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Important Safety Information
CONTRAINDICATIONS
- Nitrates: ADCIRCA should not be used in patients taking medicines that contain nitrates,
as the combination could cause a sudden, unsafe drop in blood pressure
- Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil
should not take ADCIRCA
WARNINGS AND PRECAUTIONS
- Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA
should seek immediate medical attention
- Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have
mild systemic vasodilatory properties that may result in transient decreases in
blood pressure. Before prescribing ADCIRCA, physicians should carefully consider
whether their patients with underlying cardiovascular disease could be adversely
affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular
status of patients with pulmonary veno-occlusive disease (PVOD) and administration
of ADCIRCA to these patients is not recommended
- Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications,
or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension
(light-headedness or fainting)
- Potential Drug Interactions: Tadalafil is metabolized predominantly by CYP3A in
the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and
itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment
with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting
ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA,
start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A,
such as rifampin, should be avoided
- Special Populations: The use of ADCIRCA is not recommended for patients with severe
renal or hepatic impairment. Please see Full Prescribing Information for dosing
recommendations for patients with mild to moderate renal or hepatic impairment
- Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as
Cialis®, which is used to treat erectile dysfunction (ED). The safety and efficacy
of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied.
Therefore, the use of such combinations is not recommended
- Vision/Hearing: In rare instances, men taking PDE-5is (including tadalafil)
for ED reported a sudden decrease or loss of vision or hearing, or an erection lasting
more than four hours. A patient who experiences any of these symptoms should seek
immediate medical attention
ADVERSE REACTIONS
- Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA
vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA
and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis
(13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity
pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%),
and nasal congestion (9% vs 1%)
For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.