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Previfem

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Overview

What is Previfem?

Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol).

Previfem

Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Blue No. 1 HT Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.

Each light-green placebo tablet contains only inert ingredients, as follows: FD&C Blue No. 2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.

Tri-Previfem

Each active white tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.

Each active light-blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.

Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.

Each light-green placebo tablet contains only inert ingredients, as follows: FD&C Blue No. 2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.



What does Previfem look like?



What are the available doses of Previfem?

Previfem (norgestimate/ethinyl estradiol tablets) consists of 28 round, unscored, film-coated tablets in the following order ():

•  21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol

•  7 light-green tablets (inert)

Tri-Previfem (norgestimate/ethinyl estradiol tablets) consists of 28 round, unscored, film-coated tablets in the following order ():

•  7 white tablets each containing 0.18 mg norgestimate and 0.035 mg ethinyl estradiol

•  7 light blue tablets each containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol

•  7 blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol

•  7 light-green tablets (inert)

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

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

How should I use Previfem?

Previfem (norgestimate/ethinyl estradiol tablets) and Tri-Previfem (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy .

Previfem (norgestimate/ethinyl estradiol tablets) and Tri-Previfem(norgestimate/ethinyl estradiol tablets) are dispensed in a blister pack tablet dispenser

Previfem (norgestimate/ethinyl estradiol tablets) and Tri-Previfem (norgestimate/ethinyl estradiol tablets) may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.


What interacts with Previfem?

Sorry No Records found


What are the warnings of Previfem?

Sorry No Records found


What are the precautions of Previfem?

Sorry No Records found


What are the side effects of Previfem?

Sorry No records found


What should I look out for while using Previfem?

Do not prescribe Previfemor Tri-Previfemto women who are known to have the following conditions:

Cigarette

smoking

increases

the

risk

of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke .


What might happen if I take too much Previfem?

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


How should I store and handle Previfem?

Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as:Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer.The tablets are available in bottles of 100, NDC 64980-176-01.StorageStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Rising Pharmaceuticals, Inc.Allendale, NJ 07401 USAManufactured by:5508     Rev.01/2018


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
Do not prescribe Previfemor Tri-Previfemto women who are known to have the following conditions:

Cigarette

smoking

increases

the

risk

of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke .

Table 1 includes clinically significant drug interactions with Carisoprodol, Aspirin and CodeinePhosphate Tablets.

Drug/Drug Interactions with Carisoprodol

The sedative effect of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended (see ).

Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate (see ).Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with carisoprodol could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with carisoprodol could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of carisoprodol is unknown.

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

Interactions

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