:*To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp® patch (formulated to deliver approximately 1mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required.
*Continuation of Therapy
:*If therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear.
=====Post Operative Nausea and Vomiting=====
*Initiation of Therapy
:*To prevent post operative nausea and vomiting, one Transderm Scōp® patch should be applied the evening before scheduled surgery, except for caesarian section.
:*For caesarian section surgery, to minimize exposure of the newborn baby to the drug, apply the patch one hour prior to caesarian section
*Continuation of Therapy
:*For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=
*Patients with [[angle closure glaucoma]].
*Persons who are hypersensitive to the drug scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.
<!--Warnings-->
|warnings=
====Precautions====
*Open Angle Glaucoma
:*Patients currently being treated for Open Angle Glaucoma
Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during Transderm Scōp® use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.
:*Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).
*Temporary Dilation of the Pupil
:*Scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.
*Preexisting Gastrointestinal or Urinary Bladder Obstructions
:*Transderm Scōp® should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including Transderm Scōp®, to patients suspected of having intestinal obstruction.
Patients should be instructed to remove the patch if they develop any difficulties in urinating.
*History of Seizures or Psychosis
:*Transderm Scōp® should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders.
*Idiosyncratic Reactions
:*Idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, speech disorder, hallucinations, paranoia, and delusions.
*Specific Populations
*Pediatric
:*A safe and effective dose has not been established in the pediatric population. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied.
*Elderly
:*Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. Clinical trials of Transderm Scōp® did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
*Renal and Hepatic Impaired
:*Transderm Scōp® should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scōp® has not been studied in these populations.
*Safety Hazards
*Drowsiness
:*Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.
*Disorienting Effects
:*Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine.
*MRI Skin Burns
:*Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp® contains aluminum, it is recommended to remove the system before undergoing an MRI.
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=
*Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
=====Motion Sickness=====
*In motion sickness clinical studies of Transderm Scōp®, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed.
=====Post-Operative Nausea and Vomiting=====
*In a total of five clinical studies in which Transderm Scōp® was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1).
T1
<!--Postmarketing Experience-->
|postmarketing=
*The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scōp®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.
*In worldwide marketing with Transderm Scōp®, the following adverse drug reactions were reported by body system.
=====Psychiatric disorders=====
Acute psychosis including: hallucinations disorientation, and paranoia.
=====Nervous system disorders=====
Headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness.
=====General disorders and administration site conditions=====
*The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying.
*Scopolamine should be used with caution in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
*In vitro studies indicated that the potential for scopolamine to alter the pharmacokinetics of other concomitant medications through inhibition of CYP 1A2, 2C8, 2C9, 2C19, 2D6 and 3A4 or induction of CYP 1A2 and 3A4 is low; however, in vivo studies have not been conducted.
<!--Use in Specific Populations-->
|useInPregnancyFDA=
* '''Pregnancy Category C'''
*Based on data from one prospective study of Transderm Scōp® in cesarean delivery, the rate of newborn adverse events in both the Transderm Scōp® and placebo groups were the same. The rates were 10.5% (12 events in 114 newborns) in both treatment groups. None of these events were considered life threatening or drug related. Jaundice was the only adverse event occurring more frequently with Transderm Scōp® than placebo: 9 events (7.9%) versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and did not prolong the hospital stay.
*There are no adequate and well-controlled studies of Transderm Scōp® use during pregnancy. In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Transderm Scōp® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=
*During a clinical study among women undergoing cesarean section treated with Transderm Scōp® in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in newborns. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by Transderm Scōp® did not affect uterine contractions or increase the duration of labor. Scopolamine does cross the placenta.
|useInNursing=
*Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scōp® is administered to a nursing woman.
|useInPed=
*A safe and effective dose has not been established in the pediatric population.
|useInGeri=
*Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of [[CNS]] effects, such as [[hallucinations]], confusion and [[dizziness]]. Clinical trials of Transderm Scōp® did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=
* Transdermal
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
<!--IV Compatibility-->
|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose=
===Acute Overdose===
====Signs and Symptoms====
*The signs and symptoms of anticholinergic toxicity include: lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. These symptoms can be severe and may require medical intervention.
*The symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal. Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal. Obtaining a careful history is crucial to making the correct diagnosis.
====Management====
*Because strategies for the management of drug overdose continually evolve, it is strongly recommended that a poison control center be contacted to obtain up-to-date information regarding the management of Transderm Scōp® patch overdose. The prescriber should be mindful that antidotes used routinely in the past may no longer be considered optimal treatment. For example, physostigmine, used more or less routinely in the past, is seldom recommended for the routine management of anticholinergic syndromes.
*Until up-to-date authoritative advice is obtained, routine supportive measures should be directed to maintaining adequate respiratory and cardiac function.
*In cases of toxicity remove the patch. Serious symptomatic cases of overdosage involving multiple patch applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway, and supporting respiration and circulation. This should be rapidly followed by removal of all patches from the skin and the mouth. If there is evidence of patch ingestion, gastric lavage, endoscopic removal of swallowed patches, or administration of activated charcoal should be considered, as indicated by the clinical situation. In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
| bioavailability = 0.13-8% (Oral),<ref name = EMCBut/><ref name = TGAor/> 3% (Rectal)<ref name = EMCBut/>
| protein_bound =
| metabolism = [[Hepatic]] (liver)<ref name = TGAor/>
| excretion = [[Renal]]<ref name = TGAor/>
| elimination_half-life = 4.5 hours<ref name="pmid2762223">{{cite journal | author = Putcha, L.; Cintrón, N. M.; Tsui, J.; Vanderploeg, J. M.; Kramer, W. G. | title = Pharmacokinetics and Oral Bioavailability of Scopolamine in Normal Subjects | journal = Pharmacology Research | volume = 6 | issue = 6 | pages = 481–485 | year = 1989 | pmid = 2762223 | doi = 10.1023/A:1015916423156 | url = }}</ref>
| bioavailability = 10 - 50% <ref name="pmid2762223">{{cite journal |author=Putcha L, Cintrón NM, Tsui J, Vanderploeg JM, Kramer WG |title=Pharmacokinetics and oral bioavailability of scopolamine in normal subjects |journal=Pharm. Res. |volume=6 |issue=6 |pages=481–5 |year=1989 |month=June |pmid=2762223 |doi= |url= |issn= | doi = 10.1023/A:1015916423156 <!--Retrieved from CrossRef by DOI bot--> | doi = 10.1023/A:1015916423156 <!--Retrieved from CrossRef by DOI bot-->}}</ref>
| elimination_half-life = 4.5 hours<ref name="pmid2762223">{{cite journal |author=Putcha L, Cintrón NM, Tsui J, Vanderploeg JM, Kramer WG |title=Pharmacokinetics and oral bioavailability of scopolamine in normal subjects |journal=Pharm. Res. |volume=6 |issue=6 |pages=481–5 |year=1989 |month=June |pmid=2762223 |doi= |url= |issn= | doi = 10.1023/A:1015916423156 <!--Retrieved from CrossRef by DOI bot--> | doi = 10.1023/A:1015916423156 <!--Retrieved from CrossRef by DOI bot-->}}</ref>
'''Scopolamine''', also known as '''hyoscine''', is a [[tropane alkaloid]] [[Medication|drug]] with [[muscarinic antagonist]] effects. It is obtained from plants of the family [[Solanaceae]] (nightshades), such as [[henbane]] or jimson weed (''[[Datura]]'' species). It is among the [[secondary metabolites]] of these plants. The drug can be highly toxic and should be used in minute doses. As an example, in the treatment of motion sickness, the dose, gradually released from a transdermal patch, is only 330 micrograms (µg) per day. An overdose can cause [[delirium]], [[delusion]]s, [[paralysis]], [[stupor]] and death.
==Etymology==
<!--Mechanism of Action-->
Scopolamine is named after the plant [[genus]] ''[[Scopolia]]''. The name "hyoscine" is from the scientific name for [[henbane]], ''Hyoscyamus niger''.
==Physiology==
|mechAction=
Scopolamine acts as a competitive antagonist at specific [[muscarinic acetylcholine receptors]], specifically [[M1 receptors]]; it is thus classified as an [[anticholinergic]], or, more specifically, as an [[anti-muscarinic]] drug. (See the article on the [[parasympathetic]] nervous system for details of this physiology.)
==Medical use==
* Scopolamine, a belladonna alkaloid, is an anticholinergic agent. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
In [[medicine]] scopolamine has 3 primary uses: treatment of [[nausea]] and [[motion sickness]], treatment of [[intestinal cramping]], and for ophthalmic purposes. Use as a general depressant and adjunct to narcotic painkillers is also common.
The drug is less commonly used as a [[preanesthetic agent]] and uncommonly for some forms of [[Parkinsonism]]. Scopolamine is also used as an adjunct to narcotic analgesia, such as the product [[Twilight Sleep]] which contained [[morphine]] and scopolamine, some of the original formulations of [[Percodan]] and some European brands of [[methadone]] injection, as well as use of tablets or patches to combat nausea as well as enhance the pain-killing ability of various [[opioids]]. Scopolamine can be used as an occasional sleep aid and was available in some over the counter products in the United States for this purpose until November 1990.
===Nausea===
<!--Structure-->
Its use in the form of a transdermal patch to prevent [[post-operative nausea]] is perhaps its greatest current use in the US.
===Ophthalmic===
|structure=
The drug is used in eye drops to induce [[mydriasis]] (pupillary dilation) and [[cycloplegia]] (paralysis of the eye focusing muscle), primarily in the treatment of eye disorders that benefit from its prolonged effect, e.g. [[uveitis]], [[iritis]], [[iridocyclitis]], etc.
===Memory research===
* The Transderm Scōp® (scopolamine) transdermal system is a circular flat patch designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is α -(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4] non-7-yl ester. The empirical formula is C17H21NO4 and its structural formula is:
Because of its anticholinergic effects, scopolamine has been shown to prevent the activation of [[medial temporal lobe]] structures for novel stimuli during [[working memory]] tasks.
===Nicotine addiction===
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
Scopolamine is being investigated for its possible usefulness alone or in conjunction with other drugs in assisting people in breaking the [[nicotine]] habit. The mechanism by which it mitigates withdrawal symptoms appears to be at least partially different from that of [[clonidine]] meaning that the two drugs can be used together without duplicating or cancelling out the effects of each other.
===Other medical uses===
*Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp® system is a film 0.2 mm thick and 2.5 cm2, with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir of scopolamine, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system.
*It can be used as a depressant of the [[central nervous system]], and was formerly used as a bedtime sleep aid.
*[[Anesthetic]]; Its use in general anesthesia is favored by some due to its [[amnesic]] effect. Scopolamine causes memory impairments to a similar degree as [[diazepam]].<ref>{{cite journal |author=Jones DM |coauthors=Jones ME, Lewis MJ, Spriggs TL. |title=Drugs and human memory: effects of low doses of nitrazepam and hyoscine on retention. |journal=Br J Clin Pharmacol. |volume=7 |issue=5 |pages=479-83 |month=May |year=1979 |pmid=475944}}</ref>
*In [[otolaryngology]] it is used to dry the upper airway (anti-sialogogue action) prior to instrumentation of the airway.
*In October 2006 researchers at the US [[National Institute of Mental Health]] found that scopolamine reduced symptoms of [[depression (mood)|depression]] within a few days, and the improvement lasted for at least a week after switching to a [[placebo]].<ref>{{cite journal
| last = Furey
| first = ML
| coauthors = Drevets, WC
| title = Antidepressant efficacy of the antimuscarinic drug scopolamine: a randomized, placebo-controlled clinical trial
| journal = Archives of General Psychiatry, vol 63, p 1121
*Due to its effectiveness against [[sea-sickness]] it has become commonly used by [[Scuba set|scuba]] divers.
===Routes of administration===
<!--Pharmacodynamics-->
Scopolamine can be administered by [[transdermal patch]]es,<ref name="pmid17179250">{{cite journal |author=White PF, Tang J, Song D, ''et al'' |title=Transdermal scopolamine: an alternative to ondansetron and droperidol for the prevention of postoperative and postdischarge emetic symptoms |journal=Anesth. Analg. |volume=104 |issue=1 |pages=92-6 |year=2007 |pmid=17179250 |doi=10.1213/01.ane.0000250364.91567.72 |url=http://www.anesthesia-analgesia.org/cgi/pmidlookup?view=long&pmid=17179250}}</ref> oral, subcutaneous, [[ophthalmic]] and [[intravenous]] routes.
The transdermal patch for prevention of nausea and motion sickness employs scopolamine base. The oral, ophthalmic and intravenous forms are usually scopolamine [[hydrobromide]] (for example in [[Donnatal]]).
==Recreational use==
|PD=
Scopolamine, in common with the large percentage of anticholinergics which cross the blood-brain barrier such as [[diphenhydramine]], [[dicyclomine]], [[trihexyphenidyl]] and related drugs, is said to produce euphoria at and around therapeutic doses as well as to potentiate this and other effects of [[morphine]], [[methadone]], [[hydromorphone]], [[oxycodone]] and other opioids. It is therefore occasionally seen as a recreational drug. The use of medical scopolamine (most often in the form of tablets) for euphoria is uncommon but does exist and can be seen in conjunction with opioid use. The euphoria is the result of changes in dopamine and acetylcholine levels and ratios and appears to be related to some part of the chemical structure of the drug and other factors known or unknown -- even closely related drugs like atropine and hyoscyamine do not produce euphoria whilst the others listed above certainly appear to.
Another separate group of users prefer dangerously high doses, especially in the form of [[datura]] or [[belladonna]] preparations, for the deliriant and hallucinogenic effects. The hallucinations produced by scopolamine, in common with other potent anticholinergics, are especially real-seeming and create a perception of a new world filled with frenzied, violent energy. The difference in realism of hallucinations caused by [[anticholinergics]] such as scopolamine and other [[hallucinogens]] such as the [[phenethylamines]] or dissociatives like PCP is quite large. Additionally, an overdose of scopolamine can quite often be fatal, unlike other more commonly used hallucinogens. For these reasons, naturally occurring anticholinergics are rarely used for recreational purposes.
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
==Potential use in interrogation==
<!--Pharmacokinetics-->
The use of scopolamine as a ''[[truth drug]]'' was investigated in the 1950s by various [[intelligence agencies]], including the [[CIA]] as part of [[Project MKULTRA]]. Nazi doctor [[Josef Mengele]] experimented on scopolamine as an interrogation drug.
==Criminal use==
|PK=
Scopolamine has been used under the name [[burundanga]], a jungle form of [[Rohypnol]] in [[Venezuela]]n and [[Thailand]] resorts in order to drug and then rob tourists. While there are unfounded rumours that delivery mechanisms include using [[pamphlet]]s and [[Flyer (pamphlet)|flyer]]s laced with the drug, not enough is readily absorbed through the skin to have an effect. However, spiked alcoholic drinks are occasionally used. <ref>[http://www.snopes.com/horrors/mayhem/burundanga.asp Snopes Burudanga rumour page]</ref><ref>[http://travel.timesonline.co.uk/tol/life_and_style/travel/your_say/article3287518.ece The 13 best travel scams - Times Online<!-- Bot generated title -->]</ref>
A nine part series on the drug, also known as "Colombian Devil's Breath", can be found on VBS.TV.
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
In recent years the criminal use of scopolamine has become an [[epidemic]]. Approximately fifty percent of emergency room admissions for poisoning in [[Bogotá]] have been attributed to scopolamine.<ref>Wall Street Journal, July 3, 1995</ref>
<!--Nonclinical Toxicology-->
Victims of this crime are often admitted to a hospital in police custody, under the assumption that the patient is experiencing a psychotic episode. A telltale sign is a fever accompanied by a lack of sweat.
|nonClinToxic=
Scopolamine is used criminally as a date rape drug and as an aid to robbery,<ref>http://www.sobercircle.com/index.asp?node=resources§ion=articles&fileid=8| Retrieved 20/11/07</ref> the most common act being the clandestine drugging of a victim's drink<ref>http://www.sobercircle.com/index.asp?node=resources§ion=articles&fileid=8| Retrieved 20/11/07</ref>. It is preferred because it induces [[anterograde amnesia]], or an inability to recall events a certain amount of time after its administration or during the time of intoxication.
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
==Shamanic use==
<!--Clinical Studies-->
In [[Colombia]] a plant admixture containing scopolamine called ''Burundanga'' has been used [[shamanism|shamanically]] for decades.
==Adverse effects==
|clinicalStudies=
The common side effects are related to the anticholinergic effect on [[parasympathetic]] postsynaptic receptors: dry mouth, throat and nasal passages in overdose cases progressing to impaired speech which can reach the extreme of the victim only being able to emit noises which sound like the vocalisations of a [[raccoon]], thirst, blurred vision and sensitivity to light, [[constipation]], difficulty urinating and [[tachycardia]]. Other effects include flushing and fever, as well as excitement, restlessness, hallucinations, or [[delirium]], especially with higher doses. These side effects are commonly observed with oral or parenteral uses of the drug and generally not with topical ophthalmic use. An extreme adverse reaction to ultra-high doses of drugs and other preparations containing scopolamine is temporary blindness which can last up to 72 hours
The fever and dryness associated with scopolamine has caused some recreational users to stumble into bodies of water and drown on occasion.
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
Sometimes side effects of scopolamine can be mistaken for symptoms of [[cancer]] because of the nausea and [[anisocoria]] associated with brain tumors. However, scopolamine induced [[anisocoria]] clears up usually within 3 days.
<!--How Supplied-->
Use in scuba diving to prevent [[sea sickness]] has led to the discovery of another [[Adverse effect (medicine)|side effect]]. In deep water, below 50–60 feet, some divers have reported [[pain]] in the eyes that subsides quickly if the diver ascends to a depth of 40 feet or less. Mydriatics can precipitate an attack of [[glaucoma]] in susceptible patients, so the medication should be used with extra caution among divers who intend to go below 50 feet.
|howSupplied=
=== Drug interactions ===
*
When combined with [[morphine]], it produces [[amnesia]] and a tranquilized state known as [[twilight sleep]]. Although originally used in [[obstetrics]], it is now considered dangerous for that purpose for both mother and baby.
== History ==
<!--Patient Counseling Information-->
Scopolamine was one of the active ingredients in [[Asthmador]], an over the counter smoking preparation marketed in the 1950's and 60's claiming to combat [[asthma]] and [[bronchitis]].
Scopolamine was used in the [[1940]]s through the [[1960]]s that put mothers in labor into a kind of "[[twilight sleep]]" that didn’t stop pain, but merely eliminated the memory of pain by attacking the brain functions responsible for self-awareness and self-control. Often, this resulted in a kind of [[psychosis]], followed by [[post-traumatic stress]]-like memories in thousands of new mothers.<ref>''The Business of Being Born,'' [http://www.babystepsonline.net/BoBB.htm]</ref>
|fdaPatientInfo=
Scopolamine was an ingredient used in some over-the-counter sleep aids prior to November 1990 in the United States, when the FDA forced several hundred ingredients allegedly not known to be effective off the market. Scopolamine shared a small segment of this market with [[diphenhydramine]], [[phenyltoloxamine]], [[pyrilamine]], [[doxylamine]] and other first generation [[antihistamines]], many of which are still used for this purpose in drugs like Sominex, [[Tylenol PM]], [[NyQuil]] and so on.
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
== Popular culture ==
<!--Precautions with Alcohol-->
* (1940) In one of crime fiction's all-time classic novels, ''[[Farewell, My Lovely]]'' (1940) by [[Raymond Chandler]], [[Philip Marlowe|Marlowe]] gets shot full of Scopolamine in a private sanitarium in order to both shut him up, and to pump him for knowledge, when he gets too close to the truth on a case, or rather several cases entangled into one another, that he is working on (the idenity of Velma and the whereabouts of Moose Malloy).
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<blockquote>
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
"I had been shot full of dope to keep me quiet. Perhaps scopolamine too, to make me talk." (quote by Marlowe in ''Farewell, My Lovely'')
</blockquote>
<blockquote>
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"There's a drug called scopolamine, truth serum, that sometimes makes people talk without their knowing it. It's not sure fire, any more than hypnotism is. But it sometimes works." (quote by Marlowe in "Farewell, My Lovely")
</blockquote>
* (1957) In popular culture, scopolamine has achieved a moderate level of notoriety via its mention in the film ''[[I Was a Teenage Werewolf]]'', where Dr. Alfred Brandon uses it as part of his endeavor to regress the titular character to his "primitive roots."
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* (1961) Scopolamine is featured in the World War II action classic ''[[The Guns of Navarone (film)|The Guns of Navarone]]'' as a [[Schutzstaffel]] truth serum.
* ®<ref>{{Cite web | title = | url = }}</ref>
* (1968) Scopolamine is featured in the World War II action classic ''[[Where Eagles Dare]]'' as a [[Schutzstaffel]] truth serum.
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* (1968) In [[Carlos Castaneda]]'s series of books ''The Teachings of Don Juan: A Yaqui Way of Knowledge'', the ''[[Datura]]'' plant is the favored shamanic, revelatory drug of the titular character. The book explores, in depth, Castaneda's experiences under the influence of the drug, as well as the rites surrounding its use and preparation.
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* (1974) In episode 1 "That'll Be The Day", of the fourth series of the TV Series [[Callan (TV series)|Callan]], Callan is interrogated by the KGB using the drug Scopolamine as a truth serum.
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
* (1979) Scopolamine is also mentioned several times in [[Robert Ludlum]]'s ''[[Matarese Dynasty]]'', a fictional spy novel in which the drug is known for its uses as a truth serum.
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* (1990) Scopolamine is mentioned by the villain Cain as one of the cutting agents of the drug Nuke in ''[[Robocop 2]]''
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* (1990s) The X-Files [[Red Museum]] shows Scopolamine as a suspect agent in usage for kidnappings.
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* (2000) In the pilot episode for Season 1 of [[CSI: Crime Scene Investigation]], a female thief seduces a man to sleep with her. She applies scopolamine to her [[nipples]], which knocks the man out when he ingests it orally. After she robs him and makes her escape, the scopolamine which she absorbed into her skin causes her to pass out as well.
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* (2000) Scopolamine was the drug Michael claimed he was injected with either by the military and/or the aliens in "[http://www.metatech.org/TheMarsRecords.pdf The Mars Records]". It might be worth noting in this context that scopolamine can cause [[confabulation]] (the mixing of memory and facts).
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* (2007) In the episode "[[Airborne (House episode)|Airborne]]", one character in the TV show ''[[House (TV series)|House, M.D.]]'' is shown wearing a scopolamine patch.
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== External links ==
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* [http://www.erowid.org/chemicals/scopolamine/scopolamine.shtml The Erowid Scopolamine Vault]
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To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp® patch (formulated to deliver approximately 1mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required.
Continuation of Therapy
If therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear.
Post Operative Nausea and Vomiting
Initiation of Therapy
To prevent post operative nausea and vomiting, one Transderm Scōp® patch should be applied the evening before scheduled surgery, except for caesarian section.
For caesarian section surgery, to minimize exposure of the newborn baby to the drug, apply the patch one hour prior to caesarian section
Continuation of Therapy
For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Scopolamine (transdermal) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Scopolamine (transdermal) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Scopolamine (transdermal) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Scopolamine (transdermal) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Scopolamine (transdermal) in pediatric patients.
Persons who are hypersensitive to the drug scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.
Warnings
Precautions
Open Angle Glaucoma
Patients currently being treated for Open Angle Glaucoma
Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during Transderm Scōp® use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.
Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).
Temporary Dilation of the Pupil
Scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.
Preexisting Gastrointestinal or Urinary Bladder Obstructions
Transderm Scōp® should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including Transderm Scōp®, to patients suspected of having intestinal obstruction.
Patients should be instructed to remove the patch if they develop any difficulties in urinating.
History of Seizures or Psychosis
Transderm Scōp® should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders.
Idiosyncratic Reactions
Idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, speech disorder, hallucinations, paranoia, and delusions.
Specific Populations
Pediatric
A safe and effective dose has not been established in the pediatric population. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied.
Elderly
Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. Clinical trials of Transderm Scōp® did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
Renal and Hepatic Impaired
Transderm Scōp® should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scōp® has not been studied in these populations.
Safety Hazards
Drowsiness
Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.
Disorienting Effects
Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine.
MRI Skin Burns
Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp® contains aluminum, it is recommended to remove the system before undergoing an MRI.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Motion Sickness
In motion sickness clinical studies of Transderm Scōp®, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed.
Post-Operative Nausea and Vomiting
In a total of five clinical studies in which Transderm Scōp® was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1).
T1
Postmarketing Experience
The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scōp®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.
In worldwide marketing with Transderm Scōp®, the following adverse drug reactions were reported by body system.
Psychiatric disorders
Acute psychosis including: hallucinations disorientation, and paranoia.
Nervous system disorders
Headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness.
General disorders and administration site conditions
The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying.
Scopolamine should be used with caution in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
In vitro studies indicated that the potential for scopolamine to alter the pharmacokinetics of other concomitant medications through inhibition of CYP 1A2, 2C8, 2C9, 2C19, 2D6 and 3A4 or induction of CYP 1A2 and 3A4 is low; however, in vivo studies have not been conducted.
Based on data from one prospective study of Transderm Scōp® in cesarean delivery, the rate of newborn adverse events in both the Transderm Scōp® and placebo groups were the same. The rates were 10.5% (12 events in 114 newborns) in both treatment groups. None of these events were considered life threatening or drug related. Jaundice was the only adverse event occurring more frequently with Transderm Scōp® than placebo: 9 events (7.9%) versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and did not prolong the hospital stay.
There are no adequate and well-controlled studies of Transderm Scōp® use during pregnancy. In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Transderm Scōp® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Scopolamine (transdermal) in women who are pregnant.
Labor and Delivery
During a clinical study among women undergoing cesarean section treated with Transderm Scōp® in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in newborns. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by Transderm Scōp® did not affect uterine contractions or increase the duration of labor. Scopolamine does cross the placenta.
Nursing Mothers
Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scōp® is administered to a nursing woman.
Pediatric Use
A safe and effective dose has not been established in the pediatric population.
Geriatic Use
Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion and dizziness. Clinical trials of Transderm Scōp® did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
Gender
There is no FDA guidance on the use of Scopolamine (transdermal) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Scopolamine (transdermal) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Scopolamine (transdermal) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Scopolamine (transdermal) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Scopolamine (transdermal) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Scopolamine (transdermal) in patients who are immunocompromised.
Administration and Monitoring
Administration
Transdermal
Monitoring
There is limited information regarding Monitoring of Scopolamine (transdermal) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Scopolamine (transdermal) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
The signs and symptoms of anticholinergic toxicity include: lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. These symptoms can be severe and may require medical intervention.
The symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal. Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal. Obtaining a careful history is crucial to making the correct diagnosis.
Management
Because strategies for the management of drug overdose continually evolve, it is strongly recommended that a poison control center be contacted to obtain up-to-date information regarding the management of Transderm Scōp® patch overdose. The prescriber should be mindful that antidotes used routinely in the past may no longer be considered optimal treatment. For example, physostigmine, used more or less routinely in the past, is seldom recommended for the routine management of anticholinergic syndromes.
Until up-to-date authoritative advice is obtained, routine supportive measures should be directed to maintaining adequate respiratory and cardiac function.
In cases of toxicity remove the patch. Serious symptomatic cases of overdosage involving multiple patch applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway, and supporting respiration and circulation. This should be rapidly followed by removal of all patches from the skin and the mouth. If there is evidence of patch ingestion, gastric lavage, endoscopic removal of swallowed patches, or administration of activated charcoal should be considered, as indicated by the clinical situation. In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.
Chronic Overdose
There is limited information regarding Chronic Overdose of Scopolamine (transdermal) in the drug label.
Scopolamine, a belladonna alkaloid, is an anticholinergic agent. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
Structure
The Transderm Scōp® (scopolamine) transdermal system is a circular flat patch designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is α -(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4] non-7-yl ester. The empirical formula is C17H21NO4 and its structural formula is:
Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp® system is a film 0.2 mm thick and 2.5 cm2, with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir of scopolamine, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Scopolamine (transdermal) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Scopolamine (transdermal) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Scopolamine (transdermal) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Scopolamine (transdermal) in the drug label.
How Supplied
Storage
There is limited information regarding Scopolamine (transdermal) Storage in the drug label.
Images
Drug Images
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↑Putcha, L.; Cintrón, N. M.; Tsui, J.; Vanderploeg, J. M.; Kramer, W. G. (1989). "Pharmacokinetics and Oral Bioavailability of Scopolamine in Normal Subjects". Pharmacology Research. 6 (6): 481–485. doi:10.1023/A:1015916423156. PMID2762223.CS1 maint: Multiple names: authors list (link)
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