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ALMANA GENERAL HOSPITALJubail, Kingdom of Saudi Arabia Pharmacy updates
DATE: 09.10.2011
Revised USP Standards: Revision of Product Dating Specifications
The USP Subcommittee on Packaging, Storage, and Distribution (SCPSD) has revisedproduct dating specifications as they relate to pharmacy practice., In response to commentsreceived from interested parties regarding beyond- use dates for non sterile medications that arerepackaged into unit dose or single-unit containers, the requirement has been changed from theprevious period of six months from the date of repackaging or 25% of the time remaining untilthe expiration date, whichever is less, to one year.[2] The revised requirement states, "For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers,the beyond-use date shall be one year or less, unless stability data or the manufacturer's labelingindicates otherwise. For all other types of non sterile dosage forms, the beyond-use date is oneyear or the time remaining of the expiration date. FDA Reduces Dose of Acetaminophen in Combination Prescription Products
All prescription combinations of opioids and acetaminophen can no longer contain morethan 325mg of acetaminophen per tablet. In addition, manufacturers must update the labels ofall prescription acetaminophen products to warn of the potential risk for severe liver injuryTo be aware of the potential for severe liver injury when using products containingacetaminophen, patients should:1- Check their prescription and over-the-counter medications to determine if they containacetaminophen2-Avoid taking multiple products containing acetaminophen at the same time.
3-Ensure that the amount of acetaminophen taken in a 24-hour period does not exceed thecurrently labeled maximum dose of 4,000 milligramsFDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
New warnings against use of terbutaline to treat preterm labor
Injectable terbutaline should not be used in pregnant women for prevention or prolonged
treatment The At this time, FDA recommends that Healthcare Professionals be aware that:
1-Death and serious adverse reactions, including increased heart rate, transient hyperglycemia,
hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been
reported after prolonged administration of oral or injectable terbutaline to pregnant women.
2-Treatment with terbutaline administered by injection or by continuous infusion pump should
not be used beyond 48 to 72 hours. In particular, injectable terbutaline should not be used in the
outpatient or home setting.

3-There are certain obstetrical conditions where the healthcare professional may decide that the benefit of terbutaline injection for an individual patient in a hospital setting clearly outweighsthe risk 4-Oral terbutaline is contraindicated for the treatment or prevention of preterm labor. Antipsychotic drug labels updated on use during pregnancy and risk of abnormal
muscle movements and withdrawal symptoms in newborns

The Food and Drug Administration issued a Drug Safety Communication informing
healthcare professionals that it has updated the Pregnancy section of drug labels for the entire
class of antipsychotic drugs. The new drug labels now contain more and consistent information
about the potential risk for abnormal muscle movements, including extrapyramidal signs or EPS,
and withdrawal symptoms in newborns whose mothers were treated with these drugs during the
third trimester of pregnancy.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia
and bipolar disorder, and have been shown to improve daily functioning in individuals with
these disorders. Common brand names for antipsychotic drugs include Haldol, Clozapine,
Risperdal, Zyprexa, Seroquel, Abilify,etc.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased
or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in
feeding. In some newborns, the symptoms subside within hours or days and do not require
specific treatment; the other newborns may require longer hospital stays
At this time, FDA recommends that Healthcare Professionals:
1-Know that antipsychotic medications cross the placenta.
2-Be aware that neonates exposed to antipsychotic medications during the third trimester of
pregnancy are at risk for EPS and/or withdrawal symptoms following delivery.
3-Counsel patients about the benefits and risks of taking antipsychotic drugs during pregnancy.
4-Monitor neonates exhibiting EPS or withdrawal symptoms. Some neonates recover within
hours or days without specific treatment; others may require prolonged hospitalization.
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy
and risk of abnormal muscle movements and withdrawal symptoms in newborns :

Risk of oral clefts in children born to mothers taking Topamax (topiramate)
There is a new data showing that there is an increased risk for the development of cleft lip
and/or cleft palate (also known as oral clefts) in infants born to women treated with Topamax, or
topiramate, during pregnancy
At this time, FDA recommends that Healthcare Professionals be aware that:
1-You should inform women of childbearing age of the increased risk for oral clefts when
topiramate is used in the first trimester of pregnancy.
2-You should weigh the benefits and risks of topiramate when prescribing this drug to women of
childbearing age, particularly when treating a condition not usually associated with permanent
injury or death. Alternative medications that have a lower risk of oral clefts and other adverse
birth outcomes should be considered. Healthcare professionals should discuss the relative risks
and benefits of appropriate alternative therapies.
3-If the decision is made to prescribe topiramate to women of childbearing age, healthcare
professionals should recommend use of effective contraception for women who are not planning
a pregnancy, keeping in mind the potential for a decrease in hormonal exposure and a possible
decrease in contraceptive efficacy when using estrogen-containing birth control with topiramate.
FDA Drug Safety Podcast for Healthcare Professionals: Risk of oral clefts in children born to
mothers taking Topamax (topiramate)



CapÍtulo 1 actos de habla.doc

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Preventive Veterinary Medicine 63 (2004) 237–256A meta-analysis of the milk-production responseafter anthelmintic treatment in naturallyJavier Sanchez , Ian Dohoo , Jeromy Carrier , Luc DesCˆoteaux a Department of Health Management, Atlantic Veterinary College, University of Prince Edward Island, 550 University Avenue, Charlottetown, PEI, Canada C1A 4P3 b Faculté de Médécine Vet

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