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• Pharmacology is the study of chemicals —drugs—on living tissues and how these chemicals help diagnose, treat, cure,

ure, and
prevent disease or correct the pathophysiology of living tissues.

The term pharmacology is derived from two Greek words: pharmakon,

the Greek word for drugs, and logos, the Greek word for science.

Deals with the study of drugs and their actions on living

organisms. Clayton et al, 2007

The study of biological effects of chemicals. Karch, 2013.

• Drugs are chemicals that are introduced into the body to cause some sort of

change.

• Derived from the Dutch term droog meaning dry

• are chemical substances that have an effect on living organisms.

• Therapeutic drug/medicine substances that can cure or arrest disease, relieve symptoms, ease pain and prov ide other
benefits. It includes essential vitamins and minerals that may be given to correct deficiency diseases.

• used in the prevention or treatment of disease.

• Drug therapy, also called pharmacotherapy, is the use of drugs to prevent,

diagnose, or treat signs, symptoms, and disease processes.

1. Drug Therapy/Pharmacotherapy treatment with drugs. is the use of drugs to prevent, diagnose, or treat signs, symptoms,
and disease processes.

2. Diet Therapy treatment by diet.

• Low salt for CVD patients

3. Physiotherapy treatment with natural physical forces like water, light

and heat.

4. Psychological Therapy Identification of stressors and methods to reduce

or eliminate stress and /or the use of drugs.

• The nurse is in a unique position regarding drug therapy because nur sing responsibilities include the following:

• Administering drugs

• Assessing drug effects

• Intervening to make the drug regimen more

tolerable

• Teaching clients and caregivers about accurate administration of medications, nonpharmacologic treatments to
use with or instead of pharmacologic treatments, and when to contact a health care provider.

• Monitoring the overall patient care plan to prevent


medication errors

SOURCES OF DRUGS

NATURAL AND SYNTHETIC:

1. NATURAL

a. Plants

A number of plants have medicinal qualities and have been used for centuries as natural remedies for injuries and
illnesses. Pharmaceutical firms harvest these plants and transform them into drugs that have a specific purity and strength
sufficient to treat diseases. Ex.: Alkaloids, Glycosides, Gums, Resins, Oils

b. Animals

Byproducts of animals, including humans, are a source for drugs because they contain hormones that can be
reclaimed and given to patients who need increased hormonal levels to maintain homeostasis.
For example, Premarin is a drug that contains estrogen that is recovered from mare urine. This is used as hormonal
therapy to manage menopausal symptoms.
Insulin is another hormonal drug that is used to regulate blood sugar levels in patients with diabetes mellitus. Insulin
can be recovered from humans using DNA technology
• Hormones

• Oils

• Enzymes

• Vaccines

c. inorganic compounds

Salts of various chemical elements can have therapeutic effects in the

human body. Aluminum, fluoride, iron, and even gold are used to treat

2. various conditions.

Our body requires trace elements of minerals in order to maintain homeostasis.


Minerals are inorganic crystal substances that are found naturally on earth. Patients lacking an adequate level of these
materials may take specific mineral based drugs to raise the level of minerals.
For example, an iron supplement is a common mineral-based drug that is
given to patients who suffer iron deficiency, a condition which can lead to
fatigue. Iron is a natural metal that is an integral part of body proteins such as
hemoglobin that carries oxygen throughout the body. Minerals are
obtained from animal and plant sources.

SYNTHETIC SOURCES:
Produced in the laboratory, genetically engineered to alter bacteria to produce chemicals that are therapeutic and
effective.
- created using man-made chemicals rather than natural ingredients.
- Example: arterolane- the experimental anti-malaria drug.

a) Preclinical Trials
In preclinical trials, chemicals that may have therapeutic value are tested on laboratory animals for two main purposes:
(1) to determine whether they have the presumed effects in living tissue and
(2) to evaluate any adverse effects.

Reasons why some chemicals are discarded for the next phase ;
• The chemical lacks therapeutic activity when used with living animals.
• The chemical is too toxic to living animals to be worth the risk of developing into
a drug.
• The chemical is highly teratogenic (causing adverse effects to the fetus).
• The safety margins are so small that the chemical would not be useful in the
clinical setting.

) Phase 1 Studies (i)


A phase I study uses human volunteers to test the drugs.
These studies are more tightly controlled than preclinical trials and are performed by specially trained clinical
investigators.
The volunteers are fully informed of possible risks and may be paid for their participation. Usually, the volunteers are
healthy, young men.
• They lack therapeutic effect in humans.
• They cause unacceptable adverse effects.
• They are highly teratogenic.
• They are too toxic.

Phase 2 Studies (ii)


A phase II study allows clinical investigators to try out the drug in patients who have the disease that the drug is
designed to treat.
Patients are told about the possible benefits of the drug and are invited to participate in the study.
Those who consent to participate are fully informed about possible risks and are
monitored very closely, often at no charge to them, to evaluate the drug’s effects.
Performed in hospitals, clinics, and doctors’ offices.
• It is less effective than anticipated.
• It is too toxic when used with patients.
• It produces unacceptable adverse effects.
• It has a low benefit-to-risk ratio, meaning that the therapeutic benefit it provides does not outweigh the risk of
potential adverse effects that itcauses.
• It is no more effective than other drugs already on the market, making the cost of continued research and
production less attractive to the drug company.

Phase 3 Studies (iii)


A phase III study involves use of the drug in a vast clinical market.
Prescribers are informed of all the known reactions to the drug and precautions required for
its safe use.
Prescribers Role:
1. They are informed of all the known reactions to the drug and precautions required for its safe use.
2. They need to observe patients very closely, monitoring them for any adverse effects.
3. They keep tract on patient’s journals and record any symptoms they experience.
4. They evaluate the reported effects to determine whether they are caused by the disease or by
the drug.
5. They collaborate with the drug company that is developing the drug and then, collected information is shared
with the FDA.
• Drugs that finish phase III studies are evaluated by the FDA, which relies on committees of experts familiar with
the specialty area in which the drugs will be used.
• Only those drugs that receive FDA committee approval may be marketed.
• An approved drug is given a brand name (trade name) by the pharmaceutical
company that developed it.
• The generic name of a drug is the original designation that the drug was given when the drug company applied
for the approval process.
• Chemical names are names that reflect the chemical structure of a drug.
• The entire drug development and approval process can take 5 to 6 years.
• The FDA regards public safety as primary in drug approval, so the process remains strict; however, it can
be accelerated in certain instances involving the treatment of deadly diseases

Phase 4 Studies (iv)


After a drug is approved for marketing, it enters a phase of continual evaluation, or phase IV study.
Prescribers are obligated to report to the FDA any untoward or unexpected adverse effects associated with drugs they
are using, and the FDA continually evaluates this information.
Some drugs cause unexpected effects that are not seen until wide distribution
occurs. Sometimes, those effects are therapeutic.
For example, patients taking the antiparkinsonism drug amantadine (Symmetrel) were found to have fewer cases of
influenza than other patients, leading to the discovery that amantadine is an effective antiviral agent
In other instances, the unexpected effects are dangerous.
In 1997, the diet drug dexfenfluramine (Redux) was removed from the market only months after its release because
patients taking it developed serious heart problems.

1. Preclinical Trials- animal testing


2. Phase I- Human volunteers are used to test the drug.
3. Phase II- The drug is tried in patients who have the disease that the drug is designed to treat.
4. Phase III- Use of the drug in a vast clinical market. Only those drugs that receive FDA committee approval may
be marketed.
5. Phase IV- continual evaluation. ei. Amantadine ( Symmetrel) for antiparkinsonism is effective antiviral agent for
flu.
NOTE: The entire drug development and approval process can take 5-6 years, or as long as 13 years and more.
Memory Jogger:
An approved drug is given a brand name/trade name by the pharmaceutical company that develop it. This is usually
italicized.

Food and Drug Administration Pregnancy Categories


5 Categories
1. Category A: Adequate studies in pregnant women have not
demonstrated a risk to the fetus in the first trimester of pregnancy,
and there is no evidence of risk in later trimesters.
2. Category B: Animal studies have not demonstrated a risk to the fetus but there are no adequate studies in
pregnant women, or animal studies have shown an adverse effect, but adequate studies in pregnant women
have not demonstrated a risk to the fetus
during the first trimester of pregnancy, and there is no evidence of
risk in later trimesters.
3. Category C: Animal studies have shown an adverse effect on the fetus but there are no adequate studies in
humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks,
or there are no animal reproduction studies and no adequate studies in humans.
4. Category D: There is evidence of human fetal risk, but the potential benefits from the use of the drug in
pregnant women may be acceptable despite its potential risks.
5. Category X
- Studies in animals or humans demonstrate fetal abnormalities or
adverse reaction; reports indicate evidence of fetal risk.
- The risk of use in a pregnant woman clearly outweighs any possible
benefit.
NOTE: Regardless of the designated Pregnancy Category or presumed safety, no drug should be administered during
pregnancy unless it is clearly needed.

What is the Controlled Substances Act of 1970?


• This regulates the manufacturing, distribution, and dispensing of drugs that are known to have abuse potential.
• classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of
these drugs.
- Designed to improve the administration and regulation of manufacturing, distributing, and dispensing of drugs
that have been found necessary to be controlled.
Who is responsible for the enforcement of these regulations?
- The Drug Enforcement Administration (DEA) was organized to enforce the Controlled Substances Act, gather
intelligence, and train and conduct research in the area of dangerous drugs and drug abuse.
• The DEA implements the CSA and may prosecute violators of these
laws at both the domestic and international level.
- Designed to improve the administration and regulation of manufacturing, distributing, and dispensing of drugs
that have been found necessary to be controlled.
Why Act of 1970?
• The CSA was signed into law by President Richard Nixon on October 27, 1970.

Controlled Substance Act


5 Schedules and their Criteria
I. Schedule I (C-1)
1. A high potential for abuse
2. No currently accepted medical use in the United
3. A lack of accepted safety for use under medical
Examples: lysergic acid diethylamide (LSD)
marijuana, STP, heroin, hashish
2. Schedule II (C-2)
1. A high potential for abuse
2. A currently accepted medical use in the United States.
3. An abuse potential that may lead to severe psychological or
physicaldependence. (no refill)
Examples: secobarbital, pentobarbital, amphetamines,
morphine, meperidine, methadone, methyphenidate
3. Schedule III (C3)
1. A high potential for abuse, but less so than drugs in
Schedules I and II
1. A high potential for abuse, but less so than drugs in
Schedules I and II
3. An abuse potential that may lead to moderate or low
physical dependence or high psychological dependence
Examples: Empirin with codeine, Lortab, Fiorenal, Tylenol with
codeine
4. Schedule IV (C-4)
1. A low potential for abuse, compared with those on Schedule III
2. A currently accepted medical use in the United States
5. An abuse potential that may lead to limited
6. psychological dependence, compared with drugs in
7. Examples: phenobarbital propoxyphene, chloralhydrate,
8. paraldehyde, chlordiazepoxide, diazepam, flurazepam, temazepam
9. Schedule V (C-5)
1. A low potential for abuse, compared with those on Schedule IV
2. A currently accepted medical use in the United States
3. An abuse of limited physical or psychological dependence liability, compared with drugs in
Schedule IV. Because abuse potential is low, a prescription may not be required.
Examples: Lomotil, Robitussin A-C

• Generic Drugs -When a drug receives approval for marketing from the FDA, the drug formula is given a time-
limited patent, in much the same way as an invention is patented.
• The length of time for which the patent is good depends on the type of chemical involved.
• When the patent runs out on a brand-name drug, the drug can be produced by other manufacturers.
• Generic drugs are chemicals that are produced by companies involved solely in the manufacturing of drugs.
• The Philippine government passed the Generics Act of 1988 to ensure that inexpensive and effective drugs
are made available to all Filipinos. (REPUBLIC ACT NO. 6675)
• UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008 (REPUBLIC ACT NO. 9502)

• The Orphan Drug Act of 1983- Provided tremendous financial incentives to drug companies to
adopt these drugs and develop them.
• These incentives help the drug company put the drug through the rest of the testing process.
• These incentives help the drug company put the drug through the rest of the testing process, even though the
market for the drug in the long run maybe very small.
• According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for the
treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000
persons in the United States."

• Over-the-Counter Drugs- OTC drugs are products that are available without prescription for self- treatment of a
variety of complaints.
• Some of these agents were approved as prescription drugs but later were found to be very safe and useful for
patients without the need of a prescription.
• Some were not rigorously screened and tested by the current drug evaluation protocols because they were
developed and marketed before the current laws were put into effect.
• Many of these drugs were “grandfathered” into use because they had been used for so long. The FDA is
currently testing the effectiveness of many of these products and, in time, will evaluate all of them. Karch, 2013.

Chemical name of a drug


• -The chemical name is the most meaningful to the chemist. By means of the chemical name, the chemists
understands exactly the chemical constitution of the drug and the exact placing of its atoms or molecular
groupings.
• Names that reflect the chemical structure of a drug.
• Generic name (nonproprietary name of a drug)
• - The generic name, or common name is named to a drug before it becomes official.

Brand name/ Trademark/ Proprietary name/ Registered name


- Developed by the company requesting approval for the drug and identifies it as its’
exclusive property.
- This is followed by the symbol ®. This indicates that the name is approved and registered and that use is restricted to
the owner of the drug, who is usually the manufacturer or the pharmaceutical company that develop it.
- The first letter is capitalized. The word is Italicized.
• A. Purity – Completely pure drugs are rarely attainable. Pure drugs contain only one chemical agent, but
additives may be needed to facilitate formulation or manipulate absorption. Environmental and extraneous
substances may be present in certain quantities and types.
• B. Potency – The drug’s potency, or strength, depends on the
concentration of active drug in the medicinal preparation.
• C. Bioavailability – The drug’s bioavailability is measure of the rate and extent of drug transfer from its
administration site to the systemic circulation.
• D. efficacy – a drug’s efficacy is its effectiveness in promoting desirable clinical changes. Objective measures are
rarely available, and data are interpreted subjectively. Efficacy of therapeutics is rated by the National Council
of the National Academy of Sciences for the FDA using the following scale:
• Ineffective- no substantial evidence of effectiveness
• Ineffective as a fixed combination- not effective in fixed dosage combinations for reasons of safety or because
one or more components lack substantial evidence of effectiveness.
• Possibly effective- effectiveness might be shown eventually, but at the present
time shows little evidence of effectiveness.
• Effective- substantial evidence of effectiveness
• Effective but- effective with qualification or restriction until completion of further
studies.
E. Safety/Toxicity
1. All chemicals are toxic to some degree.
2. The safety of the drug is measured by the incidence and severity of adverse reactions.
3. Safety is determined by the degree between therapeutic and toxic dosages.
4. Complete safety cannot be determined regardless of testing before release of a drug.
5. According to the BODY SYSTEM they affect (ei. drugs affecting the CNS, Cardiovascular, G.I.)
6. THERAPEUTIC USE or CLINICAL INDICATIONS (ei. antacids, antibiotics, antihypertensive, diuretics, laxatives).
7. PHYSIOLOGIC or CHEMICAL ACTION (ei. cholinergic, anticholinergics, beta adrenergic blockers, calcium channel
blockers).
8. PRESCRIPTION or NONPRESCRIPTION/OTC drugs
“Rx only or “Caution: Federal Law Prohibits Dispensing Without a Prescription”
9. Illegal drugs/Recreational Drugs- non therapeutic purposes, have not received approval for use by the FDA.

1. Drug Labels
• Drug labels have specific information that identifies a specific drug.
• Ex., the brand and generic names for the drug, the drug dosage, the expiration date, and special drug warnings.
Some labels also indicate the route and dose for administration.
2. Package Inserts
• The package insert contains all of the chemical and study information that led to the drug’s approval. Package
inserts sometimes are difficult to understand and are almost always in very small print, making them difficult to
read. The FDA Web site, www.fda.gov, is a good resource for finding the prescribing information or package
insert for most drugs.
3. Reference Books
• A wide variety of reference books are available for drug information.
• Ex. The Physician’s Desk Reference (PDR)
• American Medical Association (AMA) Drug Evaluations
• Lippincott Nursing Drug Guide (LNDG)
• North American Nursing Diagnosis Association (NANDA) Handbook
4. Journals
• - The Medical Letter - is a monthly review of new drugs, drug classes,
and specific treatment protocols.
• - The American Journal of Nursing offers information on new drugs, drug errors, and nursing implications.
5. Internet Information
Government Sites
• Agency for Health Care Research and Quality: http://www.ahcpr.gov
• CancerNet (National Cancer Institute): http://www.cancer.gov
• Centers for Disease Control: http://www.cdc.gov
• Drug Formulary: http://www.intmed.mcw.edu/drug.html
• Food and Drug Administration: http://www.fda.gov

DRUG LEGISLATION- Protects the consumer and the patient from unfounded claims of the manufacturers and
advertisers claims about the benefits of their products.
• LEGAL REGULATION OF DRUGS- In the 1930’s, the drug “elixir of sulfanilamide” was distributed in a vehicle of
ethylene glycol that had never been tested in humans and hundreds of people died and many others became
very ill. This led to the Federal Food, Drug and Cosmetic Act of 1938, which gave the FDA power to enforce
standards for testing drug toxicity and monitoring labeling.
• In the 1930’s, the drug “elixir of sulfanilamide” was distributed in a vehicle of ethylene glycol that had never
been tested in humans and hundreds of people died and many others became very ill. This led to the Federal
Food, Drug and Cosmetic Act of 1938, which gave the FDA power to enforce standards for testing drug toxicity
and monitoring labeling.
• 1938 Federal Food, Drug and Cosmetic Act- Mandated tests for drug toxicity and provided means for recall of
drugs; established procedures for introducing new drugs; gave Food and Drug Administration (FDA) the power
of enforcement

• KEFAUVER- HARRIS ACT OF 1962-In 1962, a drug Thalidomide used as a sleeping aid by pregnant women
resulted in limb deformities to newborns.
• 1962 Kefauver Harris Act
• Tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug
investigations; stated that efficacy as well as safety of drugs had to be established.

• Drugs are chemicals that are introduced into the body to bring about some sort of change.
• ■ Drugs can come from many sources: plants, animals, inorganic elements, and synthetic preparations.
• ■ The FDA regulates the development and marketing of drugs to
ensure safety and efficacy.
1. Preclinical trials: initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not
human subjects.
2. Phase I study: a pilot study of a potential drug done with a small number of selected, healthy human
volunteers.
3. Phase II study: a clinical study of a proposed drug by selected physicians using actual patients who have the
disorder the drug is designed to treat; patients must provide informed consent.
4. Phase III study: use of a proposed drug on a wide scale in the clinical setting with patients who have the disease
the drug is thought to treat.
5. Phase IV study: continual evaluation of a drug after it has been released for marketing.
• ■ FDA pregnancy categories indicate the potential or actual teratogenic effects of a drug.
• ■ DEA controlled-substance categories indicate the abuse potential and associated regulation of a drug.
• ■ Generic drugs are sold under their generic names, not brand names; they may be cheaper but in some
situations are not necessarily as safe as brand-name drugs.
• ■ Orphan drugs are chemicals that have been discovered to have some therapeutic effect but that are not
financially advantageous to develop into drugs.
• ■ OTC drugs are available without prescription for the self-treatment of various complaints.
• ■ Information about drugs can be obtained from a variety of sources, including the drug label,
reference books, journals, and Internet sites.
■ Drugs are chemicals that are introduced into the body to bring about some sort of change.
■ Drugs can come from many sources: plants, animals, inorganic elements, and synthetic
preparations.
■ The FDA regulates the development and marketing of drugs to ensure safety and efficacy.
■ Preclinical trials involve testing of potential drugs on laboratory animals to determine their
therapeutic and adverse effects.
■ Phase I studies test potential drugs on healthy human subjects.
■ Phase II studies test potential drugs on patients who have the disease the drugs are designed
to treat.
■ Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness.
■ FDA pregnancy categories indicate the potential or actual teratogenic effects of a drug.
■ DEA controlled-substance categories indicate the abuse potential and associated regulation
of a drug.
■ Generic drugs are sold under their generic names, not brand names; they may be cheaper but in some
situations are not necessarily as safe as brand-name drugs.
■ Orphan drugs are chemicals that have been discovered to have some therapeutic effect but
that are not financially advantageous to develop into drugs.
■ OTC drugs are available without prescription for the self-treatment of various complaints.
■ Information about drugs can be obtained from a variety of sources, including the drug label,
reference books, journals, and Internet sites.

Anti-Infective Drugs Anti-infective agents are drugs utilized to exert effect on invading foreign organisms on the
body, especially those which can cause infection. Its scientific investigation started in the 1920s after Paul Ehrlich
developed synthetic chemicals that would be effective only against the certain proteins or enzyme systems used
only by infecting organism and not by human cells. Drug resistance remains to be the major challenge in the use of
anti-infectives against infections. Emergent strains are rapidly adapting to repel the effects of anti -infectives. •
Mechanisms of Actions
• Therapeutic Action • Resistance • Prevention of Resistance • Indications • Adverse Effects Mechanisms of Actions
Here is a table of commonly encountered anti-infectives that would best explain the principles of anti-infective
therapy: Drug Mechanism of Action penicillins Interferes with the biosynthesis of the pathogen cell wall
sulfonamides Inhibits invading organisms from using substances essential to their growth and development
antimycobacterial trimethoprimsulfamethoxazole aminoglycosides Interferes with steps involves in protein synthesis
thereby rendering cell division non-functional macrolides chloramphenicol fluoroquinolones Interferes with DNA
synthesis leading to inability to divide and ultimately, cell death antifungals Alteration of cell membrane
permeability leading to leakage of essential cellular components and cell death antiprotozoals other antibiotics
Therapeutic Action Anti-infective agents act on invading organisms in several different ways as mentioned above. •
The goal of therapy is interference with the normal function of the invading organisms to prevent them from
reproducing and thereby causing cell death. • Narrow-spectrum anti-infectives are agents that are so selective in
their action that they are effective against only a few microorganisms. • Broad-spectrum anti-infectives are agents
that interfere with biochemical reactions in many different kinds of microorganisms. • Anti -infectives that can cause
cell death are said to have bactericidal effects. • Anti-infectives that can interfere with the ability of the cells to
reproduce or divide are said to have bacteriostatic effects. Resistance Over time, invading pathogens develop
resistance to anti-infectives. Resistance is the ability over time to adapt to an anti-infective drug and produce cells
that are no longer affected by a particular drug. Here are a number of ways that microorganisms can develop
resistance: • Enzyme production. Strains of bacteria that were once susceptible to penicillin can now produce an
enzyme called penicillinase which inactivates penicillins before they can exert their effect to the bacteria. • Cell
membrane permeability alteration. This prevents the drug from entering the cell. Some bacteria alter transport
systems to prevent the drug from being transported actively into the cell. • Binding site alteration. Prevents the drug
from being accepted into the cell. • Chemical production. Acts as antagonist to the drug. Vancomycin (Vancocin,
Vancoled) is an antibiotic that interferes with cell wall synthesis in susceptible bacte ria. This was developed as a
result of a need for a drug that could be used for patients who are allergic to penicillin and cephalosporins as well as
in treatment of patients who have staphylococcal infections resistant to penicillins and/or cephalosporins. It is
highly-toxic that it is reserved only for certain situations as it can cause renal failure, ototoxicity, superinfections, and
red man syndrome (sudden and severe hypotension, fever, chills, paresthesias, and erythema or redness of the neck
and back). Prevention of Resistance Drug resistance and emergence of new strains remain a public health concern.
Here are a number of ways in which nurses can facilitate prevention of resistance: • Drug dosing. The nurse may
collaborate with the physician for aroundthe-clock dosing to eliminate the peaks and valleys in drug concentration.
This also helps maintain a constant therapeutic level to prevent the emergence of resistant microbes during times of
low concentration. • Drug duration. The nurse should emphasized the importance of finishing the prescribed
duration (correct number of times each day for the full number of days) of anti -infective therapy to ensure that
microbes are completely eliminated and are not given the chance to grow and develop resistant strains. Indications
Here are some important aspects to remember for indication of anti -infectives: Children • Use with caution as early
exposure can lead to early sensitivity. • Use of antibiotics in pediatric ear infections (which might be a viral infection)
may contribute to development of drug resistance. • Children are susceptible to gastrointestinal (GI) and nervous
system effects of anti-infectives so it is important to monitor their hydration and nutritional status carefully. Adults •
This age group tend to demand for quick cure to various signs and symptoms. Therefore, drug allergies and
emergence of resistant strains can be a big problem with this group. • Extra caution is exercised in pregnant and
lactating women because many of these agents have teratogenic effects to the fetus and can cross into breast milk.
Older adults • They present with manifestations that are different than younger age groups so culture and sensitivity
tests are important to determine the type and extent of infection. • They are susceptible to severe GI, renal, and
neurological effects and must be monitored for nutritional status and hydration during drug therapy. • Their liver
function should always be taken in consideration when planning for anti -infective therapy. Adverse Effects Use of
anti-infectives may result to these adverse effects: • Kidney damage. Drugs like aminoglycosides have direct toxic
effect on the fragile cells in the kidney and can cause conditions ranging from renal dysfunction to full -blown renal
failure. Patients should be kept well-hydrate throughout drug therapy course to facilitate drug excretion. • GI
toxicity. Many anti-infectives have direct toxic effects on the cells lining the GIT causing nausea, vomiting, stomach
upset, and diarrhea. Some drugs have toxic effects on the liver causing hepatitis and even liver failure. •
Neurotoxicity. Some anti-infectives can damage or interfere with the function of nerve tissue, usually in areas where
drugs tend to accumulate in high concentrations. For example, aminoglycoside antibiotics collect in the 8th cranial
nerve and can cause dizziness, vertigo, and loss of hearing. Chloroquine, a drug for treatment of malaria can
accumulate in the retina and optic nerve and cause blindness. • Hypersensitivity Reactions. Most agents are protein
bound for transfer through the cardiovascular system and are able to induce antibody formation in susceptible
people. With next exposure, immediate or delayed allergic responses may occur. • Superinfections. Broad -spectrum
anti-infectives can destroy normal flora. Superinfections are infections that occur when opportunistic pathogens
that were kept in check by normal flora bacteria have the opportunity to invade tissues. Common causes of
superinfections are Proteus and Pseudomonas.

Antibiotics Antibiotics are agents made from living microorganisms, synthetic manufacturing, and genetic
engineering that are used to inhibit specific bacteria. They can be bacteriostatic, bactericidal, or both. The major
classes of antibiotics include: aminoglycosides, penicillins and penicillinase-resistant drugs, sulfonamides,
tetracyclines, and antimycobacterials (e.g. antitubercular and leprostatic) Others include ketolides, lincosamides,
lipoglycopeptides, macrolides, and monobactams. • Antibiotics: Generi c and Brand Names • Spotlight: Bacteria and
Antibiotics • Aminoglycosides o Therapeutic Action o Indications o Pharmacokinetics o Contraindications and
Cautions o Adverse Effects o Interactions • Carbapenems o Therapeutic Action o Indications o Pharmacokin etics o
Contraindications and Cautions o Adverse Effects o Interactions • Cephalosporins o Therapeutic Action o Indications
o Pharmacokinetics o Contraindications and Cautions o Adverse Effects o Interactions • Fluoroquinolones o
Therapeutic Action o Indications o Pharmacokinetics o Contraindications and Cautions o Adverse Effects o
Interactions • Penicillins and Penicillinase-Resistant Antibiotics o Therapeutic Action o Indications o
Pharmacokinetics o Contraindications and Cautions o Adverse Effects o Interactions • Sulfonamides o Therapeutic
Action o Indications o Pharmacokinetics o Contraindications and Cautions o Adverse Effects o Interactions •
Tetracyclines o Therapeutic Action o Indications o Pharmacokinetics o Contraindications and Cautions o Advers e
Effects o Interactions • Antimycobacterials o Therapeutic Action o Indications o Pharmacokinetics o
Contraindications and Cautions o Adverse Effects o Interactions • Other Antibiotics o Therapeutic Action o
Pharmacokinetics o Contraindications and Cautions o Adverse Effects o Interactions • Nursing Considerations for
Antibiotics o Nursing Assessment o Nursing Diagnoses o Implementation with Rationale o Evaluation Antibiotics:
Generic and Brand Names Here is a table of commonly encountered antibiotics, the ir generic names, and brand
names: Classification Generic Name Brand Name Aminoglycosides amikacin Amikin gentamicin Garamycin
kanamycin Kantrex neomycin Mycifradin streptomycin generic tobramycin TOBI, Tobrex Carbapenems Doripenem
Doribax Ertapenem Invanz Imipenem-cilastatin Primaxin meropenem Merrem IV Cephalosporins • First-Generation
cefadroxil generic cefazolin Zolicef cephalexin Keflex • Second-Generation cefaclor Ceclor cefoxitin generic cefprozil
generic cefuroxime Zinacef • Third-Generation cefdinir generic cefotaxime Claforan cefpodoxime Vantin ceftazidime
Ceptaz, Tazicef ceftibuten Cedax ceftizoxime Cefizox ceftriaxone Rocephin • Fourth-Generation cefditoren
Spectracef cefepime Maxipime ceftaroline Teflaro Fluoroquinolones ciprofloxacin Cipro gemifloxacin Factive
levofloxacin Levaquin moxifloxacin Avelox norfloxacin Noroxin ofloxacin Floxin, Ocuflox Penicillins and Penicillinase-
Resistant Antibiotics • Penicillins penicillin G benzathine Bicillin, Permapen penicillin G potassium Pfizerpen penicillin
G procaine Wycillin penicillin V Veetids • Extended-Spectrum Penicillins amoxicillin Amoxil, Trimox ampicillin
Principen • Penicillinase-Resistant Antibiotics nafcillin oxacillin Sulfonamides sulfadiazine generic sulfasalazine
Azulfidine cotrimoxazole Septra, Bactrim Tetracyclines demeclocycline Declomycin doxycycline Doryx, Periostat
minocycline Minocin tetracycline Sumycin Antimycobacterials Antituberculosis • First-line ethambutol Myambutol
pyrazinamide Nydrazid rifampin generic rifapentine Rifadin, Rimactane streptomycin generic • Second-line
capreomycin Capastat cycloserine Seromycin ethionamide Trecator-SC rifabutin Mycobutin Leprostatic dapsone
generic Other Antibiotics Ketolide telithromycin Ketek Lincosamides clindamycin Cleocin lincomycin Lincocin
Lipoglycopeptides telavancin Vibativ Macrolides azithromycin Zithromax clarithromycin Biaxin erythromycin Ery -Tab,
Eryc Monobactam aztreonam Azactam Spotlight: Bacteria and Antibiotics • Bacteria are microorganisms that invade
the human body through many routes like respiratory, gastrointestinal, and skin. • Human immune response is
activated once bacteria invade the body. As the body tries to rid itself of bacteria, classic signs of inflammation (e.g.
swelling, heat, redness, and pain), fever, and lethargy begin to show up. • The goal of antibiotic therapy is to
decrease the population of invading bacteria to a point at which the human immune system can effectively deal
with the invader. Aminoglycosides • Aminoglycosides are a group of antibiotics indicated for infections caused by
gram-negative aerobic bacilli. • They were replaced by newer, less-toxic drugs in treating less serious infections
because these drugs have potentially serious adverse effects. Therapeutic Action The desired and beneficial acti on
of aminoglycosides is: • Exert bactericidal effect through inhibition of protein synthesis in susceptible strains of
gram-negative bacteria. Specifically, they bind to a unit of the bacteria ribosomes and cause misreading of the
genetic code leading to cell death. Indications Aminoglycosides are indicated for the following medical conditions: •
Infections caused by susceptible strains: Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella -
Enterobacter-Serratia group, Citrobacter spp., and Staphylococcus spp. • Serious infections susceptible to penicillin
when penicillin is contraindicated. Here are some important aspects to remember for indication of antibiotics in
different age groups: Children This age group is very sensitive to GI and CNS adverse effects of antibiotics. Therefore,
it is important to monitor their nutritional and hydration status while on therapy. Oral candidiasis as a
superinfection is common in this age group which makes eating and drinking difficult. Fluoroquinolones are
associated with damage to developing cartilage and are not recommended for growing children. In addition to this,
pediatric dosages should be double-checked to decrease the risk for adverse effects. Most of all, parent education is
important in cutting down the unnecessary use of antibiotics in children. Adults This age group has the tendency to
cure simple manifestations with antibiotics. Therefore, it is important to educate them that antibiotics are effective
only for certain bacteria and not for simple manifestations like common colds, which may be viral. Storage of unused
pills for future infections and sharing antibiotics with symptomatic friends should be avoided and emphasized in
health teachings. Older adults Assessing the problem and obtaining appropriate specimens for culture is especially
important with this population. Older patients may be more susceptible to adverse effects of antibiotic therapy.
Pharmacokinetics Here are the characteristic interactions of aminoglycosides and the body in terms of absorption,
distribution, metabolism, and excretion: Route Onset Peak Duration IM, IV Rapid 30-90 min N/A T1/2: 2-3 h
Metabolism: liver Excretion: kidney (urine) Contraindications and Cautions The following are contraindications and
cautions for the use of aminoglycosides: • Known allergy to aminoglycosides. • Renal or hepatic disease. Can be
exacerbated by aminoglycosides and may interfere wih metabolism and excretion of these drugs. • Preexisting
hearing loss. Can be intensified by toxic drug effects on the auditory nerve. • Active infection with herpes or
mycobacterial infections. Can be worsened by the effects of an aminoglycoside on normal defense mechanisms. •
Myasthenia gravis or parkinsonism. Can be exacerbated by the effects of a particular aminoglycosides on the
nervous system. • Lactation. Aminoglycosides are excreted in the breast milk and can potentially cause serious
effects in the infant. • Amikacin should not be used for longer than 7-10 days because it is particularly toxic to the
bone marrow, kidneys, and GI. • Streptomycin is only for special situations because it is very toxic to the 8th cranial
nerve and kidney. Adverse Effects Use of aminoglycosides may result to these adverse effects: • CNS: ototoxicity,
irreversible deafness, vestibular paralysis, confusion, depression, disorientation, numbness, tingling, weakness •
Renal: renal failure • Hematology: bone marrow depression, leading to immunosuppression and resultant
superinfections • GI: nausea, vomiting, diarrhea, weight loss, stomatitis, hepatotoxicity • CV: palpitations,
hypotension, hypertension • Hypersensitivity reactions: purpura, rash, urticaria, exfoliative dermatitis Interactions
The following are drug-drug interactions involved in the use of aminoglycosides: • Penicillins, cephalosporins,
ticarcillin: synergistic bactericidal effect • Diuretics: increased incidence of ototoxicity, nephrotoxicity, and
neurotoxicity • Anesthetics, nondepolarizing NM blockers, succinylcholine, citrate anticoagulated blood: increased
NM blockade with paralysis Carbapenems • Carbapenems are a relatively new class of broad-spectrum antibiotics
effective against gram-positive and gram-negative bacteria. Therapeutic Action The desired and beneficial action of
carbapenems is: • Exert bactericidal effect by inhibiting cell membrane synthesis in susceptible bacteria, leading to
cell death. Indications Carbapenems are indicated for the following medical conditions: • Serious intra-abdominal,
urinary tract, skin and skin structure, bone and joint, and gynecological infections. • Infections caused by susceptible
strains: S.pneumoniae, H.influenzae, E.coli, K.pneumoniae, B.fragilis, P.mirabilis, P.aeruginosa, and P.bivia.
Pharmacokinetics Here are the characteristic interactions of carbapenems and the body in terms of absorption,
distribution, metabolism, and excretion: Route Onset Peak Duration IM, IV Rapid 30-120 min N/A T1/2: 4 h
Metabolism: N/A Excretion: kidney (urine); unchanged Contraindications and Cautions The following are
contraindications and cautions for the use of carbapenems: • Known allergy to carbapenems or beta-lactams. •
Seizure disorders. Exacerbated by drugs. • Meningitis. Safety is not established. • Lactation. Not known whether
drug can cross into breast milk or not. • Ertapenem is not recommended for use in patients younger than 18 years of
age. • Meropenem is associated with development of pseudomembranous colitis and should be used in caution in
patients with inflammatory bowel disease. Adverse Effects Use of carbapenems may result to th ese adverse effects:
• GI: pseudomembranous colitis, C.difficile diarrhea, nausea, vomiting, dehydration and electrolyte imbalance •
CNS: headache, dizziness, altered mental state • Superinfections Interactions The following are drug-drug
interactions involved in the use of carbapenems: • Valproic acid: Carbapenems reduce serum valproic acid and this
can increase risk of seizures. • Imipenem and ganciclovir can cause seizures. • Meropenem and probenecid can lead
to toxic levels of meropenem. Cephalosporins • Cephalosporins were first introduced in the 1960s. There are
currently four generations of cephalosporins, each with specific spectrum of activity. • These drugs are similar to
penicillins in structure and activity. Therapeutic Action The desired and beneficial action of carbapenems is: • Exert
bactericidal and bacteriostatic effects by interfering with the cellwall building ability of bacteria during cell division.
Therefore, they prevent the bacteria from bio synthesizing the framework of their cell wal ls. Indications
Cephalosporins are indicated for the following medical conditions: • First-generation cephalosporins are effective
against the same grampositive bacteria affected by penicillin G, as well as gram-negative bacteria P.mirabilis,
K.pneumoniae, E.coli. • Second-generation cephalosporins are effective against previously mentioned strains as well
as H.influenzae, E.aerogenes, and Neisseria spp. These drugs are less effective against gram-positive bacteria. •
Third-generation cephalosporins are effective against all of the previously mentioned strains. They are relatively
weak against grampositive bacteria but are more potent against gram-negative bacilli, as well as S.marcescens. •
Fourth-generation cephalosporins are active against gram-negative and gram-positive organisms, including
cephalosporin-resistant staphylococci and P.aeruginosa. Pharmacokinetics Here are the characteristic interactions of
cephalosporins and the body in terms of absorption, distribution, metabolism, and excretion: Route On set Peak
Duration Oral N/A 30-60 min 8-10 h T1/2: 30-60 min Metabolism: N/A Excretion: kidney (urine); unchanged
Contraindications and Cautions The following are contraindications and cautions for the use of cephalosporins: •
Known allergy to cephalosporins and bea-lacams. Cross-reacions are common. • Hepatic or renal impairment. These
drugs are toxic to the kidneys and could interfere with the metabolism and excretion of the drugs. • Pregnancy and
lactation. Potential effects on the fetus and infant are not known; use only if benefits clearly outweigh the potential
risk of toxicity to the fetus or infant. • Reserve cephalosporins for appropriate situations because cephalosporin-
resisant bacteria are appearing in increasing numbers. Perform culture and sensi tivity test before start of therapy.
Adverse Effects Use of cephalosporins may result to these adverse effects: • GI: nausea, vomiting, diarrhea,
anorexia, abdominal pain, flatulence, pseudomembranous colitis • CNS: headache, dizziness, lethargy, paresthes ias
• Nephrotoxicity in patients who have predisposing renal insufficiency • Superinfections • Phlebitis and local abscess
at the site of IM injection and/or IV administration. Interactions The following are drug-drug interactions involved in
the use of cephalosporins: • Aminoglycosides: increased risk for nephrotoxicity • Oral anticoagulants: increased
bleeding • Alcohol: avoided for 72 hours after discontinuation of the drug to prevent disulfiram -like reaction (e.g.
flushing, throbbing headache, nausea and vomiting, chest pain, palpitations, dyspnea, syncope, vertigo, convulsions,
etc.) Fluoroquinolones • Fluoroquinolones are a relatively new synthetic class of antibiotics with a broad spectrum
of activity. Therapeutic Action The desired and beneficial action of fluoroquinolones is: • Interfere with the action of
DNA enzymes necessary for growth and reproduction of the bacteria. • Has little cross -resistance but misuse of this
drug for a short time will lead to existence of resistant strains. Indications Fl uoroquinolones are indicated for the
following medical conditions: • Treating infections (respiratory, urinary tract, and skin) caused by susceptible strains:
E.coli, P.mirabilis, K.pneumoniae, P.vulgaris, M.morganii, P.aeruginosa, H.influenzae, S.aureus, S.epidermidis,
N.gonorrhoeae, and group D streptococci. • Ciprofloxacin was approved in 2001 for prevention of anthrax infection
in areas that might be exposed to germ warfare. It is also effective against typhoid fever. Pharmacokinetics Here are
the characteristic interactions of fluoroquinolones and the body in terms of absorption, distribution, metabolism,
and excretion: Route Onset Peak Duration Oral Varies 60-90 min 4-5 h IV 10 min 30 min 4-5 h T1/2: 3.5-4 h
Metabolism: liver Excretion: liver (bile), kidney (urine) Contraindications and Cautions The following are
contraindications and cautions for the use of fluoroquinolones: • Known allergy to fluoroquinolones. • Pregnancy
and lactation. Potential effects on the fetus and infant are not known; use only if benefits clearly outweigh the
potential risk of toxicity to the fetus or infant. • Seizures. Can be exacerbated by the drugs’ effects on cell membrane
channels Adverse Effects Use of fluoroquinolones may result to these adverse effects: • GI: nausea, v omiting,
diarrhea, dry mouth • CNS: headache, dizziness, insomnia, depression • Immunological: bone marrow depression •
Risk for tendinitis and tendon rupture in patients over age 60, on concurrent steroids, and those with renal, heart, or
lung transplants • Photosensitivity and severe skin reactions so advise patient to avoid sun and ultraviolet light
exposure and to use protective clothing and sunscreens. Interactions The following are drug-drug interactions
involved in the use of fluoroquinolones: • Iron salts, sucralfate, mineral supplements, antacids: increased
therapeutic effects of fluoroquinolones. Administration should be separated by at least 4 hours. • Quinidine,
procainamide, pentamidine, tricyclics, phenothiazines: severe-to-fatal cardiac reactions due to increased QTc
interval and/or torsades de pointes • Theophylline: increased theophylline levels because these two drugs have the
same metabolic pathway • Steroids: increased CNS stimulation Penicillins and Penicillinase -Resistant Antibiotics •
Penicillin was the first antibiotic introduced for clinical use. Various modifications were subsequently made to
address resistant strains and to decrease drug adverse effects. • Penicillinase-resistant antibiotics were developed to
address penicillinresistant bacteria. Therapeutic Action The desired and beneficial action of penicillins and
penicillinase-resistant antibiotics is: • Exert bactericidal effect by interfering with the ability of susceptible bacteria
to build their cell walls when they are dividing. These drugs prevent the bacteria from bio synthesizing the
framework of the cell wall, and the bacteria with weakened cell walls swell and then burst from osmotic pressure
within the cell. Indications Penicillins and penicillinase-resistant antibiotics are indicated for the following medical
conditions: • Treatment of streptococcal infections (e.g. pharyngitis, tonsillitis, scarlet fever, endocarditis). •
Treatment of meningococcal meningitis if given at high doses Pharmacokinetics Here are the characte ristic
interactions of penicillins and penicillinase-resistant antibiotics and the body in terms of absorption, distribution,
metabolism, and excretion: Route Onset Peak Duration Oral Varies 1 h 6-8 h T1/2: 1-1.4 h Metabolism: N/A
Excretion: kidney (urine) Contraindications and Cautions The following are contraindications and cautions for the
use of penicillins and penicillinase-resistant antibitiotics: • Known allergy to penicillins and cephalosporins. • Renal
disease. Drug excretion is reduced. • Pregnancy and lactation. No adequate studies on the effect on fetus but these
drugs can cause diarrhea and superinfectons may occur in the infant. Adverse Effects Use of penicillins and
penicillinase-resistant antibiotics may result to these adverse effects: • GI: nausea, vomiting, diarrhea, abdominal
pain, glossitis, stomatitis, gastritis, sore mouth, furry tongue • Pain and inflammation at the injection site can occur
with injectable forms of the drugs. • Hypersensitivity reactions: rash, fever, wheezing, anaphyl axis with repeated
exposures • Superinfections, e.g. yeast infections. Interactions The following are drug-drug interactions involved in
the use of penicillins and penicillinase-resistant antibiotics: • Tetracyclines: decrease in effectiveness of penicillins •
Parenteral aminoglycosides: inactivation of aminoglycosides Sulfonamides • Sulfonamides are drugs that inhibit folic
acid synthesis. Therapeutic Action The desired and beneficial action of sulfonamides is: • Inhibit folic acid synthesis
required as precursors of RNA and DNA. They competitively block paraaminobenzoic acid to prevent synthesis of
folic acid in susceptible bacteria that synthesize their own folates for the production of RNA and DNA. Indications
Sulfonamides are indicated for the following medical conditions: • Treatment of infections caused by susceptible
strains: C.trachomatis, Nocardia, and some strains of H.influenzae, E.coli, and P.mirabilis. • No longer used much but
they remain an inexpensive and effective treatment for UTIs and trachoma, especially in developing countries where
cost is an issue. • Can also be used in treatment of sexually transmitted diseases. • Sulfasalazine is used in treatment
of ulcerative colitis and rheumatoid arthritis. Pharmacokinetics Here are the characteri stic interactions of
sulfonamides and the body in terms of absorption, distribution, metabolism, and excretion: Route Onset Peak
Duration Oral Rapid 1-4 h N/A T1/2: 8-10 h Metabolism: N/A Excretion: kidney (urine) Contraindications and
Cautions The following are contraindications and cautions for the use of sulfonamides: • Known allergy to
sulfonamides, sulfonylureas, or thiazide diuretics. Crosssensitivity can occur. • Renal disease. Increased toxic effects
of the drug. • Pregnancy. Can cause birth defects. • Lactation. Increased risk for kernicterus, diarrhea, and rash in
infants. Adverse Effects Use of sulfonamides may result to these adverse effects: • GI: nausea, vomiting, diarrhea,
abdominal pain, anorexia, stomatitis, and hepatic injury • Renal: crystalluria, hematuria, proteinuria, toxic nephrosis
• CNS: headache, dizziness, vertigo, ataxia, convulsions, depression • Bone marrow depression • Dermatological:
photosensitivity, rash, hypersensitivity reactions Interactions The following are drug-drug interactions involved in
the use of sulfonamides: • Tolbutamide, tolazamide, glyburide, glipizide, chlorpropamide: increased risk of
hypoglycemia • Cyclosporine: increased risk of nephrotoxicity Tetracyclines • Tetracyclines are semisynthetic
antibiotics based on the structure of a common soil mold. Therapeutic Action The desired and beneficial action of
tetracyclines is: • Inhibit protein synthesis leading to inability of the bacteria to multiply. The affected protein is
similar to protein found in human cells so these drugs can be toxic to humans at high concentrations. Indications
Tetracyclines are indicated for the following medical conditions: • Treatment of infections caused by susceptible
strains: Ricketssiae, M.pneumoniae, B.recurrentis, H.influenzae, H.ducreyi, Bacteroides spp., V.comma, Shigella spp.,
D.pneumoniae, and S.aureus. • Adjunct in treatment of protozoal infections. Pharmacokinetics Here are the
characteristic interactions of tetracyclines and the body in terms of absorption, distribution, me tabolism, and
excretion: Route Onset Peak Duration Oral Varies 2-4 h N/A Topical Minimal absorption occurs N/A N/A T1/2: 6-12 h
Metabolism: N/A Excretion: kidney (urine) Contraindications and Cautions The following are contraindications and
cautions for the use of tetracyclines: • Known allergies to tetracyclines or to tartrazine • Pregnancy and lactation.
Effect on developing bones and teeth • Fungal, mycobacterial, or viral ocular infections. Ophthalmic preparations
can kill both undesired bacteria and normal flora • Use in caution in children below age of 8. Can potentially damage
developing bones and teeth. • Hepatic or renal dysfunction. Drugs are concentrated in the bile and are excreted in
urine. Adverse Effects Use of tetracyclines may result to these adverse effects: • GI: nausea, vomiting, diarrhea,
abdominal pain, glossitis, dysphagia, fatal hepatotoxicity • Skeletal and bones: weakening the structure and causing
staining and pitting of teeth and bones • Dermatological: photosensitivity and rash • Superinfection • Local: pain
and stinging with topical or ocular applications • Hematologic: hemolytic anemia, bone marrow depression •
Hypersensitivity reactions: urticaria, anaphylaxis • Intracranial hypertension Interactions The following are drug -
drug interactions involved in the use of tetracyclines: • Penicillin G: decreased effectiveness of penicillin G • Oral
contraceptives: decreased effectiveness of oral contraceptives and additional form of birth control is needed •
Digoxin: increased digoxin toxicity • Calcium salts, magnesium slats, zinc salts, aluminum salts, bismuth salts, iron,
urinary alkalinizers, and charcoal: decreased absorption of tetracyclines Antimycobacterials • Antimycobacterials are
antibiotics used in the treatment of infections caused by pathogens responsible for tuberculosis and leprosy. •
Mycobacterium tuberculosis causes tuberculosis, the leading cause of death from infectious disease in the world. •
Mycobacterium leprae causes leprosy or Hansen’s disease, characterized by disf iguring skin lesions and destructive
effects on the respiratory tract. Therapeutic Action The desired and beneficial action of antimycobacterials is: • Act
on the DNA and/or RNA of the bacteria, leading to lack of growth and eventually to bacterial death. Indications
Tetracyclines are indicated for the following medical conditions: • Treatment of tuberculosis and leprosy.
Pharmacokinetics Here are the characteristic interactions of antimycobacterials and the body in terms of absorption,
distribution, metabolism, and excretion: Route Onset Peak Duration Oral Varies 1-2 h 24 h T1/2: 1-4 h Metabolism:
liver Excretion: kidney (urine) Contraindications and Cautions The following are contraindications and cautions for
the use of antimycobacterials: • Known allergies to antimycobacterials. • Pregnancy. Adverse effects on fetus. Safest
antituberculosis regimen in pregnancy isoniazid, ethambutol, and rifampin. • Severe CNS dysfunction. Exacerbated
by the effects of the drug • Hepatic or renal dysfunction. Interfere wi th the metabolism and excretion of drugs.
Adverse Effects Use of antimycobacterials may result to these adverse effects: • CNS: neuritis, dizziness, headache,
malaise, drowsiness, and hallucinations • GI: nausea, vomiting, anorexia, stomach upset, abdominal pain • Rifampin,
rifabutin, and rifapentine can cause discoloraion of body fluids from urine to sweat and tears. They may stain
orange-tinged and may permanently stain contact lenses. Interactions The following are drug-drug interactions
involved in the use of antimycobacterials: • Rifampin and INH in combination: increased toxic liver reactions •
Rifampin and rifabutin with beta blockers, corticosteroids, OCPs, oral anticoagulants, methadone, phenytoin,
verapamil, ketoconazole, and cyclosporine: increased metabolism and decreased drug effectiveness Other
Antibiotics • Ketolides is a class of antibiotics introduced in 2004. It is indicated for treatment of mild to moderate
communityacquired pneumonia caused by susceptible bacteria. • Lincosamides are similar to macrolides but they
are more toxic. They are used to treat severe infections when penicillin or other less toxic antibiotics cannot be
used. • Lipoglycopeptides are antibiotics introduced in 2010. They are used to treat complicated skin and skin -
structure infections caused by susceptible strains of gram-positive organisms. • Macrolides are antibiotics that
interfere with protein synthesis in susceptible bacteria. They are used to treat respiratory infections and urethritis in
adults and otitis media and pharyngitis/tonsillitis in children. Eythromycin is the drug of choice for Legionnaire’s
disease and infections caused by C.diphtheriae, Ureaplasma spp., mycoplasma pneumonia, and chlamydial
infections. • Monobactam antibiotics are indicated for treatment of gram-negative enterobacterial infections.
Therapeutic Action The desired and beneficial actions of other antibiotics are: • Ketolides and lincosamides block
protein synthesis leading to cell death. Ketolamides are structurally the same with macrolides. • Lipoglycopeptides
inhibit bacterial cell wall synthesis by interfering with polymerization and cross-linking of peptidoglycans. They bind
to the bacterial membrance and disrupt the membrane barrier function causing bacterial cell death. • Macrolides
bind to the bacterial cell membrane and change protein function. This prevents bacteria from dividing and cause
their cell death. • Monobactam disrupts bacterial cell wall synthesis and promote leakage of cellular contents and
cell death. Pharmacokinetics Here are the characteristic interactions of other antibiotics and the body in terms of
absorption, distribution, metabolism, and excretion: Route Onset Peak Duration Ketolides Oral Rapid 0.5-4 h N/A
T1/2: 10 h Metabolism: N/A Excretion: kidney (urine), colon (feces) Lincosamides Oral Varies 1-2 h 8-12 h IM 20-30
min 2-3 h 8-12 h IV Immediate Minutes 8-12 h Topical Minimal absorption N/A N/A T1/2: 2-3 h Metabolism: liver
Excretion: kidney (urine), colon (feces) Lipoglycopeptides IV Rapid End of infusion N/A T1/2: 8-9.5 h Metabolism:
unknown Excretion: kidney (urine) Macrolides Oral 1-2 h 1-4 h N/A IV Rapid 1 h N/A T1/2: 3-5 h Metabolism: liver
Excretion: liver (bile), kidney (urine) Monobactam antibiotics IM Varies 60-90 min 6-8 h IV Immediate 30 min 6-8 h
T1/2: 1.5-2 h Metabolism: N/A Excretion: kidney (urine) Contraindications and Cautions The following are
contraindications and cautions for the use of other antibiotics: • Ketolides: telithromycin with antiarrhythmics and
antilipidemics can cause serious adverse effects. It might also cause potentially fatal respiratory failure in patients
with myasthenia gravis. • Lincosamides: use in caution in patients with hepatorenal insufficiency. Usage in
pregnancy and lactation is only indicated if benefit clearly outweighs the risk to the fetus or neonate. The same is
true with lipoglycopeptides, macrolides, and monobactams. Adverse Effects Use of other antibiotics may result to
these adverse effects: • GI: nausea, vomiting, potential for pseudomembranous colitis, supe rinfections, taste
alterations, risk for C.difficile diarrhea Interactions The following are drug-drug interactions involved in the use of
other antibiotics: • Ketolides: loss of therapeutic effects if combined with rifampin, phenytoin, carbamazepine,
phenobarbital; increased serum levels of digoxin and metoprolol; increased GI toxicity with theophylline •
Lipoglycopeptides: increased risk for prolonged QT interval if combined with drugs known to cause prolonged QT
interval • Macrolides: food in the stomach decreases absorption of oral macrolifes. Antibiotic should be taken on an
empty stomach with a full, 8-oz glassof water 1 hour before or at least 2-3 hours after meals. • Monobactams:
incompatible in solution with nafcillin, cephradine, and metronidazole. Nursing Considerations for Antibiotics Here
are important nursing considerations when administering antibiotics: Nursing Assessment These are the important
things the nurse should include in conducting assessment, history taking, and examination: • Assess for the
mentioned cautions and contraindications (e.g. drug allergies, CNS depression, CV disorders, etc.) to prevent any
untoward complications. • Perform a thorough physical assessment (other medications taken, CNS, skin,
respirations, and laboratory tests like renal functions tests and complete blood count or CBC) to establish baseline
data before drug therapy begins, to determine effectiveness of therapy, and to evaluate for occurrence of any
adverse effects associated with drug therapy. • Perform culture and sensitivity tests at the site of infection to ensure
appropriate use of the drug. • Conduct orientation and reflex assessment, as well as auditory testing to evaluate any
CNS effects of the drug (aminoglycosides). Nursing Diagnoses Here are some of the nursing diagnoses that can be
formulated in the use of this drug for therapy: • Acute pain related to GI or CNS drug effects • Deficient fluid volume
and imbalanced nutrition: less than body requirements related to diarrhea • Disturbed sensory perception
(auditory) related to CNS drug effects • Risk for infection related to bone marrow suppression (aminoglycosides) and
repeated injections (cephalosporins). Implementation with Rationale These are vital nursing interventions done in
patients who are taking antibiotics: • Check culture and sensitivity reports to ensure that this is the drug of choice
for this patient. • Ensure that patient receives full course of aminoglycosides as prescribed, divided around the clock
to increase effectiveness and decrease the risk for development of resistant strains of bacteria. • Monitor infection
site and presenting signs and sympoms throughout course of drug therapy because failure of these manifestations
to resolve may indicate the need to reculture the site. • Provide safety measures to protect the patient if CNS effects
(e.g. confusion, disorientation, numbness) occur. • Educate client on drug therapy to promote understanding and
compliance. • Provide the following patient teaching: safety precautions (e.g. changing positions, avoiding
hazardous tasks, ec.), drinking lots of fluids and to maintain nutrition even though nausea and vomiting may occur,
report difficulty breathing, severe headache, fever, diarrhea, and signs of infection. Evaluation Here are aspects of
care that should be evaluated to determine effectiveness of drug therapy: • Monitor patient response to therapy
(decrease in signs and symptoms of infection). • Monitor for adverse effects (e.g. orientation and affect, hearing
changes, bone marrow suppression, renal toxicity, hepatic dysfunction, etc). • Evaluate patient understanding on
drug therapy by asking patient to name the drug, its indication, and adverse effects to watch for. • Monitor patient
compliance to drug therapy.

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