|
Testosterone Pellets & Implantation Page 2 Welcome to Marty's Endo Page: Devoted to Testosterone Implants*
*As with all Hormone Replacement therapies (HRT) contact your physician about the most appropriate treatment protocol possible. Testopel® (Bartor Pharmacal) is one of the only available kinds of Testosterone Pellet in the US at this time. Dr. Charles Vincent was one of five physicians in the USA selected to complete a study of the effectiveness of hormone pellet therapy for the FDA and Bartor Pharmacal. His professional memberships include the American College of OB/GYN, MSMA, American College of Surgeons and the North American Menopause Society. In 1976, Dr. Vincent was appointed Clinical Professor of Gynecology at LSU. All in all Testosterone Implants have been around for about 60 years, but many doctors shy away from it because it is a long term dose. But now with all the research being brought forth, it is once again in the spotlight. Doctors are once again taking a look at this type of therapy because of its cost effectiveness and ease of use. Company Name: Bartor Pharmacal Co. Contact Information: Fax: 914-967-4056 Fax them with a desire to find out about their Prescribing information, and they will send you a packet. Also, they answer the phone LIVE! So it isn't a huge pharmaceutical company, lol. But unfortunately they need some written proof that you want the information, so you have to fax to find out the info… Which I have done and here it is: Prescribing Information Prescribing Information Back Side Letter From Bartor Pharmacal Co.
College Pharmacy compounds their own Testosterone Pellets in the amounts of 75 mg, 100 mg, and 200 mg. Pellets are small, sterile cylinders which are formed by compression from medicated powders. They are implanted subcutaneously and can be used whenever a prolonged continuous absorption of hormones is desired. Patients receiving the pellet implants enjoy the convenience of not having to worry about daily dosing normally associated with other delivery systems. The primary disadvantage to patients is that they require a regular scheduling with their caregiver for implantation. Contact Information: College Pharmacy Phone: 1 - 800 - 888 - 9358 or 719 - 262 - 0022 Fax: 1 - 800 - 556 - 5893 or 719 - 262 - 0035 E-mail: info@collegepharmacy.com
Implants are placed subdermally in the lower abdominal wall lateral to the umbilicus under clean conditions for routine minor office surgery. The skin is cleaned with alcohol, the incision site draped and the intended tracks are infiltrated with 2% xylocaine. A 2-cm incision is made through anaesthetized skin and tracks are created subdermally by advancing the trochar to its hilt. The pellets are then delivered, via the wide-bore cannula, each to the end of one track. Following implantation, manual pressure is applied over the incision site until any bleeding ceases and the incision site is covered with sterile adhesive strips and a transparent waterproof dressing for 1 week. The Wash Procedure The wash procedure developed for testosterone pellets prior to implantation, which aims to remove potentially surface-adherent particles, does not decrease the pellet extrusion rate. The two main alternative explanations are that either such particles are not involved in extrusion - they are not present or if present, not irritating - or the particles do determine subsequent extrusion but were not successfully removed by the wash procedure. It is difficult to fully exclude the latter possibility as, due to the cost of implants, systematic surveys were not undertaken to determine the rate of particle adherence to the implants or to assess how consistently the wash procedure removed the particles.
Extrusions Extrusion occurs when a pellet is expelled usually by tracking back along the insertion track to exit via the original insertion site. Extrusions are wasteful, uncomfortable to the patient, may lead doctors to suspect an infection and compromise testosterone delivery so as to require earlier re-implantation. The pathophysiology of extrusion is unknown. Features of pellet extrusions include: (a) being characteristically delayed with an average latency of 2 months after implantation; (b) multiple extrusions are more frequent and single extrusion less frequent than expected by chance; and (c) increased habitual physical activity at work and at leisure were predictors of extrusion ( Handelsman et al., 1997). The non-independence of extrusions events and the fact that all patients appeared to be at similar risk suggest that extrusions were determined by factors inherent in the implantation procedure or the implants themselves. Testosterone implants are packaged in glass vials containing sterile cotton wool. Microscopic surveillance of unused implants suggested that fragments of the packaging materials might be adherent to the implants. As glass fragments or cotton-wool fibres can be irritating and could potentially establish a foreign body reaction, the present study was based on the premise that extrusion of implants may be related to surface-adherent particles causing a sterile inflammation like a foreign body reaction. It was hypothesized that the removal of these particles through a washing procedure may decrease the extrusion rate.It remains unclear whether extrusion (when the pellet comes out) is primarily related to the procedure or to some property of the pellets. Extrusion was unrelated to any of the four experienced operators, although it is well known that extrusion is more frequent when implantation is performed by inexperienced operators. Overall, the evidence does not support any suggestion that extrusion is primarily determined by the pellet and/or procedure itself. On the contrary, the absence of any predilection among production batches argues against the possibility of factors related to pellet manufacture. Previously, the only predictors of extrusion identified in the retrospective survey were habitually increased physical activity at work and/or leisure ( Handelsman et al., 1997). The present study identifies that infection may predispose to subsequent early extrusion(s). Among the 10 men who had an infection requiring antibiotics following their implantation, six subsequently underwent one or more extrusions with a mean latency of 5.1 weeks (median 4 weeks). This time interval is significantly shorter than the latency to extrusion in men experiencing an extrusion without evidence of overt infection (median 9 weeks). The latter, larger group may, however, have a more indolent infective process due to organisms of low-grade pathogenicity.
Dosing Testosterone ester injections administered in an oily vehicle remains the most widely used testosterone formulation for androgen replacement therapy in clinical practice. Comparative clinical trials have demonstrated however that the durability and stability of androgenic effects after testosterone pellet implants are much preferable by patients who have experienced the alternatives. Given the calculated testosterone release rates it is possible with various pellet combinations to readily produce daily testosterone release rates of 0.75-9 mg/day in increments of 0.75 mg/day using the two available pellet sizes. Thus the normal testosterone production rate of 3-9 mg/day can be reproduced by a single implant of two to six pellets (400-1200 mg) which will last for between 4 and 6 months. Testopel® (Bartor Pharmacal) sugests that you take 75 mg for every 25 mg you take weekly. So if you are on a 250 mg dose every two weeks, it is usually necessary to implant 450 mg (6 pellets).
History of Androgen Therapy Since testosterone was first used clinically more that six decades ago ( Deansley & Parkes, 1937; Hamilton, 1937), numerous modalities for testosterone replacement have been developed (Nieschlag & Behre, 1998). These are designed to overcome the pharmacological limitations of testosterone as a therapeutic drug, namely its very low oral bioavailability and short half-life in the bloodstream. These features led to the pharmaceutical development of oral androgens as well as parenteral, depot formulations. Over the last few decades, intramuscularly injectable testosterone esters in vegetable oil formulations have been the mainstay of androgen replacement therapy. The limitations of life-long testosterone replacement with injectable, oral and transdermal formulations, including excessively frequent administration or painful injections with wide fluctuations in circulating testosterone concentrations (Mackey et al., 1995), have prompted continued searching for better tolerated modalities of testosterone delivery. Novel developments include newer testosterone formulations such as testosterone buciclate (Behre & Nieschlag, 1992), testosterone microspheres (Bhasin et al., 1992), and sublingual testosterone cyclodextrin complex (Stuenkel et al., 1991). In addition, depot testosterone implants have undergone a resurgence of popularity within the last decade (Nieschlag, 1996). Testosterone implants are a well accepted modality of androgen replacement therapy as indicated by high continuation rates during treatment (Handelsman et al., 1997). A retrospective review of nearly 1000 consecutive implantation procedures indicated very few adverse effects (minor infection 2.3%, bleeding 0.8%) apart from pellet extrusion (8.5%).
Medline Citations
|