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Antispasmodic Anticholinergic: Drug Name

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Drug Name

Generic Name: Hyoscine-N-butylbromide
Brand Name:  Buscopan
Classification: Antispasmodic; Anticholinergic
Therapeutic Actions:
Hyoscine-N-butylbromide (HNBB) acts by interfering with the transmission of nerve impulses by acetylcholine
in the parasympathetic nervous system.

Buscopan exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and urinary tracts.
As a quaternary ammonium derivative, hyoscine-N- butylbromide does not enter the central nervous system.
Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic
effects result from a ganglion-blocking action within the visceral wall as well as from anti- muscarinic activity.

Indications:
Buscopan Tablets are indicated for the relief of spasm of the genito-urinary tract or gastro- intestinal tract and
for the symptomatic relief of Irritable Bowel Syndrome

Contraindications
Buscopan Tablets should not be administered to patients with myasthenia gravis, megacolon and narrow angle
glaucoma. In addition, they should not be given to patients with a known hypersensitivity to hyoscine-N-
butylbromide or any other component of the product.

Adverse Effects:
 CNS: dizziness, anaphylactic reactions, anaphylactic shock, increased ICP,
disorientation, restlessness, irritability, dizziness, drowsiness, headache, confusion, hallucination,
delirium, impaired memory
 CV: hypotension, tachycardia, palpitations, flushing
 GI: Dry mouth, constipation, nausea, epigastric distress
 DERM: flushing, dyshidrosis
 GU: Urinary retention, urinary hesitancy
 Resp: dyspnea, bronchial plugging, depressed respiration
 EENT: mydriasis, dilated pupils, blurred vision, photopobia, increased intraocular
pressure, difficulty of swallowing.
Nursing Considerations
 Drug compatibility should be monitored closely in patients requiring adjunctive therapy
 Avoid driving & operating machinery after parenteral administration.
 Avoid strict heat
 Raise side rails as a precaution because some patients become temporarily excited or disoriented
and some develop amnesia or become drowsy.
 Reorient patient, as needed, Tolerance may develop when therapy  is prolonged
 Atropine-like toxicity may cause dose related adverse reactions. Individual tolerance varies greatly
 Overdose may cause curare-like effects, such as respiratory paralysis. Keep emergency
equipment available.
Drug Name
Generic Name: ampicillin, ampicillin sodium
Brand Name:  Ampicin (CAN), Apo-Ampi (CAN), Novo-Ampicillin (CAN), Nu-Ampi (CAN), Penbritin (CAN),
Principen
Classification: Antibiotic, Penicillin
Pregnancy Category B
Therapeutic actions

 Bactericidal action against sensitive organisms; inhibits synthesis of bacterial cell wall, causing cell
death.
Indications

 Treatment of infections caused by susceptible strains of Shigella, Salmonella, Escherichia coli,


Haemophilus influenzae, Proteus mirabilis, Neisseria gonorrhoeae, enterococci, gram-positive
organisms (penicillin G–sensitive staphylococci, streptococci, pneumococci)
 Meningitis caused by Neisseria meningitidis
 Unlabeled use: Prophylaxis in cesarean section in certain high-risk patients
Adverse effects

 CNS: Lethargy, hallucinations, seizures


 CV: CHF
 GI: Glossitis, stomatitis, gastritis, sore mouth, furry tongue, black “hairy” tongue, nausea, vomiting,
diarrhea, abdominal pain, bloody diarrhea, enterocolitis, pseudomembranous colitis, nonspecific
hepatitis
 GU: Nephritis
 Hematologic: Anemia, thrombocytopenia, leukopenia, neutropenia, prolonged bleeding time
 Hypersensitivity: Rash, fever, wheezing, anaphylaxis
 Local: Pain, phlebitis, thrombosis at injection site (parenteral)
 Other: Superinfections—oral and rectal moniliasis, vaginitis
Contraindications and cautions

Contraindicated with allergies to penicillins, cephalosporins, or other allergens.


Use cautiously with renal disorders.
Nursing considerations
Assessment
 History: Allergies to penicillins, cephalosporins, or other allergens; renal disorders; lactation
 Physical: Culture infected area; skin color, lesion; R, adventitious sounds; bowel sounds; CBC,
LFTs, renal function tests, serum electrolytes, Hct, urinalysis
Interventions
 Culture infected area before treatment; reculture area if response is not as expected.
 Check IV site carefully for signs of thrombosis or drug reaction.
 Do not give IM injections in the same site; atrophy can occur. Monitor injection sites.
 Administer oral drug on an empty stomach, 1 hr before or 2 hr after meals with a full glass of
water; do not give with fruit juice or soft drinks.
Teaching points
 Take this drug around-the-clock.
 Take the full course of therapy; do not stop taking the drug if you feel better.
 Take the oral drug on an empty stomach, 1 hour before or 2 hours after meals; do not take with
fruit juice or soft drinks; the oral solution is stable for 7 days at room temperature or 14 days
refrigerated.
 This antibiotic is specific to your problem and should not be used to self-treat other infections.
 You may experience these side effects: Nausea, vomiting, GI upset (eat frequent small meals),
diarrhea.
 Report pain or discomfort at sites, unusual bleeding or bruising, mouth sores, rash, hives, fever,
itching, severe diarrhea, difficulty breathing.

UNASYN

 Generic Name: ampicillin and sulbactam


 Brand Name: Unasyn
 Drug Class: Penicillins, Amino

What is Unasyn and how is it used?

Unasyn (ampicillin sodium/sulbactam sodium) is a combination antibiotic indicated for the treatment of


infections due to susceptible strains of microorganisms.
What are side effects of Unasyn?

Common side effects of Unasyn include:

 fever,
 sore throat,
 headache,
 rash,
 diarrhea,
 body aches,
 nausea,
 vomiting,
 stomach pain,
 bloating,
 gas,
 vaginal itching or discharge,
 itching,
 swollen/black/"hairy" tongue,
 thrush (white patches inside your mouth or throat), or
 pain, swelling, or irritation where the needle is placed.

INDICATIONS

UNASYN is indicated for the treatment of infections due to susceptible strains of the designated
microorganisms in the conditions listed below.

Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus,
Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,*
Enterobacter spp.,* and Acinetobacter calcoaceticus.*

NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and Clinical


Studies sections).

Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp.


(including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*

Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,*


and Bacteroides spp.* (including B. fragilis*).

* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible
organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed
infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to
UNASYN should not require the addition of another antibacterial.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and
identify the organisms causing infection and to determine their susceptibility to UNASYN.

Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when
there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed
above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.

To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other
antibacterial drugs, UNASYN should be used only to treat infections that are proven or strongly suspected to
be caused by susceptible bacteria. When culture and susceptibility information are available, they should be
considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.

SIDE EFFECTS
Adult Patients

UNASYN is gen erally well tolerated. The following adverse reactions have been reported in clinical trials.

Local Adverse Reactions

Pain at IM injection site - 16%


Pain at IV injection site - 3%
Thrombophlebitis - 3% Phlebitis - 1.2%

Systemic Adverse Reactions

The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2%
of the patients.
Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting,
candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine
retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain,
epistaxis and mucosal bleeding.

Pediatric Patients

Available safety data for pediatric patients treated with UNASYN demonstrate a similar adverse events profile
to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric
patient receiving UNASYN.

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.

Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and


increased lymphocytes, monocytes, basophils, eosinophils, and platelets.

Blood Chemistry: Decreased serum albumin and total proteins.

Renal: Increased BUN and creatinine.

Urinalysis: Presence of RBC’s and hyaline casts in urine.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during post-
marketing use of ampicillin sodium/sulbactam sodium or other products containing ampicillin. Because they are
reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events
have been chosen for inclusion due to a combination of their seriousness, frequency, or potential causal
connection to ampicillin sodium/sulbactam sodium.

Blood And Lymphatic System Disorders

Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis have been reported. These reactions are


usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some
individuals have developed positive direct Coombs Tests during treatment with UNASYN, as with other beta-
lactam antibacterials.

Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice,


abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia, black “hairy” tongue, and Clostridium
difficile associated diarrhea (see CONTRAINDICATIONS and WARNINGS sections).

General Disorders and Administration Site Conditions: Injection site reaction

Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions


(see WARNINGS section).

Nervous System Disorders: Convulsion and dizziness

Renal and Urinary Disorders: Tubulointerstitial nephritis

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson


syndrome, angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme,
exfoliative dermatitis, and urticaria (see CONTRAINDICATIONS and WARNINGS sections).

DRUG INTERACTIONS

Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid
with UNASYN may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent
administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving
both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of
ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with
UNASYN and allopurinol administered concurrently. UNASYN and aminoglycosides should not be
reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of
UNASYN.
WARNINGS
Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on
penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin
hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals
with a history of penicillin hypersensitivity who have experienced severe reactions when treated with
cephalosporins. Before therapy with a penicillin, careful inquiry should be made concerning previous
hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs,
UNASYN should be discontinued and the appropriate therapy instituted.

Hepatotoxicity

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of UNASYN.
Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be
monitored at regular intervals in patients with hepatic impairment.

Severe Cutaneous Adverse Reactions

UNASYN may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson
syndrome (SJS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis
(AGEP). If patients develop a skin rash they should be monitored closely and UNASYN discontinued if lesions
progress (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).

Clostridium Dfficile - Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents,
including UNASYN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing
strains of C. difficile cause increased morbidity and mortality, as these infections can
be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients
who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD
has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against  C. difficile may need
to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial
treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions
PRECAUTIONS
General

A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash. Thus, ampicillin
class antibacterial should not be administered to patients with mononucleosis. In patients treated with
UNASYN the possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during
therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued
and/or appropriate therapy instituted.

Prescribing UNASYN in the absence of proven or strongly suspected bacterial infection or


a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development
of drug-resistant bacteria.

Patient Counseling Information

Patients should be counseled that antibacterial drugs including UNASYN should only be used to treat bacterial
infections. They do not treat viral infections (e.g., the common cold). When UNASYN is prescribed to treat a
bacterial infection, patients should be told that although it is common to feel better early in the course of
therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course
of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that
bacteria will develop resistance and will not be treatable by UNASYN or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial which usually ends when the antibacterial is
discontinued. Sometimes after starting treatment with antibacterial, patients can develop watery and bloody
stools (with or without stomach cramps and fever) even as late as two or more months after having taken the
last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential.
Pregnancy

Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human
dose and have revealed no evidence of impaired fertility or harm to the fetus due to UNASYN. There are,
however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies
are not always predictive of human response, this drug should be used during pregnancy only if clearly
needed. (see –PRECAUTIONS, Drug/Laboratory Test Interactions section).

Use In Specific Populations


Labor And Delivery

Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone,
frequency of contractions, height of contractions, and duration of contractions. However, it is not known
whether the use of UNASYN in humans during labor or delivery has immediate or delayed adverse effects on
the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical
intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised
when UNASYN is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of UNASYN have been established for pediatric patients one year of age and
older for skin and skin structure infections as approved in adults. Use of UNASYN in pediatric patients is
supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric
pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse
events surveillance. (see CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, ADVERSE
REACTIONS, DOSAGE AND ADMINISTRATION, and Clinical Studies sections).

The safety and effectiveness of UNASYN have not been established for pediatric patients for intra-abdominal
infections.

CONTRAINDICATIONS

The use of UNASYN is contraindicated in individuals with a history of serious hypersensitivity reactions
(e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial
drugs (e.g., penicillins and cephalosporins).

UNASYN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction


associated with UNASYN.
Drug Name
Generic Name : metoclopramide
Brand Name:  Apo-Metoclop (CAN), Nu-Metoclopramide (CAN), Octamide PFS, Reclomide, Reglan
Classification: GI stimulant, Antiemetic, Dopaminergic blocker

Pregnancy Category B 
Therapeutic actions
 Metoclopramide enhances the motility of the upper GI tract and increases gastric emptying without
affecting gastric, biliary or pancreatic secretions. It increases duodenal peristalsis which decreases
intestinal transit time, and increases lower oesophageal sphincter tone. It is also a potent central
dopamine-receptor antagonist and may also have serotonin-receptor (5-HT3) antagonist
properties.
Indications
 Relief of symptoms of acute and recurrent diabetic gastroparesis
 Short-term therapy (4–12 wk) for adults with symptomatic gastroesophageal reflux who fail to
respond to conventional therapy
 Parenteral: Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy
 Prophylaxis of postoperative nausea and vomiting when nasogastric suction is undesirable
 Single-dose parenteral use: Facilitation of small-bowel intubation when tube does not pass the
pylorus with conventional maneuvers
 Single-dose parenteral use: Stimulation of gastric emptying and intestinal transit of barium when
delayed emptying interferes with radiologic exam of the stomach or small intestine
 Unlabeled uses: Improvement of lactation (doses of 30–45 mg/day); treatment of nausea and
vomiting of a variety of etiologies: Emesis during pregnancy and labor, gastric ulcer, anorexia
nervosa
Adverse effects
 Extrapyramidal symptoms, restlessness, drowsiness, anxiety, diarrhoea, hypotension,
hypertension, headache, depression, blood disorders (e.g. aganulocytosis,
methaemoglobinaemia), hypersensitivity reactions (e.g. bronchospasm, rash), galactorrhoea or
related disorders, transient increase in plasma aldosterone levels.
 Potentially Fatal: Neuroleptic malignant syndrome; cardiac conduction disorders may occur with IV
dosage form.
Contraindications
 GI haemorrhage, mechanical obstruction and perforation; phaeochromocytoma; history of
seizures.
Nursing considerations
Assessment
 History: Allergy to metoclopramide, GI hemorrhage, mechanical obstruction or perforation,
pheochromocytoma, epilepsy, lactation, previously detected breast cancer
 Physical: Orientation, reflexes, affect; P, BP; bowel sounds, normal output; EEG
Interventions
 Monitor BP carefully during IV administration.
 Monitor for extrapyramidal reactions, and consult physician if they occur.
 Monitor diabetic patients, arrange for alteration in insulin dose or timing if diabetic control is
compromised by alterations in timing of food absorption.
 WARNING: Keep diphenhydramine injection readily available in case extrapyramidal reactions
occur (50 mg IM).
 WARNING: Have phentolamine readily available in case of hypertensive crisis (most likely to occur
with undiagnosed pheochromocytoma).
Teaching points
 Take this drug exactly as prescribed.
 Do not use alcohol, sleep remedies, sedatives; serious sedation could occur.
 You may experience these side effects: Drowsiness, dizziness (do not drive or perform other tasks
that require alertness); restlessness, anxiety, depression, headache, insomnia (reversible);
nausea, diarrhea.
 Report involuntary movement of the face, eyes, or limbs, severe depression, severe diarrhea.
Drug Name
Generic Name : ranitidine hydrochloride
Brand Name:  Apo-Ranitidine (CAN), CO Ranitidine (CAN), Gen-Ranitidine (CAN), Novo-Ranitidine, (CAN),
Nu-Ranit (CAN), ratio-Ranitidine (CAN), Zantac, Zantac EFFERdose, Zantac GELdose, Zantac 75, Zantac 150
Classification: Histamine2 (H2) antagonist

Pregnancy Category B 
Dosage & Route
Available forms : Tablets—75, 150, 300 mg; effervescent tablets and granules—25, 150 mg; syrup—15
mg/mL; injection—1, 25 mg/mL
ADULTS
 Active duodenal ulcer: 150 mg bid PO for 4–8 wk. Alternatively, 300 mg PO once daily at bedtime
or 50 mg IM or IV q 6–8 hr or by intermittent IV infusion, diluted to 100 mL and infused over 15–20
min. Do not exceed 400 mg/day.
 Maintenance therapy, duodenal ulcer: 150 mg PO at bedtime.
 Active gastric ulcer: 150 mg bid PO or 50 mg IM or IV q 6–8 hr.
 Pathologic hypersecretory syndrome: 150 mg bid PO. Individualize dose with patient’s response.
Do not exceed 6 g/day.
 GERD, esophagitis, benign gastric ulcer: 150 mg bid PO.
 Treatment of heartburn, acid indigestion: 75 mg PO as needed.
PEDIATRIC PATIENTS
 Safety and efficacy not established.
GERIATRIC PATIENTS AND PATIENTS WITH IMPAIRED RENAL FUNCTION
 For creatinine clearance < 50 mL/min, accumulation may occur; use lowest dose possible, 150 mg
q 24 hr PO or 50 mg IM or IV q 18–24 hr. Dosing may be increased to q 12 hr if patient tolerates it
and blood levels are monitored.
Therapeutic actions
 Ranitidine blocks histamine H2-receptors in the stomach and prevents histamine-mediated gastric
acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated factor secretion or
serum gastrin.
Indications
 Short-term treatment of active duodenal ulcer
 Maintenance therapy for duodenal ulcer at reduced dosage
 Short-term treatment of active, benign gastric ulcer
 Short-term treatment of GERD
 Pathologic hypersecretory conditions (eg, Zollinger-Ellison syndrome)
 Treatment of erosive esophagitis
 Treatment of heartburn, acid indigestion, sour stomach
Adverse effects
 Headache, dizziness. Rarely hepatitis, thrombocytopaenia, leucopaenia, hypersensitivity,
confusion, gynaecomastia, impotence, somnolence, vertigo, hallucinations.
 Potentially Fatal: Anaphylaxis, hypersensitivity reactions.
Contraindications
 Porphyria.
Nursing considerations
Assessment
 History: Allergy to ranitidine, impaired renal or hepatic function, lactation, pregnancy
 Physical: Skin lesions; orientation, affect; pulse, baseline ECG; liver evaluation, abdominal
examination, normal output; CBC, LFTs, renal function tests
Interventions
 Administer oral drug with meals and at bedtime.
 Decrease doses in renal and liver failure.
 Provide concurrent antacid therapy to relieve pain.
 Administer IM dose undiluted, deep into large muscle group.
 Arrange for regular follow-up, including blood tests, to evaluate effects.
Teaching points
 Take drug with meals and at bedtime. Therapy may continue for 4–6 weeks or longer.
 If you also are using an antacid, take it exactly as prescribed, being careful of the times of
administration.
 Have regular medical follow-up care to evaluate your response.
 You may experience these side effects: Constipation or diarrhea (request aid from your health care
provider); nausea, vomiting (take drug with meals); enlargement of breasts, impotence or
decreased libido (reversible); headache (adjust lights and temperature and avoid noise).
 Report sore throat, fever, unusual bruising or bleeding, tarry stools, confusion, hallucinations,
dizziness, severe headache, muscle or joint pain.
Drug Name
Generic Name :  tramadol hydrochloride
Brand Name: Ultram

Classification: Analgesic, centrally acting

Pregnancy Category C 
Dosage & Route
Available forms : Tablets—50 mg
ADULTS
Patients who require rapid analgesic effect: 50–100 mg PO q 4–6 hr; do not exceed 400 mg/day.
Patients with moderate to moderately severe chronic pain: Initiate at 25 mg/day in the morning and
titrate in 25-mg increments q 3 days to reach 100 mg/day. Then, increase in 50 mg-increments q 3
days to reach 200 mg/day. After titration, 50–100 mg q 4–6 hr; do not exceed 400 mg/day.
 Patients with cirrhosis: 50 mg q 12 hr.
 Patients with creatinine clearance < 30 ml/min: 50–100 mg PO q 12 hr. Maximum 200 mg/day.
PEDIATRIC PATIENTS
 Safety and efficacy not established.
GERIATRIC PATIENTS OR PATIENTS WITH HEPATIC OR RENAL IMPAIRMENT
 > 75 yr: Do not exceed 300 mg/day.
Therapeutic actions
 Tramadol inhibits reuptake of norepinephrine, serotonin and enhances serotonin release. It alters
perception and response to pain by binding to mu-opiate receptors in the CNS.
Indications
 Relief of moderate to moderately severe pain
Adverse effects
 Sweating, dizziness, nausea, vomiting, dry mouth, fatigue, asthenia, somnolence, confusion,
constipation, flushing, headache, vertigo, tachycardia, palpitations, miosis, insomnia, orthostatic
hypotension, seizures, CNS stimulation e.g. hallucinations.
 Potentially Fatal: Respiratory depression.
Contraindications
 Suicidal patients, acute alcoholism; head injuries; raised intracranial pressure; severe renal
impairment; lactation.
Nursing considerations
Assessment
 History: Hypersensitivity to tramadol; pregnancy; acute intoxication with alcohol, opioids,
psychotropic drugs or other centrally acting analgesics; lactation; seizures; concomitant use of
CNS depressants or MAOIs; renal or hepatic impairment; past or present history of opioid
addiction
 Physical: Skin color, texture, lesions; orientation, reflexes, bilateral grip strength, affect; P,
auscultation, BP; bowel sounds, normal output; LFTs, renal function tests
Interventions
 Control environment (temperature, lighting) if sweating or CNS effects occur.
 WARNING: Limit use in patients with past or present history of addiction to or dependence on
opioids.
Teaching points
 You may experience these side effects: Dizziness, sedation, drowsiness, impaired visual acuity
(avoid driving or performing tasks that require alertness); nausea, loss of appetite (lie quietly, eat
frequent small meals).
 Report severe nausea, dizziness, severe constipation.
Drug Name
Generic Name :celecoxib
Brand Name: Celebrex
Classification: NSAID, Analgesic (nonopioid), Specific COX-2 enzyme blocker
Pregnancy Category C (first and second trimester)
Pregnancy Category D (third trimester) 
Dosage & Route
Oral
 Osteoarthritis
 Adult: 200 mg as a single dose or in 2 divided doses. May increase to 200 mg bid if
necessary.
 Hepatic impairment: Child-Pugh category B: Reduce dose by 50%. Child-Pugh
category C: Avoid use.
 Rheumatoid arthritis
 Adult: 100-200 mg bid.
 Elderly: 100 mg bid.
 Hepatic impairment: Child-Pugh category B: Reduce dose by 50%. Child-Pugh
category C: Avoid use.
 Dysmenorrhea
 Adult: Initially, 400 mg followed by 200 mg if necessary on the 1st day. Maintenance:
200 mg bid.
 Hepatic impairment: Child-Pugh category B: Reduce dose by 50%. Child-Pugh
category C: Avoid use.
 Pain
 Adult: Initially, 400 mg followed by 200 mg if necessary on the 1st day. Maintenance:
200 mg bid.
 Hepatic impairment: Child-Pugh category B: Reduce dose by 50%. Child-Pugh
category C: Avoid use.
 Familial adenomatous polyposis
 Adult: 400 mg bid.
 Hepatic impairment: Child-Pugh category B: Reduce dose by 50%. Child-Pugh
category C: Avoid use.
Therapeutic actions

 Celecoxib has COX-2 specific inhibitory activity. It inhibits the conversion of arachidonic acid to
prostaglandins while having no effect on the formation of prostaglandins that mediate the normal
homeostasis in the GI tract, kidneys and platelets catalyzed by COX-1.
 Absorption: Absorbed from the GI tract (oral); peak plasma concentrations after 3 hr.
 Distribution: Protein-binding: 97%.
 Metabolism: Hepatic; converted to inactive metabolites.
 Excretion: Feces and urine (as metabolites and unchanged drug); 11 hr (elimination
half-life).
Indications

 Acute and long-term treatment of signs and symptoms of rheumatoid arthritis and osteoarthritis
 Reduction of the number of colorectal polyps in familial adenomatous polyposis (FAP)
 Management of acute pain
 Treatment of primary dysmenorrhea
 Relief of signs and symptoms of anklylosing spondylitis
 Relief of signs and symptoms of juvenile rheumatoid arthritis
Adverse effects

 Abdominal pain, diarrhea, nausea, edema, dizziness, headache, insomnia, upper respiratory tract
infections; rash.
 Potentially Fatal: Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome,
and toxic epidermal necrolysis.
Contraindications

Hypersensitivity including those in whom attacks of angioedema, rhinitis and urticaria have been
precipitated by aspirin, NSAIDs or sulfonamides. Severe hepatic impairment; severe heart failure;
inflammatory bowel disease; peptic ulcer; renal impairment (CrCl <30 ml/min); pregnancy and
lactation.
Nursing considerations
CLINICAL ALERT! Name confusion has occurred between Celebrex (celecoxib), Celexa (citalopram), Xanax
(alprazolam), and Cerebyx (fosphenytoin); use caution.
Assessment
 History: Renal impairment, impaired hearing, allergies, hepatic and CV conditions, lactation,
pregnancy
 Physical: Skin color and lesions; orientation, reflexes, ophthalmologic and audiometric evaluation,
peripheral sensation; P, edema; R, adventitious sounds; liver evaluation; CBC, LFTs, renal function
tests; serum electrolytes
Interventions
 BLACK BOX WARNING: Be aware that patient may be at increased risk for CV events, GI
bleeding; monitor accordingly.
 Administer drug with food or after meals if GI upset occurs.
 Establish safety measures if CNS, visual disturbances occur.
 Arrange for periodic ophthalmologic examination during long-term therapy.
 WARNING: If overdose occurs, institute emergency procedures—gastric lavage, induction of
emesis, supportive therapy.
 Provide further comfort measures to reduce pain (eg, positioning, environmental control) and to
reduce inflammation (eg, warmth, positioning, and rest).
Teaching points
 Take drug with food or meals if GI upset occurs.
 Take only the prescribed dosage; do not increase dosage.
 You may experience these side effects: Dizziness, drowsiness (avoid driving or the use of
dangerous machinery while taking this drug).
 Report sore throat, fever, rash, itching, weight gain, swelling in ankles or fingers; changes in vision.

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