O

obinutuzumab

oh-bi-nue-tooz-ue-mab

(Gazyva)

BLACK BOX ALERT Hepatitis B reactivation resulting in hepatic failure, fulminant hepatitis, and death have occurred. Screen all pt for hepatitis B infection before initiating treatment. Progressive multifocal leukoencephalopathy (PML) including fatal PML reported.

classification

PHARMACOTHERAPEUTIC: Monoclonal antibody. CLINICAL: Antineoplastic.

Action

Targets CD20 antigen expressed on surface of B lymphocytes. Mediates B-cell lysis, cellular cytotoxicity, and antibody-dependant cellular phagocytosis (macrophage ingestion). Therapeutic Effect: Inhibits tumor cell growth and proliferation in chronic lymphocytic leukemia.

Pharmacokinetics

Metabolism and elimination not specified. Half-life: 28 days.

Uses

Treatment of previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil.

Precautions

Contraindications: None known. Cautions: History of anemia, leukopenia, neutropenia, thrombocytopenia; asthma, COPD, electrolyte imbalance, GI bleeding, gout, elderly, renal/hepatic impairment. Avoid use of live virus vaccines.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if distributed in breast milk. Must either discontinue drug or discontinue breastfeeding. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: May have increased risk of adverse reactions.

Interactions

DRUG: ACE inhibitors, angiotensin receptor blockers, beta blockers may increase risk of hypotension. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum alkaline phosphatase, AST, ALT, bilirubin, creatinine, uric acid. May decrease serum albumin, Hgb, Hct, lymphocytes, neutrophils, platelets, potassium, sodium.

Availability (Rx)

Solution, Injection: 1,000 mg/40 ml (25 mg/ml) single-use vial.

Administration/handling

◀ ALERT ▶ Administer via dedicated line. Do not administer IV push or bolus. Withhold hypertensive medications at least 12 hrs before and 1 hr after administration. Do not mix with dextrose-containing fluids.

IV

Reconstitution • Visually inspect for particulate matter or discoloration. • For 100-mg dose: withdraw 40 ml solution from vial and dilute only 4 ml (100 mg) in 100 ml 0.9% NaCl for immediate administration. Dilute remaining 36 ml (900 mg) into 250 ml 0.9% NaCl at same time and refrigerate for up to 24 hrs for cycle 1: day 2. For remaining infusions (Day 8 and 15 of cycle 1), and day 1 of cycles 2–6, dilute 40 ml (1,000 mg) solution in 250 ml NaCl infusion bag. • Gently mix by inversion. • Do not shake.

Rate of Administration • Day 1 of Cycle 1 (100 mg): Infuse over 4 hrs (25 mg/hr). • Do not increase infusion rate. • Day 2 of Cycle 1 (900 mg): Infuse at 50 mg/hr. • May increase by 50mg/hr every 30 min to maximum rate of 400 mg/hr. • Day 8 and Day 15 of Cycle 1, and Day 1 of Cycles 2–6 (1,000 mg): Start at 100 mg/hr. May increase by 100 mg/hr every 30 min to maximum rate of 400 mg/hr. • Increase rate based on tolerability.

Storage • Solution should appear clear, colorless to slightly brown. • May refrigerate diluted solution up to 24 hrs.

Indications/routes/dosage

Chronic lymphocytic leukemia (CLL)

◀ ALERT ▶ Premedicate with glucocorticoid, acetaminophen, and antihistamine to decrease severity of infusion reaction. Consider premedication with antihyperuricemics (allopurinol) 12–24 hrs for pts with high tumor burden or high circulating absolute lymphocyte count greater than 25 × 10⁹/L. Recommend antimicrobial prophylaxis throughout treatment for pts with neutropenia.

IV: ADULTS/ELDERLY: Six treatment cycles of 28 day cycle. Day 1 of Cycle 1: 100 mg. Day 2 of Cycle 1: 900 mg. Day 8 and Day 15 of Cycle 1 and Day 1 of Cycles 2–6: 1,000 mg. Discontinue treatment if any severe to life-threatening infusion reactions occur.

Side effects

Frequent (69%): Infusion reactions (pruritis, flushing, urticaria). Occasional (10%): Pyrexia, cough.

Adverse effects/toxic reactions

Thrombocytopenia, neutropenia, leukopenia, lymphopenia (47%–80% of pts) is an expected response to therapy, but more severe reactions including bone marrow failure, febrile neutropenia, opportunistic infection may result in life-threatening events. Hepatitis B reactivation may occur. Infusion reactions including hypotension, tachycardia, dyspnea, bronchospasm, wheezing, laryngeal edema, nausea, vomiting, flushing, pyrexia may occur during infusion. Tumor lysis syndrome may present as acute renal failure, hypocalcemia, hyperuricemia, hyperphosphatemia within 12–24 hrs of infusion. Immunogenicity (autoantibodies) occurred in 13% of pts. Progressive multifocal leukoencephalopathy (PML) occurred rarely and may include weakness, paralysis, vision loss, aphasia, cognition impairment.

Nursing considerations

Baseline assessment

Obtain baseline CBC, serum chemistries, ionized calcium, phosphate, uric acid; vital signs. Screen for history of anemia, asthma, arrhythmias, COPD, diabetes mellitus, GI bleeding, hypertension, hepatitis B infection, hepatic/renal impairment, peripheral edema. Receive full medication history esp. hypertension, anticoagulant medications. Perform baseline visual acuity.

Intervention/evaluation

Monitor CBC, serum electrolytes, hepatic function test, vital signs. Monitor all pts for cardiovascular alterations, respiratory distress. If respiratory reactions occur, consider administration of oxygen, epinephrine, albuterol treatments. Locate rapid-sequence intubation kit if respiratory compromise occurs. Monitor strict I&O, hydration status. If PML suspected, consult neurologist for proper management. Obtain EKG for palpitations, severe hypokalemia, hyponatremia.

Patient/family teaching

• Blood levels will be routinely monitored. • Avoid pregnancy. • Report any yellowing of skin or eyes, abdominal pain, bruising, black/tarry stools, amber or bloody urine. • Fever, cough, burning with urination, body aches, chills may indicate acute infection. • Avoid alcohol. • Immediately report difficult breathing, severe coughing, chest tightness, wheezing. • Paralysis, vision changes, impaired speech, altered mental status may indicate life-threatening neurologic event.

octreotide

ock-tree-oh-tide

(Sandostatin, Sandostatin LAR)

Do not confuse Sandostatin with Sandimmune, Sandostatin LAR, sargramostim, or simvastatin.

classification

PHARMACOTHERAPEUTIC: Somatostatin analogue. CLINICAL: Secretory inhibitory, growth hormone suppressant.

Action

Suppresses secretion of serotonin, gastroenteropancreatic peptides. Enhances fluid/electrolyte absorption from GI tract. Therapeutic Effect: Prolongs intestinal transit time.

Pharmacokinetics

Route	Onset	Peak	Duration
Subcutaneous	N/A	N/A	Up to 12 hrs

Rapidly, completely absorbed from injection site. Protein binding: 65%. Metabolized in liver. Excreted in urine. Removed by hemodialysis. Half-life: 1.7–1.9 hrs.

Uses

Controls diarrhea and flushing in pts with metastatic carcinoid tumors, treatment of watery diarrhea associated with vasoactive intestinal peptic-secreting tumors (VIPomas), acromegaly. OFF-LABEL: Control of bleeding esophageal varices, treatment of AIDS-associated secretory diarrhea, chemotherapy-induced diarrhea, insulinomas, small-bowel fistulas, Zollinger-Ellison syndrome, Cushing’s syndrome, hypothalamic obesity, malignant bowel obstruction, postgastrectomy dumping syndrome.

Precautions

Contraindications: None known. Cautions: Diabetic pts with gastroparesis, renal failure, hepatic impairment, HF, concomitant medications altering heart rate or rhythm.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if distributed in breast milk. Pregnancy Category B. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: May decrease effectiveness of cyclosporine. Glucagon, growth hormone, insulin, oral antidiabetics may alter glucose concentrations. HERBAL: Avoid herbs that have hypoglycemic activity (e.g., garlic, ginger, ginseng). FOOD: None known. LAB VALUES: May decrease serum thyroxine (T₄). May increase serum alkaline phosphatase, ALT, AST, GGT.

Availability (Rx)

Injection Solution (Sandostatin): 0.05 mg/ml, 0.1 mg/ml, 0.2 mg/ml, 0.5 mg/ml, 1 mg/ml. Injection Suspension (Sandostatin LAR): 10-mg, 20-mg, 30-mg vials.

Administration/handling

◀ ALERT ▶ Sandostatin may be given IV, IM, subcutaneous. Sandostatin LAR Depot may be given only IM.

IM

• Give immediately after mixing. • Administer deep IM in large muscle mass at 4-wk intervals. • Avoid deltoid injections.

Subcutaneous

• Do not use if discolored or particulates form. • Avoid multiple injections at same site within short periods.

IV

• Dilute in 50–100 ml 0.9% NaCl or D₅W and infuse over 15–30 min. In emergency, may give IV push over 3 min.

Indications/routes/dosage

Diarrhea

IV (Sandostatin): ADULTS, ELDERLY: Initially, 50–100 mcg q8h. May increase by 100 mcg/dose q48h. Maximum: 500 mcg q8h.

IV, Subcutaneous (Sandostatin): 1–10 mcg/kg q12h.

Carcinoid tumor

IV, Subcutaneous (Sandostatin): ADULTS, ELDERLY: Initial 2 wks, 100–600 mcg/day in 2–4 divided doses. Range: 50–750 mcg.

IM (Sandostatin Lar): ADULTS, ELDERLY: Must be stabilized on subcutaneous octreotide for at least 2 wks. 20 mg q4wks.

Vasoactive intestinal peptic-secreting tumor (VIPoma)

IV, Subcutaneous (Sandostatin): ADULTS, ELDERLY: Initial 2 wks, 200–300 mcg/day in 2–4 divided doses. Range: 150–750 mcg.

IM (Sandostatin Lar): ADULTS, ELDERLY: Must be stabilized on subcutaneous octreotide for at least 2 wks. 20 mg q4wks.

Esophageal varices

IV (Sandostatin): ADULTS, ELDERLY: Bolus of 25–100 mcg followed by IV infusion of 25–50 mcg/hr for 2–5 days.

Acromegaly

IV, Subcutaneous (Sandostatin): ADULTS, ELDERLY: 50 mcg 3 times a day. Increase as needed. Range: 300–1,500 mcg/day.

IM (Sandostatin Lar): ADULTS, ELDERLY: Must be stabilized on subcutaneous octreotide for at least 2 wks. 20 mg q4wks for 3 mos. Maximum: 40 mg q4wks.

Side effects

Frequent (10%–6%; 58%–30% in Acromegaly Pts): Diarrhea, nausea, abdominal discomfort, headache, injection site pain. Occasional (5%–1%): Vomiting, flatulence, constipation, alopecia, facial flushing, pruritus, dizziness, fatigue, arrhythmias, ecchymosis, blurred vision. Rare (Less Than 1%): Depression, diminished libido, vertigo, palpitations, dyspnea.

Adverse effects/toxic reactions

Increased risk of cholelithiasis. Prolonged high-dose therapy may produce hypothyroidism. GI bleeding, hepatitis, seizures occur rarely.

Nursing considerations

Baseline assessment

Establish baseline B/P, weight, thyroid function, serum glucose, electrolytes.

Intervention/evaluation

Monitor serum glucose, thyroid function tests; fluid, electrolyte balance; fecal fat. In acromegaly, monitor growth hormone levels. Weigh every 2–3 days, report over 5-lb gain per wk. Monitor B/P, pulse, respirations periodically during treatment. Be alert for decreased urinary output, peripheral edema (esp. ankles). Monitor daily pattern of bowel activity, stool consistency.

Patient/family teaching

• Therapy should provide significant improvement of severe, watery diarrhea.

ocular lubricant

ock-yoo-lar lube-ri-cant

(Hypotears, Lacrilube, Tears Naturale)

classification

PHARMACOTHERAPEUTIC: Topical ophthalmic. CLINICAL: Lubricant, toner, buffer, viscosity agent.

Action

Forms an occlusive film on eye surface. Therapeutic Effect: Lubricates/protects eye from drying.

Uses

Protection/lubrication of eye in exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca (particularly for nighttime use), after removal of foreign body, during and following surgery.

Precautions

Contraindications: None known. Cautions: None known. Pregnancy Category Unknown.

Interactions

DRUG: None significant. HERBAL: None significant. FOOD: None known. LAB VALUES: None significant.

Availability (OTC)

Ophthalmic ointment. solution.

 

Administration/handling

Ophthalmic

• Do not use with contact lenses. • Place gloved finger on lower eyelid and pull out until a pocket is formed between eye and lower lid. • Place prescribed number of drops (¼–½ inch of ointment) into pocket. • Instruct pt to close eye gently (so medication will not be squeezed out of the sac).

Solution

• Instruct pt to apply digital pressure to lacrimal sac at inner canthus for 1 min to minimize systemic absorption.

Ointment

• Instruct pt to roll eyeball to increase contact area of drug to eye.

Indications/routes/dosage

Usual ophthalmic dosage

Ophthalmic: ADULTS, ELDERLY: Small amount in conjunctival sac as needed.

Side effects

Frequent: Temporary blurred vision after administration, esp. with ointment.

Adverse effects/toxic reactions

None known.

Nursing considerations

Patient/family teaching

• Do not use with contact lenses. • Do not touch tip of tube or dropper to any surface (may contaminate). • Temporary blurred vision will occur, esp. with administration of ointment. • Avoid activities requiring visual acuity until blurring clears. • Report eye pain, change of vision, worsening of condition or if condition is unchanged after 72 hrs.

ofatumumab

oh-fa-tue-mue-mab

(Arzerra)

Do not confuse ofatumumab with omalizumab.

classification

PHARMACOTHERAPEUTIC: Monoclonal antibody. CLINICAL: Antineoplastic.

Action

Binds to CD20 molecule, the antigen on surface of B-cell lymphocytes; inhibits early-stage B-lymphocyte activation. Therapeutic Effect: Controls tumor growth, triggers cell death.

Pharmacokinetics

Eliminated through both a target-independent route and a B-cell–mediated route. Due to depletion of B cells, clearance is decreased substantially after subsequent infusions compared to first infusion. Half-life: 12–16 days.

Uses

Treatment of chronic lymphocytic leukemia (CLL).

Precautions

Contraindications: None known. Cautions: Carriers of hepatitis B virus.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: Bone marrow depressants may increase myelosuppression. Live virus vaccines may potentiate virus replication, increase vaccine side effects, decrease pt’s antibody response to vaccine. HERBAL: Echinacea may decrease concentration/effects. FOOD: None known. LAB VALUES: May decrease WBC count, platelets.

Availability (Rx)

Solution for Injection: 100 mg/5 ml single-use vial.

Adminstration/handling

IV

◀ ALERT ▶ Do not give by IV push or bolus. Use in-line filter supplied with product.

Reconstitution • 300-mg dose: Withdraw and discard 15 ml from 1,000 ml 0.9% NaCl. • Withdraw 5 ml from each of 3 vials and add to bag. • Gently invert. • 2,000-mg dose: Withdraw and discard 100 ml from 1,000 ml 0.9% NaCl. • Withdraw 5 ml from each of 2 vials and add to bag. • Gently invert.

Rate of Administration • Dose 1: Initiate infusion at rate of 3.6 mg/hr (12 ml/hr). • Dose 2: Initiate infusion at rate of 24 mg/hr (12 ml/hr). • Dose 3–12: Initiate infusion at rate of 50 mg/hr (25 ml/hr). • If no infusion toxicity, rate of infusion may be increased every 30 min, using following table:

Interval After Start of Infusion (min)	Dose 1 (ml/hr)	Dose 2 (ml/hr)	Doses 3–12 (ml/hr)
0–30	12	12	25
31–60	25	25	50
61–90	50	50	100
91–120	100	100	200
Over 120	200	200	400

Storage • Refrigerate vials. • After dilution, solution should be used within first 12 hrs; discard preparation after 24 hrs. • Discard if discoloration is present, but solution may contain visible, translucent-to-white particulates (will be removed by in-line filter).

IV compatibility

Prepare all doses with 0.9% NaCl. Do not mix with dextrose solutions or any other medications.

Indications/routes/dosage

◀ ALERT ▶ Premedicate 30 min to 2 hrs before each infusion with acetaminophen, an antihistamine, and a corticosteroid as prophylaxis for infusion reaction. Flush IV line with 0.9% NaCl before and after each dose.

Chronic lymphocytic leukemia

IV Infusion: ADULTS, ELDERLY: Recommended dosage is 12 doses given on the following schedule: 300 mg initial dose (dose 1), followed 1 wk later by 2,000 mg weekly for 7 doses (doses 2–8), followed 4 wks later by 2,000 mg every 4 wks for 4 doses (doses 9–12).

Side effects

Frequent (20%–14%): Fever, cough, diarrhea, fatigue, rash. Occasional (13%–5%): Nausea, bronchitis, peripheral edema, nasopharyngitis, urticaria, insomnia, headache, sinusitis, muscle spasm, hypertension.

Adverse effects/toxic reactions

Most common serious adverse reactions were bacterial, viral, fungal infections (including pneumonia and sepsis), septic shock, neutropenia, thrombocytopenia. Infusion reactions occur more frequently with first 2 infusions. Severe infusion reactions manifested as angioedema, bronchospasm, dyspnea, fever, chills, back pain, hypotension. Progressive multifocal leukoencephalopathy may occur. Small bowel obstruction has been noted.

Nursing considerations

Baseline assessment

Screen pts at high risk of hepatitis B virus. Assess baseline CBC prior to therapy.

Intervention/evaluation

Monitor CBC for evidence of myelosuppression during therapy, and increase frequency of monitoring in pts who develop grade 3 or 4 cytopenia. Monitor for blood dyscrasias (fever, sore throat, signs of local infection, unusual bruising/bleeding from any site), symptoms of anemia (excessive fatigue, weakness). Closely monitor for infusion reactions.

Patient/family teaching

• Do not have immunizations without physician’s approval (lowers body’s resistance). • Avoid contact with those who have recently received live virus vaccine. • Avoid crowds, those with infection. • Promptly report fever, sore throat, signs of infection. • Report symptoms of infusion reactions (e.g., fever, chills, breathing problems, rash); bleeding, bruising, petechiae, worsening weakness or fatigue; new neurologic symptoms (e.g., confusion, loss of balance, vision problems); symptoms of hepatitis (e.g., fatigue, yellow discoloration of skin/eyes); worsening abdominal pain, nausea.

ofloxacin

o-flox-a-sin

(Apo-Oflox , Floxin Otic, Novo-Ofloxacin , Ocuflox)

BLACK BOX ALERT May increase risk of tendonitis, tendon rupture.

Do not confuse Ocuflox with Ocufen.

classification

PHARMACOTHERAPEUTIC: Fluoroquinolone. CLINICAL: Antibiotic (see p. 26C).

Action

Interferes with bacterial cell replication, repair by inhibiting DNA-gyrase in susceptible microorganisms. Therapeutic Effect: Bactericidal.

Pharmacokinetics

Rapidly, well absorbed from GI tract. Protein binding: 20%–25%. Widely distributed (including CSF). Metabolized in liver. Primarily excreted in urine. Removed by hemodialysis. Half-life: 4.7–7 hrs (increased in renal impairment, cirrhosis, elderly).

Uses

Treatment of susceptible infections due to S. pneumoniae, S. aureus, S. pyogenes, H. influenzae, P. mirabilis, N. gonorrhoeae, C. trachomatis, E. coli, K. pneumoniae, P. aeruginosa, including infections of urinary tract, lower respiratory tract, skin/skin structure; sexually transmitted diseases, prostatitis due to E. coli, pelvic inflammatory disease (PID). Ophthalmic: Bacterial conjunctivitis, corneal ulcers. Otic: Otitis externa, acute or chronic otitis media. OFF-LABEL: Oral: Epididymitis, leprosy, traveler’s diarrhea.

Precautions

Contraindications: Hypersensitivity to any quinolones. Otic: Viral infection of external ear canal. Cautions: Renal impairment, CNS disorders, seizures, severe cerebral arteriosclerosis, prolongation of QT interval, bradycardia, cardiomyopathy, hypokalemia, hypomagnesemia, rheumatoid arthritis.

 ​Lifespan considerations

Pregnancy/Lactation: Distributed in breast milk; potentially serious adverse reactions in breastfeeding infants. Risk of arthropathy to fetus. Pregnancy Category C. Children: Safety and efficacy not established (otic not established in those younger than 1 yr). Elderly: No age-related precautions for otic. Age-related renal impairment may require dosage adjustment for oral administration.

Interactions

DRUG: Antacids, sucralfate may decrease absorption, effect. NSAIDs may increase risk of CNS stimulation, seizures. May increase theophylline concentration, risk of toxicity. HERBAL: Dong quai, St. John’s wort may increase photosensitization. FOOD: None known. LAB VALUES: May increase ALT, AST, alkaline phosphatase, amylase, LDH.

Availability (Rx)

Ophthalmic Solution (Ocuflox): 0.3%. Otic Solution (Floxin Otic): 0.3%. Tablets: 200 mg, 300 mg, 400 mg.

Administration/handling

PO

• Do not give with food; preferred dosing time is 1 hr before or 2 hrs following meals. • Do not administer antacids (aluminum, magnesium) or iron/zinc-containing products within 2 hrs of ofloxacin. • Encourage cranberry juice, citrus fruits (to acidify urine). • Give with 8 oz of water; encourage fluid intake.

Ophthalmic

• Place gloved finger on lower eyelid and pull out until a pocket is formed between eye and lower lid. Place prescribed number of drops into pocket. Instruct pt to close eye gently (so medication will not be squeezed out of the sac) and apply digital pressure to lacrimal sac at inner canthus for 1 min to minimize systemic absorption.

Otic

• Instruct pt to lie down with head turned so affected ear is upright. • Instill toward canal wall, not directly on eardrum. • Pull auricle down and posterior in children; up and posterior in adults.

Indications/routes/dosage

Usual dosage range

PO: ADULTS, ELDERLY: 200–400 mg q12h. Ophthalmic: ADULTS, ELDERLY, CHILDREN 1 YR AND OLDER: 1–2 drops q30min to 4 hrs initially, decreasing to q4–6h.

Otic: ADULTS, ELDERLY, CHILDREN OLDER THAN 12 YRS: 10 drops 1–2 times/day. CHILDREN 6 MOS–12 YRS: 5 drops once daily.

UTI

PO: ADULTS: 200 mg q12h for 3–10 days.

Pelvic inflammatory disease (PID)

PO: ADULTS: 400 mg q12h for 10–14 days.

Lower respiratory tract, skin/skin structure infection

PO: ADULTS: 400 mg q12h for 10 days.

Prostatitis, sexually transmitted disease (cervicitis, urethritis)

PO: ADULTS: 400 mg once, then 300 mg q12h for 10 days.

Usual elderly dosage

PO: ELDERLY: 200–400 mg q12–24h for 7 days up to 6 wks.

Bacterial conjunctivitis

Ophthalmic: ADULTS, ELDERLY: 1–2 drops q2–4h for 2 days, then 4 times a day for 5 days.

Corneal ulcer

Ophthalmic: ADULTS: 1–2 drops q30min while awake and q4–6h at night for 2 days, then q60min while awake for 5–7 days, then 4 times a day until clinical cure achieved.

Acute otitis media

Otic: CHILDREN 1–12 YRS: 5 drops into affected ear twice a day for 10 days.

Otitis externa

Otic: ADULTS, ELDERLY, CHILDREN 12 YRS AND OLDER: 10 drops into affected ear once daily for 7 days. CHILDREN 6 MOS–11 YRS: 5 drops into affected ear once daily for 7 days.

Dosage in renal impairment

After normal initial dose, dosage and frequency are based on creatinine clearance.

Creatinine Clearance	Adjusted Dose	Dosage Interval
Greater than 50 ml/min	None	q12h
20–50 ml/min	None	q24h
Less than 20 ml/min	Half	q24h

Side effects

Frequent (10%–7%): Nausea, headache, insomnia. Occasional (5%–3%): Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, dizziness, fatigue, drowsiness, rash, pruritus, fever. Rare (Less Than 1%): Constipation, paresthesia.

Adverse effects/toxic reactions

Antibiotic-associated colitis, other superinfections (abdominal cramps, severe watery diarrhea, fever) may occur from altered bacterial balance in GI tract. Hypersensitivity reaction (evidenced by rash, pruritus, blisters, edema, photosensitivity) occurs rarely. Arthropathy (swelling, pain, clubbing of fingers/toes, degeneration of stress-bearing portion of joint) may occur in children.

Nursing considerations

Baseline assessment

Question for history of hypersensitivity to ofloxacin, other quinolones.

Intervention/evaluation

Monitor signs/symptoms of infection, altered mental status. Monitor renal/hepatic function, WBC. Assess skin, discontinue medication at first sign of rash, other allergic reaction. Monitor daily pattern of bowel activity, stool consistency. Assess for insomnia. Check for dizziness, headache, visual difficulties, tremors; provide assistance with ambulation as needed. Be alert for superinfection: fever, vomiting, diarrhea, anal/genital pruritus, oral mucosal changes (ulceration, pain, erythema).

Patient/family teaching

• Do not take antacids within 2 hrs before or 2 hrs after taking ofloxacin. • Best taken 1 hr before or 2 hrs after meals. • May cause insomnia, headache, drowsiness, dizziness. • Avoid tasks requiring alertness, motor skills until response to drug is established. • Report tendon pain/swelling, persistent diarrhea.

olanzapine

oh-lan-za-peen

(Apo-Olanzapine , Zyprexa, Zyprexa Intramuscular, Zyprexa Relprevv, Zyprexa Zydis)

BLACK BOX ALERT Elderly pts with dementia-related psychosis are at increased risk for mortality due to cerebrovascular events.

Do not confuse olanzapine with olsalazine or quetiapine, or Zyprexa with Celexa or Zyrtec.

Fixed-combination(s)

Symbyax: olanzapine/fluoxetine (an antidepressant): 6 mg/25 mg, 6 mg/50 mg, 12 mg/25 mg, 12 mg/50 mg.

classification

PHARMACOTHERAPEUTIC: Dibenzazepine derivative. CLINICAL: Antipsychotic (see p. 67C).

Action

Antagonizes alpha₁-adrenergic, dopamine, histamine, muscarinic, serotonin receptors. Produces anticholinergic, histaminic, CNS depressant effects. Therapeutic Effect: Diminishes psychotic symptoms.

Pharmacokinetics

Well absorbed after PO administration. Rapid absorption following IM administration. Protein binding: 93%. Widely distributed. Excreted in urine (57%), feces (30%). Not removed by dialysis. Half-life: 21–54 hrs.

Uses

PO: Management of manifestations of schizophrenia. Treatment of acute mania associated with bipolar disorder. In combination with fluoxetine: treatment of depressive episodes associated with bipolar I disorder and treatment of treatment-resistant bipolar depression. IM: Zyprexa Intramuscular: Controls agitation in schizophrenia and bipolar mania. Relprevv: Long acting antipsychotic for IM injection for treatment of schizophrenia. OFF-LABEL: Psychosis/schizophrenia in children, chronic pain, prevention of chemotherapy-induced nausea/vomiting, psychosis/agitation related to Alzheimer’s dementia.

Precautions

Contraindications: None known. Cautions: Benign prostatic hyperplasia, suicidal pts, decrease GI motility, paralytic ileus, urinary retention, glaucoma, myasthenia gravis, breast cancer or history of breast cancer, hepatic impairment, elderly, concurrent use of potentially hepatotoxic drugs, dose escalation, known cardiovascular disease (history of MI, ischemia, heart failure, conduction abnormalities), cerebrovascular disease, conditions predisposing pts to hypotension (dehydration, hypovolemia, hypertensive medications), history of seizures, conditions lowering seizure threshold (e.g., Alzheimer’s dementia), those at risk for aspiration pneumonia, pts with diabetes, pts at risk for suicide.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: Alcohol, CNS depressants may increase CNS depressant effects. Anticholinergics may increase anticholinergic effects. Hepatotoxic medications may increase hepatic function test levels. HERBAL: Dong quai, St. John’s wort may increase photosensitization. Gotu kola, kava kava, St. John’s wort, valerian may increase CNS depression. FOOD: None known. LAB VALUES: May increase serum GGT, cholesterol, prolactin, AST, ALT.

Availability (Rx)

Injection, Powder for Reconstitution (Zyprexa Intramuscular): 10 mg. Suspension for IM Injection (Relprevv): 210 mg, 300 mg, 405 mg. Tablets (Zyprexa): 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg. Tablets (Orally Disintegrating [Zyprexa Zydis]): 5 mg, 10 mg, 15 mg, 20 mg.

Administration/handling

PO

• Give without regard to meals.

Orally disintegrating

• Remove by peeling back foil (do not push through foil). • Place in mouth immediately. • Tablet dissolves rapidly with saliva and may be swallowed with or without liquid.

IM (zyprexa intramuscular)

• Reconstitute 10-mg vial with 2.1 ml Sterile Water for Injection to provide concentration of 5 mg/ml. • Use within 1 hr following reconstitution. • Discard unused portion.

IM (relprevv)

• Dilute to final concentration of 150 mg/ml. • Shake vigorously to mix. • Store at room temperature for up to 24 hrs.

Indications/routes/dosage

Schizophrenia

PO: ADULTS: Initially, 5–10 mg once daily. May increase to 10 mg/day within 5–7 days. If further adjustments are indicated, may increase by 5 mg/day at 7-day intervals. Maximum: 20 mg/day. ELDERLY: Initially, 2.5 mg/day. May increase as indicated. Range: 2.5–10 mg/day. CHILDREN: Initially, 2.5–5 mg/day. Titrate in 2.5- or 5-mg increments at weekly intervals. Maximum: 20 mg/day.

IM (Short-Acting [Zyprexa Intramuscular]): ADULTS: 10 mg. May repeat after 2–4 hrs. Maximum: 30 mg/day.

IM (Long-Acting [Relprevv]): ADULTS, ESTABLISHED ON 10 MG/DAY ORALLY: 210 mg q2wks for 4 doses or 405 mg q4wks for 2 doses. Maintenance: 150 mg q2wks or 300 mg q4wks. ESTABLISHED ON 15 MG/DAY ORALLY: 300 mg q2wks for 4 doses. Maintenance: 210 mg q2wks or 405 mg q4wks. ESTABLISHED ON 20 MG/DAY ORALLY: 300 mg q2wks.

Depression associated with bipolar disorder (with fluoxetine)

PO: ADULTS: Initially, 5 mg in evening. Range: 5–12.5 mg/day.

Bipolar mania

PO: ADULTS: Initially, 10–15 mg/day. May increase by 5 mg/day at intervals of at least 24 hrs. Maximum: 20 mg/day. CHILDREN: Initially, 2.5–5 mg/day. Titrate as necessary up to 20 mg/day.

Dosage for elderly, debilitated pts, those predisposed to hypotensive reactions

Initial dosage: 5 mg/day.

Control of agitation

IM: ADULTS, ELDERLY: 2.5–10 mg. May repeat 2 hrs after first dose and 4 hrs after 2nd dose. Maximum: 30 mg/day.

Side effects

Frequent (26%–10%): Drowsiness, agitation, insomnia, headache, nervousness, hostility, dizziness, rhinitis. Occasional (9%–5%): Anxiety, constipation, nonaggressive atypical behavior, dry mouth, weight gain, orthostatic hypotension, fever, arthralgia, restlessness, cough, pharyngitis, visual changes (dim vision). Rare: Tachycardia; back, chest, abdominal, or extremity pain; tremor.

Adverse effects/toxic reactions

Rare reactions include seizures, neuroleptic malignant syndrome, a potentially fatal syndrome characterized by hyperpyrexia, muscle rigidity, irregular pulse or B/P, tachycardia, diaphoresis, cardiac arrhythmias. Extrapyramidal symptoms (EPS), dysphagia may occur. Overdose (300 mg) produces drowsiness, slurred speech.

Nursing considerations

Baseline assessment

Obtain baseline hepatic function tests, glucose, weight, lipid profile before initiating treatment. Assess behavior, appearance, emotional status, response to environment, speech pattern, thought content.

Intervention/evaluation

Monitor B/P, glucose, lipids, hepatic function tests. Assess for tremors, changes in gait, abnormal muscular movements, behavior. Supervise suicidal-risk pt closely during early therapy (as depression lessens, energy level improves, increasing suicide potential). Assess for therapeutic response (interest in surroundings, improvement in self-care, increased ability to concentrate, relaxed facial expression). Assist with ambulation if dizziness occurs. Assess sleep pattern. Notify physician if extrapyramidal symptoms (EPS) occur.

Patient/family teaching

• Avoid dehydration, particularly during exercise, exposure to extreme heat, concurrent use of medication causing dry mouth, other drying effects. • Sugarless gum, sips of water may relieve dry mouth. • Report if suspected pregnancy. • Take medication as prescribed; do not stop taking or increase dosage. • Rise slowly from sitting/lying position. • Avoid alcohol. • Avoid tasks that require alertness, motor skills until response to drug is established. • Monitor diet, exercise program to prevent weight gain.

olmesartan

ol-me-sar-tan

(Benicar, Olmetec )

BLACK BOX ALERT May cause fetal injury, mortality if used during second or third trimester of pregnancy.

Do not confuse Benicar with Mevacor.

Fixed-combination(s)

Azor: olmesartan/amlodipine (calcium channel blocker): 20 mg/5 mg, 40 mg/5 mg, 20 mg/10 mg, 40 mg/10 mg. Benicar HCT: olmesartan/hydrochlorothiazide (a diuretic): 20 mg/12.5 mg, 40 mg/12.5 mg, 40 mg/25 mg. Tribenzor: olmesartan/hydrochlorothiazide/amlodipine: 20 mg/12.5 mg/5 mg, 40 mg/12.5 mg/5 mg, 40 mg/25 mg/5 mg, 40 mg/12.5 mg/10 mg, 40 mg/25 mg/10 mg.

classification

PHARMACOTHERAPEUTIC: Angiotensin II receptor antagonist. CLINICAL: Antihypertensive (see pp. 11C, 62C).

Action

Blocks vasoconstrictor, aldosterone-secreting effects of angiotensin II by inhibiting binding of angiotensin II to AT₁ receptors in vascular smooth muscle. Therapeutic Effect: Causes vasodilation, decreases peripheral resistance, decreases B/P.

Pharmacokinetics

Moderately absorbed after PO administration. Hydrolyzed in GI tract to olmesartan. Protein binding: 99%. Eliminated in urine (35%–50%), remainder in feces. Not removed by hemodialysis. Half-life: 13 hrs.

Uses

Treatment of hypertension alone or in combination with other antihypertensives.

Precautions

Contraindications: Concomitant use with aliskiren in pts with diabetes. Cautions: Renal impairment, unstented unilateral or bilateral renal arterial stenosis, significant aortic/mitral stenosis.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if distributed in breast milk. Pregnancy Category C (D if used in second or third trimester). Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: NSAIDs may decrease antihypertensive effect. HERBAL: Ephedra, ginseng, yohimbe may worsen hypertension. Garlic may increase antihypertensive effect. FOOD: None known. LAB VALUES: May slightly decrease Hgb, Hct. May increase serum BUN, creatinine, bilirubin, hepatic enzymes.

Availability (Rx)

Tablets: 5 mg, 20 mg, 40 mg.

Administration/handling

PO

• Give without regard to meals.

Indications/routes/dosage

Hypertension

PO: ADULTS, ELDERLY: Initially, 20 mg/day. May increase to 40 mg/day after 2 wks. Lower initial dose may be necessary in pts receiving volume-depleting medications (e.g., diuretics). CHILDREN 6–16 YRS, WEIGHING 20 TO LESS THAN 35 KG: Initially, 10 mg once daily. Range: 10–20 mg once daily. WEIGHING 35 KG OR GREATER: Initially, 20 mg once daily. Range: 20–40 mg once daily.

Side effects

Occasional (3%): Dizziness. Rare (less than 2%): Headache, diarrhea, upper respiratory tract infection.

Adverse effects/toxic reactions

Overdosage may manifest as hypotension, tachycardia. Bradycardia occurs less often. Rare cases of rhabdomyolysis have been reported.

Nursing considerations

Baseline assessment

Obtain B/P, apical pulse immediately before each dose in addition to regular monitoring (be alert to fluctuations). If excessive reduction in B/P occurs, place pt in supine position, feet slightly elevated. Question for possibility of pregnancy (see Pregnancy Category). Assess medication history (esp. diuretics).

Intervention/evaluation

Maintain hydration (offer fluids frequently). Assess for evidence of upper respiratory infection. Assist with ambulation if dizziness occurs. Monitor serum potassium level. Assess B/P for hypertension, hypotension.

Patient/family teaching

• Avoid pregnancy. • Avoid tasks that require alertness, motor skills until response to drug is established (possible dizziness effect). • Report any signs of infection (sore throat, fever). • Therapy requires lifelong control, diet, exercise. • Maintain adequate hydration.

olsalazine

ol-sal-a-zeen

(Dipentum)

Do not confuse Dipentum with Dilantin, or olsalazine with olanzapine.

classification

PHARMACOTHERAPEUTIC: Salicylic acid derivative. CLINICAL: Anti-inflammatory.

Action

Converted to mesalamine in colon by bacterial action. Blocks prostaglandin production in bowel mucosa. Therapeutic Effect: Reduces colonic inflammation.

Pharmacokinetics

Small amount absorbed. Protein binding: 99%. Metabolized by bacteria in colon. Minimal elimination in urine, feces. Half-life: 0.9 hr.

Uses

Maintenance of remission of ulcerative colitis in pts intolerant of sulfasalazine medication.

Precautions

Contraindications: History of hypersensitivity to salicylates. Cautions: Renal/hepatic impairment, elderly, severe allergies, asthma.

 ​Lifespan considerations

Pregnancy/Lactation: Crosses placenta; distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: Age-related renal impairment may require dosage adjustment.

Interactions

DRUG: May increase risk of bleeding with warfarin, heparin. May increase risk of myelosuppression with mercaptopurine, thioguanine. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum AST, ALT.

Availability (Rx)

Capsules: 250 mg.

Administration/handling

PO

• Give with food.

Indications/routes/dosage

Maintenance of controlled ulcerative colitis

PO: ADULTS, ELDERLY: 1 g/day in 2 divided doses, preferably q12h.

Side effects

Frequent (10%–5%): Headache, diarrhea, abdominal pain/cramps, nausea. Occasional (4%–2%): Depression, fatigue, dyspepsia, upper respiratory tract infection, decreased appetite, rash, pruritus, arthralgia. Rare (1%): Dizziness, vomiting, stomatitis.

Adverse effects/toxic reactions

Sulfite sensitivity may occur in susceptible pts (manifested as cramping, headache, diarrhea, fever, rash, urticaria, pruritus, wheezing). Discontinue drug immediately. Excessive diarrhea associated with extreme fatigue is rarely noted.

Nursing considerations

Intervention/evaluation

Encourage adequate fluid intake. Assess bowel sounds for peristalsis. Monitor daily pattern of bowel activity, stool consistency; record time of evacuation. Assess for abdominal disturbances. Assess skin for rash, urticaria. Medication should be discontinued if rash, fever, cramping, diarrhea occur.

Patient/family teaching

• Report if diarrhea, cramping continues or worsens or if rash, fever, pruritus occur.

omacetaxine

oh-ma-set-ax-een

(Synribo)

classification

PHARMACOTHERAPEUTIC: Protein synthesis inhibitor. CLINICAL: Antineoplastic.

Action

Inhibits protein synthesis of Bcr-Abl tyrosine kinase, a translocation-created enzyme, created by the Philadelphia chromosome abnormality noted in chronic myeloid leukemia (CML). Therapeutic Effect: Inhibits tumor proliferation and growth during accelerated and chronic stages of CML.

Pharmacokinetics

Rapidly absorbed following subcutaneous administration. Maximum concentration: 30 min. Protein binding: Less than 50%. Hydrolyzed via plasma esterases. Half-life: 6 hrs.

Uses

Treatment of adult pts with chronic or accelerated phase chonic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

Precautions

Contraindications: None known. Cautions: Glucose intolerance, poorly controlled diabetes, recent GI bleeding.

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