% is safe or effective in children younger than 18 years old. Improper use of ANDROGEL 1% may affect bone growth in children.
ANDROGEL 1% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your ANDROGEL 1% in a safe place to protect it. Never give your ANDROGEL 1% to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
ANDROGEL 1% is not meant for use in women.

Do Not Use Androgel 1% If You: 

  • have breast cancer.
  • have or might have prostate cancer.
  • are pregnant. ANDROGEL 1% may harm your unborn baby.
  • Women who are pregnant should avoid contact with the area of skin where ANDROGEL 1% has been applied.

Before Using Androgel 1%, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have breast cancer.
  • have or might have prostate cancer.
  • have urinary problems due to an enlarged prostate.
  • have heart problems.
  • have liver or kidney problems.
  • have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ANDROGEL 1% with certain other medicines can affect each other.
Especially, tell your healthcare provider if you take:
  • insulin
  • corticosteroids
  • medicines that decrease blood clotting (blood thinners)

Androgel 1% Can Cause Serious Side Effects Including: 


  • If you already have an enlarged prostate, your symptoms can get worse while using ANDROGEL 1%.This can include:
    • increased urination at night.
    • trouble starting your urine stream.
    • having to pass urine many times during the day.
    • having an urge to go to the bathroom right away.
    • having a urine accident.
    • being unable to pass urine or weak urine flow.
  • Possible increased risk of prostate cancer.Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use ANDROGEL 1%.
  • Blood clots in the legs or lungs.Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses ANDROGEL 1% may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Have problems breathing while you sleep (sleep apnea).
Call your healthcare provider right away if you have any of the serious side effects listed above.

The Most Common Side Effects Of Androgel 1% Include: 

  • acne
  • skin irritation where ANDROGEL 1% is applied
  • lab test changes
  • increased prostate specific antigen (a test used to screen for prostate cancer).
Other side effects includemore erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ANDROGEL 1%. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of ANDROGEL 1%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ANDROGEL 1% for a condition for which it was not prescribed. Do not give ANDROGEL 1% to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ANDROGEL 1% that is written for health professionals.

Active Ingredient: 

testosterone

Inactive Ingredients: 

carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water and sodium hydroxide.
Marketed by: AbbVie Inc., North Chicago, IL 60064, USA
2019 AbbVie Inc.
For more information, go to www.ANDROGEL.com or call 1-800-633-9110.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 05/2019

5044279



2. How Should Androgel (pump Or Packet) Be Applied? 

It is important that you use AndroGel as prescribed by your healthcare professional. If you experience serious problems, contact your healthcare professional. Your healthcare professional will tell you how much AndroGel to use each day.

image of Figure 3: Site(s) of Gel Application

Figure3: Site(s) of Gel Application

  • AndroGel should be applied once daily at the same time each day(preferably every morning) to clean, dry, healthy, intact skin of the shoulders, upper arms and/or abdomen. If you take a bath or shower in the morning, use AndroGelafteryour bath or shower.
  • AndroGelshould notbe applied to thepenis or scrotum,or to skin with open sores, wounds or irritation.
  • Wash your handswith soap and water immediatelyafter applicationto reduce the chance that the medication will spread from your hands to other people.
  • Let AndroGel dry for a few minutes before you dress.
  • AndroGel is flammable until dry; allow the gel to dry before smoking or going near an open flame.
  • Wait 5 to 6 hoursbefore showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into your system.

How To Use The Androgel Pump? 

It is important that you read and follow these directions on how to use the AndroGel Pump properly. Before using the pump for the first time, you must prime the AndroGel pump by fully depressing the pump three times and discarding the gel. The unused gel should be discarded in a manner to avoid accidental exposure or ingestion by household members or pets. Fully depress the pump the appropriate number of times to deliver the daily dose prescribed by your healthcare provider. The product may be delivered directly into the palm of your hand and then applied to the desired application sites, either one pump depression at a time or upon completion of all pump depressions required for the daily dose.

How To Use The Androgel Packets? 

Open one AndroGel aluminum foil packet by folding the top edge at the perforation and tearing completely across the packet along the perforation. Squeeze the contents into the palm of your hand. Squeeze from the bottom of the packet toward the top. If you like, you may squeeze a portion of the gel from the packet into the palm of your hand and apply to application site(s). Repeat until the entire contents of the packet have been applied.

Before You Start Using Androgel, Tell Your Healthcare Professional If You : 

  • Have prostate cancer or breast cancer.
  • Have a known hypersensitivity to any of AndroGel's components, including individuals who are hypersensitive to testosterone that is chemically synthesized from soy.

Tell Your Healthcare Provider About All Of The Medicines You Take, Including Prescription And Non-prescription Medicines, Vitamins And Herbal Supplements. Androgel Can Affect How Your Body Handles Other Drugs. Changes In Your Dose Or Careful Monitoring May Be Needed If You Are Taking Any Of The Following Medications: 

  • Insulin
  • Corticosteroids
  • Oral Anticoagulants

Most Common: 

Skin irritation where gel is applied, breast development or tenderness, acne, prostate enlargement, changes in lab test results and changes in urinary habits.

Contact Your Healthcare Professional If You Experience Any Of The Following Adverse Reactions: 

  • Too frequent or persistent erections of the penis.
  • Any nausea, vomiting, changes in skin color or ankle swelling.
  • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
  • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.

Prostate Disorders: 

Patients treated with testosterone may be at an increased risk for prostate enlargement, and prostate cancer. Talk to your healthcare provider for more information on risk factors and ways to monitor for prostate disorders.

Testosterone Transfer: 

Transfer of testosterone to others (including women and children) can occur when vigorous skin-to-skin contact is made with the application site. AndroGel must not be used by women, and exposure to the active ingredient testosterone in pregnancy can cause fetal harm. Notify your healthcare provider if your female partner develops changes in hair distribution, increases in acne or other signs of masculinity.

6. How Should Androgel Be Stored? 

Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F) [

Your healthcare professional has prescribed AndroGel to meet your specific needs; never share your AndroGel with anyone. If you have any questions or concerns about your AndroGel treatment, ask your healthcare provider or pharmacist.

Manufactured By:
Laboratoires Besins International
Montrouge, France
For:
Unimed Pharmaceuticals, LLC
A Solvay Pharmaceuticals, Inc. Company
Marietta, GA 30062-2224

Repackaged By: 

Rebel Distributors Corp.

Thousand Oaks, CA 91320

U.S. Patent No. 6,503, 894

2007 Solvay Pharmaceuticals, Inc.

Revised: December 2007

500122/500127 Rev Dec 2007(1)

Patient Information 

Medication Guide

AndroGel(AN DROW JEL) CIII

(testosterone gel) 1%


Read the Medication Guide that comes with AndroGel before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What Is The Most Important Information I Should Know About Androgel? 

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel.

Signs And Symptoms Of Early Puberty In A Child May Include: 

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

AndroGel can transfer from your body to others.

2. Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied to your skin.

Stop using AndroGel and call your healthcare provider right away ifyou

AndroGel is a prescription medicine that contains testosterone. AndroGel is used to treat adult males who have low or no testosterone.

It is not known if AndroGel is safe or effective in children younger than 18 years old. Improper use of AndroGel may affect bone growth in children.

AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel in a safe place to protect it. Never give your AndroGel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

AndroGel is not meant for use in women.

Do Not Use Androgel If You: 

  • have breast cancer
  • have or might have prostate cancer
  • are pregnant or may become pregnant or breast-feeding. AndroGel may harm your unborn or breast-feeding baby.

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel has been applied.

  • are allergic to testosterone or any of the ingredients in AndroGel including soy.

Before You Use Androgel, Tell Your Healthcare Provider If You: 

  • have breast cancer or prostate cancer
  • have urinary problems due to an enlarged prostate
  • have heart problems
  • have liver or kidney problems
  • have problems breathing while you sleep (sleep apnea)
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using AndroGel with certain other medicines can affect each other.

Especially, Tell Your Healthcare Provider If You Take: 

  • insulin
  • corticosteroids
  • medicines that decrease blood clotting

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How Should I Use Androgel? 

  • It is important that you apply AndroGel exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much AndroGel to apply and when to apply it.
  • Your healthcare provider may change your AndroGel dose. Do not change your AndroGel dose without talking to your healthcare provider.
  • AndroGel is for skin use only.
  • Do not allow others to apply AndroGel to your body.

Applying Androgel: 

AndroGel comes in a pump or in packets.

If You Are Using The Androgel Pump: 

  • Before using the pump for the first time, you will need to prime the pump. To prime AndroGel, fully push down on the pump 3 times. Do not use any AndroGel that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your AndroGel pump is ready to use now.
  • Your healthcare provider will tell you the number of times to press the pump for each dose.

If You Are Using Androgel Packets: 

  • Tear open the packet completely at the dotted line.
  • Squeeze all of the AndroGel out of the packet into the palm of your hand. Squeeze from the bottom of the packet to the top.
  • Throw away the packet in the trash out of the reach of children to avoid accidental exposure.
  • Squeeze the medicine into the palm of your hand and apply to clean dry, intact skin at the same time each day.
  • You may also apply AndroGel from the pump or packet directly to your skin.
  • Apply AndroGel only to areas that will be covered by a short sleeve t-shirt, as shown in the shaded areas in the figure below. These areas are your shoulders and upper arms, or stomach area, or shoulders, upper arm and stomach area.

    Figure

  • Do not apply AndroGel to your penis or scrotum.
  • Wash your hands with soap and water right after you apply AndroGel.
  • Let the application areas dry for a few minutes before putting on a shirt.
  • To prevent transfer of AndroGel to others, clothes (such as a t-shirt) shouldalwaysbe worn to cover the AndroGel application areas until you have washed the application areas well with soap and water.
  • Wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into your system.
  • AndroGel is flammable until dry. Let the gel dry before smoking or going near an open flame.

Your healthcare provider will test your blood before you start and while you take AndroGel.

Androgel Can Cause Serious Side Effects Including: 

  • If you already have enlargement of your prostate gland your signs and symptoms can get worsewhile using AndroGel. This can include:
  • increased urination at night
  • trouble starting your urine stream
  • having to pass urine many times during the day
  • having an urge that you have to go to the bathroom right away
  • having a urine accident
  • being unable to pass urine or weak urine flow
  • Possible increased risk of prostate cancer.Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use AndroGel.
  • In large doses AndroGel may lower your sperm count.
  • Swelling of your ankles, feet, or body, with or without heart failure.
  • Enlarged or painful breasts.
  • Have problems breathing while you sleep (sleep apnea).
  • Blood clots in the legs.This can include pain, swelling or redness of your legs.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The Most Common Side Effects Of Androgel Include: 

  • acne
  • skin irritation where AndroGel is applied
  • increased cholesterol levels
  • increased prostate specific antigen (a test used to screen for prostate cancer)
  • increased red blood cell count
  • increased liver function tests

Other side effects includemore erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of AndroGel. For more information, ask your healthcare provider or pharmacist.

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 Androgel? 

  • Store AndroGel between 59 F to 86 F (15 C to 30 C).
  • Safely throw away used AndroGel in household trash. Be careful to prevent accidental exposure of children or pets.
  • Keep AndroGel away from fire.

Keep AndroGel and all medicines out of the reach of children.

General information about AndroGel

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AndroGel for a condition for which it was not prescribed. Do not give AndroGel to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about AndroGel. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AndroGel that is written for health professionals.

For more information, go to www.ANDROGEL.com or call 1-800-241-1643.

What Are The Ingredients In Androgel?active Ingredient: 

testosterone

Marketed By: 

Abbott Laboratories

North Chicago, IL 60064, U.S.A.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued Nov 2011

NDC 54868-4792-0

androgel 1% 2.5 g 30 ct

CIII

AndroGel(testosterone gel) 1%

30 Unit-dose Packets

Contains 2.5 grams per unit dose

Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*

Rx Only

Dispense the enclosed Medication Guide to each patient.

*See accompanying package insert.


NDC 54868-4810-0

androgel 1% 5g 30ct

CIII

AndroGel(testosterone gel 1%)

30 Unit-dose Packets

Contains 5 grams per unit dose

Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*

Dispense the enclosed Medication guide to each patient.

*See accompanying package insert.

Rx Only


NDC 54868-5814-0

androgel 1% 2 multi-dose pumps despensing 75g or 60 metered 1.25 g doses

CIII

AndroGel(testosterone 1% Pump

This package contains 2 multi-dose pumps. Each pump is capable of dispensing 75g doses each.

Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*

Dispense the enclosed Medication Guide to each patient.

Rx Only


ANDROGEL
testosterone gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5814(NDC:0051-8488)
Route of AdministrationTRANSDERMALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
testosterone(UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)testosterone10 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type C(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
isopropyl myristate(UNII: 0RE8K4LNJS)
water(UNII: 059QF0KO0R)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5814-02 in 1 CARTON
175 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02101508/29/2007
ANDROGEL
testosterone gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-4792(NDC:0051-8425)
Route of AdministrationTRANSDERMALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
testosterone(UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)testosterone10 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type C(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
isopropyl myristate(UNII: 0RE8K4LNJS)
water(UNII: 059QF0KO0R)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4792-030 in 1 CARTON
12.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02101505/15/2003
ANDROGEL
testosterone gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-4810(NDC:0051-8450)
Route of AdministrationTRANSDERMALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
testosterone(UNII: 3XMK78S47O) (testosterone - UNII:3XMK78S47O)testosterone10 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type C(UNII: 4Q93RCW27E)
alcohol(UNII: 3K9958V90M)
isopropyl myristate(UNII: 0RE8K4LNJS)
water(UNII: 059QF0KO0R)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4810-030 in 1 CARTON
15 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02101506/05/2003
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 12/2011document Id: 

e1db502f-fa92-4a34-9c93-68bdfb38ba85Set id: d466910c-9a76-44e8-8759-4717ec2c591fVersion: 3Effective Time: 20111215Physicians Total Care, Inc.



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