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Luoping Zhang PhD, MS

• Adjunct Professor, Toxicology

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Ideally symptoms 0f parkinson disease order septra with a visa, treatment decisions should be made among the adolescent medicine song generic septra 480mg with visa, the family medicine 20 purchase discount septra, and the treatment team medications similar to vyvanse generic 480 mg septra free shipping. Regimens for hormone therapy in gender dysphoric adolescents differ substantially from those used in adults (Hembree et al medications in carry on luggage septra 480 mg for sale. The hormone regimens for youth are adapted to account for the somatic medicinenetcom discount septra 480mg with visa, emotional, and mental development that occurs throughout adolescence (Hembree et al. The age threshold should be seen as a minimum criterion and not an indication in and of itself for active intervention. Chest surgery in FtM patients could be carried out earlier, preferably after ample time of living in the desired gender role and after one year of testosterone treatment. The intent of this suggested sequence is to give adolescents suffcient opportunity to experience and socially adjust in a more masculine gender role, before undergoing irreversible surgery. Risks of Withholding Medical Treatment for Adolescents Refusing timely medical interventions for adolescents might prolong gender dysphoria and contribute to an appearance that could provoke abuse and stigmatization. As the level of gender-related abuse is strongly associated with the degree of psychiatric distress during adolescence (Nuttbrock et al. World Professional Association for Transgender Health 21 the Standards of Care 7th Version Competency of Mental Health Professionals Working with Adults Who Present with Gender Dysphoria the training of mental health professionals competent to work with gender dysphoric adults rests upon basic general clinical competence in the assessment, diagnosis, and treatment of mental health concerns. Clinical training may occur within any discipline that prepares mental health professionals for clinical practice, such as psychology, psychiatry, social work, mental health counseling, marriage and family therapy, nursing, or family medicine with specifc training in behavioral health and counseling. The following are recommended minimum credentials for mental health professionals who work with adults presenting with gender dysphoria: 1. This degree or a more advanced one should be granted by an institution accredited by the appropriate national or re gional accrediting board. The mental health professional should have documented credentials from a relevant licensing board or equivalent for that country. Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the Interna tional Classifcation of Diseases for diagnostic purposes. Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria. Knowledgeable about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria. This may include attending relevant professional meetings, workshops, or seminars; obtaining supervision from a mental health professional with relevant experience; or participating in research related to gender nonconformity and gender dysphoria. In addition to the minimum credentials above, it is recommended that mental health professionals develop and maintain cultural competence to facilitate their work with transsexual, transgender, and gender nonconforming clients. This may involve, for example, becoming knowledgeable about current community, advocacy, and public policy issues relevant to these clients and their families. Additionally, knowledge about sexuality, sexual health concerns, and the assessment and treatment of sexual disorders is preferred. For example, mental health professionals may serve as a psychotherapist, counselor, or family therapist, or as a diagnostician/assessor, advocate, or educator. For example, a client may be presenting for any combination of the following health care services: psychotherapeutic assistance to explore gender identity and expression or to facilitate a coming out process; assessment and referral for feminizing/masculinizing medical interventions; psychological support for family members (partners, children, extended family); or psychotherapy unrelated to gender concerns or other professional services. Below are general guidelines for common tasks that mental health professionals may fulfll in working with adults who present with gender dysphoria. The evaluation includes, at a minimum, assessment of gender identity and gender dysphoria, history and development of gender dysphoric feelings, the impact of stigma attached to gender nonconformity on mental health, and the availability of support from family, friends, and peers (for example, in person or online contact with other transsexual, transgender, or gender nonconforming individuals or groups). The role World Professional Association for Transgender Health 23 the Standards of Care 7th Version of mental health professionals includes making reasonably sure that the gender dysphoria is not secondary to or better accounted for by other diagnoses. Mental health professionals with the competencies described above (hereafter called a qualifed mental health professional) are best prepared to conduct this assessment of gender dysphoria. However, this task may instead be conducted by another type of health professional who has appropriate training in behavioral health and is competent in the assessment of gender dysphoria, particularly when functioning as part of a multidisciplinary specialty team that provides access to feminizing/masculinizing hormone therapy. Provide information regarding options for gender identity and expression and possible medical interventions An important task of mental health professionals is to educate clients regarding the diversity of gender identities and expressions and the various options available to alleviate gender dysphoria. Mental health professionals then may facilitate a process (or refer elsewhere) in which clients explore these various options, with the goals of fnding a comfortable gender role and expression and becoming prepared to make a fully informed decision about available medical interventions, if needed. This process may include referral for individual, family, and group therapy and/or to community resources and avenues for peer support. The professional and the client discuss the implications, both short and long-term, of any changes in gender role and use of medical interventions. These implications can be psychological, social, physical, sexual, occupational, fnancial, and legal (Bockting et al. This task is also best conducted by a qualifed mental health professional, but may be conducted by another health professional with appropriate training in behavioral health and with suffcient knowledge about gender nonconforming identities and expressions and about possible medical interventions for gender dysphoria, particularly when functioning as part of a multidisciplinary specialty team that provides access to feminizing/masculinizing hormone therapy. Assess, diagnose, and discuss treatment options for co-existing mental health concerns Clients presenting with gender dysphoria may struggle with a range of mental health concerns (Gomez-Gil, Trilla, Salamero, Godas, & Valdes, 2009; Murad et al. Possible concerns include anxiety, depression, self-harm, a history of abuse and neglect, compulsivity, substance abuse, sexual concerns, personality disorders, eating disorders, psychotic disorders, and autistic spectrum disorders (Bockting et al. Mental health professionals should screen for these and other mental health concerns and incorporate 24 World Professional Association for Transgender Health the Standards of Care 7th Version the identifed concerns into the overall treatment plan. These concerns can be signifcant sources of distress and, if left untreated, can complicate the process of gender identity exploration and resolution of gender dysphoria (Bockting et al. Addressing these concerns can greatly facilitate the resolution of gender dysphoria, possible changes in gender role, the making of informed decisions about medical interventions, and improvements in quality of life. Some clients may beneft from psychotropic medications to alleviate symptoms or treat co existing mental health concerns. Mental health professionals are expected to recognize this and either provide pharmacotherapy or refer to a colleague who is qualifed to do so. The presence of co-existing mental health concerns does not necessarily preclude possible changes in gender role or access to feminizing/masculinizing hormones or surgery; rather, these concerns need to be optimally managed prior to or concurrent with treatment of gender dysphoria. In addition, clients should be assessed for their ability to provide educated and informed consent for medical treatments. Qualifed mental health professionals are specifcally trained to assess, diagnose, and treat (or refer to treatment for) these co-existing mental health concerns. Other health professionals with appropriate training in behavioral health, particularly when functioning as part of a multidisciplinary specialty team providing access to feminizing/masculinizing hormone therapy, may also screen for mental health concerns and, if indicated, provide referral for comprehensive assessment and treatment by a qualifed mental health professional. Mental health professionals can help clients who are considering hormone therapy to be both psychologically prepared (for example, has made a fully informed decision with clear and realistic expectations; is ready to receive the service in line with the overall treatment plan; has included family and community as appropriate) and practically prepared (for example, has been evaluated by a physician to rule out or address medical contraindications to hormone use; has considered the psychosocial implications). However, mental health professionals have a responsibility to encourage, guide, and assist clients with making fully informed decisions and becoming adequately prepared. World Professional Association for Transgender Health 25 the Standards of Care 7th Version Referral for feminizing/masculinizing hormone therapy People may approach a specialized provider in any discipline to pursue feminizing/masculinizing hormone therapy. Hormone therapy can be initiated with a referral from a qualifed mental health professional. Alternatively, a health professional who is appropriately trained in behavioral health and competent in the assessment of gender dysphoria may assess eligibility, prepare, and refer the patient for hormone therapy, particularly in the absence of signifcant co-existing mental health concerns and when working in the context of a multidisciplinary specialty team. Health professionals who recommend hormone therapy share the ethical and legal responsibility for that decision with the physician who provides the service. The recommended content of the referral letter for feminizing/masculinizing hormone therapy is as follows: 1. A statement about the fact that informed consent has been obtained from the patient; 6. A statement that the referring health professional is available for coordination of care and wel comes a phone call to establish this. Mental health professionals can help clients who are considering surgery to be both psychologically prepared (for example, has made a fully informed 26 World Professional Association for Transgender Health the Standards of Care 7th Version decision with clear and realistic expectations; is ready to receive the service in line with the overall treatment plan; has included family and community as appropriate) and practically prepared (for example, has made an informed choice about a surgeon to perform the procedure; has arranged aftercare). Clients should receive prompt and attentive evaluation, with the goal of alleviating their gender dysphoria and providing them with appropriate medical services. Referral for surgery Surgical treatments for gender dysphoria can be initiated with a referral (one or two, depending on the type of surgery) from a qualifed mental health professional. Mental health professionals who recommend surgery share the ethical and legal responsibility for that decision with the surgeon. Each referral letter, however, is expected to cover the same topics in the areas outlined below. A statement that the mental health professional is available for coordination of care and wel comes a phone call to establish this. Open and consistent communication may be necessary for consultation, referral, and management of postoperative concerns. Psychotherapy is not an absolute requirement for hormone therapy and surgery A mental health screening and/or assessment as outlined above is needed for referral to hormonal and surgical treatments for gender dysphoria. First, a minimum number of sessions tends to be construed as a hurdle, which discourages the genuine opportunity for personal growth. Third, clients differ in their abilities to attain similar goals in a specifed time period. Typically, the overarching treatment goal is to help transsexual, transgender, and gender nonconforming individuals achieve long-term comfort in their gender identity expression, with realistic chances for success in their relationships, education, and work. Therapy may consist of individual, couple, family, or group psychotherapy, the latter being particularly important to foster peer support. Psychotherapy for transsexual, transgender, and gender nonconforming clients, including counseling and support for changes in gender role Finding a comfortable gender role is, frst and foremost, a psychosocial process. Mental health professionals can provide support and promote interpersonal skills and resilience in individuals and their families as they navigate a world that often is ill prepared to accommodate and respect transgender, transsexual, and gender nonconforming people. Psychotherapy can also aid in alleviating any co-existing mental health concerns. For transsexual, transgender, and gender nonconforming individuals who plan to change gender roles permanently and make a social gender role transition, mental health professionals can facilitate the development of an individualized plan with specifc goals and timelines. Because changing World Professional Association for Transgender Health 29 the Standards of Care 7th Version gender role can have profound personal and social consequences, the decision to do so should include an awareness of what the familial, interpersonal, educational, vocational, economic, and legal challenges are likely to be, so that people can function successfully in their gender role. Many transsexual, transgender, and gender nonconforming people will present for care without ever having been related to or accepted in the gender role that is most congruent with their gender identity. Mental health professionals can help these clients to explore and anticipate the implications of changes in gender role, and to pace the process of implementing these changes.

Blepharoplasty Blepharoplasty is surgical repair of drooping eyelids by removing excess skin symptoms meningitis cheap septra 480mg overnight delivery, muscle and fat medicine song 480 mg septra otc. Select Public Information for Providers medications beta blockers order septra 480mg otc, Provider Support and then select Provider Handbooks medications diabetic neuropathy cheap septra 480 mg visa. Computerized Medicaid reimburses computerized corneal topography up to a maximum of Corneal Topography four times per year medications 5113 buy 480mg septra visa, per recipient holistic medicine order 480 mg septra amex. Refractions Refractions are reimbursable to physicians with an ophthalmology specialty. Medicaid will reimburse two medically necessary refractions in 365 days, per recipient. Providers with ophthalmology specialty should also enroll in the Medicaid Optometric and Visual Services Programs to bill for services related to the provision, fitting, dispensing and adjusting of corrective lenses. Note: See the Florida Medicaid Optometric Services Coverage and Limitations Handbook for additional information. December 2012 2-77 Practitioner Services Coverage and Limitations Handbook Ophthalmological Services, continued Lacrimal Punctum Medicaid reimburses for medically-necessary lacrimal punctum plugs. Reimbursement Temporary lacrimal punctum plugs are limited to 12 per year (maximum of Limitations four plugs every four months), for procedure code 68761, for treatment of dry eye syndrome when a more permanent conservative treatment will cause discomfort to the recipient. Procedure code 68761, (closure of lacrimal punctum by plug, each), includes reimbursement for plugs; therefore, the plug may not be billed separately. Service Exclusions A routine eye exam in the absence of a reported vision problem, an illness, disease, or injury is not reimbursable. MediPass Ophthalmologists are not required to obtain MediPass authorization, except Authorization for prosthetic eye services. Exemption Oral And Maxillofacial Services Description Oral and maxillofacial services are medically necessary services provided by a physician or oral surgeon for the treatment of disease or injury to the jaw or any structure contiguous to the jaw and the reduction of any fracture of the jaw or facial bone. Covered Medicaid enrolled dentists who are also enrolled with a specialty in oral surgery Procedures may be reimbursed for specific radiology and evaluation and management procedure codes. In addition, dentists who are enrolled with a specialty in oral surgery may be reimbursed for the surgical procedures codes listed on the Oral and Maxillofacial Surgery Fee Schedule. Note: See the Florida Medicaid Dental Services Coverage and Limitations Handbook for additional information. Acceptance for transplant candidacy is determined by the designated transplant hospital performing the comprehensive evaluation. Reimbursement of Medicaid-covered organ or tissue transplants is limited to those services that are determined to be reasonable, medically necessary, and be standard medical procedures. Bone Marrow, Cord Medicaid considers cord blood and stem cell transplants as synonymous with Blood, and Stem bone marrow transplants. For the purposes of reimbursement under Medicaid, Cell Transplants these transplants utilize the same illnesses, diagnoses, conditions, and disease states for which bone marrow transplant procedures are acceptable. Medicaid does review individual cases within the guidelines of the Organ Transplant Advisory Council and the Bone Marrow Advisory Panel when medically indicated. Age 20 and Under For recipients age 20 years and younger, Medicaid covers transplants that are medically necessary and appropriate as determined by the Medicaid medical consultant; and the Bone Marrow Advisory Panel or the Organ Transplant Advisory Council. Age 21 and Over For recipients age 21 years and older, Medicaid covers cornea, heart, intestine, liver, lung, multivisceral, pancreas, and bone marrow transplants that are medically necessary and determined appropriate by the Medicaid medical consultant; and the Bone Marrow Advisory Panel or the Organ Transplant Advisory Council. See the Florida Medicaid Provider General Handbook for a list of area Medicaid office telephone numbers. The comprehensive transplant evaluation may be performed in either the inpatient hospital setting, if the recipient requires hospitalization, or outpatient hospital setting. Inpatient evaluations are not permitted solely for the convenience of the physician or the recipient. Adult Heart, Liver, Adult heart, liver, lung, and intestine/multivisceral, as well as pediatric lung Lung, and Intestine/ and intestine/multivisceral transplant services are reimbursed with an all Multivisceral and inclusive global payment to include the facility and physician fees for the Pediatric Lung and transplant surgery, complications, and related follow-up care for 365 days post Intestine/ discharge. Multivisceral Transplant Global Pre-transplant medical care coverage ends the day before the transplant Reimbursement surgery. Re-transplantation of the same organ occurring within the initial transplant hospitalization is reimbursed at 25 percent of the global transplant fee for the facility and physician costs. Re-transplantation of the same organ that occurs after discharge from the initial transplant episode through the first 365 days will be reimbursed 75 percent of the global transplant fee for the facility and physician costs. The transplant facility must notify the Medicaid transplant coordinator within three days of the organ transplantation surgery. Failure to notify Medicaid per policy may result in the forfeiture of global payment. Recipients must be eligible for Medicaid at the time transplantation services are rendered for providers to receive global reimbursement. Global reimbursement for lung transplant is the same for single or bilateral lung transplantation. Global reimbursement for multivisceral transplants must include the intestine as one of the organs that was transplanted. All other unrelated care is reimbursed to physicians on a fee-for-service basis according to the Medicaid Provider Fee Schedule. December 2012 2-83 Practitioner Services Coverage and Limitations Handbook Organ and Bone Marrow Transplant Services, continued Out-of-State Facility For reimbursement from the Florida Medicaid program for an out-of-state Requirements, transplant, the facility and professional providers must be enrolled as Florida continued Medicaid providers. Pre-transplant and post-transplant medical care is reimbursable, if medically necessary and appropriate as determined by the Medicaid medical consultant. Post-transplant Care Post-transplant medical care coverage begins when the recipient is discharged from the inpatient hospital following the transplant procedure. December 2012 2-84 Practitioner Services Coverage and Limitations Handbook Organ and Bone Marrow Transplant Services, continued Anti-Rejection Anti-rejection medications and other reimbursable medications prescribed Medications specifically for use in preventing organ rejection are reimbursable under the Medicaid Pharmacy Services program, even if the transplant was not reimbursed by Medicaid. Medications Reimbursement is not available for transplant surgery if experimental (except as outlined in Rule 59B-12. Procurement Organ procurement costs, and tissue typing, searches and matches are included in the reimbursement for the transplant procedure. Donor Expenses Medicaid does not reimburse for cadaveric or living donor expenses, even if the donor is a Medicaid-eligible recipient. Medicaid does reimburse for certain reimbursable procedure codes related to autologous bone marrow transplantation. Medicaid does not reimburse for organ transplant procedures involving living donor organs except for kidney and pediatric liver transplants. Medicaid does not reimburse separately for the living donor expenses related to kidney or pediatric liver transplants. Hospice Services Medicaid recipients are not permitted to receive transplant services while enrolled in hospice care. Artificial Hearts and Medicaid does not reimburse for procedures involving artificial hearts. Ventricular Assist Devices Medicaid does not reimburse for the cost of the ventricular assist device separately. December 2012 2-85 Practitioner Services Coverage and Limitations Handbook Orthopedic Services Description Orthopedic services provide for prevention or correction of deformities or disorders of the musculoskeletal system. Closed Fracture Initial treatment of a closed fracture requiring no manipulation or anesthesia is Treatment reimbursed by billing only the appropriate closed fracture treatment code. Initial Casting and the supplies, application and removal of the first cast or strapping are Strapping included in the reimbursement for the initial service. Subsequent Casting Subsequent strapping or replacement of a cast during or after the period of and Strapping follow-up care for management of a fracture may be reimbursed separately using the allowed casting and strapping codes. Otolaryngology Services Description these services provide for diagnosis and treatment of diseases related to otology, otorhinolaryngology, and laryngology. December 2012 2-86 Practitioner Services Coverage and Limitations Handbook Otolaryngology Services, continued Included Tests Otoscopy, rhinoscopy, and tuning fork tests are not reimbursed separately from an evaluation and management visit. Pain Management Services Facet Joint A paravertebral facet joint or facet joint nerve block (also known as medial Injections branch nerve block) is a local anesthetic procedure that is performed under Definition fluoroscopic guidance to temporarily denervate (block) the facet joint. This procedure is used to differentiate between facet joint syndrome and other causes of neck or back pain. During this procedure a needle is placed in the paravertebral facet joint or facet joint nerve, generally under fluoroscopic guidance, and a long acting local anesthetic agent (with or without a steroid) is injected in the joint to temporarily denervate the facet joint. After a satisfactory blockade of the pain has been obtained, the patient is asked to perform activities that usually aggravate the pain and to record the effect of the procedure 4-8 hours after the injection. Temporary or prolonged relief of the pain suggests that facet joints were the source of the symptoms and appropriate therapeutic treatment may then be prescribed. These techniques are to be performed using fluoroscopy visualization for needle placement. Limitations Facet joint injections, in any combination, are limited to twelve (12) injections in a six-month period. Percutaneous Percutaneous radiofrequency neurolysis is a technique where painful nerve Radiofrequency fibers are selectively destroyed by heat delivered through needle electrodes. A Neurolysis critical part of the procedure is the use of fluoroscopic guidance to confirm the Definition proper positioning of the needle electrode. December 2012 2-87 Practitioner Services Coverage and Limitations Handbook Pain Management Services, continued Percutaneous Percutaneous radiofrequency neurolysis is performed to provide long-term Radiofrequency pain relief for facet joint pain, which is determined by performing a diagnostic Neurolysis facet joint injection. If the diagnostic facet joint injection provides temporary or Definition, continued prolonged pain relief, this would indicate the facet joint was the source of pain. Limitations Percutaneous radiofrequency neurolysis, in any combination, is limited to four (4) in a six-month period. Select Public Information for Providers, then Provider Support and then Fee Schedules. Pathology Services Description Pathology services are services that apply pathological procedures and techniques to investigate the nature and cause of disease. Professional A professional service component is physician interpretation of the results of a Component pathology service. A professional service component is identified by modifier 26 and is reimbursed for services provided in the inpatient or outpatient hospital setting only. If a professional service component is provided for a recipient in an emergency room, use the place of service outpatient hospital code on the claim. Technical the technical component is not reimbursed separately to providers for Component procedure codes related to laboratory or pathology services. Specimen Medicaid does not reimburse providers for venipuncture, collection, handling Collection or transportation of specimens. Pap Test Reimbursement for interpretation of the pap test is made to the pathologist. Exceptions to the limitation may be made for recipients with abnormal cytology reports. The previous pap test report and the current pap test report for medical documentation must be submitted with the claim. Independent Lab Pathology services for specimens sent to an independent laboratory are reimbursed directly to the independent laboratory. Children who are older than 6 years of age who are admitted to an intensive care unit are billed with hourly critical care codes 99291 and 99292 if they qualify for critical care services. December 2012 2-89 Practitioner Services Coverage and Limitations Handbook Pediatric Critical Care Services, continued Service Pediatric critical care codes are not applied based upon the type of unit Requirements (pediatric or neonatal) in which the child receives care or the type of provider delivering the care. December 2012 2-90 Practitioner Services Coverage and Limitations Handbook Pediatric Critical Care Services, continued Additional An additional initial consultation may be reimbursed to the same provider or Consultation for provider group during the same hospitalization if after 30 consecutive days a Separately separately identifiable medical condition warrants a new consultation from the Identifiable Medical specialist. When critical care services are provided to a pediatric patient, less than five years of age at two separate institutions (transferred) by a physician from a different group on the same date of service, the physician from the referring institution should report their critical care services with the critical care codes 99291 and 99292. The receiving institution should report the appropriate global admission code of 99471 or 99475, for the same date of service. Excluded Services Services for a recipient who no longer requires the level of care for critical care services, but continues to receive care in the intensive care unit, must be billed using subsequent hospital care codes. Psychiatric Services Description Psychiatric services are evaluation, diagnosis, and therapy services for Medicaid recipients experiencing mental disorders. Who Can Provide Psychiatric services must be directly rendered by the practitioner who is being Psychiatric Services reimbursed for the services. The only exception is that Medicaid will reimburse for psychiatric services rendered by a psychiatric resident under the direct supervision of a psychiatrist who is a member of the medical faculty at an accredited medical school or a teaching hospital as defined in Section 408.

Treatment Options the condition is treated with antibiotics medications information purchase septra 480 mg visa, with drainage in the case of an abscess medicine vending machine purchase septra 480mg with mastercard. Radiation Thyroiditis May be caused by radioiodine given for treatment of Graves disease (see Chapter 5 medications and side effects purchase 480mg septra mastercard. Patients present with mild thyroid pain and tenderness 5 to 10 days after receiving the radioiodine symptoms 8 days past ovulation generic septra 480 mg. N Thyroiditis Not Associated with Pain and Tenderness Chronic Autoimmune Thyroiditis Chronic autoimmune thyroiditis is also known as Hashimoto thyroiditis (see also Chapter 5 medications metabolized by cyp2d6 purchase septra 480 mg amex. Etiology Chronic autoimmune thyroiditis is an autoimmune disorder due to lympho cytic infiltration of the thyroid gland medications you can take during pregnancy generic 480mg septra. Note that postpartum thyroiditis must be differentiated from Graves disease, which also commonly presents in women after delivery. In nursing mothers, thyroid ultrasound with Doppler flow may be helpful in differentiating these two conditions. Hyper vascularity typically occurs with Graves disease, whereas there is decreased vascularity in hyperthyroidism associated with postpartum thyroiditis. Treatment Options Patients with symptomatic hypothyroidism should be treated with Levothy roxine for 2 to 3 months and then be reevaluated. In up to 25% of women with postpartum thyroiditis, hypothyroidism may be permanent. Fibrous Thyroiditis Fibrous thyroiditis (also known as Riedel thyroiditis and invasive thyroidi tis) is characterized by extensive fibrosis of the thyroid gland that extends into adjacent tissues. Initially euthyroid, but patients may develop hypothyroidism after the gland becomes fibrosed. Drug-Induced Thyroiditis P a t i e n t s r e c e i v i n g i n t e r f e r o n a l f a, i n t e r l e u k i n 2, a m i o d a r o n e, o r l i t h i u m m a y develop painless thyroiditis. G Undifferentiated tumors (medullary or anaplastic) are aggressive, and have a poorer prognosis. Most thyroid malignancies are well-differentiated cancers that originate from follicular cells (papillary and follicular carcinomas). Thyroid tumors can also originate from the other cell types in the thyroid gland, including the calcitonin-producing C cells (parafollicular cells), lymphocytes, other vascular components and metastases from other organs (Table 5. N Epidemiology Thyroid cancer represents the most common endocrine malignancy, annual incidence being! Annual incidence increases with age, peaking by the fifth through eighth de cades. N Well-Differentiated Thyroid Carcinomas Well-differentiated thyroid carcinomas originate from the thyroid follicular cells and include papillary and follicular carcinomas, as described below. Well-differentiated thyroid carcino mas are two to four times more common in females than males. Papillary Thyroid Cancer P a p i l l a r y t h y r o i d c a n c e r (P T C) i s t h e m o s t c o m m o n t y p e o f t h y r o i d m a l i g nancy. Epidemiology P T C a c c o u n t s f o r 8 0 t o 9 0 % o f a l l t h y r o i d c a n c e r s. Risk Factors G History of radiation exposure during childhood such as that received as a treatment of childhood malignancies. Head and Neck 485 radiation to the head and neck was used to treat a wide variety of condi tions, including enlarged tonsils, thymus, and even acne. G History of thyroid cancer in a first-degree relative or a family history of a thyroid cancer syndrome is a risk factor. Clinical Presentation P T C t y p i c a l l y p r e s e n t s a s a p a i n l e s s d i s c r e t e m a s s i n t h e t h y r o i d g l a n d. The tumor generally grows slowly and is late to break through the capsule of the gland. Nodal metastases appear classically in paratracheal nodes but may be present anywhere in the neck. It is not uncommon to find microscopic foci of papillary carcinoma at autopsy or incidentally in a thyroid removed for other indications. Prognosis W i t h t r e a t m e n t, o v e r a l l o u t c o m e i s g e n e r a l l y f a v o r a b l. H o w e v e r, a s m a l l group of patients develop local recurrence and/or distant metastases. Fea tures associated with increased risk of recurrence or mortality include age at diagnosis (age "45 years), size of the primary tumor ("2 cm), and the pres ence of soft tissue invasion and cervical lymph node or distant metastases. Other bio logically aggressive variants include a columnar variant, a tall cell variant, a diffuse sclerosing variant, and poorly differentiated carcinoma. It tends to occur in an older population, with a peak incidence between ages 40 and 60 years. The tumor is classified on the basis of degree of invasiveness into minimally invasive (encapsulated) or widely invasive. Therefore the actual diagnosis of follicular thyroid cancer is made on permanent pathologic evaluation of the thyroid speci men after surgery. Treatment of Well-Differentiated Thyroid Carcinomas the primary treatment is surgical, followed by referral to an endocrinologist for medical management. Radioactive iodine remnant ablation treatment may be given if needed; there should be lifelong follow-up and surveillance for recurrence. Surgical treatments include G Selected papillary carcinomas that are $1 cm in a young patient without a history of radiation exposure may be treated with hemithyroidectomy and isthmusthectomy. All others should be treated with total thyroidec tomy and removal of any involved lymph nodes in the central or lateral neck areas. G Hurthle cell carcinoma is treated with a total thyroidectomy and neck dissection in cases with clinically positive lymph nodes. Head and Neck 487 Postoperative Complications of Well-Differentiated Thyroid Carcinomas Permanent hypoparathyroidism, transient hypoparathyroidism, damage to the recurrent laryngeal nerve (hoarseness), and damage to the superior laryn geal nerve are possible postoperative complications. T h e R A I i s t a k e n u p b y t h e r e s i d u a l n o r m a l a n d t u m o r cells, leading to destruction or death of these cells. This not only reduces future recurrence risk, but also facilitates surveillance for future recurrence. Several days after the treatment, another whole body scan is obtained (posttreatment scan). Well-differentiated thyroid cancer has a reduced capacity to concentrate iodine when compared with normal thyroid tissue. Patients need periodic clinical follow-up to monitor for symptoms such as hoarseness, hemoptysis, pain, dysphagia, cough and dyspnea, and recurrent mass, new-onset adenopathy, or a paralyzed vocal fold. Other options include clinical trials involving gene therapy and tumor redifferentiation agents. N Other Forms of Thyroid Cancer Anaplastic Thyroid Cancer A n a p l a s t i c t h y r o i d c a n c e r, a p o o r l y d i f f e r e n t i a t e d c a n c e r, a c c o u n t s f o r! Epidemiology the annual incidence of anaplastic thyroid cancer is 1 to 2 cases per million. Anaplastic thyroid cancer is responsible for "50% of the 1200 deaths per year attributed to thyroid cancer. It is a disease of the elderly, typically presenting in the sixth or seventh decade of life. Clinical Presentation It usually presents with local symptoms caused by a rapidly growing thy roid mass and extensive local invasion. Distant metastases may occur early in the course of the disease to the lungs, liver, bones, and brain. Anaplastic thyroid cancer may arise de novo, but dedifferentiation from long-standing differentiated thyroid carcinoma is also suspected. Histopathologically, atypical cells are seen that show numerous mitoses and form different patterns. Multinucleate giant cells, spindle-shaped cells, and squamoid cells usually predominate. Treatment Surgical treatment may consist of complete resection in selected individuals when possible followed by a combination of chemotherapy and radiotherapy. Often, the tumor is not resectable, and surgery consists of a tracheotomy or cricothy roidotomy to prevent airway compromise. Radiation therapy is indicated preoperatively to increase the tumor re sectability rate, postoperatively to enhance the effect of chemotherapy or to alleviate obstruction, but its efficacy must be balanced against its toxicity. Several chemotherapeutic agents have been used with uniformly subop timal results. Calcitonin is secreted by the tumor and is a useful marker for diagnosis and follow-up. Epidemiology S e v e n t y f i v e p e r c e n t o f M T C s a r e s p o r a d i c; t h e r e m a i n d e r a r e f a m i l i a l. Clinical Presentation Medullary thyroid cancer typically presents as a painful hard nodule or mass in the thyroid gland or as an enlargement of the regional lymph nodes. Sometimes, it comes to medical attention due to a metastatic lesion at a distant site. Pathology Characteristic microscopic features are sheets of cells separated by a pink staining substance that has characteristics of amyloid. Diagnosis can be confirmed by positive immunostaining of the tumor tissue for calcitonin and carcinoembryonic antigen. Preoperatively, patients should also be evaluated for hyperparathyroidism and for pheochromocytoma. T o t a l t h y r o i d e c t o m y w i t h r e m o v a l o f r e g i o n a l lymph nodes should be performed after excluding hyperparathyroidism and pheochromocytoma. An elevated basal serum calcitonin 6 or more months after surgery indicates residual disease. In cases of advanced metastatic disease untreatable by surgery or radiation, cytotoxic chemotherapy, somatostatin analogues, and interferon or radioimmunotherapy may provide palliation. Clinical Presentation U s u a l l y t h y r o i d l y m p h o m a p r e s e n t s a s a r a p i d l y e n l a r g i n g g o i t e r. P a t i e n t s may experience symptoms or signs of compression of the trachea or esopha gus, including dysphagia, dyspnea, stridor, hoarseness, and neck pain. On physical examination, the thyroid is usually firm, slightly tender, and is fixed to surrounding structures. In addition, 10% of patients have systemic (B) symptoms of lymphoma, including fever, night sweats, and weight loss (10% of body weight or more). Patients may also present with symptoms and signs of hypothyroidism or hyperthyroidism. Head and Neck 491 lymphoma from chronic thyroiditis; often surgical specimens are required for diagnosis. Pathology, immunohistochemical staining, or flow cytometry may be necessary to establish monoclonality and characterize surface markers, espe cially to diagnose small cell lymphomas. Treatment Surgery is not the primary treatment and is typically used for diagnostic biopsy and surgical airway only. If disease is confined to the neck, treatment is guided by the histologic features of the lymphoma. Patients with large cell lymphoma are treated with chemotherapy with or without radiation. For patients with localized extranodal marginal zone lymphoma of the thyroid, follicular lymphoma and small cell lymphoma radiotherapy alone may be adequate. The lymph nodes must be specifically identified to classify regional node involvement. Tumor of any size extending beyond the thyroid capsule to invade the subcutaneous soft tissues, the larynx, the trachea, the esophagus, or the recurrent laryngeal nerve pT4b: Very advanced disease. Tumor invades the prevertebral fascia or encases the carotid artery or mediastinal vessels Note: There is no category of carcinoma in situ (pTis) relative to carcino mas of thyroid gland. N Embryology the upper pair of parathyroid glands arises from the fourth branchial cleft and descends with the thyroid gland, usually at the cricothyroid junction. The lower pair arises from the third branchial cleft and descends with the thymus; the location of the lower parathyroids may be variable. Ectopic parathyroids may be found anywhere along the pathway of descent of the branchial pouches. The (lower) parathyroid glands have been described in the carotid sheath, anterior mediastinum, and intrathyroid. N Anatomy Grossly the parathyroid glands are yellow-brown, weighing 25 to 40 mg per gland. N Histology Parathyroid glands are composed primarily of chief cells and fat with a thin fibrous capsule dividing the gland into lobules; the glands may have a pseudofollicle pattern resembling thyroid follicles. Head and Neck 495 N Blood Supply the arterial supply to the parathyroid glands gland originates from the superior and inferior parathyroid arteries, both of which usually arise from the inferior thyroid artery. G Hyperparathyroidism is usually subdivided into primary, second ary, and tertiary hyperparathyroidism. G Hyperparathyroidism results in elevated levels of plasma calcium by increasing the release of calcium and phosphate from bone ma trix, increasing calcium reabsorption by the kidney, and increasing intestinal absorption of calcium. There are three types of hyperparathyroidism: primary, secondary, and tertiary, which are described below. Other familial conditions associated with all four gland hyperplasia include familial hyperparathyroidism-jaw tumor syndrome and familial isolated hyperparathyroidism. Epidemiology P r i m a r y h y p e r p a r a t h y r o i d i s m c a n o c c u r a t a n y a g e, b u t t h e g r e a t m a j o r ity of cases occur over the age of 45 years. Clinical Primary hyperparathyroidism is most often detected incidentally by routine biochemical screening.

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Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy medications xyzal purchase septra with paypal. Dose Modifications for Hematologic Toxicity for Patients with Myelofibrosis Starting Treatment with Platelet Counts of 50 X 109/L to Less Than 100 X 109/L 9 9 this section applies only to patients with platelet counts of 50 X 10 /L to less than 100 X 10 /L prior to any treatment with Jakafi symptoms uterine cancer buy generic septra online. Dose Reductions 9 Reduce the dose of Jakafi for platelet counts less than 35 X 10 /L as described in Table 4 medicine cabinets with mirrors buy 480mg septra with mastercard. Dose Modifications Based on Insufficient Response for Patients with Myelofibrosis and Starting Platelet Count of 50 X 109/L to Less Than 100 X 109/L Do not increase doses during the first 4 weeks of therapy natural pet medicine discount 480mg septra mastercard, and do not increase the dose more frequently than every 2 weeks symptoms you need a root canal purchase 480 mg septra with visa. Continuation of treatment for more than 6 months should be limited to patients in whom the benefits outweigh the potential risks treatment models cheap 480mg septra with amex. Dose Modification for Bleeding Interrupt treatment for bleeding requiring intervention regardless of current platelet count. Once the bleeding event has resolved, consider resuming treatment at the prior dose if the underlying cause of bleeding has been controlled. If the bleeding event has resolved but the underlying cause persists, consider resuming treatment with Jakafi at a lower dose. Dose Reductions Dose reductions should be considered for hemoglobin and platelet count decreases as described in Table 5. After recovery of the hematologic parameter(s) to acceptable levels, dosing may be restarted. Table 6 illustrates the dose that may be used in restarting Jakafi after a previous interruption. Dose Management after Restarting Treatment After restarting Jakafi following treatment interruption, doses may be titrated, but the maximum total daily dose should not exceed 5 mg less than the dose that resulted in the dose interruption. An exception to this is dose interruption following phlebotomy-associated anemia, in which case the maximal total daily dose allowed after restarting Jakafi would not be limited. Dose Modifications Based on Insufficient Response for Patients with Polycythemia Vera If the response is insufficient and platelet, hemoglobin, and neutrophil counts are adequate, doses may be increased in 5 mg twice daily increments to a maximum of 25 mg twice daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every two weeks. Tapering of Jakafi may be considered after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. Taper Jakafi by one dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily). Dose Modification Guidelines for Patients with Acute Graft Versus Host Disease Evaluate blood parameters before and during treatment with Jakafi. Patients who are currently receiving Jakafi 10 mg twice daily may have their dose reduced to 5 mg twice daily; patients receiving 5 mg twice daily may have their dose reduced to 5 mg once daily. Patients who are unable to tolerate Jakafi at a dose of 5 mg once daily should have treatment interrupted until their clinical and/or laboratory parameters recover. Additional dose modifications should be made with frequent monitoring of safety and efficacy. Make additional dose modifications with frequent monitoring of safety and efficacy. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose. When discontinuing Jakafi therapy for reasons other than thrombocytopenia, gradual tapering of the dose of Jakafi may be considered, for example by 5 mg twice daily each week. The effect of tube feeding preparations on Jakafi exposure during administration through a nasogastric tube has not been evaluated. Platelet transfusions may be necessary [see Dosage and Administration (2), and Adverse Reactions (6. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines. Tuberculosis Tuberculosis infection has been reported in patients receiving Jakafi. Observe patients receiving Jakafi for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Jakafi, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to , prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a 12 person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Jakafi. The decision to continue Jakafi during treatment of active tuberculosis should be based on the overall risk-benefit determination. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions (6. If one or more of these occur after discontinuation of, or while tapering the dose of Jakafi, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. When discontinuing or interrupting therapy with Jakafi for reasons other than thrombocytopenia or neutropenia [see Dosage and Administration (2. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Jakafi. Assess lipid parameters approximately 8-12 weeks following 13 initiation of Jakafi therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In patients starting treatment with 9 15 mg twice daily (pretreatment platelet counts of 100 to 200 X 10 /L) and 20 mg twice daily 9 (pretreatment platelet counts greater than 200 X 10 /L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy. In a double-blind, randomized, placebo-controlled study of Jakafi, among the 155 patients treated with Jakafi, the most frequent adverse reactions were thrombocytopenia and anemia [see Table 12]. The three most frequent nonhematologic adverse reactions were bruising, dizziness and headache [see Table 11]. Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with Jakafi and 11% of patients treated with placebo. Table 11 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. Platelet transfusions were administered to 5% of patients receiving Jakafi and to 4% of patients receiving control regimens. Discontinuation of treatment 15 because of thrombocytopenia occurred in <1% of patients receiving Jakafi and <1% of patients 9 9 receiving control regimens. Patients with a platelet count of 100 X 10 /L to 200 X 10 /L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients 9 with a platelet count greater than 200 X 10 /L (17% versus 7%). Neutropenia In the two Phase 3 clinical studies, 1% of patients reduced or stopped Jakafi because of neutropenia. Table 12 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study. Table 12: Myelofibrosis: Worst Hematology Laboratory Abnormalities in the Placebo Controlled Studya Jakafi Placebo (N=155) (N=151) All All Gradesb Grade 3 Grade 4 Grades Grade 3 Grade 4 Laboratory Parameter (%) (%) (%) (%) (%) (%) Thrombocytopenia 70 9 4 31 1 0 Anemia 96 34 11 87 16 3 Neutropenia 19 5 2 4 <1 1 a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. The incidence of Grade 2 cholesterol elevations was <1% for Jakafi with no Grade 3 or 4 cholesterol elevations. Discontinuation for adverse events, regardless of causality, was observed in 4% of patients treated with Jakafi. An adverse reaction resulting in treatment discontinuation occurred in 31% of patients. The most common adverse reaction leading to treatment discontinuation was infection (10%). Increased exposure may increase the risk of 19 exposure-related adverse reactions. No dose adjustment is recommended; however, monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Clinical Pharmacology (12. There are no studies with the use of Jakafi in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Data Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data). Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for Jakafi in human studies, discontinue breastfeeding during treatment with Jakafi and for two weeks after the final dose. Data Animal Data 14 Lactating rats were administered a single dose of [ C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma. The patients had a median age of 14 years (range, 2 to 21 years) and included 18 children (age 2 to <12 years), and 14 adolescents (age 12 to <17 2 years). The dose levels tested were 15, 21, 29, 39, or 50 mg/m twice daily in 28-day cycles with up to 6 patients per dose group. Overall, 38 (81%) patients were treated with no more than a single cycle of Jakafi, while 3, 1, 2, and 3 patients received 2, 3, 4, and 5 or more cycles, respectively. A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 21 dose higher than the recommended dose for adults. Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Higher than recommended repeat doses are associated 22 with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Each tablet contains ruxolitinib phosphate equivalent to 5 mg, 10 mg, 15 mg, 20 mg and 25 mg of ruxolitinib free base together with microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, sodium starch glycolate, povidone and hydroxypropyl cellulose. Food Effect No clinically relevant changes in the pharmacokinetics of ruxolitinib were observed upon administration of Jakafi with a high-fat, high-calorie meal (approximately 800 to 1000 calories of which 50% were derived from fat). Elimination the mean elimination half-life of ruxolitinib is approximately 3 hours and the mean half-life of ruxolitinib + metabolites is approximately 5. Excretion Following a single oral dose of radiolabeled ruxolitinib, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out. Ruxolitinib was not mutagenic in a bacterial mutagenicity assay (Ames test) or clastogenic in in vitro chromosomal aberration assay (cultured human peripheral blood lymphocytes) or in vivo in a rat bone marrow micronucleus assay. In a fertility study, ruxolitinib was administered to male rats prior to and throughout mating and to female rats prior to mating and up to the implantation day (gestation day 7). Ruxolitinib had no effect on fertility or reproductive function in male or female rats at doses of 10, 30 or 60 mg/kg/day. However, in female rats doses of greater than or equal to 30 mg/kg/day resulted in increased post-implantation loss.