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TADALAFIL

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Overview

What is CIALIS?

CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula CHNO representing a molecular weight of 389.41. The structural formula is:

The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.



What does CIALIS look like?



What are the available doses of CIALIS?

Tablets (not scored): 2.5 mg, 5 mg, 10 mg, 20 mg ().

What should I talk to my health care provider before I take CIALIS?

Hepatic Impairment (, , ):

Renal Insufficiency (, , ):

How should I use CIALIS?

CIALIS is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) ().

CIALIS for use as needed: Starting dose: 10 mg up to once daily. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose ().

CIALIS for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ().

CIALIS may be taken without regard to food ().


What interacts with CIALIS?

Sorry No Records found


What are the warnings of CIALIS?

Sorry No Records found


What are the precautions of CIALIS?

Sorry No Records found


What are the side effects of CIALIS?

Sorry No records found


What should I look out for while using CIALIS?

Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates ().

History of known serious hypersensitivity reaction to CIALIS or ADCIRCA ()


What might happen if I take too much CIALIS?

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.


How should I store and handle CIALIS?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366 Metoprolol Tartrate Tablets USP 50 mgWatson 462Metoprolol Tartrate Tablets USP 100 mgWatson 463Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP).Protect from moisture.Manufactured By: Verna, Salcette Goa 403 722 INDIADistributed By: Corona, CA 92880 USARevised: December 2008                        1208B                                                                 174366


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

Studies have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.

In vitro

In vitro,

Non-Clinical Toxicology
Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates ().

History of known serious hypersensitivity reaction to CIALIS or ADCIRCA ()

Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs.

Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects.

However, a crossover study in healthy subjects receiving either 300 mg four times daily or 800 mg at bedtime of cimetidine concomitantly with a 300 mg twice daily dosage of theophylline (Theo-Dur®) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.)

Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping the concomitant administration of cimetidine to maintain optimum therapeutic blood levels.

Alteration of pH may affect the absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.

Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.

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

Before prescribing CIALIS, it is important to note the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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