7. CUIDADO DE ALMACENAMIENTO
Evitar calor excesivo (temperatura superior a 40°C) y proteger de
la luz.
El plazo de validez del producto es de 24 meses, contados a partir
de la fecha de fabricación.
Número de lote y fecha de fabricación y plazo de validez: ver
embalaje.
No use medicamento después de su plazo de validez. Guárdelo
en su embalaje original.
Antes de usar, observe el aspecto del producto.
Todo medicamento se debe mantener fuera del alcance de los
niños.
8. POSOLOGÍA Y MODO DE USAR
Como ocurre con todos os anestésicos locales, la dosis varía y
depende del área a ser anestesiada, de la vascularización de los
tejidos, del número de segmentos nerviosos a ser bloqueados, de la
tolerancia individual y de la técnica anestésica usada. Se debe usar
la menor dosis necesaria y suficiente para proporcionar una
anestesia específica. La dosis necesaria se debe determinar en
función del estado de cada individuo. La dosis máxima sugerida
por el Consejo de Terapéutica Odontológica de la Asociación
Americana de Odontología y por la Convención de la USP es de 4,4
mg/kg, con o sin vasoconstrictor. Esta dosis permite, además, el
uso de una cantidad significativa del fármaco para obtener una
anestesia clínica profunda con un riesgo un poco menor de
reacciones tóxicas (superdosificación). La dosis máxima
recomendada para niños menores de 10 años, con peso y desarrollo
normales, se debe determinar por medio de la fórmula pediátrica
standard (ej.: Regla de Clark). La dosis máxima recomendada de
epinefrina es de 0,2 mg (o el equivalente a 5,5 Carpules de
ALPHACAINE 50, 8,8 Carpules de ALPHACAINE 80 o 11
Carpules de ALPHACAINE 100) para pacientes adultos sanos.
La dosis máxima recomendada para los individuos sensibles a la
epinefrina, como determinados pacientes ASA III o ASA IV y
pacientes clínicamente hipertireóideos, es de 0,04 mg por consulta
(1 Carpule de ALPHACAINE 50 1 y ½ Carpule de
ALPHACAINE 80 o 2 Carpules de ALPHACAINE 100). En la
infiltración oral y/o bloqueo mandibular, la dosis inicial
usualmente efectiva es de 1 a 5 ml de lidocaína (½ a 2 e ½
Carpules). En niños menores de 10 años raramente se necesita
administrar más que 0,9 a 1,0 ml (½ Carpule) de lidocaína por
procedimiento para conseguir anestesia local para un único diente.
Se recomienda aspirar durante la aplicación para evitar el riesgo de
una inyección intravascular.
Dosis máximas: 4,4 mg de clorhidrato de lidocaína/kg
0,2 mg de epinefrina/kg
(Cada Carpule de 1,8 ml contiene 36 mg de clorhidrato de
lidocaína)
Peso
(Kg)
0
N Carpules
ALPHACAINE 50
1 (44 mg)
10
2 (88 mg)
20
3,5 (132 mg)
30
40 40 4,5 (176 mg)
6 (220 mg)
50
6 (220 mg)
60
6 (220 mg)
70
6 (220 mg)
80
6 (220 mg)
90
6 (220 mg)
100
0
0
0
N Carpules
N Carpules
N Carpules
ALPHACAINE 80 ALPHACAINE 100 ALPHACAINE 200
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
Las dosis indicadas representan lo máximo sugerido para
individuos sanos normales; para pacientes debilitados o ancianos
deben ser menores.
Se aconseja desinfectar la tapa del carpule que entra en contacto
con la aguja con algodón embebido en alcohol al 70%. No inmergir
los carpules bajo ningún concepto, cualquiera que sea la solución.
Se recomienda aspirar durante la aplicación para evitar el riesgo de
una inyección intravascular. Para aspirar, la aguja debe ser
posicionada hasta que no ocurra ninguno retorno de sangre con la
aspiración. Sin embargo, se debe observar que la ausencia de
sangre en la jeringa no garantiza que se evitó la inyección
intravascular y siempre se recomienda una doble aspiración. No se
deben reaprovechar los Carpules parcialmente usados.
9. REACCIONES ADVERSAS
Los efectos colaterales son similares a los observados con otros
anestésicos locales del tipo amida. Las acciones adversas, en
general, están relacionadas con la dosificación y pueden resultar
de altos niveles plasmáticos causados por dosis excesiva,
absorción rápida, o inyección intravascular accidental, o también
pueden ser el resultado de hipersensibilidad, idiosincrasia o
tolerancia reducida por parte del paciente. Pueden ocurrir efectos
sobre el sistema cardiovascular y el SNC. Las manifestaciones del
SNC pueden ser de excitación o depresión, como fotofobia,
nerviosismo, aprensión, euforia, confusión, mareos, somnolencia,
zumbidos, visión borrosa, vómitos, sensación de calor, frío,
hormigueo, temblores, pérdida de la conciencia, depresión y
parada respiratoria. Las manifestaciones cardiovasculares
normalmente son de depresión del sistema y caracterizadas por
bradicardia, hipotensión y colapso cardiovascular, que pueden
conducir a una parada cardíaca. Las señales y los síntomas de una
función cardiovascular deprimida comúnmente pueden ser el
resultado de una reacción vasovagal pero, eventualmente, pueden
ser el resultado de un efecto directo de la droga. Los tratamientos
de auxilio para estas manifestaciones deben estar al alcance del
profesional para el caso de ser necesaria una acción rápida.
Prácticamente no existe la alergia a los anestésicos locales del tipo
amida.; a pesar de que sean factibles son extremamente raras las
reacciones alérgicas documentadas y reproducibles. Las
manifestaciones alérgicas suaves se caracterizan por lesiones
cutáneas, urticaria, edema. Las reacciones anafilácticas son
sumamente raras. Las manifestaciones neurológicas, por ejemplo
deficiencia neurológica persistente, asociadas al uso de
anestésicos locales pueden estar relacionadas a la técnica
utilizada, la dosis total de anestésico administrada, la vía de
administración y las condiciones físicas del paciente. Puede
ocurrir parestesia con el uso de ALPHACAINE.
En casos de eventos adversos, notifique al Sistemas de
Notificaciones en Vigilancia Sanitaria – NOTIVISA, disponible
en www.anvisa.gov.br/hotsite/notivisa/index.htm, o para la
Vigilancia Sanitaria del Estado o del Municipio.
10. SOBREDOSIS
Reacciones generalizadas del SNC o reacciones cardiovasculares
generalmente están relacionadas con altos niveles plasmáticos por
causa de una inyección intravascular accidental o sobredosis. (Ver
Advertencias y Acciones Adversas). Los primeros señales y
síntomas de la intoxicación por lidocaína pueden incluir
somnolencia lo que puede llevar a la pérdida de la conciencia y
parada respiratoria. En estos casos se debe proceder de la siguiente
manera:
- Coloque al paciente en posición supina. Levántele las piernas con
una inclinación de 30° a 45º sobre la horizontal.
- Asegúrese de que haya pasaje de aire. Si la ventilación es
inadecuada, ventile al paciente con oxígeno (si es posible).
- Si el pulso está bajo (< 40) o no lo puede determinar, comience a
hacerle masaje cardíaco externo.
- El tratamiento de auxilio de la deficiencia circulatoria puede
necesitar la administración de líquidos por vía intravenosa (suero).
En caso de intoxicación llame al 0800 722 6001, si necesitar
más ayuda.
VENTA BAJO PRESCRIPCIÓN MÉDICA
PRODUCTO DE USO EXCLUSIVAMENTE
PROFESIONAL
Aprobada por ANVISA en 21/05/2013.
ALPHACAINE 1:50,000 / 1:80,000 / 1:100,000 / 1:200,000
Lidocaine Hydrochloride + Epinephrine
ENGLISH
PRESENTATIONS:
- Sterile injectable solution of Lidocaine Hydrochloride 2%
(20mg/mL) +Epinephine 20µg /mL packaged in glass cartridge of
1,8 mL. Each package contains 50 cartridges.
- Sterile injectable solution of Lidocaine Hydrochloride 2%
(20mg/mL) +Epinephine 12.5µg /mL packaged in glass cartridge
of 1,8 mL. Each package contains 50 cartridges.
- Sterile injectable solution of Lidocaine Hydrochloride 2%
(20mg/mL) +Epinephine 10µg /mL packaged in glass cartridge of
1,8 mL. Each package contains 50 cartridges.
- Sterile injectable solution of Lidocaine Hydrochloride 2%
(20mg/mL) +Epinephine 5µg /mL packaged in glass cartridge of
1,8 mL. Each package contains 50 cartridges.
USE ONLY IN INFILTRATION OR NERVE BLOCK VIA
SUBMUCOSA AND INTRAORAL.
FOR ADULT AND/OR PEDIATRIC USE
COMPOSITION:
Each mL of ALPHACAINE 1:50,000 injection contains:
Lidocaine hydrochloride.......................................20.0 mg
Epinephrine .........................................................20.0µg
Excipients e.f.........................................................1.0 mL
Excipients: Sodium Bisulfite, Sodium Chloride and Water
for Injection.
Each mL of ALPHACAINE 1:80,000 injection contains:
Lidocaine hydrochloride......................................20.0 mg
Epinephrine ........................................................12.5µg
Excipients e.f........................................................1.0 mL
Excipients: Sodium Bisulfite, Sodium Chloride and Water
for Injection.
Each mL of ALPHACAINE 1:100,000 injection contains:
Lidocaine hydrochloride......................................20.0 mg
Epinephrine ........................................................10.0µg
Excipients e.f........................................................1.0 mL
Excipients: Sodium Bisulfite, Sodium Chloride and Water
for Injection.
Each mL of ALPHACAINE 1:200,000 injection contains:
Lidocaine hydrochloride......................................20.0 mg
Epinephrine ..........................................................5.0µg
Excipients e.f........................................................1.0 mL
Excipients: Sodium Bisulfite, Sodium Chloride and Water
for Injection.
TECHNICAL INFORMATION FOR HEALTH CARE
PROFESSIONALS
1. INDICATIONS
The product is indicated for local anesthesia by nerve block or
infiltration, for general dental interventions, multiple extractions,
immediate dentures and endodontic and periodontal procedures
simple and complex.
2. EFFICACY RESULTS
Several clinical studies have been conducted in order to evaluate
the ability of anesthetics to block conduction in nerve axons of the
peripheral nervous system (Friedman, P.M. and others:
Comparative study of the efficacy of four topical anesthetics,
Dermatol Surg 25:12, 1999/Buckley, J.A.; Ciancio, S.G.; Mc
Mullen, J.A.: Efficacy of epinephrine concentration in local
anesthesia during periodontal surgery, J. Periodontol 55:653-657,
1984) and its efficacy in provide anesthesia when associated to
several vasoconstrictor (Jacob, W.: Local anaesthesia and
vasoco nstrictive additional components, Newslett Int Fed Dent
Anesthesiol Soc 2(1):3, 1989/Bennett, C.R.: Monheim's local
anesthesia and pain control in dental practice, ed 7, St. Louis,
1983, Mosby-Year Book).
3. PHARMACOLOGY
Lidocaine Hydrochloride
Classification: Amide
Other names: Xylocaine
Chemical formula: 2-Diethylamino 2',6-acetoxylidide
hydrochloride.
Potency: 2 (procaine = 1)
Toxicity: 2 (in comparison with procaine)
Mechanism of action: Promotes local anesthesia through the
stabilization of neuronal membranes, inhibiting the ionic flux
required for the onset and conduction of impulses.
Absorption: Lidocaine is completely absorbed following
parenteral administration and its margin of absorption depends on
the site of administration and the presence or otherwise of
vasoconstrictors. The link between plasma and lidocaine depends
on the concentration of the drug and the linked fraction decreases
in accordance with the increase of concentration. It crosses the
blood-brain and placentary barriers, presumably via passive
diffusion.
Metabolism: It is metabolized in the liver by the microsomal
fixed-functions oxidases, to monoethylglyceine and xylidide;
xylidide is a local anesthetic and potentially toxic.
Excretion: Via the kidneys; less than 10% unchanged, more than
80% various metabolites.
Vasodilating properties: Considerably less than those of
procaine; however, more than those of prilocaine or mepivacaine.
Onset of action: Rapid (2 to 3 minutes).
Anesthetic half-life: 1.6 hours.
Topical anesthetic action: Yes (in clinically acceptable
concentrations).
Epinephrine
Other chemical names: Adrenaline
It is a sympathomimetic amine, being chemically recognized as
3,4-dihydroxi (methylamino) methyl benzilic alcohol. It acts on
both á- and â-adrenergic receptors, where â effects predominate. It
has been used in minimal concentrations which permit a prolonged
anaesthetic effect, necessary for lengthy surgical interventions or
where major bleeding occurs.
4. CONTRAINDICATIONS
ALPHACAINE is contraindicated in patients with a known
history of hypersensitivity to local anesthetics of the amide type or
to any other substance present in formula and in patients receiving
drugs known to produce blood pressure alterations, as MAO
inhibitors, tricyclic antidepressants and phenothiazines.
5. WARNINGS AND PRECAUTIONS
The safety and efficacy of local anesthetics depend on the
recommended dosage, the correct technique employed, the
previous anamnesis, the appropriate precautions taken and the
fastness and qualification of the health care professional during
emergencies. It should be used the lowest doses that are able to
provide efficient anesthesia.
The administration of frequent doses of lidocaine may cause a
sharp increase of levels in the blood with each additional dose, due
to the increase of the drug, its metabolites or to slow metabolic
breakdown. Tolerance may vary depending on the patient's state,
those debilitated by old age or serious illnesses or children should
be given reduced doses, calculated in accordance with their age
and physical condition.
Special care is recommended in frequent application in patients
with serious kidney or liver problems due to their inability to
normally metabolize the anesthetic drug, thereby being subject to
the risk of toxic concentrations in the plasma. Special care should
be taken in the administration of local anesthetics in patients with
known drug sensitivities or allergies to any of the substances in the
formula.
Patients with hypertension, coronary or cardiovascular problems
(particularly related to sequela of acute rheumatic fever), must
avoid the use of anesthetics containing vasoconstrictors as
ALPHACAINE. In patients with peripheral vascular disease,
there is a little potential risk that vasoconstrictors cause ischemic
injury or local necrosis. The presence of Sodium Bisulfite in the
formula must be taken into account when treating patients who are
susceptible to asthma. Parents should be advised, as well as people
liable for patients with mental disturbance, to observe them, in
order to avoid possible inadvertent trauma to the lips. This product
is not to be used if the solution is yellowish or with particles.
In elderly patients, in who the metabolic, renal and hepatic
functions are usually diminished, care must be taken in terms of
administering the smallest necessary dose that is enough for
providing a specific kind of anesthesia. Care should be taken in the
use of ALPHACAINE in patients with liver or kidney problems
and in patients susceptible to asthma.
The use in children under 10 years old should follow the
recommendations described in Dosage.
There aren't available adequate and well-controlled studies in
pregnant and breastfeeding women so ALPHACAINE must be
used, in this risk group, carefully and under professional
supervision.
There is no data available on the possible excretion of lidocaine in
human milk and as many drugs are excreted in this way, it is
recommended special caution when this product is administered to
mothers during the breastfeeding period.
6. DRUG INTERACTIONS
According to studies undertaken by P. Henry and J. Van der
Driessche of the pharmacology laboratory of the Rennes
University Hospital Center, the use of local anesthetic associated
with the consumption of alcohol and/or tranquilizing medication
directly interferes in the efficiency of the anesthetic, potentially
increasing or decreasing its time of action and potency.
ALPHACAINE should not be used in patients in treatment with
drugs known to affect blood pressure, as monoamine oxidase
inhibitors, tricyclic antidepressants or phenothiazines. Serious
cardiac arrhythmia may occur if preparations containing
vasoconstrictors are used in patients during or after the
administration of halotane, trichloroethylene, cyclopropane or
chloroform. Concurrent administration of vasopressor drugs and
ergot-type oxytocic drugs may cause severe, persistent
hypertension or cerebrovascular accidents.
7. STORAGE CONDITIONS
Excessive heat (temperature above 40°C) must be avoided, protect
from light.
The expiry date of this produc t is equivalent to 24 months after
manufacturing date.
Batch number and manufacturing and expiry date: see
product box.
Do not use medicine with expiry date. Store in its original
package.
Before use, observe the medicine aspect.
Every drug should be kept out of the reach of children.
8. DOSAGE AND HOW TO USE
As occurs with all local anesthetics, dosages vary and depend on
the area to be anesthetized, the vascularity of tissues, the number of
nerve segments to be blocked, the individual tolerance and the
technique of anesthesia. The least volume of injection that results
in effective local anesthesia should be administered. The
necessary dosage must be determined on an individual basis. The
maximum dosage suggested by the Council on Dental
Therapeutics of the American Dental Association and the USP
Convention is 4.4 mg/kg for lidocaine with or without a
vasoconstrictor additive. This dose still allows for a significant
volume of drug to be used to achieve profound clinical anesthesia
with a somewhat diminished risk of development of toxic
(overdose) reactions. For children of less than ten years who have a
normal lean body mass and normal body development, the
maximum dose may be determined by the application of one of the
standard pediatric drug formulas (e.g., Clark's rule). The
maximum recommended dosage of epinephrine is 0.2 mg (or the
equivalent to 5.5 cartridges of ALPHACAINE 50, 8.8 cartridges
of ALPHACAINE 80 or 11 cartridges of ALPHACAINE 100)
for healthy adult patients. The maximum recommended dosage for
epinephrine-sensitive patients, such as ASA III and ASA IV and
clinically hyperthyroid patients, is 0.04 mg of epinephrine (1
cartridge of ALPHACAINE 50, 1and ½ cartridge of
ALPHACAINE 80 or 2 cartridges of ALPHACAINE 100) per
appointment. In oral infiltration and/or mandibular block, initial
dosages of 1.0-5.0 ml of lidocaine (1/2 to 21/2 cartridges of
ALPHACAINE) are usually effective. In children under 10 years
of age it is rarely necessary to administer more than one-half
cartridge of ALPHACAINE (0.9 to 1.0 ml of lidocaine) per
procedure, to achieve local anesthesia for a procedure involving a
single tooth. During administration, it is recommended to perform
a slight aspiration in order to avoid the risks of intravenous
injection.
Maximum dose: 4.4 mg of lidocaine hydrochloride/kg and 0.2
mg of epinephrine/kg
(Each 1.8 ml cartridge contains 36 mg of lidocaine
hydrochloride)
Weight
Number of
(Kg) ALPHACAINE 50
Cartridges
1 (44 mg)
10
2 (88 mg)
20
3,5 (132 mg)
30
40 40 4,5 (176 mg)
6 (220 mg)
50
6 (220 mg)
60
6 (220 mg)
70
6 (220 mg)
80
6 (220 mg)
90
6 (220 mg)
100
Number of
Number of
Number of
ALPHACAINE 80 ALPHACAINE 100 ALPHACAINE 200
Cartridges
Cartridges
Cartridges
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
1 (44 mg)
2 (88 mg)
3,5 (132 mg)
40 4,5 (176 mg)
6 (220 mg)
7 (264 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
8 (300 mg)
Doses indicated are the maximum suggested for normal healthy
individuals: they should be decreased for debilitated or elderly
patients.
It is recommended that chemical disinfection of the cartridge cap
be accomplished by wiping it thoroughly with a pledget of cotton
that has been moistened with 70% ethyl alcohol just prior to use.
Immersion is not recommended. During administration, it is
recommended to perform a slight aspiration in order to avoid the
risks of an undesirable intra-vascular injection. However, it should
be noted that the absence of blood in the syringe does not guarantee
that intravascular injection was avoided and a double aspiration is
always recommended. Cartridges partially used should not be
reused.
9. ADVERSE REACTIONS
Side effects following lidocaine administration are similar to those
observed in other amide-based anesthetics. Adverse reactions are
normally the result of high plasma levels caused by excessive
dosage, rapid absorption or unintentional intra-vascular injection,
or may result from hypersensitivity, idiosyncrasy, or reduced
tolerance on the part of the patient. Effects involving
cardiovascular and central nervous systems may occur. Reactions
in the CNS are exciting and/or depressing and may be
characterized by photo-phobia, irritability, apprehension,
euphoria, confusion, dizziness, drowsiness, ringing in the ears,
blurred vision, vomiting, burning sensation, cold or numbness,
loss of consciousness, respiratory depression and arrest.
Cardiovascular reactions are normally depressive and
characterized by bradycardia, hypertension and cardiovascular
collapse, which may lead to cardiac arrest. Signs and symptoms of
a depressed cardiovascular system are commonly the result of a
vasovagal reaction but may also be the result of a direct effect of
the drug. The health care professional should have support
treatments for these reactions available within easy reach so as to
effect a rapid response if, and when, necessary. Resuscitative
equipment, oxygen, and other resuscitative drugs should be
available for immediate use. Allergy to amide local anesthetics is
virtually nonexistent; true, documented and reproducible allergic
reactions are extremely rare, though possible. Mild allergic
reactions may include cutaneous lesions, itchiness and edema.
Anaphylactic reactions are extremely rare. Neurological
reactions, as persistent neurological deficiency, associated with
the use of local anesthetics may be related to the technique used,
the total dose of anesthetic administered, the route of
administration and the patient's physical condition. Paresthesia
may occur using ALPHACAINE.
In case of adverse events, notify the Health Surveillance
Notifications System – NOTIVISA, available at
www.anvisa.gov.br/hotsite/notivisa/index.htm, or the Health
Surveillance of State or City.
10. OVERDOSE
Generalized reactions in the central nervous system or
cardiovascular reactions are generally related to high plasmatic
levels due to accidental intravenous injection or overdose (See
Warnings and Adverse R eactions). The first signs and symptoms
of lidocaine overdose may be drowsiness, leading to a loss of
consciousness and respiratory arrest.
In such cases, the following procedure should be followed:
- Place the patient in the supine position. Raise the legs 30-45
above horizontal level.
- The passage of air must be ensured. If the ventilation is
inadequate, ventilate the patient with oxygen if possible.
- If the pulse is weak (<40) or non-determinable, initiate external
cardiac massage.
- Support treatment of circulatory deficiency may require the
intravenous administration of parenteral solutions (saline).
In case of poisoning call 0800 722 6001, if you need further
informations.
SALES UNDER MEDICAL PRESCRIPTION
FOR PROFESSIONAL USE ONLY
Approved by ANVISA in 21/05/2013.
Fabricado e distribuído por/ Fabricado y distribuido por/
Manufactured and distributed by:
Estrada do Guerenguê, 2059 - Rio de Janeiro/RJ - Brasil
CEP: 22713-002
CNPJ : 33.112.665/0001-46
Indústria Brasileira/Industria Brasileña/Made in Brazil
SAC: 0800 602 68 80
Fax: 55 (21) 3342-4009
www.dfl.com.br - [email protected]
Farmacêutico Responsável/Farmacéutico Responsable/
Pharmacist in Charge:
Evaldo Rodrigues de Oliveira
CRF-RJ N°: 2897
MS N°: 101770016
consumo de alcohol y de medicamentos tranquilizantes interfiere
directamente en la eficiencia del anestésico ya sea aumentando o
disminuyendo su tiempo de acción o afectando su potencia.
ALPHACAINE no se debe usar en pacientes que hagan uso de
medicamentos provocan alteraciones de la presión arterial como
inhibidores de la monoaminooxidase (MAO), antidepresivos
tricíclicos y fenotiacinas. Pueden ocurrir serias arritmias
cardíacas si se emplean preparaciones con vasoconstrictores
durante o después de la administración de halotano,
tricloroetileno, ciclopropano o cloroformo. La administración
simultánea de fármacos vasopresores y de drogas oxitócicas del
tipo ergot puede causar hipertensión severa persistente o
accidentes vasculares cerebrales.
Rev. 12