Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter's syndrome, chemotherapy, or toxic damagefrom alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired) — idiopathic gonadotropin or 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.
DOSAGE AND ADMINISTRATION
The recommended dosing schedule for Striant® (testosterone) is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart). Striant® (testosterone) should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant® (testosterone) 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® (testosterone) 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 4 hours prior to the next dose, a new buccal system should be applied and it may remain in place until the time of next regularly scheduled dosing.
Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant® (testosterone) is in place following toothbrushing, use of mouthwash and consumption of food or alcoholic/non-alcoholic beverages. Striant® (testosterone) should not be chewed or swallowed. To remove Striant® (testosterone) , gently slide it downwards from the gum towards the tooth to avoid scratching the gum.
Striant® (testosterone buccal system) is for buccal administration only. It contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Striant® (testosterone) 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® (testosterone) 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||Strength||Package Size|
|55056-3060-1||30 mg||6 blister packs, 10 buccal systems per blister: 30 mg pe buccal system|
Storage and Disposal
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. Discarded Striant® (testosterone) buccal systems should be disposed of 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: Columbia Laboratories, Inc. Livingston, NJ 07039.
Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.
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