Medication Guide ANDROGEL (AN DROW JEL) CIII (testosterone gel) 1.62%

Transcription

1 Medicatin Guide ANDROGEL (AN DROW JEL) CIII (teststerne gel) 1.62% Read this Medicatin Guide befre yu start using ANDROGEL 1.62% and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur healthcare prvider abut yur medical cnditin r treatment. What is the mst imprtant infrmatin I shuld knw abut ANDROGEL 1.62%? ANDROGEL 1.62% can transfer frm yur bdy t thers. This can happen if ther peple cme int cntact with the area where the ANDROGEL 1.62% was applied. Signs f puberty that are nt expected (fr example, pubic hair) have happened in yung children wh were accidentally expsed t teststerne thrugh skin-t-skin cntact with men using tpical teststerne prducts like ANDROGEL 1.62%. Wmen and children shuld avid cntact with the unwashed r unclthed area where ANDROGEL 1.62% has been applied. If a wman r child makes cntact with the ANDROGEL 1.62% applicatin area, the cntact area n the wman r child shuld be washed well with sap and water right away. T lwer the risk f transfer f ANDROGEL 1.62% frm yur bdy t thers, yu shuld fllw these imprtant instructins: Apply ANDROGEL 1.62% nly t yur shulders and upper arms that will be cvered by a shrt sleeve t-shirt. Wash yur hands right away with sap and water after applying ANDROGEL 1.62%. After the gel has dried, cver the applicatin area with clthing. Keep the area cvered until yu have washed the applicatin area well r have shwered. If yu expect anther persn t have skin-t-skin cntact with yur shulders r upper arms, first wash the applicatin area well with sap and water. Stp using ANDROGEL 1.62% and call yur healthcare prvider right away if yu see any signs and symptms in a child r a wman that may have ccurred thrugh accidental expsure t ANDROGEL 1.62%. 1

2 Signs and symptms in children may include: enlarged penis r clitris early develpment f pubic hair increased erectins r sex drive aggressive behavir Signs and symptms in wmen may include: changes in bdy hair a large increase in acne What is ANDROGEL 1.62%? ANDROGEL 1.62% is a prescriptin medicine that cntains teststerne. ANDROGEL 1.62% is used t treat adult males wh have lw r n teststerne. Yur healthcare prvider will test yur bld befre yu start and while yu are taking ANDROGEL 1.62%. It is nt knwn if ANDROGEL 1.62% is safe r effective in children yunger than 18 years ld. Imprper use f ANDROGEL 1.62% may affect bne grwth in children. ANDROGEL 1.62% is a cntrlled substance (CIII) because it cntains teststerne that can be a target fr peple wh abuse prescriptin medicines. Keep yur ANDROGEL 1.62% in a safe place t prtect it. Never give yur ANDROGEL 1.62% t anyne else, even if they have the same symptms yu have. Selling r giving away this medicine may harm thers and is against the law. ANDROGEL 1.62% is nt meant fr use in wmen. Wh shuld nt use ANDROGEL 1.62%? D nt use ANDROGEL 1.62% if yu: have breast cancer have r might have prstate cancer are pregnant r may becme pregnant r are breast-feeding. ANDROGEL 1.62% may harm yur unbrn r breast-feeding baby. Wmen wh are pregnant r wh may becme pregnant shuld avid cntact with the area f skin where ANDROGEL 1.62% has been applied. Talk t yur healthcare prvider befre taking this medicine if yu have any f the abve cnditins. 2

3 What shuld I tell my healthcare prvider befre using ANDROGEL 1.62%? Befre yu use ANDROGEL 1.62%, tell yur healthcare prvider if yu: have breast cancer have r might have prstate cancer have urinary prblems due t an enlarged prstate have heart prblems have kidney r liver prblems have prblems breathing while yu sleep (sleep apnea) have any ther medical cnditins Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Using ANDROGEL 1.62% with certain ther medicines can affect each ther. Especially, tell yur healthcare prvider if yu take: insulin medicines that decrease bld cltting crticsterids Knw the medicines yu take. Ask yur healthcare prvider r pharmacist fr a list f all f yur medicines, if yu are nt sure. Keep a list f them and shw it t yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I use ANDROGEL 1.62%? It is imprtant that yu apply ANDROGEL 1.62% exactly as yur healthcare prvider tells yu t. Yur healthcare prvider will tell yu hw much ANDROGEL 1.62% t apply and when t apply it. Yur healthcare prvider may change yur ANDROGEL 1.62% dse. D nt change yur ANDROGEL 1.62% dse withut talking t yur healthcare prvider. ANDROGEL 1.62% is t be applied t the area f shulders and upper arms that will be cvered by a shrt sleeve t-shirt. D nt apply ANDROGEL 1.62% t any ther parts f yur bdy such as yur stmach area (abdmen), penis, r scrtum. Apply ANDROGEL 1.62% at the same time each mrning. ANDROGEL 1.62% shuld be applied after shwering r bathing. 3

4 Wash yur hands right away with sap and water after applying ANDROGEL 1.62%. Avid shwering, swimming r bathing fr at least 2 hurs after yu apply ANDROGEL 1.62%. ANDROGEL 1.62% is flammable until dry. Let ANDROGEL 1.62% dry befre smking r ging near an pen flame. Applying ANDROGEL 1.62%: Befre using a new bttle f ANDROGEL 1.62 % fr the first time, yu will need t prime the pump. T prime the ANDROGEL 1.62% pump, slwly push the pump all the way dwn 3 times. D nt use any ANDROGEL 1.62% that came ut while priming. Wash it dwn the sink t avid accidental expsure t thers. Yur ANDROGEL 1.62% pump is nw ready t use. Use ANDROGEL 1.62% exactly as yur healthcare prvider tells yu t use it. Yur healthcare prvider will tell yu the dse f ANDROGEL 1.62% that is right fr yu. Befre applying ANDROGEL 1.62% make sure that yur shulders and upper arms are clean, dry, and that there is n brken skin. Remve the cap frm the pump. Then, psitin the nzzle ver the palm f yur hand and slwly and fully depress the pump. The applicatin sites fr ANDROGEL 1.62% are the upper arms and shulders that will be cvered by a shrt sleeve t-shirt (See Figure 1). (Figure 1) 4

5 Find Yur Dse as Prescribed by Yur Physician 1 PUMP DEPRESSION 2 PUMP DEPRESSIONS 3 PUMP DEPRESSIONS 4 PUMP DEPRESSIONS Applicatin Methd mg Using the palm f the hand, apply ne depressin f ANDROGEL 1.62% t 1 upper arm and shulder mg Using the palm f the hand, apply ne pump depressin f ANDROGEL 1.62% t ne upper arm and shulder and then apply ne pump depressin f ANDROGEL 1.62% t the ppsite upper arm and shulder mg Using the palm f the hand, apply tw pump depressins f ANDROGEL 1.62% t ne upper arm and shulder and then apply ne pump depressin f ANDROGEL 1.62% t the ppsite upper arm and shulder. 81 mg Using the palm f the hand, apply tw pump depressins f ANDROGEL 1.62% t ne upper arm and shulder and then apply tw pump depressins f ANDROGEL 1.62% t the ppsite upper arm and shulder. Let the applicatin site dry cmpletely befre putting n a t-shirt. Wash yur hands with sap and water right away. What are the pssible side effects f ANDROGEL 1.62%? See What is the mst imprtant infrmatin I shuld knw abut ANDROGEL 1.62%? ANDROGEL 1.62% can cause serius side effects including: If yu already have enlargement f yur prstate gland yur signs and symptms can get wrse while using ANDROGEL 1.62%. This can include: increased urinatin at night truble starting yur urine stream having t pass urine many times during the day having an urge that yu have t g t the bathrm right away having a urine accident being unable t pass urine r weak urine flw Pssible increased risk f prstate cancer. Yur healthcare prvider shuld check yu fr prstate cancer r any ther prstate prblems befre yu start and while yu use ANDROGEL 1.62%. 5

6 In large dses ANDROGEL 1.62% may lwer yur sperm cunt. Swelling f yur ankles, feet, r bdy, with r withut heart failure. Enlarged r painful breasts. Have prblems breathing while yu sleep (sleep apnea). Bld clts in the legs. This can include pain, swelling, r redness f yur legs. Call yur healthcare prvider right away if yu have any f the serius side effects listed abve. The mst cmmn side effects f ANDROGEL 1.62% include: increased prstate specific antigen (a test used t screen fr prstate cancer) md swings hypertensin increased red bld cell cunt skin irritatin where ANDROGEL 1.62% is applied Other side effects include mre erectins than are nrmal fr yu r erectins that last a lng time. Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f ANDROGEL 1.62%. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre ANDROGEL 1.62%? Stre ANDROGEL 1.62% at 59ºF t 86ºF (15ºC t 30ºC). When it is time t thrw away the pump, safely thrw away used ANDROGEL 1.62% in husehld trash. Be careful t prevent accidental expsure f children r pets. Keep ANDROGEL 1.62% away frm fire. Keep ANDROGEL 1.62% and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f ANDROGEL 1.62%: 6

7 Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use ANDROGEL 1.62% fr a cnditin fr which it was nt prescribed. D nt give ANDROGEL 1.62% t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut ANDROGEL 1.62%. If yu wuld like mre infrmatin, talk t yur healthcare prvider. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut ANDROGEL 1.62% that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in ANDROGEL 1.62%? Active ingredient: teststerne Inactive ingredients: carbpl 980, ethyl alchl, isprpyl myristate, purified water and sdium hydrxide. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin Abbtt Labratries Distributed by: Abbtt Labratries Nrth Chicag, IL, 60064, U.S.A E Rev Apr 2011 Apprved: 04/ E Rev Apr