Adcirca

What is Adcirca?

• Adcirca (Tadalafil) is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of pulmonary arterial hypertension (PAH).

Tadalafil skeletal

Tadalafil Formula V.1

What are the uses of this medicine?

• Adcirca (Tadalafil) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.

How does this medicine work?

• Tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
• Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations in the pulmonary vascular smooth muscle.
• Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take any medicines called nitrates.
• use recreational drugs called “poppers” like amyl nitrate, butyl nitrate or nitrite.
• take any medicines called guanylate cyclase stimulators (eg: Riociguat)
• are allergic to tadalafil or any other ingredient in ADCIRCA.

What drug interactions can this medicine cause?

ADCIRCA and other medicines may affect each other.

Especially tell your healthcare provider if you take any of these medicines:

• nitrates or guanylate cyclase stimulators
• anti-hypertensives, used to treat high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
• alpha blockers, used to treat prostate disease and high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
• protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir®, Kaletra®)
• ketoconazole (Extina®, Xolegel®, Ketozole®, Nizoral A-D®, Nizoral®) itraconazole (Sporanox®)
• erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine)
• rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
• bosentan (Tracleer®)
• phenobarbital, phenytoin (Dilantin®), carbamazepine (Tegretol®)
• CIALIS® or other medicines or treatments for erectile dysfunction (impotence).
• ADCIRCA is also marketed as CIALIS for the treatment of male erectile dysfunction (ED, impotence) and for the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). Do not take both ADCIRCA and CIALIS. Do not take ADCIRCA and other medicines or treatments for erectile dysfunction.

Never take ADCIRCA with any nitrate or guanylate cyclase stimulator medicines:

• Your blood pressure could drop quickly to an unsafe level
• You could get dizzy, faint and even have a heart attack or stroke.

Nitrates include:

• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Other nitrate medicines (isosorbide mononitrate or dinitrate)
• Street drugs that are inhaled, called “poppers” (amyl nitrate, butyl nitrate or nitrite)

Guanylate cyclase stimulators include:

• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension

Is this medicine FDA approved?

• Tadalafil was approved for medical use in the United States in 2003.

How should this medicine be used?

Recommended dosage:

• The recommended dose of ADCIRCA is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

Renal Impairment

• Mild: Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.
• Severe: Avoid use of ADCIRCA.

Hepatic Impairment

• Mild or moderate:Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.
• Severe: Avoid use of ADCIRCA.

• In patients receiving ritonavir for at least one week, start ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability

Administration:

• Take ADCIRCA tablets at the same time every day. You should take both tablets at the same time, one after the other, every day. Do not split your dose.
• ADCIRCA can be taken with or without food.
• Do not change your dose or stop taking ADCIRCA without speaking to your healthcare provider.
• If you take too much ADCIRCA, call your healthcare provider or go to an emergency department right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets (not scored): 20 mg

This medicine is available in fallowing brand namesː

• ADCIRCA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• muscle pain
• getting red or hot in the face (flushing)
• nausea
• pain in the arms, legs, or back
• upset stomach
• stuffy or congested nose

What special precautions should I follow?

• Do not have more than 4 alcohol-containing drinks in a short period of time while you take ADCIRCA. Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.
• PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Carefully consider whether patients with certain underlying conditions (e.g., cardiovascular disease, impaired autonomic control of blood pressure, aortic stenosis) could be adversely affected by vasodilatory effects of ADCIRCA. Not recommended in patients with pulmonary veno-occlusive disease
• Note additive blood pressure-lowering effects.
• In patients receiving ritonavir for at least one week, start ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
• Avoid use of ADCIRCA during the initiation of ritonavir. Stop ADCIRCA at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ADCIRCA at 20 mg once daily.
• Avoid oncomitant use of potent CYP3A inhibitors with ADCIRCA.
• Avoid use of ADCIRCA in patients chronically taking potent inducers of CYP3A (e.g., rifampin).
• Non–arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported postmarketing in temporal association with the use of all PDE5 inhibitors. Patients should seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy (NAION).
• Events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including ADCIRCA. Advise patients to seek immediate medical attention if sudden decrease or loss of hearing occurs.
• Tadalafil is also marketed as CIALIS. The safety and efficacy of taking ADCIRCA together with CIALIS or other PDE5 inhibitors have not been studied. Avoid use with CIALIS or other PDE5 inhibitors.
• There have been rare reports of prolonged erections greater than 4 hours and priapism. Advise patients to seek emergency treatment if an erection lasts >4 hours.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Adverse reactions were similar to those seen at lower doses which may include:

• headache
• muscle pain
• getting red or hot in the face (flushing)
• nausea
• pain in the arms, legs, or back
• upset stomach
• stuffy or congested nose

Management of overdosage:

• In cases of overdose, standard supportive measures should be adopted as needed.
• Hemodialysis contributes negligibly to tadalafil elimination.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies of tadalafil in pregnant women.
• Tadalafil should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness of ADCIRCA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient: tadalafil Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

• Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA
• Marketed by: United Therapeutics Corporation

What should I know about storage and disposal of this medication?

• Store ADCIRCA at room temperature between 59° and 86°F (15° and 30°C).

• Dailymed label info on Adcirca
• FDA Adcirca

Adcirca Resources
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