Archive for the ‘Tablets’ Category

Questions and Answers for Cialis (tadalafil)

Tuesday, March 27th, 2007

1.  What is Cialis used to treat?

         Cialis is approved for the treatment of men who experience difficulty having and maintaining an erection (impotence).

2.  How does Cialis work?

Cialis works by enhancing the effects of one of the chemicals the body normally releases into the penis during sexual arousal. This allows an increase of blood flow into the penis. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3.  How is Cialis different from the currently approved products for erectile dysfunction (ED)?

Cialis is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of Cialis to other products.

4.  How do I take Cialis?

Cialis is taken orally before sexual activity, not more than once daily. Cialis may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5.  Are there any side effects with Cialis?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with Cialis during the testing of the product were:

  • headache
  • indigestion
  • back pain
  • muscle pain
  • flushing
  • stuffy nose

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking Cialis and these usually go away by themselves within 48 hours. A small number of patients taking Cialis also reported abnormal vision.

6.  What important information should you know about Cialis?:

· CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication (alpha blockers are medicines used to treat benign prostatic hyperplasia and high blood pressure) other than FLOMAX (tamsulosin) 0.4 mg daily. You could get dizzy, faint or have a heart attack or stroke.

· Tell your healthcare provider that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your health care provider to know when you last took Cialis.

· After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

7.  What should I talk to my doctor about when considering if Cialis is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if Cialis is right for you. Patients who have a condition called “left ventricular outlet obstruction” from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with Cialis, Cialis is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8.  Who should not take Cialis?

Cialis should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) or any alpha blocker other than FLOMAX 0.4mg daily because the combination of these with Cialis could significantly lower blood pressure and lead to fainting or even death in some men.

9.  Can Cialis be used with other treatments for impotence?

The safety and effectiveness of Cialis when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with Cialis is not recommended.

10. What if I am taking other drugs?

Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter) that way, you can receive the best advice for your own situation. Cialis is not recommended for people taking any form of nitroglycerin and most alpha-blockers, other than FLOMAX, because the combination may lower blood pressure to an unsafe level.

11.  How will Cialis be supplied?

Cialis will be available as oral tablets in 5mg, 10mg and 20mg strengths.

12. Will Cialis be prescription or OTC (over-the-counter)?

Cialis will be available by prescription only.

13.  When will Cialis be available to pharmacies?

FDA has no control over when products are available in pharmacies after FDA approval for marketing. The decision of availability is completely up to the company marketing the product. For further information contact your pharmacist or Eli Lilly and Company directly.

14.  How can I report a serious side effect with Cialis to FDA?

FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.

Call 1-800-FDA-1088

GPs slam delay on brittle bone drugs

Tuesday, March 6th, 2007

Thousands of women with the brittle bone disease osteoporosis have been denied the necessary drugs to ease their condition because the medical debate about the most cost-effective treatment has taken five years to complete.Sufferers in some areas have been faced with ‘treatment blight’ - the reluctance of doctors to prescribe drugs because no decision has been made by Nice, the independent body that decides which drugs can be used.

Fewer than 500,000 of the three million people with brittle bone disease have received drugs that reduce their chances of sustaining a fracture, according to evidence assembled by the National Osteoporosis Society. ‘The upshot must be that more patients will have suffered broken hips than were necessary because some of the patients that might have had their bone density improved haven’t been able to get hold of drugs,’ said a spokesman.

Nice is finally due to reveal its findings tomorrow, although it is expected to impose age conditions on treatment. Critics have warned that this is likely to force the NHS to spend even more than the existing £1.73bn a year on treating the affects of osteoporosis when a course of drugs that costs as little as 27p a day can reduce the risk of fracture by up to half.

The society, whose patron is the Duchess of Cornwall, calls osteoporosis ‘Britain’s silent epidemic’. One in two women over 50 and one in five men of the same age are affected. Treatment of broken hips and vertebrae costs the NHS about the same as dealing with heart disease, and a broken hip means an average of 26 days in hospital.

The society, whose members include senior medical experts on the condition, has evidence that doctors have been waiting to see what Nice’s final recommendations are before prescribing a course of drugs. It claims that this ‘treatment blight’ means that some GPs have not been implementing Nice’s existing guidance on osteoporosis.

For example, present rules say that most women over 65 who have already had a fracture should receive a drug treatment. But the society’s research shows that, one year after fracture, most patients have not been prescribed a drug to prevent another breakage.

‘The Nice advice has been a long time coming - it’s been looking into this for five years - and has left the medical community uncertain what to do,’ said a society official. ‘We’re concerned that doctors’ disinclination to prescribe osteoporosis drugs, pending Nice’s final decision, is one reason why only 480,000 of Britain’s three million sufferers currently receive any form of drug treatment.’

Dr Mayur Lakhani, president of the Royal College of General Practitioners, confirmed that some doctors were not prescribing drugs due both to financial constraints and clinical and scientific uncertainty about the most effective treatments. ‘There’s a policy vacuum and lack of clear policy on osteoporosis in the NHS generally, not just with Nice,’ he said. ‘We need clarity on this, because osteoporosis is an important and common condition that the NHS doesn’t tackle effectively. More needs to be done. There are some difficult decisions to be made here and I hope Nice can help resolve some of these issues.’

A spokeswoman for Age Concern said: ‘We strongly urge Nice to make the right decision and ensure older people get access to the drugs and treatment that they need.’ Nice declined to comment before its advice was published.

ZOCOR (simvastatin)

Monday, March 5th, 2007

USES OF ZOCOR

ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high cholesterol. For patients at high risk of coronary heart disease (CHD) because of existing heart disease, diabetes, vascular disease, or history of stroke, ZOCOR is indicated along with diet to reduce the risk of death by reducing coronary death; reduce the risk of heart attack and stroke; and reduce the need for revascularization procedures.

WHEN ZOCOR SHOULD NOT BE USED

ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a preservative.

Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.)

Women who are or may become pregnant: Pregnant women should not take ZOCOR because it may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once.

Women who are breast-feeding should not take ZOCOR.

SIDE EFFECTS

Most patients tolerate treatment with ZOCOR well; however, like all prescription drugs, ZOCOR can cause side effects, and some of them can be serious. Side effects that do occur are usually mild and short-lived. Only your doctor can weigh the risks versus the benefits of any prescription drug. In clinical studies with ZOCOR, less than 1.5% of patients dropped out of the studies because of side effects. In 2 large, 5-year studies, patients taking ZOCOR experienced similar side effects to those patients taking placebo (sugar pills). Some of the side effects that have been reported with ZOCOR or related drugs are listed below. This list is not complete. Be sure to ask your doctor about side effects before taking ZOCOR and to discuss any side effects that occur.

Digestive System: Constipation, diarrhea, upset stomach, gas, heartburn, stomach pain/cramps, anorexia, loss of appetite, nausea, inflammation of the pancreas, hepatitis, jaundice, fatty changes in the liver, and, rarely, severe liver damage and failure, cirrhosis, and liver cancer.

Muscle, Skeletal: Muscle cramps, aches, pain, and weakness; joint pain; muscle breakdown.

Nervous System: Dizziness, headache, insomnia, tingling, memory loss, damage to nerves causing weakness and/or loss of sensation and/or abnormal sensations, anxiety, depression, tremor, loss of balance, psychic disturbances.

Skin: Rash, itching, hair loss, dryness, nodules, discoloration.

Eye/Senses: Blurred vision, altered taste sensation, progression of cataracts, eye muscle weakness.

Hypersensitivity (Allergic) Reactions: On rare occasions, a wide variety of symptoms have been reported to occur either alone or together in groups (referred to as a syndrome) that appeared to be based on allergic-type reactions, which may rarely be fatal. These have included 1 or more of the following: a severe generalized reaction that may include shortness of breath, wheezing, digestive symptoms, and low blood pressure and even shock; an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing; symptoms mimicking lupus (a disorder in which a person’s immune system may attack parts of his or her own body); severe muscle and blood vessel inflammation, sometimes including rash; bruises; various disorders of blood cells (that could result in anemia, infection, or blood clotting problems) or abnormal blood tests; inflamed or painful joints; hives; fatigue and weakness; sensitivity to sunlight; fever, chills; flushing; difficulty breathing; and severe skin disorders that vary from rash to a serious burn-like shedding of skin all over the body, including mucous membranes such as the lining of the mouth.

Other: Loss of sexual desire, breast enlargement, impotence.

Laboratory Tests: Liver function test abnormalities including elevated alkaline phosphatase and bilirubin; thyroid function abnormalities.