10 mg/1
Tadalafil · TABLET, FILM COATED · Bostal LLC
is a tablet, film coated containing tadalafil at 10 mg/1, taken oral. Manufactured by Bostal LLC.
Key Facts
- Brand Name
- Generic Name
- Tadalafil
- NDC Code (Product)
35561-256- Manufacturer
- Bostal LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208824
- Drug Class
- Phosphodiesterase 5 Inhibitor [EPC]
- Marketing Start
- 11/29/2019
Recall History
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Albek De Mexico S.A. De C.V.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
ProRx LLC
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Pfizer Inc.
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Little Moon Essentials LLC
CGMP deviations
Pharm D Solutions, LLC
Lack of Assurance of Sterility
AmeriSource Bergen
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not split tadalafil tablets; entire dose should be taken. Tadalafil tablets for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day ( 2.1 ). Tadalafil tablets for once daily use: ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ( 2.2 ). BPH: 5 mg, taken at approximately the same time every day ( 2.3 ) ED and BPH: 5 mg, taken at approximately the same time every day ( 2.3 , 2.4 ) Tadalafil tablets may be taken without regard to food ( 2.5 ). 2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. Tadalafil tablets for use as needed were shown to…
Contraindications
4 CONTRAINDICATIONS Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil was shown to potentiate the hypotensive effect of nitrates ( 4.1 ). History of known serious hypersensitivity reaction to tadalafil or ADCIRCA ® ( 4.2 ). Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 ). 4.1 Nitrates Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2 )] . 4.2 Hypersensitivity Reactions Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA ® ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] . 4.3 Concomitant Guanylate Cyclase (GC) Stimulators Do not use tadalafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including tadalafil may potentiate the hypotensive effec…
Drug Interactions
7 DRUG INTERACTIONS Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5 mg CYP3A4 inducers (e.g. rifampin) decrease tadalafil exposure ( 7.2 ). 7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets Nitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration ( 2.7 …
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact VKT Pharma Pvt. Ltd at 1 844-387-1231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of tadalafil tablets for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For tadalafil tablets for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. Tadalafil Tablets for Use as Needed for ED In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 …
Frequently Asked Questions
What is used for?
contains Tadalafil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is a controlled substance?
is not classified as a controlled substance by the DEA.
What is the generic name for ?
The generic name for is Tadalafil. There are 12 other brand versions of Tadalafil.
What is the NDC code for 10 mg/1?
The NDC (National Drug Code) for 10 mg/1 is 35561-256, listed by Bostal LLC.