"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
The following adverse reactions are described in greater detail, in other sections:
- Bradycardia and AV block [see WARNINGS AND PRECAUTIONS]
- Heart failure [see WARNINGS AND PRECAUTIONS]
- Acute hepatic injury [see WARNINGS AND PRECAUTIONS]
- Severe Skin reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
For the hypertension studies, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg.
|Adverse Reactions (MedDRA Term)||Placebo||Diltiazem hydrochloride extended-release|
|n=120 # pts. (%)||120-360 mg
n=501 # pts. (%)
n=123 # pts. (%)
|Edema lower limb||4 (3)||24 (5)||10 (8)|
|Sinus congestion||0 (0)||2 (1)||2 (2)|
|Rash||0 (0)||3 (1)||2 (2)|
In the angina study, the adverse event profile of CARDIZEM LA was consistent with what has been previously described for CARDIZEM LA and other formulations of diltiazem HCl. The most frequent adverse effects experienced by CARDIZEM LA-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).
In addition, the following events have been reported infrequently (less than 1%) in angina or hypertension trials:
Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.
The following adverse reactions have been identified during post-approval use of diltiazem. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
The following post-marketing reactions have been reported infrequently in patients receiving diltiazem: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), erythema multiforme, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia.
In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients.
A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported.
Read the Cardizem LA (diltiazem) Side Effects Center for a complete guide to possible side effects
Agents Known To Impair Cardiac Contractility And Conduction
Using other agents known to affect cardiac conduction or contractility with diltiazem may increase the risk of bradycardia, AV block, and heart failure [see WARNINGS AND PRECAUTIONS].
Interactions With Cytochrome P-450 3A4 Substrates, Inhibitors And Inducers
Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system.
Simvastatin: Limit daily dose of simvastatin 10 mg and diltiazem to 240 mg, if co-administration of both drugs are required [see Drug Interactions under CLINICAL PHARMACOLOGY].
Rifampin: Avoid co-administration of rifampin with diltiazem [see Drug Interactions under CLINICAL PHARMACOLOGY].
Read the Cardizem LA Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/17/2016
Additional Cardizem LA Information
Cardizem LA - User Reviews
Cardizem LA User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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