TADALAFIL 20MG TAB 60CT

Name: TADALAFIL 20MG TAB 60CT
Brand: AJANTA PHARMA L
SKU: 10229521

Product Details

Manufacturer: AJANTA PHARMA L

MFG#: 27241-0123-02

NDC: 27241-0123-02

PID: 638206

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Additional Information

Product Name	Tadalafil 20 mg Tab 60Ct
Active Ingredient	Tadalafil
Drug Class	Phosphodiesterase type 5 (PDE5) inhibitor
Mechanism of Action	Inhibits PDE5 enzyme, increases cGMP levels, relaxes smooth muscles, enhances blood flow to penile and prostate tissues
Strength	20 mg per tablet
Dosage Form	Film-coated tablet
Route of Administration	Oral
Side Effects	Headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, dizziness, vision disturbances
Precaution	Avoid in severe cardiovascular disease, hepatic impairment, hypotension; do not use with nitrates; caution in renal impairment
Packaging	Bottle containing 60 tablets
Uses	Erectile dysfunction (ED), benign prostatic hyperplasia (BPH)

Description

Tadalafil 20 mg is a phosphodiesterase type 5 (PDE5) inhibitor used primarily for treating erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). It enhances blood flow to the penile tissue by relaxing smooth muscles in the blood vessels, facilitating an erection when sexual stimulation occurs. It helps alleviate urinary symptoms in BPH by relaxing the muscles in the prostate and bladder.

Each tablet contains 20 mg of tadalafil as the active ingredient, along with excipients like lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablets are film-coated for easy swallowing and come in a standard pack of 30 tablets, typically intended for once-daily use as prescribed by a healthcare provider. The onset of action occurs within 30 to 60 minutes, with effects lasting up to 36 hours.

Common side effects include headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, and dizziness. Patients with cardiovascular disorders, severe hepatic impairment, or hypotension should use tadalafil cautiously. It should not be taken with nitrates or guanylate cyclase stimulators due to the risk of severe hypotension.

Product Properties:

Description	N
Description	-
DESI Drug Ind	-
DESI Drug Ind	-; -
DESI2 Drug Ind	AB
Drug Category	-
Drug Category	USES: Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.
Drug Type Code	COMMON BRAND NAME(S): Adcirca, Alyq, Tadliq
Drug Type Code	N
FDA Approval Date	02/06/2019
FDA Therap Equiv	TAB
HCPCS	-
HCPCS	1
Market Entry Date	-
Medical Coverage	-
Medical Coverage	-
Termination Date	(ta-DA-la-fil)
Termination Date	1
Unit	60
Units Per Pkg	02/05/2019
Active Ingredients	9874 tadalafil 171596295
Active Ingredients	9874 tadalafil 171596295
AHFS Class	24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS; 48480000 VASODILATING AGENTS (RESPIRATORY TRACT)
AHFS Class	24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS; 48480000 VASODILATING AGENTS (RESPIRATORY TRACT)
DEA Class	NC
DEA Class	NC
Dose Form	TABLET
Dose Form	TABLET
Fine Line Class	850085008510 All Rx Products
Fine Line Class	850085008510 All Rx Products
Gen Code and Des	65368 tadalafil ORAL TABLET 20 MG
Gen Code and Des	65368 tadalafil ORAL TABLET 20 MG
Inactive Ingredients	2432 lactose 64044515
Inactive Ingredients	2432 lactose 64044515
OMP Family	-
OMP Family	-
Product Category	RX Pharmaceuticals
Product Category	RX Pharmaceuticals
Strength	20MG
Strength	20MG
Common Brand Name	-
Common Brand Name	COMMON BRAND NAME(S): Adcirca, Alyq, Tadliq
Drug Interaction	-
Drug Interaction	DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: riociguat, vericiguat. Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use any of the following with tadalafil or within 48 hours of your last dose of tadalafil: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite. If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may adjust your medications to minimize your risk of low blood pressure. Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as lopinavir), rifampin, ritonavir, among others. Do not take this medication with any other product that contains tadalafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).
Allocation Period	-
Allocation Period	-
Case Quantity	72
Case Quantity	72
Drug Form Pack Size	60
Drug Form Pack Size	60
Form	TABLET
Form	TABLET
Hazard Code	-
Hazard Code	-
Listed Chemical	-
Listed Chemical	-
NIOSH Code	-
NIOSH Code	-
Orange Book	AB Products meeting necessary bioequivalence requirements.
Orange Book	AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity	1
Retail Pack Quantity	1
Returnable Status	Returnable
Returnable Status	Returnable
Special Storage Cond	00 None
Special Storage Cond	00 None
Temp Zone	10 Room Temperature
Temp Zone	10 Room Temperature
Unit	EA
Unit	EA
Unit Size	60
Unit Size	60
How to Use	-
How to Use	HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. To treat high blood pressure in the lungs, take this medication by mouth with or without food as directed by your doctor, usually once daily. If you are using the liquid form of this medication, shake the bottle well for 30 seconds before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose	MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose	60
Notes	TAB
Notes	NOTES: Do not share this medication with others.
Overdose	OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose	AB
Phonetic Pronunciation	-
Phonetic Pronunciation	(ta-DA-la-fil)
Precautions	-
Precautions	PRECAUTIONS: Before taking tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers, other lung conditions (such as pulmonary veno-occlusive disease). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, tadalafil should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects	SIDE EFFECTS: Dizziness, lightheadedness, headache, muscle pain, flushing, nausea, stuffy nose, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke. Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. Get medical help right away if you have any very serious side effects, including: increased shortness of breath or trouble breathing. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects	-
Storage	02/05/2019
Storage	STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses	USES: Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.
Uses	-

Product Details