Striant

Striant Manufacturers

• Columbia Laboratories, Inc.
  

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  Striant | Columbia Laboratories, Inc.

  

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  The recommended dosing schedule for Striant® is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart). 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 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® is in place following toothbrushing, use of mouthwash and 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 towards the tooth to avoid scratching the gum.

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• Actient Pharmaceuticals Llc
  

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  Striant | Bracco Diagnostics Inc

  

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  As a convenience to the physician, the following guidelines which have proven satisfactory are provided (seePRECAUTIONS, General). Patients should be counseled prior to radiographic examination (seePRECAUTIONS, Information for the Patient).

  Preparation of the patient: Hysterosalpingography should be performed three to five days after the cessation of the patient’s menstrual period as a precautionary measure. An enema and vaginal douche one hour before the examination are helpful, but not essential. The patient should empty her bladder before the examination. Since the procedure is remarkably free of pain when Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is used, the use of a narcotic or anesthesia is unnecessary.

  Dosage: 3 to 4 mL of Sinografin, administered in fractional doses of approximately 1 mL, are usually adequate to visualize the uterus; an additional 3 to 4 mL will demonstrate the tubes. Total doses varying from 1.5 to 10 mL have been employed with satisfactory results.

  Administration: The patient is placed in the lithotomy position and the vulva is cleansed with a suitable antiseptic solution. A Graves-type vaginal speculum is introduced, the cervix is exposed, and the vaginal vault is sponged with antiseptic solution.

  A tenaculum is placed on the cervical lip, usually the anterior lip. A sterile sound may be passed to determine the position of the uterus and the direction of the cervical canal, and, when necessary, the cervical canal may be dilated. (Sounding the uterine cavity and dilatation of the canal are not usually required when a flexible cannula tip is used.)

  A sterile syringe containing the Sinografin is attached by Luer-Lok to a uterine cannula. The two-way cannula valve is opened and all air bubbles in the cannula and syringe are expressed. About 1.5 to 2 mL of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) are required to fill the cannula. (If preferred, a tubal insufflator under controlled pressure with a salpingogram attachment may be used instead of the syringe.)

  The cannula tip is inserted into the cervical canal so that the adjustable rubber acorn obturator fits snugly at the external os. Careful placement of the cannula is important to avoid trauma and pain. Squeezing the trigger of the cannula to provide simultaneous traction on the tenaculum and forward pressure on the cannula should give a nonleaking cervical seal. Sinografin flows freely so that only gentle pressure on the plunger is necessary; however, the medium should be used as promptly as possible following withdrawal into the syringe. The syringe should be rinsed as soon after the procedure as possible to prevent freezing of the plunger.

  The connection at the external os is checked for leakage. If the acorn obturator is inadequate, an inflatable balloon-obturator may be used to seal the cervical canal. When the equipment has been positioned satisfactorily, the tenaculum and cannula may be fixed in position until the procedure is terminated.

  Radiography: A scout film may be made before the medium is administered. After the initial fractional injection, a film should be made using a Bucky diaphragm. After each successive injection of 1 mL, a film is taken, developed immediately, and inspected in the dark room before the next fractional dose of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is given, until the procedure is completed. Further injection and subsequent films can be made as required using posterior-anterior or oblique angles.

  Clinical experience indicates that tubal patency, if present, will be demonstrable at the time of the injection and delayed films have not been required.

  General

  Diatrizoate Meglumine and lodipamide Meglumine Injection should be inspected visually for particulate matter and discoloration prior to instillation whenever solution and container permit. The solution may vary in color from essentially colorless to pale yellow. Solutions which may have become substantially darker should not be used.

  In the event that crystallization occurs, the solution may be clarified by placing the vial in hot water and shaking gently for several minutes or until the solution is clear. If cloudiness persists, the preparation should not be used. Allow the solution to cool to body temperature before administering.

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