CIALIS (Tadalafil)

Manufactured by: Eli Lilly and Company
Cialis (Tadalafil) is a prescription drug that is used to treat erectile dysfunction and benign prostate hyperplasia (BPH) in men. It is a phosphodiesterase 5 (PDE5) inhibitor that increases cGMP level in the smooth muscles. Increased cGMP level relaxes muscles and increases blood flow to the penis.

Cialis is to be used in men only.

What is Cialis used for?

Cialis is used to treat:

  1. Erectile dysfunction in men – a medical condition where an individual is unable to achieve penile erection sufficient to initiate and sustain sexual intercourse.
  2. Benign Prostatic Hyperplasia (BPH): a medical condition in which prostate becomes enlarged. When prostate, the walnut-sized gland located right between bladder and penis, is swollen, it squeezes or blocks the urethra, the narrow tube that expels urine out of the body. BPH is a benign condition, it may be asymptomatic in some patients, and cause extreme discomfort in others.  

What is the dosage form and potency (strength) of Cialis?

Cialis is available as debossed tablets in 2.5mg, 5mg, 10mg, and 20mg.

What should you know about Cialis?

  • Read the medication guide thoroughly.
  • Cialis may give you prolonged erection. Consult your doctor if erection lasts for more than 4 hours per day. Priapism (erection lasting for more than 6 hours) can lead to irreversible damage.
  • Some part of the drug may retain in the body for more than 2 days.
  • Do not take any other similar medicine used for treating erectile dysfunction with Cialis.
  • You need to limit the dose and frequency of Cialis administration if your liver is impaired.
  • Do not under any circumstances (before consulting your physician and cardiologist) take Cialis if you had a recent heart attack or have anginal pains, high blood pressure, and stroke.
  • Cialis is not to be used in women and children.
  • You may acquire sexually transmitted diseases (STD) even if using this drug as it does not protect against STD.
  • You can take Cialis on an empty stomach as well as after a meal.
  • You should not, in any case, take Cialis if you are already taking any kind of nitrates as the use of tadalafil with this class of drugs can highly potentiate their hypotensive effects and could lead to life-threatening situations. Consult your pharmacist to know which medicines have nitrate in them.
  • Talk to your pharmacist about the safety of administering Cialis with other medicines that you are using.
  • Your doctor may require you to undergo some diagnostic testing and evaluation before prescribing Cialis.
  • Do not consume large amounts of alcohol with Cialis. It can markedly reduce your blood pressure.
  • Do not administer Cialis if you have congenital eye disorder.
  • Discontinue the drug and consult your health care provider on experiencing ringing in your ears accompanied by a headache and dizziness.
  • You will need to have the state of your renal functioning determined by before using Cialis.
  • Do not administer this drug with other agents which inhibit the CYP3A4 class of enzymes. These drugs include erythromycin, ketoconazole, itraconazole, indinavir, ritonavir.
  • Same goes for the use of CYP3A4 inducers (e.g., rifampin, St John’s wort) with Cialis in this case the serum levels of tadalafil can decrease.
  • If you have a bleeding disorder or suffer from GI ulcers, use Cialis only if your doctor tells you to in such cases.

What are the instructions for using Cialis?

  • You can take the drug on full or empty stomach.
  • Swallow the tablet with a glass of water. Avoid taking it with alcohol.
  • Do not discontinue Cialis before talking to your physician.
  • For the detection of optimal results by this drug and prevention of any adverse events, you might have to undergo blood testing. So you should not miss your follow-up.

Contraindications and precautions:

  • Cialis is contraindicated in those who are allergic to tadalafil or any of its constituents.
  • Its use is prohibited with riociguat, a drug used for treating raised blood pressure in the arterial vessels of lungs.
  • Never take Cialis with nitrate drugs as it could lead to severe adverse effects.

Use Cialis with care if you have any of the following listed below;

  • Liver disease
  • Heart diseases
  • Hearing loss
  • Defect in eyes by birth
  • With other drugs, that inhibits the isoenzyme system of CYP3A4

What are the adverse effects of Cialis?

You may suffer from any or all of the following side effects of the drug;

  • Cardiovascular: pain in the chest, low blood pressure (hypotension), heart attack, a sudden drop in blood pressure upon standing (postural hypotension), unconsciousness, rapid heartbeat.
  • Gastrointestinal: deranged liver functioning, dry mouth, painful swallowing, inflamed esophagus, gastritis, diarrhea, nausea, vomiting, painful piles, rectal bleeding.
  • Pain in the muscles and neck.
  • Nervous: dizziness, numbness, lack of sleep, tingling sensation in skin, dizziness.
  • Kidney failure
  • Respiratory: shortness of breath, throat infections and nose bleeds.
  • Itching, rash, and sweating.
  • Eye: blurred vision, changes in color vision, inflammation of the conjunctiva and eyelids, eye pain, and increased tear formation
  • Ear: sudden decrease or loss of hearing.
  • Spontaneous penile erection or painful erection

Post-marketing reported adverse effects:

  • Sudden heart arrest
  • Stroke
  • Palpitations
  • Life-threatening allergic response, i.e., Stevens-Johnson syndrome
  • Convulsions
  • Sudden loss of hearing

How can tadalafil interact with the other drugs?

With nitrates: using tadalafil with drugs containing nitrates can cause severe hypotension.

With alpha blockers and blood pressure lowering drugs: both of these drugs are vasodilators and together can lead to dangerous blood pressure lowering effects.

With alcohol: together alcohol and tadalafil can lead to hyptension, increased heart rate, headache, and dizziness.

With antacids: antacids on administration with Cialis reduce its rate of absorption.

With cytochrome P450 inhibitors: as Cialis is principally metabolized by CYP3A4, drugs that inhibit CYP3A4 enzymes can increase the levels and effects of tadalafil.

With Cytochrome P450 Inducers: These drugs can decrease tadalafil availability.

Can this drug be used in the specific populations?

  • In pregnant mothers: tadalafil should not be used by pregnant women.
  • In nursing females: breast feeding women should not use this drug because its secretion in milk is unknown.

Cialis is used for a specific condition that affects men only. Its use is not indicated in women, particularly those who are or planning on becoming pregnant.

  • In pediatrics: this drug is marked unsafe for children.
  • In geriatrics: no dose adjustments are required for Cialis based on age alone. However, consult your doctor if you are 65 and older as the drug can sensitize your body.

Pharmacology of Cialis:

What is the mode of action of Cialis?

Cialis selectively inhibits the obstructing enzyme PDE-5 (phosphodiesterase type 5) which causes a rush of blood flow to the penis helping it achieve the required erection. One dose of Cilias can improve erectile function for up to 36 hours.

What is the pharmacokinetics of Cialis?

Absorption: it reaches its maximum concentration between 30 minutes and 6 hours. Food has no effect on its absorption.

Distribution: a large amount of this drug binds to the plasma proteins present in the human body. 63 L gets distributed throughout the body.

Metabolism and excretion: its metabolism takes place through cytochrome enzymatic system. It has a half-life of 17.5 hours. The major route of excretion is feces. Less than 40% of the administered drug is eliminated through the urine.

How do different patient populations affect the Pharmacokinetics of Cialis?

  • It is safe for use in diabetes.
  • It should be taken with caution if the patient has a failing liver.
  • Patients with an existing cardiac disease should practice caution during sexual intercourse. In fact, if possible, the drug should not be used if sex is unadvisable.

What is the toxicology profile of this drug?

  • Cialis did not produce cancerous cells or mutated cells in the animals tested by it.
  • Fertility and sexual reproduction of animal subjects remained unaffected by tadalafil.
  • Animal studies did reveal vascular disease, damage to lymph and thymus cells in rats, mice, and dogs.

What should you inform your doctor before using Cialis?

Before taking Cialis, a patient should inform his/her doctor about;

  • Blood pressure problems
  • Previous stroke if any
  • Liver diseases
  • Kidney injuries
  • Eye and ear diseases/disorders
  • Stomach ulcer
  • Blood cancer

What are the ingredients used in Cialis?

  • Active Ingredient: tadalafil
  • Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

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