Tadalafila Sandoz Overdose

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• Overdose of Tadalafila Sandoz in details
• Tadalafila Sandoz warnings
• Tadalafila Sandoz precautions
• Tadalafila Sandoz reviews

What happens if I overdose Tadalafila Sandoz?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe dizziness; severe or persistent back or muscle pain; severe or persistent vision changes.

Proper storage of Tadalafila Sandoz:

Store Tadalafila Sandoz at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tadalafila Sandoz out of the reach of children and away from pets.

Overdose of Tadalafila Sandoz in details

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 Tadalafila Sandoz elimination.

What should I avoid while taking Tadalafila Sandoz?

Drinking alcohol can increase certain side effects of Tadalafila Sandoz.

Grapefruit and grapefruit juice may interact with Tadalafila Sandoz and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid using other medicines to treat erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra) while you are taking Tadalafila Sandoz.

Tadalafila Sandoz warnings

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.

Before prescribing Tadalafila Sandoz, it is important to note the following:

Cardiovascular

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including Tadalafila Sandoz, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Tadalafila Sandoz. In such a patient, who has taken Tadalafila Sandoz, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadalafila Sandoz before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Tadalafila Sandoz should seek immediate medical attention..

Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Tadalafila Sandoz, and therefore until further information is available, Tadalafila Sandoz is not recommended for the following groups of patients:

• myocardial infarction within the last 90 days
• unstable angina or angina occurring during sexual intercourse
• New York Heart Association Class 2 or greater heart failure in the last 6 months
• uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
• stroke within the last 6 months.

As with other PDE5 inhibitors, Tadalafila Sandoz has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, Tadalafila Sandoz 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects. While this effect should not be of consequence in most patients, prior to prescribing Tadalafila Sandoz, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Potential for Drug Interactions When Taking Tadalafila Sandoz for Once Daily Use

Physicians should be aware that Tadalafila Sandoz for once daily use provides continuous plasma Tadalafila Sandoz levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol.

Prolonged Erection

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Tadalafila Sandoz should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).

Effects on the Eye

Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including Tadalafila Sandoz, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50. An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION. The results suggest an approximate 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. From this information, it is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors.

Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including Tadalafila Sandoz, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including Tadalafila Sandoz, for this uncommon condition.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Sudden Hearing Loss

Physicians should advise patients to stop taking PDE5 inhibitors, including Tadalafila Sandoz, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Tadalafila Sandoz. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

Alpha-blockers and Antihypertensives

Physicians should discuss with patients the potential for Tadalafila Sandoz to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications.

Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Tadalafila Sandoz, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly, which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:

ED

• Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
• In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.
• In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
• Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.

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BPH

• The efficacy of the coadministration of an alpha-blocker and Tadalafila Sandoz for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of Tadalafila Sandoz and alpha-blockers is not recommended for the treatment of BPH..
• Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting Tadalafila Sandoz for once daily use for the treatment of BPH.

Renal Impairment

Tadalafila Sandoz for Use as Needed

Tadalafila Sandoz should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis. The starting dose of Tadalafila Sandoz in patients with creatinine clearance 30 – 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours..

Tadalafila Sandoz for Once Daily Use

ED

Due to increased Tadalafila Sandoz exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Tadalafila Sandoz for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min.

BPH and ED/BPH

Due to increased Tadalafila Sandoz exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Tadalafila Sandoz for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. In patients with creatinine clearance 30 – 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to 5 mg once daily based upon individual response.

Hepatic Impairment

Tadalafila Sandoz for Use as Needed

In patients with mild or moderate hepatic impairment, the dose of Tadalafila Sandoz should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of Tadalafila Sandoz in this group is not recommended.

Tadalafila Sandoz for Once Daily Use

Tadalafila Sandoz for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if Tadalafila Sandoz for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Tadalafila Sandoz in this group is not recommended.

Alcohol

Patients should be made aware that both alcohol and Tadalafila Sandoz, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with Tadalafila Sandoz can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

Tadalafila Sandoz is metabolized predominantly by CYP3A4 in the liver. The dose of Tadalafila Sandoz for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole. In patients taking potent inhibitors of CYP3A4 and Tadalafila Sandoz for once daily use, the maximum recommended dose is 2.5 mg.

Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

The safety and efficacy of combinations of Tadalafila Sandoz and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Tadalafila Sandoz with other PDE5 inhibitors, including Tadalafila Sandoz.

Effects on Bleeding

Studies in vitro have demonstrated that Tadalafila Sandoz is a selective inhibitor of PDE5. PDE5 is found in platelets. When administered in combination with aspirin, Tadalafila Sandoz 20 mg did not prolong bleeding time, relative to aspirin alone. Tadalafila Sandoz has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Tadalafila Sandoz has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

Counseling Patients About Sexually Transmitted Diseases

The use of Tadalafila Sandoz offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

Prior to initiating treatment with Tadalafila Sandoz for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

What should I discuss with my healthcare provider before taking Tadalafila Sandoz?

You should not take Tadalafila Sandoz if you are allergic to it.

Tadalafila Sandoz should not be used together with nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Tadalafila Sandoz with a nitrate medicine for chest pain or heart problems can cause a sudden and serious decrease in blood pressure.

To make sure you can safely take Tadalafila Sandoz, tell your doctor if you have any of these other conditions:

• heart disease or heart rhythm problems;
• a recent heart attack (within the past 90 days);
• a recent history (in the past 6 months) of a stroke, or congestive heart failure;
• angina (chest pain), high or low blood pressure;
• liver disease;
• kidney disease (or if you are on dialysis);
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie's disease); or
• if you have been told you should not have sexual intercourse for health reasons.

Tadalafila Sandoz can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Tadalafila Sandoz, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

It is not clear whether Tadalafila Sandoz is the actual cause of vision loss. Stop using Tadalafila Sandoz and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B. Tadalafila Sandoz is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Tadalafila Sandoz.

It is not known whether Tadalafila Sandoz passes into breast milk or if it could harm a nursing baby. Do not use Tadalafila Sandoz without telling your doctor if you are breast-feeding a baby.

Tadalafila Sandoz precautions

Cardiovascular Effects

Discuss with patients the appropriate action to take in the event that they experience anginal chest pain requiring nitroglycerin following intake of Tadalafila Sandoz. At least 48 hours should elapse after the last dose of Tadalafila Sandoz before taking nitrates. If a patient has taken Tadalafila Sandoz within 48 hours, administer nitrates under close medical supervision with appropriate hemodynamic monitoring. Patients who experience anginal chest pain after taking Tadalafila Sandoz should seek immediate medical attention.

PDE5 inhibitors, including Tadalafila Sandoz, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing Tadalafila Sandoz, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure or with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary venoocclusive disease (PVOD). Since there are no clinical data on administration of Tadalafila Sandoz to patients with veno-occlusive disease, administration of Tadalafila Sandoz to such patients is not recommended. Should signs of pulmonary edema occur when Tadalafila Sandoz is administered, the possibility of associated PVOD should be considered.

There is a lack of data on safety and efficacy in the following groups who were specifically excluded from the PAH clinical trials:

• Patients with clinically significant aortic and mitral valve disease
• Patients with pericardial constriction
• Patients with restrictive or congestive cardiomyopathy
• Patients with significant left ventricular dysfunction
• Patients with life-threatening arrhythmias
• Patients with symptomatic coronary artery disease
• Patients with hypotension ( < 90/50 mm Hg) or uncontrolled hypertension

Use with Alpha Blockers and Antihypertensives

PDE5 inhibitors, including Tadalafila Sandoz, and alpha–adrenergic blocking agents are vasodilators with blood pressure– lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly, which may lead to symptomatic hypotension (e.g., fainting). Safety of combined use of PDE5 inhibitors and alpha blockers may be affected by other variables, including intravascular volume depletion and use of other antihypertensive drugs.

Use with Alcohol

Both alcohol and Tadalafila Sandoz are mild vasodilators. When mild vasodilators are taken in combination, blood pressure-lowering effects are increased.

Use With Potent CYP3A Inhibitors Or Inducers

Co-administration of Tadalafila Sandoz in Patients on Ritonavir

In patients receiving ritonavir for at least one week, start Tadalafila Sandoz at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.

Co-administration of Ritonavir in Patients on Tadalafila Sandoz

Avoid use of Tadalafila Sandoz during the initiation of ritonavir. Stop Tadalafila Sandoz at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume Tadalafila Sandoz at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.

Other Potent Inhibitors of CYP3A

Tadalafila Sandoz is metabolized predominantly by CYP3A in the liver. In patients taking potent inhibitors of CYP3A such as ketoconazole and itraconazole, avoid use of Tadalafila Sandoz.

Potent Inducers of CYP3A

For patients chronically taking potent inducers of CYP3A, such as rifampin, avoid use of Tadalafila Sandoz.

Use In Renal Impairment

In Patients With Mild Or Moderate Renal Impairment

Start dosing at 20 mg once daily. Increase the dose to 40 mg once daily based upon individual tolerability.

In patients with severe renal impairment

Avoid use of Tadalafila Sandoz because of increased Tadalafila Sandoz exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis.

Use In Hepatic Impairment

In Patients With Mild To Moderate Hepatic Cirrhosis (Child-Pugh Class A and B)

Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once daily Tadalafila Sandoz.

In Patients With Severe Hepatic Cirrhosis (Child-Pugh Class C)

Patients with severe hepatic cirrhosis have not been studied. Avoid use of Tadalafila Sandoz.

Visual Loss

Physicians should advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non–arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported postmarketing in temporal association with the use of all PDE5 inhibitors. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥ 50 in the general population. An observational study evaluated whether recent episodic use of PDE5 inhibitors, as a class, typical of erectile dysfunction treatment, was associated with acute onset of NAION. The results suggest an approximate 2-fold increase in the risk of NAION within 1 to 4 days of PDE5 inhibitor use.

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Hearing Impairment

Physicians should advise patients to seek immediate medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Tadalafila Sandoz. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

Combination With Other PDE5 Inhibitors

Tadalafila Sandoz is also marketed as Tadalafila Sandoz. The safety and efficacy of taking Tadalafila Sandoz together with Tadalafila Sandoz or other PDE5 inhibitors have not been studied. Inform patients taking Tadalafila Sandoz not to take Tadalafila Sandoz or other PDE5 inhibitors.

Prolonged Erection

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Tadalafila Sandoz should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).

Effects On Bleeding

PDE5 is found in platelets. When administered in combination with aspirin, Tadalafila Sandoz 20 mg did not prolong bleeding time, relative to aspirin alone. Tadalafila Sandoz has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Tadalafila Sandoz has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment.

Patient Counseling Information

• Inform patients of contraindication of Tadalafila Sandoz with any use of organic nitrates or GC stimulators.
• Inform patients that Tadalafila Sandoz is also marketed as Tadalafila Sandoz for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking Tadalafila Sandoz not to take Tadalafila Sandoz or other PDE5 inhibitors.
• Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking Tadalafila Sandoz. Such an event may be a sign of NAION.
• Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking Tadalafila Sandoz. These events may be accompanied by tinnitus and dizziness.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Tadalafila Sandoz 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 Tadalafila Sandoz, 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

Tadalafila Sandoz was not mutagenic in the in vitro bacterial Ames assays or the forward mutation test in mouse lymphoma cells. Tadalafila Sandoz 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 Tadalafila Sandoz up to 400 mg/kg/day, a dose producing AUCs for unbound Tadalafila Sandoz of 6–fold for males or 17–fold for females the exposures at the MRHD of 40 mg. In beagle dogs given Tadalafila Sandoz 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 Tadalafila Sandoz 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.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Animal reproduction studies in rats and mice revealed no evidence of fetal harm. There are, however, no adequate and well-controlled studies of Tadalafila Sandoz in pregnant women. Because animal reproduction studies are not always predictive of human response, Tadalafila Sandoz should be used during pregnancy only if clearly needed.

Non–teratogenic effects

Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when Tadalafila Sandoz was given to pregnant rats or mice at unbound Tadalafila Sandoz exposures up to 7 times the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to unbound Tadalafila Sandoz concentrations greater than 5 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 8 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance.

Nursing Mothers

It is not known whether Tadalafila Sandoz is excreted into human milk. While Tadalafila Sandoz or some metabolite of Tadalafila Sandoz was excreted into rat milk, drug levels in animal breast milk may not accurately predict levels of drug in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Tadalafila Sandoz is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Tadalafila Sandoz in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in the clinical study of Tadalafila Sandoz for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. No overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. No dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered..

Renal Impairment

For patients with mild or moderate renal impairment, start Tadalafila Sandoz at 20 mg once daily. Increase the dose to 40 mg once daily based upon individual tolerability.

In patients with severe renal impairment, avoid use of Tadalafila Sandoz because of increased Tadalafila Sandoz exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis.

Hepatic Impairment

Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A or B), consider a starting dose of Tadalafila Sandoz 20 mg once daily. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied, thus avoid use of Tadalafila Sandoz in such patients.

What happens if I miss a dose of Tadalafila Sandoz?

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

If you take Tadalafila Sandoz 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.

References

1. DailyMed. "TADALAFIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DrugBank. "Tadalafil". http://www.drugbank.ca/drugs/DB00820 (accessed September 17, 2018).
3. MeSH. "Vasodilator Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology