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Tadalafil (Alyq)

Trade Name : ALYQ

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 20 mg/1

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

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tadalafil (Alyq) which is also known as ALYQ and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 20 mg/1 per ml. Read more

Tadalafil (Alyq) 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.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ALYQu2122 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%).
  • ALYQu2122 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 to III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ()
  • No data
  • 40 mg once daily, with or without food. ()
  • Dividing the dose (40 mg) over the course of the day is not recommended. ()
  • Use with ritonavir requires dosage adjustments. ()
  • 20 mg, orange, oval-shaped, film-coated tablets (not scored) debossed with u201cTEVAu201d on one side and with u201c3334u201d on the other side.
  • Tablets (not scored): 20 mg ()
  • No data
  • Concomitant organic nitrates ()
  • Concomitant Guanylate Cyclase (GC) Stimulators ()
  • History of known serious hypersensitivity reaction to ALYQu2122 or CIALIS ()
  • No data
  • Cardiovascular effects: 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 ALYQu2122. Not recommended in patients with pulmonary veno-occlusive disease. ()
  • Concomitant alpha-blockers or alcohol: Note additive blood pressure-lowering effects. ()
  • Use with Ritonavir: Requires dosage adjustment. (, )
  • Other concomitant potent CYP3A inhibitors: Avoid use with ALYQu2122. ()
  • Potent Inducers of CYP3A: Avoid use of ALYQu2122 in patients chronically taking potent inducers of CYP3A (e.g., rifampin). (, )
  • Effects on the eye: Patients should seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy (NAION). ()
  • Hearing impairment: Advise patients to seek immediate medical attention if sudden decrease or loss of hearing occurs. ()
  • Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. ()
  • Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ()
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • The most common adverse reaction is headache. ()n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Renal Impairment (, , , )
  • Hepatic Impairment (, , , )
  • 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.
  • ALYQu2122 (tadalafil, USP), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)u2013specific phosphodiesterase type 5 (PDE5). The structural formula is:
  • 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 white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
  • ALYQu2122 is available as orange, film-coated, oval-shaped tablets for oral administration. Each tablet contains 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.
  • No data
  • No data
  • No data
  • No data
  • See FDA-Approved Patient Labeling ()
  • Brands listed are the trademarks of their respective owners.
  • Manufactured In Israel By:n n Jerusalem, 9777402, Israeln n
  • Manufactured For:n n North Wales, PA 19454
  • Iss. 01/2019
  • ALYQu2122u00a0n- (ah-LIQ)
  • (tadalafil tablets USP)
  • Read this patient information before you start taking ALYQu2122 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.
  • u00a0
  • What is the most important information I should know about ALYQu2122?
  • Never take ALYQu2122 with any nitrate or guanylate cyclase stimulator medicines:
  • Nitrates include:
  • Guanylate cyclase stimulators include:
  • Ask your healthcare provider or pharmacist if you are not sure if you take a nitrate or guanylate cyclase stimulator medicine.
  • What is ALYQu2122?
  • ALYQu2122 is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.
  • It is not known if ALYQu2122 is safe or effective in children.
  • Who should not take ALYQu2122?
  • u00a0n- Do not take ALYQu2122 if you
  • See n
  • u00a0
  • What should I tell my healthcare provider before taking ALYQu2122?
  • Before taking ALYQu2122, tell your healthcare provider about all of your medical conditions, including if you:
  • u00a0
  • Tell your healthcare provider about all the medicines you take,
  • Especially tell your healthcare provider if you take any of these medicines:
  • Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. 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.
  • u00a0
  • How should I take ALYQu2122?
  • u00a0
  • What should I avoid while taking ALYQu2122?
  • Do not have more than 4 alcohol-containing drinks in a short period of time while you take ALYQu2122. Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.
  • u00a0
  • What are the possible side effects of ALYQu2122?
  • The following side effects were reported rarely in patients taking tadalafil:
  • See n
  • u00a0
  • The most common side effects with ALYQu2122 include:
  • Tell your healthcare provider about any side effect that bothers you or does not go away.
  • u00a0
  • These are not all the possible side effects of ALYQu2122. 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.
  • u00a0
  • How should I store ALYQu2122?
  • Store ALYQu2122 tablets at room temperature between 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C).
  • Keep ALYQu2122 and all medicines out of the reach of children.
  • u00a0
  • General Information about the safe and effective use of ALYQu2122
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ALYQu2122 for a condition for which it was not prescribed. Do not give ALYQu2122 to other people, even if they have the same symptoms you have. It may harm them.
  • This patient information leaflet summarizes the most important information about ALYQu2122. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ALYQu2122 that is written for healthcare professionals. For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
  • u00a0
  • What are the ingredients in ALYQu2122?
  • Active Ingredient: tadalafil, USP
  • Inactive Ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured In Israel By:n n Jerusalem, 9777402, Israeln n
  • Manufactured For:n n North Wales, PA 19454
  • Iss. 01/2019
  • NDC 0093-3334-06ALYQn (tadalafil tablets USP)20 mgRx only60 TABLETSTEVA

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