The first of a new pack of 20, it's the first in a series of two for the erectile dysfunction drug Cialis. This week the drug is being launched in Singapore.
The launch comes two weeks after the drug was rejected by the FDA, prompting the company to seek approval in the United States.
It is the first time a drug has been rejected twice by the FDA, with the first time coming after a review that included more than 80 drugs.
The first of the new pack is for the treatment of benign prostatic hyperplasia, also known as BPH, or enlarged prostate. But it's the first to be approved for the treatment of erectile dysfunction.
The drug has been approved for two different reasons. It's a "pioneer" of Cialis, which is used in Europe and Australia.
The first reason is that Cialis is used to treat benign prostatic hyperplasia, or BPH. But in the U. S. it's used to treat erectile dysfunction.
In the UK, Cialis is also used to treat impotence, a condition in which a man's heart beats too fast.
The other reason that Cialis is being approved for this treatment is to treat the symptoms of BPH, such as frequent urination, difficulty in urination, or pain during urination. In the U. S., Cialis can help to lower the blood pressure.
"We're in the very early stages of clinical development, we're in a very exciting era in BPH treatment," said Dr Michael Dickson, a urologist at St John's General Hospital in Melbourne.
He noted that the first UK study on Cialis has shown that it could be beneficial for treating men with BPH symptoms.
He noted that "we have been very interested in looking at how this drug might work in patients with BPH and also in patients with erectile dysfunction."
Cialis and Viagra are the only drugs approved for this indication.
Dr Dickson said he had not heard of any studies that looked at the effects of Cialis in BPH.
"It's not been seen that way in a large number of clinical trials," he said.
The drug has been nicknamed the "little blue pill" because it increases blood flow to the penis, leading to an erection.
But the drug's effects last for up to 36 hours.
"The duration of action is not as long as other drugs that have similar effects," said Dr Dickson. "We don't know what effect Viagra has on the overall duration of erections."
He noted that the drug is available in generic form.
However, he added that it was still possible that Cialis could increase the blood flow to the penis.
Cialis is also used to treat BPH, a condition in which a man's heart beats too fast.
But the drug isn't available in a generic form.
Cialis has also been used to treat erectile dysfunction in men who have had surgery for an enlarged prostate.
But Dr Dickson said it was still possible that Cialis could increase the blood flow to the penis.
"We don't know what effect Viagra has on the overall duration of erections," he said.
He cautioned that "this drug can cause side effects in some people."
Dr Dickson said it was still possible that Cialis could increase the blood flow to the penis.
He added that "we don't know what effect Viagra has on the overall duration of erections."
He said that "we don't know what effect Cialis has on the overall duration of erections" and that he was confident it would work.
"We have tried to make sure that it is not too long or too short of an erection for some people. We have tried to make sure that it is not too short of an erection for some people," he said.
He said that the drug was also safe for people to take, with no reported side effects.
He noted that Cialis was approved for use in Australia, but he said that the drug could still be effective.
it is also used to treat erectile dysfunction in men.
In a review of the drug's safety, Dr Dickson warned that it could cause dizziness or fainting, especially in people with heart disease.
Product name:Cialis
Company name:
DIN:0062-1153-8
Status:Marketed
Status date:2019-06-25
Active ingredient(s) | Strength |
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Tadalafil | 20 mg |
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For consumersResource | Description |
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Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product. | |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
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Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. All suspected side effects should be reported, especially those that are:
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Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital. This regulatory requirement only applies to hospitals. |
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
1.Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Cialis and nitrates both lower blood pressure. Taking them together can cause a significant and potentially life-threatening drop in blood pressure (hypotension), leading to dizziness, fainting, or even heart attack or stroke. It is contraindicated to use Cialis with nitrates or recreational "poppers" (amyl nitrites).
2.Alpha-blockers (e.g., prazosin, terazosin, tamsulosin): Both Cialis and alpha-blockers relax blood vessels, which can lead to excessive blood pressure reduction when used together. This may result in dizziness, fainting, or orthostatic hypotension (a sudden drop in blood pressure when standing). If needed, your doctor may adjust the dosage or recommend spacing the medications.
3.Other antihypertensive drugs (e.g., atenolol, propranolol, enalapril, lisinopril): Cialis can enhance the blood-pressure-lowering effects of these medications. While this interaction is usually less severe than with nitrates or alpha-blockers, it can still cause dizziness or fainting in sensitive individuals. Close monitoring of blood pressure is recommended.
Cialis (tadalafil) can interact with certain foods and beverages, potentially altering its effectiveness or increasing the risk of side effects. Here are the key drug-food interactions to be aware of:
If you have any questions or concerns about taking Cialis, consult your doctor directly.
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How can I send my test results to Dr. Gellert?Cialis has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Cialis use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
Read More What is Cialis and How It Works:Do not take more than the prescribed dose. Cialis can interact with other medications, causing potentially serious adverse reactions.
What is the recommended starting dose of Cialis:Cialis can be taken at least 30 minutes before sexual activity but may be taken more than once a day. Your doctor will start you on a low dose, maximum 100mg, and monitor you for signs of side effects or safe sex once your treatment has finished.
What is the maximum dosage of Cialis:Your doctor will start you on a low dose, maximum 100mg and monitor you for signs of side effects or safe sex once your treatment has finished.