541 Final Exam

-Statements on pediatric use of a drug for an INDICATION approved for adults must be based on substantial evidence derived from adequate and well-controlled studies, unless the requirement is waived.

-higher risk of serious life-threatening situations in children with 1. Congenital Heart Disease and 2. Pulmonary Hypertension who need lower doses than predicted to prevent respiratory compromise.

-Recognition of a need for a dose of two (2) to three (3) times (in mg/kg) the dose used in adults for effective treatment of childhood arthritis

-Need to use HIGHER doses in children less than five (5) years old in order to control seizures and new adverse events such as hostility and aggression identified in children less than twelve (12) years.

-Increased mortality when used for pediatric ICU sedation; concomitant administration with fentanyl MAY result in serious slowing of the heart rate

-NEW PRECAUTION about the potential of the product to cause seizures in children without a previous history of such

-efficacy NOT ESTABLISHED AT THE DOSE STUDIED IN PEDIATRIC CLINICAL TRIALS.

-a newborn infant, especially one less than four (4) weeks old

-birth to twelve (12) months

-12 to 36 months (1 to 3 years)

-individuals less than 12 years old.
---children 6-12 months
---children 1-12 years of age

-Teenagers, age 13-19

-How much to give
-How often to give it
-What is the medication
-WARNINGS about the medication
-IS THE DRUG SAFE FOR KIDS? ...if no dose for children under 12, ask doctor of pharmacist
-If the medication has ALCOHOL in it, (ie cough and cold syrups) may want to double-check with DR

-DO NOT USE unless given SPECIFIC directions to do so by a healthcare provider

-Do not give children medications that are packaged and made for adults

-too much medicine may lead to serious and life-threatening side effects, especially in children aged 2 years and younger

-Use the measuring device that is packaged with the medicine.

-a Kitchen teaspoon is NOT appropriate for measuring child's meds

-Purchase one at the pharmacy!
-Make sure the dropper has markings on it that match the dosing that is in the DIRECTIONS in the "Drug Facts" box on the package label or is recommending by the child's health care provider

-NO. Cough and cold medicines only treat the SYMPTOMS of the common cold such as runny nose, congestion, fever, aches, and irritability.
-Children get better with time. :)

-STOP USING THE PRODUCT and immediately take the child to a HCP for evaluation

-using a drug that has not been tested in children.

-Most drugs have NOT been tested in children

-Only 20-30% of drugs approved by the FDA are labeled for pediatric use

-the child is "IN AN EXPERIMENT" with every use

-UNDERTREATMENT: failure of therapy
-OVERTREATMENT: toxicity

-Inappropriate dose and use may lead to effect on GROWTH and DEVELOPMENT

-Drug safety for pediatric patients cannot be adequately assessed from adult studies!

-an Act to amend the Federal Food, Drug and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children

-Difficulty swallowing Tablets

-NPO

-Poor GI absorption

-Need to discharge or problematic, IV access

-Flavor/taste

-Children are a work in progress

-Vast changes occur in :
=Physiology
=body size/composition
=growth and development
=cognitive/motor function
=Special Organ System Maturation

-Developmental changes in metabolism (includes the phase I and phase II enzyme activities)

-Body composition (water and lipid partitions)

-Receptor expression and function

-Growth Rate

-Organ functional capacity

-Chloramphenicol in the newborn

-tetracyclines in infants and children

-benzyl alcohol containing IV fludis in premies/neonates

-aminoglycosides in the newborn

-acetaminophen acute overdose in young children

-Children and Teenagers should NEVER take aspirin or products containing other salicylates if:
--they have chickenpox
-flu symptoms
-recovering from these or other viruses

-associated with aspirin use in children

-can result form aspirin use during or after viral infections such as flu or chickenpox.

-Reye is a RARE but SERIOUS condition that can cause death.

-extemporaneous formulations are important for infants and young children that cannot swallow tablets or capsules

-These patients also require DOSES BASED ON BODY WEIGHT, and fixed doses in tablets or capsules intended for adults CANNOT be given to infants or children.

-should be avoided as sorbitol can lead to diarrhea and propylene glycol can lead to HYPEROSMOLARITY

-this should be assessed because a palatable formulation is more likely to improve a patients compliance and minimize SPILLAGE during administration of doses.

-used to assess palatability of formulations in peds

-Cinnamon, raspberry, orange, maple, butterscotch, licorice

-Fruit, berry, vanilla

-fruit, citrus, cherry

-cocoa, chocolate, mint, cherry, walnut, licorice, raspberry, tutti fruity

-wintergreen, peppermint oil, lemon, anise

-Mint, marshmallow

-cherry, maple, pineapple, orange

-apricot, cherry, cinnamon, grape, honey

-anise, apricot, butterscotch, cherry

-cherry, grape, lemon-lime

-75% use household teaspoons

-ALL of them involve dosing errors

-syringes
-droppers
-cylindrical dosing spoons
-dosage cups

-Cherry Juice 475 mL
-Sucrose 800g
-Alcohol 20mL <-----
-purified water qs ad 1000mL

-5 to 10mL (1 to 2 teaspoons) preceded or followed by 120 to 240mL (1/2 to 1 cup) of water

-15mL (1 tablespoon) preceded or followed by 120 to 240 mL (1/2 to 1 cup) of water

-15 to 30 mL (1 to 2 tablespoons) FOLLOWED IMMEDIATELY by 240mL (1 cup) of water

-can cause major toxicity and neuronal dysfunction

25mg/100ml (25%mg)

-Never give enough to produce ethanol concentration of 25mg/100mL

-Children < 6 years should be monitored by physicians when using products containing alcohol

-Change dosing interval to avoid alcohol accumulation

-SAFETY CLOSURES

-no effective FDA approved products available

-when available dosing forms are inappropriate

-multiple and concurrent disease states are present

-minimize side effects

-when economic realities would preclude treatment with the approved product (Vet driven)

-when compounding would encourage compliance of dosage/therapeutic regimens

-Name and address of attending Vet
-Date dispensed
-Medically active ingredients
-Identity of animal(s) to be treated (species, class, group, or individual animals)
-Directions for use
-Cautionary statements if needed
-Slaughter-withdrawal times and/or milk withholding times, if appropriate
-ADDITIONAL INFO on LABEL:
---Disease conditions to be treated
---Expiration date

-should NOT be administered to CATS due to a deficiency in glucuronyl transferase, required to metabolize the drug.....death may occur

-during sickness, some animals maintain their hydration while others do not

-This alters the drug distribution within the bodies as well as metabolism and excretion

-differs from animal to animal

-urinary pH of herbivores is slightly alkaline

-urinary pH of carnivores is slightly acidic

-short GI tract (2hours)
-longer intestinal villi, resulting in greater absorption

-higher bile salt secretion, increasing the solubility of some poorly water soluble drugs
-dogs have a higher pH in the intestine...resulting in better absorption of drugs that are WEAK BASES
-Dogs have lower basal acid secretion than people

-Legal requirements concerning Drug Residues

-Short-half-life drugs are often chosen...they are readily eliminated from the animal prior to market

-Not only concerned with welfare of the animal, but also for public health.

-Oral
-Parenteral
-Implants
-Intramammary
-Topical
-Body Cavity

-Boluses
-Lick Blocks
-Rumen Retention
-Collars that release toxins/meds that are absorbed into the animals subQ fat

-Alcohol = toxic
-Chocolate = CNS and cardiac toxicity
-Coffee and Tea = Caffeine
-Ham Fat Trimmings = Pancreatitis
-Grapes & Raisins = Kidney Damage
-Milk & Dairy Products = >50% of dogs are lactose intolerant
-Onions and Garlic = Hemolytic Anemia

-soft, easy to chew, medicated pet treats which are custom compounded to the vet's specifications

-prednisolone
-methimazole
-metronidazole
-atenolol
-amlodipine
-diethylstilbestrol
-phenylpropanolamine
-cisapride

-used for behavior problems
-Urine spraying for male cats is a big problem that can be solved using this med
-Transdermal formulations of both buspirone and amitriptyline are routinely advertised by vet compounding pharmacies.

-penetration enhancer

-"pleuronic lecithin organogel"

-ingredients in PLO act as surfactants, emulsifiers, and solubilizing agents

-Shelf-life : 6 months
-store in a sealed plastic bag at room temp. Store away from extreme heat.

-Give directly as a treat or mix with food

-Porcine insulin has three amino acid differences and is structurally closest to canine insulin.

-Cats accept bovine insulin much better because it is most like their own.

-Desirable to administer one dose per day, better compliance

-diseases that can be passed from animals, whether wild or domesticated, to humans

-coming in contact with ANIMAL WASTE
-direct contact with infected animals
-some diseases spread by drinking water that contains parasite eggs
-Tapeworms are spread by eating the infected flesh of animals
-insect vectors: flea or ticks

-a disease of warm blooded animals, particularly cattle and sheep.

-causes severe skin and lung damage

-progressive fatal disease of the nervous system of domestic animals.
-transmitted by eating infected food

-acute disease usually marked by skin rash, fever, fatigue, and chills

-if untreated, can result in cardiac and nervous system damage

-high fever, chills, and muscle pain

-spread by drinking raw milk or tick bites

-rabies

-carry several other viral infections that can be spread to humans

-can carry the causative organisms for the plague, anthrax, cowpox, tapeworm, and many bacterial infections

-plague, tapeworm, rabies, Rocky Mountain Spotted Fever, and Lyme Disease

-anthrax, rabies, and Salmonella infections

-anthrax, European tick-borne encephalitis, rabies, tapeworm, Salmonella infections and many bacterial and viral disease

-tapeworm, anthrax, influenza, and rabies

-rabies, European tick borne encephalitis, Salmonella infections and many bacterial and viral infections

-plague and Q Fever

-Chlamydia, Pasteurella, Histoplasma

-The preparation of Components into a Drug product 1.) as the result of a Practitioner's Prescription Drug Order or initiative based on the Practitioner/patient/Pharmacist relationship in the course of professional practice or 2.) for the purpose of, or as an incident to , research, teaching or chemical analysis and not for sale or Dispensing. Compounding also includes the preparation of Drugs or Devices in anticipation of receiving Prescription Drug Orders based on routine, regularly observed prescribing patterns.