Home Antidepressants Facts
- 3. LORAZEPAM
- a. MAXIMUM RATE: The rate
of intravenous administration of lorazepam should not exceed 2
milligrams/minute (Prod Info Ativan(R), 1999).
- b. ADULT LORAZEPAM DOSE: 2
to 8 milligrams intravenously. Initial doses may be repeated in 10 to
15 minutes if seizures persist (Prod Info, Ativan(R), 1999; AMA,
- c. PEDIATRIC LORAZEPAM
DOSE: 0.05 to 0.1 milligram/kilogram intravenously, (maximum 4
milligrams/dose) repeated twice at intervals of 10 to 15 minutes
(Benitz & Tatro, 1995).
- 4. PHENOBARBITAL
- a. ADULT PHENOBARBITAL
LOADING DOSE: 600 to 1200 milligrams of phenobarbital intravenously
initially (10 to 20 milligrams per kilogram) diluted in 60
milliliters of 0.9 percent saline given at 25 to 50 milligrams per
- b. ADULT PHENOBARBITAL
MAINTENANCE DOSE: Additional doses of 120 to 240 milligrams may be
given every 20 minutes.
- c. MAXIMUM SAFE ADULT
PHENOBARBITAL DOSE: No maximum safe dose has been established. Patients
in status epilepticus have received as much as 100 milligrams/minute
until seizure control was achieved.
- d. PEDIATRIC PHENOBARBITAL
LOADING DOSE: 15 to 20 milligrams per kilogram of phenobarbital
intravenously at a rate of 25 to 50 milligrams per minute.
- e. PEDIATRIC PHENOBARBITAL
MAINTENANCE DOSE: Repeat doses of 5 to 10 milligrams per kilogram may
be given every 20 minutes.
- f. MAXIMUM SAFE PEDIATRIC
PHENOBARBITAL DOSE: No maximum safe dose has been established. Children
in status epilepticus have received doses of 30 to 120
milligrams/kilogram within 24 hours. Vasopressors and mechanical
ventilation were needed in some patients receiving these doses.
- g. MONITOR: For
hypotension, respiratory depression, and the need for endotracheal
- h. NEONATAL PHENOBARBITAL
LOADING DOSE: 20 to 30 milligrams/kilogram intravenously at a rate of
no more than 1 milligram/kilogram per minute in patients with no
preexisting phenobarbital serum levels.
- i. NEONATAL PHENOBARBITAL
MAINTENANCE DOSE: Repeat doses of 2.5 milligrams/kilogram every 12
hours may be given; adjust dosage to maintain serum levels of 20 to
- j. MAXIMUM SAFE NEONATAL
PHENOBARBITAL DOSE: Doses of up to 20 milligrams/kilogram/minute up
to a total of 30 milligrams/kilogram have been tolerated in neonates.
- k. CAUTIONS: Adequacy of
ventilation must be continuously monitored in children and adults. Intubation
may be necessary with increased doses.
- l. SERUM LEVEL MONITORING:
Monitor serum levels over next 12 to 24 hours for maintenance of
therapeutic levels (20 to 40 micrograms per milliliter).
- 5. PHENYTOIN/FOSPHENYTOIN
- a. Benzodiazepines and/or
barbiturates are generally preferred to phenytoin or fosphenytoin in
the treatment of drug or withdrawal induced seizures.
- b. PHENYTOIN
- (1) PHENYTOIN INTRAVENOUS
PUSH VERSUS INTRAVENOUS INFUSION: Manufacturer does not recommend
intravenous infusions due to lack of solubility and resultant precipitation,
however infusions are commonly used.
- (a) Administer phenytoin
undiluted, by very slow intravenous push or dilute 50 milligrams
per milliliter solution in 50 to 100 milliliters of 0.9 percent
- (2) PHENYTOIN
ADMINISTRATION RATE: Rate of administration by either method should
not exceed 0.5 milligram per kilogram per minute or 50 milligrams
- (3) ADULT PHENYTOIN
LOADING DOSE: 15 to 18 milligrams per kilogram of phenytoin
initially. Rate of administration by very slow intravenous push or
diluted to 50 milligrams per milliliter should not exceed 0.5
milligram per kilogram per minute or 50 milligrams per minute.
- (4) ADULT PHENYTOIN
MAINTENANCE DOSE: Manufacturers recommend a maintenance dose of 100
milligrams orally or intravenously every 6 to 8 hours. The goal is
to maintain a serum concentration between 10 to 20
- (5) PEDIATRIC PHENYTOIN
LOADING DOSE: 15 to 20 milligrams per kilogram or 250
milligrams/square meter of phenytoin. Rate of intravenous administration
should not exceed 0.5 to 1.5 milligrams per kilogram per minute.
- (6) PEDIATRIC PHENYTOIN
MAINTENANCE DOSE: Repeat doses of 1.5 milligrams per kilogram may be
given every 30 minutes to a maximum daily dose of 20 milligrams per
- (7) CAUTIONS: Administer
phenytoin while monitoring ECG. Stop or slow infusion if arrhythmias
or hypotension occur. Be careful not to extravasate. Follow each
injection with injection of sterile saline through the same needle.
- (8) SERUM LEVEL
MONITORING: Monitor serum levels over next 12 to 24 hours for
maintenance of therapeutic levels (10 to 20 micrograms per
- c. FOSPHENYTOIN
- (1) ADULT DOSAGE AND
ADMINISTRATION: The dose, concentration in dosing solutions, and
infusion rate of fosphenytoin are expressed as phenytoin sodium
- (2) ADULT LOADING DOSE
FOSPHENYTOIN: 15 to 20 milligrams/kilogram of phenytoin sodium
equivalents at a rate of 100 to 150 milligrams phenytoin
- (3) Fosphenytoin should
not be infused at rates greater than 150 milligrams phenytoin
equivalent/minute because of the risk of hypotension.
- (4) CAUTIONS: Perform
continuous monitoring of respiratory function, cardiac rhythm, and
blood pressure throughout infusion and for at least 30 minutes
- (5) ADULT MAINTENANCE
DOSING: 4 to 6 milligrams phenytoin equivalents/kilogram/day. Rate
of administration should not exceed 150 milligrams phenytoin
- (6) SERUM LEVEL
MONITORING: Monitor serum phenytoin levels over the next 12 to 24
hours; therapeutic levels 10 to 20 microgram/milliliter. Do not
obtain serum phenytoin concentrations until at least 2 hours after
infusion is complete to allow for conversion of fosphenytoin to
- C. HYPOTENSION
- 1. SUMMARY
- a. Infuse 10 to 20
milliliters/kilogram of isotonic fluid and place in Trendelenburg
position. If hypotension persists, administer dopamine or
norepinephrine. Consider central venous pressure monitoring to guide
further fluid therapy.
- 2. DOPAMINE
- a. PREPARATION: Add 200
or 400 milligrams to 250 milliliters of normal saline or dextrose 5%
in water to produce 800 or 1600 micrograms per milliliter or add 400
milligrams to 500 milliliters of normal saline or dextrose 5% in
water to produce 800 micrograms per milliliter.
- b. DOSE: Begin at 5
micrograms per kilogram per minute progressing in 5 micrograms per
kilogram per minute increments as needed. Norepinephrine should be
added if more than 20 micrograms/kilogram/minute of dopamine is
- c. CAUTION: If
VENTRICULAR DYSRHYTHMIAS occur, decrease rate of administration. Extravasation
may cause local tissue necrosis, administration through a central
venous catheter is preferred.
- 3. NOREPINEPHRINE
- a. PREPARATION: Add one
milligram norepinephrine to 250 milliliters of dextrose 5% in water
to produce 4 micrograms/milliliter.
- b. DOSE
- (1) ADULT: 2 to 3
milliliters (8 to 12 micrograms)/minute
- (2) ADULT AND CHILD: 0.1
to 0.2 microgram/kilogram/minute. Titrate to maintain adequate
- (3) CAUTION:
Extravasation may cause local tissue ischemia, administration by
central venous catheter is advised.
- 6.11 ENHANCED ELIMINATION
- A. EXTRACORPOREAL ELIMINATION
- 1. Mirtazapine is 85% bound
to plasma protein over a concentration range of 0.01 to 10
micrograms/milliliter; it is UNLIKELY that hemodialysis or peritoneal
dialysis would be effective in enhancing elimination.
- 7.0 RANGE OF TOXICITY
- 7.1 SUMMARY
- A. An overdose of 30 to 45 milligrams of
mirtazapine, in conjunction with amitriptyline and chlorprothixene,
produced CNS depression and tachycardia. NO ECG changes, coma, or
seizures were evident following overdoses of mirtazapine alone during
premarketing clinical trials.
- B. Overdoses of 10 to 30 times the
maximum recommended dose have produced no serious adverse effects in a
series of 6 patients. Overdoses of 30 to 50 times the normal daily dose
produced no complications in 2 adults.
- 7.2 THERAPEUTIC DOSE
- 7.2.1 ADULT
- A. DISEASE STATE
- 1. DEPRESSION - Normal
adult dose is 15 milligrams/day as a single dose initially. The dose
may be titrated upwards after 1 to 2 weeks. An effective dosage range
appears to be 15 to 45 milligrams/day (Prod Info Remeron(R), 1996). Dosages
should be modified in patients with moderate to severe renal or
hepatic impairment and in the geriatric population (Prod Info
- a. Doses of 60 and up to
76 milligrams/day have been well tolerated in clinical studies
(Bruijn et al, 1996).
- 2. ANXIOLYTIC - Mirtazapine
15 milligrams orally has been given the night prior to gynecological
surgery to reduce insomnia and minimize presurgical anxiety the
following morning (Sorensen et al, 1985).
- 7.2.2 PEDIATRIC
- A. GENERAL
- 1. Mirtazapine is not yet
recommended for use in pediatrics (Prod Info Remeron(R), 1996).
- 7.4 MAXIMUM TOLERATED EXPOSURE
- A. CASE REPORTS
- 1. ADULT
- a. An acute overdose of 30
to 45 milligrams of mirtazapine, in conjunction with overdoses of
amitriptyline and chlorprothixene, produced tachycardia and central
nervous depression, including disorientation, lethargy, and impaired
memory (Prod Info Remeron(R), 1996).
- b. No reports of ECG
changes, coma, or seizures were reported following overdoses of
mirtazapine alone in premarketing clinical studies (Prod Info
- c. In a series of 6
patients, with overdoses ranging from 10 to 30 times the maximum
recommended dose (maximum dose, 1350 mg), all patients recovered with
no serious adverse effects. No seizures were reported and no
clinically significant changes in ECG or vital signs were seen. CNS
depressant effects were seen in 4 patients, possibly due to
concomitant ingestion of other CNS depressants (Bremner et al, 1998).
- d. Holzbach et al (1998)
reported 2 patients who ingested 900 milligrams and 1500 milligrams, respectively,
in suicide attempts. No complications developed and both patients made
full and uneventful recoveries.
- e. The only adverse effects
of an 810 milligram mirtazapine and 300 milligram dothiepin overdose
were anxiety and confusion in a 45-year-old woman (Gerritsen, 1997).
- f. Following an overdose of
mirtazapine 1200 milligrams and lorazepam 20 milligrams, complicated
by severe environmental hypothermia (core temperature 26 C) a
41-year-old female was found with compromised cardiac and respiratory
function. Following supportive therapy, she fully recovered by day 5
(Retz et al, 1998). Most of the observed effects were probably due to
- g. Following an overdose of
900 milligrams of mirtazapine and 210 milligrams of midazolam, an
81-year-old woman was admitted to the hospital in a semi-comatose
state, with no other neurological signs/symptoms. After 1 hour the
patient awoke spontaneously. Transitory somnolence was observed for 3
days (Hoes & Zeijpveld, 1996).
- 2. PEDIATRIC
- a. An accidental overdose
of 60 milligrams in a 3-year-old child resulted in a rapid heart rate.
Otherwise, the child was alert, responsive, and interactive. The child
recovered with no adverse sequelae (Bremner et al, 1998).
- 7.5 SERUM/PLASMA/BLOOD
- 7.5.1 THERAPEUTIC
- A. GENERAL
- 1. Therapeutic serum levels
have not been well established, however, Bruijn et al (1996) based
dosing of mirtazapine in their clinical trials on predefined mean
serum levels of approximately 70 nanograms/milliliter, which were
derived from steady-state blood levels of patients maintained on 60
milligrams/day in previous studies.
- 7.5.2 TOXIC CONCENTRATIONS
- A. ADULT
- 1. Holzbach et al (1998)
reported plasma levels of 2300 nanograms/milliliter approximately 18
hours after an overdose of 900 milligrams mirtazapine in a 44-year-old
female. Plasma level at 26 hours post-ingestion was 1370
nanograms/milliliter, which further decreased to 1060
nanograms/milliliter at 40 hours post-ingestion. No clinical
complications were seen in conjunction with the high plasma levels.
- 2. Plasma level of 368
nanograms/milliliter was reported 41 hours following an overdose of
mirtazapine 1200 milligrams and lorazepam 20 milligrams in a
41-year-old female (Retz et al, 1998).
- 8.0 KINETICS
- 8.1 ABSORPTION
- A. ORAL
- 1. Absorption is rapid and
complete following oral doses, with peak plasma levels reached within
approximately 2 hours. Absolute oral bioavailability is about 50% (Prod
Info Remeron(R), 1996).
- 8.2 DISTRIBUTION
- 8.2.1 DISTRIBUTION SITES
- A. PROTEIN BINDING
- 1. Mirtazapine is
approximately 85% bound to plasma proteins. The concentration range
was 0.01 to 10 micrograms/mL (Prod Info Remeron(R), 1996).
- 8.3 METABOLISM
- 8.3.1 METABOLISM SITES AND
- A. GENERAL
- 1. Mirtazapine is extensively
metabolized; major pathways of biotransformation include demethylation
and hydroxylation followed by glucuronide conjugation.
- a. In vitro studies
indicate cytochrome 2D6 and 1A2 are metabolic pathways for the
formation of the 8-hydroxy metabolite of mirtazapine, while
cytochrome 3A is considered responsible for the formation of the
N-desmethyl and N-oxide metabolite. Several unconjugated metabolites
are active but are present in the plasma at very low levels (Prod
Info Remeron(R), 1996).
- 8.3.2 METABOLITES
- A. GENERAL
- 1. Metabolites include the
8-hydroxy metabolite, the N-desmethyl and N-oxide metabolite. There
are several active, unconjugated metabolites in the plasma, but at
very low levels (Prod Info Remeron(R), 1996).
- 8.4 EXCRETION
- 8.4.1 KIDNEY
- A. Mirtazapine is primarily
eliminated via the urine (75%). Renal clearances are decreased in
patients with liver and/or kidney dysfunction, and in elderly patients
(Prod Info Remeron(R), 1996).
- 8.4.2 FECES
- A. Approximately 15% of an
oral dose of mirtazapine is eliminated in the feces (Prod Info
- 8.4.4 OTHER
- A. BREAST MILK - It is not
known if mirtazapine is excreted in human milk (Prod Info Remeron(R),
1996). Mianserin and its major metabolite, desmethylmianserin, which
are chemically related to mirtazapine, have been detected and measured
in human breast milk (Buist et al, 1993).
- 8.5 ELIMINATION HALF-LIFE
- 8.5.1 PARENT COMPOUND
- A. GENERAL
- 1. Mean half-life is
reported to be approximately 20 to 40 hours. Females showed
significantly longer elimination half-lives than males (mean half-life
for females was 37 hours versus 26 hours for males) (Prod Info
- 8.5.2 METABOLITE
- A. GENERAL
- 1. The (-) enantiomer has
an elimination half-life that is approximately twice as long as the
(+) enantiomer; thus, the (-) enantiomer achieves plasma levels that
are about 3 times as high as the (+) entaniomer (Prod Info Remeron(R),
- 9.0 PHARMACOLOGY/TOXICOLOGY
- 9.1 PHARMACOLOGIC MECHANISM
- 1. SUMMARY - Mirtazapine
acts as a potent and selective presynaptic alpha-2-adrenoceptor
antagonist and enhances noradrenergic transmission by increasing
noradrenergic cell firing and norepinephrine release.
- a. Mirtazapine is the 6-aza
analogue of the tetracyclic antidepressant mianserin (Fink &
Irwin, 1982; de Boer et al, 1988). Antihistaminic (H1) and
antiserotonergic properties have been demonstrated (de Boer et al,
1988; Ruigt et al, 1990). Mirtazapine mainly affects serotonin (5-HT)
receptors of the 5-HT2, 5-HTd, and 5-HT3 subtypes, possessing low
affinity for 5-HT1A, 5-HT1B, and 5-HT1C receptors (Ruigt et al, 1990).
As a 5-HT2 antagonist, mirtazapine is significantly less potent than
mianserin (de Boer et al, 1988).
- b. The increase in
extracellular 5-HT is most likely due to indirect alpha-1-
adrenoceptor-mediated enhancement of 5-HT firing and direct blockade
of inhibitory alpha-2-heteroreceptors located on 5-HT terminals (de
Boer et al, 1994; de Boer et al, 1996).
- c. Mirtazapine blocks
noradrenergic transmission by selectively blocking pre- and
postsynaptic alpha-2-adrenoceptors (de Boer et al, 1988; de Boer et
- d. Similar to mianserin,
mirtazapine has strong alpha-2 receptor blocking actions, but unlike
mianserin, it has NO significant effect on the synaptic reuptake of
catecholamines (Nickolson et al, 1982; de Boer et al, 1988; Ruigt et
al, 1990; de Boer et al, 1994). Mirtazapine has actions similar to
mianserin in healthy subjects (Fink & Irwin, 1982) and appears to
be an effective antidepressant (Smith et al, 1990). Significant
anxiolytic effects have been observed in animal studies, actions
shared by mianserin (Sorensen et al, 1985).
- B. ENANTIOMERS -
- 1. Enantiomers of
mirtazapine were shown to be stereoselective for alpha-2 antagonism in
preclinical studies, with the most activity attributed to the
(+)-enantiomer (Nickolson et al, 1982; Fink & Irwin, 1982). However,
Fink & Irwin (1982) studied the effects on the central nervous
system in healthy volunteers, and it appears that both (-)- and
(+)-enantiomer possess antidepressant activity.
- 2. Enantiomers of
mirtazapine appear to have no 5-HT3 agonist properties when studied in
mouse neuroblastoma N1E-115 cells (Kooyman et al, 194).
- C. ELECTROENCEPHALOGRAPHIC STUDIES -
Pharmacologic and electroencephalographic (EEG) studies in healthy
subjects have shown the effects of mirtazapine 2 mg to be similar to
mianserin 6 mg. Mirtazapine was associated with slightly faster onset of
action on the EEG and a tendency toward fewer anticholinergic effects
than mianserin (Fink & Irwin, 1982).
- 10.0 PHYSICOCHEMICAL
- 10.1 PHYSICAL CHARACTERISTICS
- A. Mirtazapine is a slightly water
soluble, white to creamy white crystalline powder (Prod Info Remeron(R),
- 10.3 MOLECULAR WEIGHT
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- 13.0 AUTHOR
CONTRIBUTOR(S) TO THIS DOCUMENT
- A. Original
- A. Most recent
- 13.3 LAST
1. Anthony Manoguerra, PharmD
2. Katherine M Hurlbut, MD
3. POISINDEX(R) Editorial Staff
- A. Specialty
- Refer to the
POISINDEX EDITORIAL BOARD section for more information. (MG2060)
End of Document