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Xadago

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Overview

What is Xadago?

XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below.

The molecular formula of safinamide mesylate is CHFNO∙CHOS and its molecular weight is 398.45.

Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5.

XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide.



What does Xadago look like?



What are the available doses of Xadago?

Tablets: 50 mg and 100 mg ()

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

Pregnancy: Based on animal data, may cause fetal harm ().

How should I use Xadago?

XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.

The recommended starting dosage of XADAGO is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability.

Daily dosages of XADAGO above 100 mg have not been shown to provide additional benefit, and higher dosages increase the risk for adverse reactions. XADAGO has been shown to be effective only in combination with levodopa/carbidopa .

If a dose is missed, the next dose should be taken at the same time the next day.

XADAGO 100 mg should be tapered by decreasing the dose to 50 mg for one week before stopping .


What interacts with Xadago?

Sorry No Records found


What are the warnings of Xadago?

Sorry No Records found


What are the precautions of Xadago?

Sorry No Records found


What are the side effects of Xadago?

Sorry No records found


What should I look out for while using Xadago?

XADAGO is contraindicated in patients with:


What might happen if I take too much Xadago?

There is no human experience with XADAGO overdose.

There is no known antidote to XADAGO nor any specific treatment for XADAGO overdose. If an important overdose occurs, XADAGO treatment should be discontinued and supportive treatment should be administered as clinically indicated. In cases of overdose with XADAGO, dietary tyramine restriction should be observed for several weeks.

The Poison Control Center should be called at 1-800-222-1222 for the most current treatment guidelines.


How should I store and handle Xadago?

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.How Supplied 5 mg TabletsAlendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side.NDC 69097-234-02    Bottles of 3010 mg TabletsAlendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side.NDC 69097-235-02    Bottles of 3035 mg TabletsAlendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side.NDC 69097-223-16    Unit-of-use blister package of 4NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4)40 mg TabletsAlendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side.NDC 69097-236-02    Bottles of 3070 mg TabletsAlendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side.NDC 69097-224-16    Unit-of-use blister package of 4NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4)StorageStore at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The precise mechanism by which XADAGO exerts its effect in Parkinson's disease is unknown. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.

Non-Clinical Toxicology
XADAGO is contraindicated in patients with:

In clinical trials, no significant adverse reactions occurred with other drugs commonly used in the perioperative period, including: central nervous system depressants, autonomic drugs, skeletal muscle relaxants, anti-infective agents, hormones and synthetic substitutes, blood derivatives, and cardiovascular drugs.

XADAGO may cause hypertension or exacerbate existing hypertension. In clinical trials, the incidence of hypertension was 7% for XADAGO 50 mg, 5% for XADAGO 100 mg, and 4% for placebo. Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting XADAGO. Medication adjustment may be necessary if elevation of blood pressure is sustained.

Monitor for hypertension if XADAGO is prescribed concomitantly with sympathomimetic medications, including prescription or nonprescription nasal, oral, and ophthalmic decongestants and cold remedies .

XADAGO is a selective inhibitor of MAO-B at the recommended dosages of 50 mg or 100 mg daily. Selectivity for inhibiting MAO-B decreases above the recommended daily dosages . Therefore, XADAGO should not be used at daily dosages exceeding those recommended because of the risks of hypertension, exacerbation of existing hypertension, or hypertensive crisis.

Dietary tyramine restriction is not required during treatment with recommended doses of XADAGO. However, use with certain foods that contain very high amounts (i.e., more than 150 mg) of tyramine could cause severe hypertension, resulting from an increased sensitivity to tyramine in patients taking recommended dosages of XADAGO, and patients should be advised to avoid such foods.

Isoniazid has some monoamine oxidase inhibiting activity. Monitor for hypertension and reaction to dietary tyramine in patients treated concomitantly with isoniazid and XADAGO .

The following serious adverse reactions are discussed in greater detail in other sections of labeling:

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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

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).