Tadalafil (ADCIRCA)

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Trade Name: ADCIRCA

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: United Therapeutics Corporation

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 20 mg/1

Storage and handling

TADALAFIL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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ADCIRCA is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II u2013 III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).n
ADCIRCA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II u2013 III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ()n

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40 mg once daily, with or without food. ()n
Dividing the dose (40 mg) over the course of the day is not recommended. ()n
Use with ritonavir requires dosage adjustments. ()n

20 mg, orange, film-coated, almond-shaped tablets (not scored) debossed with u201c4467u201d.n
Tablets (not scored): 20 mg ()n

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Concomitant organic nitrates ()n
Concomitant Guanylate Cyclase (GC) Stimulators ()n
History of known serious hypersensitivity reaction to ADCIRCA or CIALIS ()n

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Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of ADCIRCA. Not recommended in patients with pulmonary veno-occlusive disease. (, )n
Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. ()n
Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. ()n
Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. ()n
Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ()n

The following serious adverse reactions are discussed elsewhere in the labeling:n
The most common adverse reaction is headache. ()n
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545 5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Renal Impairment (, , )n
Hepatic Impairment (, , )n

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.n

ADCIRCA (tadalafil), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)u2013specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula CHNO representing a molecular weight of 389.41. The structural formula is:n
The chemical designation is pyrazino[1u00b4,2u00b4:1,6]pyrido[3,4u2013b]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.n
ADCIRCA is available as orange, filmu2013coated, almondu2013shaped 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.n

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See FDA-Approved Patient Labeling ()

Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA
Marketed by: United Therapeutics Corporation
Copyright u00a9 2009, 2020, Eli Lilly and Company. All rights reserved.n
ADC-0005-USPI-20200915n

PATIENT INFORMATION
ADCIRCAn- Arrayn- (Ad-sur-kuh)
(tadalafil) tablets
Read this patient information before you start taking ADCIRCA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.n
What is the most important information I should know about ADCIRCA?
Never take ADCIRCA with any nitrate or guanylate cyclase stimulator medicines:n
Nitrates include:n
Guanylate cyclase stimulators include:n
Ask your healthcare provider or pharmacist if you are not sure if you take a nitrate or guanylate cyclase stimulator medicine.n
What is ADCIRCA?
ADCIRCA is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.n
It is not known if ADCIRCA is safe or effective in children.n
Who should not take ADCIRCA?
Do not take ADCIRCA if you
See n
What should I tell my healthcare provider before taking ADCIRCA?
Before taking ADCIRCA, tell your healthcare provider about all of your medical conditions, including if you:n
Tell your healthcare provider about all the medicines you take,
Especially tell your healthcare provider if you take any of these medicines:n
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.n
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.n
How should I take ADCIRCA?
What should I avoid while taking ADCIRCA?
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.n
What are the possible side effects of ADCIRCA?
The following side effects were reported rarely in patients taking tadalafil:
See n
The most common side effects with ADCIRCA include:
Tell your healthcare provider about any side effect that bothers you or does not go away.n
These are not all the possible side effects of ADCIRCA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How Should I Store ADCIRCA?
Store ADCIRCA at room temperature between 59u00b0u00a0andu00a086u00b0Fu00a0(15u00b0u00a0andu00a030u00b0C).n
Keep ADCIRCA and all medicines out of the reach of children.
General Information about the safe and effective use of ADCIRCA
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ADCIRCA for a condition for which it was not prescribed. Do not give ADCIRCA to other people, even if they have the same symptoms you have. It may harm them.n
This patient information leaflet summarizes the most important information about ADCIRCA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ADCIRCA that is written for healthcare professionals. For more information, go to www.ADCIRCA.com or call 1-800-LILLYRX (1-800-545-5979).n
What Are The Ingredients In ADCIRCA?
Active Ingredient: tadalafiln
Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.n
Rx onlyn
ADCIRCA (tadalafil) is a trademark of Eli Lilly and Company.n
Revised 09/2020n
Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA
Marketed by: United Therapeutics Corporation
ADC-0004-PPI-20200915n

60 tabletsn
NDC 66302-467-60n
Rx onlyn
TA 4467n
adcircan
tadalafil tabletsn
20 mgn
United Therapeutics Corporationn
Lillyn
Same active ingredient as Cialisn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Tadalafil (ADCIRCA) which is also known as ADCIRCA and Manufactured by United Therapeutics Corporation. It is available in strength of 20 mg/1.

Tadalafil (ADCIRCA) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.