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ISOVUE-M
Overview
What is ISOVUE-M?
ISOVUE-M (lopamidol Injection) formulations
are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal
administration.
Each
mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol
with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution
contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically
bound iodine per mL.
Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg
iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium.
The solution contains approximately 0.043 mg (0.002 mEq) sodium and
300 mg organically bound iodine per mL.
The pH of ISOVUE-M contrast media has bean
adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide.
Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol
Injection) is hypertonic as compared to plasma and cerebrospinal fluid
(approximately 285 and 301 mOsm/kg water, respectively).
lopamidol is designated
chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide.
Structural formula:
What does ISOVUE-M look like?
What are the available doses of ISOVUE-M?
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What should I talk to my health care provider before I take ISOVUE-M?
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How should I use ISOVUE-M?
ISOVUE-M (lopamidol Injection)
is indicated for intrathecal administration in adult neuroradiology
including myelography (lumbar, thoracic, cervical, total columnar),
and for contrast enhancement of computed tomographic (CECT) cisternography
and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated
for thoraco-lumbar myelography in children over the age of two years.
In a solution that is
approximately isotonic (ISOVUE-M 200) is recommended for examination
of the lumbar region. For movement of the contrast medium to distant
target areas the more concentrated ISOVUE-M 300 preparation should
be used to compensate for dilution of ISOVUE-M (lopamidol Injection)
with cerebrospinal fluid.
The usual recommended adult dose range for iopamidol is 2000-3000
mg iodine. Iopamidol formulated to contain more than 300 mgl/mL should
not be used intrathecally in adults. The minimum dose needed to perform
a procedure should always be used.
In a solution
that is approximately isotonic (ISOVUE-M 200) is recommended for all
intrathecal procedures. In children, loss of contrast due to mixing
on movement of the medium is less apt to occur because of their shorter
spinal cord.
The usual
recommended pediatric dose range for iopamidol is 1400-2400 mg iodine.
Iopamidol formulated to contain more than 200 mgl/mL should not be
used intrathecally in children. The minimum dose needed to perform
a procedure should always be used. See .
Anesthesia is not necessary. However, young
children may require general anesthesia for technical reasons. Premedication
with sedatives or tranquillizers is usually not needed. In patients
with a history of seizure activity who are not on anticonvulsant therapy,
premedication with barbiturates or phenytoin should be considered.
Lumbar puncture is usually made
between L3 and L4; if pathology is suspected at this level, the interspace
immediately above or below may be selected. A lateral cervical puncture
may also be used.
Rate of Injection:
An interval of at least 48 hours should be
allowed before repeat examination; however, whenever possible five
to seven days is recommended.
As with all radiopaque contrast agents,
only the lowest dose of ISOVUE-M necessary to obtain adequate visualization
should be used. A lower dose reduces the possibility of an adverse
reaction. Most procedures do not require use of either a maximum dose
or the highest available concentration of ISOVUE-M; the combination
of dose and ISOVUE-M concentration to be used should be carefully
individualized, and factors such as age, body size, anticipated pathology
and degree and extent of opacification required, structure(s) or area
to be examined, disease processes affecting the patient, and equipment
and technique to be employed should be considered.
Following are the usual recommended pediatric and adult doses of
ISOVUE-M.
The
pediatric doses listed below, intended as a guideline, are based on
age rather than weight because the brain and CSF capacity is independent
of weight. Variations will depend on such factors as height, suspected
pathology, the patient’s condition, technique used, etc. (e.g. CT
or standard radiology or movement of the contrast media directed distal
to the site of injection).
Following subarachnoid
injection, conventional radiography will continue to provide good
diagnostic contrast for at least 30 minutes. At about one hour, diagnostic
degree of contrast will not usually be available. However, sufficient
contrast for CT myelography will be available for several hours. CT
myelography following conventional myelography should be deferred
for at least four hours to reduce the degree of contrast.
Aspiration of iopamidol is unnecessary
following intrathecal administration (see ).
Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Iopamidol solutions should
be used only if clear and within the normal colorless to pale yellow
range. Discard any product
which shows signs of crystallization or damage to the container-closure
system, which includes the glass container, stopper and/or crimp.
It is desirable that solutions
of radiopaque diagnostic agents for intrathecal use be at body temperature
when injected. Withdrawal of contrast agents from their containers
should be accomplished under aseptic conditions with sterile syringes.
Spinal puncture must always be performed under sterile conditions.
Patients should be well
hydrated prior to and following ISOVUE-M (Iopamidol Injection) administration.
What interacts with ISOVUE-M?
Intrathecal administration of corticosteroids with iopamidol is contraindicated. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see interval recommendation under ). Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.
What are the warnings of ISOVUE-M?
Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
The need for myelographic examination
should be carefully evaluated. Iopamidol should be administered with
caution in patients with increased intracranial pressure or suspicion
of intracranial tumor, abscess or hematoma, those with a history of
convulsive disorder, severe cardiovascular disease, chronic alcoholism,
or multiple sclerosis, and elderly patients.
Particular attention must be given to state
of hydration, concentration of medium, dose, and technique used in
these patients.
Contrast
media may promote sickling in individuals who are homozygous for sickle
cell disease when injected intravenously or intra-arterially. Although
ISOVUE-M is not injected intravascularly, measurable plasma levels
are attained after intrathecal administration of iopamidol.
If frankly bloody cerebrospinal
fluid is observed, the possible benefits of a myelographic examination
should be considered in terms of risk to the patient.
Patients on anticonvulsant medication should
be maintained on this therapy.
Direct intracisternal or ventricular administration
for standard radiography (without computerized tomographic enhancement)
is not recommended. Inadvertent intracranial entry of a large or concentrated
bolus of the contrast medium, which increases the risk of neurotoxicity,
can be prevented by careful patient management. Also, effort should
be directed to avoid rapid dispersion of the medium causing inadvertent
rise to intracranial levels (e.g., by active patient movement). If
such intracranial entry of the medium occurs, prophylactic anticonvulsant
treatment with diazepam or barbiturates orally for 24 to 48 hours
should be considered.
Use of medications that may lower the seizure threshold (phenothiazine
derivatives, including those used for their antihistaminic properties;
tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics;
antipsychotic agents) should be carefully evaluated. While the contributory
role of such medications has not been established, some physicians
have discontinued these agents at least 48 hours before and for at
least 24 hours following intrathecal use.
Focal and generalized motor seizures have
been reported after intrathecal use of water-soluble contrast agents
including iopamidol. In several of those cases reported with iopamidol,
higher than recommended doses were employed. Therefore
Severe Cutaneous
Adverse Reactions
- Deviations from recommended neuroradiologic procedure or patient management.
- Use in patients with a history of epilepsy unless medically justified.
- Overdosage.
- Intracranial entry of a bolus or premature diffusion of a high concentration of the medium.
- Failure to maintain elevation of the head during the procedure, on the stretcher, and in bed.
- Excessive and particularly active patient movement or straining.
What are the precautions of ISOVUE-M?
General
Diagnostic
procedures which involve the use of any radiopaque agent should be
carried out under the direction of personnel with the prerequisite
training and with a thorough knowledge of the particular procedure
to be performed. Appropriate facilities should be available for coping
with any complication of the procedure, as well as for emergency treatment
of severe reaction to the contrast agent itself. After parenteral
administration of a radiopaque agent, competent personnel and emergency
facilities should be available for at least 30 to 60 minutes since
severe delayed reactions may occur.
Preparatory dehydration is dangerous and may
contribute to acute renal failure in patients with advanced vascular
disease, diabetic patients, and in susceptible nondiabetic patients
(often elderly with preexisting renal disease).
The possibility of
a reaction, including serious, life-threatening, fatal, anaphylactoid
or cardiovascular reactions, should always be considered (see ). Patients at increased
risk include those with a history of a previous reaction to a contrast
medium, patients with a known sensitivity to iodine per se, and patients
with a known clinical hypersensitivity (bronchial asthma, hay fever,
and food allergies). The occurrence of severe idiosyncratic reactions
has prompted the use of several pretesting methods. However, pretesting
cannot be relied upon to predict severe reactions and may itself be
hazardous for the patient. It is suggested that a thorough medical
history with emphasis on allergy and hypersensitivity, prior to the
injection of any contrast medium, may be more accurate than pretesting
in predicting potential adverse reactions. A positive history of allergies
or hypersensitivity does not arbitrarily contraindicate the use of
a contrast agent where a diagnostic procedure is thought essential,
but caution should be exercised. Premedication with antihistamines
or corticosteroids to avoid or minimize possible allergic reactions
in such patients should be considered (see ). Reports indicate that such pretreatment
does not prevent serious life-threatening reactions, but may reduce
both their incidence and severity.
The possibility of inducing bacterial meningitis
in patients during intrathecal procedures should always be considered.
To avoid bacterial contamination during spinal puncture, a sterile
field should be maintained at all times.
If nondisposable equipment is used, scrupulous
care should be taken to prevent residual contamination with traces
of cleansing agents.
Information for Patients
- Inform your physician if you are pregnant.
- Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or known thyroid disorder.
- Inform your physician if you are allergic to any drugs, food, or if you had any reactions to previous injections of substances used for x-ray procedures (see ).
- Inform your physician about any other medications you are currently taking, including nonprescription drugs, before you have this procedure.
- Advise patients to inform their physician if they develop a rash after receiving Isovue-M.
Patients receiving injectable radiopaque diagnostic agents should be instructed to:
Drug Interactions
Other drugs should not be admixed with iopamidol (see ).
Drug/Laboratory Test Interactions
The results of PBI and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. However, thyroid function tests not depending on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.
Any test which might be affected by contrast media should be performed prior to administration of the contrast medium.
Laboratory Test Findings
In vitro
Transitory changes may occur in red cell and leucocyte counts, serum calcium, serum creatinine, serum glutamic oxalacetic transaminase (SGOT), and uric acid in urine; transient albuminuria may occur.
These findings have not been associated with clinical manifestations.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. No evidence of genetic toxicity was obtained tests.
Pregnancy:
p20881301426566792
Pregnancy Category B
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when iopamidol is administered to a nursing woman.
Pediatric Use
See section.
What are the side effects of ISOVUE-M?
The most frequently reported adverse
reactions following intrathecal administration of iopamidol are headache,
nausea, vomiting, and musculoskeletal pain. These reactions usually
occur 1 to 10 hours after injection, almost all occurring within 24
hours. They are usually mild to moderate in degree, lasting for a
few hours and usually disappearing within 24 hours. Rarely, headaches
may be severe or persist for days. Headache is often accompanied by
nausea and vomiting, and tends to be more frequent and persistent
in patients not optimally hydrated. Backache, neck stiffness, numbness
and paresthesias, leg or sciatic-type pain occurred less frequently,
often in the form of a transient exacerbation of preexisting symptomatology.
Transient alterations in vital signs may occur and their significance
must be assessed on an individual basis.
The following table of incidence of reactions
is based on clinical studies with ISOVUE-M (lopamidol Injection) in
about 686 patients.
Other adverse effects reported
in clinical literature for iopamidol include facial neuralgia, tinnitus,
and sweating.
Major
motor seizures have been reported in the clinical literature and since
market introduction in the United States. Early onset of seizures
(less than two hours) is indicative of early substantial intracranial
entry. Transitory EEG changes occur and usually take the form of slow
wave activity.
While
not observed in controlled clinical studies with ISOVUE-M (lopamidol
Injection), the following adverse reactions may occur because they
have been reported with ISOVUE-M and other nonionic water soluble
contrast agents: cardiovascular (arrhythmias); pulmonary (apnea);
bacterial meningitis, and aseptic meningitis syndrome; allergy or
idiosyncrasy (chills, pruritus, nasal congestion, Guillain-Barre syndrome);
CNS irritation (psycho-organic syndrome: mild and transitory perceptual
aberrations such as depersonalization, anxiety, depression, hyperesthesia,
disturbances in speech, sight, or hearing, and disorientation; in
addition, hyperreflexia or areflexia, hypertonia or flaccidity, restlessness,
tremor, echoacousia, echolalia, asterixis or dysphasia have occurred).
Profound mental disturbances have rarely been reported (various forms
and degrees of aphasia, mental confusion or disorientation); the onset
is usually at 8 to 10 hours and lasts for about 24 hours without aftereffects.
However, occasionally they have been manifest as apprehension, agitation
or progressive withdrawal to the point of stupor or coma. In a few
cases, these have been accompanied by transitory hearing loss or other
auditory symptoms and visual disturbances (believed subjective or
delusional). Persistent cortical loss of vision in association with
convulsions, and ventricular block have been reported. Rarely, persistent
though transitory weakness in the leg or ocular muscles has been reported. have been rare and transitory. They
include sensory and/or motor or nerve root disturbances, myelitis,
persistent leg muscle pain or weakness, or sixth nerve palsy, or cauda
equina syndrome. Muscle cramps, fasciculation or myoclonia, spinal
convulsion, paralysis, or spasticity are unusual.
| Estimated Overall Incidence | |||
|---|---|---|---|
| System | > 1% | ≤ 1% | |
| Body as a Whole | headache (16.4%) | pyrexiamuscle weaknesshot flashesmalaisefatigueweakness | |
| Digestive | nausea (7.3%)vomiting (3.6%) | diarrheaheartburn | |
| Musculoskeletal | back pain (2.2%)leg pain (1.4%)neck pain (1.1%) | leg crampssciaticacervicobrachial irritationmeningeal irritationradicular irritation lumbosacralother musculoskeletal paininvoluntary movementburning sensation | |
| Cardiovascular | hypotension (1.1%) | tachycardiahypertensionchest pain | |
| Nervous | none | emotional stressdizzinessparesthesiaconfusionhallucinationslightheadednesssyncopenumbnesscold extremitiesataxiairritability | |
| Urogenital | none | urinary retention | |
| Respiratory | none | dyspnea | |
| Skin and Appendages | none | rash | |
| Miscellaneous | none | injection site pain |
General Adverse Reactions To Contrast Media
Reactions known to occur with parenteral administration of iodinated ionic contrast agents (see the listing below) are possible with any nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of other water-soluble intravascularly administered contrast agents are mild to moderate in degree. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Reported incidences of death from the administration of other iodinated contrast media range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. The incidence of shock is estimated to be 1 out of 20,000 (0.005 percent) patients.
Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions. Chemotoxic reactions result from the physicochemical properties of the contrast medium, the dose, and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category. During intrathecal use, there is a lower incidence of electroencephalographic changes as well as neurotoxicity by virtue of the intrinsic properties of the iopamidol molecule.
Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of drug injected, the speed of injection, the mode of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.
The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that for the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations. Most adverse reactions to intravascular contrast agents appear within one to three minutes after the start of injection, but delayed reactions may occur (see ).
Because measurable plasma levels are attained following the intrathecal administration of iopamidol, adverse reactions reported with the use of intravascular contrast agents are theoretically possible. These include:
Cardiovascular:
Digestive:
Nervous:
Respiratory:
Urogenital:
Special Senses:
Endocrine:
Skin and Subcutaneous Tissue Disorders
The following reactions may also occur: neutropenia, thrombophlebitis, flushing, pallor, weakness, severe retching and choking, wheezing, cramps, tremors, and sneezing.
What should I look out for while using ISOVUE-M?
Intrathecal administration of
corticosteroids with iopamidol is contraindicated. Because of overdosage
considerations, immediate repeat myelography in the event of technical
failure is contraindicated (see interval recommendation under ). Myelography
should not be performed in the presence of significant local or systemic
infection where bacteremia is likely.
The need for myelographic examination
should be carefully evaluated. Iopamidol should be administered with
caution in patients with increased intracranial pressure or suspicion
of intracranial tumor, abscess or hematoma, those with a history of
convulsive disorder, severe cardiovascular disease, chronic alcoholism,
or multiple sclerosis, and elderly patients.
Particular attention must be given to state
of hydration, concentration of medium, dose, and technique used in
these patients.
Contrast
media may promote sickling in individuals who are homozygous for sickle
cell disease when injected intravenously or intra-arterially. Although
ISOVUE-M is not injected intravascularly, measurable plasma levels
are attained after intrathecal administration of iopamidol.
If frankly bloody cerebrospinal
fluid is observed, the possible benefits of a myelographic examination
should be considered in terms of risk to the patient.
Patients on anticonvulsant medication should
be maintained on this therapy.
Direct intracisternal or ventricular administration
for standard radiography (without computerized tomographic enhancement)
is not recommended. Inadvertent intracranial entry of a large or concentrated
bolus of the contrast medium, which increases the risk of neurotoxicity,
can be prevented by careful patient management. Also, effort should
be directed to avoid rapid dispersion of the medium causing inadvertent
rise to intracranial levels (e.g., by active patient movement). If
such intracranial entry of the medium occurs, prophylactic anticonvulsant
treatment with diazepam or barbiturates orally for 24 to 48 hours
should be considered.
Use of medications that may lower the seizure threshold (phenothiazine
derivatives, including those used for their antihistaminic properties;
tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics;
antipsychotic agents) should be carefully evaluated. While the contributory
role of such medications has not been established, some physicians
have discontinued these agents at least 48 hours before and for at
least 24 hours following intrathecal use.
Focal and generalized motor seizures have
been reported after intrathecal use of water-soluble contrast agents
including iopamidol. In several of those cases reported with iopamidol,
higher than recommended doses were employed. Therefore
Severe Cutaneous
Adverse Reactions
What might happen if I take too much ISOVUE-M?
A dose of 3000 mgl in adults and
2400 mgl in children is sufficient for most myelographic procedures.
Doses above these levels may result in an increased frequency and
severity of adverse reactions including seizures. However, in myelography,
even use of a recommended dose can produce mental aberrations tantamount
to overdosage, if incorrect management of the patient during or immediately
following the procedure permits inadvertent early intracranial entry
of a large portion of the medium.
Treatment of an overdose of an injectable
radiopaque contrast medium is directed toward the support of all vital
functions, and prompt institution of symptomatic therapy.
How should I store and handle ISOVUE-M?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.ISOVUE-M 200 (lopamidol Injection 41%)Ten 10 mL single dose vials (NDC 0270-1411-11)Ten 20 mL single dose vials (NDC 0270-1411-25)ISOVUE-M 300 (lopamidol Injection 61%)Ten 15 mL single dose vials (NDC 0270-1412-15)ISOVUE-M 200 (lopamidol Injection 41%)Ten 10 mL single dose vials (NDC 0270-1411-11)Ten 20 mL single dose vials (NDC 0270-1411-25)ISOVUE-M 300 (lopamidol Injection 61%)Ten 15 mL single dose vials (NDC 0270-1412-15)ISOVUE-M 200 (lopamidol Injection 41%)Ten 10 mL single dose vials (NDC 0270-1411-11)Ten 20 mL single dose vials (NDC 0270-1411-25)ISOVUE-M 300 (lopamidol Injection 61%)Ten 15 mL single dose vials (NDC 0270-1412-15)ISOVUE-M 200 (lopamidol Injection 41%)Ten 10 mL single dose vials (NDC 0270-1411-11)Ten 20 mL single dose vials (NDC 0270-1411-25)ISOVUE-M 300 (lopamidol Injection 61%)Ten 15 mL single dose vials (NDC 0270-1412-15)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacokinetics of intravenously administered
iopamidol in normal subjects conform to an open two-compartment model
with first order elimination (a rapid alpha phase for drug distribution
and a slow beta phase for drug elimination). The elimination serum
or plasma half-life is approximately two hours; the half-life is not
dose dependent. No significant metabolism, deiodination, or biotransformation
occurs.
Iopamidol is
rapidly absorbed into the bloodstream from cerebrospinal fluid (CSF);
following intrathecal administration, iopamidol appears in plasma
within one hour and virtually all of the drug reaches the systemic
circulation within 24 hours. Iopamidol is excreted mainly through
the kidneys following intrathecal administration, and the drug is
essentially undetectable in the plasma 48 hours later. In patients
with impaired renal function, the elimination half-life is prolonged
dependent upon the degree of impairment. In the absence of renal dysfunction,
the cumulative urinary excretion for iopamidol, expressed as a percentage
of administered intravenous dose is approximately 35 to 40 percent
at 60 minutes, 80 to 90 percent at 8 hours, and 90 percent or more
in the 72- to 96-hour period after administration. In normal subjects,
approximately 1 percent or less of the administered dose appears in
cumulative 72- to 96-hour fecal specimens.
Iopamidol displays little tendency to bind
to serum or plasma proteins.
No evidence of complement
activation has been found in normal subjects.
Animal studies indicate that iopamidol does
not cross the blood-brain barrier to any significant extent following
intravascular administration.
Non-Clinical Toxicology
Intrathecal administration of corticosteroids with iopamidol is contraindicated. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see interval recommendation under ). Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.The need for myelographic examination should be carefully evaluated. Iopamidol should be administered with caution in patients with increased intracranial pressure or suspicion of intracranial tumor, abscess or hematoma, those with a history of convulsive disorder, severe cardiovascular disease, chronic alcoholism, or multiple sclerosis, and elderly patients.
Particular attention must be given to state of hydration, concentration of medium, dose, and technique used in these patients.
Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously or intra-arterially. Although ISOVUE-M is not injected intravascularly, measurable plasma levels are attained after intrathecal administration of iopamidol.
If frankly bloody cerebrospinal fluid is observed, the possible benefits of a myelographic examination should be considered in terms of risk to the patient.
Patients on anticonvulsant medication should be maintained on this therapy.
Direct intracisternal or ventricular administration for standard radiography (without computerized tomographic enhancement) is not recommended. Inadvertent intracranial entry of a large or concentrated bolus of the contrast medium, which increases the risk of neurotoxicity, can be prevented by careful patient management. Also, effort should be directed to avoid rapid dispersion of the medium causing inadvertent rise to intracranial levels (e.g., by active patient movement). If such intracranial entry of the medium occurs, prophylactic anticonvulsant treatment with diazepam or barbiturates orally for 24 to 48 hours should be considered.
Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated. While the contributory role of such medications has not been established, some physicians have discontinued these agents at least 48 hours before and for at least 24 hours following intrathecal use.
Focal and generalized motor seizures have been reported after intrathecal use of water-soluble contrast agents including iopamidol. In several of those cases reported with iopamidol, higher than recommended doses were employed. Therefore
Severe Cutaneous Adverse Reactions
Other drugs should not be admixed with iopamidol (see ).
Diagnostic procedures which involve the use of any radiopaque agent should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast agent itself. After parenteral administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions may occur.
Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease).
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered (see ). Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast medium, may be more accurate than pretesting in predicting potential adverse reactions. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is thought essential, but caution should be exercised. Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered (see ). Reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.
The possibility of inducing bacterial meningitis in patients during intrathecal procedures should always be considered. To avoid bacterial contamination during spinal puncture, a sterile field should be maintained at all times.
If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
The most frequently reported adverse reactions following intrathecal administration of iopamidol are headache, nausea, vomiting, and musculoskeletal pain. These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours. They are usually mild to moderate in degree, lasting for a few hours and usually disappearing within 24 hours. Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting, and tends to be more frequent and persistent in patients not optimally hydrated. Backache, neck stiffness, numbness and paresthesias, leg or sciatic-type pain occurred less frequently, often in the form of a transient exacerbation of preexisting symptomatology. Transient alterations in vital signs may occur and their significance must be assessed on an individual basis.
The following table of incidence of reactions is based on clinical studies with ISOVUE-M (lopamidol Injection) in about 686 patients.
Other adverse effects reported in clinical literature for iopamidol include facial neuralgia, tinnitus, and sweating.
Major motor seizures have been reported in the clinical literature and since market introduction in the United States. Early onset of seizures (less than two hours) is indicative of early substantial intracranial entry. Transitory EEG changes occur and usually take the form of slow wave activity.
While not observed in controlled clinical studies with ISOVUE-M (lopamidol Injection), the following adverse reactions may occur because they have been reported with ISOVUE-M and other nonionic water soluble contrast agents: cardiovascular (arrhythmias); pulmonary (apnea); bacterial meningitis, and aseptic meningitis syndrome; allergy or idiosyncrasy (chills, pruritus, nasal congestion, Guillain-Barre syndrome); CNS irritation (psycho-organic syndrome: mild and transitory perceptual aberrations such as depersonalization, anxiety, depression, hyperesthesia, disturbances in speech, sight, or hearing, and disorientation; in addition, hyperreflexia or areflexia, hypertonia or flaccidity, restlessness, tremor, echoacousia, echolalia, asterixis or dysphasia have occurred). Profound mental disturbances have rarely been reported (various forms and degrees of aphasia, mental confusion or disorientation); the onset is usually at 8 to 10 hours and lasts for about 24 hours without aftereffects. However, occasionally they have been manifest as apprehension, agitation or progressive withdrawal to the point of stupor or coma. In a few cases, these have been accompanied by transitory hearing loss or other auditory symptoms and visual disturbances (believed subjective or delusional). Persistent cortical loss of vision in association with convulsions, and ventricular block have been reported. Rarely, persistent though transitory weakness in the leg or ocular muscles has been reported. have been rare and transitory. They include sensory and/or motor or nerve root disturbances, myelitis, persistent leg muscle pain or weakness, or sixth nerve palsy, or cauda equina syndrome. Muscle cramps, fasciculation or myoclonia, spinal convulsion, paralysis, or spasticity are unusual.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).