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I. Propecia Fact File

Propecia was introduced by in 1998.

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories.

II. Propecia Medication

Generic Propecia is developed to treat mild to moderate male pattern hair loss on the vertex (top of head) and anterior mid-scalp area (middle front of head) in MEN ONLY. There is not sufficient evidence that Generic Propecia works for receding hairlines at the temples.

Generic Propecia is for the treatment of male pattern hair loss in MEN ONLY and Generic Propecia should NOT be used by women or children.

Generic Propecia works on a key cause of hair loss by significantly reducing the amount of DHT(DHT – dihydrotestosterone is a substance in the body that can shrink the hair follicle until it no longer produces visible hair). Specifically, Generic propecia inhibits the formation of DHT in your scalp. Lowering DHT appears to inhibit the further shrinking of affected hair follicles. Generic Propecia helps regrow visible hair and reduces further hair loss. (See Diagram 1)

Generic Propecia is, in fact, the first and only FDA-approved pill proven to treat male pattern hair loss on the vertex (top of head) and anterior mid-scalp area (middle front of head) in men.

Take propecia daily and you could see results in as little as 3 months. If you stop taking propecia, however, your results will gradually go away over 12 months. And if Generic propecia has not worked in 12 months, further treatment is unlikely to be of benefit.

Although results will vary, generally you will not be able to grow back all the hair you have lost.

Women who are or may potentially be pregnant must not use Generic propecia and should not handle crushed or broken propecia tablets because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in Generic propecia, a doctor should be consulted.

Generic Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that Propecia tablets are not broken or crushed.

Contact with the semen from a man being treated with Generic propecia is not a risk to the unborn child of a pregnant woman.

Clinical Studies of propecia

Vertex (top of the head) Study
Generic Propecia was demonstrated to be effective in the longest controlled study of male pattern hair loss ever conducted. In this 5-year study of men with mild to moderate hair loss:

Almost 9 out of 10 men on Generic Propecia had visible results (either regrowth of hair, 48% [134 out of 279], or no further hair loss, 42% [117 out of 279]) vs. 25% (4 out of 16) on placebo (sugar pill), according to an assessment of photographs by an independent panel of dermatologists.

In the longest reported controlled clinical study of men with certain types of male pattern hair loss and bold ness, 2 out of 3 men on propecia regrew hair, as measured by actual hair counts over time. All the men in the study who were not taking propecia lost hair.

A majority of men on Generic propecia were rated as improved by doctors: 77% (210 out of 271) vs 15% (2 out of 13) with placebo. Majority of men on Generic propecia reported their bald spot getting smaller, their hair loss slowing down, and the appearance of their hair improving.

Even more, in the first year of the study, 86% (587 out of 679) of men on Generic propecia maintained hair or increased the number of visible hairs vs. 42% (282 out of 672) on placebo.

Anterior Mid-Scalp (middle front of the head) Study
Generic Propecia was also shown to be effective in a study of men with hair loss on the middle front of the head.

In clinical studies for Generic propecia, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking propecia because of them.

Hair Loss: Information

Male pattern hair loss is the most common form of hair loss and Bald ness, representing close to 95% of all cases of hair loss in men. And about half of all men experience male pattern hair loss by age 50. So if you have male pattern hair loss, you are certainly not alone.

Male Pattern Baldness (MPB): Signs and Symptoms

  • Receding hairline
  • Moderate to extensive loss of hair, especially on the crown

We are probably very familiar with this type of hair loss and Bald ness. It begins with a receding hairline and/or slow balding at the crown. It is typically a progressive condition—left untreated the hair loss will likely continue. Scientists believe male pattern hair loss is inherited from either side of your family and that a chemical called dihydrotestosterone, more commonly referred to as DHT, is a key factor in hair loss.

At any one time, about 10 to 12 percent of the hair on your scalp is in a resting phase. After 2 to 3 months, the resting hair falls out and new hair starts to grow in its place. This growing phase lasts for 2 to 6 years. Each hair grows approximately 1 centimeter per month during this phase. About 90 percent of the hair on your scalp is growing at any one time.

It is normal to shed some hair each day as part of this cycle. However, Many people may experience excessive (more than normal) hair loss.

Causes of Hair Loss

  • A number of things can cause excessive hair loss. For example, about 3 or 4 months after an illness or a major surgery, you may suddenly lose a large amount of hair. This hair loss is related to the stress of the illness and is temporary.
  • Hormonal problems may cause hair loss. If your thyroid gland is overactive or underactive, your hair may fall out. This hair loss usually can be helped by treatment of the thyroid disease. Hair loss may occur if male or female hormones, known as androgens and estrogens, are out of balance. Correcting the hormone imbalance may stop your hair loss.
  • Many women notice hair loss about 3 months after they've had a baby. This loss is also related to hormones. During pregnancy, high levels of certain hormones cause the body to keep hair that would normally fall out. When the hormones return to pre-pregnancy levels, that hair falls out and the normal cycle of growth and loss starts again.
  • Some medicines can cause hair loss. This type of hair loss improves when you stop taking the medicines. Medicines that can cause hair loss include blood thinners (also called anticoagulants), medicines used for gout, medicines used in chemotherapy to treat cancer, vitamin A (if too much is taken), birth control pills and antidepressants.
  • Certain infections can cause hair loss. Children may have hair loss caused by a fungal infection of the scalp. The infection is easily treated with antifungal medicines.
  • Finally, hair loss may occur as part of an underlying disease, such as lupus or diabetes. Since hair loss may be an early sign of a disease, it is important to find the cause so that it can be treated.

Treatment of Hair Loss

  • Some types of hair loss can be reversed with the discontinuation of a behavior, a change in diet, or the return to health after illness. Pattern baldness, on the other hand, is irreversible without treatment. Fortunately, treatments are available, in the form of both medication and surgery.
  • Medication for the treatment of androgenetic alopecia come in both topical and oral forms.
  • The prevalent topical medication is minoxidil, an ointment that is rubbed directly onto the scalp. The most commonly used oral medication is finasteride. Finasteride has been shown to be more effective than minoxidil, though both have shown some success at both stopping hair loss and growing new hair.
  • Surgical treatments are primarily designed for the treatment of male pattern baldness, though in some cases women can also benefit from them. They include hair transplantation, flap surgery, tissue expansion, and scalp reduction.
  • Hair transplant surgery – also referred to as hair grafting involves the removal of hairy sections of scalp from the back and sides of the head and their subsequent replacement in spots with no hair. The scalp sections are removed in one of two ways: small grafts can be removed with a cylindrical punch, while larger sections can be cut out with a scalpel and divided up. The patient may choose to have the transplants divided into narrow strips, even more narrow slit-grafts, or tiny sections of only a few hairs. Openings are created in the bald area to receive the grafts, which are then inserted. The openings are then closed with stitches. The grafts are spaced out to allow them plenty of blood flow. The hair follicles in the transplant will die and fall out, but new, natural follicles will grow in to replace them. If extensive replacement is necessary, the surgery will often be completed in several stages spaced out a few months apart.
  • Flap surgery takes a strip of hairy scalp and relocates it to a bald spot while still leaving it connected to blood flow. To begin the procedure, the bald skin is removed, creating a receptor location along the edge of the hairline. Then, a matching hair-bearing flap of scalp is created immediately adjacent to the receptor site. This flap is removed, except for a hinge of skin at one end, and rotated over to its new position. Nourishing blood flows through the hinge to the rest of the flap, allowing it to keep growing. Usually, the flap is placed near the front of the scalp, so that other methods – such as tissue expansion or scalp reduction – can be used to fill in the area behind.
  • Tissue expansion is performed using a small empty sack that is inserted under the skin. The sack is gradually filled with saline over the course of a few months. The skin begins to grow new cells to expand around the bulge. This new skin contains hair follicles, so it can be placed over adjacent bald patches.
  • Scalp reduction involves the removal of bald skin around the crown of the head and the subsequent stretching of adjacent hair-bearing scalp to cover the area. Sutures hold the stretched skin in place while it acclimates to its new position. Scalp reduction is often used in conjunction with flap surgery to cover a bald crown.

Hair: Information

Hair is composed of keratin, the same protein that makes up nails and the outer layer of our skin. The part seen rising out of the skin is called hair shaft or strand. Each strand consists of three layers. The outermost protective layer (cuticle) is thin and colorless. The middle layer, or cortex, is the thickest. It provides strength, determines your hair color and whether your hair is straight or curly.

Diagram: Hair shaft under microscope: light is reflected from the colorless cuticle and bent as it passes through the hair - this effect gives hair the color we see.

Side Effects of Hair Loss Treatments

  • Most common side effects include dry itching and flaking scalp. Rare side effects include low blood pressure, which is completely reversible once stopping medication.
  • Side effects while using Generic Propecia are rare and include, lowered libido, lowered amount of ejaculant, and erectile dysfunction in less that 2% of the men in the clinical trials. Note: 1.3% of the men in the placebo group experienced the same side effects.
  • Hair Transplantation: Accelerated hair loss or shock fall out. Donor site scarring, unnatural appearance in hair growth and all other complications related to surgery. Note: anyone performing follicular unit transplantation at a superior level will not experience most of these side effects.

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