Adult Dosing

Replacement therapy for deficiency or absence of endogenous testosterone, Congenital and acquired hypogonadism, Congenital and acquired hypogonadotropic hypogonadism

• Apply one buccal system to the gum region q12hrs, preferably morning and evening
• Note: If the buccal system falls out of position within 4 hours prior to the next dose, apply a new buccal system and keep it in place until the time of next regularly scheduled dosing
• Care should be taken to avoid dislodging the buccal system; check for positioning of the buccal system after toothbrushing, use of mouthwash and consumption of food or alcoholic/non-alcoholic beverages
• Do not chew or swallow
• Remove before next dose; to remove the buccal device, gently slide it downwards from the gum towards the tooth to avoid scratching the gum

Pediatric Dosing

• Safety and effectiveness in pediatric male patients < 18 yrs of age have not established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As replacement therapy for deficiency or absence of endogenous testosterone in men
• Congenital hypogonadism
• Acquired hypogonadism due to
• Testicular failure due to cryptorchidism
• Bilateral torsion
• Orchitis
• Vanishing testis syndrome
• Orchidectomy
• Klinefelter syndrome
• Chemotherapy
• Toxic damage from alcohol or heavy metals

• Congenital hypogonadotropic hypogonadism
• Acquired hypogonadotropic hypogonadism due to
• Idiopathic gonadotropin or LHRH deficiency
• Pituitary hypothalamic injury from tumors, trauma, or radiation

• Hypersensitivity to any of the ingredients in the product
• CA breast
• Known or suspected CA of prostate
• Women

Renal dose adjustment

• Use with caution; dose adjustments not defined

Hepatic dose adjustment

• Use with caution; dose adjustments not defined

• Prolonged use of high doses can cause serious hepatic adverse effects including peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice
• Evaluate geriatric patients for presence of prostate cancer prior to starting therapy
• Periodically evaluate patients for signs and symptoms of benign prostatic hyperplasia
• Edema with or without congestive heart failure is a serious complication in patients with preexisting cardiac, renal, or hepatic disease; discontinue the drug and initiate diuretic therapy
• Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism
• Treatment with testosterone esters potentiates sleep apnea in some patients with obesity or chronic lung diseases
• Inform women of child bearing potential or lactating women about the potential for transfer of testosterone from men treated with testosterone. It may cause fetal harm or serious adverse reactions in nursing infants
• Patients should wash their hands immediately with soap and water after application and cover the application site with clothing after the gel had dried
• Monitor Hgb, HCT periodically if long term treatment; LFTs, PSA and Lipid panel

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• CV disease
• CHF
• Edema
• Diabetes mellitus
• Chronic Pulmonary disease
• Obese patients
• Hyperlipidemia
• BPH
• Geriatric population (increased risk of prostate CA)

Pregnancy Category:X

Breastfeeding: Contraindicated.

• CV: CHF exacerbation, edema, hypertension
• CNS: Headache, anxiety, fatigue, headache
• RESP: Acute asthma
• GI: Abdominal cramps, peliosis hepatis, nausea, vomiting, hepatocellular CA
• EENT: Gum or Mouth Irritation, bitter taste, gum pain, gum tenderness, gum edema, taste Perversion, buccal mucosal roughening, gingivitis, gum blister, diminished gustatory sense, nose edema, stinging of lips, and toothache, buccal inflammation, dry mouth, gum redness, toothache
• GU: Difficulty in micturition, abnormal renal function, priapism, frequent/prolonged erections
• DERM: Acne
• HEMA: Polycythemia
• ENDO: Gynecomastia, hypercholesterolemia, prostate hypertrophy, prostate CA
• PSYCHIATRY: Anxiety, emotional lability, depression
• LABTEST: Increased hematocrit, increased lipids serum, abnormal liver function tests, increased serum prostate specific antigen (PSA)
• MISC: Sleep apnea, generalized edema, breast enlargement, breast pain, infection, medication error, pruritus

• Androgen; activates androgen receptor by conversion to estradiol and activation of certain estrogen receptors
• Hepatic metabolism: Metabolised to active estradiol and dihydrotestosterone; absorption from buccal mucosa bypasses initial liver metabolism; CYP450: 3A4 substrate
• Extra hepatic metabolism: Metabolized to 3-alpha and 3-beta androstanediol in reproductive tissues
• Renally excreted: 90% (as metabolites), feces: 6%
• Half-life: 10-100 mins

US Trade Name(s)

• Striant

US Availability

Striant

• ETABS: 30 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Striant SR

UK Availability

Striant SR

• ETABS: 30 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Sex Hormones

Androgens & Anabolic Steroids

Urologic

Sex Hormones

Androgens & Anabolic Steroids

Pricing data from www.DrugStore.com in U.S.A.

• Striant 30 MG MISC [Disp Pack] (ACTIENT PHARMACEUTICALS)
  60 mg = $357.9
  180 mg = $1027.07

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Striant 30 MG Buccal Film

Ingredient(s): Testosterone

Imprint: Columbia;C

Color(s): White

Shape: Round

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): anhydrous lactose / carbomer 934 / hypromellose / magnesium stearate / lactose monohydrate / polycarbophil / silicon dioxide / starch, corn / talc

Drug Label Author:
Columbia Laboratories, Inc.

DEA Schedule:
CIII