HALOPERIDOL

Drugs in Pregnancy and Lactation.

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Name: HALOPERIDOL
Class: Tranquilizer
Risk Factor:    CM

Fetal Risk Summary

Animal reproductive studies with haloperidol in mice, rats, rabbits, and dogs have not revealed a teratogenic effect attributable to this tranquilizer (1,2). In rodents, doses 2 to 8 times the usual maximum human dose (oral or parenteral) were associated with an increased incidence of resorption, reduced fertility, delayed delivery, and pup mortality (1,2). With single injections up to maternal toxic levels in hamsters, haloperidol was associated with fetal mortality and dose-related anomalies (3). Exposure of male rats in utero to haloperidol throughout most of gestation had no effect on typical parameters of adult sexual activity other than subtle changes involving ultrasonic vocalization (4).

Two reports describing limb reduction malformations after 1st trimester use of haloperidol have been located (5,6). In one of these cases, high doses (15 mg/day) were used (6). Other investigations have not found these defects (7,8,9,10 and 11). Defects observed in the two infants were: ectromelia (phocomelia) (5), multiple upper and lower limb defects, aortic valve defect, and death (6).

In 98 of 100 patients treated with haloperidol for hyperemesis gravidarum in the 1st trimester, no effects were produced on birth weight, duration of pregnancy, sex ratio, or fetal or neonatal mortality, and no malformations were found in abortuses, stillborn, or liveborn infants (7). Two of the patients were lost to followup. In 31 infants with severe reduction deformities born over a 4-year period, none of the mothers remembered taking haloperidol (8). Haloperidol has been used for the control of chorea gravidarum and manic-depressive illness during the 2nd and 3rd trimesters (12,13). During labor, the drug has been administered to the mother without causing neonatal depression or other effects in the newborn (9).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 56 newborns had been exposed to haloperidol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Three (5.4%) (two expected) major birth defects were observed, two of which were cardiovascular defects (0.6 expected). No anomalies were observed in five other defect categories (oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which specific data were available.

Premature labor, loss of fetal cardiac variability and acceleration, an unusual fetal heart rate pattern (double phase baseline), and depression at birth (Apgar scores of 4 and 7 at 1 and 5 minutes, respectively), were observed in a comatose mother and her infant after an acute overdose of an unknown amount of haloperidol and lithium at 31 weeks' gestation (14). Because of progressive premature labor, the 1526-g female infant was delivered about 3 days after the overdose. The lithium concentrations of the maternal plasma, amniotic fluid, and cord vein plasma were all greater than 4 mmol/L (severe toxic effect >2.5 mmol/L) whereas the maternal level of haloperidol at delivery was about 1.6 ng/mL (14). The effects observed in the fetus and newborn were attributed to cardiac and cerebral manifestations of lithium intoxication. No follow-up on the infant was reported.

Breast Feeding Summary

Haloperidol is excreted into breast milk. In one patient receiving an average of 29.2 mg/day, a milk level of 5 ng/mL was detected (15). When the dose was decreased to 12 mg, a level of 2 ng/mL was measured. In a second patient taking 10 mg daily, milk levels up to 23.5 ng/mL were found (16). A milk:plasma ratio of 0.6–0.7 was calculated. No adverse effects were noted in the nursing infant.

A 1992 Reference measured haloperidol in the breast milk of three women receiving chronic therapy (17). The maternal doses were 3, 4, and 6 mg/day, and the corresponding haloperidol concentrations in their milk were 32, 17, and 4.7 ng/mL, respectively. The patient receiving 6 mg/day, but with the lowest milk concentration, was thought to be noncompliant with her therapy. No mention of nursing infants was made (17).

A study published in 1998 described 12 mothers who breast-fed their infants while taking haloperidol, chlorpromazine or trifluoperazine for bipolar depression (3 cases), manic disorder (1 case), schizo-affective disorder (5 cases), or schizophrenia (3 cases) (18). Haloperidol was given in a dose ranging from 1 to 40 mg/day. The age of the nursing infants at the start of therapy ranged from 1 to 18 weeks. Using an enzyme immunoassay technique, the range of concentrations in fore-milk and hind-milk were <10–988 ng/mL and 23–140 ng/mL, respectively, whereas the range of ratios of fore-milk and hind-milk to maternal plasma were 0.8–5.2 and 1.7–8.0, respectively. Plasma concentrations of haloperidol in the four nursing infants that were tested were 0.8, 1.2 and 2.1, 6.8, and 8.0 ng/mL, respectively. Two of the samples (6.8 and 8.0 ng/mL) were in the adult range. In addition, the urine of all seven infants tested contained haloperidol in concentrations ranging from 1.6 to 7.9 ng/mL. The maximum infant dose ingested was 3% of the weight-adjusted maternal dose. As assessed using the Bayley Scales of Infant Development, all three of the infants whose mothers were taking both haloperidol (20–40 mg/day) and chlorpromazine (200–600 mg/day) showed a decline in mental and psychomotor development from the first (at 1–4 months of age) to the second assessment (at 12–18 months of age). Because of this decline, the investigators concluded that breast feeding may not be best if a breast feeding mother is taking neuroleptics, either alone or in combination, at the upper end of their recommended dose ranges (18).

The American Academy of Pediatrics classifies haloperidol as an agent whose effect on the nursing infant is unknown but may be of concern (19).

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World’s leading meds delivered to your door – and you don’t even need a prescription! Only certified, first class drugs on offer! Buy more and spend less with our great discount system.

References

  1. Tuchmann-Duplessis H, Mercier-Parot L. Influence of neuroleptics on prenatal development in mammals. In: Malformations, Tumors and Mental Defects, Pathogenetic Correlations. H Tuchmann- Duplessis, G Fanconi and GR Burgio, eds. Milan:Carlo Erba Foundation, 1971. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:308–9.
  2. Product information. Haldol. Ortho-McNeil Pharmaceutical, 2000.
  3. Gill TS, Guram MS, Geber WF. Haloperidol teratogenicity in the fetal hamster. Dev Pharmacol Ther 1982;4:1–5. As cited in Elia J, Katz IR, Simpson GM. Teratogenicity of psychotherapeutic medications. Psychopharmacol Bull 1987;23:531–86.
  4. Bignami G, Laviola G, Alleva E, Cagiano R, Lacomba C, Cuomo V. Developmental aspects of neurobehavioural toxicity. Toxicol Ltrs 1992;64/65:231–7.
  5. Dieulangard P, Coignet J, Vidal JC. Sur un cas d'ectrophocomelie peutetre d'origine medicamenteuse. Bull Fed Gynecol Obstet 1966;18:85–7.
  6. Kopelman AE, McCullar FW, Heggeness L. Limb malformations following maternal use of haloperidol. JAMA 1975;231:62–4.
  7. Van Waes A, Van de Velde E. Safety evaluation of haloperidol in the treatment of hyperemesis gravidarum. J Clin Pharmacol 1969;9:224–7.
  8. Hanson JW, Oakley GP. Haloperidol and limb deformity. JAMA 1975;231:26.
  9. Ayd FJ Jr. Haloperidol: fifteen years of clinical experience. Dis Nerv Syst 1972;33:459–69.
  10. Magnier P. On hyperemesis gravidarum; a therapeutical study of R 1625. Gynecol Prat 1964;15:17–23.
  11. Loke KH, Salleh R. Electroconvulsive therapy for the acutely psychotic pregnant patient: a review of 3 cases. Med J Malaysia 1983;38:131–3.
  12. Donaldson JO. Control of chorea gravidarum with haloperidol. Obstet Gynecol 1982;59:381–2.
  13. Nurnberg HG. Treatment of mania in the last six months of pregnancy. Hosp Community Psychiatry 1980;31:122–6.
  14. Nishiwaki T, Tanaka K, Sekiya S. Acute lithium intoxication in pregnancy. Int J Gynecol Obstet 1996;52:191–2.
  15. Stewart RB, Karas B, Springer PK. Haloperidol excretion in human milk. Am J Psychiatry 1980;137:849–50.
  16. Whalley LJ, Blain PG, Prime JK. Haloperidol secreted in breast milk. Br Med J 1981;282:1746–7.
  17. Ohkubo T, Shimoyama R, Sugawara K. Measurement of haloperidol in human breast milk by high-performance liquid chromatography. J Pharm Sci 1992;81:947–9.
  18. Yoshida K, Smith B, Craggs M, Kumar R. Neuroleptic drugs in breast milk: a study of pharmacokinetics and of possible adverse effects in breast-fed infants. Psychol Med 1998;28:81–91.
  19. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.

Index

Q&A about Haloperidol

it's_jus...
Haloperidol?
Has anyone expirienced shaking/ trembling as side effect of haloperidol? My bf has, and he even broke 3 ashtrays with trying to hold them.....I'm worried about him, but we kind of have long distant relationship (long story)....Did anyone expirience anything like this? And can anyone tell me how serious that shaking can be? I mean if anyone can describe it? (the strenghts of that shaking, how it looks like, is it disabiling etc.?)
psychgra...
Haloperidol can cause extrapyramidal side effects, such as rigidity, persistent muscle spasms, tremors, and restlessness. It is very common and can be sort of like the symptoms of Parkinson's. For some people, these side effects can be very debilitating, almost to the point that the psychiatrist will change the drug.

Extrapyramidal side effects are common with the older antipsychotics, like haldol. However, the newer "atypical antipsychotics," like Zyprexa and Clozaril have a lower incidence of these side effects. Some psychiatrists will just switch the patient from the older drug to the newer ones. However, some people respond so well to the older drug, that they don't want to change it, so they may prescribe another drug to just treat the extrapyramidal side effect. Cogentin is commonly prescribed.

The Extrapyramidal side effects can lead to Tardive Dyskinesia, which includes repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur.

This problem can get worse, so I would suggest that you tell your boyfriend to go see his psychiatrist soon.

I know it sounds like the medications are awful and they do have these side effects. However, sometimes the side effects are not nearly as bad as the disorder they are treating. Always have your boyfriend talk to his psychiatrist before making ANY changes.
Yara R
does haloperidol shop up in blood tests? and which blood test should i take?
I think someone in my family is adding haloperidol into my food and water and stuff, but i cant be sure. what blood teste should i take, and will it show up?

haloperidol's trade names are; halidol, peridol,Serenace and dozic

thxx.
Paula84
u can take a specific blood test testing for the drug ... however it has many side effects so i think you'd notice (eg dry mouth, tremors, weight gain)
Angelfir...
What are the effects of combining ketamine with haloperidol?
I want to know if the use of both in a medical setting would cause adverse effects in the patient.
alphabra...
You have to search: ketamine and haloperidol interaction

For example:

Interactive effects of subanesthetic ketamine and haloperidol in healthy humans.

http://www.springerlink.com/(sulmbu555mh...

Chronic Administration of Haloperidol and Olanzapine Attenuates Ketamine-Induced Brain Metabolic Activation

http://jpet.aspetjournals.org/cgi/conten...

Other examples:

http://peyote.com/jonstef/ketamine.htm
Angele
How many prescriptions have been written this year for the antipsychotic drug Haloperidol?
Where can I find this information, I need to reference it for a paper.
tamumd
because it is a generic drug, there is no way of tracking that information accurately. But from the political ads on TV- I'd say not enough prescriptions filled yet.
Angele
When was the drug Haloperidol first approved by the fda?
Tell me where this information can be found so I can reference it in a paper.
yachadho...
It was first approved by the FDA 4/12/1967.

The FDA has a website that lists all drugs approved by them and eveything about the approval history for these drugs.

Here is the info on Haldol:

http://www.accessdata.fda.gov/scripts/cd...

Surely you can reference the FDA's website in your paper...
MD
What's the advantage of giving diphenhydramine with haloperidol?
i think its about the side effect but forgot what the exact point is
choadstr
haldol for sleep or agitation? a side effect of benadryl is that it will make you sleepy and therefore a little calmer but other than that I see no reason to combine the two
Time travler
Anyone ever tried Haloperidol for mental illness?
I'd like to hear your experiences with this antipsychotic drug. Thanks. it is also called haldol
Alex62
I haven't had it but know a couple who have. They say it zaps the mania, puts you down, and leaves you out of it. These folks were ER manic cases shot up to calm down, so their experiences weren't the same as being prescribed as maintenance. It's a first generation antipsychotic so is more inclined to cause side effects like shuffle walk and so forth, which is part of what they did not like.
reader10...
can you become addicted to the prescription drug haldol (haloperidol)?
i really need the symptoms of abuse (addiction) and withdrawl symptoms. i have a friend and am really worried she is abusing her medication. i have checked sites but to no avail. they all say tranquilizers are addictive, but when listed haldol is not among them. i would appreciate resources listed if any are used. thank you for your time
NH Baritone
There are two varieties of tranquilizers: Major and Minor tranquilizers. Haldol is a MAJOR Tranquilizer, similar to phenothiazines like Stelazine and Thorazine.

Oddly, the MINOR tranquilizers are the ones that are addictive for the following reasons: (1) They provide an immediate anxiety reduction and a pleasant sense of well-being; (2) over time you must take more & more to get the same effect; and (3) cessation can lead to physical withdrawal symptoms, including seizure.

Drugs like Haldol are only prescribed for thought disorders such as profound delusions or hallucinations. They can also help people sleep if they are in the midst of a manic episode. However, the mechanism of action does not lead to a need for increasing dosages, and in general, they don't provide the sense of well-being associated with minor tranquilizers. As a matter of fact, the side-effects to drugs such as haldol can be quite unpleasant, and include muscle rigidity, loss of control of your tongue, blurred vision, dry mouth, breathing problems, and pacing. While you can experience an increase in anxiety and psychotic symptoms upon cessation of the drug, there is no physical risk during drug withdrawal.

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azn g
what is a better drug for psychosis/racing thoughts? risperdal or haloperidol?
and what is a good medication to counter the restleness side effect caused by these drugs?
hazegrey
i dont no but also try quiting caffine and lower your sugar intake