Sprintec
23 June, 2023
Subutex
23 June, 2023
Striant
Description
Generic name:
Testosterone
Drug class:
Androgen; Anabolic steroid
Dosage form:
Buccal mucoadhesive system (transbuccal adhesive tablet)
Root of administration:
Buccal
Dose:
- Adults: One 30 mg buccal tablet applied to the gum above the incisor twice daily (every 12 hours) for a total of 60 mg/day
- Adjust dose based on serum testosterone levels and clinical response
- Varies by indication; consult label
Mechanism of action:
Testosterone is released through the buccal mucosa into systemic circulation, binds to intracellular androgen receptors, and modulates gene expression to produce androgenic and anabolic effects.
Drug usage cases:
- Approved: Replacement therapy in adult males with primary or secondary hypogonadism
- Off-label: Muscle wasting in HIV/AIDS
- Off-label: Osteoporosis in men
- Off-label: Delayed puberty in adolescent males
- Off-label: Anemia associated with bone marrow failure
Drug contra indications:
- Male breast carcinoma
- Known or suspected prostate carcinoma
- Pregnancy and lactation
- Hypersensitivity to testosterone or formulation components
- Severe cardiac, hepatic, or renal disease (varies by indication; consult label)
Side effects:
- Gum or buccal mucosa irritation
- Headache
- Increased prostate-specific antigen (PSA)
- Edema and fluid retention
- Polycythemia (increased hematocrit/hemoglobin)
- Hypercalcemia
- Hypertension
- Acne and oily skin
- Male pattern baldness (alopecia)
- Gynecomastia
- Mood swings, irritability, depression
- Cholesterol changes (decreased HDL, increased LDL)
- Sleep apnea exacerbation
Warnings:
- Risk of prostate cancer; monitor PSA and perform digital rectal exam regularly
- Polycythemia risk; monitor hematocrit
- Cardiovascular risk; assess for hypertension, edema, and heart failure
- Liver toxicity; monitor liver function in patients with hepatic impairment
- Possible secondary exposure; advise patients to avoid skin contact with applied area
- May unfavorably alter lipid profile
- May exacerbate sleep apnea
- Use with caution in benign prostatic hyperplasia (BPH)
Use during pregnancy or breastfeeding:
Testosterone is contraindicated in pregnant women (FDA category X) due to risk of virilization of a female fetus. It is not recommended during breastfeeding and may cause virilization of a nursing infant. Women who are pregnant or breastfeeding should avoid handling the dosage form; if contact occurs, wash the area immediately with soap and water.
