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Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium

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Overview

What is Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below:

The inactive ingredients in the orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose USP, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF and ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF.

Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of CHO.

Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of CHO.

Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B and has a molecular weight of 497.5 and a molecular formula of CHCaNO

The structural formulas are as follows:



What does Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium look like?



What are the available doses of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium consists of 28 film-coated, biconvex tablets in the following order ():

What should I talk to my health care provider before I take Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Nursing mothers: Not recommended; can decrease milk production. ()

How should I use Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated for use by women to prevent pregnancy.

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive effectiveness, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.


What interacts with Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Sorry No Records found


What are the warnings of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Sorry No Records found


What are the precautions of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Sorry No Records found


What are the side effects of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Sorry No records found


What should I look out for while using Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Do not prescribe Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium to women who are known to have the following:


What might happen if I take too much Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

DRSP is a spironolactone analogue which has antimineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium) were well tolerated after long-term treatment up to 12 weeks.


How should I store and handle Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?

Store at 20 to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Keep in outer carton. HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13HydrALAZINE Hydrochloride Tablets, USP25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other sideNDC 67046-270-07 blisterpacks of 7NDC 67046-270-14 blisterpacks of 14NDC 67046-270-15 blisterpacks of 15NDC 67046-270-20 blisterpacks of 20NDC 67046-270-21 blisterpacks of 21NDC 67046-270-28 blisterpacks of 28NDC 67046-270-30 blisterpacks of 30NDC 67046-270-60 blisterpacks of 6050 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other sideNDC 67046-280-07 blisterpacks of 7NDC 67046-280-14 blisterpacks of 14NDC 67046-280-15 blisterpacks of 15NDC 67046-280-20 blisterpacks of 20NDC 67046-280-21 blisterpacks of 21NDC 67046-280-28 blisterpacks of 28NDC 67046-280-30 blisterpacks of 30NDC 67046-280-60 blisterpacks of 60Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.MANUFACTURED FOR: Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13


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Clinical Information

Chemical Structure

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Clinical Pharmacology

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Non-Clinical Toxicology
Do not prescribe Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium to women who are known to have the following:

MAO inhibitors should be used with caution in patients receiving hydrALAZINE

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.





Administration of hydrALAZINE with food results in higher plasma levels.

Stop Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium if an arterial or venous thrombotic (VTE) event occurs.

Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs .

A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel. Those that were required or sponsored by regulatory agencies are summarized in Table 1.

In addition to these “regulatory studies,” other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 1): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007]. An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 1), and two from Denmark [Lidegaard 2009, Lidegaard 2011]. There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011]. The results of all of these studies are presented in Figure 1.

Figure : VTE Risk with Yasmin Relative to LNG-Containing COCs (adjusted risk)

Risk ratios displayed on logarithmic scale; risk ratio 1 indicates an increased risk of VTE for DRSP.

*Comparator “Other COCs”, including LNG- containing COCs

† LASS is an extension of the EURAS study

#Some adjustment factors are indicated by superscript letters: a) Current heavy smoking, b) hypertension, c) obesity, d) family history, e) age, f) BMI, g) duration of use, h) VTE history, i) period of inclusion, j) calendar year, k) education, l) length of use, m) parity, n) chronic disease, o) concomitant medication, p) smoking, q) duration of exposure, r) site

(References: Ingenix [Seeger 2007], EURAS (European Active Surveillance Study) [Dinger 2007], LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011], Danish [Lidegaard 2009], Danish re-analysis [ Lidegaard 2011], MEGA study [van Hylckama Vlieg 2009], German Case-Control study [Dinger 2010], PharMetrics [Jick 2011], GPRD study [Parkin 2011])

Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2). The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE.

If feasible, stop Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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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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Tips

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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).