Testosterone

Class: Androgens
Note: This monograph also contains information on Testosterone Cypionate, Testosterone Enanthate
VA Class: HS100
CAS Number: 58-22-0
Brands: Androderm, AndroGel, Delatestryl, Striant, Testim

• 
  

  Risk of virilization in children and women following secondary exposure to testosterone in topically administered testosterone gel.^{157 166 170 171} Advise children and women to avoid contact with application sites of men using testosterone gel.^{166 170 171} (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

  
  


• 
  

  Advise men using testosterone gel to strictly adhere to recommended instructions for use.^{170 171} (See Administration under Dosage and Administration.)

  
  

REMS:

FDA approved a REMS for testosterone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of testosterone and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Androgenic anabolic steroid hormone; the principal endogenous androgen.^a

Uses for Testosterone

Male Hypogonadism

Management of congenital or acquired primary hypogonadism such as that resulting from orchidectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.^{117 133 135 157 161 162 a}

Management of congenital or acquired hypogonadotropic hypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin-releasing hormone (luteinizing hormone-releasing hormone) deficiency or from pituitary-hypothalamic injury caused by tumors, trauma, or radiation.^{117 133 135 157 161 162 a} Should be used in the treatment of hypogonadotropic hypogonadism only in patients uninterested in or unable to achieve fertility.^f

Considered the androgen of choice for the treatment of androgen deficiency (e.g., hypogonadism) and AIDS wasting in HIV-infected men.¹²⁶

May be used to stimulate puberty when the diagnosis is well established in carefully selected males with delayed puberty (designated an orphan drug by FDA for this use).^{a 162}

Some experts (e.g., American College of Rheumatology) recommend that men who develop low serum testosterone concentrations (<300 ng/mL) while receiving long-term corticosteroid therapy receive testosterone replacement therapy in an attempt to treat hypogonadism and possibly reduce the risk of corticosteroid-induced osteoporosis†.¹²²

Clinical evidence to date regarding testosterone therapy in aging men suggests some beneficial effects (e.g., on body composition, strength, bone density, frailty, cognitive function, mood, sexual function, quality of life), but risks relating to benign prostatic hyperplasia and prostate cancer need to be quantified.¹⁵⁶ The Institute of Medicine states that the nature and extent of therapeutic benefits in older men require additional study.¹⁵⁶

Not indicated for the treatment of erectile dysfunction† in men with normal testosterone concentrations.¹⁵⁸

Breast Cancer

Palliative treatment of androgen-responsive, advanced, inoperable, metastatic (skeletal) breast cancer in women who are 1–5 years postmenopausal and in premenopausal women who have benefited from oophorectomy.^{a 162}

Poorly tolerated (see Virilization under Cautions); other hormonal agents (e.g., tamoxifen, anastrozole, letrozole, exemestane) currently are preferred for this use.^{d e}

Misuse and Abuse

Has been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique†.^{100 101 102 103 104 105 106 107 108 109 110 111 112 114 115 116 120}

Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae and because such use by athletes is contrary to the rules and ethical principles of athletic competition.^{101 102 107 114 115 116}

Testosterone Dosage and Administration

General

Male Hypogonadism

• 
  

  Individualize dosage according to the condition being treated; the severity of symptoms; the patient’s age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.^a

  
  


• 
  

  Monitor every 3–4 months during the first year of testosterone replacement and periodically thereafter (e.g., every 4–6 months) for response and tolerance.¹²³

  
  

Delayed Puberty

• 
  

  Prior to initiation of therapy, fully discuss the potential risk of therapy with the patient and his parents.^{a 162}

  
  


• 
  

  Take into consideration the chronological and skeletal ages of the patient, both in determining the initial dosage and in adjusting the dosage.^{117 162 a}

  
  


• 
  

  Perform radiographic examination of the hand and wrist at 6-month intervals to determine the rate of bone maturation and to assess the effect of therapy on the epiphyseal centers.^{117 162 a} (See Pediatric Use under Cautions.)

  
  

Breast Cancer

• 
  

  Administer only under supervision of a qualified clinician experienced in the treatment of breast cancer.^{162 a}

  
  


• 
  

  May occasionally appear to accelerate progression of the disease;^{162 a} monitor patients closely.¹⁶²

  
  


• 
  

  Discontinue the drug if hypercalcemia occurs, since this may indicate progression of metastases to the bone.¹⁶²

  
  

Administration

Administer testosterone topically or intrabuccally.^{133 157 161 166}

Administer testosterone cypionate and testosterone enanthate by deep IM injection;^{117 162} not for IV administration.¹¹⁷

IM Administration

Administer by deep IM injection into the upper outer quadrant of the gluteus maximus.^{117 162}

Topical Administration

Gel

AndroGel: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and upper arms and/or abdomen.¹⁶⁶ Do not apply to the genitals.¹⁶⁶

AndroGel unit-dose packet: Upon opening the unit-dose packet, squeeze the entire contents into the palm of the hand and immediately apply to the application site.¹³⁵ Alternatively, squeeze a portion of the contents into the palm of the hand and immediately apply to application site; repeat procedure until entire contents of the packet has been applied.¹³⁵

AndroGel metered-dose pump: Collect gel in the palm of the hand by pressing the pump firmly and fully; apply to application site.¹³⁵ This can be done one pump actuation at a time or after completion of all pump actuations needed for the daily dose.¹³⁵ Alternatively, apply the gel directly to application site (direct application prevents loss of gel during transfer to hand).¹³⁵ Prime pump by depressing 3 times before using the pump for the first dose; discard gel so that household members or pets are not exposed to the gel (i.e., rinse down sink).¹³⁵

Testim: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and/or upper arms¹⁵⁷ Do not apply to abdomen or genitals.¹⁵⁷ Upon opening the unit-dose tube, squeeze the entire contents into the palm of the hand and immediately apply to the application site.¹⁵⁷

Immediately wash hands with soap and water after application of the gel.^{157 166 170 171}

Allow the application site to dry for a few minutes after application of gel.^{166 170 171} After the gel has dried, cover site with clothing (e.g., a shirt) to prevent transfer to another individual.^{157 166}

Manufacturer of AndroGel recommends waiting ≥5–6 hours¹⁶⁶ and the manufacturer of Testim recommends waiting ≥2 hours after application before showering or swimming.¹⁵⁷ However, showering or swimming after the elapse of just 1 hour should have a minimal effect on the amount of testosterone gel absorbed if done very infrequently.¹³⁵

Wash the application site(s) thoroughly with soap and water to remove any testosterone residue prior to situations in which skin-to-skin contact with other individuals is anticipated at the site of testosterone gel application.^{170 171} If unwashed or unclothed skin at the site of testosterone gel application comes in contact with the skin of another individual, wash the general area of contact with soap and water as soon as possible.^{157 166 170 171}

Consider the possibility of secondary exposure to testosterone topical gel.^{157 166 170 171} (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

Transdermal System

Apply the transdermal system to clean, dry area of skin on the back, abdomen, upper arm, or thigh by firmly pressing the system with the adhesive side touching the skin.¹³³ Do not apply to the scrotum or to oily, damaged, or irritated areas of the skin.^{133 134}

To avoid burn-like blisters, do not apply systems over bony prominences or on a part of the body that may be subject to prolonged pressure during sleep or sitting (e.g., the deltoid region of the upper arm, the greater trochanter of the femur, the ischial tuberosity).¹³³

Apply once daily at night (e.g., 10 p.m.).¹³³ Leave transdermal system in place for 24 hours; after 24 hours, remove system and apply a new system.¹³³ Apply system immediately after removal from its protective pouch and removal of the protective liner.¹³³

To minimize and/or prevent potential skin irritation, apply each transdermal system at a different site, with ≥1 week between applications to a particular site.¹³³

Mild skin irritation may be ameliorated with topical hydrocortisone 0.5 or 1% cream after system removal; alternatively, apply a small amount of triamcinolone acetonide 0.1% cream to the skin under the drug reservoir (do not use ointment formulations because they may reduce testosterone absorption).^{133 143}

Transdermal system does not need to be removed during sexual intercourse or while showering or bathing.¹³³

Intrabuccal Administration

Press the extended-release buccal (transmucosal) tablet against the gum above the upper left or right incisor twice daily (morning and evening) about 12 hours apart.¹⁶¹ These tablets will adhere to the gum and do not dissolve completely; do not chew or swallow.¹⁶¹ Dislodge and remove the tablet after 12 hours.¹⁶¹ Alternate application sites above the left and right upper incisors.¹⁶¹

Consult manufacturer’s patient information for instructions on proper intrabuccal administration and removal of the tablet.¹⁶¹

If the tablet fails to properly adhere to the gum or falls off within the first 8 hours, replace the old tablet with a new one.¹⁶¹ The new tablet may remain in place until the time of the next regularly scheduled dose (i.e., 12 hours after the original buccal tablet was administered).¹⁶¹ If the buccal tablet falls off after 8 hours but before 12 hours, replace the original tablet with one that can serve as the second dose for that day.¹⁶¹

Dosage

Available as testosterone; dosage expressed in terms of testosterone.^{133 135 157 161} Also available as testosterone enanthate or testosterone cypionate; dosage expressed in terms of the salts.^{117 162}

AndroGel unit-dose packets contain 2.5 or 5 g of gel (25 or 50 mg of testosterone).¹³⁵ Each depression of the metered-dose pump delivers 1.25 g of gel (12.5 mg of testosterone) after priming.¹³⁵

Testim unit-dose tubes contain 5 g of gel (50 mg of testosterone).¹⁵⁷

Pediatric Patients

Male Hypogonadism

Delayed Puberty

IM

Dosage regimens vary.^{117 162 a} Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels.^{117 162 a} Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.^{117 162 a}

Usual dosage of testosterone enanthate: 50–200 mg every 2–4 weeks for a limited period of time (e.g., 4–6 months).^{a 162}

Adults

Male Hypogonadism

IM

Usual dosage: 50–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.^{117 162}

Some clinicians recommend testosterone cypionate or testosterone enanthate dosage of 50–100 mg every 7–10 days or 100–150 mg every 2 weeks.^f While dosage of 300 mg every 3 weeks also may be considered for convenience, such dosing is associated with wider testosterone fluctuations and generally is inadequate to ensure a consistent clinical response.¹²³ Serum total testosterone concentrations generally should exceed lower limit of normal (in the range of 250–300 ng/dL) just before the next dose.¹²³

Adult males with prepubertal onset of hypogonadism who are going through puberty for the first time with testosterone replacement: Initially, 50 mg every 3–4 weeks;^f increase dosage gradually in subsequent months as tolerated up to full replacement within 1 year.¹²³

Attainment of full virilization may require up to 3–4 years of IM testosterone replacement.¹²³

Topical (Gel)

AndroGel and Testim: Apply 50 mg of testosterone (5 g of 1% gel) once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically.^{135 157} Adjust dosage according to serum testosterone concentrations obtained at regular intervals after initiating daily application of AndroGel¹⁶⁶ and approximately 14 days after initiating Testim.¹⁵⁷

AndroGel: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, the dosage can be increased initially to 75 mg of testosterone (7.5 g of 1% gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of 1% gel).¹³⁵ If serum testosterone concentrations exceed the normal range, the daily dosage may be decreased.¹⁶⁶ If serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of 1% gel), discontinue application of the gel.¹⁶⁶

Testim: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, may increase dosage to 100 mg of testosterone (10 g of 1% gel).¹⁵⁷

Topical (Transdermal System)

Usual initial dosage is 1 system delivering 5 mg/24 hours or 2 systems delivering 2.5 mg/24 hours applied to the skin nightly.¹³³

Adjust dosage according to morning serum testosterone concentrations.¹³³ Depending on requirements, increase dosage to 7.5 mg once daily (administered nightly as 1 system delivering 5 mg/24 hours plus 1 system delivering 2.5 mg/24 hours or as 3 systems delivering 2.5 mg/24 hours) or decrease dosage to 2.5 mg once daily (administered nightly as 1 system delivering 2.5 mg/24 hours).¹³³

Intrabuccal

30 mg (1 extended-release transmucosal tablet) twice daily (morning and evening) about 12 hours apart.¹⁶¹ Serum testosterone concentration may be determined just prior to the morning dose at 4–12 weeks after initiation of intrabuccal therapy; if total serum testosterone concentration is excessive, discontinue intrabuccal therapy and consider alternative treatments.¹⁶¹

Breast Cancer

IM

200–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.^{162 a}

Special Populations

No special population dosage recommendations at this time.^{157 166}

Cautions for Testosterone

Contraindications

• 
  

  Men with breast cancer or known or suspected prostate cancer.^{117 133 157 161 162 166}

  
  


• 
  

  Known hypersensitivity to testosterone, testosterone cypionate, testosterone enanthate, or any ingredient in the formulation.^{117 133 157 161 162 166 a}

  
  


• 
  

  Some manufacturers state that testosterone is contraindicated in patients with serious cardiac, renal, or hepatic disease.¹¹⁷

  
  


• 
  

  Manufacturers of testosterone cypionate and testosterone enanthate injections (preparations indicated for the treatment of breast cancer) state that androgens are contraindicated in women who are or may become pregnant.^{117 162}

  
  


• 
  

  Manufacturers of testosterone gel (AndroGel, Testim) state that testosterone is contraindicated in women who are or may become pregnant, or who are breastfeeding.^{157 166}

  
  


• 
  

  Manufacturers of buccal and transdermal testosterone preparations state that these preparations should not be used in women.^{133 161}

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

May cause fetal harm;^{117 133 157 162 166} dose-related virilization of the external genitalia (e.g., clitoral hypertrophy, abnormal vaginal development, fusion of genital folds to form a scrotal-like structure) of female fetus reported, particularly when exposure to androgens occurs during the 1st trimester.^{162 166 a}

Virilization in Children and Women from Secondary Exposure to Testosterone

Virilization in children and women can occur following secondary exposure to testosterone in topically administered gel.^{170 171 172 173} Enlargement of penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age reported in children 9 months to 5 years of age during postmarketing surveillance of testosterone gel.^{167 168 169 170 171 172 173} Direct contact of children with testosterone gel application sites on men's skin reported in most cases.^{170 172 173} Secondary exposure to testosterone also possible from contact with items (e.g., shirts, bed linens) of men receiving testosterone gel.^{170 172 173} Signs and symptoms generally resolved with removal of testosterone exposure.^{169 170 171 172} In some cases, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronologic age.^{169 170 171}

Children and women should avoid contact with application sites on the skin of men using testosterone gel.^{166 170 171} Consider also the possibility of secondary exposure from contact with items (e.g., shirts, bed linens) of men using testosterone gel.^{170 172 173}

Risk of testosterone transfer in some cases increased by lack of adherence to precautions for appropriate use of testosterone gel.¹⁷⁰ Advise men using topical gel to strictly adhere to the recommended instructions for use and appropriate precautions from the manufacturers to minimize the potential for secondary exposure to testosterone in other individuals.^{170 171} (See Administration under Dosage and Administration.)

If unwashed or unclothed skin to which testosterone gel has been applied comes in contact with the skin of another individual, wash the general area of contact with soap and water as soon as possible.^{157 166}

Inform clinicians of inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, substantial increases in acne, or other signs of virilization in women.^{166 170 171} Consider the possibility of secondary exposure to testosterone as the cause of virilization in these patients.^{166 170 171} Discontinue testosterone gel promptly at least until the cause of virilization in such children and women is identified.^{170 171}

Hepatic Effects

Potentially serious and/or life-threatening adverse hepatic effects (e.g., peliosis hepatis, hepatic adenomas, hepatocellular carcinoma, cholestatic hepatitis, jaundice) associated with prolonged use of high dosages of androgens (e.g., testosterone enanthate).^{117 133 134 135 157 161 162} Abnormal liver function tests (e.g., ALT, AST, gamma-glutamyltranspeptidase [GGTP], bilirubin) reported with AndroGel during postmarketing surveillance.¹⁶⁶

If cholestatic jaundice or hepatitis occurs or if liver function test results become abnormal during therapy, discontinue the drug and investigate the etiology of these disorders.¹⁶² Drug-induced jaundice usually is reversible following discontinuance of the drug.¹⁶² Discontinuance of androgen therapy following development of hepatocellular carcinoma does not always result in regression of the tumor.^{117 133 135 157 161 162}

GU Effects

Priapism or excessive sexual stimulation possible, especially in geriatric men.^{117 133 135 a} Oligospermia and decreased ejaculatory volume may also occur in men receiving excessive dosage or prolonged administration of testosterone.^{117 a} If any of these adverse effects occur, discontinue the drug temporarily.^{117 a} If therapy is restarted, use lower dosages.^{117 a}

Possible increased risk for the development of prostatic hyperplasia and prostate cancer, particularly in geriatric patients.^{117 133 134 135 157 161 162} Testosterone therapy has been associated with increases in PSA (of 0.3 ng/mL) in men with hypogonadism.^{135 163} Increased serum PSA concentrations observed in 18% of hypogonadal men receiving AndroGel for up to 42 months; most increases occurred within the first year of therapy.¹⁶⁶ Evaluate geriatric patients and other patients with known clinical or demographic risk factors for prostate cancer for the presence of the disease prior to initiation of testosterone replacement therapy.^{133 135 157 161 162} Perform rectal prostate examinations at baseline and periodically thereafter.¹²³ Baseline and annual determinations of PSA also recommended in older men, particularly in those >50 years of age.¹²³

Acute urethral obstruction possible in patients with benign prostatic hypertrophy who receive IM testosterone cypionate.¹¹⁷

Gynecomastia frequently develops and occasionally persists.^{117 135 157 161 162} Consider concomitant use of an aromatase inhibitor or surgery.¹²³

Postmarketing reports with AndroGel include impaired urination, prostatic enlargement, testicular atrophy, oligospermia, priapism, gynecomastia, and mastodynia.¹⁶⁶

Fluid Retention

Edema, with or without CHF, possible as a result of sodium and water retention and may be a serious complication in patients with preexisting cardiac, renal, and/or hepatic disease.^{117 133 157 161 162 166} (See Contraindications under Cautions.)

If edema occurs and is considered a serious complication, discontinue the drug and, if necessary, initiate diuretic therapy.^{133 135 157 161 162 a}

Hypercalcemia

Possible hypercalcemia resulting from osteolysis, especially in immobile patients and in women with metastatic breast cancer.^{161 166 a} In patients with cancer, hypercalcemia may indicate progression of metastases to the bone.^{161 a} Monitor urine and serum calcium concentrations frequently during the course of androgen therapy in women with metastatic breast cancer.^{162 166}

If hypercalcemia occurs, discontinue the drug and institute appropriate measures to reduce serum calcium concentrations.^{162 a}

Sleep Apnea

May potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.^{157 161 166}

If manifestations of sleep apnea occur or worsen during therapy, perform sleep studies.^{123 144} If sleep apnea is confirmed, decrease the dosage or discontinue the drug.^{123 144}

Some clinicians consider a history of sleep apnea to be a relative contraindication to testosterone therapy.¹²³

Misuse and Abuse

Potential for serious adverse effects (e.g., increased aggression,^{100 101 102 104 107 108 109 116} antisocial behavior,^{100 101 102 104 107 108 109 116} manic episode,^{102 104 105 106 107 108 112 114} depression,^{102 104 105 106 107 108 112 114} changes in libido,^{101 102 107 109 116} increased risk of cardiovascular disease,^{100 101 102 104 107 108 111 112 114 116 119} hepatotoxicity^{100 101 102 104 107 108 109 110 112 114 116} ) associated with misuse and abuse of androgens (see Misuse and Abuse under Uses); testosterone preparations currently subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs.^{113 164}

Flammability

Testosterone gels contain alcohol and are flammable until dry; keep away from open flame.¹⁶⁶

Sensitivity Reactions

Allergic contact dermatitis possible with transdermal systems.^{133 137 142} Topical application of testosterone gel (i.e., AndroGel) is not associated with phototoxicity.¹³⁵ Hypersensitivity reactions (e.g., anaphylactoid reactions, skin manifestations) rarely reported with testosterone.^a

General Precautions

Virilization in Women Receiving Testosterone Therapy

Virilization, including deepening of the voice, hirsutism, and clitoral enlargement, occurs commonly in females receiving testosterone therapy; these changes may not be reversible following discontinuance of the drug.^{162 a}

Monitor women receiving testosterone therapy for signs of virilization (e.g., deepening of the voice, hirsutism, clitoromegaly, menstrual irregularities).¹⁶¹ If virilization occurs, discontinue therapy.¹⁶¹

See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.

Lipid Abnormalities

Androgens may alter serum cholesterol concentration.^{117 162} Although lipid abnormalities generally do not develop during testosterone replacement therapy because of aromatization of testosterone to estradiol,¹²³ consider the possibility that such changes could occur and use testosterone with caution in patients with a history of MI or CAD.¹⁶²

Perform a lipid profile at baseline and after 6–12 months; adjust therapy accordingly.^{123 135 157 161 162} Changes in serum lipid profiles may require dosage adjustment or discontinuance of testosterone therapy.¹⁶⁶

Hematologic Effects

Supraphysiologic concentrations of testosterone can stimulate erythropoiesis^{123 166} and may increase the risk for a thromboembolic event.¹⁶⁶ Increases in hematocrit may require dosage reduction or discontinuation of testosterone.¹⁶⁶ To detect polycythemia, perform periodic hemoglobin and hematocrit determinations in patients receiving long-term therapy.^{117 123 133 135 157 161 162}

Some clinicians consider hyperviscosity to be a relative contraindication to testosterone therapy.¹²³

Transfer of Topically Administered Testosterone to Other Individuals

Possible transfer of testosterone from patients treated with topical gel to their sexual partners or other individuals in close physical contact.^{157 166} (See Pregnancy and also see Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

Androderm transdermal system has an occlusive backing that prevents the partner from coming in contact with testosterone in the system; the system does not need to be removed during sexual intercourse.¹³³ Transfer of the transdermal system itself from the patient’s body to that of his partner is unlikely.¹³³

Specific Populations

Pregnancy

Category X.^{117 133 135 157 161 162} (See Fetal/Neonatal Morbidity and also see Contraindications under Cautions.)

Avoid transfer of testosterone from topical preparations of the drug to pregnant women.^{157 166} (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, wash the general area of contact with soap and water as soon as possible.^{157 166}

Lactation

Not known whether testosterone is distributed into milk.¹⁶² Potential for serious adverse reactions in nursing infants.^{162 166} Testosterone also may adversely affect lactation.¹⁶⁶ Discontinue nursing or testosterone enanthate injection taking into account the importance of the drug to the woman.¹⁶² Use of testosterone gel, transdermal system, and buccal tablets not recommended.^{117 133 157 161 166}

Pediatric Use

Safety and efficacy not established for topical testosterone gel ^{157 166} or extended-release buccal (transmucosal) testosterone tablets in children <18 years of age;¹⁶¹ testosterone transdermal systems in males <15 years of age;¹³³ or testosterone cypionate in children <12 years of age.¹¹⁷ Secondary exposure to testosterone in children can occur with use of testosterone gel in other individuals.^{170 171} (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

Testosterone enanthate injection may accelerate bone maturation without producing compensatory gain in linear growth, possibly resulting in compromised adult stature.^{162 a} The younger the child, the greater the risk of testosterone compromising final mature stature.^{162 a} Use with extreme caution in children and only under the supervision of a specialist who is aware of the adverse effects of testosterone on bone maturation.^{162 a} Perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.^{162 a}

Geriatric Use

Possible increased risk of developing prostatic hypertrophy and prostate cancer during androgen therapy.^{117 133 157 166 161 a} (See GU Effects under Cautions.)

Total amount of testosterone delivered over 24 hours in men 65–79 years of age following application of transdermal testosterone system (Androderm) was approximately 20% less than the average amount delivered in younger patients.¹³³

Clinical studies evaluating testosterone enanthate injection (Delatestryl) and topical testosterone gel (AndroGel) have not included sufficient numbers of adults ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^{162 166}

No substantial differences in safety and efficacy of extended-release buccal (transmucosal) testosterone tablets (Striant)in geriatric patients relative to younger adults.¹⁶¹ Pharmacokinetic differences observed between geriatric and younger adults in studies with Striant, but not known whether these differences are clinically important.¹⁶¹

Insufficient long-term safety data with Delatestryl and AndroGel to determine the potential risks of cardiovascular disease, prostate cancer, and prostatic hyperplasia in geriatric adults.^{162 166}

Common Adverse Effects

Acne, flushing of the skin, gynecomastia, increased or decreased libido, habituation, edema,^a local irritation at the site of application (with topical or intrabuccal administration).^{133 137 138 139 140 143 157 161 166}

Interactions for Testosterone

Specific Drugs

Drug	Interaction	Comment
Anticoagulants, oral	Testosterone may potentiate the action of oral anticoagulantsa and decrease anticoagulant requirements117 133 162	Monitor INR and prothrombin time closely when androgen therapy is initiated or discontinued in patients receiving oral anticoagulants and adjust anticoagulant dosage

Sodium Phosphate P 32

Rx Only.

Sodium Phosphate P 32 Description

Sterile, non-pyrogenic Sodium Phosphate P 32 is available for therapeutic application as an intravenous solution dosage form with a concentration of 24.8 megabecquerels (0.67 millicurie) per milliliter. The intravenous solution contains 1.6 milligrams per milliliter of sodium acetate as a buffer, 0.9% sodium chloride for isotonicity and may contain sodium hydroxide or hydrochloric acid for pH adjustment. The pH of the solution is between 5.0 and 6.0.

PHYSICAL CHARACTERISTICS

Phosphorus P 32 decays by beta emission with a physical half-life of 14.3 days.1 The mean energy of the phosphorus P 32 beta particle is 694.9 keV.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
Beta-1	100.0	694.9

1

Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC 11026, page 70 (1981).

EXTERNAL RADIATION

The range of the phosphorus P 32 beta particle, which has a maximum energy of 1.71 MeV, is 2.8 mm of aluminum.

To correct for physical decay of this radionuclide, the fractions remaining at selected time intervals before and after the day of calibration are shown in Table 2.

Table 2. Physical Decay Chart; Phosphorus P 32, Half-Life 14.3 days

*Calibration Day
Days	Fraction Remaining		Days	Fraction Remaining
0*	1.000		30	0.233
1	0.953		35	0.183
2	0.908		40	0.144
5	0.785		45	0.113
10	0.616		50	0.089
15	0.483		55	0.070
20	0.379		60	0.055
25	0.297

Sodium Phosphate P 32 - Clinical Pharmacology

Phosphorus is necessary to metabolic and proliferative activity of cells. Radioactive phosphorus concentrates to a very high degree in rapidly proliferating tissue.

Indications and Usage for Sodium Phosphate P 32

The principal use of Sodium Phosphate P 32 is for the treatment of polycythemia vera, and it is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. Sodium Phosphate P 32 is also used in palliative treatment of selected patients with multiple areas of skeletal metastases.

Contraindications

Sodium Phosphate P 32 should not be used as a part of sequential treatment with a chemotherapeutic agent.

In polycythemia vera, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 5,000/cu mm, or a platelet count is below 150,000/cu mm.

In chronic myelocytic leukemia, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 20,000/cu mm.

For treatment of bone metastases it is usually not administered when the leukocyte count is below 5,000/cu mm, and platelet count is below 100,000/cu mm.

Warnings

This radiopharmaceutical should administered for intracavitary use.

Overdose of Sodium Phosphate P 32 may produce serious effects on the hemopoietic system. The blood and bone marrow should be carefully monitored at regular intervals.

Sodium Phosphate P 32 ordinarily does not localize in retinoblastomas.

PRECAUTIONS.

General

As in the use of any other radioactive material, care should be taken to insure minimum radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Sodium Phosphate P 32 affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Phosphate P 32. It is also not known whether Sodium Phosphate P 32 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Phosphate P 32 should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken when a patient is being given Sodium Phosphate P 32.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

None known.

Sodium Phosphate P 32 Dosage and Administration

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Oral administration of high-specific-activity Sodium Phosphate P 32 in the fasting state may equal intravenous administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Waterproof gloves should be used during the entire handling and administration procedure.

Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the drug.

For polycythemia vera, intravenous dosages from 37 to 296 megabecquerels (1 to 8 millicuries) are given depending upon the stage of disease and size of the patient. Repeat doses must be adjusted to individual needs.

For chronic leukemia, the individual dose is 222 to 555 megabecquerels (6 to 15 millicuries), usually administered with concomitant hormone manipulation.

RADIATION DOSIMETRY

The estimated absorbed radiation doses2 to an average patient (70 kg) following intravenous administration of 555 megabequerels (15 millicuries) of Sodium Phosphate P 32 are shown in Table 3.

Table 3. Absorbed Radiation Doses

	Absorbed radiation doses for 555 megabecquerels (15 millicuries)
Tissue	grays	rads
Skeleton	9.45	945
Liver	0.93	93
Spleen	1.10	110
Brain	0.45	45
Testes	0.15	15
Ovaries	0.12	12
Total Body	1.50	150

2

Method of Calculation: “S”, Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet #11 (1975).

How is Sodium Phosphate P 32 Supplied

Catalog Number 461

Sodium Phosphate P 32 is supplied as a sterile, non-pyrogenic solution in single dose vials containing 185 megabequerels (5 millicuries) of phosphorus P 32. Each milliliter contains 24.8 megabecquerels (0.67 millicuries) Sodium Phosphate P 32 at the time of calibration, 1.6 milligrams sodium acetate and 9 milligrams sodium chloride. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment.

STORAGE AND HANDLING

Store at controlled room temperature 20-25°C (68-77°F).

Storage and disposal of Sodium Phosphate P 32 Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.

Revised 11/2000

Mallinckrodt Inc.

St. Louis, MO 63134

A461I0

Sodium Phosphate P 32  sodium phosphate, p-32  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-N461 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Sodium Phosphate, P-32 (Sodium Phosphate, P-32) Active 0.67 MILLICURIE  In 1 MILLILITER sodium acetate Inactive 1.6 MILLIGRAM  In 1 MILLILITER sodium chloride Inactive 0.9 MILLIGRAM  In 1 MILLILITER sodium hydroxide Inactive   hydrochloric acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-N461-F0 1 VIAL In 1 CAN contains a VIAL 1 7.5 mL (MILLILITER) In 1 VIAL This package is contained within the CAN (0019-N461-F0)

Revised: 03/2007Mallinckrodt Inc.

More Sodium Phosphate P 32 resources

• Sodium Phosphate P 32 Drug Interactions
• Sodium Phosphate P 32 Support Group
• 0 Reviews · Be the first to review/rate this drug

Tronolane Anesthetic for Hemorrhoids

Generic Name: pramoxine and zinc oxide topical (pra MOX een and ZINK OX ide TOP ik al)

Brand Names: Anusol, Tronolane Anesthetic for Hemorrhoids, Tucks Hemorrhoidal

What is Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

Pramoxine is an anesthetic, or "numbing medicine." It works by interfering with pain signals sent from the nerves to the brain.

Zinc oxide is a mineral.

The combination of pramoxine and zinc oxide topical (for the skin) is used to treat itching, burning, irritation, or other rectal discomfort caused by hemorrhoids or painful bowel movements.

Pramoxine and zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

You should not use this medication if you are allergic to pramoxine, zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax. Avoid getting this medicine in your eyes, nose, or vagina. If this does happen, rinse with water. Pramoxine and zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing lesions around your rectum. Stop using pramoxine and zinc oxide topical and call your doctor if your symptoms do not improve after 7 day of treatment, or if your condition clears up and then comes back.

What should I discuss with my healthcare provider before using Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

You should not use this medication if you are allergic to pramoxine, zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you are allergic to any drugs or any other numbing medicines.

FDA pregnancy category C. It is not known whether pramoxine and zinc oxide topical will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. It is not known whether pramoxine and zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I use Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying this medicine. Wash the affected skin area with warm water and a mild soap. Rinse and dry the area thoroughly.

Pramoxine and zinc oxide topical may be used on the rectum after each bowel movement to treat hemorrhoid pain and itching.

Do not insert this medication into your rectum. Use pramoxine and zinc oxide topical only on the outside of the area.

Pramoxine and zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing lesions around your rectum. Stop using this medicine and call your doctor if your symptoms do not improve after 7 day of treatment, or if your condition clears up and then comes back. Store at room temperature away from moisture and heat. Keep the cap tightly closed when not in use.

What happens if I miss a dose?

Since pramoxine and zinc oxide topical is used on an as needed basis, you are not likely to miss a dose. Using extra cream or ointment to make up a missed dose will not make the medication more effective.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

Avoid getting this medicine in your eyes, nose, or vagina. If this does happen, rinse with water.

Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical) side effects

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 pramoxine and zinc oxide topical and call your doctor at once if you have a serious side effect such as:

• 
  

  any new redness or swelling where the medicine was applied;

  
  


• 
  

  severe pain, burning, or stinging where the medicine is applied; or

  
  


• 
  

  rectal bleeding or continued pain.

  
  

Less serious side effects are more likely, and you may have none at all.

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 other drugs will affect Tronolane Anesthetic for Hemorrhoids (pramoxine and zinc oxide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied pramoxine and zinc oxide. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Tronolane Anesthetic for Hemorrhoids resources

• Tronolane Anesthetic for Hemorrhoids Side Effects (in more detail)
• Tronolane Anesthetic for Hemorrhoids Use in Pregnancy & Breastfeeding
• 0 Reviews for Tronolane Anesthetic for Hemorrhoids - Add your own review/rating

• Tucks Hemorrhoidal Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tronolane Anesthetic for Hemorrhoids with other medications

• Hemorrhoids

Where can I get more information?

• Your pharmacist can provide more information about pramoxine and zinc oxide topical.

See also: Tronolane Anesthetic for Hemorrhoids side effects (in more detail)

Norpramin

Generic Name: desipramine (des IP ra meen)

Brand Names: Norpramin

What is Norpramin (desipramine)?

Desipramine is a tricyclic antidepressant. Desipramine affects chemicals in the brain that may become unbalanced.

Desipramine is used to treat symptoms of depression.

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

What is the most important information I should know about Norpramin (desipramine)?

Do not use this medication if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Norpramin (desipramine)?

Do not use this medication if you are allergic to desipramine, or if you have recently had a heart attack. Do not use desipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take desipramine before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take desipramine:

• 
  

  heart disease, or a history of heart attack, stroke, or seizures;

  
  


• 
  

  a family history of sudden death related to a heart rhythm disorder;

  
  


• 
  

  bipolar disorder (manic-depression);

  
  


• 
  

  schizophrenia or other mental illness;

  
  


• 
  

  liver disease;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  diabetes (desipramine may raise or lower blood sugar);

  
  


• 
  

  glaucoma; or

  
  


• 
  

  problems with urination.

  
  

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Desipramine may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether desipramine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

Do not give desipramine to anyone under 18 years old without the advice of a doctor.

How should I take Norpramin (desipramine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking desipramine. You may need to stop using the medicine for a short time.

Do not stop using desipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment. Store desipramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of desipramine can be fatal. Symptoms may include uneven heartbeats, extreme drowsiness, vomiting, blurred vision, confusion, hallucinations, muscle stiffness, feeling hot or cold, seizure (convulsions), or coma.

What should I avoid while taking Norpramin (desipramine)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with desipramine.

Grapefruit and grapefruit juice may interact with desipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Desipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Desipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Norpramin (desipramine) side effects

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.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, problems with vision, speech, or balance;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  tremors, restless muscle movements in your eyes, tongue, jaw, or neck;

  
  


• 
  

  very stiff (rigid) muscles, high fever, sweating, confusion, tremors, feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness;

  
  


• 
  

  skin rash, severe tingling or numbness, pain and muscle weakness; or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  vomiting, constipation;

  
  


• 
  

  dry mouth, unpleasant taste;

  
  


• 
  

  weakness, lack of coordination;

  
  


• 
  

  feeling anxious, restless, dizzy, or drowsy;

  
  


• 
  

  sleep problems (insomnia), nightmares;

  
  


• 
  

  blurred vision, trouble concentrating, headache, ringing in your ears;

  
  


• 
  

  breast swelling (in men or women); or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

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 other drugs will affect Norpramin (desipramine)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by desipramine. Tell your doctor if you regularly use any of these medicines, or any other antidepressants.

Before taking desipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Tell your doctor about all other medicines you use, especially:

• 
  

  cimetidine (Tagamet); or

  
  


• 
  

  heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

  
  

This list is not complete and there are many other medicines that can interact with desipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Norpramin resources

• Norpramin Side Effects (in more detail)
• Norpramin Use in Pregnancy & Breastfeeding
• Drug Images
• Norpramin Drug Interactions
• Norpramin Support Group
• 0 Reviews for Norpramin - Add your own review/rating

• Norpramin Prescribing Information (FDA)


• Norpramin MedFacts Consumer Leaflet (Wolters Kluwer)


• Norpramin Monograph (AHFS DI)


• Norpramin Advanced Consumer (Micromedex) - Includes Dosage Information


• Desipramine Prescribing Information (FDA)

Compare Norpramin with other medications

• ADHD
• Depression
• Dysautonomia
• Vulvodynia

Where can I get more information?

• Your pharmacist can provide more information about desipramine.

See also: Norpramin side effects (in more detail)

Taclonex Topical Suspension

Dosage Form: scalp topical suspension
FULL PRESCRIBING INFORMATION

Indications and Usage for Taclonex Topical Suspension

Indication

Taclonex Scalp® Topical Suspension is indicated for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older.

Limitations of Use

• Taclonex Scalp® Topical Suspension should not be used on the face, axillae or groin


• Taclonex Scalp® Topical Suspension should not be used if there is atrophy at the treatment site

Taclonex Topical Suspension Dosage and Administration

Usual Dosage and Administration

Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. The maximum weekly dose should not exceed 100 g. Patients should shake the bottle prior to using the product. Patients should wash their hands after applying Taclonex Scalp® Topical Suspension.

Taclonex Scalp® Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Dosage Forms and Strengths

Suspension.

Each gram of Taclonex Scalp® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone).

Contraindications

None.

Warnings and Precautions

Effects on Calcium Metabolism

Hypercalcemia and hypercalciuria have been observed with use of Taclonex Scalp® Topical Suspension. If hypercalcemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. The effects of Taclonex Scalp® Topical Suspension on calcium metabolism following treatment durations of more than 8 weeks have not been evaluated.

Effects on Endocrine System

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

In a study of 32 subjects treated with Taclonex Scalp® Topical Suspension on the scalp and Taclonex® Ointment on the body, adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks. [See CLINICAL PHARMACOLOGY Pharmacodynamics (12.2)]

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations (8.4)]

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Allergic Contact Dermatitis with Topical Calcipotriene

Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Taclonex Scalp® Topical Suspension should be discontinued until the infection has been adequately treated.

Unevaluated Uses

The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with known or suspected disorders of calcium metabolism have not been evaluated.

The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with erythrodermic, exfoliative or pustular psoriasis have not been evaluated.

The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Eye Exposures

Avoid eye exposures. Taclonex Scalp® Topical Suspension may cause eye irritation.

Ultraviolet Light Exposures

Patients who apply Taclonex Scalp® Topical Suspension to exposed skin (e.g. a bald scalp) should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy to the scalp in patients who use Taclonex Scalp® Topical Suspension.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active-controlled clinical studies in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly

dose was 12.6 g.

Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex Scalp® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:

Table 1

Number and Percentage of Patients with Adverse Reactions in Scalp Psoriasis Studies (Events Reported by ≥ 1% of Subjects and for Which a Relationship is Possible)
	Taclonex Scalp® Topical Suspension N=1,953	Betamethasone dipropionate in vehicle N=1,214	Calcipotriene in vehicle N=979	Vehicle N=173
Event	# of subjects (%)
Folliculitis	16 (1%)	12 (1%)	5 (1%)	0 (0%)
Burning sensation of skin	13 (1%)	10 (1%)	29 (3%)	0 (0.0%)

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.

In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with Taclonex Scalp® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). The effects of Taclonex Scalp® Topical Suspension on calcium metabolism and the HPA axis were not investigated in the 52-week study.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Taclonex Scalp® Topical Suspension. Taclonex Scalp® Topical Suspension contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex Scalp® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 mcg/kg/day (144 mcg/m2/day); a dosage of 36 mcg/kg/day (432 mcg/m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (324 mcg/m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles were most likely due to the effect of calcipotriene upon calcium metabolism. The estimated maternal and fetal no-adverse effect levels (NOAEL) in the rat (108 mcg/m2/day) and rabbit (48 mcg/m2/day) derived from oral studies are lower than the maximum topical dose of calcipotriene in man (460 mcg/m2/day).

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at doses of 156 mcg/kg (468 mcg/m2/day) and 2.5 mcg/kg (30 mcg/m2/day), respectively. Those dose levels are lower than the maximum topical dose in man (about 5,950 mcg/m2/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palate.

Pregnant women were excluded from the clinical studies conducted with Taclonex Scalp® Topical Suspension.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Taclonex Scalp® Topical Suspension is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of the use of Taclonex Scalp® Topical Suspension in pediatric patients have not been studied. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years may be at particular risk of systemic adverse effects when they are treated with topical corticosteroids. [See Warnings and Precautions (5.2)]

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Of the total number of patients in the controlled clinical studies of Taclonex Scalp® Topical Suspension, 334 were 65 years or older, while 84 were 75 years or older.

No overall differences in safety or effectiveness of Taclonex Scalp® Topical Suspension were observed between these patients and younger patients. All other reported clinical experience has not identified any differences in response between elderly and younger

patients.

Overdosage

Taclonex Scalp® Topical Suspension can be absorbed in sufficient amounts to produce systemic effects [See WARNINGS AND PRECAUTIONS ( 5.1)].

Taclonex Topical Suspension Description

Taclonex Scalp® Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use on the scalp.

Calcipotriene hydrate is a synthetic vitamin D3 analogue.

Chemically, calcipotriene hydrate is 9,10-Secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclo-propyl-, monohydrate, (1α,3ß,5Z,7E,22E,24S) with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene hydrate is a white to almost white, crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name Pregna-1,4- diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to almost white, crystalline powder.

Each gram of Taclonex Scalp® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Taclonex Topical Suspension - Clinical Pharmacology

Mechanism of Action

Taclonex Scalp® Topical Suspension combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analogue and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in psoriasis vulgaris are unknown.

Pharmacodynamics

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression:

HPA axis suppression was evaluated in adult subjects (N=32) with extensive psoriasis involving at least 30% of the scalp and, in total, 15-30% of the body surface area. Treatment consisted of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL was observed in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks.

Effects on Calcium Metabolism:

In the study described above, the effects of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks on calcium metabolism were also examined. Following once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body, elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).

Pharmacokinetics

Absorption

Taclonex Scalp® Topical Suspension:

The systemic effect of Taclonex Scalp® Topical Suspension in extensive psoriasis was investigated in the study described above. In this study, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body. Calcipotriene and betamethasone dipropionate were below the lower limit of quantification in all serum samples of the 34 subjects evaluated.

However, one major metabolite of calcipotriene (MC1080) was quantifiable in 10 of 34 (29.4%) subjects at week 4 and in five of 12 (41.7%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17-propionate (B17P) was also quantifiable in 19 of 34 (55.9%) subjects at week 4 and seven of 12 (58.3%) subjects at week 8. The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown.

Metabolism

Calcipotriene:

Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver. The primary metabolites of calcipotriene are less potent than the parent compound.

Calcipotriene is metabolized to MC1046 (the α,ß-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog). MC1080 is the major metabolite in plasma. MC1080 is slowly metabolized to calcitroic acid.

Betamethasone dipropionate:

Betamethasone dipropionate is metabolized to betamethasone 17-propionate and betamethasone, including the 6ß-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcipotriene was applied topically for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m2/day), no biologically significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test.

Betamethasone dipropionate did not elicit any genotoxic effect in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.

Studies in rats at doses of up to 54 mcg/kg/day (324 mcg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Studies in male rats at oral doses of up to 200 mcg/kg/day (1,200 mcg/m2/day), and in female rats at oral doses of up to 1,000 mcg/kg/day (6,000 mcg/m2/day) of betamethasone dipropionate indicated no impairment of fertility.

Clinical Studies

Controlled Clinical Studies

Two multicenter, randomized, double-blind studies were conducted. In Study One, 1,407 subjects were randomized to one of four treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene hydrate in the same vehicle, or the vehicle alone. Study Two did not include a vehicle arm; 1,280 subjects were randomized to one of three treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, or calcipotriene hydrate in the same vehicle. Both studies enrolled subjects with moderate to very severe scalp psoriasis. The majority of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.

Efficacy was assessed as the proportion of patients at Week 8 with absent or very mild disease according to an Investigator’s Global Assessment of Disease Severity. "Clear" was defined as no evidence of redness, thickness or scaling. "Almost clear" was defined as an overall clinical picture of lesions with the presence of minimal erythema. Table 2 contains the response rates in each of these two trials.

Table 2

Percentage of Patients with Clear or Almost Clear Disease According to the Investigator’s Global Assessment of Disease Severity
	Taclonex Scalp® Topical Suspension	Betamethasone dipropionate in vehicle	Calcipotriene in vehicle	Vehicle
Study One Week 2	(N = 494) 55.5%	(N = 531) 46.1%	(N = 256) 18.4%	(N = 126) 9.5%
Week 8	70.0%	63.1%	36.7%	19.8%
Study Two Week 2	(N = 512) 47.1%	(N = 517) 36.4%	(N = 251) 12.7%	- -
Week 8	67.2%	59.6%	41.0%	-

How Supplied/Storage and Handling

How Supplied

Taclonex Scalp® Topical Suspension is available in bottles of:

30 g (NDC 50222-501-03)

60 g (NDC 50222-501-06)

2 x 60 g (NDC 50222-501-66)

Storage

Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).

Do not refrigerate. Keep the bottle in the outer carton when not in use.

The product should be used within three months after it has been opened.

Handling

Keep out of reach of children.

Shake before use.

Rx only.

Patient Counseling Information

This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients using Taclonex Scalp® Topical Suspension should receive the following information and instructions.

Instructions for Use

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash hands after application. This medication should not be used for any disorder other than that for which it has been prescribed. The treated skin area should not be bandaged or otherwise covered as to be occlusive, unless directed by the physician.

Adverse Reactions

Patients should report any signs of adverse reactions to their physician.

Concomitant Use of Other Corticosteroids

Other products containing calcipotriene or a corticosteroid should not be used with Taclonex Scalp® Topical Suspension without first talking to the physician.

Excessive Exposure to Light

Patients who use Taclonex Scalp® Topical Suspension should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients who use Taclonex Scalp® Topical Suspension.

PATIENT INFORMATION

Taclonex Scalp® (pronounced TAK-lo-NEKS skalp)

(calcipotriene, 0.005% and betamethasone dipropionate, 0.064%)

Topical Suspension

Read the Patient Information that comes with Taclonex Scalp® Topical Suspension before you start using it and each time you refill your prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

Important information: Taclonex Scalp® Topical Suspension is for use on the scalp only (topical use only). Do not use Taclonex Scalp® Topical Suspension on the face, under arms or on groin area. Do not swallow Taclonex Scalp®Topical Suspension. Another product, Taclonex® Ointment contains the same medicine that is in Taclonex Scalp® Topical Suspension and is used to treat psoriasis vulgaris of the skin. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medicines.

What is Taclonex Scalp®Topical Suspension?

Taclonex Scalp® Topical Suspension is a prescription medicine that is for use on the scalp only (a topical medicine). Taclonex Scalp® Topical Suspension is used to treat psoriasis vulgaris in adults 18 years of age and older. Taclonex Scalp® Topical Suspension is not recommended for use in children. Taclonex Scalp® Topical Suspension has not been studied in patients under the age of 18.

Who should not use Taclonex Scalp®Topical Suspension?

Do not use Taclonex Scalp®Topical Suspension if you:

• have a calcium metabolism disorder


• have one of the following types of psoriasis:
  
  • erythrodermic psoriasis
  
  
  • exfoliative psoriasis
  
  
  • pustular psoriasis
  
  


• have severe kidney or liver disease.

What should I tell my doctor before using Taclonex Scalp®Topical Suspension?

Tell your doctor about all of your health conditions, including if you:

• have a skin infection on your scalp. Your skin infection should be treated before you start using Taclonex Scalp® Topical Suspension


• have thin-skin (atrophy) at the site to be treated. You should not use Taclonex Scalp® Topical Suspension


• are getting phototherapy treatments (light therapy) for your psoriasis


• are pregnant or planning to become pregnant. It is not known if Taclonex Scalp® Topical Suspension can harm your unborn baby. You and your doctor will have to decide if Taclonex Scalp® Topical Suspension is right for you while pregnant


• are breastfeeding. It is not known if Taclonex Scalp® Topical Suspension passes into your milk and can harm your baby.

Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins and herbal supplements.

Taclonex Scalp® Topical Suspension and some other medicines may interact with each other. Especially tell your doctor if you use:

• other corticosteroid medicines


• other medicines for your psoriasis.

How should I use Taclonex Scalp®Topical Suspension?

• Use Taclonex Scalp® Topical Suspension exactly as prescribed by your doctor.


• Do not use more than the maximum recommended weekly amount of 100 grams of Taclonex Scalp® Topical Suspension.


• Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. Do not use Taclonex Scalp® Topical Suspension for more than 8 weeks unless prescribed by your doctor.


• Taclonex Scalp® Topical Suspension should only be used on the scalp. Do not use Taclonex Scalp® Topical Suspension on the face, under arms or on groin area. If you accidentally get Taclonex Scalp® Topical Suspension on your face or in your eyes wash the area with water right away.


• If you forget to use Taclonex Scalp® Topical Suspension, use it as soon as you remember. Then go on as before.


• Wash your hands well after using Taclonex Scalp® Topical Suspension.


• Do not wash your hair right after applying Taclonex Scalp® Topical Suspension. The medicine will not work as well to treat your psoriasis.

Using Taclonex Scalp®Topical Suspension:

• Do not bandage or tightly cover or wrap the treated skin area.


• Do not apply Taclonex Scalp® Topical Suspension in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your doctor first.


• Shake the bottle before use.

Remove the cap and apply Taclonex Scalp® Topical Suspension one time each day to the areas of your scalp affected by psoriasis, using the following steps (See the figures below).

What should I avoid while using Taclonex Scalp®  Topical Suspension?

Avoid spending a long time in sunlight. Avoid tanning booths and sun lamps. Use sunscreen and wear a hat if you have to be in sunlight.  Talk to your doctor if you get a sunburn.

What are the possible side effects of Taclonex Scalp®  Topical Suspension?

Taclonex Scalp®  Topical Suspension may cause serious side effects.

Serious side effects are more likely to happen if you use too much  Taclonex Scalp® Topical Suspension, use it for too long, or use it  with other topical medicines that contain corticosteroids, calcipotriene,  or certain other ingredients. Check with your health care  professional before using other topical medicines. Taclonex Scalp®  Topical Suspension can pass through your skin and be absorbed  into the body.

Serious side effects may include:

• too much calcium in your blood or urine
  


• adrenal gland problems

Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex Scalp® Topical Suspension.

Other side effects include:

• itching


• inflamed hair pores (folliculitis)


• skin pain or irritation


• skin burning


• redness of the skin


• worsening of psoriasis

Call your doctor about any side effect that bothers you or that does not go away.

These are not all of the side effects with Taclonex Scalp® Topical Suspension. Ask your doctor or pharmacist for more information.

How should I store Taclonex Scalp®  Topical Suspension?

• Store Taclonex Scalp® Topical Suspension between 68-77°F (20-25°C). Do not refrigerate.


• Keep the bottle in the carton when not in use.


• Taclonex Scalp® Topical Suspension has an expiration date (exp.) marked on the bottom of the bottle. Do not use the topical suspension after this date.


• Use Taclonex Scalp® Topical Suspension within three months after it has been opened. After three months, safely throw away the bottle with any leftover Taclonex Scalp® Topical Suspension. If you need to keep using Taclonex Scalp® Topical Suspension or begin using it again, use a new bottle.


• Keep Taclonex Scalp®  Topical Suspension and all medicines out of the reach of children.

General information about Taclonex Scalp®  Topical Suspension.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex Scalp® Topical Suspension for a condition for which it was not prescribed. Do not give your Taclonex Scalp® Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Taclonex Scalp® Topical Suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex Scalp® Topical Suspension that is written for health professionals. For more information, please visit www.taclonex.com or call 1-877-494-4536.

What are the ingredients in Taclonex Scalp® Topical Suspension?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate.

Inactive ingredients: hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Manufactured by:

LEO Pharma A/S

Ballerup, Denmark

LEO®    

Distributed by:

LEO Pharma Inc.

1 Sylvan Way, Parsippany, NJ 07054, USA

1-877-494-4536

U.S. Patent Nos. RE39,706 E, 6,753,013 and 6,787,529.

024580-04

Revised: 1/2011

PRINCIPAL DISPLAY PANEL - Carton Label 60g

NDC 50222-501-06

Rx only

TACLONEX SCALP®

(calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension

For Topical Use Only

Net Wt. 60 g

Each gram contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Store Taclonex Scalp® Topical Suspension between 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). Do not refrigerate. Keep the bottle in the outer carton when not in use. Shake before use.

Discard product three months after opening.

Keep out of the reach of children.

Usual dosage: Apply once daily, or as directed by physician. See insert for complete information. 

TACLONEX SCALP  calcipotriene and betamethasone dipropionate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50222-501 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug  in 1 g BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE DIPROPIONATE 0.643 mg  in 1 g

Inactive Ingredients Ingredient Name Strength HYDROGENATED CASTOR OIL   MINERAL OIL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50222-501-51 40 CARTON In 1 CASE contains a CARTON 1 1 BOTTLE In 1 CARTON This package is contained within the CASE (50222-501-51) and contains a BOTTLE 1 4 g In 1 BOTTLE This package is contained within a CARTON and a CASE (50222-501-51) 2 50222-501-52 40 CARTON In 1 CASE contains a CARTON 2 1 BOTTLE In 1 CARTON This package is contained within the CASE (50222-501-52) and contains a BOTTLE 2 15 g In 1 BOTTLE This package is contained within a CARTON and a CASE (50222-501-52) 3 50222-501-03 40 CARTON In 1 CASE contains a CARTON 3 1 BOTTLE In 1 CARTON This package is contained within the CASE (50222-501-03) and contains a BOTTLE 3 30 g In 1 BOTTLE This package is contained within a CARTON and a CASE (50222-501-03) 4 50222-501-06 40 CARTON In 1 CASE contains a CARTON 4 1 BOTTLE In 1 CARTON This package is contained within the CASE (50222-501-06) and contains a BOTTLE 4 60 g In 1 BOTTLE This package is contained within a CARTON and a CASE (50222-501-06) 5 50222-501-66 10 PACKAGE In 1 BOX contains a PACKAGE 5 2 BOTTLE In 1 PACKAGE This package is contained within the BOX (50222-501-66) and contains a BOTTLE 5 60 g In 1 BOTTLE This package is contained within a PACKAGE and a BOX (50222-501-66)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022185	06/01/2008

Labeler - LEO Pharma Inc. (832692615)

Establishment
Name	Address	ID/FEI	Operations
LEO Pharma A/S		306218108	MANUFACTURE

Revised: 04/2011LEO Pharma Inc.

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