Sildenafil (Page 5 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Sildenafil tablets, USP are supplied as white, film-coated, circular, biconvex tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:
Sildenafil Tablets, USP | |||
Package Configuration | Strength | NDC | Debossing on Tablet |
Bottle of 4 Tablets | 20 mg | 68788-7974-4 | ‘SC’ on one side and ’20’ on other side |
Bottle of 30 Tablets | 20 mg | 68788-7974-3 | ‘SC’ on one side and ’20’ on other side |
Bottle of 60 Tablets | 20 mg | 68788-7974-6 | ‘SC’ on one side and ’20’ on other side |
Bottle of 90 Tablets | 20 mg | 68788-7974-9 | ‘SC’ on one side and ’20’ on other side |
Recommended Storage for Sildenafil Tablets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
See FDA-approved patient labeling (Patient Information).
- •
- Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates.
- •
- Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.
- •
- Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION.
- •
- Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness.
Marketed by:
Ajanta Pharma USA Inc. Bridgewater, NJ 08807.
Made in India.
Repackaged By: Preferred Pharmaceuticals Inc.
PATIENT INFORMATION
PATIENT INFORMATION Sildenafil (sil den’ a fil) Tablets, USP |
What is the most important information I should know about sildenafil tablets? Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines.
Nitrate include:
Ask your healthcare provider or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. See “What are the possible side effects of sildenafil tablets?” for more information about side effects. |
What are sildenafil tablets? Sildenafil tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. Sildenafil tablets may be used in:
It is not known if sildenafil tablets is safe and effective in children younger than 1 year of age. |
Do not take sildenafil tablets if you:
|
Before taking sildenafil tablets, tell your healthcare provider about all of your medical conditions, including if you:
|
Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sildenafil tablets and certain other medicines may affect each other and can cause side effects.Especially tell your healthcare provider if you take:
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 your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. |
How should I take sildenafil tablets?
|
What are the possible side effects of sildenafil tablets? Sildenafil tablets may cause serious side effects, including:
|
The most common side effects of sildenafil tablets in adults include: • nosebleeds • headache • upset stomach • getting red or hot in the face (flushing) • arm or leg pain • muscle aches and pain • back pain • diarrheaThese are not all the possible side effects of sildenafil tablets. 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 sildenafil tablets?
Keep sildenafil tablets and all medicines away from children. General information about the safe and effective use of sildenafil tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals. |
What are the ingredients in sildenafil tablets? Active ingredients: sildenafil citrate Inactive ingredients: Sildenafil tablets: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxideNew Dosing Regimen in Adults with Pulmonary Arterial Hypertension (PAH) and treatment of PAH in Pediatric Patients (Ages 1-17) information are approved for Viatris Specialty LLC’s Revatio (Sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with these information. Marketed by:Ajanta Pharma USA Inc. Bridgewater, NJ 08807. Made in India. |
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: April 2023
Repackaged By: Preferred Pharmaceuticals Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.