Tadalafil (Tadalafil)

Trade Name : Tadalafil

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 2.5 mg/1

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

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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 (Tadalafil) which is also known as Tadalafil and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Tadalafil (Tadalafil) 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

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Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2017

Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ().

erectile dysfunction (ED) ()
the signs and symptoms of benign prostatic hyperplasia (BPH) ()
ED and the signs and symptoms of BPH (ED/BPH) ()

Do not split tadalafil tablets; entire dose should be taken.

Tadalafil tablets for use as needed:
Tadalafil tablets for once daily use:
Tadalafil tablets may be taken without regard to food ().

Four strengths of round or oval-shaped, film-coated tablets are available as:
2.5 mg tablets debossed with u201cTEVAu201d on one side and u201c3016u201d on the other side
5 mg tablets debossed with u201cTEVAu201d on one side and u201c3017u201d on the other side
10 mg tablets debossed with u201cTEVAu201d on one side and u201c3018u201d on the other side
20 mg tablets debossed with u201cTEVAu201d on one side and u201c3019u201d on the other side
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ().

No data

Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates ().
History of known serious hypersensitivity reaction to tadalafil or ADCIRCA ().
Administration with guanylate cyclase (GC) stimulators, such as riociguat ().

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.
Before prescribing tadalafil, it is important to note the following:

Patients should not use tadalafil if sex is inadvisable due to cardiovascular status ().
Use of tadalafil with alpha-blockers, antihypertensives or substantial amounts of alcohol (u22655 units) may lead to hypotension (, ).
Tadalafil is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil is used as a treatment for ED in men taking alpha-blockers (, , , ).
Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil with caution in patients predisposed to priapism ().
Patients should stop tadalafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a u201ccrowdedu201d optic disc may also be at an increased risk of NAION (, ).
Patients should stop tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing ().
Prior to initiating treatment with tadalafil for BPH, consideration should be given to other urological conditions that may cause similar symptoms ().

Most common adverse reactions (u22652%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ().
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

Tadalafil can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ().
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) increase tadalafil exposure (, , ) requiring dose adjustment:n
CYP3A4 inducers (e.g., rifampin) decrease tadalafil exposure ().

Hepatic Impairment (, , ):
Renal Impairment (, , ):

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is:
CHNO M.W. 389.41
The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol u2013 part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.

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u201cSee FDA-approved patient labeling (Patient Information)u201d

Tadalafil (ta da' la fil) Tablets USP
Read this important information before you start taking tadalafil tablets and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about tadalafil tablets when you start taking them and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.
What Is The Most Important Information I Should Know About Tadalafil Tablets?
Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if they are taken with certain other medicines.
Do not take tadalafil tablets if you Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
Do not take tadalafil tablets if you take medicines called guanylate cyclase stimulators which include:
Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.
(See )
Tell all of your healthcare providers that you take tadalafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took tadalafil tablets.
After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. n- u201cCan Other Medicines Affect Tadalafil Tablets?u201d
Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
See also n
What Are Tadalafil Tablets?
Tadalafil tablets are a prescription medicine taken by mouth for the treatment of:
Tadalafil Tablets for the Treatment of ED
ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Tadalafil tablets help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets.
Tadalafil tablets do not:
Tadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.
Tadalafil Tablets for the Treatment of Symptoms of BPH
BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.
Tadalafil Tablets for the Treatment of ED and Symptoms of BPH
ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions.
Tadalafil tables are not for women or children.
Tadalafil tablets must be used only under a healthcare provideru2019s care.
Who Should Not Take Tadalafil Tablets?
Do not take tadalafil tablets if you:
Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.
What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets?
Tadalafil tablets are not right for everyone. Before taking tadalafil tablets, tell your healthcare provider about all your medical problems, including if you:
Can Other Medicines Affect Tadalafil Tablets?
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tadalafil tablets and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following:
How Should I Take Tadalafil Tablets?
How Should I Take Tadalafil Tablets for Symptoms of BPH?
For symptoms of BPH, tadalafil tablets are taken once daily.
How Should I Take Tadalafil Tablets for ED?
For ED, there are two ways to take tadalafil tablets - either for use as needed OR for use once daily.
Tadalafil tablets for use as needed:
OR
Tadalafil tablets for once daily use is a lower dose you take every day.
How Should I Take Tadalafil Tablets for Both ED and the Symptoms of BPH?
For both ED and the symptoms of BPH, tadalafil tablets are taken once daily.
What Should I Avoid While Taking Tadalafil Tablets?
What Are The Possible Side Effects Of Tadalafil Tablets?
See n
The most common side effects with tadalafil tablets are:
Call your healthcare provider if you get any side effect that bothers you or one that does not go away.
Uncommon side effects include:
An erection that wonu2019t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil tablets) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including tadalafil tablets, and call a healthcare provider right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking tadalafil tablets and contact a healthcare provider right away.
These are not all the possible side effects of tadalafil tablets. For more information, ask your healthcare provider or pharmacist.
How Should I Store Tadalafil Tablets?
Store tadalafil tablets at 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C).
Keep tadalafil tablets and all medicines out of the reach of children.
General Information About Tadalafil Tablets:
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use tadalafil tablets for a condition for which they were not prescribed. Do not give tadalafil tablets to other people, even if they have the same symptoms that you have. They may harm them.
This is a summary of the most important information about tadalafil tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about tadalafil tablets that is written for health providers. For more information you can call 1-888-838-2872.
What Are The Ingredients In Tadalafil Tablets USP?
Active Ingredient: tadalafil, USP
Inactive Ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol u2013 part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Rx only
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Rev. C 5/2018

NDCn- 3016
Tadalafilu00a0n- Tablets USP
2.5 mg
for once daily use
Rx only
30 TABLETS (2 cards of 15 tablets)
TEVA

NDCn- 3017
Tadalafilu00a0n n- Tablets USP
5 mg
Tablets should not be split.
Entire dose should be taken.
Rx only
30 TABLETS
TEVA

NDCn- 3018
Tadalafilu00a0n n- Tablets USP
10 mg
Tablets should not be split.
Entire dose should be taken.
Rx only
30 TABLETS
TEVA

NDCn- 3019
Tadalafilu00a0n n- Tablets USP
20 mg
Tablets should not be split.
Entire dose should be taken.
Rx only
30 TABLETS
TEVA

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Tadalafil (Tadalafil)

Trade Name : Tadalafil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Tadalafil (Tadalafil)

Trade Name : Tadalafil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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