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INJECTIONS
Injections - sterile, pyrogen-free preparations intended to be administered parenterally. parenteral - injectable routes of administration. - derived from the Greek words para (outside) and enteron (intestine) - additives: buffer, stabilizer, antibacterial preservative, antioxidant - packaged in hermetic containers Pyrogens - fever-producing organic substances arising from microbial contamination - responsible for many of the febrile reactions in patients following IV injections.
DIFF. PARENTERAL ROUTES ADMINISTRATION Drugs may be injected into the almost any organ or area of the body: joints (intra-articular) joint fluid area (intrasynovial) spinal column (intraspinal) spinal fluid (intrathecal) arteries (intra-arterial) heart (intracardiac) vein (intravenous, IV) muscle (intra-muscular, IM) skin (intradermal, ID, intracutaneous) under the skin (subcutaneous, SC, sub-Q, SQ, hypodermic, hypo)
INTRAVENOUS ROUTE
INTRVENOUS ROUTE
Thrombus
Embolus
Intravenous drugs Advantages: - rapid action compared with other routes of administration. - Optimum blood levels achieved with accuracy and immediacy not possible by other routes. - lifesaving in emergencies, prompt action with the direct placement of the drug to the circulation Disadvantages: - once administered it cannot be retrieved. - drug cannot be easily removed from the circulation in adverse drug reaction
Intravenous drugs
part selected: veins of the antecubital area (in front of the elbow) - large, superficial, and easy to see and enter.
Sterile/disinfected:
*injectable solutions, syringes and needles, and the point of entrance - reduces the chance of carrying bacteria from the skin into the blood via the needle.
infusion or flow rate for intravenous fluids - adjusted according to the needs of patient - expressed in mL/hour and range from 42 to 150 mL/hour.
Intravenous drugs - in aqueous solution - must mix with the circulating blood and not precipitate from solution: lead to pulmonary microcapillary occlusion and blockage of blood flow. Intravenous fat emulsions - use: source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods.
ADVANTAGES: - provides constant & uniform analgesia - prevents pharmacokinetic and pharmacodynamic differences between patients from interfering with the effectiveness of analgesia - permits patients to medicate themselves for breakthrough pain
INTRAMUSCULAR ROUTE
the lower muscle - creates a Z pattern that blocks infiltration of medication into the subcutaneous tissue - injection is 2 to 3 inches deep, and 20-gauge and 22-gauge needle is used.
SUBCUTANEOUS ROUTE Use: for injection of small amounts of medication. Usual route for insulin injection Injection beneath the skin - in the loose interstitial tissue of the outer, upper arm, the anterior thigh, or the lower abdomen. maximum amount of medication injected - 1.3 mL, *greater than 2 mL will most likely cause painful pressure.
SUBCUTANEOUS ROUTE
Syringes used - up to 3 mL capacities and 24-gauge to 26-gauge needles are. Irritating drugs and those in thick suspension - produce indurations, sloughing, or abscess and may be painful
INTRADERMAL ROUTE injected into the corium, the more vascular layer of the skin just beneath the epidermis. substances include - various agents for diagnostic determinations, desensitization, or immunization. site for intradermal injection -anterior forearm. needle employed - short (three-eights of an inch) and narrow (23gauge to 26 gauge)
INTRADERMAL ROUTE
OFICIAL TYPES OF INJECTIONS Injection -liquid preparations that are drug substances or solutions For Injection -dry solids + suitable vehicles solutions conforming to the requirements for injections Injectable Emulsion -liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium Injectable suspension -liquid preparation of solid suspended in a suitable liquid medium For Injectable Suspension -dry solid + suitable vehicle preparation conforming to the requirements for injectable suspensions
Purified Water, USP - not more than 1 mg/100 mL Water for Injection
Sterile Water for Injection, USP - may contain slightly more total solids than Water for Injection because of the leaching of solids from the glass-lined tanks during sterilization - use: solvent or diluent for already sterilized and packaged injectable medication. Bacteriostatic Water for Injection, USP - sterile water for injection containing one or more suitable antimicrobial agents. - not intended for neonates - use: only in parenterals administered in small volumes because of the presence of antimicrobial agents
NONAQUEOUS VEHICLES
- use: when physical or chemical factors limit the use of a wholly aqueous vehicle Qualities: - nonirritating, nontoxic, and not sensitizing - must not exert a pharmacologic activity of its own, nor affect the activity of the medicinal agent - physical and chemical properties evaluated and determined: stability at various pH levels, viscosity, fluidity, boiling point, miscibility with body fluids, low vapor pressure and constant purity.
METHODS OF STERILIZATION
Sterilization - destruction of all living organisms and their spores or their complete removal from the preparation. Steam Sterilization - conducted in an autoclave and employs steam under pressure - microbial destruction is caused by denaturation & coagulation of bacterial proteins by moist heat - Bacillus stearothermophilus: biological indicator - applicable to pharmaceutical preparations and materials: *withstand the required temperatures *penetrated but not adversely affected by moisture
Dry Heat Sterilization - carried out in ovens, heated by gas or electricity and are generally thermostatically controlled - Bacillus subtilis: biological indicator - use: for substances not effectively sterilized by moist heat Sterilization by Filtration - depends on the physical removal of microorganisms by adsorption on the filter medium or by a sieving mechanism - use: for heat-sensitive solutions Millipore filter - thin plastic membrane of cellulosic esters with millions of pores per square inch
Bacterial Filtration
- Best suited for extemporaneous preparation of sterile
solution advantages - speed in the filtration of small quantities of solution - ability to sterilize thermolabile materials - relatively inexpensive equipment required - development and proliferation of membrane filter technology - complete removal of living and dead microorganisms and other particulate matter from the solution disadvantage - membrane tends to be fragile - essential to determine that the assembly was properly made (membrane not ruptured/flawed during assembly, sterilization, or use).
Gas Sterilization
- requires specialized equipment resembling an autoclave, and many combination steam autoclaves and ethylene oxide sterilizers - for sterilizing heat resistant & moisture resistant products
VALIDATION OF STERILITY
- effectiveness of thermal sterilization quantified:
*determination & calculation of F value to express thermal death. Biologic Indicator - best used to validate sterility for steam sterilization - a characterized preparation of specific microorganisms resistant to a particular sterilization process - use: to monitor a sterilization cycle and/or periodically to revalidate the process Thermal Death Time - time required to kill a particular organism under specified conditions
PYROGENS
causative material of pyrogens - a lipopolysaccharide from the outer cell wall of the bacteria and endotoxins. - material is thermostable and water soluble (remain in water even after sterilization by autoclaving or by bacterial filtration). common means of removing pyrogens - by oxidizing: easily eliminate gases or nonvolatile salts of any acidic compounds present.
Pyrogen Test, USP Uses: healthy rabbits properly maintained in terms of environment and diet before the test Normal, or control, temperatures are taken for each animal - used as the base for the determination of any temperature increase resulting from injection of a test solution - rabbits used: temperatures do not differ by more than 1C from each other
Examples of sterile drugs prepared and packaged without pharmaceutical additives (buffers, preservatives, stabilizers, and tonicity agents):
Ampicillin sodium Ceftizoxime sodium Ceftazidime sodium Cefuroxime sodium Kanamycin sulfate Nafcillin sodium Penicillin G benzathine Streptomycin sulfate Tobramycin sulfate
Sterile drugs formulated with pharmaceutical additives and intended to be reconstituted prior to injection:
Cyclophosphamide Dactinomycin Eryhtromycin lactobionate Hydrocortisone sodium succinate Mitomycin Nafcillin sodium Oxytetracycline hydrochloride Penicillin G potassium Vinblastine sulfate
ASHP RISK LEVEL CLASSIFICATION OF PHARMACY-PREPARED STERILE PRODUCTS Risk Level 1 1. Products Stored at: - room temperature and administered within 28 hours of preparation - under refrigerator for 7 days or less before complete administration over a period not to exceed to 24 hours Frozen for 30 days or less before complete administration
ASHP RISK LEVEL CLASSIFICATION OF PHARMACY-PREPARED STERILE PRODUCTS Risk Level 2 Products : stored beyond 7 days under refrigeration/stored beyond 30 days frozen or administered beyond 28 hours after preparation and storage at room temperature Batch-prepared without preservatives for use by more than one patient. compounded by complex or numerous manipulations of sterile ingredients obtained from: - licensed manufacturers in a sterile container or reservoir obtained from a licensed manufacturer by using closed-system aseptic transfer
ASHP RISK LEVEL CLASSIFICATION OF PHARMACY-PREPARED STERILE PRODUCTS Risk Level 3 Products: compounded from nonsterile ingredients or compounded with nonsterile compounds with nonsterile components, containers, or equipment before terminal sterilization prepared by combining multiple ingredients by using an open-system transfer or open reservoir before terminal sterilization.
CRITERIA IN DETERMINING THE PRODUCTS TITLE FOR ESTABLISHED NAMES OF INJECTABLE PRODUTCS a. Liquids [Drug]Injection
- title for liquid preparations that are drug substances or solutions thereof
[Drug]Injectable suspension
- title for liquid preparations of solids suspended in a suitable liquid medium
[Drug]Injectable emulsions
- title for liquid preparations of drug substances dissolved or dispersed in suitable emulsion medium
Human Insulin
- produced by using a special non-diseasesforming laboratory strain of E. coli and recombinant DNA technology
Lispro Insulin Solution - consists of zinc insulin lispro crystals dissolved in a clear aqueous fluid - created when the amino acids at positions 28 and 29 on the insulin B-chain are reversed Insulin Aspart - recombinant ultra-short acting insulin using Saccharomyces cerevisiae (bakers yeast) as the production organism Isophane Insulin Suspension (NPH/neutral protamine hagedorn Insulin) - protamine is added - sterile suspension in aqueous vehicle buffered with dibasic sodium phosphate to pH 7.1 to 7.4
Humalog Mix
- manufactured premixed insulin lispro and neutral protamine lispro (NPL) in fixed ratio
Insulin Glargine - long-acting basal insulin preparation intended for once daily subcutaneous administration at bedtime in the treatment of type I diabetes melitus in adults and children - can also be used by adults with type II diabetes who require long-acting insulin
Extended Insulin Zinc-Suspension - sterile suspension of zinc insulin crystals in an aqueous solution medium buffered with sodium acetate to pH 7.2 to 2.5
INSULIN PREPARATIONS: - Expiration date is set after 24 months after filling - Amorphous form of zinc chloride added to insulin prep. Has prompt action than the crystals - Freezing is avoided during storage - Preparations with neutral pH are more stable than with acidic pH
SOME INJECTIONS USUALLY PACKAGED AND ADMINISTERED IN SMALL VOLUME Chlorpromazine HCl - Antipsychotic drug with antiemetic Cimetidine HCl - Histamine H2 antagonist Dexamethasone sodium phosphate - Glucocorticoid Digoxin - Carditonic Diphenhydramine HCl - Ethaqnolamine, nonselective antihistamine Furosemide - Loop diuretic
Phenytoin sodium
- Anticonvulsant
Procaine penicillin G
- Anti-infective
Propranolol HCl
- Beta-adrenergic receptor blocker for hypertension
Verapamil HCl
- Calcium channel blocker
Heparin sodium
- Anticoagulant
Hydromorphone HCl
- Opioid analgesic
Lidocaine HCl
- Cardiac depressant
Meperidine HCl
- Opioid analgesic
Methoclopramide monohydrochloride
- Gastrointestinal stimulant
Morphine sulfate
- Opioid analgesic
Oxytocin
- Oxytocic
SOME INTRAVENOUS INFUSIONS ADMINISTERED IN VOLUMES OF 1 L OR MORE (ALONE OR WITH OTHER DRUGS) Amino acid
- Fluid and nutrient replenisher
LARGE-VOLUME PARENTERALS Maintenance Therapy Replacement Therapy Water Requirement Electolyte Requirement Caloric Requirement Parenteral Nutrition Electrolytes - Sodium - Potassium - Magnesium - Calcium - Chloride - Acetate - Phosphate Enteral Nutrition Intravenous Infusion Devices
SPECIAL CONSIDERATIONS ASSOCIATED WITH PARENTERAL THERAPY Look-alike Products Adsorption of Drugs - Chlorpromazine HCl - Diazepam - Insulin - Nitroglycerin - Promazine HCl - Promethazine HCl - Thiopental sodium - Thioridazine HCl - Thrifluoperazine HCl - Warfarin sodium Handling and Disposal of Chemotherapeutic Agents for Cancer
IRRIGATION AND DIALYSIS SOLUTIONS - Does not enter into the circulatory system - Packaged as LVP Irrigation Solutions - intended to bathe or wash wounds, surgical incisions, or body tissues Dialysis Solutions - separations of substances from one another in solution by taking advantage of their differing diffusibility through membranes
EXAMPLES OF IRRIGATION SOLUTIONS Acetic Acid Irrigation, USP Neomycin and Polymixin B Sulfates Solution for Irrigation, USP Ringers Irrigatio, USP Sodium Chloride Irrigation, USP Sterile Water for Irrigation USP
Some precautions observed during manufacture, storage & use of products to prevent entry of contaminants
Once opened, ampul cannot be resealed, unused portion not retained & used (content loss sterility) Prime requisite of parenteral soln: clarity - sparkling clear & free of particulate matter During mfture, parenteral soln is filtered before it goes into the container Containers are selected: - Chemically resistant to the soln - Highest quality to minimize chances of container components leaching into the solns During container filling use laminar flow hoods
Some precautions observed during manufacture, storage & use of products to prevent entry of contaminants
Personnel mfg parenterals - provided with monofilament fabrics (does not lint), face hoods, caps, gloves & disposable shoe covers to prevent contamination After filling & sealing: visual/automatic inspection for particulate matter - clarity : test requirement done to avoid distribution & use of parenterals that contain particulate matter
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