MAXIBOLIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MAXIBOLIN (MAXIBOLIN).
MAXIBOLIN (methandienone) is an anabolic steroid that binds to androgen receptors, increasing protein synthesis and nitrogen retention in muscle tissue. It also inhibits glucocorticoid receptors, reducing catabolism and promoting anabolic effects.
| Metabolism | Hepatic metabolism via 6β-hydroxylation and reduction, primarily by CYP3A4; excreted renally as conjugated metabolites. |
| Excretion | Primarily renal (90% as metabolites, 5% unchanged); biliary/fecal elimination accounts for approximately 10%. |
| Half-life | Terminal elimination half-life of 9-10 hours; supports every-other-day dosing in androgen replacement therapy. |
| Protein binding | Approximately 98% bound to sex hormone-binding globulin (SHBG) and albumin. |
| Volume of Distribution | 0.5-0.8 L/kg, indicating distribution into total body water and some tissue binding. |
| Bioavailability | Oral: 40-60% due to first-pass metabolism; intramuscular: 100%. |
| Onset of Action | Oral: 2-4 hours for increase in protein synthesis and nitrogen retention; intramuscular: 1-2 hours. |
| Duration of Action | Clinical effects on muscle mass and strength persist for 2-3 days after a single dose; requires consistent dosing for sustained anabolic effect. |
Oral: 2 mg three times daily; optimal response may require 4-8 mg daily for 2-3 weeks, then reduce to maintenance of 2-4 mg daily.
| Dosage form | TABLET |
| Renal impairment | No specific guidelines; caution in severe impairment. GFR <30 mL/min: consider dose reduction to 50% of normal dose, monitor for fluid retention. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce dose by 50%; Class C: avoid use. |
| Pediatric use | Not recommended for pediatric use due to risk of premature epiphyseal closure and virilization. |
| Geriatric use | Use lowest effective dose (e.g., 2 mg daily) due to increased risk of fluid retention, prostatic hypertrophy, and hepatotoxicity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MAXIBOLIN (MAXIBOLIN).
| Breastfeeding | Excretion into breast milk unknown; likely present. M/P ratio not available. Contraindicated during lactation due to potential virilizing effects on the infant and suppression of lactation. |
| Teratogenic Risk | MAXIBOLIN (oxandrolone) is an anabolic-androgenic steroid (AAS) classified as Category X in pregnancy. Teratogenic effects include virilization of female fetuses (clitoromegaly, labial fusion, urogenital sinus abnormalities) and potential for growth restriction. Avoid in all trimesters due to documented adverse fetal outcomes. |
■ FDA Black Box Warning
Anabolic steroids can cause serious cardiovascular and hepatic adverse effects. Peliosis hepatis, hepatocellular carcinoma, and lipid abnormalities have been reported. Prolonged use increases risk of atherosclerosis and myocardial infarction.
| Serious Effects |
Hypersensitivity to any component, prostate or breast carcinoma in males, breast carcinoma in females, hypercalcemia, nephrotic syndrome, severe cardiac or hepatic disease, pregnancy, and lactation.
| Precautions | Monitor liver function, lipid profile, and cardiac status. Use caution in patients with pre-existing cardiac, renal, or hepatic disease. May cause virilization in women, priapism, and gynecomastia in men. Avoid in children due to premature epiphyseal closure. |
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| Fetal Monitoring |
| Pregnancy testing before initiation; monitor for maternal hepatotoxicity (LFTs), lipid profile (HDL suppression), glucose intolerance, signs of virilization (acne, hirsutism, voice deepening). Fetal ultrasound for growth and genital development if exposure occurs. |
| Fertility Effects | May impair fertility in males (oligospermia, azoospermia) and females (anovulation, menstrual irregularities) via disruption of HPG axis. Effects may be reversible upon drug discontinuation. |