July 27, 2016


How Supplied


Striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired) –Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range.

Limitations of use

  • Safety and efficacy of Striant in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
  • Safety and efficacy of Striant in males less than 18 years old have not been established [see Use in Specific Populations].


Prior to initiating, Striant confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Dosage Information

The recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).

To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Striant therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.

Administration Instructions

Striant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.

Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.

If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.

Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed. To remove Striant, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Striant buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.


Dosage Forms And Strengths

Each Striant buccal system contains 30 mg of testosterone.

It is white to off-white colored with a flat edge on one side and a convex surface on the other.

Striant is debossed on its flat side, as shown below:


Storage And Handling

Striant (testosterone buccal system) mucoadhesive is supplied in transparent blister packs containing 10 doses. It is white to off-white colored with a flat edge on one side and a convex surface on the other.

Striant is debossed on its flat side, as shown below:


Each Striant buccal system contains 30 mg of testosterone and is supplied as follows:

NDC Number Package Size
52244-030-60 6 blister packs, 10 buccal systems per blister pack, 30 mg of testosterone per buccal system

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from heat and moisture. Damaged blister packages should not be used. Discard used Striant buccal systems in household trash in a manner that prevents accidental application or ingestion by children or pets.

Manufactured by: Mipharm S.p.A, Milan, Italy Manufactured for: Actient Pharmaceuticals LLC, Chesterbrook, PA 19087. Revised: May 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/8/2015

How Supplied

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