Trimel Pharmaceuticals Corporation

Trimel Pharmaceuticals Corporation Drugs

• Natesto Nasal Gel
  

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  Natesto Nasal Gel

  

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  2.1. Dosing

  The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations; 1 actuation per nostril) administered intranasally three times daily for a total daily dose of 33 mg.

  Serum total testosterone concentrations should be checked periodically, starting as soon as one month after initiating treatment with Natesto. When the total testosterone concentration consistently exceeds 1050 ng/dL, therapy with Natesto should be discontinued. If the total testosterone concentration is consistently below 300 ng/dL, an alternative treatment should be considered.

  2.2. Administration Instructions

  Natesto is administered intranasally three times daily once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart), preferably at the same time each day. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose. Do not administer Natesto to other parts of the body.

  Preparing the Pump

  When using Natesto for the first time, patients should be instructed to prime the pump by inverting the pump, depressing the pump 10 times, and discarding any small amount of product dispensed directly into a sink and then washing the gel away thoroughly with warm water. The tip should be wiped with a clean, dry tissue. If the patient gets Natesto gel on their hands, it is recommended that they wash their hands with warm water and soap. This priming should be done only prior to the first use of each dispenser.

  Administering the Dose

  To administer the dose, patients should be instructed to perform the following steps:

  Blow the nose. Remove the cap from the dispenser. Place the right index finger on the pump of the actuator and while in front of a mirror, slowly advance the tip of the actuator into the left nostril upwards until their finger on the pump reaches the base of the nose. Tilt the actuator so that the opening on the tip of the actuator is in contact with the lateral wall of the nostril to ensure that the gel is applied to the nasal wall. Slowly depress the pump until it stops. Remove the actuator from the nose while wiping the tip along the inside of the lateral nostril wall to fully transfer the gel. Using your left index finger, repeat the steps outlined in bullets 3 through 6 for the right nostril. Use a clean, dry tissue to wipe the tip of the actuator. Replace the cap on the dispenser. Press on the nostrils at a point just below the bridge of the nose and lightly massage. Refrain from blowing the nose or sniffing for 1 hour after administration.

  The dispenser should be replaced when the top of the piston inside the dispenser reaches the arrow at the top of the inside label. The inside label may be found by unwrapping the outer flap from around the container.

  2.3. Use with Nasally Administered Drugs Other Than Sympathomimetic Decongestants

  The drug interaction potential between Natesto and nasally administered drugs other than sympathomimetic decongestants is unknown. Therefore, Natesto is not recommended for use with nasally administered drugs other than sympathomimetic decongestants (e.g., oxymetazoline) [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)].

  2.4. Temporary Discontinuation of Use for Severe Rhinitis

  If the patient experiences an episode of severe rhinitis, temporarily discontinue Natesto therapy pending resolution of the severe rhinitis symptoms. If the severe rhinitis symptoms persist, an alternative testosterone replacement therapy is recommended.

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