Adcirca: Tadalafil Brand and PAH Product Context

Adcirca Product Facts at a Glance

ADCIRCA is a branded oral tadalafil product marketed under New Drug Application NDA 022332. FDA marketing approval for Adcirca dates to May 22, 2009, and the current DailyMed record identifies United Therapeutics Corporation as the labeler and marketer and Eli Lilly and Company as the manufacturer.

The product is supplied as a single 20 mg tablet strength. Its branded identity, dosage form, indication and dosing framework should be read together because tadalafil also appears in other products with different strengths, dosage forms and labeled uses.

Adcirca Is a Specific Tadalafil Product

Tadalafil is the active pharmaceutical ingredient in Adcirca, while ADCIRCA is the proprietary name of a specific finished tablet product. The distinction is important because the active molecule alone does not define the product's indication, tablet strength or dosing instructions.

Adcirca uses tadalafil in a pulmonary arterial hypertension context. Other tadalafil products can have different labeled indications and dosage forms, so seeing the word tadalafil on two labels does not make the products identical in clinical use.

The wider naming landscape is covered on tadalafil brand names. This page stays focused on the current ADCIRCA tablet and its own prescribing context.

What Is Adcirca Approved to Treat?

Current U.S. ADCIRCA labeling indicates the product for pulmonary arterial hypertension, classified as WHO Group 1, to improve exercise ability. The studies supporting effectiveness predominantly included patients with functional limitations and PAH arising from several etiologic backgrounds.

That indication is narrower than the broad phrase pulmonary hypertension. Pulmonary hypertension includes multiple clinical groups, while the ADCIRCA indication is specifically framed around PAH, WHO Group 1.

The disease-level distinction, diagnostic categories and broader clinical role of tadalafil are intentionally left to the tadalafil and pulmonary hypertension page so that this page remains a product-label overview.

Why Adcirca 20 mg Tablets Produce a 40 mg Daily Framework

The current ADCIRCA label supplies 20 mg tablets but recommends 40 mg once daily for the standard PAH framework. In practical label terms, that means two 20 mg tablets are taken together once per day, with or without food.

The label specifically states that dividing the 40 mg amount over the course of the day is not recommended. This is an important product detail because a search for "Adcirca 20 mg" refers to tablet strength, while 40 mg refers to the usual total labeled daily dose for PAH.

Organ impairment and certain interacting medicines can change the labeled framework, so the standard 40 mg statement should not be interpreted as a universal instruction for every patient.

What Current Branded Adcirca Tablets Look Like

Current DailyMed labeling describes ADCIRCA 20 mg as an orange, film-coated, almond-shaped tablet. The tablet is not scored and is debossed with the imprint "4467."

The marketed package contains 60 tablets under NDC 66302-467-60. Those characteristics describe the branded ADCIRCA product and should not be assumed to describe every tadalafil tablet or every product used for pulmonary arterial hypertension.

Tablet identification is more reliable when strength, imprint, package information and labeler are considered together rather than using color alone.

How Tadalafil Works in the Adcirca PAH Context

Tadalafil inhibits phosphodiesterase type 5, the enzyme responsible for degrading cyclic GMP. In pulmonary arterial hypertension, the nitric oxide-cGMP pathway is relevant to pulmonary vascular tone, and PDE5 is an important phosphodiesterase within pulmonary vascular smooth muscle.

By inhibiting PDE5, tadalafil increases cGMP concentrations and promotes relaxation of pulmonary vascular smooth muscle and vasodilation of the pulmonary vascular bed. That mechanism is the same molecular starting point associated with tadalafil in other tissues, but the therapeutic objective on the ADCIRCA label is specific to PAH.

Keeping molecule and product context separate prevents a common mistake: the same PDE5 inhibitor can appear in different labeled products without making their clinical uses interchangeable.

How Adcirca's PAH Effectiveness Was Established

The current prescribing information summarizes a randomized, double-blind, placebo-controlled 16-week study involving 405 patients with pulmonary arterial hypertension. Participants were assigned to tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg or placebo, and the primary endpoint was change in six-minute walk distance.

For the ADCIRCA 40 mg group, the label reports a placebo-adjusted mean increase of 33 meters in six-minute walk distance at week 16. The improvement was apparent by week 8 and maintained through weeks 12 and 16 in the study.

Those data explain the evidence basis behind the branded product rather than serving as a complete review of PAH treatment effectiveness. Disease-level interpretation, treatment positioning and broader pulmonary-hypertension context belong on the dedicated PAH page.

Adcirca Has a PAH-Specific Pharmacokinetic Context

Tadalafil pharmacokinetics in the ADCIRCA label should not simply be copied from an ED product context. After a single oral dose, maximum observed tadalafil concentration is reached between approximately 2 and 8 hours, with a median time of about 4 hours in the ADCIRCA clinical-pharmacology section.

With 20 mg or 40 mg once-daily dosing, steady-state plasma concentrations are reached within about five days. Following 40 mg, the label reports a mean terminal half-life of about 15 hours in healthy subjects but about 35 hours in patients with pulmonary hypertension not receiving concomitant bosentan, reflecting lower apparent clearance in that population.

These values describe exposure and disposition rather than treatment response clocks. Broader ADME concepts belong on the tadalafil pharmacokinetics page.

Adcirca Can Be Taken With or Without Food

Current ADCIRCA labeling states that the 40 mg once-daily framework may be taken with or without food. The clinical-pharmacology section reports that food does not influence the rate or extent of tadalafil absorption under the studied conditions.

Food independence therefore belongs to the product's administration context, while timing relative to meals should not be confused with questions about dose adjustment, drug interactions or individual tolerability.

Major Adcirca Contraindications and Safety Boundaries

Current ADCIRCA labeling contraindicates use with organic nitrates because tadalafil can potentiate nitrate-related hypotension. Guanylate cyclase stimulators such as riociguat are also contraindicated, as is use in a patient with a known serious hypersensitivity reaction to tadalafil.

The label further addresses hypotension, worsening pulmonary vascular occlusive disease, sudden visual loss, hearing impairment, use with other PDE5 inhibitors and prolonged erection or priapism. These safety issues are part of tadalafil's systemic pharmacology but must be interpreted within the ADCIRCA treatment setting.

For broader safety architecture, see tadalafil contraindications and tadalafil drug interactions.

Common Adverse Reactions in the Adcirca PAH Studies

Headache is identified in the ADCIRCA highlights as the most common adverse reaction. In the placebo-controlled PAH study, other treatment-emergent events reported more often with ADCIRCA included myalgia, flushing, respiratory tract infection, pain in an extremity, nausea, back pain and dyspepsia.

Adverse-event percentages in a PAH trial should not automatically be transferred to Cialis or another tadalafil product context. Patient populations, background therapy, dose and study design differ, which is another reason to keep the Adcirca product label distinct.

Adcirca Has Important PAH-Relevant Drug-Interaction Context

ADCIRCA interaction assessment extends beyond the absolute contraindications with nitrates and GC stimulators. Tadalafil is predominantly metabolized through CYP3A, so strong inhibitors or inducers can materially alter exposure.

Ritonavir has a specific dosage section because its effect on CYP3A changes over time, while bosentan is also relevant in the PAH setting because it can reduce tadalafil systemic exposure through enzyme induction. The label additionally discusses alpha-blockers, antihypertensive medicines and substantial alcohol exposure because of additive blood-pressure effects.

Medication-specific interaction depth belongs on tadalafil drug interactions, with enzyme mechanics covered separately on tadalafil and CYP3A4.

Kidney and Liver Function Can Change the Adcirca Framework

The standard 40 mg once-daily PAH framework does not apply unchanged across all levels of renal or hepatic function. For mild or moderate renal impairment, current labeling starts ADCIRCA at 20 mg once daily and allows an increase to 40 mg based on individual tolerability.

ADCIRCA should be avoided in severe renal impairment because tadalafil exposure is increased, clinical experience is limited and dialysis has little effect on clearance. For mild or moderate hepatic cirrhosis, the label says to consider a 20 mg once-daily starting dose; use should be avoided in severe hepatic cirrhosis because that population has not been adequately studied.

Condition-specific evidence and exposure changes are covered more deeply on tadalafil and renal impairment and tadalafil and hepatic impairment.

Adcirca and Cialis Contain the Same Active Drug but Are Not the Same Product

Adcirca and Cialis both contain tadalafil, but their U.S. product identities are built around different indications, tablet presentations and dosing frameworks. ADCIRCA is a PAH product supplied as a 20 mg tablet and uses a 40 mg once-daily standard framework, while CIALIS labeling is centered on ED, BPH and combined ED/BPH.

The shared active ingredient therefore does not mean the branded labels are interchangeable. A tadalafil dose, strength or instruction must be interpreted in the context of the product and indication from which it came.

This page intentionally stops at that product-level distinction. The complete head-to-head comparison belongs on Cialis vs Adcirca.

How to Identify the Current Branded Adcirca Product

Branded Adcirca is best identified using several product attributes together. Current DailyMed information identifies a 20 mg orange, almond-shaped, film-coated, unscored tablet with the imprint 4467, packaged as 60 tablets under NDC 66302-467-60.

The current DailyMed record lists United Therapeutics Corporation as the labeler and marketer, while the prescribing information identifies Eli Lilly and Company as the manufacturer. These details are more reliable for product identification than assuming that every tadalafil tablet used in PAH should look like branded Adcirca.

A different-looking tadalafil product should therefore be checked using the dispensing label, strength, imprint, manufacturer or labeler and official product information rather than visual resemblance alone.

Common Misunderstandings About Adcirca

The most common Adcirca misunderstandings come from treating every tadalafil product as if the brand name and indication were interchangeable. Adcirca contains tadalafil, but that does not make Adcirca an ED product or make the CIALIS dosing framework applicable to PAH.

Another source of confusion is the relationship between tablet strength and daily dose. An Adcirca tablet contains 20 mg tadalafil, while the standard PAH labeling uses a total of 40 mg once daily, taken as two 20 mg tablets together rather than splitting the dose across the day.

Finally, the label's PAH indication should not be broadened to every form of pulmonary hypertension. ADCIRCA is specifically indicated for PAH, WHO Group 1, to improve exercise ability.

Key Takeaways: Adcirca

Adcirca is a branded tadalafil tablet product indicated in the United States for pulmonary arterial hypertension, WHO Group 1, to improve exercise ability. The current branded product is a 20 mg orange, almond-shaped tablet, while the standard labeled PAH framework is 40 mg once daily as two tablets taken together.

Its product context is materially different from Cialis even though both brands contain tadalafil. Adcirca dosing, clinical evidence, pharmacokinetics and safety information should therefore be interpreted within the PAH label rather than transferred from an ED or BPH product framework.

Current labeling also contains important adjustments or restrictions for renal impairment, hepatic impairment and interacting drugs, together with contraindications involving nitrates and guanylate cyclase stimulators. These details reinforce why indication-specific product labeling matters when the same active ingredient exists under multiple brand and treatment contexts.