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Duloxetine
Overview
What is Irenka?
Irenka™ (duloxetine delayed-release capsules USP) is selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-()--methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is CHNOS.HCl, which corresponds to a molecular weight of 333.88. The structural formula is:
Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol.
Each capsule contains enteric-coated mini tablets comprising of duloxetine hydrochloride equivalent to 40 of duloxetine. These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, talc, titanium dioxide and triethyl citrate.
What does Irenka look like?
What are the available doses of Irenka?
Irenka is available as delayed-release capsules:
40 mg: Size '2' Capsules with white cap and white body imprinted with "LU" on cap and "H25" in black ink on body, containing eight white to off white mini tablets.
What should I talk to my health care provider before I take Irenka?
How should I use Irenka?
Irenka™ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Swallow Irenka whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Irenka can be given without regard to meals. If a dose of Irenka is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Irenka at the same time.
What interacts with Irenka?
Sorry No Records found
What are the warnings of Irenka?
Sorry No Records found
What are the precautions of Irenka?
Sorry No Records found
What are the side effects of Irenka?
Sorry No records found
What should I look out for while using Irenka?
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Irenka or within 5 days of stopping treatment with Irenka. Do not use Irenka within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Irenka in a patient who is being treated with linezolid or intravenous methylene blue ().
What might happen if I take too much Irenka?
How should I store and handle Irenka?
Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “25 mg” in blue, containing 25 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5740-65).Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “50 mg” in blue, containing 50 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5741-65).Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, imprinted “Ivax hourglass logo” “100 mg” in blue, containing 100 mg Cyclosporine, USP MODIFIED and 18.6% v/v (14.7% wt/vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-5742-65).Store and DispensePHARMACIST: Dispense in original unit-dose container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.Manufactured In Czech Republic By:TEVA CZECH INDUSTRIES s.r.o.Opava-Komarov, Czech Republic Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. H 4/2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Non-Clinical Toxicology
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Irenka or within 5 days of stopping treatment with Irenka. Do not use Irenka within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Irenka in a patient who is being treated with linezolid or intravenous methylene blue ().Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms ].
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Irenka should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Irenka is not approved for use in treating bipolar depression.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).