Drug Monographs Ancillary

210 Pages·2013·0.74 MB·English

Alprazolam (Xanax/Xanax XR/Niravam) / 1
Amitriptyline (Elavil) / 4
Aripiprazole (Abilify) / 8
Armodafi nil (Nuvigil) / 11
Asenapine (Saphris) / 13
Atomoxetine (Strattera) / 16
B Complex (Vitamin B1/Thiamine Hydrochloride) / 18
Bromocriptine (Parlodel) / 19
Buprenorphine Ho, Buprenorphine Hcl, and Naloxone Hcl Dihydrate
(Subutex, Suboxone) / 20
Bupropion (Wellbutrin, Zyban) / 22
Carbamazepine (Tegretol, Carbatrol, Tegretol XR) / 25
Chlordiazepoxide (Librium) / 27
Citalopram (Celexa) / 29
Clomipramine (Anafranil) / 32
Clonazepam (Klonopin) / 35
Clonidine (Catapres, Catapres-TTS) / 37
Clorazepate (Tranxene) / 39
Clozapine (Clozaril, FazaClo) / 41
Cyproheptadine (Periactin) / 45
i
DDrruugg MMoonnooggrraapphhss..iinnddbb ii 33//2277//22001133 88::2255::1155 AAMM
ii (cid:31) LIST OF DRUG MONOGRAPHS
Dantrolene (Dantrium) / 46
Desipramine (Norpramin) / 47
Desvenlafaxine (Pristiq) / 49
Dexmethylphenidate (Focalin) / 52
Dextroamphetamine and Amphetamine (Adderall) / 54
Diazepam (Valium) / 56
Dicyclomine (Bentyl) / 59
Divalproex Sodium (Depacon, Depakene, Depakote, Depakote Er, Depakote
Sprinkle) / 61
Donepezil Hydrochloride (Aricept) / 64
Doxepin (Sinequan, Silenor) / 66
Droperidol (Inapsine) / 68
Duloxetine (Cymbalta) / 69
Escitalopram (Lexapro) / 72
Eszopiclone (Lunesta) / 76
Fluoxetine (Prozac) / 78
Fluphenazine (Prolixin) / 82
Flurazepam (Dalmane, Dalmadorm) / 85
Fluvoxamine (Luvox) / 87
Galantamine (Razadyne and Razadyne ER) / 91
Guanfacine (Intuniv) / 93
Haloperidol (Haldol) / 95
Hydroxyzine (Vistaril) / 98
Ibuprofen (Motrin) / 100
Imipramine (Tofranil) / 101
Isocarboxazid (Marplan) / 104
DDrruugg MMoonnooggrraapphhss..iinnddbb iiii 33//2277//22001133 88::2255::1155 AAMM
LIST OF DRUG MONOGRAPHS (cid:31) iii
Lamotrigine (Lamictal, Lamictal XR) / 106
Lisdexamfetamine (Vyvanse) / 108
Lithium (Eskalith, Lithobid) / 110
Loperamide (Imodium) / 113
Lorazepam (Ativan) / 114
Memantine (Namenda) / 116
Methadone Hcl (Methadose Oral Concentrate) / 118
Methylphenidate Transdermal (Daytrana Patch) / 120
Methylphenidate (Methylin) / 122
Midazolam (Versed) / 125
Mirtazapine (Remeron) / 128
Modafi nil (Provigil) / 130
Naloxone (Narcan) / 132
Naltrexone (Revia) / 134
Nefazodone (Serzone) / 137
Nicotine (Nicotrol NS, Nicotrol Inhaler, Commit, Habitrol, Nicoderm, Nicotrol
ProStep, Nicorette Gum, Nicorette DS); Varenicline, (Chantix) / 139
Nortriptyline (Pamelor) / 141
Olanzapine (Zyprexa) / 144
Oxazepam (Serax) / 147
Paliperidone (Invega) / 149
Paroxetine (Paxil, Paxil CR) / 151
Phenelzine (Nardil) / 153
Pimozide (Orap) / 155
Propranolol (Inderal) / 158
Quetiapine (Seroquel, Seroquel XR) / 160
DDrruugg MMoonnooggrraapphhss..iinnddbb iiiiii 33//2277//22001133 88::2255::1166 AAMM
iv (cid:31) LIST OF DRUG MONOGRAPHS
Ramelteon (Rozerem) / 163
Risperidone (Risperdal, Risperdal Consta) / 165
Rivastigmine Tartrate (Exelon and Exelon Patch) / 170
Sertraline (Zoloft) / 172
Temazepam (Restoril) / 176
ThiOpental Sodium (Pentothal) / 178
Thioridazine (Mellaril) / 181
Tranylcypromine (Parnate) / 184
Trazodone (Desyrel) / 186
Triazolam (Halcion) / 188
Trifl uoperazine (Stelazine) / 190
Varenicline (Chantix) / 192
Venlafaxine (Effexor) / 194
Zaleplon (Sonata) / 198
Ziprasidone (Geodon) / 200
Zolpidem (Ambien) / 203
Zonisamide (Zonegran) / 205
DDrruugg MMoonnooggrraapphhss..iinnddbb iivv 33//2277//22001133 88::2255::1166 AAMM
ALPRAZOLAM (Xanax/Xanax XR/Niravam)
Classifi cation: Benzodiazepine (BZD).
Indications: Short-acting BZD used to treat GADs and PD. May be used as a
short-term adjunct to an SSRI while waiting for the therapeutic effects of the SSRI
to develop.
Available Forms: Tablet, 0.25, 0.5, 1, and 2 mg; extended-release capsule, 0.5, 1,
and 2 mg; melt, 0.5, 1, 2, and 3 mg.
Dosage:
Xanax: Starting dose, 0.25–0.5 mg up to 2–3 times daily; maximum, 4 mg daily.
Can be increased every 3–4 days. Treatment should be limited to as short a period
as possible (less than 4 months) and/or reevaluated for continued use. Xanax XR:
Starting dose, 0.5–1 mg PO, daily, can increase up to 1 mg/day every 3–4 days.
Niravam (melt): Starting dose, 0.25 to 0.5 mg up to 2–3 times daily; maximum,
4 mg daily. Can be increased every 3–4 days.
Administration:
(cid:31) PO with a glass of water.
(cid:31) Do not crush, cut, or chew extended-release tablets.
(cid:31) Orally disintegrating form (Niravam) has special instructions.
(cid:31) Concentrated liquid must be measured with a special dose-measuring spoon or
cup.
Side Effects: Drowsiness, lightheadedness, dry mouth, headache, changes in
bowel habits, sialorrhea, amnesia, and changes in appetite. Changes in appe-
tite, changes in sexual desire, constipation, dizziness, drowsiness, dry mouth,
increased saliva production, lightheadedness, tiredness, trouble concentrating,
unsteadiness, and weight changes. Syncope, tachycardia, seizures, respiratory
depression, dependency, withdrawal syndrome, and suicidal ideation.
Drug Interactions: This medicine may interact with the following medications:
(cid:31) Absolute contraindications include clarithromycin, fl uvoxamine, and
ketoconazole.
(cid:31) Avoid using with calcium channel blockers, erythromycins, tamoxifen, and
zafi rlukast.
1
DDrruugg MMoonnooggrraapphhss..iinnddbb 11 33//2277//22001133 88::2255::1166 AAMM
2 (cid:31) DRUG MONOGRAPHS
(cid:31) Avoid sodium oxybate, as it can increase CNS and respiratory depression.
Chloramphenicol, cimetidine (Tagamet), clarithromycin (Biaxin), onivaptan
(Vaprisol), cyclosporine (Gengraf/Neoral), delavirdine (Rescriptor), imatinib
(Gleevec), isoniazid, itraconazole (Sporanox), ketoconazole, nefazodone (Serzone),
posaconazole (Noxafi l), protease inhibitors, telithromycin (Ketek), and voricon-
azole (Vfend) may increase benzodiazepine levels, risk of CNS depression, and
psychomotor impairment.
(cid:31) The action of benzodiazepines may be potentiated by barbiturates, narcotics,
phenothiazines, MAOIs, or other antidepressants.
(cid:31) Alert: This list may not describe all possible interactions. Instruct patients to
provide a list of all medicines, herbs, nonprescription drugs, or dietary supple-
ments used, and if they smoke, drink alcohol, or use illegal drugs.
Pharmacokinetics: Metabolized in the liver (CYP450) and is excreted in the
urine. It binds to benzodiazepine receptors and enhances GABA effects.
BZDs enhance the activity of GABA, a major CNS neurotransmitter, known to open
CNS Cl-channels leading to an inhibition of subsequent CNS neuronal signaling.
BZDs with similar action can differ in their potency and rate of absorption.
(cid:31) Metabolism: By the liver in the CYP450 3A4.
(cid:31) Excretion: Urine.
(cid:31) Half-life: 11.2 hr, 16.3 hr (elderly), 19.7 hr (alcoholic liver disease).
Precautions:
(cid:31) Do not abruptly stop taking the medication.
(cid:31) Not prescribed for children.
(cid:31) Use lowest effective dose for shortest duration.
(cid:31) Alprazolam can be habit forming; do not increase dosage without checking
patient compliance and review of chief complaints.
(cid:31) Keep out of light in a tightly closed container.
(cid:31) Store at room temperature.
(cid:31) See patients as often as necessary to ensure that the drug is working on the
panic attacks, determine compliance, and review side effects.
(cid:31) Instruct patients and their families to watch for worsening depression or
thoughts of suicide. Also watch out for sudden or severe changes in feelings
such as feeling anxious, agitated, panicky, irritated, hostile, aggressive, impul-
sive, severely restless, overly excited, hyperactive, or not being able to sleep. If
this happens, especially at the beginning of antidepressant treatment or after a
change in dose, patient should call the health care provider. Serious reactions to
the drug include syncope, tachycardia, seizures, respiratory depression, coma,
suicidal ideation, and hypomania/mania.
(cid:31) Drowsiness or dizziness: Patients should not drive or use machinery or do any-
thing that needs mental alertness until the effects of this medicine are known.
(cid:31) Caution patients not to stand or sit up quickly, especially if older. This reduces
the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this
medicine. Avoid alcoholic drinks.
(cid:31) Do not abruptly withdraw this drug as it may cause seizures.
(cid:31) Caution should be exercised in the following:
(cid:31) MDD, psychosis, or bipolar affective disorder.
(cid:31) Respiratory disease.
DDrruugg MMoonnooggrraapphhss..iinnddbb 22 33//2277//22001133 88::2255::1166 AAMM
ALPRAZOLAM (Xanax/Xanax XR/Niravam) (cid:31) 3
(cid:31) Heart disease.
(cid:31) Liver disease.
(cid:31) Seizures (convulsions).
(cid:31) Suicidal thoughts, plans, or attempts by patients or a family member.
(cid:31) An unusual or allergic reaction to alprazolam, other medicines, foods, dyes,
or preservatives.
Patient and Family Education:
(cid:31) Tell the health care provider of glaucoma, hepatic or renal impairment, drug-
abuse history, salivary fl ow decrease (interferes with ODT absorption), or
pregnancy.
(cid:31) Missed doses should be taken as soon as possible; however, if it is too close to
next dose, then it should be skipped.
(cid:31) Take medicine as prescribed and do not stop it abruptly, without fi rst discuss-
ing with health care provider.
(cid:31) Store alprazolam at room temperature away from moisture, heat, and light.
Remove any cotton from the bottle of disintegrating tablets, and keep the bottle
tightly closed.
(cid:31) Before taking this medicine tell the health care provider of medical history of
liver disease, kidney disease, lung/breathing problems, drug or alcohol abuse,
or any allergies.
(cid:31) Do not drive, operate heavy machinery, or perform dangerous activities until it
is known how this medicine will exert its effects.
(cid:31) This drug may be habit forming and should be used only by the person for
whom it was prescribed. Alprazolam should never be shared with another per-
son, especially someone who has a history of drug abuse or addiction. Keep the
medication in a secure place where others cannot get to it.
(cid:31) Do not purchase alprazolam on the Internet or outside of the United States, as
dangerous ingredients may be present. Some Internet purchases of alprazolam
have been found to contain haloperidol (Haldol), an antipsychotic drug.
Special Populations:
(cid:31) Elderly: Older patients may be more sensitive to the effects of BZDs. Give 0.25
mg PO bid or tid. Use lowest, most effective dose. Dose adjustment is neces-
sary for patients with liver impairment and/or renal disease due to excessive
metabolites excreted by the kidney. Due to increased risk of sedation leading
to falls and fractures, all BZDs are included on the Beers List of Potentially
Inappropriate Medications for Geriatrics.
(cid:31) Renal impairment: No adjustment needed.
(cid:31) Hepatic impairment: With advanced hepatic disease, start at 0.25 mg PO bid or
tid and titrate gradually.
(cid:31) Pregnancy: Category D; can cause teratogenic fetal effects. Infants born to moth-
ers taking BZDs may be at risk for withdrawal symptoms contraindicated in
the postnatal period.
(cid:31) Lactation: Excreted in human breast milk; infants can become lethargic and lose
weight.
(cid:31) Children: Not indicated for use in children younger than 18 years of age.
bhmnbm / 52
DDrruugg MMoonnooggrraapphhss..iinnddbb 33 33//2277//22001133 88::2255::1166 AAMM
4 (cid:31) DRUG MONOGRAPHS
AMITRIPTYLINE (Elavil)
Classifi cation: Tricyclic antidepressant (TCA).
Indications: Used to treat adults with depression/anxiety.
Available Forms: Tablet, 10, 25, 50, 75, 100, and 150 mg.
Dosage:
Adults: Between 50 and 150 mg PO at bedtime. Dosage can be increased by
25–50 mg/day every 2–3 days until desired effect occurs.
Elderly: Starting dose, 10–25 mg PO at night in elderly patients; increase
10–25 mg/day every 2–3 days; maximum, 300 mg/day.
Children (9–12 years old): 1–3 mg/kg/day PO divided tid with gradual
increase by 0.5 mg/kg/day every 2–3 days. Must taper dose gradually to
discontinue.
Administration:
(cid:31) PO with a glass of water.
(cid:31) Do not abruptly stop taking the medication.
(cid:31) Use lowest effective dose for shortest duration.
Side Effects: Common reactions include:
(cid:31) Most common: Drowsiness, dry mouth, dizziness, constipation, blurred
vision, palpitations, tachycardia, lack of coordination, appetite increase,
nausea/vomiting, sweating, weakness, disorientation, confusion, restless-
ness, insomnia, anxiety/agitation, urinary retention/urinary frequency,
rash/urticaria, pruritus, weight gain, libido changes, impotence, gyneco-
mastia, galactorrhea, tremor, hypo/hyperglycemia, paresthesias, and
photosensitivity.
(cid:31) Less common: Hypertension or orthostatic hypotension, ventricular arrhyth-
mias, extrapyramidal symptoms, thrombocytopenia.
Drug Interactions:
(cid:31) Class 1A antiarrhythmics, such as procainamide, quinidine gluconate,
quinidine sulfate, disopyramide may increase risk of QT prolongation; and
all MAOIs.
(cid:31) Cisapride (Propulsid) may increase risk of QT prolongation, cardiac arrhyth-
mias; dronedarone (Multaq) may increase TCA levels and risk of adverse
effects, increase risk of QT prolongation, cardiac arrhythmias; fl umazenil
(Romazicon) may increase risk of cardiac arrhythmias, seizures.
(cid:31) MAOIs such as selegiline (Eldepryl/Zelapar), procarbazine (Matulane),
phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan),
selegiline transdermal (Eldepryl/Zelapar), rasagiline (Azilect) may result in
CNS overstimulation, hyperpyrexia, seizures, death.
(cid:31) Pimozide (Orap) may increase risk of CNS depression, psychomotor
impairment, QT prolongation, arrhythmias, anticholinergic effects, hyper-
pyrexia; potassium salts such as potassium acid phosphate, potassium
DDrruugg MMoonnooggrraapphhss..iinnddbb 44 33//2277//22001133 88::2255::1166 AAMM
AMITRIPTYLINE (Elavil) (cid:31) 5
citrate, potassium chloride, potassium iodide, potassium phosphate/
sodium phosphate, potassium acid, phosphate/sodium acid phosphate,
and potassium phosphate are contraindicated for solid potassium dose
forms.
(cid:31) Avoid using with amiodarone, cimetadine, clarithromycin, haldoperidol,
St. John’s wort.
(cid:31) Alert: This list may not describe all possible interactions. Instruct patients to
provide a list of all medicines, herbs, nonprescription drugs, or dietary supple-
ments used, and if they smoke, drink alcohol, or use illegal drugs.
(cid:31) Weigh risk/benefi t of thyroid protection with solid iodide salt forms, may
delay solid potassium passage through GI tract and increase risk of ulcera-
tive/stenotic lesions.
Pharmacokinetics:
(cid:31) TCAs are thought to work by inhibiting reuptake of norepinephrine and
serotonin in the CNS, which potentiates the neurotransmitters. They also
have signifi cant anticholinergics, antihistaminic, and alpha-adrenergic activ-
ity on the cardiac system. These classes of antidepressants also possess class
1A antiarrhythmic activity, which can lead to depression of cardiac conduc-
tion, potentially resulting in heart block or ventricular arrhythmias.
(cid:31) Metabolism: Extensively by the liver within the CYP450: 1A2, 2D6 (primary),
3A4 substrate; active metabolites include nortriptyline.
(cid:31) Excretion: Primarily in urine (18% unchanged), feces.
(cid:31) Half-life: 10–26 hr (amitriptyline), 18–44 hr (nortriptyline).
Precautions:
(cid:31) See patients as often as necessary to ensure that the drug is working on the
panic attacks, determine compliance, and review side effects.
(cid:31) Instruct patients and families to watch for worsening depression or
thoughts of suicide. Also, watch out for sudden or severe changes in
feelings such as feeling anxious, agitated, panicky, irritated, hostile,
aggressive, impulsive, severely restless, overly excited, hyperactive, or not
being able to sleep. If this happens, especially at the beginning of antide-
pressant treatment or after a change in dose, patient should call the health
care provider.
(cid:31) Drowsiness or dizziness: Patients should not drive, use machinery, or do
anything that needs mental alertness until the effects of this medicine are
known. Other medications that cause drowsiness can add to the drowsiness
of imipramine.
(cid:31) Caution patients not to stand or sit up quickly, especially if older. This
reduces the risk of dizzy or fainting spells. Alcohol may interfere with the
effect of this medicine. Avoid alcoholic drinks.
(cid:31) Do not abruptly withdraw this drug, as it may cause headache, nausea, and
malaise.
(cid:31) Advise to protect skin from ultraviolet light due to increased skin
sensitivity.
(cid:31) Grapefruit and grapefruit juice may interact with imipramine.
DDrruugg MMoonnooggrraapphhss..iinnddbb 55 33//2277//22001133 88::2255::1166 AAMM
6 (cid:31) DRUG MONOGRAPHS
(cid:31) Caution should be exercised in the following:
(cid:31) MDD, psychosis, or bipolar affective disorder.
(cid:31) Contraindicated in patients with a recent myocardial infarction.
(cid:31) Blood dyscrasias.
(cid:31) Respiratory disease.
(cid:31) Heart disease.
(cid:31) Liver disease, diabetes mellitus, asthma, and increased intracranial pressure.
(cid:31) Seizures (convulsions).
(cid:31) Suicidal thoughts, plans, or attempts by patients or a family member.
(cid:31) An unusual or allergic reaction to imipramine, other medicines, foods, dyes,
or preservatives.
Patient and Family Education:
(cid:31) Do not stop taking this medicine without notifying the health care
provider.
(cid:31) Anxiety symptoms may temporarily worsen when fi rst starting
clomipramine.
(cid:31) Notify doctor or pharmacist promptly if any of these effects persist or worsen.
(cid:31) To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugar-
less) gum, drink water, or use a saliva substitute.
(cid:31) To prevent constipation, maintain a diet adequate in fi ber, drink plenty of
water, and exercise. In case of constipation, consult pharmacist for help in
selecting a laxative (e.g., stimulant type with stool softener).
(cid:31) Inform clinician immediately if any of these unlikely but serious side effects
occur: mental/mood changes (e.g., confusion, depression, hallucinations,
memory problems), enlarged/painful breasts, unwanted breast milk produc-
tion, irregular/painful menstrual periods, muscle stiffness/twitching, feelings
of restlessness, ringing in the ears, sexual problems (e.g., decreased sexual abil-
ity, changes in desire), shakiness (tremors), numbness/tingling of the hands/
feet, trouble urinating, severe vomiting.
(cid:31) Inform clinician immediately if any of these rare but very serious side effects
occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore
throat), unusual/uncontrolled movements (especially of the tongue/face/lips),
severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.
(cid:31) Seek immediate medical attention if any of these rare but very serious side
effects occur: black stools, chest pain, fainting, high fever, slow/fast/irregular
heartbeat, seizures, vomit that looks like coffee grounds.
(cid:31) Store amitriptyline at room temperature away from moisture and heat.
(cid:31) Stopping this medication suddenly could result in unpleasant side effects.
(cid:31) Take the missed dose as soon as remembered. If it is almost time for the next
dose, skip the missed dose and take the medicine at the next regularly sched-
uled time. Do not take extra medicine to make up the missed dose.
Special Populations:
(cid:31) Elderly: Elderly patients may need a reduced dose for they may be more sensi-
tive to usual dosages. 10–25 mg each day with increases of 10–25 mg at bedtime
every 2–3 days may be suffi cient. Amitriptyline is included in the Beers List of
Potentially Inappropriate Medications for Geriatrics.
(cid:31) Renal impairment: Use with caution when renal impairment is suspected. Confer
with renal specialist.
DDrruugg MMoonnooggrraapphhss..iinnddbb 66 33//2277//22001133 88::2255::1166 AAMM