Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Fetal Toxicity
(Additions and/or revisions underlined)
Olmesartan medoxomil. Tribenzor can cause
fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin
system during the second and third trimesters of pregnancy reduces fetal renal function
and increases fetal and neonatal morbidity
and death. Resulting
oligohydramnios can be associated with fetal lung hypoplasia
and skeletal
deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension,
renal failure, and death. When pregnancy is detected, discontinue Tribenzor
as soon as possible [see Use in specific
Populations (8.1].
Hydrochlorothiazide. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific
Populations (8.1)].
8
Use in Specific Populations
Lactation
(PLLR conversion.
Please refer to label for complete information.)
Pregnancy
(PLLR conversion.
Please refer to label for complete information.)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Counseling Information
(Newly added information)
Lactation: Advise nursing women not to breastfeed during treatment with Tribenzor [see Use in Specific Populations (8.2)].
Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting
their healthcare
provider.
Acute myopia and secondary angle-closure glaucoma: Advise patients
to discontinue Tribenzor and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.9)].
Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined:
Because of the hydrochlorothiazide component,
Tribenzor is contraindicated in patients with anuria, hypersensitivity to any component, or
hypersensitivity to other sulfonamide-derived drugs ...
5
Warnings and Precautions
5.10 Sprue-like Enteropathy
Additions and/or revisions
underlined:
Olmesartan
medoxomil. Severe, chronic
diarrhea with …
5.2 Hypotension in Volume- or Salt-Depleted Patients
Additions and/or revisions underlined:
Olmesartan
medoxomil. In
patients with an activated renin-angiotensin system, such as
of volume- and/or salt-depleted patients
(e.g., those being treated with high doses of diuretics) symptomatic
hypotension may be anticipated after initiation of treatment with olmesartan
medoxomil. Initiate treatment with Tribenzor …
Amlodipine.
Symptomatic
hypotension is possible, particularly in patients with severe aortic stenosis.
Because of the gradual onset of action, acute hypotension is unlikely.
5.4 Impaired Renal Function
Additions and/or revisions underlined:
Impaired renal function was reported in
2.1% of subjects receiving Tribenzor compared to 0.2% to 1.3% of subjects
receiving dual combination therapy of olmesartan medoxomil and amlodipine,
olmesartan medoxomil and hydrochlorothiazide or amlodipine and
hydrochlorothiazide.
If progressive renal impairment becomes
evident consider withholding or discontinuing Tribenzor …
5.5 Patients with Hepatic Impairment
Additions and/or revisions underlined:
Amlodipine.
Since
amlodipine is
extensively metabolized by the liver and the plasma elimination half-life
(t1/2) is 56
hours in patients
with severely impaired
hepatic function, titrate slowly when administering to patients with
severe hepatic impairment.
5.6 Electrolyte and Metabolic Imbalances
Additions and/or revisions underlined:
Tribenzor contains
hydrochlorothiazide which can cause hypokalemia, hyponatremia nad
hypomagnesmia. Hypomagnesmia can result
in hypokalemia which may be difficult to treat despite potassium repletion.
Tribenzor also contains olmesartan, a drug that affects the RAS. Drugs that inhibit the RAS can also cause
hyperkalemia.
Hydrochlorothiazide may alter glucose
tolerance and raise serum levels of cholesterol and triglycerides.
Hydrochlorothiazide decreases urinary
calcium excretion and may cause elevations of serum calcium. Monitor calcium
levels.
6
Adverse Reactions
6.2 Post-Marketing Experience
Olmesartan medoxomil.
The following
adverse reactions have
been reported in post-marketing experience:
Addition
underlined:
Urogenital
System: acute
renal failure, increased blood creatinine
Additions and/or revisions
underlined:
Amlodipine.
… In post-marketing experience, jaundice and
hepatic enzyme elevations
(mostly consistent with
cholestasis or hepatitis), in
some cases severe enough to require hospitalization, have been reported in
association with use
of amlodipine. Postmarketing
reporting has also
revealed a possible association
between extrapyramidal disorder and amlodipine.
7
Drug Interactions
7.2 Drug Interactions with Amlodipine
Additions and/or revisions underlined:
Simvastatin
Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin.
Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Immunosuppressants
Amlodipine may increase the systemic
exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring
of trough blood levels of cyclosporine and tacrolimus is recommended and adjust
the dose when appropriate.
CYP3A
Inhibitors
Co-administration of amlodipine with
CYP3A inhibitors (moderate and strong) results in increased systemic exposure
to amlodipine and may require dose reduction. Monitor for symptoms of
hypotension and edema when amlodipine is co-administered with CYP3A inhibitors
to determine the need for dose adjustment.
CYP3A
Inducers
No information is available on the
quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be
closely monitored when amlodipine is co- administered with CYP3A inducers.
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or revisions underlined:
Tribenzor. In a
controlled clinical trial,
123 hypertensive patients
treated with
Tribenzor were ?65 years of age and 18
patients were ?75 years of age. No
overall differences in the efficacy or safety of Tribenzor were observed in
these patient populations; however, greater sensitivity of some older
individuals cannot be ruled out. The recommended initial dose of amlodipine
in patients ? 75 years of age is 2.5 mg, a dose not available with Tribenzor.
8.6 Hepatic Impairment
Additions and/or revisions underlined:
There are no studies of Tribenzor in
patients with hepatic
insufficiency, but both
amlodipine and
olmesartan medoxomil show
moderate increases in
exposure in patients with severe
hepatic impairment. The recommended initial dose of
amlodipine in patients with
severe hepatic impairment
is 2.5 mg,
a dose not
available with Tribenzor.
Amlodipine.
Amlodipine
is extensively metabolized by the liver and the plasma elimination half-life
(t½) is 56
hours in patients
with severely impaired
hepatic function.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
What should I tell my doctor before
taking Tribenzor?
Some
of your other medicines and Tribenzor could affect each other, causing serious
side effects.
Especially
tell your doctor if you are taking:
Addition
of the following:
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
See FDA-Approved Patient Labeling
Pregnancy:
Tell female patients
of childbearing age about the consequences of exposure to Tribenzor during pregnancy. Discuss treatment
options with women planning to become pregnant. Tell patients to report pregnancies to
their physicians as soon as possible.
Symptomatic
Hypotension: Advise patients that lightheadedness
can occur, especially during the first days of therapy, and that it should be
reported to the prescribing physician. Tell patients that if syncope occurs,
Tribenzor should be discontinued until the physician has been consulted.
Tell patients that inadequate fluid
intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive
fall in blood pressure, with the same consequences of lightheadedness and
possible syncope.
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