Fioricet and Esgic are brand name drugs made from a combination of acetaminophen (325 mg), butalbital (a barbiturate, 50 mg), and caffeine (40 mg). They are indicated for the treatment of tension headaches and muscle contraction headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments.

Usage and Dosage

Fioricet is indicated for the treatment of complex tension and muscle contraction headaches. It is also commonly prescribed for migraines although it is not FDA indicated for this use. The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24 hour period.

Variations

* Phrenilin is an equivalent combination of butalbital and acetaminophen, without the caffeine (325/50).
* Esgic Plus and Phrenilin Forte contains 500 and 650 miligrams of acetaminophen respectively, instead of 325 milligrams. Additionally, Esgic Plus contains 40 milligrams of caffeine.
* Fiorinal contains aspirin instead of acetaminophen.
* Fiorinal and Fioricet also come as a combination drug with codeine called Fiorinal with Codeine and Fioricet with Codeine which adds 30 milligrams of codeine phosphate to each mixture.

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Finasteride (marketed as Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX) is an antiandrogen which acts by inhibiting type II 5-alpha reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). It is used as a treatment in benign prostatic hyperplasia (BPH) in low doses, and in prostate cancer in higher doses. It is also indicated for use in combination with doxazosin therapy to reduce the risk for symptomatic progression of BPH. Additionally, it is registered in many countries for male-pattern baldness.

Finasteride was approved initially in 1992 as Proscar, a treatment for prostate enlargement, but the sponsor had studied 1 mg of finasteride and demonstrated hair growth in male pattern hair loss. On December 22, 1997, the FDA approved finasteride to treat male pattern hair loss.

The Prostate Cancer Prevention Trial (PCPT) showed at a dosage of 5mg per day, as is commonly prescribed for BPH, though much higher than the 1mg generally prescribed for hair loss, participants taking finasteride were 25% less likely to have developed prostate cancer at the end of the trial compared to those taking a placebo.[1] Further, finasteride increased the specificity and selectivity of prostate cancer detection, thus, a seemly increased rate of high Gleason grade tumor.

Recognized side effects, experienced by around >1% of users, include erectile dysfunction, and less often gynecomastia (breast gland enlargement). As expected from its short 6-8 hour half-life, in trial studies, side effects ceased after dosage was discontinued.

Brand names

Drug trade names include Propecia and Proscar, both products of Merck & Co. (the former is marketed for hair loss in male pattern baldness, and the latter for BPH). There is 1 mg of finasteride in Propecia and 5 mg in Proscar.

Cipla also manufactures finasteride (trade names Fincar and Finpecia), as does Dr. Reddy's (trade names Finax and Finast), Ranbaxy (trade name Finara), Intas (trade name Finalo), and Aleppo Pharmaceutical (trade name Prosteride), who sell the drug at a significantly lower cost than Merck.

Use as a treatment for hair loss

In a 5-year study of men with mild to moderate hair loss, 48% of those treated with Propecia (finasteride 1mg) experienced some regrowth of hair, and 42% had no further loss. Average hair count in the treatment group remained above baseline, and showed an increasing difference from hair count in the placebo group, for all five years of the study.[2]. Propecia is effective only for as long as it is taken; the hair gained or maintained is lost within 6-12 months of ceasing therapy (Rossi, 2004). In clinical studies, Propecia, like minoxidil, was shown to work on both the crown area and the hairline,[6] but is most successful in the crown area.

Some users, in an effort to save money, buy Proscar instead of Propecia, and split the Proscar pills to approximate the Propecia dosage. Doing so is generally considered unadvisable if women of pregnancy age are in the household; this is because finasteride, even in small concentrations, can cause birth defects in a developing male fetus. The birth defects involve the development of male genitalia (no such effects have been noted in developing female fetuses). On most product inserts, it will be mentioned that the dust or crumbs from broken Propecia tablets should be kept away from pregnant women.

Propecia has been shown to be ineffective for treating hair loss in women.However, Propecia's supporters respond that the study was on post-menopausal women whose hair loss was more likely related to the loss of estrogen versus a sensitivity to testosterone. Many doctors prescribe it for women, but not without either careful birth control measures or assurance that the woman cannot become pregnant.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

Tadalafil is a drug used to treat male erectile dysfunction (impotence). It was developed by the biotechnology firm ICOS and marketed worldwide by Eli Lilly and Company under the brand name Cialis.

In the United States, tadalafil has Food and Drug Administration approval and became available in December, 2003 as the third impotence pill after sildenafil (Viagra) and vardenafil (Levitra). Due to its 36-hour effect it is also known as the weekend pill. It should be noted that the drug has not been formally studied in regard to multiple sexual attempts during a 36 hour period.

Tadalafil is also currently undergoing Phase III clinical trials for the treatment of pulmonary hypertension.

History

The history of Cialis cannot be discussed without mentioning Pfizer's drug, Viagra. The FDA's approval on March 27, 1998, led this prescription drug, Viagra, to a ground breaking success in just the first year of introduction as Pfizer sold drugs worth over a billion dollars. However, things changed considerably for the giant of erectile dysfunction drugs when the FDA also approved Levitra on August 19, 2003, and Cialis on November 21, 2003. In 1993 the drug company Icos began studying IC351, which is a PDE5 enzyme inhibitor, and this is basically the process through which the erectile dysfunction drugs work. In 1994, Pfizer scientists discovered that sildenafil citrate, which is a white crystalline powder that temporarily normalizes erectile function of the penis by blocking an enzyme known to inhibit the production of a chemical that causes erections, caused the heart patients that were participating in a clinical study of a heart medicine to have erections. Although the scientists were not testing the chemical compound IC351 for erectile dysfunction, the compound seemed to have a side effect which could potentially be worth millions, if not billions of dollars. Soon Icos received its very first patent in 1994 on IC351, and the clinical trials of phase 1 took place in 1995. In 1997, phase 2 clinical studies began and Icos performed its first study on patients with erectile dysfunction. Phase 2 lasted about two years, and after that phase 3 began.

In 1998, ICOS Corporation, and Eli Lilly and Company, commercialized the drug for erectile dysfunction, and two years later they filed a new drug application with the U.S. Food and Drug Administration for IC351; the only difference was that this time they decided to call the drug Cialis. In May of 2002, Icos and Eli Lilly and Company reported to the American Urological Association that the phase 3 tests show that Cialis works for up to 36 hours, and one year later Icos and Eli Lilly and Company received the U.S. FDA's approval for Cialis. One advantage that Cialis has over Viagra is that tadalafil has a half-life of 17.5 hours[2] (and thus Cialis is advertised to work for up to 36 hours, even if by that time there is still about one quarter of the absorbed dose in the body) as compared to 4 hours half-life for sildenafil (Viagra).

Eli Lilly purchased ICOS corporation for $2.1 billion dollars in 2006.

Chemistry

The empirical formula for tadalafil is C22H19N3O4, and its official organic name is (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a- hexahydro-2-methyl-pyrazino[1 ,2 :1,6]pyrido[3,4-b]indole-1,4-dione. The molecular weight is 389.41. Tadalafil tablets are yellow, film-coated, and almond-shaped, and are produced in 5, 10, or 20 mg doses.

Mechanism of action

Tadalafil works by inhibiting PDE5, an enzyme found primarily in the arterial wall smooth muscle tissue of the penis and the lungs. A 20 mg dose of tadalafil is comparable to a 100 mg dose of sildenafil (Viagra).[citation needed] By inhibiting PDE5, tadalafil relaxes blood vessels in the penis, thereby increasing blood flow and aiding in erection.

Part of the physiological process of erection involves the parasympathetic nervous system causing the release of nitric oxide (NO) in the corpus cavernosum of the penis. NO binds to the receptors of the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation (vasodilation) in the corpus cavernosum, resulting in increased inflow of blood and an erection.

Tadalafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum. The molecular structure of tadalafil is similar to that of cGMP and acts as a competitive binding agent of PDE5 in the corpus cavernosum, resulting in more cGMP and better erections. Without sexual stimulation, and therefore lack of activation of the NO/cGMP system, tadalafil should not cause an erection. Other drugs that operate by the same mechanism include sildenafil (Viagra®) and vardenafil (Levitra®).

Tadalafil is currently undergoing clinical trials for the treatment of pulmonary hypertension. The clinical trials are based on tadalafil's inhibitiong of PDE5. It is hoped that by inhibiting this enzyme, tadalafil will prove effective in opening up blood vessels in the lungs, lowering pulmonary arterial resistance and pressure, and thus reducing the workload of the right ventricle of the heart.

Side effects

The most common side effects when using tadalafil are headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Back pain and muscle aches can occur 12 to 24 hours after taking the drug, and the symptom usually disappears after 48 hours.

In May 2005, the U.S. Food and Drug Administration found that tadalafil (along with other PDE5 inhibitors) could lead to vision impairment in certain patient groups, including diabetics. An investigation is currently ongoing.

Drug interactions

Since PDE5 inhibitors such as tadalafil may cause transiently low blood pressure (hypotension), organic nitrates should not be taken for at least 48 hours after taking the last dose of tadalafil. Using organic nitrates (such as the sex drug amyl nitrite) within this timeframe may increase the risk of life-threatening hypotension.

Since people who have taken tadalafil within the past 48 hours cannot take organic nitrates to relieve angina (such as glyceryl trinitrate spray), these patients should seek immediate medical attention if they experience anginal chest pain.[5] In the event of a medical emergency, paramedics and medical personnel should be notified of any recent doses of tadalafil.

Marketing

In the United States, Eli Lilly has a multiyear agreement to promote tadalafil (Cialis) with professional golf's PGA Tour.

Cialis is one of the most frequent offerings of spam.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

Mechanism of action

Part of the physiological process of erection involves the parasympathetic nervous system causing the release of nitric oxide (NO) in the corpus cavernosum of the penis. NO binds to the receptors of the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation (vasodilation) in the corpus cavernosum, resulting in increased inflow of blood and an erection.

Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum. The molecular structure of sildenafil is similar to that of cGMP and acts as a competitive binding agent of PDE5 in the corpus cavernosum, resulting in more cGMP and better erections. Without sexual stimulation, and therefore lack of activation of the NO/cGMP system, sildenafil should not cause an erection. Other drugs that operate by the same mechanism include tadalafil (Cialis®) and vardenafil (Levitra®).

Sildenafil is metabolised by hepatic enzymes and excreted by both the liver and kidneys. If taken with a high-fat meal, there may be a delay in absorption of sildenafil and the peak effect might be reduced slightly as the plasma concentration will be lowered.

Dosage and price

As with all prescription drugs, proper dosage is at the discretion of a licensed medical doctor. The dose of sildenafil is 25 mg to 100 mg taken once per day between 30 minutes and 4 hours prior to sexual intercourse.

It is usually recommended to start with a dosage of 50 mg and then lower or raise the dosage as appropriate. The drug is sold in three dosages (25, 50, and 100 mg), all three costing about US$10 per pill. Name-brand Viagra sildenafil is not scored and a fairly hard coating makes it more difficult to accurately cut the pills in half, even with a pill cutter.

Viagra pills are blue and diamond-shaped with the words "Pfizer" on one side, and "VGR xx" (where xx stands for "25", "50" or "100", the dose of that pill in milligrams) on the other.

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From Wikipedia, the free encyclopedia
The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective.

The CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. In keeping with this, reviews are generally staffed by teams that are intended to come to consensus on decisions.

Within the CDER "Review teams" of around 1,300 employees approve new drugs. Additionally, the CDER employs a "safety team" has 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.

The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.

The current Director is Dr. Steve Galson.

Role of Advisory Committees

CDER submits requests for advice to many different Advisory Committees. These committees, composed of experts in their respective fields, provide non-binding advice to CDER about the advisability of approving particular drugs.

There are sixteen advisory committees functioning within CDER:

* Anesthetic and Life Support Drugs
* Anti-Infective Drugs
* Antiviral Drugs
* Arthritis Drugs
* Cardiovascular and Renal Drugs
* Dermatologic and Ophthalmic Drugs
* Drug Safety and Risk Management
* Endocrinologic and Metabolic Drugs
* Gastrointestinal Drugs
* Nonprescription Drugs
* Onologic Drugs, also known as the Oncology Drug Advisory Committee
* Peripheral and Central Nervous System Drugs
* Pharmaceutical Science and Clinical Pharmacology
* Psychopharmacologic Drugs
* Pulmonary-Allergy Drugs
* Reproductive Health Drugs

Labels: No Prescription, Online Pharmacy, Prescription Drugs

From Wikipedia, the free encyclopedia

Recently, a number of pharmacies have begun operating over the internet. Many such pharmacies are, in some ways, similar to community pharmacies; the primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient than traveling to a community drugstore.

Some internet pharmacies sell prescription drugs without requiring a prescription. Some customers order drugs from such pharmacies to avoid the inconvenience of visiting a doctor or to obtain medications which their doctors were unwilling to prescribe. However, this practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and an individual's overall suitability for use of a medication. There have also been reports of such pharmacies dispensing substandard products.

In the United States, there has been a push to legalize importation of medications from Canada and other countries, in order to reduce consumer costs. Although importation of prescription medication currently violates Food and Drug Administration (FDA) regulations and federal laws, enforcement is generally targeted at international drug suppliers, rather than consumers.

Overseas online pharmacies and U.S. law

Legality and risks of purchasing drugs online depend on the specific kind of drug being purchased, as well as its amount.

* It is illegal to purchase controlled substances from an overseas pharmacy. Generally speaking, a person purchasing a controlled substance from such a pharmacy may be violating two federal laws which can carry stiff penalties. The act of importation of the drug from overseas violates 21 USC, Section 952 (up to 5 years in prison and $250,000 fine for importation of non-narcotic Schedule III, IV, or V drugs; possibly more for narcotics and Schedule I and II drugs). The act of simple possession of a controlled substance without a valid prescription violates 21 USC, Section 844 (up to 1 year in prison and $1,000 fine). Note that FDA does not recognize "online prescriptions"; in order for the prescription to be valid, there has to be a face-to-face relationship between the patient and the health care professional prescribing the drug. Sections 956 and 1301 provide exemptions for travellers who bring small quantities of controlled substances in or out of the country in person, but these exemptions do not cover delivery via a mail carrier.
* The act of importation of any prescription drug (not necessarily a controlled substance) violates 21 USC, Section 301(aa), unless the following conditions are met (as listed in Section 804):
1. The drug is imported from Canada, from a seller registered with the Secretary (i.e. with FDA);
2. The drug is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;
3. The drug is accompanied by a copy of a valid prescription;
4. The drug is a prescription drug approved by the Secretary;
5. The drug is in the form of a final finished dosage that was manufactured in an establishment registered under section 510; and
6. The drug is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.
* The law further specifies that enforcement should be focused on cases in which the importation by an individual poses a significant threat to public health, and discretion should be exercised to permit individuals to make such importations in circumstances in which the prescription drug or device imported does not appear to present an unreasonable risk to the individual.
* According to Department of Homeland Security Appropriations Act, Section 535, Customs and Border Patrol are not allowed to prevent people from importing FDA-approved prescription drugs. Although originally the law was worded to cover all prescription drugs, countries of origin, and methods of delivery, its final edition specifies that it only applies to importation from Canada, and to "...individuals transporting on their person a personal-use quantity of the prescription drug, not to exceed a 90-day supply". Controlled substances are also explicitly excluded. Therefore, it does not disallow Customs to screen and intercept drugs sent by mail.
* It is also technically illegal to import non-approved drugs (21 USC sections 331(d) and 355(a)); however, FDA policies suggest that, under certain circumstances, the patients may be allowed to keep these drugs.
* Individual U.S. states may implement their own laws regulating importation, possession, and trafficking in prescription drugs and/or controlled substances.

Enforcement

Laws listed in the previous section are not always enforced (or otherwise all online pharmacies would quickly run out of customers and go bankrupt). Among other reasons, strict drug law enforcement is politically unpopular because many customers of online pharmacies are seniors who can't afford to buy their prescription drugs in the United States.

* Any package containing prescription drugs may, in principle, be seized by customs. The package may be held until the addressee provides proof that he is allowed to receive these drugs (e.g. a valid prescription), and eventually returned to the sender if the addressee does not respond. (Sample package detention notification letter) In practice, the number of packages containing prescription drugs sent to United States on a daily basis far exceeds customs' capabilities to inspect them. In the past, packages often passed through customs even if they weren't sent from Canada or otherwise didn't meet the requirements of section 804 of 21 USC. Up until recently, about 5% of all prescription drug packages sent from Canada were being seized.
* At the present time, US customs do not seize packages from Canada.
* DEA and FDA generally do not target consumers unless drugs are imported in large quantities (suggesting intent to distribute) or represent danger to public health (opiates, amphetamines). However, this may change at any time.
* Sometimes drug importation laws are enforced on the local level. For example, in June 2005 in Baton Rouge, Louisiana, a number of customers of online pharmacies were arrested by local law enforcement officers and charged with possession of a controlled substance without prescription.

Labels: No Prescription, Online Pharmacy, Prescription Drugs