Componentes:
Método de ação:
Opção de tratamento:
Medicamente revisado por Oliinyk Elizabeth Ivanovna, Farmácia Última atualização em 14.03.2022
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20 principais medicamentos com os mesmos componentes:
Dosage Forms And Strengths
The Transderm Scop® system is a tan-colored circular flat patch which contains 1.5 mg of scopolamine base and is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days.
Storage And Handling
The Transderm Scop® system is a tan-colored circular patch, 2.5 cm², on a clear, oversized, hexagonal peel strip, which is removed prior to use.
Each Transderm Scop system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately 1 mg of scopolamine over 3 days. Transderm Scop® is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included.
1 Package (4 patches) NDC 0067-4345-04
Storage
The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F).
Handling
Since 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.
Manufactured by: ALZA Corporation, Vacaville, CA 95688. Distributed by: Novartis Cons umer Health, Inc., Parsippany, NJ 07054-0622. Revised: Dec 2014
Doença de movimento
O Transderm Scop® é indicado em adultos para prevenção de náuseas e vômitos associados a enjoos.
Náusea e vômito pós-operatórios (PONV)
O Transderm Scop® é indicado em adultos para prevenção de náuseas e vômitos associados à recuperação da anestesia analgesia e cirurgia opiáceos.
Each Transderm Scop® patch is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days. Only one patch should be worn at any time. Do not cut the patch.
The patch should be applied only to the skin in the postauricular (hairless area behind one ear) area.
Handling
After the patch is applied on the dry skin behind the ear, the hands should be washed thoroughly with soap and water and dried. Upon removal, the patch should be discarded. To prevent any traces of scopolamine from coming into direct contact with the eyes, after administration of the patch, the hands and the application site should be washed thoroughly with soap and water and dried.
Initiation Of Therapy
Motion Sickness
- To prevent the nausea and vomiting associated with motion sickness, one Transderm Scop® 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.
Post Operative Nausea and Vomiting
- To prevent post operative nausea and vomiting, one Transderm Scop® 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
Sections or subsections omitted from the full prescribing information are not listed.
Continuation Of Therapy
Should the patch become displaced, it should be discarded, and a fresh one placed on the hairless area behind the other ear.
Motion Sickness
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
For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.
O Transderm Scop® está contra-indicado no seguintes populações :
- Pacientes com glaucoma de fechamento angular.
- Pessoas hipersensíveis à droga escopolamina ou outros alcalóides da beladona ou a qualquer ingrediente ou componente da formulação ou sistema de entrega.
WARNINGS
Included as part of the PRECAUTIONS section.
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 Scop 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 Scop 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 Scop, 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 Scop 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 Scop 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 Scop 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 Scop should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scop 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 Scop contains aluminum, it is recommended to remove the system before undergoing an MRI.
Patient Counseling Information
See FDA-approved patient labeling (PATIENT INFORMATION)
Please read this instruction sheet carefully before opening the system package.
Transderm Scop® Transdermal System
Generic Name: scopolamine, pronounced skoe-POL-a-meen
- Elderly patients should be informed that Transderm Scop may cause a greater likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome and to seek immediate medical care if they become confused, disoriented or dizzy while wearing the patch or after removing.
- Patients should be informed that since Transderm Scop may cause drowsiness, disorientation and confusion they should avoid engaging in activities that require mental alertness such as driving a motor vehicle or operating dangerous machinery.
- Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of Transderm Scop.
- Because of the possibility of drowsiness, disorientation
and confusion, patients should be informed that they should avoid drinking
alcohol. In addition, patients should be informed that the following medications
should be used with caution when taking Transderm Scop:
- sedatives or tranquilizers
- drugs with anticholinergic properties (e.g., other belladonna alkaloids),
- antihistamines (including meclizine)
- tricyclic antidepressants
- muscle relaxants
- Patients with the following conditions should be informed
about the chance of developing serious reactions with Transderm Scop®:
- patients with open angle glaucoma (may cause an increase in intraocular pressure)
- patients with impaired kidney or liver function (increased likelihood of CNS effects)
- patients with a history of seizures or psychosis (can potentially worsen both disorders)
- patients with obstruction at the level of the pylorus, which is the outlet of the stomach, or urinary
- bladder neck obstruction (may cause difficulties in urinating)
- patients suspected of having intestinal obstruction
- pregnant or nursing mothers
- Patients should be informed that if they remove the Transderm Scop patch suddenly before treatment is complete, the following withdrawal symptoms may occur: dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, slow heart rate and low blood pressure. Patients should be instructed to seek immediate medical care if they develop any of these symptoms after removing Transderm Scop.
- Patients should be informed that Transderm Scop can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Patients should be informed to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, patients should be informed that used patches must be disposed of properly to avoid contact with children or pets.
- Patients should be informed that 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 Scop contains aluminum, patients should be advised to remove the system before undergoing an MRI.
- Patients should be advised to use only one patch at a time.
- Patients should be advised not to cut the patch.
Use In Specific Populations
Pregnancy
Pregnancy Category C
Based on data from one prospective study of Transderm Scop in cesarean delivery, the rate of newborn adverse events in both the Transderm Scop 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 Scop 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 Scop 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 Scop should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.
Labor And Delivery
During a clinical study among women undergoing cesarean section treated with Transderm Scop 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 Scop 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 Scop is administered to a nursing woman.
Pediatric Use
A safe and effective dose has not been established in the pediatric population.
Geriatric Use
Transderm Scop 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 Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
Renal Or Hepatic Impairment
Transderm Scop should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects.
SIDE EFFECTS
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 Scop, 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 Scop 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).
Table 6.1 PONV: Adverse Drug Reactions in ≥ 3% of
Patients
Transderm Scop (N=461) |
Placebo (N=457) |
|||
n | % | n | % | |
Adverse Drug Reactions | 303 | 65.7 | 259 | 56.7 |
Dry mouth | 133 | 28.9 | 72 | 15.8 |
Dizziness | 57 | 12.4 | 33 | 7.2 |
Somnolence | 36 | 7.8 | 16 | 3.5 |
Urinary Retention | 33 | 7.2 | 30 | 6.6 |
Agitation | 28 | 6.1 | 20 | 4.4 |
Visual Impairment. | 23 | 5.0 | 12 | 2.6 |
Confusion | 18 | 3.9 | 14 | 3.1 |
Mydriasis | 16 | 3.5 | 2 | 0.4 |
Pharyngitis | 15 | 3.3 | 10 | 2.2 |
Postmarketing Experience
The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. 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 Scop, 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: application site burning.
Eye disorders: dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation.
Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema.
Renal and urinary disorders: dysuria.
Ear and Labyrinth Disorders: vertigo.
Drug Withdrawal/Post-Removal Symptoms
Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scop. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scop system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.
These symptoms can be severe and may require medical intervention.
DRUG INTERACTIONS
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.
Laboratory Test Interactions
Scopolamine will interfere with the gastric secretion test.
Drug Abuse And Dependence
Controlled Substance Class
Scopolamine is not a controlled substance.
Abuse
Scopolamine is an antagonist at muscarinic receptors in the cholinergic system. Drugs in this class are not known to have significant abuse potential in humans.
Dependence
Abrupt termination of Transderm Scop may result in withdrawal symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. These withdrawal symptoms indicate that anticholinergic drugs, like scopolamine may produce physical dependence. These symptoms can be severe and may require medical intervention.
Pregnancy Category C
Based on data from one prospective study of Transderm Scop in cesarean delivery, the rate of newborn adverse events in both the Transderm Scop 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 Scop 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 Scop 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 Scop should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother.
Experiência em ensaios clínicos
Porque os ensaios clínicos são realizados amplamente condições variadas, taxas de reação adversa observadas nos ensaios clínicos de a o medicamento não pode ser comparado diretamente às taxas nos ensaios clínicos de outro medicamento e pode não refletir as taxas observadas na prática clínica.
Doença de movimento
Estudos clínicos de doença de movimento de Transderm Scop, a reação adversa mais frequente foi boca seca. Isso ocorreu em cerca de dois terços dos pacientes em uso de drogas. Uma reação adversa medicamentosa menos frequente foi sonolência, que ocorreu em menos de um sexto dos pacientes em uso de drogas. Compromisso transitório da acomodação dos olhos, incluindo visão turva e dilatação das pupilas também foi observada.
Náusea e vômito pós-operatórios
Num total de cinco estudos clínicos em que Transderm Scop foi administrado perioperativamente a um total de 461 pacientes, onde a segurança foi avaliada, a boca seca foi a reação adversa medicamentosa mais frequentemente relatada que ocorreu em aproximadamente 29% dos pacientes em uso de drogas. Tontura foi relatada em aproximadamente 12% dos pacientes em uso de drogas. Outras reações adversas a medicamentos relatadas desses estudos, com uma frequência ≥ 3% dos pacientes tratados O Transderm Scop e com uma frequência maior que o placebo foram, em descida ordem: sonolência, retenção urinária, agitação / inquietação, visual comprometimento, confusão, midríase e faringite (ver Tabela 6.1).
Tabela 6.1 PONV: Reações adversas a medicamentos em ≥ 3% de
Pacientes
Transderm Scop (N = 461) |
Placebo (N = 457) |
|||
n | % | n | % | |
Reações adversas a medicamentos | 303 | 65,7 | 259 | 56,7 |
Boca seca | 133 | 28,9 | 72 | 15,8 |
Tontura | 57 | 12,4 | 33 | 7.2 |
Sonolência | 36 | 7.8 | 16 | 3.5 |
Retenção urinária | 33 | 7.2 | 30 | 6.6 |
Agitação | 28 | 6.1 | 20 | 4.4 |
Compromisso visual. | 23 | 5.0 | 12 | 2.6 |
Confusão | 18 | 3.9 | 14 | 3.1 |
Midríase | 16 | 3.5 | 2 | 0.4 |
Faringite | 15 | 3.3 | 10 | 2.2 |
Experiência pós-comercialização
As seguintes reações adversas a medicamentos, além daquelas relatados em ensaios clínicos, foram identificados durante o uso pós-aprovação de Transderm Scop. Porque essas reações são relatadas voluntariamente de a população de tamanho incerto, nem sempre é possível estimar com segurança sua frequência ou para confirmar uma relação causal definitiva.
No marketing mundial com a Transderm Scop, a após reações adversas a medicamentos foram relatadas pelo sistema corporal.
Distúrbios psiquiátricos : psicose aguda, incluindo: desorientação das alucinações e paranóia.
Distúrbios do sistema nervoso: dor de cabeça, amnésia anormalidades de coordenação, distúrbio da fala, perturbação da atenção, inquietação.
Perturbações gerais e alterações no local de administração : gravação do site de aplicação.
Afecções oculares: olhos secos, prurido ocular, ângulo glaucoma de fechamento, ambliopia, irritação palpebral.
Afecções dos tecidos cutâneos e subcutâneos : erupção cutânea generalizado, irritação da pele, eritema.
Distúrbios renais e urinários : disúria.
Distúrbios do ouvido e do labirinto : vertigem.
Sintomas de retirada / pós-remoção de medicamentos
Sintomas como tonturas, náuseas, vômitos, abdominais cãibras, sudorese, dor de cabeça, confusão mental, fraqueza muscular, bradicardia e pode ocorrer hipotensão após a descontinuação abrupta de medicamentos anticolinérgicos como Transderm Scop. Sintomas semelhantes, incluindo distúrbios de equilíbrio foram relatados em alguns pacientes após a descontinuação do uso do Sistema de escopo do transderm. Esses sintomas geralmente não aparecem até 24 horas ou mais após a remoção do patch. Esses sintomas podem ser graves e podem requer intervenção médica. Alguns sintomas podem estar relacionados à adaptação de a ambiente de movimento para um ambiente livre de movimento.
Esses sintomas podem ser graves e podem exigir assistência médica intervenção.
Porque estratégias para o gerenciamento da overdose de drogas evoluir continuamente, é altamente recomendável que seja um centro de controle de veneno contatado para obter informações atualizadas sobre o gerenciamento da Transderm Overdose de adesivo Scop®. O o prescritor deve estar ciente de que os antídotos usados rotineiramente no passado podem não mais tempo seja considerado tratamento ideal. Por exemplo, a fisostigmina, usou mais ou menos rotineiramente no passado, raramente é recomendado para o gerenciamento de rotina de síndromes anticolinérgicas.
Até que seja obtido aconselhamento oficial atualizado medidas de suporte de rotina devem ser direcionadas para manter a adequada função respiratória e cardíaca. Os sinais e sintomas do anticolinérgico toxicidade incluem: letargia, sonolência, coma, confusão, agitação, alucinações convulsão, distúrbio visual, pele seca e lavada, boca seca, intestino diminuído sons, retenção urinária, taquicardia, hipertensão e supraventricular arritmias. Esses sintomas podem ser graves e podem exigir intervenção médica.
Em casos de toxicidade, remova o adesivo. Sério casos sintomáticos de superdosagem envolvendo várias aplicações de patches e / ou a ingestão pode ser gerenciada, garantindo inicialmente que o paciente tenha um adequado vias aéreas e suporte à respiração e circulação. Isso deve ser rápido seguido pela remoção de todos os adesivos da pele e da boca. Se houver evidência de ingestão de adesivo, lavagem gástrica, remoção endoscópica de adesivos engolidos ou a administração de carvão ativado deve ser considerada, conforme indicado por a situação clínica. Em qualquer caso em que haja superdosagem ou sinais graves de toxicidade aguda em evolução, monitoramento contínuo de sinais vitais e ECG, estabelecimento acesso intravenoso e administração de oxigênio são todos recomendados.
Os sintomas de sobredosagem / toxicidade devido à escopolamina deve ser cuidadosamente distinguido da síndrome ocasionalmente observada de retirada. Embora confusão mental e tontura pode ser observado com toxicidade aguda e abstinência, outras características os resultados diferem: taquiarritmias, pele seca e diminuição dos sons intestinais sugerem toxicidade anticolinérgica, enquanto bradicardia, dor de cabeça, náusea e cãibras abdominais e suar sugerem retirada pós-remoção. Obter uma história cuidadosa é crucial para fazer o diagnóstico correto.
A farmacocinética da escopolamina é fornecida através do sistema são devidos às características da forma farmacêutica e da dose. O o sistema é formulado para fornecer in vivo aproximadamente 1 mg de escopolamina em an taxa aproximadamente constante para a circulação sistêmica ao longo de 3 dias. Em aplicação na pele pós-auricular, uma dose inicial inicial de escopolamina é liberado da camada adesiva para locais saturados de ligação à pele. O a entrega subsequente de escopolamina no sangue é determinada pela taxa controlando a membrana e foi projetado para produzir níveis plasmáticos estáveis em a intervalo terapêutico. Após a remoção do sistema usado, há algum grau de absorção sistêmica contínua de escopolamina ligada nas camadas da pele.
Absorção
A escopolamina é bem absorvida por via percutânea. Seguindo aplicação na pele atrás da orelha, são detectados níveis plasmáticos circulantes dentro de 4 horas, com níveis de pico sendo obtidos, em média, dentro de 24 horas. A concentração plasmática média produzida é de 87 pg / mL (0,28 nM) gratuitamente escopolamina e 354 pg / mL para escopolamina total (livre + conjugados).
Distribuição
A distribuição da escopolamina não está bem caracterizado. Atravessa a placenta e a barreira do cérebro sanguíneo e pode ser reversivelmente ligado às proteínas plasmáticas.
Metabolismo e excreção
O padrão exato de eliminação da escopolamina não foi determinado. Após a remoção do adesivo, os níveis plasmáticos de escopolamina diminuem em a log linear moda com uma meia-vida observada de 9,5 horas. Menos de 10% de a dose total é excretada na urina como medicamento original e metabolitos 108 horas.A escopolamina é extensamente metabolizada e conjugada com menos 5% da dose total que parece inalterada na urina. As enzimas responsáveis pelo metabolização da escopolamina são desconhecidos.
Interação medicamentosa
Um in vitro estudo usando hepatócitos humanos examinou o indução do CYP1A2 e CYP3A4 por escopolamina.
A escopolamina não induziu isoenzimas do CYP1A2 e CYP3A4 nas concentrações de até 10 nM .
Em um in vitro estudar usando microssomas hepáticos humanos que avaliou a inibição do CYP1A2, 2C8, 2C9, 2C19, 2D6 e 3A4, escopolamina não inibiu essas isoenzimas do citocromo P450 em concentrações de até 1 mcM