Testosterone

Name: Testosterone

Testosterone Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisone (Medrol), and prednisone (Deltasone)
  • Inhaled steroids such as beclomethasone (QVAR), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid), fluticasone (Flovent, in Advair), and triamcinolone (Azmacort)
  • Topical steroids such as alclometasone (Aclovate), betamethasone (Diprolene, Valisone), clobetasol (Temovate), desonide (DesOwen), Desoximetasone (Topicort), diflorasone (Psorcan, Florone), Fluocinolone (Derma-Smoother, Flurosyn, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort), mometasone (Elocon), and triamcinolone (Aristocort)
  • Anticoagulants such as warfarin (Coumadin)
  • Cosyntropin
  • Propanolol (Inderal)
  • Insulin

This is not a complete list of testosterone drug interactions. Ask your doctor or pharmacist for more information.

Other Requirements

Store testosterone at room temperature.

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

Used pumps, packets, or storage containers for this medication should be disposed of in household trash in a manner that prevents accidental application or ingestion by children or pets.

Testosterone FDA Warning

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel.
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Testosterone - Clinical Pharmacology


Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous Testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.

Pharmacokinetics


Testosterone esters are less polar than free Testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, Testosterone cypionate can be given at intervals of two to four weeks.


Testosterone in plasma is 98 percent bound to a specific Testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of Testosterone between free and bound forms, and the free Testosterone concentration will determine its half-life.
 
About 90 percent of a dose of Testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of Testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways.
 
The half-life of Testosterone cypionate when injected intramuscularly is approximately eight days.
 
In many tissues the activity of Testosterone appears to depend on reduction to dihydroTestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.

Precautions

General


Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

Testosterone cypionate should not be used interchangeably with Testosterone propionate because of differences in duration of action.
 
Testosterone cypionate is not for intravenous use.

Information for patients


Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Laboratory tests


Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.


Serum cholesterol may increase during androgen therapy.

Drug interactions


Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
 
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Drug/Laboratory test Interferences


Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis


Animal data

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of Testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
 
Human data
 
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
 
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Pregnancy


Teratogenic Effects
 
Pregnancy Category X. (See CONTRAINDICATIONS)


Benzyl alcohol can cross the placenta. See WARNINGS.

Nursing mothers


Testosterone cypionate is not recommended for use in nursing mothers.

Pediatric use


Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Drug Abuse and Dependence

Controlled Substance


Testosterone cypionate injection contains Testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Abuse

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of Testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained Testosterone than prescribed and continuing Testosterone despite adverse events or against medical advice.


Abuse-Related Adverse Reactions


Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.


The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.


The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.


The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.


Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dependence

Behaviors Associated with Addiction


Continued abuse of Testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:

  • Taking greater dosages than prescribed
  • Continued drug use despite medical and social problems due to drug use
  • Spending significant time to obtain the drug when supplies of the drug are interrupted
  • Giving a higher priority to drug use than other obligations
  • Having difficulty in discontinuing the drug despite desires and attempts to do so
  • Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of Testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.


Drug dependence in individuals using approved doses of Testosterone for approved indications has not been documented.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-200mg/1mL-LABEL



NDC 62756-015-40
Testosterone Cypionate Injection, USP CIII
200 mg/mL
FOR INRAMUSCULAR USE ONLY
Rx only
1 mL Single-dose vial



 

 

 


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2000mg/10mL-LABEL



NDC 62756-016-40
Testosterone Cypionate Injection, USP CIII
2,000 mg/10 mL (200 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only
10 mL Multiple-Dose Vial


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2000mg/10mL-SHOWBOX



NDC 62756-016-40
Testosterone Cypionate Injection, USP CIII
2,000 mg/10 mL (200 mg/mL)
FOR INRAMUSCULAR USE ONLY
Rx only
One 10 mL Multiple-Dose Vial
SUN PHARMA


Testosterone CYPIONATE 
Testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62756-017
Route of Administration INTRAMUSCULAR DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone CYPIONATE (Testosterone) Testosterone CYPIONATE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.1 mL  in 1 mL
COTTONSEED OIL 736 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:62756-017-40 1 VIAL, MULTI-DOSE in 1 CARTON
1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
Testosterone CYPIONATE 
Testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62756-015
Route of Administration INTRAMUSCULAR DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone CYPIONATE (Testosterone) Testosterone CYPIONATE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.2 mL  in 1 mL
COTTONSEED OIL 560 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:62756-015-40 1 VIAL in 1 CARTON
1 1 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
Testosterone CYPIONATE 
Testosterone cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62756-016
Route of Administration INTRAMUSCULAR DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone CYPIONATE (Testosterone) Testosterone CYPIONATE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.2 mL  in 1 mL
COTTONSEED OIL 560 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:62756-016-40 1 VIAL, MULTI-DOSE in 1 CARTON
1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201720 06/17/2013
Labeler - Sun Pharmaceutical Industries Limited (650172430)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS(62756-015, 62756-016, 62756-017), MANUFACTURE(62756-015, 62756-016, 62756-017)
Revised: 08/2017   Sun Pharmaceutical Industries Limited

Reconstitution

Injection:

Testosterone enanthate, testosterone cypionate: Warm and rotate vial between palms of hands to redissolve crystals that have formed after storage.

Testosterone undecanoate: Inject 3 mL of air through the gray rubber stopper into the vial to create positive pressure, and then withdraw 3 mL of solution (750 mg) from the vial. Expel any air bubbles from the syringe and change the syringe needle to a new IM needle. Discard unused portion.

Administration

IM: Administer by deep IM injection into the gluteal muscle.

Testosterone undecanoate: Inject into the gluteus medius; alternate injection between left and right buttock. Avoid intravascular injection, may lead to pulmonary oil microembolism; avoid the superior gluteal arteries and sciatic nerve.

Intranasal gel (Natesto): Administer intranasally 3 times daily, 6 to 8 hours apart, preferably at the same time each day. Prime pump prior to first use by inverting then depressing pump 10 times (discard this portion of product into sink). Blow nose prior to application. To administer the dose, insert actuator into nostril until pump reaches base of nose; tilt so the tip is in contact with the lateral wall of nostril. Depress slowly until pump stops, then remove from nose while wiping tip to transfer gel to lateral side of nostril. Following administration, press on the nostrils at a point just below the bridge of the nose and lightly massage. Refrain from blowing nose or sniffing for 1 hour after administration. If gel gets on hands, wash with warm soap and water. Temporarily discontinue with episodes of severe rhinitis; if severe rhinitis symptoms persist consider an alternative therapy.

Oral, buccal application (Striant): One mucoadhesive for buccal application (buccal system) should be applied to a comfortable area above the incisor tooth twice daily. Gently push the curved side against the upper gum. Hold buccal system firmly in place by pushing down on outside of the upper lip for 30 seconds to ensure adhesion. The buccal system should adhere to gum until it is removed. Rotate to alternate sides of mouth with each application. If the buccal system falls out, replace with a new system. If the system falls out within the first 8 hours of dosing, replace with a new buccal system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours, then continue with the next regularly scheduled dosing. System will soften and mold to shape of gum as it absorbs moisture from mouth. Do not chew or swallow the buccal system. The buccal system will not dissolve; gently remove by sliding downwards from gum; avoid scratching gum. Remove prior to routine morning and evening oral care, prior to application of new system.

Oral, capsule (Andriol [Canadian product]): Administer with meals. Should be swallowed whole; do not crush or chew.

Subcutaneous implant (Testopel): Using strict sterile technique, must be surgically implanted.

Transdermal patch (Androderm): Apply to skin immediately upon removal from the protective pouch. Apply at the same time each night to clean, dry area of skin on the back, abdomen, upper arms, or thigh. Do not apply to bony areas or parts of the body that are subject to prolonged pressure while sleeping or sitting. Do not apply to oily, damaged or irritated skin. Do not apply to the scrotum. Rotate administration sites, allowing 7 days between applying to the same site. Avoid showering, washing the site, or swimming for ≥3 hours after application. Following patch removal, mild skin irritation may be treated with OTC hydrocortisone cream. A small amount of triamcinolone acetonide 0.1% cream may be applied under the system to decrease irritation; do not use ointment (triamcinolone ointment decreases testosterone absorption). Dispose of any used or unused patches by folding adhesive ends together, replace in pouch or sealed container and discard properly in trash away from children and pets.

Topical gel and solution: Alcohol-based gels and solutions are flammable; avoid fire, flames, or smoking until dry. Testosterone may be transferred to another person following skin-to-skin contact with the application site. Strict adherence to application instructions is needed in order to decrease secondary exposure. Thoroughly wash hands after application and cover application site with clothing (ie, shirt) once gel or solution has dried, or clean application site thoroughly with soap and water prior to contact in order to minimize transfer. In addition to skin-to-skin contact, secondary exposure has also been reported following exposure to secondary items (eg, towel, shirt, sheets). If secondary exposure occurs, the other person should thoroughly wash the skin with soap and water as soon as possible. The application sites and doses of these products are not interchangeable.

AndroGel 1%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the genitals, chest, back, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering or washing the application site for ≥5 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 12.5 mg of testosterone (4 actuations = 50 mg; 6 actuations = 75 mg; 8 actuations = 100 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

AndroGel 1.62%: Apply at the same time each morning to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to other parts of the body such as the abdomen, genitals, chest, axillae, or knees. Upon opening the packet(s), the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Alternatively, a portion may be squeezed onto palm of hand and applied, repeating the process at the same or other site until entire packet has been applied. Avoid swimming, showering or washing the application site for ≥2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times (and discard this portion of product) prior to initial use. Each actuation delivers 20.25 mg of testosterone (2 actuations = 40.5 mg; 3 actuations = 60.75 mg; 4 actuations = 81 mg). When using the pump, the gel may be delivered into the palm of the hand prior to application or applied directly to the application site.

Axiron: Apply using the applicator to clean, dry, intact skin on an area of the axilla at the same time each morning. Do not apply to other parts of the body (eg, abdomen, genitals, shoulders, upper arms). Avoid washing the site or swimming for 2 hours after application. Prior to first use, prime the applicator pump by depressing it 3 times (discard this portion of the product). After priming, position the nozzle over the applicator cup and depress pump fully one time; ensure liquid enters cup. Each pump actuation delivers testosterone 30 mg. No more than 30 mg (one pump) should be added to the cup at one time. The total dose should be divided between axilla (example, 30 mg/day: apply to one axilla only; 60 mg/day: apply 30 mg to each axilla; 90 mg/day: apply 30 mg to each axilla, allow to dry, then apply an additional 30 mg to one axilla; etc). To apply dose, keep applicator upright and wipe into the axilla; if solution runs or drips, use cup to wipe. Do not rub into skin with fingers or hand. If more than one 30 mg dose is needed, repeat process. Apply roll-on or stick antiperspirants or deodorants prior to testosterone. Once application site is dry, cover with clothing. After use, rinse applicator under running water and pat dry with a tissue.

Fortesta: Apply to clean dry intact skin once daily in the morning to skin of front and inner thighs. Do not apply to genitals or other parts of the body. Use one finger to rub gel evenly onto skin of each thigh. Avoid showering, washing the site, or swimming for ≥2 hours after application. Prior to first dose, prime the pump by holding canister upright and fully depressing the pump 8 times (discard this portion of the product). Each pump actuation delivers testosterone 10 mg. The total dose should be divided between thighs (example, 10 mg/day: apply 10 mg to one thigh only; 20 mg/day: apply 10 mg to each thigh; 30 mg/day: apply 20 mg to one thigh and 10 mg to the other thigh; etc). Once application site is dry, cover with clothing.

Testim: Apply once daily (preferably in the morning) to clean, dry, intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or abdomen. Upon opening the tube, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). Avoid swimming, showering or washing the application site for ≥2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried.

Vogelxo: Apply once daily at the same time each morning to clean dry intact skin to an area of the shoulder and upper arms that will be covered by a short sleeve t-shirt. Do not apply to the genitals or to the abdomen. Upon opening the tube or packet, the entire contents should be squeezed into the palm of the hand and immediately applied to the application site(s). If two doses (testosterone 100 mg) are needed, apply one dose (50 mg) to upper arm and or/shoulder, then apply the second dose (50 mg) to the opposite upper arm and/or shoulder. Avoid showering, washing the site, or swimming for at least 2 hours following application. Cover application site with clothing (eg t-shirt) once the gel has dried. When using the multidose pump, prime pump 3 times by fully depressing the pump mechanism (actuation) and discard this portion of product. Each actuation delivers testosterone 12.5 mg (4 actuations = 50 mg; 8 actuations = 100 mg).

Drug Interactions

Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy

Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy

Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy

CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification

Dehydroepiandrosterone: May enhance the adverse/toxic effect of Testosterone. Avoid combination

Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification

Test Interactions

May decrease thyroxine-binding globulin, resulting in decreased total T4 and increased resin uptake of T3 and T4; free thyroid hormone levels are not changed.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience acne, diarrhea, emotional instability, decreased libido, sexual dysfunction, loss of strength and energy, insomnia, cough, pharyngitis, change in taste, bad taste, back pain, or injection site pain. Have patient report immediately to prescriber signs of high calcium (weakness, confusion, fatigue, headache, nausea and vomiting, constipation, or bone pain), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), severe headache, severe dizziness, passing out, vision changes, priapism, polyuria, urinary retention, change in amount of urine passed, depression, mood changes, behavioral changes, enlarged breasts, breast pain, shortness of breath, excessive weight gain, swelling of arms or legs, nausea, vomiting, difficulty breathing during sleep, day fatigue, skin discoloration, testicle irregularities, severe application site irritation, nosebleed, nasal dryness, rhinitis, rhinorrhea, nasal scabs, sneezing, gingival changes, or signs of virilization (in females a deep voice, facial hair, acne, or menstrual changes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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