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NATESTO
Hypogonadism
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Drug Name:

NATESTO CIII

Generic Name and Formulations:
Testosterone 5.5mg; per pump actuation; nasal gel.

Company:
Endo Pharmaceuticals

Therapeutic Use:

Indications for NATESTO:

Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.

Limitations Of use:

Not established in men with age-related hypogonadism.

Adult:

Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Administer intranasally once in the morning, afternoon, and evening (6–8hrs apart) at same time each day. ≥18yrs: 11mg (1 pump per nostril) three times daily (total dose: 33mg daily); check serum testosterone levels periodically as soon as one month after initiation. If severe rhinitis occurs; temporarily discontinue until resolve; use alternative if symptoms persist.

Children:

<18yrs: not established.

Contraindications:

Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Not for use in women. History of nasal disorders, nasal or sinus surgery, nasal fracture within previous 6 months or one that caused a deviated anterior nasal septum, mucosal inflammatory disorders (eg, Sjogren’s syndrome), or sinus disease: not recommended. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer before starting therapy, and 3–6 months after initiation. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal, or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Consider alternative if total testosterone consistently <300ng/dL; discontinue if consistently >1050ng/dL. Monitor for nasal adverse reactions; discontinue if appropriate. Men with BMI >35kg/m2: not established. Elderly.

Interactions:

Concomitant intranasal drugs other than sympathomimetic decongestants (eg, oxymetazoline): not recommended. May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Monitor INR and PT with concomitant oral anticoagulants. Increased fluid retention with concomitant corticosteroids; monitor. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

PSA increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper RTI, sinusitis, nasal scab; azoospermia, gynecomastia.

How Supplied:

Metered-dose pump—11g (60 actuations)

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