Hypertension: Blood Pressure Classification in Children

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HYPERTENSION

HYPERTENSION
In general, the optimal blood pressure (BP) for nonelderly adults is <120/80 mm Hg. Consistent systolic blood pressure (SBP)
≥140 mm Hg or a diastolic blood pressure (DBP) ≥90 mm Hg defines hypertension in many cases. The definition of hypertension
can change slightly depending on the guidelines being referenced and individual comorbidities present. Hypertension affects
~33% of the US population (67 million cases). Of those patients on antihypertensive medication, only 47% have adequately
controlled blood pressure. Controlling systolic hypertension has been much more difficult than controlling diastolic hypertension.
Educating patients on lifestyle management, cardiovascular risk reduction, and drug therapy aids in improving the morbidity and
mortality of patients with hypertension.
The 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults, a report created by the Eighth Joint
National Committee (JNC 8), is an excellent reference and guide for the treatment of hypertension (James 2014). While JNC 8
does not reference stages of hypertension, other guidelines still recognize this staging system, including the Clinical Practice
Guidelines for the Management of Hypertension in the Community, published by the American Society of Hypertension and the
International Society of Hypertension (ASH/ISH). Of note, although these guidelines were endorsed by ASH, they should be
considered more as an expert opinion piece. For adults, hypertension may be classified by stages (see following table).

Blood Pressure Classification in Adults

Category Systolic Diastolic


(mm Hg) (mm Hg)
Normal <120 and <80
Prehypertension 120 to 139 or 80 to 89
Hypertension
Stage 1 140 to 159 or 90 to 99
Stage 2 ≥160 or ≥100
Adapted from Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by
the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014;16(1):14-26.

Blood Pressure Classification in Children


The National High Blood Pressure Education Program (NHBPEP) Working Group on Hypertension Control in Children and
Adolescents categorized hypertension into stages in The Fourth Report on the Diagnosis, Evaluation, and Treatment of High
Blood Pressure in Children and Adolescents to create consistency with the JNC 7 Guidelines. The following are the staging
categories of hypertension in children and adolescents, followed by a table displaying selected 90th percentile information. Refer
to The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents for more
information on the 95th and 99th percentiles.
• Normal: SBP and DBP <90th percentile (based on gender, age, and height)
• Prehypertension: Average SBP and/or DBP levels that are ≥90th percentile (based on gender, age, and height) but <95th
percentile; may be referred to as "high normal"
– Children and adolescents with a BP ≥120/80 mm Hg but <95th percentile are considered prehypertensive
• Hypertension: Average SBP and/or DBP ≥95th percentile (based on gender, age, and height) measured on three separate
occasions
– Stage 1: SBP or DBP 95th to 99th percentile plus 5 mm Hg
– Stage 2: SBP or DBP >99th percentile plus 5 mm Hg

90th Percentile for Blood Pressure in Children and Adolescents


Girls' SBP/DBP Boys' SBP/DBP
Age (mm Hg) (mm Hg)
(y)
50th Percentile for Height 75th Percentile for Height 50th Percentile for Height 75th Percentile for Height
1 100/54 101/55 99/52 100/53
6 108/70 109/70 110/70 111/71
12 119/76 120/77 120/76 121/77
17 125/80 126/81 132/82 134/83

DBP = diastolic blood pressure, SBP = systolic blood pressure


Adapted from the report by the NHBPEP Working Group on Hypertension Control in Children and Adolescents. Pediatrics. 2004;114(2):555-576.

PATIENT ASSESSMENT
• Cardiovascular risk factors: Hypertension, cigarette smoking, obesity (BMI ≥30), inactive lifestyle, dyslipidemia, diabetes
mellitus, microalbuminuria or estimated GFR <60 mL/minute, age (>55 years of age for men, >65 years of age for women),
family history of premature cardiovascular disease (first-degree men <55 years of age or first-degree women <65 years of
age)
• Components of metabolic syndrome include hypertension, obesity, dyslipidemia (increased triglycerides, reduced HDL-C,
elevated fasting glucose, elevated waist circumference)
• Identify causes of high BP
• Assess target-organ damage and CVD

Target-Organ Disease
Organ System Manifestation
Clinical, ECG, or other diagnostic evidence of coronary artery disease; prior MI, angina; left ventricular
Cardiac
hypertrophy (LVH); left ventricular dysfunction or cardiac failure; prior coronary revascularization
Cerebrovascular Transient ischemic attack or stroke
Peripheral vascular Aneurysm, peripheral arterial disease
Renal Elevated serum creatinine; proteinuria; microalbuminuria; chronic kidney disease
Ocular Retinal hemorrhages or exudates, with or without papilledema; retinopathy

1996
THERAPY RECOMMENDATIONS

BLOOD PRESSURE MEASUREMENT


At an office visit, patients should be seated quietly for ≥5 minutes in a chair with feet on the floor and arm supported at heart level.
At least two measurements should be obtained. Patients should be given their results and their goal BP.
Ambulatory BP monitoring is useful in evaluating "white coat hypertension" (no end-organ damage), drug resistance,
hypotensive symptoms, episodic hypertension, and autonomic dysfunction. Ambulatory BP monitoring correlates better with
end-organ damage than office measurements.
Having patients monitor their own BP helps to improve compliance and provides information on response to therapeutic
interventions.

Management of Blood Pressure According to the JNC 8 Guidelines


Age Blood Pressure Goal2
Patient Classification1 Considerations for Preferred Initial Therapy2
(y) (mm Hg)
General population <60 SBP <140 and DBP <90 Nonblack: Thiazide-type diuretic, ACEI, ARB, or CCB
(without diabetes or CKD) (alone or in combination if necessary3)
≥60 SBP <150 and DBP <90
Black: Thiazide-type diuretic or CCB (alone or in
combination if necessary)
Patients with diabetes ≥18 SBP <140 and DBP <90 Nonblack: Thiazide-type diuretic, ACEI, ARB, or CCB
(without CKD) (alone or in combination if necessary3)
Black: Thiazide-type diuretic or CCB (alone or in
combination if necessary)
Patients with CKD ≥18 SBP <140 and DBP <90 All races: ACEI or ARB (alone or in combination with
(regardless of diabetes another drug class3)
status)

ACEI = angiotension-converting enzyme inhibitor, ARB = angiotension receptor block, CCB = calcium channel blocker, CKD = chronic kidney disease,
DBP = diastolic blood pressure, SBP = systolic blood pressure
1
For individuals with hypertension, implement lifestyle interventions and continue throughout therapy.
2
Refer to JNC 8 guidelines for strength of recommendations.
3
ACEIs and ARBs are not recommended to be used together.
Note: Recommendations are not intended for individuals <18 years of age.
Adapted from James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the
panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520.

ACHIEVING BLOOD PRESSURE CONTROL


Treatment of hypertension should be individualized. Keep in mind slight variations exist between different hypertension
guidelines in regards to both the treatment goals for specific patient populations and the level of evidence provided to support
the given recommendations. For instance, elderly patients 65 to 79 years of age should achieve a goal SBP ≤140 mm Hg if
tolerated for uncomplicated hypertension according to the ACCF/AHA 2011 Expert Consensus Document on Hypertension in the
Elderly. Additionally, for patients ≥80 years of age, a goal SBP of ≤140 mm Hg should be achieved; if not tolerated, 140 to 145
mm Hg is acceptable (Aronow 2011). In comparison, the JNC 8 guidelines recommend a blood pressure goal of <150/90 mm Hg
for individuals ≥60 years of age without comorbidities. Refer to the table below for additional information regarding blood
pressure goals for various patient populations.
More recently, the SPRINT trial, which enrolled older patients (ie, >50 years) without diabetes at risk for cardiovascular events
demonstrated a reduction in fatal and nonfatal major cardiovascular events and death from any cause when an intensive blood
pressure reduction (SBP target of <120 mmHg) was employed compared to standard blood pressure management (SBP target
of <140 mmHg). Automated oscillometric blood pressure (AOBP) measurements were used instead of manual auscultatory
blood pressure measurements within the study. AOBP measurements are typically lower than manual auscultatory blood
pressure measurements, so clinicians may need to adjust blood pressure goals based on the type of blood pressure
measurement used (eg, SBP target of 125 to 135 mmHg if using standard manual auscultatory measurements). Patients
should be monitored more closely for adverse events (eg, hypotension, electrolyte abnormalities) when targeting these lower
blood pressures (SPRINT Research Group 2015).

Age Blood Pressure Goal1


Patient Classification Guideline
(y) (mm Hg)
General population AHA/ACC/CDC ≥18 <140/902
(without diabetes or CKD)
ASH/ISH <80 <140/90
ASH/ISH ≥80 <150/90
JNC 8 ≥60 <150/90
JNC 8 ≥18 <140/90
Patients with diabetes AACE ≥18 <130/80
(without CKD)
ADA ≥18 <140/803
ASH/ISH ≥18 <140/90
JNC 8 ≥18 <140/90
Patients with CKD
(regardless of diabetes status) JNC 8 ≥18 <140/90

Patients with CKD and


ASH/ISH ≥18 <130/80
albuminuria
AACE = American Association of Clinical Endocrinologists, ADA = American Diabetes Association, AHA/ACC/CDC = American Heart Association/
American College of Cardiology/Centers for Disease Control and Prevention, ASH/ISH = American Society of Hypertension/International Society of
Hypertension, JNC 8 = Eighth Joint National Committee
1
Refer to cited guidelines for strength of recommendations and/or supportive evidence.
2
Lower targets may be necessary for patients based on disease states and individual factors but are not specified by the AHA/ACC/CDC.
3
Lower BP targets may be appropriate (eg, younger patients) per the ADA.
Note: Recommendations are not intended for individuals <18 years of age.

1997
DEGARELIX

Additional Information Complete prescribing information may require discontinuation of therapy; usually occurs
should be consulted for additional detail. within 1-3 weeks and lasts <2 weeks. Most patients may
Dosage Forms Excipient information presented when resume therapy following a treatment interruption. Use with
available (limited, particularly for generics); consult specific caution in patients taking strong CYP3A4 inhibitors, mod-
product labeling. erate or strong CYP3A4 inducers and major CYP3A4
Solution Reconstituted, Subcutaneous, as acetate: substrates (see Drug Interactions); consider alternative
Firmagon: 80 mg (1 ea); 120 mg (1 ea) agents that avoid or lessen the potential for CYP-mediated
interactions.
^ Degarelix Acetate see Degarelix on page 513 Adverse Reactions Frequency of adverse reactions
^ Dehydrobenzperidol see Droperidol on page 607 reported from occurrence in clinical trials with delavirdine
^ Delatestryl see Testosterone on page 1766 when used as part of combination antiretroviral therapy.
>10%:
Delavirdine (de la VIR deen) Central nervous system: Headache (19% to 20%),
depressive symptoms (10% to 15%), fever (4% to 12%)
Brand Names: US Rescriptor Dermatologic: Rash (16% to 32%)
Brand Names: Canada Rescriptor Gastrointestinal: Nausea (20% to 25%), vomiting (3%
Index Terms DLV; U-90152S to 11%)
Pharmacologic Category Antiretroviral, Reverse Tran- 1% to 10%:
scriptase Inhibitor, Non-nucleoside (Anti-HIV) Central nervous system: Anxiety (6% to 8%)
Endocrine & metabolic: Transaminases increased (2% to
Use Treatment of HIV-1 infection in combination with at
5%), amylase increased (3%), bilirubin increased (2%)
least two additional antiretroviral agents
Gastrointestinal: Diarrhea, vomiting, abdominal pain (4%
Pregnancy Considerations Adverse events were
to 6%)
observed in some animal reproduction studies. Hyper-
Hematologic: Prothrombin time increased (2%), hemo-
sensitivity reactions (including hepatic toxicity and rash)
globin decreased (1% to 3%)
are more common in women on NNRTI therapy; it is not
Respiratory: Bronchitis (6% to 8%)
known if pregnancy increases this risk.
Frequency not defined (limited to important or life threat-
Regardless of CD4 count or HIV RNA copy number, all ening): Abscess, adenopathy, alkaline phosphatase
HIV-infected pregnant women should receive a combina- increased, allergic reaction, angioedema, anorexia,
tion antiretroviral (ARV) drug regimen. A combination of arrhythmia, bloody stool, bone pain, bruising, cardiac
antepartum, intrapartum, and infant ARV prophylaxis is insufficiency, cardiac rate abnormal, cardiomyopathy,
recommended. ARV therapy should be started as soon chest congestion, cognitive impairment, colitis, confu-
as possible in women with symptomatic infection. Although sion, conjunctivitis, dermal leukocytoclastic vasculitis,
earlier initiation may be more effective in reducing the desquamation, diverticulitis, dyspnea, emotional lability,
perinatal transmission of HIV, initiation may be delayed eosinophilia, erythema multiforme, fecal incontinence,
until after 12 weeks gestation in women who do not require fungal dermatitis, gamma glutamyl transpeptidase
immediate treatment after careful consideration of mater- increased, gastroenteritis, gastrointestinal bleeding,
nal conditions (eg, nausea and vomiting) and the potential granulocytosis, gum hemorrhage, hallucination, hematu-
risks of first trimester fetal exposure for specific agents. A ria, hepatomegaly, hyperglycemia, hyperkalemia, hyper-
scheduled cesarean delivery at 38 weeks gestation is tension, hypertriglyceridemia, hyperuricemia,
recommended for all women with HIV RNA >1000 cop- hypocalcemia, hyponatremia, hypophosphatemia, infec-
ies/mL or unknown concentrations near delivery in order to tion, jaundice, kidney pain, leukopenia, lipase increased,
decrease transmission. If ARV therapy must be interrupted menstrual irregularities, moniliasis (oral/vaginal), ortho-
for <24 hours during the peripartum period, stop then static hypotension, pancreatitis, pancytopenia, paralysis,
restart all medications simultaneously in order to decrease peripheral vascular disorder, pneumonia, purpura, redis-
the chance of developing resistance. Long-term follow-up tribution of body fat, renal calculi, serum creatinine
is recommended for all infants exposed to ARV medica- increased, spleen disorder, Stevens-Johnson syndrome,
tions. In couples who want to conceive, the HIV-infected tetany, thrombocytopenia, urinary tract infection, vertigo
partner should attain maximum viral suppression prior to Postmarketing and/or case reports: Acute renal failure,
conception. hemolytic anemia, hepatic failure, immune reconstitution
syndrome, rhabdomyolysis
Health care providers are encouraged to enroll pregnant Drug Interactions
women exposed to antiretroviral medications in the Anti- Metabolism/Transport Effects Substrate of CYP2D6
retroviral Pregnancy Registry (1-800-258-4263 or www.- (minor), CYP3A4 (major); Note: Assignment of Major/
APRegistry.com). Health care providers caring for HIV- Minor substrate status based on clinically relevant drug
infected women and their infants may contact the National interaction potential; Inhibits CYP1A2 (weak), CYP2C19
Perinatal HIV Hotline (888-448-8765) for clinical consulta- (strong), CYP2C9 (strong), CYP2D6 (strong), CYP3A4
tion (HHS [perinatal] 2014). (weak)
Breast-Feeding Considerations It is not known if dela- Avoid Concomitant Use
virdine is excreted into breast milk. Maternal or infant Avoid concomitant use of Delavirdine with any of the
antiretroviral therapy does not completely eliminate the following: Astemizole; CarBAMazepine; Efavirenz; Etra-
risk of postnatal HIV transmission. In addition, multiclass- virine; Fosamprenavir; Fosphenytoin; H2-Antagonists;
resistant virus has been detected in breast-feeding infants Mequitazine; Phenytoin; Pimozide; Proton Pump Inhib-
despite maternal therapy. Therefore, in the United States, itors; Rifamycin Derivatives; Rilpivirine; St Johns Wort;
where formula is accessible, affordable, safe, and sustain- Tamoxifen; Terfenadine; Thioridazine
able, and the risk of infant mortality due to diarrhea and Increased Effect/Toxicity
respiratory infections is low, complete avoidance of breast- Delavirdine may increase the levels/effects of: ARIPipra-
feeding by HIV-infected women is recommended to zole; ARIPiprazole Lauroxil; Astemizole; AtoMOXetine;
decrease potential transmission of HIV (HHS [perinatal] Bosentan; Brexpiprazole; Cilostazol; Citalopram;
2014). CYP2C19 Substrates; CYP2C9 Substrates; CYP2D6
Contraindications Hypersensitivity to delavirdine or any Substrates; Dapoxetine; Diclofenac (Systemic); Dofeti-
component of the formulation; concurrent use of alprazo- lide; DOXOrubicin (Conventional); Dronabinol; DULoxe-
lam, astemizole, cisapride, ergot alkaloids, midazolam, tine; Efavirenz; Eliglustat; Etravirine; Fesoterodine;
pimozide, rifampin, terfenadine, or triazolam Flibanserin; Fosamprenavir; Fosphenytoin; Hydroco-
Warnings/Precautions Use with caution in patients with done; Iloperidone; Lacosamide; Lomitapide; Mequita-
hepatic or renal dysfunction; due to rapid emergence of zine; Metoprolol; Nebivolol; NiMODipine; Ospemifene;
resistance, delavirdine should not be used as monother- Parecoxib; Phenytoin; Pimozide; Propafenone; Protease
apy or as a component of an initial antiretroviral regimen; Inhibitors; Ramelteon; Rifamycin Derivatives; Rilpivirine;
cross-resistance may be conferred to other non-nucleo- Tamsulosin; Terfenadine; Tetrabenazine; Tetrahydrocan-
side reverse transcriptase inhibitors, although potential for nabinol; Thioridazine; TiZANidine; TraMADol; Vortioxe-
cross-resistance with protease inhibitors is low. Long-term tine
effects of delavirdine are not known. May cause redistrib-
The levels/effects of Delavirdine may be increased by:
ution of fat (eg, buffalo hump, peripheral wasting with
Cannabis; Osimertinib
increased abdominal girth, cushingoid appearance).
Decreased Effect
Patients may develop immune reconstitution syndrome
Delavirdine may decrease the levels/effects of: CarBA-
resulting in the occurrence of an inflammatory response
Mazepine; Clopidogrel; Codeine; Efavirenz; Etravirine;
to an indolent or residual opportunistic infection during
Hydrocodone; Iloperidone; Rilpivirine; Tamoxifen; TraMA-
initial HIV treatment or activation of autoimmune disorders
Dol
(eg, Graves’ disease, polymyositis, Guillain-Barré syn-
drome) later in therapy; further evaluation and treatment The levels/effects of Delavirdine may be decreased by:
may be required. Safety and efficacy have not been Antacids; Bosentan; CarBAMazepine; CYP3A4 Inducers
established in children. Rash, which occurs frequently, (Moderate); CYP3A4 Inducers (Strong); Dabrafenib;

514
DENOSUMAB

Deferasirox; Enzalutamide; Fosamprenavir; Fospheny- Dosing


toin; H2-Antagonists; Mitotane; Osimertinib; Phenytoin; Adult & Geriatric
Protease Inhibitors; Proton Pump Inhibitors; Rifamycin Susceptible infections: Manufacturer’s labeling: Oral:
Derivatives; Siltuximab; St Johns Wort; Tocilizumab 150 mg 4 times/day or 300 mg twice daily
Storage/Stability Store at 20°C to 25°C (68°F to 77°F). SIADH (off-label use): Oral: 600 to 1,200 mg/day (Goh,
Protect from humidity. 2004; Gross, 2008, Verbalis, 2013). Note: Limited high
Mechanism of Action Delavirdine binds directly to quality evidence exists to define the clinical role, if any,
reverse transcriptase, blocking RNA-dependent and of demeclocycline in this condition. European clinical
DNA-dependent DNA polymerase activities practice guidelines recommend against the use of
Pharmacodynamics/Kinetics demeclocycline for the management of hyponatremia
Absorption: Rapid in patients with SIADH (Spasovski, 2014).
Distribution: Low concentration in saliva and semen; CSF Pediatric Susceptible infections: Manufacturer’s label-
0.4% concurrent plasma concentration ing: Oral: Children >8 years: 7-13 mg/kg/day (maximum:
Protein binding: ~98%, primarily albumin 600 mg/day) divided every 6-12 hours
Metabolism: Hepatic via CYP3A4 and 2D6 (Note: May Renal Impairment Use with caution; dosage adjustment
reduce CYP3A activity and inhibit its own metabolism.) and/or increase in time interval between doses recom-
Bioavailability: Tablet: 85% as tablet; ~100% as oral slurry mended in manufacturer’s labeling; no specific adjust-
Half-life elimination: 5.8 hours (range: 2-11 hours) ment recommendations provided.
Time to peak, plasma: 1 hour Hepatic Impairment Use with caution; dosage adjust-
Excretion: Urine (51%, <5% as unchanged drug); feces ment and/or increase in time interval between doses
(44%); nonlinear kinetics exhibited recommended in manufacturer’s labeling; no specific
Dosing adjustment recommendations provided.
Adult & Geriatric HIV-1 infection (part of combina- Additional Information Complete prescribing information
tion): Oral: 400 mg 3 times/day should be consulted for additional detail.
Pediatric HIV-1 infection (part of combination): Ado- Dosage Forms Excipient information presented when
lescents ≥16 years: Refer to adult dosing. available (limited, particularly for generics); consult specific
Renal Impairment No dosage adjustment provided in product labeling.
manufacturer’s labeling (has not been studied). Guide- Tablet, Oral, as hydrochloride:
Generic: 150 mg, 300 mg
lines state that no dosage adjustment is necessary in
renal impairment (HHS [adult] 2015). ^ Demeclocycline Hydrochloride see Demeclocycline
Hepatic Impairment No dosage adjustment provided in on page 515
manufacturer’s labeling (has not been studied). However, ^ Demerol see Meperidine on page 1144
delavirdine is primarily metabolized by the liver, use with
^ 4-Demethoxydaunorubicin see IDArubicin on page 910
caution.
Dietary Considerations May be taken without regard to ^ Demethylchlortetracycline see Demeclocycline
meals. on page 515
Administration Patients with achlorhydria should take the ^ Demser see Metyrosine on page 1200
drug with an acidic beverage; antacids and delavirdine ^ Demulen see Ethinyl Estradiol and Ethynodiol Diacetate
should be separated by 1 hour. A dispersion of delavirdine on page 702
may be prepared by adding four 100 mg tablets to at least ^ Demulen 30 (Can) see Ethinyl Estradiol and Ethynodiol
3 oz of water. Allow to stand for a few minutes and stir until
Diacetate on page 702
uniform dispersion. Drink immediately. Rinse glass and
mouth, then swallow the rinse to ensure total dose admin- ^ Denavir see Penciclovir on page 1418
istered. The 200 mg tablets should be taken intact.
Monitoring Parameters Liver function tests if adminis- Denosumab (den OH sue mab)
tered with saquinavir
Additional Information Potential compliance problems, Brand Names: US Prolia; Xgeva
frequency of administration, and adverse effects should be Brand Names: Canada Prolia; Xgeva
discussed with patients before initiating therapy to help Index Terms AMG-162
prevent the emergence of resistance. Pharmacologic Category Bone-Modifying Agent; Mono-
Dosage Forms Excipient information presented when clonal Antibody
available (limited, particularly for generics); consult specific Use
product labeling. Hypercalcemia of malignancy (Xgeva): Treatment of
Tablet, Oral, as mesylate: hypercalcemia of malignancy refractory to bisphospho-
Rescriptor: 100 mg, 200 mg nate therapy
Extemporaneous Preparations A dispersion of delavir- Osteoporosis/bone loss (Prolia): Treatment of osteopo-
dine may be made with tablets. Add four 100 mg tablets to rosis in postmenopausal women at high risk of fracture;
at least 3 oz of water; allow to stand for a few minutes and treatment of osteoporosis (to increase bone mass) in
stir until uniform dispersion. Administer immediately. To men at high risk of fracture; treatment of bone loss in
ensure full dose is administered, rinse glass and drink men receiving androgen-deprivation therapy (ADT) for
liquid; also rinse mouth and swallow following ingestion. nonmetastatic prostate cancer; treatment of bone loss
in women receiving aromatase inhibitor (AI) therapy for
^ Delestrogen see Estradiol (Systemic) on page 681 breast cancer
^ Delsym Cough + Chest Congestion DM [OTC] see Tumors (Xgeva): Prevention of skeletal-related events
Guaifenesin and Dextromethorphan on page 861 (eg, fracture, spinal cord compression, bone pain requir-
^ Delta-9-tetrahydro-cannabinol see Dronabinol ing surgery/radiation therapy) in patients with bone meta-
on page 606 stases from solid tumors; treatment of giant cell tumor of
the bone in adults and skeletally mature adolescents that
^ Delta-9 THC see Dronabinol on page 606
is unresectable or where surgical resection is likely to
^ Deltacortisone see PredniSONE on page 1496 result in severe morbidity
^ Deltadehydrocortisone see PredniSONE on page 1496 Limitation of use: Denosumab is NOT indicated for pre-
^ Deltasone see PredniSONE on page 1496
vention of skeletal-related events in patients with multiple
myeloma
^ Delyla see Ethinyl Estradiol and Levonorgestrel Pregnancy Considerations Use of Prolia is contraindi-
on page 703 cated in pregnant women. Adverse events were observed
^ Delzicol see Mesalamine on page 1151 in animal reproduction studies. Specifically, increased fetal
^ Demadex see Torsemide on page 1816 loss, stillbirths, postnatal mortality, absent lymph nodes,
abnormal bone growth, and decreased neonatal growth
was observed in cynomolgus monkeys exposed to deno-
Demeclocycline (dem e kloe SYE kleen) sumab throughout pregnancy. Denosumab was measura-
ble in the offspring at one month of age. Fetal exposure to
Index Terms Declomycin; Demeclocycline Hydrochloride; monoclonal antibodies is expected to increase as preg-
Demethylchlortetracycline nancy progresses. Women of reproductive potential
Pharmacologic Category Antibiotic, Tetracycline Deriva- should be advised to use effective contraception during
tive denosumab treatment and for at least 5 months following
Use Treatment of susceptible bacterial infections (eg, acne, the last dose. Studies of denosumab when used for
urinary tract infections, respiratory infections) caused by osteoporosis/bone loss in men demonstrated that it is
both gram-negative and gram-positive organisms unlikely that a female partner or fetus would be exposed
Note: Use of demeclocycline as an antibacterial agent is during unprotected sex to pharmacologically relevant
uncommon; alternative tetracycline agents (eg, doxycy- denosumab concentrations via seminal fluid; however,
cline, minocycline, tetracycline) are generally preferred. exposure from seminal fluid of men receiving denosumab

515

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