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Jantoven
Overview
What is Jantoven?
JANTOVEN (Warfarin Sodium Tablets, USP) is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the - and -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is CHNaO, and its structural formula is represented by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
JANTOVEN tablets for oral use contain: 1 mg, 2 mg, 2½ mg, 3 mg, 4 mg, 5 mg, 6 mg, 7½ mg or 10 mg of crystalline warfarin sodium, USP. They also contain:
What does Jantoven look like?
What are the available doses of Jantoven?
Scored tablets: 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 mg ()
What should I talk to my health care provider before I take Jantoven?
How should I use Jantoven?
JANTOVEN is indicated for:
Limitations of Use
Warfarin Sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
The dosage and administration of JANTOVEN must be individualized for each patient according to the patient's INR response to the drug. Adjust the dose based on the patient's INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines from the American College of Chest Physicians (ACCP) to assist in the determination of the duration and intensity of anticoagulation with JANTOVEN [see ].
What interacts with Jantoven?
Sorry No Records found
What are the warnings of Jantoven?
Sorry No Records found
What are the precautions of Jantoven?
Sorry No Records found
What are the side effects of Jantoven?
Sorry No records found
What should I look out for while using Jantoven?
JANTOVEN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [
and
]. JANTOVEN can cause fetal harm when administered to a pregnant woman. JANTOVEN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If JANTOVEN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see
and
].
What might happen if I take too much Jantoven?
How should I store and handle Jantoven?
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.TabletsJANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:1 mg - Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).2 mg - Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).2½ mg -Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).3 mg - Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).4 mg - Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).5 mg - Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).6 mg - Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).7½ mg - Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).10 mg - Compressed tablet, white, round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Vitamin K promotes the biosynthesis of γ-carboxyglutamic acid residues in the proteins that are essential for biological activity. Warfarin is thought to interfere with clotting factor synthesis by inhibition of the C1 subunit of vitamin K epoxide reductase (VKORC1) enzyme complex, thereby reducing the regeneration of vitamin K epoxide [see ].
Non-Clinical Toxicology
JANTOVEN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [and
]. JANTOVEN can cause fetal harm when administered to a pregnant woman. JANTOVEN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If JANTOVEN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see
and
].
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, quinolones and beta adrenergic blocking agents. When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide with these drugs.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glipizide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for hypoglycemia.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of fluconazole and glipizide was reported in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single daily oral dose for 7 days. The mean percentage increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35 to 81).
In studies assessing the effect of colesevelam on the pharmacokinetics of glipizide ER in healthy volunteers, reductions in glipizide AUC and C of 12% and 13%, respectively were observed when colesevelam was coadministered with glipizide ER. When glipizide ER was administered 4 hours prior to colesevelam, there was no significant change in glipizide AUC or C , -4% and 0%, respectively. Therefore, glipizide should be administered at least 4 hours prior to colesevelam to ensure that colesevelam does not reduce the absorption of glipizide.
JANTOVEN can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors [see ], certain concomitant drugs [see ], and long duration of warfarin therapy.
Perform regular monitoring of INR in all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shortest duration of therapy appropriate for the clinical condition. However, maintenance of INR in the therapeutic range does not eliminate the risk of bleeding.
Drugs, dietary changes, and other factors affect INR levels achieved with JANTOVEN therapy. Perform more frequent INR monitoring when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs [see ].
Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see ].
The following serious adverse reactions to JANTOVEN are discussed in greater detail in other sections of the labeling:
Other adverse reactions to JANTOVEN include:
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).