The Ingredients: Clobetasol Propionate
Dosage Form and Administration: Shampoo; Topical
U Drug Trade Name: Clobex
Firm: Galderma Labs
Strength: 0.05%
New Drug Application Type: N
The Drug Application Number: 21644
Medicine Product Number: 1
Approval Date: 2/5/2004
Reference Listed Drug: Yes
Type: RX
Applicant Full Name: Galderma Laboratories Inc
Local Number: 25768

Effective Treatment Principles

Addiction is a complex but treatable condition that affects brain function and behavior. The abuse of drugs alters the structure and function of the brain, resulting in changes that persist long after drug use. This may explain why drug abusers are at risk for relapse even after long periods of abstinence and despite the potentially devastating consequences. No single treatment is appropriate for every user in recovery. Matching treatment settings, interventions and services to the particular problems and needs of a patient is critical to achieving success in returning to productive functioning in the family, workplace and society. Treatment needs to be readily available. Because individuals addicted to drugs may be uncertain about entering treatment, it is critical to take advantage of available services the moment people are ready for treatment. Patients can be lost if treatment is not immediately available or readily accessible. As with other chronic conditions, the earlier the user seeks treatment, the greater the likelihood of positive outcomes. Effective treatment addresses the multiple needs of the individual, not just drug abuse. To be effective, treatment must address the drug abuse and any associated medical, psychological, social, vocational and legal problems. It is also important that treatment be appropriate to the age, gender, ethnicity and culture of the user. It is critical that the user remain in treatment for an adequate recovery period. The appropriate duration for an individual depends on the type and degree of problems and needs. Research indicates that most addicted individuals need at least three months in treatment to significantly reduce or stop drug use. Studies also suggest that the best recovery outcomes occur with longer durations of treatment. Recovery from drug addiction is a long process and frequently requires multiple episodes of treatment. As with other chronic illnesses, relapses to drug abuse can occur and signifies that treatment should be reinstated or adjusted. Because individuals often leave treatment prematurely, programs should include strategies to engage and keep patients in treatment. The most commonly used forms of drug abuse treatment are counseling in individual and or groups and other behavioral therapies. Behavioral therapies vary in focus and may involve addressing a the motivation of a user to change, providing incentives for abstinence, building skills to resist drug use, replacing activities involving drugs with constructive and rewarding activities, improving problem solving skills and facilitating better interpersonal relationships. Participation in group therapy and other peer support programs during and following treatment can help maintain abstinence from drugs. Medications can be an important element of treatment for many patients, especially when combined with counseling and other behavioral therapies. For example, methadone and buprenorphine are effective in helping individuals addicted to heroin or other opioids stabilize and reduce illicit drug use. Naltrexone is also an effective medication for some individuals addicted to opioids and some patients with alcohol dependence. Other medications for alcohol dependence include acamprosate, disulfiram and topiramate. For persons addicted to nicotine, a nicotine replacement product such as patches, gum or lozenges or an oral medication such as bupropion or varenicline can be an effective component of treatment when part of a comprehensive behavioral rehab program. Doctors must modify and monitor the treatments and services for each patient to ensure that the rehabilitation meets the changing needs of the addict in recovery. A patient may require varying combinations of services and treatment components during the course of treatment and recovery. In addition to counseling or psychotherapy, a patient may require medication, medical services, family therapy, parenting instruction, vocational rehabilitation and or social and legal services. For many patients, a continuing care approach provides the best results, with the treatment intensity varying according to changing needs. Many individuals addicted to drugs also have other mental disorders. Because drug abuse and addiction, which are both mental disorders, often occur together with additional mental illnesses, doctors should carefully assess patients that present with one condition for the other. When these problems occur together, treatment should address both by the use of medication. Medically assisted detoxification is only the first stage of addiction treatment and by itself does little to change the effects of drug abuse. Although medically assisted detoxification can safely manage the acute physical symptoms of withdrawal and, for some, can pave the way for effective addiction treatment in the end, detoxification alone is rarely sufficient to help addicted individuals achieve a new lifestyle of abstinence. Thus, patients should be encouraged to continue drug treatment following detoxification. Motivational enhancement and incentive strategies, begun at initial patient intake, can improve treatment engagement. Specialists must continually monitor drug use during treatment, as patients can lapse during treatment. Another powerful motivator to get clean is if patients know that doctors monitor the drug intake of each patient. Monitoring also provides an early indication of a return to drug use, signaling the possible need to adjust the treatment plan of an individual to better meet changing needs. Drug abuse treatment can facilitate adherence to other medical treatments. Patients may be reluctant to accept screening for HIV and other infectious conditions. Specialists should encourage and support HIV screening and inform patients that highly active antiretroviral therapy can be effective in combating HIV. Treatments vary, depending on the type of drug and the characteristics of the patient. The best programs provide a combination of therapies and other services.

FDA Medical Device Registration

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States must register annually with the FDA, which is a process known as establishment registration. Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee is available at "Who Must Register, List and Pay the Fee." There are no reductions in annual establishment registration fees for small businesses or any other group. Most establishments that are required to register with the FDA are also required to list the devices made there and the functions of those devices. If a device requires pre-market approval or notification before marketed in the U.S., then the owner/operator should also submit the FDA pre-market submission number. The amendments to the Medical Device User Fee Modernization Act require that after September 30, 2007, all businesses submit registration and listing information electronically. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. This information augments the ability of the United States to prepare for and respond to public health emergencies.

Rash

Rashes involve changes in the color or texture of the skin. Doctors can determine the cause of a rash from its visible characteristics and other symptoms. Dermatitis is the name of a simple rash and means inflammation of the skin. Contact dermatitis presents from things the skin touches, such as: dyes and other chemicals in clothing; chemicals in elastic, latex and rubber products; cosmetics, soaps and detergents; and poison ivy and oak.

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Surgical Weight

A fat loss surgeon performs bariatric surgery, bypass surgery, gastric banding and obesity surgery. Surgical weight control is an option for very overweight who cannot lose pounds with only a healthy diet and exercise. Weight loss surgery limits the amount of food a person can intake. Some operations also restrict the amount of food the stomach can digest. Many people who have fat loss surgery lose weight quickly. If patients follow all diet and exercise recommendations, most can keep the weight off. Like all surgeries, fat loss surgery has risks and complications, including infections, hernias and blood clots. Men who are at least 100 pounds overweight and women who are at least 80 pounds overweight are eligible for this surgery. If candidates somewhat less overweight, surgery still might be an option if they also have diabetes, heart disease or sleep apnea. Bariatric surgery, or weight loss surgery, is a type of procedure that doctors perform on people who are dangerously obese. This procedure achieves weight loss by surgical reduction of the size of the stomach by means of an implanted gastric banding device, through removal of a portion of the stomach or by re-sectioning and re-routing the small intestines to a small stomach pouch as gastric bypass surgery. Long-term studies show the procedures result in significant long-term weight loss, recovery from diabetes, improvement in cardiovascular risk factors and a reduction in mortality of 23 percent to 40 percent. The U.S. National Institutes of Health recommends bariatric surgery for obese people with a body mass index (BMI) of at least 40.