Tetanus Toxiod

8/4/2019 Tetanus Toxiod

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ategory 80:08

Tetanus Toxoid

For Booster Use Only

(Not recommended for primary immunization)

DESCRIPTION

Tetanus Toxoid, for intramuscular or subcutaneous use, is a sterile solution of toxoid in isotonic sodium

chloride solution. The

vaccine is clear or slightly turbid in appearance.

Clostridium tetani culture is grown in a peptone-based medium and detoxified with formaldehyde. The

detoxified material is

then purified by serial ammonium sulfate fractionation, followed by sterile filtration. The toxoid is then

diluted with

physiological saline solution (0.85%). Each dose contains the preservative thimerosal [(mercury

derivative), 25 g mercury/dose].

This product does not contain an aluminum-containing adjuvant.

Each 0.5 mL dose is formulated to contain 4 Lf (flocculation units) of tetanus toxoid and passes the

guinea pig potency test. The

residual formaldehyde content, by assay, is less than 0.02%.

CLINICAL PHARMACOLOGY

Tetanus manifests systemic toxicity primarily by neuromuscular dysfunction caused by a potent exotoxin

elaborated by

Clostridium tetani.

Following routine use of tetanus toxoid in the United States (US), the occurrence of tetanus decreased

dramatically from 560

reported cases in 1974 to an average of 50-100 cases reported annually from the mid 1970s through the

late 1990s. The


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case-fatality rate has been relatively constant at approximately 30%. During the years 1982-1998, 52%

of reported cases were

among persons 60 years of age or older. In the mid to late 1990s, the age distribution of reported cases

shifted to a younger age

group, in part due to an increased number of cases among injection drug users in California. From 1995-

1997, persons 20 to

59 years of age accounted for 60% of all cases, with persons 60 years of age or older accounting for only

35%. In the US, tetanus

occurs almost exclusively among unvaccinated or inadequately vaccinated persons.

1

In 4% of tetanus cases reported during 1987 and 1988, no wound or other condition was implicated.

Non-acute skin lesions,

such as ulcers, or medical conditions such as abscesses, were reported in association with 14% of cases.

2

Neonatal tetanus occurs among infants born under unhygienic conditions to inadequately vaccinated

mothers. Vaccinated

mothers confer protection to their infants through transplacental transfer of maternal antibody. From

1972 through 1984, 29 cases

of neonatal tetanus were reported in the US.

2

Since 1984, only three cases of neonatal tetanus have been reported in all infants of

unvaccinated or inadequately vaccinated mothers.

3

Spores of C tetani are ubiquitous. Serologic tests indicate that naturally acquired immunity to tetanus

toxin does not occur in the

US.

2

Thus, universal primary vaccination, with subsequent maintenance of adequate antitoxin levels by

means of appropriately


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timed boosters, is necessary to protect all age-groups. Tetanus toxoid is a highly effective antigen, and a

completed primary

series generally induces protective levels of serum antitoxin that persists for 10 or more years.

2

In a trial of 26 adults given a

booster dose of Tetanus Toxoid, 81% of the subjects demonstrated a 2-fold or greater rise in serum

antitoxin antibody

levels.

4

There are no studies of this product used as a primary series.

INDICATIONS AND USAGE

Tetanus Toxoid is indicated for booster injection only for persons 7 years of age or older against tetanus.

This vaccine is NOT

indicated for primary immunization.

Primary immunization schedule for children under 7 years of age (prior to seventh birthday) should

consist of five doses of a

vaccine containing tetanus toxoid. The initial three doses are given as Diphtheria and Tetanus Toxoids

and Acellular Pertussis

Vaccine Adsorbed (DTaP) vaccine, administered intramuscularly at intervals of 4 to 8 weeks. A fourth

dose of DTaP is

recommended at 15 to 20 months of age. The interval between the third and fourth dose should be at

least 6 months. A fifth

dose of DTaP is given before school entry (kindergarten or elementary school) at 4 to 6 years of age,

unless the fourth dose was

given after the fourth birthday.

5 , 6

In instances where the pertussis vaccine component is contraindicated, Diphtheria and

Tetanus Toxoids Adsorbed (For Pediatric Use) (DT) should be used for the remaining doses. For persons

7 years of age and older,


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Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) is preferred to tetanus toxoid alone.

2 , 5

Tetanus Toxoid is interchangeable with Tetanus Toxoid Adsorbed (contains aluminum adjuvant) as a

booster, and would only be

preferred if aluminum was to be avoided. Although the rate of seroconversion is essentially equivalent

with either form,

adsorbed toxoids induce more persistent antitoxin titers.

2

Tetanus Toxoid would be preferred over diphtheria-containing

vaccines if there was a contraindication to the diphtheria component.

For the prevention of neonatal tetanus in unvaccinated pregnant women, see PREGNANCY CATEGORY C

section.

2

This vaccine is NOT to be used for the treatment of tetanus infection.

As with any vaccine, vaccination with Tetanus Toxoid may not protect 100% of individuals.

Page 2 of X

If pa s s i ve immuni z at ion i s requi red, Te t anus Immune Globul in ( T IG) (Human) should be

us ed ( s e e DOSAGE AND

ADMINISTRATION section).

CONTRAINDICATIONS

HYPERS ENS I T IVI T Y TO ANY COMPONENT OF THE VA C C INE , INC LUDING THIMEROSAL , A

MER CURY DERIVAT IVE , I S A

CONTRAINDICATION FOR FURTHER USE OF THIS VACCINE.

It is a contraindication to use this or any other related vaccine after a serious adverse event temporally

associated with a

previous dose including an anaphylactic reaction.


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A history of systemic allergic or neurologic reactions following a previous dose of Tetanus Toxoid is an

absolute contraindication

for further use.

2 , 5

If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not

completed a primary

immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive

immunization should be

given using TIG (Human).

2

Elective immunization should be deferred during the course of any febrile illness or acute infection. Aminor afebrile illness such

as a mild upper respiratory infection should not preclude immunization.

2

Elective immunization procedures should be deferred during an outbreak of poliomyelitis.

8

It is a contraindication to use this or any other related vaccine after a serious adverse reaction

temporally associated with a

previous dose, including an anaphylactic reaction.

WARNINGS

Intramuscular injections should be given with great care in patients suffering from thrombocytopenia or

other coagulation

disorders. In this situation, subcutaneous administration of Tetanus Toxoid may be advisable.

A routine booster should not be given more frequently than every ten years. (This guideline should not

preclude wound

management considerations.)

Persons who experienced Arthus-type hypersensitivity reactions or temperature greater than 39.4C

(103F) after a previous dose


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of a tetanus toxoid-containing preparation usually have very high serum tetanus antibody levels and

should not be given even

emergency doses of tetanus toxoid-containing preparation more frequently than every 10 years, even if

they have a wound that

is neither clean nor minor.

9

Deaths have been reported in temporal association with the administration of Tetanus Toxoid (see

ADVERSE REACTIONS section).

PRECAUTIONS

GENERAL

Care is to be taken by the health-care provider for the safe and effective use of Tetanus Toxoid.

EPINEPHRINE INJECTION (1:1,000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE

ANAPHYLACTIC REACTION OCCUR

DUE TO ANY COMPONENT OF THE VACCINE.

There is an increased incidence of local and systemic reactions to booster doses of tetanus toxoid when

given to previously

immunized persons. (Refer to DOSAGE AND ADMINISTRATION section for timing of booster injections.)

Prior to an injection of

any vaccine, all known precautions should be taken to prevent adverse reactions. The physician should

have a current

knowledge of the literature concerning the use of the vaccine under consideration, including the nature

of the adverse reactions

that may follow its use. The patients medical history should be reviewed with respect to possiblesensitivity and any previous

adverse reactions to the vaccine or similar vaccines, possible sensitivity to dry natural latex rubber,

previous immunization

history, and current health status (see CONTRAINDICATIONS section).


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Persons who have a history of Guillain-Barr syndrome (GBS) may be at increased risk of recurrent GBS

after subsequent doses of

Tetanus Toxoid vaccines. However, in a study in which an estimated 1.2 million doses of tetanus-

containing toxoid were

administered to persons >18 years of age, two cases of GBS were expected by chance alone during the 6

weeks after vaccination,

and only one case was reported. This finding suggests that the risk of GBS after administration of

tetanus toxoid is extremely low.

The decision to administer tetanus-toxoid-containing vaccine to persons who have had GBS within 6

weeks after receiving

tetanus toxoid should be based on the benefits of subsequent vaccination and the risk of the recurrence

of GBS.

9

The expected immune response to Tetanus Toxoid may not be obtained in immunosuppressed patients.

Administration of

Tetanus Toxoid is not contraindicated in patients with HIV infection.

10

Special care should be taken to ensure that the injection does not enter a blood vessel.

Immunosuppressive therapies including radiation, corticosteroids, antimetabolites, alkylating agents,

and cytotoxic drugs may

reduce the immune response to vaccines. Therefore, routine vaccination should be deferred, if possible,

while patients are

receiving such therapy.

2

If Tetanus Toxoid has been administered to persons receiving immunosuppressive therapy, or having an

immunodeficiency disorder, an adequate antibody response may not be obtained.

5

When possible, immunosuppressive

treatment should be interrupted when immunization is required due to a tetanus-prone wound.


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It is advisable to use DT (For Pediatric Use 6 years of age and younger) or Td (For Adult Use 7 years of

age and older) in

wound prophylaxis instead of tetanus toxoid alone in order to maintain adequate levels of diphtheria

immunity.

5

A separate, sterile syringe and needle or a sterile disposable unit must be used for each patient to

prevent transmission of

hepatitis or other infectious agents from person to person. Needles should not be recapped and should

be properly disposed.

Page 3 of 5

Caution: The stopper of the vial contains dry natural latex rubber, that may cause allergic reactions.

INFORMATION FOR PATIENTS

As part of the child's or adult's immunization record, the date, lot number and manufacturer of the

vaccine administered MUST

be recorded.

1 1 - 1 3

Patients should be fully informed of the benefits and risks of immunization with Tetanus Toxoid vaccine.

The physician should inform the patients about the potential for adverse reactions that have been

temporally associated with

Tetanus Toxoid administration. The health-care provider should provide the Vaccine Information

Statements (VISs) which are

required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

Parents or guardians should

be instructed to report any adverse reactions to their health-care provider.


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IT IS EXTREMELY IMPORTANT WHEN THE CHILD OR ADULT PATIENT RETURNS FOR THE NEXT DOSE IN

THE SERIES, THE PARENT,

GUARDIAN, OR ADULT PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY

SYMPTOMS AND/OR SIGNS OF AN

ADVERSE REACTION AFTER THE PREVIOUS DOSE (SEE CONTRAINDICATIONS AND ADVERSE REACTIONS

SECTIONS).

The health-care provider should inform the parent, guardian, or adult patient of the importance of

completing the

immunization series, unless a contraindication to further immunization exists.

The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting

System (VAERS) to accept

all reports of suspected adverse events after the administration of any vaccine, including but not limited

to the reporting of

events required by the National Childhood Vaccine Injury Act of 1986.

5

The toll-free number for VAERS forms and information is

1-800-822-7967.

DRUG INTERACTIONS


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If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer

protection than antitoxin

of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG

(Human) for wounds of

average severity is 250 units intramuscularly. When a vaccine containing tetanus toxoid is given at the

same time as TIG (Human),

separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed

toxoid in this situation.

2

The vaccine should be administered subcutaneously in patients on anticoagulant therapy.

Immunosuppressive therapies may reduce the response to vaccines (see PRECAUTIONS section).

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

PREGNANCY CATEGORY C

Adequate immunization by routine boosters in non-pregnant women of child-bearing age can obviate

the need to vaccinate

women during pregnancy (see DOSAGE AND ADMINISTRATION section).


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Animal reproduction studies have not been conducted with Tetanus Toxoid. The risk to the fetus from

tetanus toxoid is

unknown. The ACIP recommends that an appropriate tetanus toxoid-containing preparation be given to

inadequately

immunized pregnant women because it affords protection against neonatal tetanus.

10

Waiting until the second trimester is a

reasonable precaution to minimize any theoretical teratogenic concern.

5

It has been reported that Tetanus Toxoid administered to pregnant women prevents neonatal tetanus in

newborns.

1 4 , 1 5

However, the data reported on the safety of Tetanus Toxoid when so used is inconclusive because the

incidence of neonatal

deaths in New Guinea was significantly higher than in the US. A prospective study in the US has not been

done to confirm these

reports.

14


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NURSING MOTHERS

Tetanus Toxoid does not affect the safety of mothers who are breastfeeding or their infants.

Breastfeeding does not adversely

affect immune response and is not a contraindication for vaccination.

10

PEDIATRIC USE

SAFETY AND EFFECTIVENESS OF TETANUS TOXOID IN INFANTS BELOW THE AGE OF SIX WEEKS HAS NOT

BEEN ESTABLISHED.

HOWEVER, THIS VACCINE IS NOT INDICATED FOR CHILDREN UNDER 7 YEARS OF AGE.

GERIATRIC USE

Tetanus Toxoid should only be used in geriatric patients known to have received a primary series (at

least 2 doses) of tetanuscontaining vaccine, since many such persons have no prior immunity.

1 6

Clinical studies of Tetanus Toxoid did not include

sufficient numbers of subjects aged 65 and over to determine whether they respond differently from

younger subjects. Other

reported clinical experience has not identified differences in responses between the elderly and younger

patients.

ADVERSE REACTIONS

BODY SYSTEM AS A WHOLE

Adverse reactions may be local and include redness, warmth, edema, induration with or without

tenderness as well as urticaria,


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and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some

patients after the injection.

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8

hours after an injection)

may occur, particularly in persons who have received multiple prior boosters.

2

On rare occasions, anaphylaxis has been reported

following administration of products containing tetanus toxoid. Upon review, a report by the Institute of

Medicine (IOM)

concluded the evidence established a causal relationship between tetanus toxoid and anaphylaxis.

17

Deaths have been reported

in temporal association with the administration of tetanus toxoid-containing vaccines.

Page 4 of 5

NERVOUS SYSTEM

The following neurologic illnesses have been reported as temporally associated with vaccines containing

tetanus toxoid:

neurological complications

18 , 1 9

including cochlear lesion,

2 0

brachial plexus neuropathies,


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20 , 2 1

paralysis of the radial

nerve,

2 2

paralysis of the recurrent nerve,

2 0

accommodation paresis, Guillain-Barr syndrome, and EEG disturbances with

encephalopathy. The IOM, following review of the reports of neurologic events following vaccination

with tetanus toxoid, DT or

Td, concluded the evidence favored acceptance of a causal relationship between tetanus toxoid and

brachial neuritis and GBS.

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Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine

Injury Act of 1986, requires

physicians and other health-care providers who administer vaccines to maintain permanent vaccination

records and to report

occurrences of certain adverse events to the US Department of Health and Human Services.

1 1 - 1 3

Reportable events include those

listed in the Act for each vaccine and events such as anaphylaxis or anaphylactic shock within 7 days,

brachial neuritis within

28 days; any acute complication or sequela (including death) of an illness,

5

disability, injury, or condition referred to above, or any

events that would contraindicate further doses of vaccine, according to this Tetanus Toxoid for Booster

Use Only package insert.


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Adverse events following immunization with vaccine should be reported by health-care providers to the

US Department

of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting

forms and information

about reporting requirements or completion of the form can be obtained from VAERS through a toll-free

number

1-800-822-7967.

11 - 1 3

Health-care providers also should report these events to the Pharmacovigilance Department, Sanofi

Pasteur Inc.,

Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

DOSAGE AND ADMINISTRATION

2, 5

Parenteral drug products should be inspected visually for extraneous particulate matter and/or

discoloration prior to administration

whenever solution and container permit. The vaccine should not be used if particulate matter or

discoloration is found.

FOR BOOSTER USE ONLY NOT RECOMMENDED FOR PRIMARY IMMUNIZATION

SHAKE VIAL WELL before withdrawing each dose.

Inject intramuscularly or subcutaneously in the area of the vastus lateralis (lateral mid-thigh) or deltoid.

The vaccine should not

be injected into the gluteal area or areas where there may be a major nerve trunk.

A needle length one inch is preferred for these age groups because needles less than one inch might be

of insufficient length to

penetrate muscle tissue in certain adults and older children.

10

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After

insertion of the needle,

aspirate to ensure that the needle has not entered a blood vessel.


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After the initial immunization series is completed (see INDICATIONS AND USAGE section), a booster dose

of 0.5 mL of Tetanus

Toxoid should be given intramuscularly every 10 years to maintain adequate immunity. This 10-year

period is determined from

the last dose administered irrespective of whether it was given earlier in routine childhood

immunization or as part of wound

management.

5

Booster Injection After Injury:

A thorough attempt must be made to determine whether a patient has completed primary

immunization. Patients with

unknown or uncertain previous immunization histories should be considered to have no previous

tetanus toxoid doses. Persons

who had military service since 1941 can be considered to have received at least one dose. Although

most people in the military

since 1941 may have completed a primary series of tetanus toxoid, this cannot be assumed for each

individual. Patients who

have not completed a primary series may require tetanus toxoid and passive immunization (TIG

Human) at the time of wound

cleaning and debridement (TABLE 1).

2

Available evidence indicates that complete primary vaccination with tetanus toxoid provides long-lasting

protection 10 years

for most recipients. Consequently, after complete primary tetanus vaccination, boosters, even for

wound management, need to

be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster

is appropriate if the

patient has not received tetanus toxoid within the preceding five years. Persons who have received at

least two doses of tetanus

toxoid rapidly develop antitoxin antibodies.


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2

Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) is the preferred vaccine for active tetanus

immunization in wound

management of patients 7 years of age. Because a large proportion of adults are susceptible to

diphtheria, this vaccine

enhances diphtheria protection. Thus, by taking advantage of acute health-care visits, such as for wound

management, some

patients can be protected who otherwise would remain susceptible. For inadequately vaccinated

patients of all ages, completion

of primary vaccination at the time of discharge or at follow-up visits should be ensured.

2

Tetanus Toxoid is interchangeable with Tetanus Toxoid Adsorbed (contains aluminum adjuvant) as a

booster, and would only be

preferred if aluminum was to be avoided. Tetanus Toxoid would be preferred over diphtheria-containing

vaccines if there was a

contraindication to the diphtheria component. Page 5 of 5

TABLE 1

2,5

Summary Guide to Tetanus Prophylaxis in Routine Wound Management*

History of Adsorbed Tetanus

Toxoid (Doses)

Clean, Minor Wounds

Td TIG

All Other Wounds**

Td TIG

Unknown or < three

Three

Yes No


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No No

Yes Yes

No No

* Important details are in the text of the insert.

** Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture

wounds; avulsions;

and wounds resulting from missiles, crushing, burns, and frostbite.

Yes, if >10 years since last dose.

Yes, if >5 years since last dose. (More frequent boosters are not needed and can accentuate side

effects.)

If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer

protection than antitoxin

of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG

(Human) for wounds of

average severity is 250 units intramuscularly. When tetanus toxoid and TIG (Human) are given

concurrently, separate syringes and

separate sites should be used. TIG should not be given with Tetanus Toxoid, but only with Tetanus

Toxoid Adsorbed.

2

HOW SUPPLIED

Vial, 15 Doses (7.5 mL) Product No. 49281-812-84

CPT Code: 90749

CPT is a registered trademark of the American Medical Association.

STORAGE

Store at 2 to 8C (35 to 46F). DO NOT FREEZ


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Introduction

The appendix is a small fingerlike appendage about 10 cm (4 in) long, attached to the cecum just below the ileocecal

valve. No definite functions can be assigned to it in humans. The appendix fills with food and empties as regularly as

does the cecum, of which it is small, so that it is prone to become obstructed and is particularly vulnerable to infection

(appendicitis).

Appendicitis is the most common cause of acute inflammation in the right lower quadrant of the abdominal cavity.

About 7% of the population will have appendicitis at some time in their lives, males are affected more than females,

and teenagers more than adults. It occurs most frequently between the age of 10 and 30.

The disease is more prevalent in countries in which people consume a diet low in fiber and high in refined

carbohydrates.

The lower quadrant pain is usually accompanied by a low-grade fever, nausea, and often vomiting. Loss of appetite is

common. In up to 50% of presenting cases, local tenderness is elicited at Mc Burneys point applied located at

halfway between the umbilicus and the anterior spine of the Ilium.

Rebound tenderness (ex. Production or intensification of pain when pressure is released) may be present. The extent

of tenderness and muscle spasm and the existence of the constipation or diarrhea depend not so much on the

severity of the appendiceal infection as on the location of the appendix.

If the appendix curls around behind the cecum, pain and tenderness may be felt in the lumbar region. Rovsings sign

maybe elicited by palpating the left lower quadrant. If the appendix has ruptured, the pain become more diffuse,

abdominal distention develops as a result of paralytic ileus, and the patient condition become worsens.

Constipation can also occur with an acute process such as appendicitis. Laxative administered in the instance may

result in perforation of the in flared appendix. In general a laxative should never be given when a persons has fever,

nausea or pain.

Anatomy and Physiology of Digestive System

The mouth, or oral cavity, is the first part of the digestive tract. It is adapted to receive food by ingestion, break it into

small particles by mastication, and mix it with saliva. The lips, cheeks, and palate form the boundaries. The oral cavity

contains the teeth and tongue and receives the secretions from the salivary glands.

Lips and Cheeks

The lips and cheeks help hold food in the mouth and keep it in place for chewing. They are also used in the formation

of words for speech. The lips contain numerous sensory receptors that are useful for judging the temperature andtexture of foods.

Palate

The palate is the roof of the oral cavity. It separates the oral cavity from the nasal cavity. The anterior portion, the

hard palate, is supported by bone. The posterior portion, the soft palate, is skeletal muscle and connective tissue.

Posteriorly, the soft palate ends in a projection called the uvula. During swallowing, the soft palate and uvula move

upward to direct food away from the nasal cavity and into the oropharynx.

Tongue

The tongue manipulates food in the mouth and is used in speech. The surface is covered with papillae that provide

friction and contain the taste buds.

Teeth

A complete set of deciduous (primary) teeth contains 20 teeth. There are 32 teeth in a complete permanent(secondary) set. The shape of each tooth type corresponds to the way it handles food.

Pharynx

The pharynx is a fibromuscular passageway that connects the nasal and oral cavities to the larynx and esophagus. It

serves both the respiratory and digestive systems as a channel for air and food. The upper region, the nasopharynx,

is posterior to the nasal cavity. It contains the pharyngeal tonsils, or adenoids, functions as a passageway for air, and

has no function in the digestive system. The middle region posterior to the oral cavity is the oropharynx. This is the

first region food enters when it is swallowed. The opening from the oral cavity into the oropharynx is called the


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fauces. Masses of lymphoid tissue, the palatine tonsils, are near the fauces. The lower region, posterior to the larynx,

is the laryngopharynx, or hypopharynx. The laryngopharynx opens into both the esophagus and the larynx.

Esophagus

The esophagus is a collapsible muscular tube that serves as a passageway between the pharynx and stomach. As it

descends, it is posterior to the trachea and anterior to the vertebral column. It passes through an opening in the

diaphragm, called the esophageal hiatus, and then empties into the stomach. The mucosa has glands that secrete

mucus to keep the lining moist and well lubricated to ease the passage of food. Upper and lower esophageal

sphincters control the movement of food into and out of the esophagus. The lower esophageal sphincter is

sometimes called the cardiac sphincter and resides at the esophagogastric junction

Stomach

the stomach, which receives food from the esophagus, is located in the upper left quadrant of the abdomen. The

stomach is divided into the fundic, cardiac, body, and pyloric regions. The lesser and greater curvatures are on the

right and left sides, respectively, of the stomach.

Small Intestine

The small intestine extends from the pyloric sphincter to the ileocecal valve, where it empties into the large intestine.

The small intestine finishes the process of digestion, absorbs the nutrients, and passes the residue on to the large

intestine. The liver, gallbladder, and pancreas are accessory organs of the digestive system that are closely

associated with the small intestine. The small intestine is divided into the duodenum, jejunum, and ileum. The small

intestine follows the general structure of the digestive tract in that the wall has a mucosa with simple columnar

epithelium, submucosa, smooth muscle with inner circular and outer longitudinal layers, and serosa. The absorptive

surface area of the small intestine is increased by plicae circulares, villi, and microvilli. Exocrine cells in the mucosa of

the small intestine secrete mucus, peptidase, sucrase, maltase, lactase, lipase, and enterokinase. Endocrine cells

secrete cholecystokinin and secretin. The most important factor for regulating secretions in the small intestine is the

presence of chyme. This is largely a local reflex action in response to chemical and mechanical irritation from the

chyme and in response to distention of the intestinal wall. This is a direct reflex action, thus the greater the amount of

chyme, the greater the secretion.

Large Intestine

The large intestine is larger in diameter than the small intestine. It begins at the ileocecal junction, where the ileum

enters the large intestine, and ends at the anus. The large intestine consists of the colon, rectum, and anal canal. Thewall of the large intestine has the same types of tissue that are found in other parts of the digestive tract but there are

some distinguishing characteristics. The mucosa has a large number of goblet cells but does not have any villi. The

longitudinal muscle layer, although present, is incomplete. The longitudinal muscle is limited to three distinct bands,

called teniae coli, that run the entire length of the colon. Contraction of the teniae coli exerts pressure on the wall and

creates a series of pouches, called haustra, along the colon. Epiploic appendages, pieces of fat-filled connective

tissue, are attached to the outer surface of the colon. Unlike the small intestine, the large intestine produces no

digestive enzymes. Chemical digestion is completed in the small intestine before the chyme reaches the large

intestine. Functions of the large intestine include the absorption of water and electrolytes and the elimination of feces.

Rectum and Anus

The rectum continues from the signoid colon to the anal canal and has a thick muscular layer. It follows the curvature

of the sacrum and is firmly attached to it by connective tissue. The rectum and ends about 5 cm below the tip of thecoccyx, at the beginning of the anal canal. The last 2 to 3 cm of the digestive tract is the anal canal, which continues

from the rectum and opens to the outside at the anus. The mucosa of the rectum is folded to form longitudinal anal

columns. The smooth muscle layer is thick and forms the internal anal sphincter at the superior end of the anal canal.

This sphincter is under involuntary control. There is an external anal sphincter at the inferior end of the anal canal.

This sphincter is composed of skeletal muscle and is under voluntary control.

Clinical Manifestations

1. Generalized or localized abdominal pain in the epigastric or periumbilical areas and upper right abdomen. Within

2 to 12 hours, the pain localizes in the right lower quadrant and intensity increases.


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2. Anorexia, moderate malaise, mild fever, nausea and vomiting.

3. Usually constipation occurs ; occasionally diarrhea.

4. Rebound tenderness, involuntary guarding, generalized abdominal rigidity.

Diagnostic Evaluation

1. Physical examination consistent with clinical manifestations.

2. WBC count reveal moderate leukocytosis (10,000 to 16,000/mm3) with shift to the left (increased immature

neutrophils).

3. Urinalysis rule out urinary disorders.

4. Abdominal x-ray may visualize shadow consistent with fecalith in appendix; perforation will reveal free air.

5. Abdominal ultrasound or CT scan can visualize appendix and rule out other conditions, such as diverticulitis and

crohns disease. Focused appendiceal CT can quickly evaluate for appendicitis.

Medications

Analgesics

Intravenous fluids replacements

Analgesics

Treatment

Appendectomy is the effective treatment if peritonitis develops treatment involves.

GI Intubation

Parenteral replacement of IV fluids and electrolytes

Administration of Antibiotics

Surgery is indicated if appendicitis is diagnosed. Antibiotics and IV fluids are administered until surgery is performed

analgesics can be administered after the diagnosed is made.

An appendectomy (surgical removal of the appendix) is performed as soon as possible to decrease the risk of

perforation. T he appendectomy may be performed under a (general or spinal anesthetics) with a low abdominal

incisions or by (laparoscopy) which is recently highly effective method.

Complications

The major complication of appendicitis is perforation of the appendix, which can lead to peritonitis, abscess formation

(collection of purulent material), or portal pylephlebitis, which is septic thrombosis of the portal vein caused by

vegetative emboli that arise from septic intestines.Perforation generally occurs 24 hours after the onset of pain symptoms include a fever of 37.7 degree Celsius or 100

degree Fahrenheit or greater, a toxic appearance and continued abdominal pain or tenderness.

Nursing Interventions

1. Monitor frequently for signs and symptoms of worsening condition, indicating perforation, abscess, or peritonitis

(increasing severity of pain, tenderness, rigidity, distention, absent bowel sounds, fever, malaise, and

tachycardia).

2. Notify health care provider immediately if pain suddenly ceases, this indicates perforation, which is a medical

emergency.

3. Assist patient to position of comfort such as semi-fowlers with knees are flexed.

4. Restrict activity that may aggravate pain, such as coughing and ambulation.

5. Apply ice bag to abdomen for comfort.6. Avoid indiscriminate palpation of the abdomen to avoid increasing the patients discomfort.

7. Promptly prepare patient for surgery once diagnosis is established.

8. Explain signs and symptoms ofpostoperative complications to report-elevated temperature, nausea and vomiting,

or abdominal distention; these may indicate infection.

9. Instruct patient on turning, coughing, or deep breathing, use of incentive spirometer, and ambulation. Discuss

purpose and continued importance of these maneuvers during recovery period.

10. Teach incisional care and avoidance of heavy lifting or driving until advised by the surgeon.


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11. Advise avoidance of enemas or harsh laxatives; increased fluids and stool softeners may be used for

postoperative constipation.

Discharge Planning

M Antibiotics for infection

Analgesic agent (morphine) can be given for pain after the surgery

E Within 12 hrs of surgery you may get up and move around.

You can usually return to normal activities in 2-3 weeks after laparoscopic surgery.

T Pretreatment of foods with lactase preparations (e.g. lactacid drops) before ingestion can reduce symptoms.

Ingestion of lactase enzyme tablets with the first bite of food can reduce symptoms.

H To care wound perform dressing changes and irrigations as prescribe avoid taking laxative or applying heat to

abdomen when abdominal pain of unknown cause is experienced.

Reinforce need for follow-up appointment with the surgeon

Call your physician for increased pain at the incision site

O Document bowel sounds and the passing of flatus or bowel movements (these are signs of the return of

peristalsis)

Watch for surgical complications such as continuing pain or fever, which indicate an abscess or wound

dehiscence

Stitches removed between fifth and seventh day (usually in physicians office)

D Liquid or soft diet until the infection subsides

Soft diet is low in fiber and easily breaks down in the gastrointestinal tract

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Tetanus Toxiod

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