Ik but some got recalled for batch errors
Testostone levels declining with injections
- Thread starter Kettlebells
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madman
Super Moderator
This was the most recent recall.
Sun Pharma recalls 36,275 cartons of testosterone injection in US
As per the USFDA report, the affected lot of the intramuscular injections was manufactured by the drug maker in India and distributed in the US by Princeton, New Jersey-based Sun Pharmaceutical Industries Inc.
www.businesstoday.in
Pharma major Sun Pharmaceutical Industries is recalling 36,275 cartons of a drug used to treat low testosterone levels in the US market for incorrect labeling. The Testosterone Cypionate Injection is being recalled in the American market by the US arm of Sun Pharma, as per the latest enforcement report of the US Food and Drug Administration. The company started the nationwide recall on January 11, 2021.
Sun Pharma recalls testosterone injection in the US for labelling error
Companies News:Sun Pharma recalls testosterone injection in the US for labelling error
Elaborating on the reasons for the Class III recall, the USFDA said: "Incorrect Labelling: Incorrect lot number on secondary packaging." As per the USFDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".
The company initiated the nationwide recall on January 11, 2021.
madman
Super Moderator
Indeed.
Depending on the immunoassay used let alone dosage of biotin (high doses).
Competitive immunoassay is used for testosterone:
*In competitive immunoassays, excessive biotin is likely to produce a falsely high result
The OP was hitting an absurdly low TT 249 ng/dL 2 days post-injection using (100 mg esterified T).
Impact of Biotin on Immunoassays
An excess biotin intake may adversely affect immunoassays in two different ways:- In competitive immunoassays, excessive biotin is likely to produce a falsely high result;
- In immunometric, or sandwich assays, it may result in false low results.
ivankonst2017
Member
From my experience I see two things that can be causing this. Either you are doing sub q and your absorbtion has dropped(happened to me), or your SHBG was crashed and now you excrete test more quickly.
if I were you I would test total t at peak and trough and split that dose in two and inject it IM. With IM injections you will eliminate one variable(I say that in case you are doing sub q now)
if I were you I would test total t at peak and trough and split that dose in two and inject it IM. With IM injections you will eliminate one variable(I say that in case you are doing sub q now)
Neither scenario is plausible. The available research says that absorption of subcutaneous injections matches that of IM injections, and both are close to 100%. SHBG cannot control the rate of excretion of testosterone. That rate is limited by the rate of absorption; with exogenous testosterone you can't excrete it any faster than you put it in.
Kettlebells
Member
The brand is Cipla, which I believe is an Indian generic manufacturer.
Anyway, my doctor decided to adjust my dosage and retest. I was on a higher dosage and doing well blood test-wise, but I was having issues with my blood pressure that turned out to be unrelated to testosterone, so I scaled my dose down. I probably would do as well with a twice a week protocol on a lower dosage. I am open to that as well, but I am not open to injecting every day. I worked really hard a few years back to lose the weight necessary to come off of an injectable diabetes medicine, so I would not have to inject everyday.
Kettlebells
Member
My girlfriend is an RN. She injects me IM into my glutes, alternating sides.
Kettlebells
Member
Testostorone manufacturers do have recalls. Cipla had a recall in 2019.
Dr Reddy's, Cipla arm recall drugs in US market
Dr Reddy's, Cipla arm recall drugs in US market
Last edited:
ivankonst2017
Member
For the SHBG it is a theory Ive heard from some doctors, but I hope it is wrong and you are right.
However for IM and sub q allow me to disagree.
Ive seen this studies but I dont think they sample large enough sample.
On the same dose of 160 per week, both EOD, same ester, 8 weeks each protocol - on sub q my test levels were 700ng/dl, on IM - 1500ng/dl(both tested on trough)
Low SHBG is a problem, but for other reasons. It can result in a higher ratio of free estradiol to free testosterone at the same dose, and it may also lead to inefficient utilization of testosterone. It can result in lower total testosterone at the same dose, but not due to a greater excretion rate.
You and another guy on here have reported some unusual results when comparing IM and SC injections. It's hard to know what's happening without detailed measurements under more controlled conditions. The research studies, such as the one for Xyosted, take enough samples to verify that areas under the curves are similar between the different injection methods. The sample size for the Xyosted study isn't huge, but it's still enough to be far more compelling than scattered anecdotes. In particular there were 29 in the SC arm and 10 in the IM arm.[R]
ivankonst2017
Member
For the described case I was using sustanon, ive heard it is not good for sub q but initially when I started it was absorbing well. I guess the build up of nodules may have influenced that but ever since I wouldnt like to try sub q. And believe me I dont enjoy doing IM injections at all, - it is more painful, scar tissue, bigger needle and so on. But I like to have steady absorption and my blood levels to correspond to my dose.
A friend of mine here on 200mg enanthate split in two - on sub q he was getting 1000ng/dl, IM - 1500+. Both two days after injection. Also since he started IM he feels much better, better libido and so on.
Differing isolated measurements like this can often be explained by the differing absorption rates. SC is slower, which mutes the peaks and valleys compared to IM. But the average hormone levels end up similar at the same dose.
madman
Super Moderator
Unless you tested at the same lab using the same assay (most accurate) TT (LC/MS-MS) and FT (Equilibrium Dialysis or Ultrafiltration) then I would still have my doubts!
post# 5 and beyond
Anyone inject inner thigh? Getting Muscle Spasms (daily injector)
I am a daily injector (29 gauge 1/2 inch) I was injecting outer thigh shallow IM for a while, concerned about scar tissue moved over to inner thigh (which is more fatty). Has worked well so far, but had the expect increase in E2 and decrease in TT as most see with a move to sub-q, though it is...
www.excelmale.com
My reply:
This is far from common and even then unless those same individuals have kept everything consistent such as protocol (dose T/injection frequency), same ester, waiting the full 4-6 weeks for levels to stabilize, testing at the true trough, using the same lab, same assay (most accurate) when comparing lab results for TT/FT between sub-q vs IM than I would have my doubts.
Trust me when I tell you that some of these same individuals making such claims as poor absorption/lower T levels have slipped up on one of the points stated above.
For the majority, there should be no difference in the absorption let alone the effectiveness when injecting exogenous esterified testosterone subcutaneously.
madman
Super Moderator
Methods: From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT>54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis.
*This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics
Sub-q Testosterone Autoinjector is a safe and effective alternative method for TRT
Introduction: Xyosted® is a subcutaneous testosterone enanthate-autoinjector (SCTE-AI) which was approved by the Food and Drug Administration in 2018 for patient-administered weekly testosterone replacement therapy (TRT). Objective: This is the largest non-industry sponsored post-market study...
www.excelmale.com
ivankonst2017
Member
Unless you tested at the same lab using the same assay (most accurate) TT (LC/MS-MS) and FT (Equilibrium Dialysis or Ultrafiltration) then I would still have my doubts!
post# 5 and beyond
Anyone inject inner thigh? Getting Muscle Spasms (daily injector)
I am a daily injector (29 gauge 1/2 inch) I was injecting outer thigh shallow IM for a while, concerned about scar tissue moved over to inner thigh (which is more fatty). Has worked well so far, but had the expect increase in E2 and decrease in TT as most see with a move to sub-q, though it is...
My reply:
This is far from common and even then unless those same individuals have kept everything consistent such as protocol (dose T/injection frequency), same ester, waiting the full 4-6 weeks for levels to stabilize, testing at the true trough, using the same lab, same assay (most accurate) when comparing lab results for TT/FT between sub-q vs IM than I would have my doubts.
Trust me when I tell you that some of these same individuals making such claims as poor absorption/lower T levels have slipped up on one of the points stated above.
For the majority, there should be no difference in the absorption let alone the effectiveness when injecting exogenous esterified testosterone subcutaneously.
I dont wanna argue, but just share my experience. I havent come to the forum for arguing, but seeking help so please dont accept my opinion as trying to get into a debate.
I always use the same lab, ever since before starting TRT trying to fix my hormones naturally. They are the most consistent lab in my country and never had produced doubtful results for me.
Also when I was at the same dose at sub q I felt totally different compared to the IM case I described. On sub q I felt like NOT on TRT when I got 700ng/dl. On IM I felt like I was suppose to feel on TRT- mood, confidence, libido etc.
For both measurements I waited 8 weeks, because I was using sustanon and it has longer half life than cypionate. I used the same batch of testosterone, even the first 2 weeks on the IM case I used the same vial of testosterone with which I tested 700 on sub q.
I talk about total t only, not free t.
My friend who reported similar experience also used the same lab for both cases, but he was using enanthate in both cases, not sustanon. Now on IM he not only has higher levels, but feels way better.
Ive read other such reports on reddit, people claim they dont get same levels on sub q, or they get the same levels but dont feel the effects of TRT so potently. Based on my subjective experience I trust them.
One last note - seems the guy above in the links talks about shallow IM with 29g, Im doing only deep IM with 3/4 or 1 inch needle.
madman
Super Moderator
Sure some may not do well on sub-q but it would be far from common and even then I would bet a majority of these same individuals are not following all the critical steps need to truly gauge the effectiveness of sub-q vs IM..... kept everything consistent such as protocol (dose T/injection frequency), same ester, waiting the full 4-6 weeks for levels to stabilize, testing at the true trough, using the same lab, same assay (most accurate) when comparing lab results for TT/FT.
Let alone I hope you understand hormones are in flux during the weeks leading up until blood levels have stabilized (4-6 weeks) and it is common to experience ups/downs during the transition as the body is trying to adjust.
Even then once blood levels have stabilized will take another 2-3 months for the body to adapt to those new levels and this is the critical time period when one should gauge how they truly feel overall regarding relief/improvement of low-t symptoms/overall well-being.
Otherwise one could not truly claim such (sub-q is inferior to IM)!
madman
Super Moderator
post #3
www.excelmale.com
26.What is a reasonable timeline to begin to observe improvements in the signs and symptoms of testosterone deficiency?
*Following the initiation of testosterone therapy, serum concentrations of testosterone are known to correct earlier than the symptomatic, structural, and metabolic signs associated with TD.76,77 As such, patients should be counseled that symptom response will not be immediate. Expectations for treatment response should be established with each patient. Patients can anticipate improvements in many of the common symptoms of TD (libido, energy levels, sexual function) after 3 months of treatment or longer. Metabolic and structural (body composition, muscle mass, bone density) changes may take upwards of 6-months. 77 In addition, patients should be counseled that diet and exercise in combination with testosterone therapy are recommended for body composition changes.
*Appreciating this pattern of response to testosterone therapy is fundamental when determining the impact of treatment and the appropriate timing of follow-up evaluations while on therapy. For example, if patients undergo a symptom review and measurement of testosterone levels too early (< 3 months), it may lead both physicians and patients to conclude that the treatment has not been impactful (i.e. normal levels of testosterone without symptomatic/structural/metabolic benefit). However, if the same assessment was scheduled 3-6 months after the initiation of therapy, the clinical response tends to be more reflective of normalized levels of serum testosterone.
Canadian Urology Guideline on Testosterone Replacement
Canadian Urological Association clinical practice guideline on testosterone deficiency in men: Evidence-based Q&A (2021) Ethan D. Grober, MD; Yonah Krakowsky, MD; Mohit Khera, MD; Daniel T. Holmes, MD; Jay C. Lee, MD; John E. Grantmyre, MD; Premal Patel, MD; Richard A. Bebb, MD; Ryan...
www.excelmale.com
26.What is a reasonable timeline to begin to observe improvements in the signs and symptoms of testosterone deficiency?
*Following the initiation of testosterone therapy, serum concentrations of testosterone are known to correct earlier than the symptomatic, structural, and metabolic signs associated with TD.76,77 As such, patients should be counseled that symptom response will not be immediate. Expectations for treatment response should be established with each patient. Patients can anticipate improvements in many of the common symptoms of TD (libido, energy levels, sexual function) after 3 months of treatment or longer. Metabolic and structural (body composition, muscle mass, bone density) changes may take upwards of 6-months. 77 In addition, patients should be counseled that diet and exercise in combination with testosterone therapy are recommended for body composition changes.
*Appreciating this pattern of response to testosterone therapy is fundamental when determining the impact of treatment and the appropriate timing of follow-up evaluations while on therapy. For example, if patients undergo a symptom review and measurement of testosterone levels too early (< 3 months), it may lead both physicians and patients to conclude that the treatment has not been impactful (i.e. normal levels of testosterone without symptomatic/structural/metabolic benefit). However, if the same assessment was scheduled 3-6 months after the initiation of therapy, the clinical response tends to be more reflective of normalized levels of serum testosterone.
Did you ever get an update on the bloodwork? Also do you know if your vial was a 10ml dark vial or possibly the lot number? I think hikma manufactures for Cipla
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