Kamagra Soft

By U. Muntasir. Kentucky Christian College. 2019.

If you decide to use a CAM treatment that would be given by a practitioner order kamagra soft 100 mg overnight delivery, choose the practitioner carefully to help minimize any possible risks order generic kamagra soft pills. While some scientific evidence exists regarding the effectiveness of some CAM therapies order 100 mg kamagra soft amex, for most there are key questions that are yet to be answered through well-designed scientific studies--questions such as whether they are safe trusted kamagra soft 100 mg, how they work, and whether they work for the diseases or medical conditions for which they are used. NCCAM supports research on CAM therapies to determine if they work, how they work, whether they are effective, and who might benefit most from the use of specific therapies. Ask your physician, other health professionals, or someone you believe to be knowledgeable regarding CAM whether they have recommendations. Contact a nearby hospital or a medical school and ask if they maintain a list of area CAM practitioners or could make a recommendation. Some regional medical centers may have a CAM center or CAM practitioners on staff. Contact a professional organization for the type of practitioner you are seeking. Often, professional organizations have standards of practice, provide referrals to practitioners, have publications explaining the therapy (or therapies) that their members provide, and may offer information on the type of training needed and whether practitioners of a therapy must be licensed or certified in your state. Professional organizations can be located by searching the Internet or directories in libraries (ask the librarian). One directory is the Directory of Information Resources Online (DIRLINE) compiled by the National Library of Medicine ( http://dirline. It contains locations and descriptive information about a variety of health organizations, including CAM associations and organizations. NCCAM does not provide CAM therapies or referrals to practitioners. NCCAM supports clinical trials (research studies in people) of CAM therapies. Clinical trials of CAM are taking place in many locations worldwide, and study participants are needed. To find out more about clinical trials in CAM, see the NCCAM fact sheet " About Clinical Trials and Complementary and Alternative Medicine. You can search this site by the type of therapy being studied or by disease or condition. Box 7923, Gaithersburg, MD 20898-7923Fax-on-Demand service: 1-888-644-6226The NCCAM Clearinghouse provides information about CAM and about NCCAM. ODS provides all its public information through its Web site. One of its services is the International Bibliographic Information on Dietary Supplements (IBIDS) database, at http://ods. CAM on PubMed, a database accessible via the Internet, was developed jointly by NCCAM and the National Library of Medicine (NLM). It contains bibliographic citations to articles in scientifically based, peer-reviewed journals on CAM. CAM on PubMed displays links to publisher Web sites; some sites offer the full text of articles. The National Institutes of Health (NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH Institutes and the U. The site currently contains more than 6,200 clinical studies sponsored by NIH, other Federal agencies, and the pharmaceutical industry in over 69,000 locations worldwide. To report serious adverse events or illnesses related to FDA-regulated products, such as drugs, medical devices, medical foods, and dietary supplements, contact MedWatch:To report a general complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the FDA District Office nearest you. Toll-free: 1-877-FTC-HELP (1-877-382-4357)The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint or to get free information on consumer issues, call toll-free 1-877-FTC-HELP, or use the online complaint form found at www. Consumers who want to learn how to recognize fraudulent or unproved health care products and services can learn more at www. MEDLINE contains indexed journal citations and abstracts from more than 4,600 journals published in the United States and more than 70 other countries. A dietary supplement is a product (other than tobacco) taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Under current law, dietary supplements are considered foods, not drugs. They can separate conjoined twins, reattach severed limbs, and shuffle organs between patients like peas in a shell game. But sit down with someone whose body is racked with the pain of osteoarthritis, migraines, or fibromyalgia, and the shortcomings of traditional medicine become blindingly clear. The humbling fact is that at least 50 million Americans live in chronic pain, and the vast majority are pretty much at its mercy. And painkillers like nonsteroidal anti-inflammatories, opioids, and morphine come packaged with a slew of side effects as well as some addictive properties, which can be more disruptive than the pain itself. The uneasy relationship many chronic pain patients have with doctors is driving them into the arms of alternative healers. In fact, pain is the number one reason people use alternative medicine, according to the Journal of the American Medical Association. Some therapies, such as acupuncture, biofeedback, and massage, are scientifically proven to reduce certain types of pain, while others, like reiki and meditation, can help a person get a handle on the emotional demons that chronic pain unleashes. A naturopath who tells a patient her pain will vanish with the right combination of supplements is just as irresponsible as a doctor who dashes off a prescription for opiates before running out the door. Enter James Dillard, a specialist in integrative pain management and the author of The Chronic Pain Solution. Trained first as an acupuncturist and chiropractor and only later as a physician, Dillard believes an integrative approach is especially important for people who struggle with chronic pain. And the payoff is more than just feel-good reassurance. In fact, Dillard often leans heavily on prescription drugs in the early stages of treatment. Once the pain has receded from center stage, Dillards brings up complementary pain management tools, such as acupuncture, chiropractic, meditation, and biofeedback. By covering all the bases???calming the mind, stretching the muscles, soothing inflammation, and manipulating the skeleton???Dillard hopes to begin addressing pain at its roots instead of just muffling its voice with painkillers. In all cases, Dillard added some essential ingredients to the mix, and sent his patients on their way with tools for weathering the inevitable storms that chronic pain can stir up. In 1995, Fred Kramer, a 44-year-old registered nurse, was in a minor auto accident from which he walked away unhurt. The next morning, his left shoulder was in such pain that he could barely move his arm, so he tossed back a couple of Motrin, put on an ice pack, and called in sick. After a couple of days on the couch, however, he grew impatient and hauled himself back to work, still in pain. Two months after the accident, the searing pain had put an end to all but the mildest activities. Often accompanying another injury, MPS results when muscles lock themselves into place to protect a part of the body from injury, forming a shield of sorts. Over time the tension slows circulation to the muscles. Without sufficient blood, the cells become starved for oxygen, and strained nerves send the brain increasingly loud pain signals. As the muscles tighten, so do the surrounding sheaths of tissue, called fasciae. Unless the muscles are coaxed back into relaxing soon after the injury, the initial problem can spiral into greater levels of pain and continuing loss of mobility. Kramer, relieved to have an actual diagnosis, began chiropractic treatments that he hoped would unlock his tight muscles. They helped, but not enough, and by this time he had become seriously depressed.

cheap kamagra soft online american express

The workaholic uses work to escape from difficult feelings and in this process loses awareness of her desires and needs buy kamagra soft with visa. The family members and friends of the workaholic experience themselves as a lower priority than his/her work cheap kamagra soft online, and this experience frequently erodes relationships cheap kamagra soft 100 mg free shipping. If you answer yes to 3 or more questions buy kamagra soft, you may have a problem worth discussing with a mental health counselor or your doctor. Do you get more excited about your work than about family or anything else? Is work the activity you like to do best and talk about most? Do you turn your hobbies into money-making ventures? Do you take complete responsibility for the outcome of your work efforts? Have your family or friends given up expecting you on time? Do you underestimate how long a project will take and then rush to complete it? Do you believe that it is okay to work long hours if you love what you are doing? Do you get impatient with people who have other priorities besides work? Is the future a constant worry for you even when things are going very well? Do you do things energetically and competitively including play? Do you get irritated when people ask you to stop doing your work in order to do something else? Have your long hours hurt your family or other relationships? Do you think about your work while driving, falling asleep or when others are talking? Do you believe that more money will solve the other problems in your life? Learn about work addiction treatment through therapy and support groups like Workaholics Anonymous and what recovery from workaholism really means. Confronting the workaholic will generally meet with denial. They may enlist the help of a therapist who works with workaholics to assess the person and recommend treatment options for work addiction. The work addict has often taken on parental responsibilities as a child to manage a chaotic family life or to take refuge from emotional storms, or physical or sexual abuse. Cognitive-behavioral therapy will assist him/her to examine the rigid beliefs and attitudes that fuel overwork. A core belief such as "I am only lovable if I succeed" may be replaced by the more functional belief, "I am lovable for who I am, not for what I accomplish. In treatment for work addiction, the workaholic develops a moderation plan that introduces balance into life, including a schedule that allows time for physical health, emotional well-being, spiritual practices, and social support. Setting boundaries between home and work is critical, as is scheduling daily and weekly time for self-care, friendships, and play. Each day, the recovering workaholic makes time for a quiet period, for prayer or meditation, listening to music, or engaging in another "non-productive" activity. Meetings of Workaholics Anonymous, a 12-step program, can provide support and tools for recovery. In some cases, Attention Deficit Disorder (ADD) underlies workaholism. Assessment by a psychologist can clarify whether ADD or ADHD is a factor. If anxiety or depression is a contributing factor, medication may help to provide a more stable emotional climate as the workaholic makes the needed behavioral changes. The work addiction treatment can also provide an occasion for the co-workers, family members and friends to examine themselves. Do tensions exist at work or home that the workaholic and others avoid by overworking or other addictive behaviors? Do family members hold an ideal of "the good father/mother" that does not allow for the normal successes and failures of human life? As the others who surround the workaholic examine their own lives, these people will be better able to support the workaholic as he/she continues his/her recovery. These workaholic articles provide insight into the life of the workaholic. Get in-depth information on work addiction, from signs and symptoms of a workaholic to work addiction treatment. Urschel was a guest on the HealthyPlace Mental Health TV show talking about his new, revolutionary, science-based program for addictions recovery. Keith MillerReader Comment: "I found this book well written and comprehensive, but what was the most moving to me was the way in which it touched the most painful, sad and hidden part of my relationships. Shaw, Jane Irvine, Paul RitvoReader Comment: "Covers all the most important treatment approaches without moralizing and helps you choose what is most helpful or appropriate to your situation. Ruden, Marcia Byalick, Marcia Byalick Reader Comment: "It provides a good, solid scientific understanding of addiction in simple language and offers useful guidelines about moving beyond sobriety and toward cure. Washton, Donna Boundy, Donn Boundy Reader Comment: "Highly recommended to any thinking person interested in understanding and recovering from their addiction. Some meth addiction treatment methodologies like those found at the Matrix Institute (or the matrix model) have been developed specifically for meth addicts. The first and easiest step to make when a meth addict wishes to get treatment for a meth addiction is to go to the doctor. Meth addiction, like all addictions, is a medical and mental health issue and should always be handled by professionals. Meth addiction is serious and the health effects of meth addiction and meth addiction treatment should not be taken lightly. A doctor can also provide the crystal meth addict with meth addiction resources and meth addiction treatment information. Meth addiction is known to be a huge problem, particularly in urban areas, so the Substance Abuse and Mental Health Services Administration (SAMHSA), part of the US Department of Health and Human Services, has built a Substance Abuse Treatment Facility Locator. The Substance Abuse Treatment Facility Locator provides information on where a crystal meth addict can get help, also where people suffering from other addictions can get help. There are more than 11,000 treatment programs listed and they include:Residential treatment centersOutpatient treatment programsHospital inpatient programsTreatment centers listed typically help any drug addiction, meth addiction included. These treatment facilities also typically handle mental health issues as well as meth addiction treatment. A sliding scale means that facility charges based on how much a client can pay. Individual meth addiction facilities should be contacted regarding specific policies. For low or no-cost meth addiction treatment, crystal meth addicts may also contact the State Substance Abuse Agency or call a SAMHSA help line for further details on meth addiction services. Substance Abuse and Mental Health Services Administration (SAMHSA): http://www. Behavioral signs of an alcohol addict can be some of the easiest to notice but unfortunately also may cause some of the most damage to those around the alcoholic. Behavioral signs of an alcoholic may be seen by friends, family or even coworkers of the alcoholic. Behavioral signs of an alcoholic include:Has legal trouble such as DUI, domestic abuse or assaultArrives for appointments, interviews, or meetings intoxicated, or misses them altogetherFrequently goes "on and off-the-wagon"Behaves in an uncharacteristic, impulsive, or inappropriate mannerIs increasingly angry or defiantOverreacts to ordinary circumstances and problems, advice and criticismIs uncharacteristically isolated and withdrawnDenies, lies, covers up or is secretive about behaviors and whereaboutsLoses interest in hobbies and activitiesTakes unnecessary risks or acts in a reckless mannerHas increasing financial problems (may borrow or steal from family and friends)Mental signs of an alcoholic can be more difficult to spot and are often noticed by those who live with the alcoholic. Mental symptoms of an alcoholic often indicate a severe worsening of the disease and should not be ignored.

safe 100mg kamagra soft

David Roberts: Recovering from an eating disorder on your own -- is that possible or next to impossible? Kerr-Price: It is possible but much less likely than receiving help through a team of professionals who can address the different components of the disorder discount 100mg kamagra soft with visa. But just from my experience here at and doing these conferences 100 mg kamagra soft visa, most cannot recover on their own purchase 100mg kamagra soft otc. David Roberts: Earlier order kamagra soft 100 mg on-line, you were talking about patients needing assistance during meals. Kerr-Price: Sometimes people become very distressed when trying to eat a meal because of the fears they have around food. So, assistance can include talking them through it, encouragement, distraction, etc. Also, it may entail helping the person recognize what she does with her food, like cutting it into small pieces ( a food ritual), or eating her meal at too quick a pace. I have a juejostomy tube and am wondering about medical support that is needed? Kerr-Price: Our treatment includes the help of a primary care physician who can assess everything from heart functioning to vital signs, to liver functions, kidneys... David Roberts: Do you have people who come to Remuda and are treated for medical problems as well as psychological issues or are the medical issues handled at a medical hospital? Often eating disorders create physical problems that need to be addressed. In the instance of someone who is severely medically comprimised, say to the point of not being cleared to travel here, then she would go to a medical facility first for stabilization. Remuda Ranch is in Arizona, but people from all over the country go there for treatment. Galiena: What about the families of these girls/women? Are there support for them while their loved ones are in your facility? Kerr-Price: For our adolescent and adult patients, they and their families get to experience a "family week" which is an important piece of treatment so that family is included in the process. Also, adolescents have weekly teleconfereces with their families and therapist to deal with issues. Lost_Count: Is there a waiting list to enter your program? Kerr-Price: Often yes, but the length does vary so sometimes, the wait may be less. For instance, currently we have some space available. I was wondering how lenghty the process is to be accepted into their program and if that takes a long time to do? Kerr-Price: The process may vary for different families but I do know that, sometimes, people come very soon after the initial call is made to us. Kerr-Price, does one need to be referred by a therapist or medical doctor to get into a eating disorders treatment center or can one self-refer? Kerr-Price: Yes, I have known many individuals who once had eating disorders and are now symptom-free. David Roberts: And can you define "recovery" for us? What does that mean exactly in terms of someone with anorexia or bulimia? Someone may not exhibit enough eating disorder symptoms to meet criteria for an eating disorder diagnosis but may still struggle with the desires for instance. Hopefully, one can reach a place of being absolutely free of the disorder but purging half as much as one did at one time is progress on the recovery continuum. Kerr-Price: At times, that is very appropriate despite not being underweight. If the disorder has taken over your life, then help is definitely needed. Often, when I begin to feel healthy, I get scared of being "too healthy. That person could help assess if a more intensive program is necessary. Kerr-Price, thank you for being our guest this evening and for sharing this information with us. And to those in the audience, thank you for coming and participating. We have a very large and active eating disorders community here at HealthyPlace. You will always find people interacting with various sites. Kerr-Price: Thank you very much and thanks to the audience for joining us. Our first conference of the year, tonight, is "Breaking Free From Your Eating Disorder--Getting the Help You Need". We are always trying to focus on doing positive things and offering things to help with recovery. Rader is the Chief Executive and Clinical Director for Rader Programs, one of the nations leading providers of inpatient, daycare, and outpatient eating disorder services. He has worked in the field of eating disorders for over 17 years. His work has been documented in eating disorder journals. Rader and welcome to the Concerned Counseling website. Rader: We, at Rader Programs have been treating anorexia, bulimia, and compulsive overeating since 1979 and we currently have two locations, one in Tulsa, Oklahoma and one in Los Angeles, California. A person really needs to look at the amount of dysfunction the eating disorder has caused in all areas of their life; physical, emotional, social, family, and work. Bob M: One of the big questions we always get is what kind of treatment should you get. Outpatient, inpatient, or just see a therapist once a week or so. Can you explain the criteria one should use to evaluate that issue? Rader: Unfortunately there is not a simple answer to that question. It is important not to ignore the nutritional, exercise, and physical components of the eating disorder. Our topic is: "Breaking Free From Your Eating Disorder--Getting the Help You Need". Rader:Shanna: After you have recovered (symptom free) and you still get the feelings to purge, what are some good ways to get past the feelings? Rader: At Rader, we look at eating disorders as an ongoing recovery process. Even though you may no longer be in the throes of your disordered eating, feelings may still come up around eating disorder issues. It is okay to have these feelings and to realize that you did not develop your eating disorder overnight nor will all of the feelings disappear overnight. Bob M: Is it possible to prevent a relapse, and if so, how? Rader: Sometimes relapse can be part of eating disorder recovery. We often say it is important to never be too hungry, angry, lonely, or tired. Winkerbean: What do you recommend for getting through denial, even after having completed outpatient treatment and still being in denial? It gives an individual the opportunity to look how their life has become unmanageable because of the eating disorder. The person writes down the first remembrances of their eating disorder up until the present time.

kamagra soft 100 mg line

Such management often results in prompt reversal of symptoms and recovery [see Contraindications buy kamagra soft 100 mg online; Warnings and Precautions ] cheap 100 mg kamagra soft visa. Before initiation of therapy with Janumet and at least annually thereafter discount 100 mg kamagra soft with visa, renal function should be assessed and verified as normal order genuine kamagra soft line. In patients in whom development of renal dysfunction is anticipated, particularly in elderly patients, renal function should be assessed more frequently and Janumet discontinued if evidence of renal impairment is present. Levels In controlled clinical trials of metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin Blevels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B-intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or Vitamin Bsupplementation. Measurement of hematologic parameters on an annual basis is advised in patients on Janumet and any apparent abnormalities should be appropriately investigated and managed. In these patients, routine serum Vitamin Bmeasurements at two- to three-year intervals may be useful. As is typical with other antihyperglycemic agents used in combination with a sulfonylurea, when sitagliptin was used in combination with metformin and a sulfonylurea, a medication known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo in combination with metformin and a sulfonylurea [see Adverse Reactions ]. Therefore, patients also receiving an insulin secretagogue (e. Metformin hydrochlorideHypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking ~b-adrenergic blocking drugs. Sitagliptin and Metformin Co-administration in Patients with Type 2 Diabetes Inadequately Controlled on Diet and ExerciseTable 1 summarizes the most common (?-U5% of patients) adverse reactions reported (regardless of investigator assessment of causality) in a 24-week placebo-controlled factorial study in which sitagliptin and metformin were co-administered to patients with type 2 diabetes inadequately controlled on diet and exercise. Table 1: Sitagliptin and Metformin Co-administered to Patients with Type 2 Diabetes Inadequately Controlled on Diet and Exercise: Adverse Reactions Reported (Regardless of Investigator Assessment of Causality) in ?-U5% of Patients Receiving Combination Therapy (and Greater than in Patients Receiving Placebo)*?-P Data pooled for the patients given the lower and higher doses of metformin. Sitagliptin Add-on Therapy in Patients with Type 2 Diabetes Inadequately Controlled on Metformin AloneIn a 24-week placebo-controlled trial of sitagliptin 100 mg administered once daily added to a twice daily metformin regimen, there were no adverse reactions reported regardless of investigator assessment of causality in ?-U5% of patients and more commonly than in patients given placebo. Discontinuation of therapy due to clinical adverse reactions was similar to the placebo treatment group (sitagliptin and metformin, 1. Adverse reactions of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. The overall incidence of pre-specified adverse reactions of hypoglycemia in patients with type 2 diabetes inadequately controlled on diet and exercise was 0. In patients with type 2 diabetes inadequately controlled on metformin alone, the overall incidence of adverse reactions of hypoglycemia was 1. Gastrointestinal Adverse ReactionsThe incidences of pre-selected gastrointestinal adverse experiences in patients treated with sitagliptin and metformin were similar to those reported for patients treated with metformin alone. Table 2: Pre-selected Gastrointestinal Adverse Reactions (Regardless of Investigator Assessment of Causality) Reported in Patients with Type 2 Diabetes Receiving Sitagliptin and Metformin. Study of Sitagliptin and Metformin in Patients Inadequately ControlledStudy of Sitagliptin Add-on in Patients Inadequately Controlled on Metformin AloneSitagliptin 100 Pmg QD and Metformin?-P Abdominal discomfort was included in the analysis of abdominal pain in the study of initial therapy. Sitagliptin in Combination with Metformin and GlimepirideIn a 24-week placebo-controlled study of sitagliptin 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on metformin and glimepiride (sitagliptin, N=116; placebo, N=113), the adverse reactions reported regardless of investigator assessment of causality in ?-U5% of patients treated with sitagliptin and more commonly than in patients treated with placebo were: hypoglycemia (sitagliptin, 16. No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with the combination of sitagliptin and metformin. The most common adverse experience in sitagliptin monotherapy reported regardless of investigator assessment of causality in ?-U5% of patients and more commonly than in patients given placebo was nasopharyngitis. The most common (>5%) established adverse reactions due to initiation of metformin therapy are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The incidence of laboratory adverse reactions was similar in patients treated with sitagliptin and metformin (7. In most but not all studies, a small increase in white blood cell count (approximately 200 cells/microL difference in WBC vs placebo; mean baseline WBC approximately 6600 cells/microL) was observed due to a small increase in neutrophils. This change in laboratory parameters is not considered to be clinically relevant. In controlled clinical trials of metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin BThe following additional adverse reactions have been identified during postapproval use of Janumet or sitagliptin, one of the components of Janumet. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions include anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome [see Warnings and Precautions ]; upper respiratory tract infection; hepatic enzyme elevations; pancreatitis. These increases are not considered likely to be clinically meaningful. Digoxin, as a cationic drug, has the potential to compete with metformin for common renal tubular transport systems, thus affecting the serum concentrations of either digoxin, metformin or both. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or Janumet is recommended. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects make the clinical significance of this interaction uncertain. No information is available about the interaction of metformin and furosemide when co-administered chronically. In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when co-administered in single-dose interaction studies. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins. There are no adequate and well-controlled studies in pregnant women with Janumet or its individual components; therefore, the safety of Janumet in pregnant women is not known. Janumet should be used during pregnancy only if clearly needed. Health care providers are encouraged to report any prenatal exposure to Janumet by calling the Pregnancy Registry at (800) 986-8999. No animal studies have been conducted with the combined products in Janumet to evaluate effects on reproduction. The following data are based on findings in studies performed with sitagliptin or metformin individually. Reproduction studies have been performed in rats and rabbits. Doses of sitagliptin up to 125 mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies with sitagliptin in pregnant women. Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) was not teratogenic at oral doses up to 250 mg/kg (rats) and 125 mg/kg (rabbits), or approximately 30 and 20 times human exposure at the maximum recommended human dose (MRHD) of 100 mg/day based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100 times human exposure at the MRHD. Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1000 mg/kg. No functional or behavioral toxicity was observed in offspring of rats. Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg /kg/day. This represents an exposure of about 2 and 6 times the maximum recommended human daily dose of 2,000 mg based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin. Because sitagliptin and metformin are substantially excreted by the kidney, and because aging can be associated with reduced renal function, Janumet should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and young patients.

Share :

Comments are closed.