Generic Name
Tadalafil
Brand Names
Adcirca, ALYQ, Cialis, Opsynvi, Tadliq
FDA approval date: November 26, 2003
Classification: Phosphodiesterase 5 Inhibitor
Form: Tablet, Suspension
What is Adcirca (Tadalafil)?
ADCIRCA is a phosphodiesterase 5 inhibitor indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases .
Approved To Treat
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Brand Information
ADCIRCA (Tadalafil)
1DOSAGE FORMS AND STRENGTHS
20 mg, orange, film-coated, almond-shaped tablets (not scored) debossed with “4467”.
2ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hypotension
- Visual Loss
- Hearing loss
- Priapism
2.1Clinical 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.
Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of ADCIRCA, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for ADCIRCA 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with ADCIRCA 40 mg was 4% compared to 5% in placebo-treated patients.
In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity.
2.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.
Cardiovascular and cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil [see Contraindications (. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors.
Body as a whole — Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis
Nervous — Migraine, seizure and seizure recurrence, and transient global amnesia
Ophthalmologic — Visual field defect, retinal vein occlusion, retinal artery occlusion, and NAION [see Warnings and Precautions (
Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (.
Urogenital — Priapism [see Warnings and Precautions (.
3OVERDOSAGE
Single doses up to 500 mg have been given to healthy male subjects, and multiple daily doses up to 100 mg have been given to male patients with erectile dysfunction. Adverse reactions were similar to those seen at lower doses. Doses greater than 40 mg have not been studied in patients with pulmonary arterial hypertension. In cases of overdose, standard supportive measures should be adopted as needed. Hemodialysis contributes negligibly to tadalafil elimination.
4DESCRIPTION
ADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C
The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
ADCIRCA is available as orange, film–coated, almond–shaped tablets for oral administration. Each tablet contains 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.
5PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (
- Inform patients of contraindication of ADCIRCA with any use of organic nitrates or GC stimulators.
- Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking ADCIRCA not to take CIALIS or other PDE5 inhibitors.
- Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking ADCIRCA. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.
- Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking ADCIRCA. These events may be accompanied by tinnitus and dizziness.
6PACKAGE LABEL – ADCIRCA 20 mg
60 tablets
NDC 66302-467-60
Rx only
TA 4467
adcirca
tadalafil tablets
20 mg 4467
United Therapeutics Corporation
Lilly
Same active ingredient as Cialis
