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Trandolapril
Overview
What is Trandolapril?
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin
converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically
described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]
hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its molecular formula is
CHNO and its structural formula is
M.W.=430.54 Melting Point=125°C
Trandolapril is a colorless, crystalline substance that is soluble (>100
mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets
contain 1 mg, 2 mg or 4 mg of trandolapril for oral administration. Each tablet
also contains the inactive ingredients: corn starch, croscarmellose sodium,
hypromellose, lactose monohydrate, povidone, sodium stearyl fumarate. In
addition, trandolapril tablets 1 mg and 4 mg contain red 30 iron oxide and
trandolapril tablets 2 mg contain yellow 10 iron oxide.
What does Trandolapril look like?
What are the available doses of Trandolapril?
Sorry No records found.
What should I talk to my health care provider before I take Trandolapril?
Sorry No records found
How should I use Trandolapril?
Hypertension:
Trandolapril tablets are indicated for the treatment of hypertension. They
may be used alone or in combination with other antihypertensive medication such
as hydrochlorothiazide.
In considering the use of trandolapril tablets, it should be noted that in
controlled trials ACE inhibitors (for which adequate data are available) cause a
higher rate of angioedema in black than in non-black patients. (See .)
When using trandolapril tablets, consideration should be given to the fact
that another angiotensin converting enzyme inhibitor, captopril, has caused
agranulocytosis, particularly in patients with renal impairment or
collagen-vascular disease. Available data are insufficient to show that
trandolapril tablets do not have a similar risk. (See .)
Hypertension:
Patients inadequately treated with once-daily dosing at 4 mg may be treated
with twice-daily dosing. If blood pressure is not adequately controlled with
trandolapril tablets monotherapy, a diuretic may be added.
In patients who are currently being treated with a diuretic, symptomatic
hypotension occasionally can occur following the initial dose of trandolapril
tablets. To reduce the likelihood of hypotension, the diuretic should, if
possible, be discontinued two to three days prior to beginning therapy with
trandolapril tablets. (See WARNINGS.) Then, if blood pressure is not controlled
with trandolapril tablets alone, diuretic therapy should be resumed. If the
diuretic cannot be discontinued, an initial dose of 0.5 mg trandolapril tablets
should be used with careful medical supervision for several hours until blood
pressure has stabilized. The dosage should subsequently be titrated (as
described above) to the optimal response. (See , , and .)
Concomitant administration of trandolapril tablets with potassium
supplements, potassium salt substitutes, or potassium sparing diuretics can lead
to increases of serum potassium. (See .)
Dosage Adjustment in Renal Impairment or Hepatic
Cirrhosis:
What interacts with Trandolapril?
Trandolapril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
What are the warnings of Trandolapril?
Retinal vascular thrombosis has been reported in women receiving
estrogens. Discontinue medication pending examination if there is sudden partial
or complete loss of vision, or a sudden onset of proptosis, diplopia or
migraine. If examination reveals papilledema or retinal vascular lesions,
estrogens should be permanently discontinued.
Anaphylactoid and Possibly Related Reactions:
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Intestinal Angioedema:
In patients with concomitant congestive heart failure, with or without
associated renal insufficiency, ACE inhibitor therapy may cause excessive
hypotension, which may be associated with oliguria or azotemia, and rarely, with
acute renal failure and death. In such patients, trandolapril therapy should be
started at the recommended dose under close medical supervision. These patients
should be followed closely during the first 2 weeks of treatment and,
thereafter, whenever the dosage of trandolapril or diuretic is increased. (See
) Care in
avoiding hypotension should also be taken in patients with ischemic heart
disease, aortic stenosis, or cerebrovascular disease.
If symptomatic hypotension occurs, the patient should be placed in the supine
position and, if necessary, normal saline may be administered intravenously. A
transient hypotensive response is not a contraindication to further doses;
however, lower doses of trandolapril or reduced concomitant diuretic therapy
should be considered.
Neutropenia/Agranulocytosis:
Hepatic Failure:
Fetal/Neonatal Morbidity and
Mortality:
The use of ACE inhibitors during the second and third trimesters of pregnancy
has been associated with fetal and neonatal injury, including hypotension,
neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and
death. Oligohydramnios has also been reported, presumably resulting from
decreased fetal renal function; oligohydramnios in this setting has been
associated with fetal limb contractures, craniofacial deformation, and
hypoplastic lung development. Prematurity, intrauterine growth retardation, and
patent ductus arteriosus have also been reported, although it is not clear
whether these occurrences were due to the ACE inhibitor exposure.
These adverse effects do not appear to have resulted from intrauterine
ACE-inhibitor exposure that has been limited to the first trimester. Mothers
whose embryos and fetuses are exposed to ACE inhibitors only during the first
trimester should be so informed. Nonetheless, when patients become pregnant,
physicians should make every effort to discontinue the use of trandolapril as
soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no
alternative to ACE inhibitors will be found. In these rare cases, the mothers
should be apprised of the potential hazards to their fetuses, and serial
ultrasound examinations should be performed to assess the intra-amniotic
environment.
If oligohydramnios is observed, trandolapril should be discontinued unless it
is considered life-saving for the mother. Contraction stress testing (CST), a
non-stress test (NST), or biophysical profiling (BPP) may be appropriate,
depending upon the week of pregnancy.
Patients and physicians should be aware, however, that oligohydramnios may
not appear until after the fetus has sustained irreversible injury.
Infants with histories of exposure to ACE
inhibitors should be closely observed for hypotension, oliguria, and
hyperkalemia. If oliguria occurs, attention should be directed toward support of
blood pressure and renal perfusion. Exchange transfusions or dialysis may be
required as a means of reversing hypotension and/or substituting for disordered
renal function.
Doses of 0.8 mg/kg/day (9.4 mg/m/day) in rabbits,
1000 mg/kg/day (7000 mg/m/day) in rats, and 25 mg/kg/day
(295 mg/m/day) in cynomolgus monkeys did not produce
teratogenic effects. These doses represent 10 and 3 times (rabbits), 1250 and
2564 times (rats), and 312 and 108 times (monkeys) the maximum projected human
dose of 4 mg based on body-weight and body-surface-area, respectively assuming a
50 kg woman.
What are the precautions of Trandolapril?
GeneralImpaired Renal Function:
In hypertensive patients with unilateral or bilateral renal artery stenosis,
increases in blood urea nitrogen and serum creatinine have been observed in some
patients following ACE inhibitor therapy. These increases were almost always
reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In
such patients, renal function should be monitored during the first few weeks of
therapy.
Some hypertensive patients with no apparent preexisting renal vascular
disease have developed increases in blood urea and serum creatinine, usually
minor and transient, especially when ACE inhibitors have been given
concomitantly with a diuretic. This is more likely to occur in patients with
preexisting renal impairment. Dosage reduction and/or discontinuation of any
diuretic and/or the ACE inhibitor may be required.
Evaluation of hypertensive patients should always include
assessment of renal function. (See )
Hyperkalemia and potassium-sparing diuretics:
Cough:
Surgery/anesthesia:
What are the side effects of Trandolapril?
The safety experience in U.S. placebo-controlled trials included
1067 hypertensive patients, of whom 831 received trandolapril. Nearly 200
hypertensive patients received trandolapril for over one year in open-label
trials. In controlled trials, withdrawals for adverse events were 2.1% on
placebo and 1.4% on trandolapril. Adverse events considered at least possibly
related to treatment occurring in 1% of trandolapril-treated patients and more
common on trandolapril than placebo, pooled for all doses, are shown below,
together with the frequency of discontinuation of treatment because of these
events.
Headache and fatigue were all seen in more than 1% of trandolapril-treated
patients but were more frequently seen on placebo. Adverse events were not
usually persistent or difficult to manage.
Clinical adverse experiences possibly or probably related or of uncertain
relationship to therapy occurring in 0.3% to 1.0% (except as noted) of the
patients treated with trandolapril (with or without concomitant calcium ion
antagonist or diuretic) in controlled or uncontrolled trials (N=1134) and less
frequent, clinically significant events seen in clinical trials or
post-marketing experience (the rarer events are in italics) include (listed by
body system):
General Body Function:
Cardiovascular:
Central Nervous System:
Dermatologic:
Eye, Ear, Nose, Throat:
Emotional, Mental, Sexual States:
Gastrointestinal:
pancreatitis.
Hemopoietic:
decreased
leukocytes, decreased neutrophils.
Metabolism and Endocrine:
increased creatinine, increased potassium,
Musculoskeletal System:
Pulmonary:
Angioedema:
Hypotension:
Fetal/Neonatal Morbidity and Mortality: (See ,
.)
Cough:
Clinical Laboratory Test Findings
Hematology:
Serum Electrolytes:
Creatinine and Blood Urea Nitrogen:
Liver Function Tests:
Other:
| TRANDOLAPRIL (N=832)% Incidence(% Discontinuance) | PLACEBO(N=237) % Incidence (% Discontinuance) | ||
| Cough | 1.9 (0.1) | 0.4 (0.4) | |
| Dizziness | 1.3 (0.2) | 0.4 (0.4) | |
| Diarrhea | 1.0 (0.0) | 0.4 (0.0) |
What should I look out for while using Trandolapril?
Trandolapril tablets are contraindicated in patients who are hypersensitive to
this product and in patients with a history of angioedema related to previous
treatment with an ACE inhibitor.
Anaphylactoid and Possibly Related Reactions:
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Head and Neck Angioedema:
Where there
is involvement of the tongue, glottis, or larynx, likely to cause airway
obstruction, emergency therapy, including but not limited to subcutaneous
epinephrine solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered.
(See and )
Intestinal Angioedema:
Hypotension:
In patients with concomitant congestive heart failure, with or without
associated renal insufficiency, ACE inhibitor therapy may cause excessive
hypotension, which may be associated with oliguria or azotemia, and rarely, with
acute renal failure and death. In such patients, trandolapril therapy should be
started at the recommended dose under close medical supervision. These patients
should be followed closely during the first 2 weeks of treatment and,
thereafter, whenever the dosage of trandolapril or diuretic is increased. (See
) Care in
avoiding hypotension should also be taken in patients with ischemic heart
disease, aortic stenosis, or cerebrovascular disease.
If symptomatic hypotension occurs, the patient should be placed in the supine
position and, if necessary, normal saline may be administered intravenously. A
transient hypotensive response is not a contraindication to further doses;
however, lower doses of trandolapril or reduced concomitant diuretic therapy
should be considered.
Neutropenia/Agranulocytosis:
Hepatic Failure:
Fetal/Neonatal Morbidity and
Mortality:
The use of ACE inhibitors during the second and third trimesters of pregnancy
has been associated with fetal and neonatal injury, including hypotension,
neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and
death. Oligohydramnios has also been reported, presumably resulting from
decreased fetal renal function; oligohydramnios in this setting has been
associated with fetal limb contractures, craniofacial deformation, and
hypoplastic lung development. Prematurity, intrauterine growth retardation, and
patent ductus arteriosus have also been reported, although it is not clear
whether these occurrences were due to the ACE inhibitor exposure.
These adverse effects do not appear to have resulted from intrauterine
ACE-inhibitor exposure that has been limited to the first trimester. Mothers
whose embryos and fetuses are exposed to ACE inhibitors only during the first
trimester should be so informed. Nonetheless, when patients become pregnant,
physicians should make every effort to discontinue the use of trandolapril as
soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no
alternative to ACE inhibitors will be found. In these rare cases, the mothers
should be apprised of the potential hazards to their fetuses, and serial
ultrasound examinations should be performed to assess the intra-amniotic
environment.
If oligohydramnios is observed, trandolapril should be discontinued unless it
is considered life-saving for the mother. Contraction stress testing (CST), a
non-stress test (NST), or biophysical profiling (BPP) may be appropriate,
depending upon the week of pregnancy.
Patients and physicians should be aware, however, that oligohydramnios may
not appear until after the fetus has sustained irreversible injury.
Infants with histories of exposure to ACE
inhibitors should be closely observed for hypotension, oliguria, and
hyperkalemia. If oliguria occurs, attention should be directed toward support of
blood pressure and renal perfusion. Exchange transfusions or dialysis may be
required as a means of reversing hypotension and/or substituting for disordered
renal function.
Doses of 0.8 mg/kg/day (9.4 mg/m/day) in rabbits,
1000 mg/kg/day (7000 mg/m/day) in rats, and 25 mg/kg/day
(295 mg/m/day) in cynomolgus monkeys did not produce
teratogenic effects. These doses represent 10 and 3 times (rabbits), 1250 and
2564 times (rats), and 312 and 108 times (monkeys) the maximum projected human
dose of 4 mg based on body-weight and body-surface-area, respectively assuming a
50 kg woman.
What might happen if I take too much Trandolapril?
No data are available with respect to overdosage in humans. The oral LD50 of
trandolapril in mice was 4875 mg/Kg in males and 3990 mg/Kg in females. In rats,
an oral dose of 5000 mg/Kg caused low mortality (1 male out of 5; 0 females). In
dogs, an oral dose of 1000 mg/Kg did not cause mortality and abnormal clinical
signs were not observed. In humans the most likely clinical manifestation would
be symptoms attributable to severe hypotension.
Laboratory determinations of serum levels of trandolapril and its metabolites
are not widely available, and such determinations have, in any event, no
established role in the management of trandolapril overdose. No data are
available to suggest that physiological maneuvers (e.g., maneuvers to change the
pH of the urine) might accelerate elimination of trandolapril and its
metabolites. Trandolaprilat is removed by hemodialysis. Angiotensin II could
presumably serve as a specific antagonist antidote in the setting of
trandolapril overdose, but angiotensin II is essentially unavailable outside of
scattered research facilities. Because the hypotensive effect of trandolapril is
achieved through vasodilation and effective hypovolemia, it is reasonable to
treat trandolapril overdose by infusion of normal saline solution.
How should I store and handle Trandolapril?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows:Bottles of 90 (NDC 54868-6061-1)Bottles of 100 (NDC 54868-6061-0)Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in well-closed container with safety closure as defined in the USP.Keep this and all drugs out of the reach of children. Manufactured by:Corepharma LLCMiddlesex, NJ 08846 for:Sandoz IncPrinceton ,NJ 08540MF# 572-01Rev.08-2007Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action:
Trandolapril is deesterified to the diacid metabolite, trandolaprilat, which
is approximately eight times more active as an inhibitor of ACE activity. ACE is
a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the
vasoconstrictor, angiotensin II. Angiotensin II is a potent peripheral
vasoconstrictor that also stimulates secretion of aldosterone by the adrenal
cortex and provides negative feedback for renin secretion. The effect of
trandolapril in hypertension appears to result primarily from the inhibition of
circulating and tissue ACE activity thereby reducing angiotensin II formation,
decreasing vasoconstriction, decreasing aldosterone secretion, and increasing
plasma renin. Decreased aldosterone secretion leads to diuresis, natriuresis,
and a small increase of serum potassium. In controlled clinical trials,
treatment with trandolapril alone resulted in mean increases in potassium of 0.1
mEq/L. (See .)
ACE is identical to kininase II, an enzyme that degrades bradykinin, a potent
peptide vasodilator; whether increased levels of bradykinin play a role in the
therapeutic effect of trandolapril remains to be elucidated.
While the principal mechanism of antihypertensive effect is thought to be
through the renin-angiotensin-aldosterone system, trandolapril exerts
antihypertensive actions even in patients with low-renin hypertension.
Trandolapril was an effective antihypertensive in all races studied. Both black
patients (usually a predominantly low-renin group) and non-black patients
responded to 2 to 4 mg of trandolapril.
Pharmacokinetics and Metabolism:
Pharmacokinetics
Metabolism and Excretion
Serum protein binding of trandolapril is about 80%, and is independent of
concentration. Binding of trandolaprilat is concentration-dependent, varying
from 65% at 1000 ng/mL to 94% at 0.1 ng/mL, indicating saturation of binding
with increasing concentration.
The volume of distribution of trandolapril is about 18 liters. Total plasma
clearances of trandolapril and trandolaprilat after approximately 2 mg IV doses
are about 52 liters/hour and 7 liters/hour respectively. Renal clearance of
trandolaprilat varies from 1-4 liters/hour, depending on dose.
Special populations:
Pediatric
Geriatric and Gender
Race
Renal Insufficiency
Hepatic Insufficiency
Drug Interactions
Pharmacodynamics and Clinical Effects:
Hypertension:
Administration of trandolapril to patients with mild to moderate hypertension
results in a reduction of supine, sitting and standing blood pressure to about
the same extent without compensatory tachycardia.
Symptomatic hypotension is infrequent, although it can occur in patients who
are salt- and/or volume-depleted. (See .) Use of trandolapril in combination with
thiazide diuretics gives a blood pressure lowering effect greater than that seen
with either agent alone, and the additional effect of trandolapril is similar to
the effect of monotherapy.
Non-Clinical Toxicology
Trandolapril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.Anaphylactoid and Possibly Related Reactions:
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Head and Neck Angioedema:
Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including but not limited to subcutaneous epinephrine solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered. (See and )
Intestinal Angioedema:
Hypotension:
In patients with concomitant congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia, and rarely, with acute renal failure and death. In such patients, trandolapril therapy should be started at the recommended dose under close medical supervision. These patients should be followed closely during the first 2 weeks of treatment and, thereafter, whenever the dosage of trandolapril or diuretic is increased. (See ) Care in avoiding hypotension should also be taken in patients with ischemic heart disease, aortic stenosis, or cerebrovascular disease.
If symptomatic hypotension occurs, the patient should be placed in the supine position and, if necessary, normal saline may be administered intravenously. A transient hypotensive response is not a contraindication to further doses; however, lower doses of trandolapril or reduced concomitant diuretic therapy should be considered.
Neutropenia/Agranulocytosis:
Hepatic Failure:
Fetal/Neonatal Morbidity and Mortality:
The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE inhibitor exposure.
These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of trandolapril as soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment.
If oligohydramnios is observed, trandolapril should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
Doses of 0.8 mg/kg/day (9.4 mg/m/day) in rabbits, 1000 mg/kg/day (7000 mg/m/day) in rats, and 25 mg/kg/day (295 mg/m/day) in cynomolgus monkeys did not produce teratogenic effects. These doses represent 10 and 3 times (rabbits), 1250 and 2564 times (rats), and 312 and 108 times (monkeys) the maximum projected human dose of 4 mg based on body-weight and body-surface-area, respectively assuming a 50 kg woman.
Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.
GeneralImpaired Renal Function:
In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy.
Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when ACE inhibitors have been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of any diuretic and/or the ACE inhibitor may be required.
Evaluation of hypertensive patients should always include assessment of renal function. (See )
Hyperkalemia and potassium-sparing diuretics:
Cough:
Surgery/anesthesia:
The safety experience in U.S. placebo-controlled trials included 1067 hypertensive patients, of whom 831 received trandolapril. Nearly 200 hypertensive patients received trandolapril for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on trandolapril. Adverse events considered at least possibly related to treatment occurring in 1% of trandolapril-treated patients and more common on trandolapril than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events.
Headache and fatigue were all seen in more than 1% of trandolapril-treated patients but were more frequently seen on placebo. Adverse events were not usually persistent or difficult to manage.
Clinical adverse experiences possibly or probably related or of uncertain relationship to therapy occurring in 0.3% to 1.0% (except as noted) of the patients treated with trandolapril (with or without concomitant calcium ion antagonist or diuretic) in controlled or uncontrolled trials (N=1134) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):
General Body Function:
Cardiovascular:
Central Nervous System:
Dermatologic:
Eye, Ear, Nose, Throat:
Emotional, Mental, Sexual States:
Gastrointestinal:
pancreatitis.
Hemopoietic:
decreased leukocytes, decreased neutrophils.
Metabolism and Endocrine:
increased creatinine, increased potassium,
Musculoskeletal System:
Pulmonary:
Angioedema:
Hypotension:
Fetal/Neonatal Morbidity and Mortality: (See , .)
Cough:
Clinical Laboratory Test Findings
Hematology:
Serum Electrolytes:
Creatinine and Blood Urea Nitrogen:
Liver Function Tests:
Other:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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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).