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Raloxifene Hydrochloride

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Overview

What is Raloxifene Hydrochloride?

Raloxifene hydrochloride is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:

C H NO S•HCl M.W. 510.05

The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[ ]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.

Raloxifene hydrochloride is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet USP contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.

USP Dissolution Test Pending



What does Raloxifene Hydrochloride look like?



What are the available doses of Raloxifene Hydrochloride?

Tablets (not scored): 60 mg ( )

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

How should I use Raloxifene Hydrochloride?

Raloxifene hydrochloride tablets USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [ ].

The recommended dosage is one 60 mg raloxifene hydrochloride tablet USP daily, which may be administered any time of day without regard to meals [ ].

For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [ ].


What interacts with Raloxifene Hydrochloride?

Sorry No Records found


What are the warnings of Raloxifene Hydrochloride?

Sorry No Records found


What are the precautions of Raloxifene Hydrochloride?

Sorry No Records found


What are the side effects of Raloxifene Hydrochloride?

Sorry No records found


What should I look out for while using Raloxifene Hydrochloride?

Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ( )

Pregnancy, women who may become pregnant, and nursing mothers. ( , , )


What might happen if I take too much Raloxifene Hydrochloride?

In an 8 week study of 63 postmenopausal women, a dose of raloxifene HCl 600 mg/day was safely tolerated. In clinical trials, no raloxifene overdose has been reported.

In postmarketing spontaneous reports, raloxifene overdose has been reported very rarely (less than 1 out of 10,000 [< 0.01%] patients treated). The highest overdose has been approximately 1.5 grams. No fatalities associated with raloxifene overdose have been reported. Adverse reactions were reported in approximately half of the adults who took ≥ 180 mg raloxifene and included leg cramps and dizziness.

Two 18-month-old children each ingested raloxifene 180 mg. In these two children, symptoms reported included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, as well as elevation in alkaline phosphatase.

There is no specific antidote for raloxifene.

No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m ) or in monkeys at 1000 mg/kg (80 times the AUC in humans).


How should I store and handle Raloxifene Hydrochloride?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-043-06 in bottles of 30 tabletsNDC 68382-043-18 in bottles of 50 tabletsNDC 68382-043-14 in bottles of 60 tabletsNDC 68382-043-16 in bottles of 90 tabletsNDC 68382-043-01 in bottles of 100 tabletsNDC 68382-043-05 in bottles of 500 tabletsNDC 68382-043-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows:NDC 68382-044-06 in bottles of 30 tabletsNDC 68382-044-14 in bottles of 60 tabletsNDC 68382-044-16 in bottles of 90 tabletsNDC 68382-044-01 in bottles of 100 tabletsNDC 68382-044-05 in bottles of 500 tabletsNDC 68382-044-10 in bottles of 1,000 tabletsSertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows:NDC 68382-045-06 in bottles of 30 tabletsNDC 68382-045-14 in bottles of 60 tabletsNDC 68382-045-16 in bottles of 90 tabletsNDC 68382-045-01 in bottles of 100 tabletsNDC 68382-045-40 in bottles of 5,000 tabletsStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDRis registered trademark of Thomson Healthcare.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM). The biological actions of raloxifene are largely mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). The agonistic or antagonistic action of raloxifene depends on the extent of recruitment of coactivators and corepressors to estrogen receptor (ER) target gene promotors.

Raloxifene appears to act as an estrogen agonist in bone. It decreases bone resorption and bone turnover, increases bone mineral density (BMD) and decreases fracture incidence. Preclinical data demonstrate that raloxifene is an estrogen antagonist in uterine and breast tissues. These results are consistent with findings in clinical trials, which suggest that raloxifene hydrochloride lacks estrogen-like effects on the uterus and breast tissue.

Non-Clinical Toxicology
Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ( )

Pregnancy, women who may become pregnant, and nursing mothers. ( , , )

Aspirin

Concomitant administration of oxaprozin and aspirin is not recommended because oxaprozin displaces salicylates from plasma protein binding sites. Coadministration would be expected to increase the risk of salicylate toxicity. As with other NSAIDs, concomitant administration of oxaprozin and aspirin is not generally recommended because of the potential for increased adverse effects.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Coadministration of oxaprozin with methotrexate results in approximately a 36% reduction in apparent oral clearance of methotrexate. A reduction in methotrexate dosage may be considered due to the potential for increased methotrexate toxicity associated with the increased exposure.

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. Oxaprozin has been shown to alter the pharmacokinetics of enalapril (significant decrease in dose-adjusted AUC and C ) and its active metabolite enalaprilat (significant increase in dose-adjusted AUC ). This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Diuretics

Clinical studies, as well as post marketing observations, have shown that oxaprozin can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see , ), as well as to assure diuretic efficacy.

Lithium

Oxaprozin like other NSAIDs has produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the nonsteroidal anti-inflammatory drug. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Glyburide

While oxaprozin does alter the pharmacokinetics of glyburide, coadministration of oxaprozin to type II non-insulin dependent diabetic patients did not affect the area under the glucose concentration curve nor the magnitude or duration of control. However, it is advisable to monitor patients' blood glucose in the beginning phase of glyburide and oxaprozin cotherapy.

Warfarin

The effects of warfarin and NSAIDs on gastrointestinal (GI) bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that of users of either drug alone.

H -receptor antagonists

The total body clearance of oxaprozin was reduced by 20% in subjects who concurrently received therapeutic doses of cimetidine or ranitidine; no other pharmacokinetic parameter was affected. A change of clearance of this magnitude lies within the range of normal variation and is unlikely to produce a clinically detectable difference in the outcome of therapy.

Beta-blockers

Subjects receiving 1200 mg oxaprozin QD with 100 mg metoprolol bid exhibited statistically significant but transient increases in sitting and standing blood pressures after 14 days. Therefore, as with all NSAIDs, routine blood pressure monitoring should be considered in these patients when starting oxaprozin therapy.





The coadministration of oxaprozin and antacids, acetaminophen, or conjugated estrogens resulted in no statistically significant changes in pharmacokinetic parameters in single- and/or multiple-dose studies. The interaction of oxaprozin with cardiac glycosides has not been studied.

In clinical trials, raloxifene hydrochloride-treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events also could occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with raloxifene hydrochloride than with placebo. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy. Because immobilization increases the risk for venous thromboembolic events independent of therapy, raloxifene hydrochloride should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and raloxifene hydrochloride therapy should be resumed only after the patient is fully ambulatory. In addition, women taking raloxifene hydrochloride should be advised to move about periodically during prolonged travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons, such as congestive heart failure, superficial thrombophlebitis, and active malignancy [ ].

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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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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).