testosterone buccal system (Rx)

Brand and Other Names:Striant
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, buccal: Schedule III

  • 30mg

Testosterone Replacement Therapy

Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above normal range

Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; these men have low testosterone serum concentrations but have gonadotropins in the normal or low range

1 buccal system (30 mg) to gum region q12hr; place above incisor on alternate sides of mouth

Dosing Considerations

Prior to initiating therapy, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range

Limitations of use

  • Safety and efficacy of testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established
  • Safety and efficacy of testosterone in males aged <18 years have not been established

Safety and efficacy not established

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Interactions

Interaction Checker

and testosterone buccal system

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (6)

              • cyclosporine

                testosterone buccal system increases effects of cyclosporine by decreasing metabolism. Avoid or Use Alternate Drug.

              • lonafarnib

                testosterone buccal system will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • pexidartinib

                testosterone buccal system and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                testosterone buccal system, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              • sotorasib

                sotorasib will decrease the level or effect of testosterone buccal system by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • warfarin

                testosterone buccal system increases levels of warfarin by decreasing metabolism. Avoid or Use Alternate Drug.

              Monitor Closely (16)

              • atogepant

                testosterone buccal system will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • avapritinib

                testosterone buccal system will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                testosterone buccal system increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                testosterone buccal system increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.

              • finerenone

                testosterone buccal system will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • insulin degludec

                testosterone buccal system increases effects of insulin degludec by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • insulin degludec/insulin aspart

                testosterone buccal system increases effects of insulin degludec/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • insulin inhaled

                testosterone buccal system increases effects of insulin inhaled by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • isavuconazonium sulfate

                testosterone buccal system will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ivacaftor

                testosterone buccal system increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lemborexant

                testosterone buccal system will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • lomitapide

                testosterone buccal system increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • midazolam intranasal

                testosterone buccal system will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • mipomersen

                mipomersen, testosterone buccal system. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.

              • stiripentol

                stiripentol will increase the level or effect of testosterone buccal system by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

              • tinidazole

                testosterone buccal system will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (39)

              • acarbose

                testosterone buccal system increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

              • androstenedione

                androstenedione increases effects of testosterone buccal system by pharmacodynamic synergism. Minor/Significance Unknown.

              • budesonide

                testosterone buccal system, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • chlorpropamide

                testosterone buccal system increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • clobetasone

                testosterone buccal system, clobetasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • cortisone

                testosterone buccal system, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • deflazacort

                testosterone buccal system, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • dexamethasone

                testosterone buccal system, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • epoetin alfa

                testosterone buccal system increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.

              • fludrocortisone

                testosterone buccal system, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • glimepiride

                testosterone buccal system increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

              • glipizide

                testosterone buccal system increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

              • glyburide

                testosterone buccal system increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

              • hydrocortisone

                testosterone buccal system, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • insulin aspart

                testosterone buccal system increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin detemir

                testosterone buccal system increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glargine

                testosterone buccal system increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glulisine

                testosterone buccal system increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin lispro

                testosterone buccal system increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin NPH

                testosterone buccal system increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin regular human

                testosterone buccal system increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

              • metformin

                testosterone buccal system increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

              • methylprednisolone

                testosterone buccal system, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • miglitol

                testosterone buccal system increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

              • nateglinide

                testosterone buccal system increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • pioglitazone

                testosterone buccal system increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • prednisolone

                testosterone buccal system, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • prednisone

                testosterone buccal system, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • repaglinide

                testosterone buccal system increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • rosiglitazone

                testosterone buccal system increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • ruxolitinib

                testosterone buccal system will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • saw palmetto

                saw palmetto decreases effects of testosterone buccal system by pharmacodynamic antagonism. Minor/Significance Unknown.

              • saxagliptin

                testosterone buccal system increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • sitagliptin

                testosterone buccal system increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • tacrolimus

                testosterone buccal system increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.

              • tolazamide

                testosterone buccal system increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • tolbutamide

                testosterone buccal system increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                testosterone buccal system, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • vildagliptin

                testosterone buccal system increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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              Adverse Effects

              1-10%

              Gum or mouth irritation

              Abnormal taste

              Gum pain or tenderness

              Gum edema

              Headache

              Postmarketing Reports

              Vascular Disorders: Venous thromboembolism

              Myocardial infarction, stroke

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              Warnings

              Contraindications

              Male breast or prostate cancer

              Hypersensitivity to ingredients, including soy

              Women who are breast feeding, may become pregnant or are pregnant

              Cautions

              Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease

              Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions

              Potential for gynecomastia

              Risk of sleep apnea in susceptible patients

              Increase risk of BPH and prostate cancer in elderly; monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH

              Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically

              Skin burns reported at application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI); because transdermal testosterone patch contains aluminum, it is recommended to remove system before undergoing MRI

              Venous thromboembolism, including DVT and PE reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if venous thromboembolic event suspected, discontinue treatment with testosterone and initiate appropriate workup and management

              Cardiovascular risks

              • Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy
              • January 31, 2014: The FDA is investigating the risk of stroke, MI, and death in men taking prescription testosterone drugs
              • The investigationwas prompted by findings from 2 studies that suggest an increased risk of MI in men who take testosterone
              • PLOS ONE (Jan 29, 2014): Analysis of men with a history of MI (N=55,593)showed men >65 yr had a 2-fold increase in the risk of MI within 90 days of filling an initial prescription for a testosterone drug; among younger men (<65 yr) with a history of heart disease, there was a 2- to 3-fold increased risk of MI
              • The PLOS ONE study confirmed results of a much smaller study (JAMA November 6, 2013) which found that older men, many with underlying heart disease, had a 30% increased chance of death, MI, and stroke after taking testosterone therapy
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              Pregnancy & Lactation

              Pregnancy Category: X

              Lactation: Contraindicated

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Androgen that promotes the growth and development of male sex organs and maintains secondary sex characteristics in androgen deficient males.

              Pharmacokinetics

              Peak plasma time: 10-12 hr

              Half-Life: 10-100 min

              Protein binding: 98%

              Concentration: 520-550 ng/dL

              Excretion: Urine (90%); feces (6%)

              Absorption: 10% of applied dose

              Metabolism: Liver

              Metabolites: Estradiol, dihydrotestosterone

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.