Safety Profile of Meropenem: An Updated Review of Over 6000 Patients Treated with Meropenem

Meropenem is a broad-spectrum carbapenem antibacterial with potent antimicrobial activity against a broad range of Gram-negative, Gram-positive and anaerobic bacteria. The second parenteral carbapenem to be introduced worldwide, meropenem has been in clinical use since 1994. Two previous safety reviews have established that meropenem has a favourable and acceptable safety profile. This new review was conducted after the approval of meropenem in the US in 2005 for the treatment of patients with complicated skin and skin-structure infections, in addition to the previously approved indications of intra-abdominal infections and paediatric bacterial meningitis. The analysis includes the clinical trial data from the previous safety reviews, updated with expanded experience across a number of serious bacterial infections, including a large international study in patients with skin or skin-structure infections and further experience in patients with intra-abdominal infections and bacterial meningitis. A total of 6154 patients with 6308 meropenem exposures were compared with 4483 patients treated with comparator agents (4593 exposures), and the paediatric population base for which safety data are available has doubled to over 1000 patients.
The data presented reinforce the favourable safety profile of meropenem. In general, the incidence and pattern of adverse events occurring with meropenem were similar to those of the first carbapenem, imipenem/cilastatin, and to those of the cephalosporin- and clindamycin-based regimens to which it had been compared. The most common adverse events reported for meropenem were diarrhoea (2.5%), rash (1.4%) and nausea/vomiting (1.2%). No adverse event occurred in more than 3% of patient exposures to meropenem, indicating a low overall frequency of adverse events as well as excellent gastrointestinal tolerability. Furthermore, no unexpected adverse events were identified, and the very low incidence of seizures in patients with meningitis was not considered to be drug related. In infections other than meningitis, the incidence of seizures considered by investigators to be related to meropenem treatment was 0.07%. In the new studies that updated the earlier safety data, no new cases of drug-related seizure were reported for any treatment or patient group (meningitis/non-meningitis infections).
In conclusion, meropenem is well tolerated and has good CNS and gastrointestinal tolerability when used for the treatment of serious bacterial infections in a wide range of adult and paediatric patient populations.

Author: Linden, Peter1
Source: Drug Safety, Volume 30, Number 8, 2007 , pp. 657-668(12)
Publisher: Adis International

Nasal beclomethasone prevents the seasonal increase in bronchial responsiveness in patients with allergic rhinitis and asthma.

Corren J, Adinoff AD, Buchmeier AD, Irvin CG.

National Jewish Center for Immunology and Respiratory Medicine, Department of Internal Medicine, University of Colorado Health Sciences Center, Denver.

Experimental studies have demonstrated that induction of a nasal allergic reaction can lead to an increase in bronchial responsiveness (BR). To assess the clinical relevance of these experimental changes to chronic asthma, we sought to determine the effect of nasal beclomethasone dipropionate (Bdp) on BR in patients with seasonal allergic rhinitis and asthma. Eighteen subjects with histories of seasonal allergic rhinitis and asthma during the fall pollen season with positive skin tests to short ragweed and bronchial hyperresponsiveness to inhaled methacholine were assigned to receive either nasal Bdp (336 micrograms/day) or placebo for the entire ragweed season. Patients recorded daily nasal and chest symptoms, nasal blockage index, oral peak expiratory flow rates, and supplemental medication use. BR to methacholine was measured during the baseline period and 6 weeks into the ragweed season. Although the Bdp group did have a significant improvement in nasal blockage index, there was no improvement in daily asthma symptom scores, oral peak expiratory flow, or asthma medication use. However, subjects treated with Bdp were protected from the increase in BR seen in the placebo group (geometric mean PC20 placebo group: baseline = 0.70, week 6 = 0.29; Bdp group: baseline = 0.80, week 6 = 0.93; intergroup difference, p = 0.022). We conclude that nasal corticosteroid therapy can prevent the increase in BR associated with seasonal pollen exposure in patients with allergic rhinitis and asthma.

Anti-insomnia drugs

Definition
Anti-insomnia drugs are medicines that help people fall asleep or stay asleep.
Purpose
Physicians prescribe anti-insomnia drugs for short-term treatment of insomnia-a sleep problem in which people have trouble falling asleep or staying asleep or wake up too early and can't go back to sleep. These drugs should be used only for occasional treatment of temporary sleep problems and should not be taken for more than a week or two at a time. People whose sleep problems last longer than this should see a physician. Their sleep problems could be a sign of another medical problem.
Description
The anti-insomnia drug described here, zolpidem (Ambien), is a classified as a central nervous system (CNS) depressant. CNS depressants are medicines that slow the nervous system. Physicians also prescribe medicines in the benzodiazepine family, such as flurazepam (Dalmane), quazepam (Doral), triazolam (Halcion), estazolam (ProSom), and temazepam (Restoril), for insomnia. Benzodiazepine drugs are described in the essay on antianxiety drugs. Zaleplon (Sonata) is another anti-insomnia drug that is not related to other drugs with the same effect. The barbiturates, such as pentobarbital (Nembutal) and secobarbital (Seconal) are no longer commonly used to treat insomnia because they are too dangerous if they are taken in overdoses. For patients with mild insomnia, some antihistamines, such as diphenhydramine (Benadryl) or hydroxyzine (Atarax) may be used, since these also cause sleepiness.
Zolpidem is available only with a physician's prescription and comes in tablet form.
Recommended dosage
The recommended dose for adults is 5-10 mg just before bedtime. The medicine works quickly, often within 20 minutes, so it should be taken right before going to bed.
For older people and others who may be more sensitive to the drug's effects, the recommended starting dosage is 5 mg just before bedtime.
Zolpidem may be taken with food or on an empty stomach, but it may work faster when taken on an empty stomach. Check with a physician or pharmacists for instructions on how to take the medicine.
Precautions
Zolpidem is meant only for short-term treatment of insomnia. If sleep problems last more than seven to 10 days, check with a physician. Longer-lasting sleep problems could be a sign of another medical problem. Also, this drug may lose its effectiveness when taken every night for more than a few weeks.
Some people feel drowsy, dizzy, confused, lightheaded, or less alert the morning after they have taken zolpidem. The medicine may also cause clumsiness, unsteadiness, double vision, or other vision problems the next day. For these reasons, anyone who takes these drugs should not drive, use machines or do anything else that might be dangerous until they have found out how zolpidem affects them.
This medicine has caused cause behavior changes in some people, similar to those seen in people whose behavior changes when they drink alcohol. Examples include giddiness and rage. More extreme changes, such as confusion, agitation, and hallucinations, also are possible. Anyone who starts having strange or unusual thoughts or behavior while taking this medicine should get in touch with his or her physician.
Zolpidem and other sleep medicines may cause a special type of temporary memory loss, in which the person does not remember what happens between the time they take the medicine and the time its effects wear off. This is usually not a problem, because people go to sleep right after taking the medicine and stay asleep until its effects wear off. But it could be a problem for anyone who has to wake up before getting a full night's sleep (seven to eight hours). In particular, travelers should not take this medicine on airplane flights of less than seven to eight hours.
Because zolpidem works work on the central nervous system, it may add to the effects of alcohol and other drugs that slow down the central nervous system, such as antihistamines, cold medicine, allergy medicine, medicine for seizures, tranquilizers, some pain relievers, and muscle relaxants. Zolpidem may also add to the effects of anesthetics, including those used for dental procedures. The combined effects of zolpidem and alcohol or other CNS depressants (drugs that slow the central nervous system) can be very dangerous, leading to unconsciousness or even death. People who take zolpidem should not drink alcohol and should check with their physicians before taking any other CNS depressant. Anyone who shows signs of an overdose or of the effects of combining zolpidem drugs with alcohol or other drugs should have immediate emergency help. Warning signs include severe drowsiness, severe nausea or vomiting, breathing problems, and staggering.
Anyone who takes zolpidem for more than 1-2 weeks should not stop taking it without first checking with a physician. Stopping the drug abruptly may cause rebound insomnia; increased difficulty falling asleep for the first one of two nights after the drug has been discontinued. In rare cases, withdrawal symptoms, such as vomiting, cramps, and unpleasant feelings may occur. Gradual tapering may be necessary.
Older people may be more sensitive to the effects of zolpidem. This may increase the chance of side effects, such as confusion, and may also increase the risk of falling.
In people with breathing problems, zolpidem may worsen the symptoms.
Special conditions
People with certain other medical conditions or who are taking certain other medicines can have problems if they take zolpidem. Before taking this medicine, be sure to let the physician know about any of these conditions:
ALLERGIES
Anyone who has had unusual reactions to zolpidem in the past should let his or her physician know before taking the drugs again. The physician should also be told about any allergies to foods, dyes, preservatives, or other substances.
PREGNANCY
Women who are pregnant or who may become pregnant should check with their physicians about the safety of using zolpidem during pregnancy.
BREASTFEEDING
Women who are breastfeeding should check with their physicians before using zolpidem.
OTHER MEDICAL CONDITIONS
Before using zolpidem, people with any of these medical problems should make sure their physicians are aware of their conditions:
Chronic lung diseases (emphysema, asthma, or chronic bronchitis)
Liver disease
Kidney disease
Current or past alcohol or drug abuse
Depression
Sleep apnea
USE OF CERTAIN MEDICINES
Taking zolpidem with certain other drugs may affect the way the drugs work or may increase the chance of side effects.
Side effects
The most common minor side effects are daytime drowsiness or a "drugged" feeling, vision problems, memory problems, nightmares or unusual dreams, vomiting, nausea, abdominal or stomach pain, diarrhea, dry mouth, headache, and general feeling of discomfort or illness. These problems usually go away as the body adjusts to the drug and do not require medical treatment.
More serious side effects are not common, but may occur. If any of the following side effects occur, check with the physician who prescribed the medicine as soon as possible:
Confusion
Depression
Clumsiness or unsteadiness
Patients who take zolpidem may notice side effects for several weeks after they stop taking the drug. They should check with their physicians if these or other troublesome symptoms occur:
Agitation, nervousness, feelings of panic
Uncontrolled crying
Worsening of mental or emotional problems
Seizures
Tremors
Lightheadedness
Sweating
Flushing
Nausea or abdominal or stomach cramps
Muscle cramps
Unusual tiredness or weakness
Other rare side effects may occur. Anyone who has unusual symptoms after taking zolpidem should get in touch with his or her physician.
Interactions
Zolpidem may interact with other medicines. When this happens, the effects of one or both of the drugs may change or the risk of side effects may be greater. Anyone who takes zolpidem should let the physician know all other medicines he or she is taking. Among the drugs that may interact with zolpidem are:
Other central nervous system (CNS) depressants such as medicine for allergies, colds, hay fever, and asthma; sedatives; tranquilizers; prescription pain medicine; muscle relaxants; medicine for seizures; barbiturates; and anesthetics.
The major tranquilizer chlorpromazine (Thorazine).
Tricyclic antidepressants such as imipramine (Tofranil) and amitriptyline (Elavil).


Gale Encyclopedia of Medicine, Published December, 2002 by the Gale Group The Essay Author is Nancy Ross-Flanigan.
This article was updated on 08-14-2006

The "Quit Smoking" Prescription Drug

What is Champix?
Champix, generic name varenicline, is a prescription pill designed to help smokers stop smoking.

How does it work?
Champix works primarily in two ways. Firstly, it reduces the smoker's craving for nicotine by binding to nicotine receptors in the brain and reduces the symptoms of withdrawal. Secondly, it reduces the satisfaction a smoker receives when smoking a cigarette.

How successful was it in clinical trials?
In trials, 44% of the group treated with Champix had stopped smoking after being treated for 12 weeks, as opposed to 11% of smokers taking the placebo. Over the same duration, it was also shown to be twice as effective as Zyban (bupropion), the other main anti-smoking drug treatment.

Has Champix been approved by the European Commission and the FDA for use as an aid to quitting smoking?
The European Commission approved Champix on September 29th, 2006 as a "stop smoking" aid for adults, based on the results from clinical trials. It should be noted that continued abstinence from cigarettes is higher (70% compared with 50%) when patients take the drug for 24 weeks as opposed to 12, so it may be appropriate for patients who have succeeded in quitting smoking at the 12 week point to take the drug for a further 12 weeks.

The FDA approved the drug in May 2006. See FDA approves novel drug for smoking cessation for further details.

Is Champix available on the NHS?
On May 31st, 2007 Nice (the National Institute for Health and Clinical Excellence) published draft guidance recommending that this drug should be available on NHS prescription. Further details on the Final Appraisal Determination period can be found on the NICE website.

It was approved for prescription on the NHS in Scotland on 14th January, 2007.

How is the drug taken and what is the recommended dose?
It is taken orally. For the first three days, the dosage is 0.5 mg once daily (the 0.5 mg tablet is white). For days four to seven, the dosage is 0.5 mg twice a day. From day eight until the end of the treatment, the dose is 1 mg twice a day (the 0.5 mg tablet is blue).

You should set a date to quit smoking, and start taking the drug one week before this date.

Body weight changes associated with psychopharmacology

The authors discuss changes in body weight associated with various psychopharmaceuticals. METHODS: A large number of articles and books about drug-induced changes in body weight, selected on the basis of various literature searches and the authors' clinical experiences with psychopharmaceuticals, were reviewed. RESULTS: Many psychotropic drugs with antipsychotic, mood stabilizing, and antidepressant properties are associated with weight gain. Others, such as fluoxetine, isocarboxazid, nefazadone, topiramate, and psychostimulants, may cause weight loss. The antipsychotic drugs chlorpromazine, clozapine, and olanzapine are often associated with weight gain. Among antidepressants, amitriptyline and mirtazapine are known to cause weight gain. However, reductions are sometimes observed, and each antidepressant has its own unique weight-effect profile. Mood stabilizers, especially valproate-related products, are also associated with weight gain. CONCLUSIONS: Careful monitoring and consideration of alternative therapies are essential.

Vanina Y, Podolskaya A, Sedky K, Shahab H,
Siddiqui A, Munshi F, Lippmann S.
Department of Psychiatry and Behavioral Science
of the University of Louisville,
Kentuchy 40202, USA.
Psychiatr Serv. 2002 Jul; 53(7): 842-7

Prescription Drug

Depresants
Xanax™ (alprazolam) is from the benzodiazepine family of depressants. It is used to treat insomnia in patients with daytime anxiety or as an anticonvulsant. Alprazolam and diazepam are the two most frequently encountered benzodiazepines on the illicit market.

Valium™ (diazepam) is from the benzodiazepine family of depressants. It is utilized to treat insomnia in patients with daytime anxiety or as an anticonvulsant. It is among the most widely prescribed medications in the United States . Abuse is frequently associated with adolescents and young adults who take the drug to get high. Concurrent use of alcohol or other depressants with Valium™ can be life-threatening. Abuse of benzodiazepines is particularly high among heroin and cocaine abusers.

Stimulants

Methylphenidate (Ritalin™, Concerta™) is a stimulant which is prescribed for attention deficit/hyperactivity disorder. It has a high potential for abuse and produces many of the same effects as cocaine and amphetamines. Binge use, psychotic episodes, cardiovascular complications, and severe psychological addiction have all been associated with methylphenidate abuse.

According to the National Institute on Drug Abuse, methylphenidate is a valuable medicine, for adults as well as children with attention deficit and hyperactivity disorder. Research shows that individuals with ADHD do not become addicted to stimulant medications when taken in the form and dosage prescribed by doctors. In fact, it has been reported that stimulant therapy in childhood is associated with a reduction in the risk for subsequent drug and alcohol use disorders.

Adderall™ is an amphetamine which is used to treat attention deficit hayperactivity disorder (ADHD) in children 6 years of age and older and in adults. Amphetamines have a high potential for abuse. Taking amphetamines for long periods of time may lead to drug addiction. Misuse of amphetamine may cause sudden death and serious heart damage.

Pain Killer

Hydrocodone
Hydrocodone is a semi-synthetic opioid similar in effects to morphine. Vicodin™ is hydrocodone mixed with acetaminophen. Hydrocodone products, when abused, can lead to dependence, tolerance, and addiction. Vicodin™ is one of the most frequently prescribed medications for pain. Other products include Vicoprophen™, Tussionex™, and Lortab™ .

Oxycodone
Oxycodone is used as an analgesic and is formulated into numerous pharmaceuticals including OxyContin™ (a controlled-release product) and with aspirin (Percodan™) or with acetaminophen (Percoset™). These drugs are prescribed for pain relief. They all require a doctor's prescription and are prescribed for moderate to severe pain.

FENTANYL™ is extensively used for anesthesia and analgesia. Duragesic™ is a fentanyl transdermal patch used in chronic pain management, and Actiq is a solid formulation of fentanyl citrate on a stick that dissolves slowly in the mouth for transmucosal absorption. Illicit use of pharmaceutical fentanyl first appeared in the mid-1970's in the medical community. To date, over 12 different analogues of fentanyl have been produced clandestinely and identified in the U.S. drug traffic. The biological effects are indistinguishable from those of heroin, with the exception that the fentanyls may be hundreds of times more potent. Fentanyls are most commonly used by intravenous administration, but like heroin, they may also be smoked or snorted.

ULTRAM™(tramadol hydrochloride) and ULTRACET™ (tramadol with acetaminophen) are prescription medications indicated for the management of moderate to moderately severe pain. Side effects include: dizziness, drowsiness, or headache; nervousness, tremor, or anxiety; nausea, vomiting, constipation, or diarrhea; or itching, dry mouth, or sweating.

Tramadol is habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment.

Insulin Pump

If we have Patient diabetes mellitus with blood glucose level over 300mg% again though have put some anti diabetic oral we can use Insulin pump to decrease the blood glucose level. This is new treatment method there we can give intensive insulin after check level of blood glucose, insulin demand dose in the body. This is the best solution for treatment Diabetes Type 1 and Type 2.
Insulin Pump Danadiabecare have designed with high technology by two micro computer and the best safety system.
Insulin Pump will give insulin inject continous 24 hours with terapeutic dose that be made by a doctor depend on patient's insulin demand. The spectaculare news is insulin pump can be programmed to give injection from 0,01 unit/hour to the maximum dose that evaluation by a doctor.

1. Complication Prevention
Insulin pump will suplay insulin in the body continously with the doctor recommend dose. So, blood glucose level will be normal and prevents the diabetic complications, like renal disorder, eye disorder, stroke and ulkus diabeticum.

2. Lose The Level of Diabetes/ Recovery
Give the treatment dose insulin by insulin pump into the body that evaluation by demand of the Diabetes Mellitus Type 2 will give a rest for Beta Cells and make its get the function again. So, next time patient won't need out insulin again.

3. Increase Life Quailty
Patient with insulin pump get free diet than another patient. So, they have enough callory and feel better and they won't need the diabetic oral drugs again.

Diabetes Mellitus Friendship

Diabetes Mellitus Friendship Seminar:
Date : May 17th, 2008 at 09.00 - 12.00 am
Place : Jogja International Hospital,
Jl. Ringroad Utara no. 160, Condong Catur, Depok, Sleman, Yogyakarta - Indonesia.55283
phone: +622744463535; fax: +622744463444.
e-mail: prabata@rs-jih.com

Anti-anxiety Medications

Benzodiazepines are used to treat anxiety, but they can be addictive and are only prescribed only for short periods. One exception is panic disorder, for which they may be used for six months to a year.

Some people have withdrawal symptoms when they stop taking benzodiazepines, although reducing the dosage gradually can diminish bothersome symptoms. In certain instances, the symptoms of anxiety can rebound after these medications are stopped.

Other medications

If you have been diagnosed with an anxiety disorder, your doctor may give you a beta-blocker for going into a situation where an attack may happen. The beta-blocker can keep your heart from pounding, your hands from shaking and other physical symptoms from developing.

Before taking medication for an anxiety disorder:

• Ask your doctor to tell you about the effects and side effects.
• Tell your doctor about any alternative therapies or over-the-counter medications you are using.
• Ask your doctor when and how the medication will be stopped. Some drugs have to be tapered slowly under a doctor's care.
• Be aware some medications are effective in anxiety disorders only as long as they are taken regularly, and symptoms may come back if you stop the medication.