Erectile dysfunction and ED Treatment » Tadalafil

Cialis Drug Description

Viagra Wiki — Tue, 17 Nov 2009 06:01:13 +0000

CIALIS®
(tadalafil) Tablets for Oral Administration

DRUG DESCRIPTION

CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C₂₂H₁₉N₃O₄ representing a molecular weight of 389.41. The structural formula is:

The chemical designation is pyrazino[1?,2?:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a- hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

INDICATIONS

Erectile Dysfunction

CIALIS is indicated for the treatment of erectile dysfunction.

DOSAGE AND ADMINISTRATION

Erectile Dysfunction

CIALIS for Use as Needed

The recommended starting dose of CIALIS 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.
CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.

CIALIS for Once Daily Use

The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Use with Food

CIALIS may be taken without regard to food.

Use in Special Populations

Renal Insufficiency

CIALIS for Use as Needed

Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.
Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.
Severe (creatinine clearance < 30 mL/min and on hemodialysis): The maximum recommended dose is 5 mg not more than once in every 72 hours [see WARNINGS and PRECAUTIONS and Use In Specific Populations].

CIALIS for Once Daily Use

Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.
Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.
Severe (creatinine clearance < 30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see WARNINGS and PRECAUTIONS and Use In Specific Populations].

Hepatic Impairment

CIALIS for Use as Needed

Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised.
Severe (Child Pugh Class C): The use of CIALIS is not recommended [see WARNINGS and PRECAUTIONS and Use In Specific Populations].

CIALIS for Once Daily Use

Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.
Severe (Child Pugh Class C): The use of CIALIS is not recommended [see WARNINGS and PRECAUTIONS and Use In Specific Populations].

Geriatrics

No dose adjustment is required in patients > 65 years of age.

Concomitant Medications

Nitrites

Concomitant use of nitrates in any form is contraindicated [see CONTRAINDICATIONS]. Alpha Blockers
When CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see WARNINGS and PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

CYP3A4 Inhibitors

CIALIS for Use as Needed – For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours [see WARNINGS and PRECAUTIONS and DRUG INTERACTIONS].

CIALIS for Once Daily Use – For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the dose should not exceed 2.5 mg [see WARNINGS and PRECAUTIONS and DRUG INTERACTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Four strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow: 2.5-mg tablets debossed with “C 2 1/2″

5-mg tablets debossed with “C 5″

10-mg tablets debossed with “C 10″

20-mg tablets debossed with “C 20″

CIALIS (tadalafil) is supplied as follows:

Four strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow, and supplied in the following package sizes:

2.5 mg tablets debossed with “C 2 1/2″

Blisters of 2 x 15……………………. NDC 0002-4465-34

5-mg tablets debossed with “C 5″

Bottles of 30……………………. NDC 0002-4462-30
Blisters of 2 x 15……………………. NDC 0002-4462-34

10-mg tablets debossed with “C 10″

Bottles of 30……………………. NDC 0002-4463-30

20-mg tablets debossed with “C 20″

Bottles of 30……………………. NDC 0002-4464-30

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Erectile Dysfunction Treatments and drugs

Viagra Wiki — Tue, 17 Nov 2009 03:42:22 +0000

A variety of options exist for treating erectile dysfunction. They range from medications and simple mechanical devices to surgery and psychological counseling. The cause and severity of your condition are important factors in determining the best treatment or combination of treatments for you.

Oral medications
Oral medications available to treat ED include:

Sildenafil (Viagra)
Tadalafil (Cialis)
Vardenafil (Levitra)

All three medications work in much the same way. Chemically known as phosphodiesterase inhibitors, these drugs enhance the effects of nitric oxide, a chemical that relaxes muscles in the penis. This increases the amount of blood flow and allows a natural sequence to occur — an erection in response to sexual stimulation.

These medications don’t automatically produce an erection. Instead they allow an erection to occur after physical and psychological stimulation. Many men experience improvement in erectile function after taking these medications regardless of the cause of their impotence.

These medications share many similarities, but they have differences as well. They vary in dosage, duration of effectiveness and possible side effects. Other distinctions — for example, which drug is best for certain types of men — aren’t yet known. No study has directly compared these three medications.

Not all men benefit
Although these medications can help many people, not all men can or should take them to treat erectile dysfunction. You should not take these medications if:

You take nitrate drugs for angina, such as nitroglycerin (Nitro-Bid, others), isosorbide mononitrate (Imdur) and isosorbide dinitrate (Isordil)
You take a blood-thinning (anticoagulant) medication
You take certain types of alpha blockers for enlarged prostate (benign prostatic hyperplasia) or high blood pressure

Viagra, Levitra or Cialis may not be a good choice for you if:

You have severe heart disease or heart failure
You’ve had a stroke
You have very low blood pressure (hypotension)
You have uncontrolled high blood pressure (hypertension)
You have uncontrolled diabetes

Don’t expect these medications to fix your erectile dysfunction immediately.

Work with your doctor to find the right treatment and dose for you. Dosages may need adjusting. Or you may need to alter when you take the medication.

Before taking any medication — including Viagra, Levitra or Cialis — make sure to discuss with your doctor:

Potential benefits and side effects of the medication you are considering
Any illnesses or serious health problems you have now or have had in the past
Any prescription or over-the-counter medications you take (including herbal remedies)

Prostaglandin E (alprostadil)
Two treatments involve using a drug called alprostadil. Alprostadil is a synthetic version of the hormone prostaglandin E. The hormone helps relax muscle tissue in the penis, which enhances the blood flow needed for an erection. There are two ways to use alprostadil:

Needle-injection therapy. With this method, you use a fine needle to inject alprostadil (Caverject, Edex) into the base or side of your penis. This generally produces an erection in five to 20 minutes that lasts about an hour. Because the injection goes directly into the spongy cylinders that fill with blood, alprostadil is an effective treatment for many men. And because the needle used is so fine, pain from the injection site is usually minor. Other side effects may include bleeding from the injection, prolonged erection and formation of fibrous tissue at the injection site. The cost per injection can be expensive. Injecting a mixture of alprostadil and other prescribed drugs may be a less expensive and more effective option. These other drugs may include papaverine and phentolamine.
Self-administered intraurethral therapy (Muse). This treatment involves using a disposable applicator to insert a tiny alprostadil suppository, about half the size of a grain of rice, into the tip of your penis. The suppository, placed about two inches into your urethra, is absorbed by erectile tissue in your penis, increasing the blood flow that causes an erection. Although needles aren’t involved, you may still find this method painful or uncomfortable. Side effects may include pain, minor bleeding in the urethra, dizziness and formation of fibrous tissue.

Hormone replacement therapy
For the small number of men who have testosterone deficiency, testosterone replacement therapy may be an option.

Penis pumps
This treatment involves the use of a hollow tube with a hand-powered or battery-powered pump. The tube is placed over the penis, and then the pump is used to suck out the air. This creates a vacuum that pulls blood into the penis. Once you achieve an adequate erection, you slip a tension ring around the base of your penis to maintain the erection. You then remove the vacuum device. The erection typically lasts long enough for a couple to have sex. You remove the tension ring after intercourse.

Vascular surgery
This treatment is usually reserved for men whose blood flow has been blocked by an injury to the penis or pelvic area. Surgery may also be used to correct erectile dysfunction caused by vascular blockages. The goal of this treatment is to correct a blockage of blood flow to the penis so that erections can occur naturally. But the long-term success of this surgery is unclear.

Penile implants
This treatment involves surgically placing a device into the two sides of the penis, allowing erection to occur as often and for as long as desired. The inflatable device allows you to control when and how long you have an erection, the semirigid rods keep the penis in a rigid state all the time. These implants consist of either an inflatable device or semirigid rods made from silicone or polyurethane. This treatment is often expensive and is usually not recommended until other methods have been considered or tried first. As with any surgery, there is a small risk of complications such as infection.

Psychological counseling and sex therapy
If stress, anxiety or depression is the cause of your erectile dysfunction, your doctor may suggest that you, or you and your partner, visit a psychologist or counselor with experience in treating sexual problems (sex therapist). Even if it is caused by something physical, erectile dysfunction can create stress and relationship tension. Counseling can help, especially when your partner participates.