Viagra Description

 

VIAGRA®

(sildenafil citrate) Tablets

 

 

VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H- pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formulaViagra

 

Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.

INDICATIONS

VIAGRA is indicated for the treatment of erectile dysfunction.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

The following factors are associated with increased plasma levels of sildenafil: age > 65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatinine clearance < 30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)]. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.

Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC, see DRUG INTERACTIONS.) Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg of VIAGRA in a 48 hour period.

VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.

When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha- blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose (see DRUG INTERACTIONS).

HOW SUPPLIED

VIAGRA® (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

 

  25 mg 50 mg 100 mg
Obverse VGR25 VGR50 VGR100
Reverse PFIZER PFIZER PFIZER
Bottle of 30 NDC-0069-4200-30 NDC-0069-4210-30 NDC-0069-4220-30
Bottle of 100 N/A NDC-0069-4210-66 NDC-0069-4220-66

 

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised February 2008. FDA rev date: 2/25/2008

ED Glossary B

bacteria:
    Single-celled microorganisms that can exist independently (free-living) or dependently upon another organism for life (parasite). They can cause infection and are usually treated with antibiotics.
 
bacterial:
    Of or pertaining to a bacteria.
 
bacterial prostatitis:
    Swelling of the prostate caused by bacteria.
 
balanitis:
    Inflammation of the head of the penis.
 
balanitis xerotica obliterans:
    Also known as BXO. Chronic skin condition that causes scarring and thickening of the skin of the penis.
 
balanoposthitis:
    Inflammation of glans and foreskin.
 
balloon angioplasty:
    The surgical repair or reconstruction of narrowed or obstructed arteries where an inflatable balloon attached to the tip of a catheter is passed to the diseased site and inflated to enlarge the passage.
 
balloon dilation:
    A treatment for benign prostatic hyperplasia or prostate enlargement. A tiny balloon is inflated inside the urethra to make it wider so urine can flow more freely from the bladder.
 
balloon urethroplasty:
    A thin tube with a balloon is inserted into the opening of the penis and guided to the narrow portion of the urethra where the balloon is inflated to widen the urethra and restore the flow of urine.
 
bedside commode:
    A portable toilet used by individuals who have difficulty walking to standard facilities.
 
behavioral techniques:
    Methods of changing a person’s symptoms or behavior for the treatment of abnormal urination patterns. Includes modifying bladder habits by methods such as bladder training or timed urination.
 
benign:
    Not malignant; not cancerous.
 
benign prostatic hyperplasia:
    Also known as BPH. An enlarged prostate not caused by cancer. BPH can cause problems with urination because the prostate squeezes the urethra at the opening of the bladder.
 
benign tumor:
    Tumor that is non-cancerous. Generally do not spread to other organs or come back when they are removed.
 
Bethwith-Wiedemann syndrome:
    A consistent group of findings of unknown causes and characterized by a large tongue, large organs, large body size, umbilical hernia, navel hernia and low blood sugar in the newborn.
 
bicornate uterus:
    Uterus that has two horns and is shaped like a heart.
 
bilateral:
    Term describing a condition that affects both sides of the body or two paired organs.
 
bilateral hyperplasia:
    Abnormal growth on one side.
 
biofeedback:
    A procedure that uses electrodes to help an individual gain awareness and control of their pelvic muscles.
 
biofeedback therapy:
    A behavioral technique in which a person learns how to consciously control involuntary responses such as muscle contractions. The person receives a visual, auditory or tactile signal (the feedback) that indicates how well the person’s muscles are responding to the commands of the person’s nervous system. Thi technique is used most often to teach pelvic muscle exercises.
 
biopsied:
    Tiny piece of a body part that was removed with a needle or during surgery and examined under a microscope to determine if cancer or other abnormal cells are present.
 
biopsies:
    Tiny pieces of body parts are removed with a needle or during surgery and examined under a microscope to determine if cancer or other abnormal cells are present.
 
biopsy:
    A procedure in which a tiny piece of a body part (tissue sample), such as the kidney or bladder, is removed (with a needle or during surgery) for examination under a microscope; to determine if cancer or other abnormal cells are present.
 
bladder:
    The bladder is a thick muscular balloon-shaped pouch in which urine is stored before being discharged through the urethra.
 
bladder augmentation:
    Operation that uses a piece of the intestine (bowel) to enlarge the bladder.
 
bladder capacity:
    The amount (maximum volume) of urine that the bladder can hold. Often referred to as bladder volume.
 
bladder control:
    The ability to control the timing of urination. Also referred to as continence.
 
bladder diverticula:
    They are pouches in the bladder wall that a person is born with (congenital) or later acquires. A congenital bladder diverticulum represents an area of weakness in the bladder wall through which some of the lining of the bladder is forced out. (A small balloon squeezed in a fist will create a diverticular-like effect between the fingers.) Bladder diverticula may be multiple and they often occur at the entrance of the upper urinary system into the bladder.
 
bladder exstrophy:
    A congenital birth defect that is the malformation of the bladder and urethra, in which the bladder is turned “inside out” and exposed on the outside of the abdomen. Because the bladder and other structures are exposed to the outside of the body, urine constantly trickles onto the skin causing irritation.
 
bladder infection:
    Also known as cystitis. Urinary tract infection involving the bladder. Typical symptoms include burning with urination, frequency, urgency and wetting.
 
bladder instillation:
    Also known as a bladder wash or bath. The bladder is filled with a solution that is held for varying periods of time before being drained through a catheter.
 
bladder irrigation:
    A continuous flow of fluid through the bladder with the use of a catheter.
 
bladder neck:
    Area of thickened muscle fiber where the bladder joins the urethra. Acting on signals from the brain, bladder neck muscles can either tighten to hold urine in the bladder or relax to allow urine out and into the urethra. These muscles also tighten during ejaculation to prevent backflow of semen into the bladder.
 
bladder neck contracture:
    Scarring of tissue at the bladder neck as a complication of surgery. May lead to urinary problems that require further surgery to correct.
 
bladder prolapse:
    When the bladder slips out of its correct position.
 
bladder relaxants:
    Medications used to improve urgency and frequency to urinate.
 
bladder suspension:
    Also called bladder neck suspension. A term for several surgical procedures employed to treat urethral hyper mobility by elevating and securing the bladder to its proper position within the body. Used for stress urinary incontinence.
 
bladder training:
    A behavioral technique that teaches the patient to urinate on a regular schedule and to empty the bladder completely.
 
bladder ultrasound:
    Also referred to as bladder scan. A method of measuring the urine that remains in the bladder. This is a test that is used to diagnose incomplete bladder emptying. An ultrasound uses sound waves to measure the urine volume–its painless and doesn’t involve the use of radiation like X-rays.
 
bladder X-ray:
    The use of an X-ray picture to examine the bladder and urethra. An X-ray is taken during urination while a radiactive substance is in the bladder.
 
blood transfusion:
    The transfer of blood from a healthy donor into the bloodstream of somebody who has lost blood or has a blood disorder.
 
blood urea nitrogen:
    Also known as BUN. A waste product in the blood that comes from the breakdown of food protein. The kidneys filter blood to remove urea. As kidney function decreases, the BUN level increases.
 
bone anchors:
    A type of surgery for stress urinary incontinence that uses “bone anchors” by drilling screws into the pelvic bone to secure and lift (suspend) the bladder in a fixed position.
 
bone marrow:
    A soft, reddish substance inside some bones that is involved in the production of blood cells.
 
bone scan:
    A nuclear image of the skeleton.
 
bovine tuberculosis:
    Contagious disease caused by an infection in the lymph nodes which spreads to other organs like the lungs.
 
bowel:
    Another word for intestines or colon.
 
bowel movement:
    The act of passing feces (stool) through the anus.
 
bowel vaginoplasty:
    Surgical repair or reconstruction of the vagina using portions of the intestines.
 
BPH:
    Also known as benign prostatic hyperplasia. An enlarged prostate not caused by cancer. BPH can cause problems with urination because the prostate squeezes the urethra at the opening of the bladder.
 
brachytherapy:
    Treatment for prostate cancer that involves the placement of tiny radioactive pellets into the prostate by utilizing ultrasound.
 
bulbar:
    Bulb-shaped.
 
bulbar urethral stricture:
    Stricture at the widest part of the urethra.
 
bulbourethral glands:
    Also referred to as Cowper’s glands. A pair of pea-sized glands that lie beneath the prostate gland that secrete an alkaline fluid that forms part of the semen. This fluid neutralizes the acidic environment of the urethra, thereby protecting the sperm.
 
bulbous urethra:
    Rounded and swollen urethra, the narrow tube that carries urine outside the body from the bladder.
 
bulking agent:
    Substance injected under the urethra to improve urinary control (continence).
 
BUN:
    Also known as blood urea nitrogen. A waste product in the blood that comes from the breakdown of food protein. The kidneys filter blood to remove urea. As kidney function decreases, the BUN level increases.
 
burch suspension:
    An abdominal surgery that supports the vagina to the pubic bone.
 
buried penis:
    Also called concealed penis or hidden penis. A normal-sized penis that lays hidden in the pubic fat pad. Often this penis can easily be exposed by gently pulling on it or pressing down on the surrounding fat pad.
 
buried penis:
    Also referred to as concealed or hidden penis. Condition where the penile shaft is buried below the surface of the pubic skin.
 
BXO:
    Also known as balanitis xerotica obliterans. Chronic skin condition that causes scarring and thickening of the skin of the penis.

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