What is the maximum recommended weekly dose of testosterone (intramuscular) for adult males with hypogonadism?

Maximum Weekly Dose of Intramuscular Testosterone for Adult Male Hypogonadism

The FDA-approved maximum dose for testosterone cypionate is 400 mg every 2-4 weeks, which translates to approximately 100-200 mg weekly when divided into more frequent administrations; exceeding 200 mg weekly is not recommended as it increases risk of supraphysiologic levels and adverse effects including erythrocytosis. 1

FDA-Approved Dosing Parameters

• The official FDA labeling for testosterone cypionate specifies a dosage range of 50-400 mg administered every 2-4 weeks for hypogonadal males 1
• When converted to weekly administration, this equates to a practical maximum of 100-200 mg per week 2, 3
• Doses of 600 mg weekly have been studied in research settings but are considered well into the supraphysiologic range and are associated with significant HDL reduction 4

Evidence-Based Optimal Dosing

• The most effective regimen for maintaining physiologic testosterone levels is 200 mg every 2 weeks, which effectively suppresses elevated LH and FSH to normal range while keeping serum testosterone within physiologic levels 2, 5
• Weekly dosing of 50-100 mg provides more stable serum testosterone levels compared to biweekly administration and is the preferred approach 3
• The 200 mg every 2 weeks and 300 mg every 3 weeks regimens demonstrated superior efficacy in suppressing LH to normal levels compared to 400 mg every 4 weeks 5

Target Testosterone Levels and Monitoring

• Target serum testosterone should be maintained in the mid-normal range of 450-600 ng/dL (or 500-600 ng/dL per some guidelines) 2, 3
• For injectable formulations, testosterone levels should be measured midway between injections at 2-3 months after initiation, then every 6-12 months once stable 2, 6, 3
• Peak testosterone occurs 2-5 days after injection with return to baseline by days 10-14 6

Critical Safety Thresholds

• Doses exceeding 200 mg weekly significantly increase the risk of erythrocytosis, particularly with intramuscular formulations 2, 3
• Hematocrit must be monitored regularly, and therapy should be withheld if hematocrit exceeds 54% 2, 6
• Only the 600 mg weekly dose (supraphysiologic range) was associated with significant HDL reduction in controlled studies 4

Common Pitfalls to Avoid

• Do not prescribe doses exceeding 200 mg weekly as this increases time spent in supraphysiologic ranges, elevating cardiovascular risk and erythrocytosis 2, 3
• Do not use 400 mg every 4 weeks as this regimen fails to adequately suppress LH to normal levels and produces excessive peak-to-trough fluctuations 5
• Do not initiate therapy without confirming two separate morning testosterone measurements below 300 ng/dL along with hypogonadal symptoms 2, 6
• Injectable testosterone carries higher cardiovascular risk than transdermal preparations due to fluctuating levels that result in periods of both supraphysiologic and subtherapeutic concentrations 2, 3

Practical Dosing Algorithm

• Start with 50-100 mg weekly (or 100-200 mg every 2 weeks) for most patients 3, 1
• Measure testosterone levels at 2-3 months, targeting mid-normal values of 500-600 ng/dL 3
• Adjust dose in 25-50 mg increments based on laboratory results and clinical response 3
• Maximum practical dose: 200 mg weekly (or 400 mg every 2 weeks), beyond which risks outweigh benefits 1
• Monitor hematocrit, PSA, and cardiovascular risk factors regularly 2, 6, 3