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AndroGel Complete Drug-Drug Interaction Profile

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At a glance

  • Listed interactions / Insulin; oral anticoagulants; ACTH or corticosteroids [1]
  • Oral anticoagulants / Anticoagulant activity may change; more frequent INR and prothrombin-time monitoring, especially at the initiation and termination of androgen therapy [1]
  • Insulin / Blood glucose and insulin requirements may decrease [1]
  • Corticosteroids and ACTH / Increased fluid retention; careful monitoring, particularly with cardiac, renal or hepatic disease [1]
  • Quantified effects / None given for any of the three entries [1]
  • Other drugs / Not named in the label's interactions section [1]

Oral anticoagulants

The label says changes in anticoagulant activity may be seen with androgens, and that more frequent monitoring of international normalized ratio (INR) and prothrombin time is recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy [1].

The entry does not name warfarin, does not say which direction INR moves, and gives no expected change or anticoagulant dose adjustment [1]. It also does not name apixaban, rivaroxaban or other direct oral anticoagulants [1].

Insulin

The label says changes in insulin sensitivity or glycemic control may occur in patients treated with androgens, and that in diabetic patients the metabolic effects of androgens may decrease blood glucose and therefore may decrease insulin requirements [1]. Insulin is the only diabetes medicine the entry names; there is no glucose target and no insulin adjustment figure in it [1].

ACTH and corticosteroids

The label says concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease [1]. The warnings section adds that edema, with or without congestive heart failure, may be a complication in patients with preexisting cardiac, renal or hepatic disease [1].

The entry does not separate prednisone from dexamethasone, fludrocortisone or inhaled steroids, and it gives no rate for the combination [1].

What the interactions section leaves out

None of the three entries gives a percentage, a measured size of effect, or a dose adjustment [1]. Blood pressure medicines, beta-blockers, opioids, antiretrovirals and transplant immunosuppressants are not named in the label's interactions section [1]. The label states that dosing and administration for testosterone gel 1% differ from testosterone gel 1.62% and refers readers to that product's full prescribing information [1].

Frequently asked questions

Which drugs does the testosterone gel 1% label list as interacting?
Three: insulin, oral anticoagulants, and ACTH or corticosteroids [1]. No other drug is named in that section [1].
How much does testosterone gel change INR in someone on warfarin?
The label gives no figure and does not name warfarin. It says changes in anticoagulant activity may be seen with androgens and recommends more frequent INR and prothrombin-time monitoring, especially at the initiation and termination of androgen therapy [1].
Can testosterone gel change blood sugar or insulin needs?
The label says changes in insulin sensitivity or glycemic control may occur, and that the metabolic effects of androgens may decrease blood glucose and insulin requirements in diabetic patients [1]. It gives no size for the change and names no other diabetes medicine [1].
Does testosterone gel interact with prednisone or other corticosteroids?
The label lists a caution rather than a measured effect: use with ACTH or corticosteroids may increase fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease [1]. No rate is given [1].

References

  1. U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) prescribing information. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) label
  2. Testosterone Information | FDA. Testosterone Information | FDA
Evidence overview for AndroGel Complete Drug-Drug Interaction Profile