MIRTAZAPINE

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, 1991).
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 minute.
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 intubation.
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 40 micrograms/milliliter.
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 saline.

(2) PHENYTOIN ADMINISTRATION RATE: Rate of administration by either method should not exceed 0.5 milligram per kilogram per minute or 50 milligrams per minute.
(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 micrograms/milliliter.
(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 kilogram.
(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 milliliter).

c. FOSPHENYTOIN

(1) ADULT DOSAGE AND ADMINISTRATION: The dose, concentration in dosing solutions, and infusion rate of fosphenytoin are expressed as phenytoin sodium equivalents.
(2) ADULT LOADING DOSE FOSPHENYTOIN: 15 to 20 milligrams/kilogram of phenytoin sodium equivalents at a rate of 100 to 150 milligrams phenytoin equivalent/minute.
(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 thereafter.
(5) ADULT MAINTENANCE DOSING: 4 to 6 milligrams phenytoin equivalents/kilogram/day. Rate of administration should not exceed 150 milligrams phenytoin equivalent/minute.
(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 phenytoin.

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 needed.
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 blood pressure.
(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 Remeron(R), 1996).

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 Remeron(R), 1996).
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 hypothermia.
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 CONCENTRATIONS

7.5.1 THERAPEUTIC CONCENTRATIONS

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 KINETICS

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 Remeron(R), 1996).

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 Remeron(R), 1996).

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), 1996).

9.0 PHARMACOLOGY/TOXICOLOGY

9.1 PHARMACOLOGIC MECHANISM

A. ANTIHISTAMINIC/ANTISEROTONERGIC/NORADRENERGIC -

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 al, 1996).
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), 1996).

10.3 MOLECULAR WEIGHT

A. 265.36

12.0 REFERENCES

12.2 GENERAL BIBLIOGRAPHY
1. AMA Department of Drugs: Drug Evaluation Subscription. American Medical Association, Chicago, IL, 1991.
2. Bailer U, Fischer P, Kufferle B et al: Occurrence of mirtazapine-induced delirium in organic brain disorder. Intl Clin Psychopharmacol 2000; 15:239-243.
3. Barceloux D, McGuigan M, Hartigan-Go K: Position statement: cathartics. American Academy of Clinical Toxicology; European Association of Poisons Centres and Clinical Toxicologists. Clin Toxicol 1997; 35:743-752.
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6. Bremner JD: A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression. J Clin Psychiatry 1995; 56:519-525.
7. Bruijn JA, Moleman P, Mulder PGH et al: A double-blind, fixed blood-level study comparing mirtazapine with imipramine in depressed in-patients. Psychopharmacol 1996; 127:231-237.
8. Buist A, Norman TR & Dennerstein L: Mianserin in breast milk (letter). Br J Clin Pharmacol 1993; 36:133-134.
9. Chamberlain JM, Altieri MA, Futterman C et al; A prospective, randomized study comparing intramuscular midazolam with intravenous diazepam for the treatment of seizures in children. Ped Emerg Care, 1997; 13:92-94.
10. Chyka PA & Seger D: Position statement: single-dose activated charcoal. American Academy of Clinical Toxicology; European Association of Poisons Centres and Clinical Toxicologists. Clin Toxicol 1997; 35:721-736.
11. Claghorn JL & Lesem MD: A double-blind placebo-controlled study of Org 3770 in depressed outpatients. J Affect Disorders 1995; 34:165-171.
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28. Product Information Ativan(R), 1999, Wyeth-Ayerst Co, Philadelphia, PA
29. Product Information: Remeron(TM), mirtazapine. Organon Inc., West Orange, NJ, 1996.
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34. Sorensen M, Jorgensen J, Viby-Mogensen J et al: A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgery. Acta Psychiatr Scand 1985; 71:339-346.
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13.0 AUTHOR INFORMATION

13.1 CONTRIBUTOR(S) TO THIS DOCUMENT

A. Original publication: 02/97

13.2 REVIEWERS

A. Most recent revision: 11/00

13.3 LAST CONTRIBUTION DATE

A. List of contributors:

§ 1. Anthony Manoguerra, PharmD

§ 2. Katherine M Hurlbut, MD

§ 3. POISINDEX(R) Editorial Staff

13.4 SPECIALTY BOARD

A. Specialty Board: PSYCHOACTIVE

Refer to the POISINDEX EDITORIAL BOARD section for more information. (MG2060)

End of Document