Precautions – Ripple (Sildenafil Citrate) Tablets
To ensure safe and effective use of Ripple, please consider the following precautions:
“A medical history and physical examination of the patient should be performed to diagnose erectile dysfunction and determine potential underlying causes before considering drug treatment.”
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects. Sildenafil tablets should be used with caution in following cases:
1. Cardiovascular
There is a potential for cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including Sildenafil tablets, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
2. Prolonged Erection and Priapism
Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. Sildenafil tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism.
3. Effects on the Eye
Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including Sildenafil tablets, 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 rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.
4. Hearing Loss
Physicians should advise patients to stop taking PDE5 inhibitors, including Sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
5. Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives
Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers & antihypertensive medications. Concomitant use of these two drug classes can lower blood pressure significantly.
6. Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies
The use of such combinations is not recommended.
7. Counseling Patients About Sexually Transmitted Diseases
The use of Sildenafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.
8. Not for Women or Children:
Sildenafil tablets are not for use in women or children. It is strictly intended for adult men only.
9. Renal & Hepatic Impairment:
Use with caution in patients with hepatic & renal impairment.
10. Overdose:
Doses of 200 mg did not increase efficacy, but did increase the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and visual disturbances.
In the event of an overdose, standard supportive measures should be adopted as needed. Since sildenafil is highly bound to plasma proteins and is not excreted in urine, renal dialysis is not expected to accelerate sildenafil clearance.