Adcirca

Name: Adcirca

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What should I discuss with my healthcare provider before taking tadalafil?

You should not take tadalafil if you are allergic to it.

Taking tadalafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take tadalafil if you also use:

  • riociguat (to treat pulmonary arterial hypertension); or

  • a nitrate drug (for chest pain or heart problems) such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as amyl nitrate or nitrite "poppers".

Some tadalafil can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

To make sure tadalafil is safe for you, tell your doctor if you have ever had:

  • heart disease or heart rhythm problems;

  • a heart attack or stroke;

  • angina (chest pain), high or low blood pressure;

  • pulmonary hypertension (unless you are taking tadalafil for this);

  • a condition called pulmonary veno-occlusive disease (narrowing of the veins that carry blood from the lungs to the heart);

  • liver or kidney disease (or if you are on dialysis);

  • vision loss, or retinitis pigmentosa (an inherited condition of the eye);

  • a bleeding disorder;

  • a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

  • a physical deformity of the penis (such as Peyronie's disease), or an erection lasting longer than 4 hours;

  • a stomach ulcer; or

  • health problems that make sexual activity unsafe.

Sudden vision loss has occurred in a small number of people taking medicines like tadalafil (Viagra or others). Most of these people already had certain eye problems or risk factors for blood vessel disorders (heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether the medicine was the actual cause of vision loss.

Tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tadalafil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Tadalafil is not approved for use by anyone younger than 18 years old.

What happens if I miss a dose?

If tadalafil is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tadalafil?

Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Before Using Adcirca

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of Cialis® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Adcirca™ tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving tadalafil.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amyl Nitrite
  • Boceprevir
  • Erythrityl Tetranitrate
  • Isosorbide Dinitrate
  • Isosorbide Mononitrate
  • Nitroglycerin
  • Pentaerythritol Tetranitrate
  • Propatyl Nitrate
  • Riociguat
  • Telaprevir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Atazanavir
  • Bunazosin
  • Clarithromycin
  • Cobicistat
  • Darunavir
  • Erythromycin
  • Fosamprenavir
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Moxisylyte
  • Nefazodone
  • Phenoxybenzamine
  • Phentolamine
  • Prazosin
  • Ritonavir
  • Saquinavir
  • Simeprevir
  • Simvastatin
  • Tamsulosin
  • Telithromycin
  • Terazosin
  • Tipranavir
  • Trimazosin
  • Urapidil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Doxazosin
  • Rifampin
  • Silodosin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.
  • Age greater than 50 years or
  • Coronary artery disease or
  • Diabetes or
  • Hyperlipidemia (high lipids or fats in the blood) or
  • Hypertension (high blood pressure) or
  • Low cup to disc ratio (eye condition also called "crowded disc") or
  • Smoking—May increase risk for a serious eye problem called NAION.
  • Angina (severe chest pain) or
  • Arrhythmia (irregular heartbeat), uncontrolled or
  • Heart attack (within the last 3 months) or
  • Heart failure (within the last 6 months) or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure), uncontrolled or
  • Retinal disorders (eye problem) or
  • Retinitis pigmentosa (an inherited eye disorder) or
  • Stroke, recent history of—Should not be used in patients with these conditions.
  • Bleeding disorders or
  • Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.
  • Heart or blood vessel disease—Chance of low blood pressure occurring is greater; tadalafil should be used carefully in these patients.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Leukemia (blood related cancer) or
  • Multiple myeloma (blood related cancer) or
  • Sickle-cell anemia (blood disorder)—Tadalafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.
  • NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.
  • Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution. May make this condition worse.

What are some other side effects of Adcirca?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Flushing.
  • Headache.
  • Back pain.
  • Muscle pain.
  • Upset stomach.
  • Nose or throat irritation.
  • Stuffy nose.
  • Runny nose.
  • Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Contraindications

Concomitant Organic Nitrates

Do not use Adcirca in patients who are using any form of organic nitrate, either regularly or intermittently. Adcirca potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and Adcirca on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].

Concomitant Guanylate Cyclase (GC) Stimulators

Do not use Adcirca in patients who are using a GC stimulator, such as riociguat. Adcirca may potentiate the hypotensive effects of GC stimulators.

Hypersensitivity Reactions

Adcirca is contraindicated in patients with a known serious hypersensitivity to tadalafil (Adcirca or CIALIS). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

Overdosage

Single doses up to 500 mg have been given to healthy male subjects, and multiple daily doses up to 100 mg have been given to male patients with erectile dysfunction. Adverse reactions were similar to those seen at lower doses. Doses greater than 40 mg have not been studied in patients with pulmonary arterial hypertension. In cases of overdose, standard supportive measures should be adopted as needed. Hemodialysis contributes negligibly to tadalafil elimination.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Tadalafil was not carcinogenic to rats or mice when administered daily for 2 years at doses up to 400 mg/kg/day. Systemic drug exposures, as measured by AUC of unbound tadalafil, were approximately 5–fold for mice, and 7– and 14–fold for male and female rats, respectively, the exposures at the maximum recommended human dose (MRHD) of 40 mg.

Mutagenesis Tadalafil was not mutagenic in the in vitro bacterial Ames assays or the forward mutation test in mouse lymphoma cells. Tadalafil was not clastogenic in the in vitro chromosomal aberration test in human lymphocytes or the in vivo rat micronucleus assays.

Impairment of Fertility There were no effects on fertility, reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg/kg/day, a dose producing AUCs for unbound tadalafil of 6–fold for males or 17–fold for females the exposures at the MRHD of 40 mg. In beagle dogs given tadalafil daily for 3 to 12 months, there was treatment–related non–reversible degeneration and atrophy of the seminiferous tubular epithelium in the testes in 20–100% of the dogs that resulted in a decrease in spermatogenesis in 40–75% of the dogs at doses of ≥10 mg/kg/day. Systemic exposure (based on AUC) at no–observed–adverse-effect–level (NOAEL) (10 mg/kg/day) for unbound tadalafil was similar to that expected in humans at the MRHD of 40 mg.

There were no treatment–related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.

Animal Toxicology and/or Pharmacology

Animal studies showed vascular inflammation in tadalafil–treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 1– to 17–fold the human exposure (AUCs) at the MRHD of 40 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1– and 6-month studies at unbound tadalafil exposure of 0.5– to 38–fold the human exposure (AUC) at the MRHD of 40 mg. In a 12–month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 4– to 10–fold the human exposure at the MRHD of 40 mg. The abnormal blood–cell findings were reversible within 2 weeks upon removal of the drug.

Reproductive Toxicology Studies

Reproduction studies have been performed in rats and mice at exposures up to 17 times the MRHD of 40 mg and have revealed no evidence of impaired fertility or harm to the fetus because of tadalafil. In addition, there was no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at exposures up to 7 times the MRHD during the period of major organ development.

In a rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no-observed-effect-level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day. This gives approximately 8- and 5-fold exposure multiples, respectively, of the human AUC for the MRHD of 40 mg. Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.

Tadalafil and/or its metabolites were secreted into the milk in lactating rats at concentrations approximately 2.4–fold greater than found in the plasma.

Before taking this medicine

You should not take Adcirca if you are allergic to tadalafil.

Taking Adcirca with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take this medicine if you also use:

  • riociguat (to treat pulmonary arterial hypertension); or

  • a nitrate drug (for chest pain or heart problems) such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as amyl nitrate or nitrite "poppers".

Some Adcirca can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • heart disease or heart rhythm problems;

  • a heart attack or stroke;

  • angina (chest pain), high or low blood pressure;

  • pulmonary hypertension (unless you are taking tadalafil for this);

  • a condition called pulmonary veno-occlusive disease (narrowing of the veins that carry blood from the lungs to the heart);

  • liver or kidney disease (or if you are on dialysis);

  • vision loss, or retinitis pigmentosa (an inherited condition of the eye);

  • a bleeding disorder;

  • a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

  • a physical deformity of the penis (such as Peyronie's disease), or an erection lasting longer than 4 hours;

  • a stomach ulcer; or

  • health problems that make sexual activity unsafe.

Sudden vision loss has occurred in a small number of people taking medicines like tadalafil (Viagra or others). Most of these people already had certain eye problems or risk factors for blood vessel disorders (heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether the medicine was the actual cause of vision loss.

Adcirca is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tadalafil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Adcirca is not approved for use by anyone younger than 18 years old.

How should I take Adcirca?

Adcirca is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Adcirca can be taken with or without food.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

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