STENDRA*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Avanafil- mg,
Avanafil- mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Erectile dysfunction- adult males
List Of Drugs:
- Avanafil- Stendra- @- (Apr 2012)- Sexual Stimulant
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
STENDRA can potentiate the hypotensive effect of nitrates, alpha-blockers,
antihypertensives, and alcohol
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase
STENDRA exposure
Indication:
STENDRA (avanafil) tablets, for oral use
Initial U.S. Approval: 2012
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye (5.4) 04/2014
Adverse Reactions, Postmarketing Experience (6.2) 04/2014
Patient Counseling Information, Sudden Loss of Vision (6.2) 04/2014
Drug Name- Stendra
Active Ingredient - Avanafil
To treat erectile dysfunction
Indication-
To treat erectile dysfunction
Approved by FDA on 27-4-2012 (Ref- FDA Approved List- 2012)
Adverse Reaction:
Most common adverse reactions (greater than or equal to 2%) include headache,
flushing, nasal congestion, nasopharyngitis, and back pain
Contra-Indications:
CONTRAINDICATIONS
Administration of STENDRA to patients using any form of organic nitrate
is contraindicated
Hypersensitivity to any component of the STENDRA tablet
WARNINGS AND PRECAUTIONS
Patients should not use STENDRA if sexual activity is inadvisable due to
cardiovascular status or any other reason
Use of STENDRA with alpha-blockers, other antihypertensives, or substantial
amounts of alcohol (greater than 3 units) may lead to hypotension
Patients should seek emergency treatment if an erection lasts greater than 4 hours
Patients should stop STENDRA and seek medical care if a sudden loss of vision
occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic
Neuropathy (NAION).
STENDRA should be used with caution, and only when the anticipated benefits
outweigh the risks, in patients with a history of NAION.
Patients with a crowded optic disc may also be at an increased risk of NAION
Patients should stop taking STENDRA and seek prompt medical attention in the
event of sudden decrease or loss of hearing
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment
of erectile dysfunction
DOSAGE AND ADMINISTRATION
For most patients, the starting dose is 100 mg taken approximately 30 minutes
before sexual activity, on an as needed basis
Take STENDRA no more than once a day
The dose may be increased to 200 mg or decreased to 50 mg based on
efficacy and/or tolerability. Use the lowest dose that provides benefit
STENDRA may be taken with or without food
Do not use STENDRA with strong CYP3A4 inhibitors
If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg
in a 24-hour period
In patients on stable alpha-blocker therapy, the recommended starting dose
of STENDRA is 50 mg
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 100 mg, 200 mg
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
1. Nitrates
Physicians should discuss with patients the contraindication of STENDRA with regular
and/or intermittent use of organic nitrates. Patients should be counseled that
concomitant use of STENDRA with nitrates could cause blood pressure to
suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart
attack or stroke.
In such circumstances, nitrates should still only be administered under close
medical supervision with appropriate hemodynamic monitoring.
Patients who experience anginal chest pain after taking STENDRA should seek
immediate medical attention
2. Cardiovascular Considerations
Physicians should discuss with patients the potential cardiac risk of sexual activity
in patients with preexisting cardiovascular risk factors.
Patients who experience symptoms upon initiation of sexual activity should be
advised to refrain from further sexual activity and should seek immediate
medical attention
3. Concomitant Use with Drugs Which Lower Blood Pressure
Physicians should advise patients of the potential for STENDRA to augment
the blood pressure-lowering effect of alpha-blockers and other antihypertensive
medications
4. Potential for Drug Interactions
Patients should be advised to contact the prescribing physician if new medications
that may interact with STENDRA are prescribed by another healthcare provider
5. Priapism
There have been rare reports of prolonged erections greater than 4 hours and priapism
(painful erections greater than 6 hours in duration) for this class of compounds.
Priapism, if not treated promptly, can result in irreversible damage to the
erectile tissue. Physicians should advise patients who have an erection lasting
greater than 4 hours, whether painful or not, to seek emergency medical attention.
6. Sudden Loss of Vision
Physicians should advise patients to stop use of all PDE5 inhibitors, including
STENDRA, and seek medical attention in the event of a sudden loss of vision
in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic
optic neuropathy (NAION), a cause of decreased vision including permanent
loss of vision that has been reported rarely in temporal association with the
use of PDE5 inhibitors.
6. Sudden Hearing Loss
Physicians should advise patients to stop taking PDE5 inhibitors, including
STENDRA, and seek prompt medical attention in the event of sudden decrease
or loss of hearing. Use of PDE5 inhibitors has been associated with sudden
decrease or loss of hearing, which may be accompanied by tinnitus and dizziness.
7.Alcohol
Patients should be made aware that both alcohol and PDE5 inhibitors including
STENDRA act as mild vasodilators. When mild vasodilators are taken in combination,
blood pressure-lowering effects of each individual compound may be increased.
Therefore, physicians should inform patients that substantial consumption
of alcohol (e.g., greater than 3 units) in combination with STENDRA can increase the
potential for orthostatic signs and symptoms, including increase in heart rate, decrease
in standing blood pressure, dizziness, and headache.
8. Sexually Transmitted Disease
The use of STENDRA offers no protection against sexually transmitted diseases
Counseling of patients about the protective measures necessary to guard against
sexually transmitted diseases, including Human Immunodeficiency Virus (HIV)
should be considered.
9. Recommended Administration
Physicians should discuss with patients the appropriate use of STENDRA and its
anticipated benefits. It should be explained that sexual stimulation is required
for an erection to occur after taking STENDRA. STENDRA should be taken
approximately 30 minutes before initiating sexual activity.
10.Patients should be counseled regarding the dosing of STENDRA. Inform patients
that the recommended starting dose of STENDRA is 100 mg.
The dose may be increased to a maximum recommended dose of 200 mg or
decreased to 50 mg based on efficacy and tolerability. The lowest dose that provides
benefit should be used.
Patients should be advised to contact their healthcare provider for dose modification.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
The physiologic mechanism of erection of the penis involves release of nitric oxide
(NO) in the corpus cavernosum during sexual stimulation. NO then activates the
enzyme guanylate cyclase, which results in increased levels of cGMP, producing
smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C
STENDRA is not indicated for use in women. There are no adequate and well-controlled
studies of STENDRA in pregnant women.
2.Pediatric Use
STENDRA is not indicated for use in pediatric patients. Safety and efficacy in patients
below the age of 18 years has not been established.
3. Geriatric Use
Of the total number of subjects in clinical studies of avanafil, approximately 23%
were 65 and over. No overall differences in efficacy and safety were observed
between subjects over 65 years of age compared to younger subjects; therefore
no dose adjustment is warranted based on age alone.
However, a greater sensitivity to medication in some older individuals should
be considered
