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Incassia

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Overview

What is Incassia?

Each light yellow to yellow Incassia tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone USP daily, and the inactive ingredients include corn starch, D&C Yellow No. 10 aluminum lake, FD&C Yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone and talc. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:



What does Incassia look like?



What are the available doses of Incassia?

Sorry No records found.

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

Sorry No records found

How should I use Incassia?

1. Indications 

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Emergency Contraceptive Pills

temporary

To achieve maximum contraceptive effectiveness, Incassia tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See  for detailed instructions.


What interacts with Incassia?


  • Progestinonly oral contraceptives (POPs) should not be used by women who currently have the following conditions:


    • Known or suspected pregnancy
    • Known or suspected carcinoma of the breast
    • Undiagnosed abnormal genital bleeding
    • Hypersensitivity to any component of this product
    • Benign or malignant liver tumors
    • Acute liver disease




What are the warnings of Incassia?

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of , and surgical evaluation should be instituted as clinically indicated.


What are the precautions of Incassia?

1

. General

Anti-Infective Agents and Anticonvulsants.

Anti-HIV Protease Inhibitors.

Herbal Products.

6. Carcinogenesis

INFORMATION FOR THE PATIENT

1.

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  • Sex hormone-binding globulin (SHBG) concentrations may be decreased.
  • Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).



What are the side effects of Incassia?

  • Menstrual irregularity is the most frequently reported side effect.
  • Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.
  • Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.
  • Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.


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What should I look out for while using Incassia?

Progestinonly oral contraceptives (POPs) should not be used by women who currently have the following conditions:

Incassia does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestinonly pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. The incidence of ectopic pregnancies for progestinonly oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention. Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. Some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increase the risk. Women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia. Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage. Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.


What might happen if I take too much Incassia?

There have been no reports of serious ill effects from overdosage, including ingestion by children.


How should I store and handle Incassia?

Incassia Norethindrone Tablets USP, 0.35 mg) The blister packs are available in the following packages:    Carton of 1 Pouch                               NDC 65862-925-87    Carton of 3 Pouches                           NDC 65862-925-88    Carton of 6 Pouches                           NDC 65862-925-92    Carton of 1 Blister Pack                  NDC 65862-925-28    Carton of 3 Blister Packs                 NDC 65862-925-85     Carton of 6 Blister Packs                 NDC 65862-925-86  controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].Incassia Norethindrone Tablets USP, 0.35 mg) The blister packs are available in the following packages:    Carton of 1 Pouch                               NDC 65862-925-87    Carton of 3 Pouches                           NDC 65862-925-88    Carton of 6 Pouches                           NDC 65862-925-92    Carton of 1 Blister Pack                  NDC 65862-925-28    Carton of 3 Blister Packs                 NDC 65862-925-85     Carton of 6 Blister Packs                 NDC 65862-925-86  controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].Incassia Norethindrone Tablets USP, 0.35 mg) The blister packs are available in the following packages:    Carton of 1 Pouch                               NDC 65862-925-87    Carton of 3 Pouches                           NDC 65862-925-88    Carton of 6 Pouches                           NDC 65862-925-92    Carton of 1 Blister Pack                  NDC 65862-925-28    Carton of 3 Blister Packs                 NDC 65862-925-85     Carton of 6 Blister Packs                 NDC 65862-925-86  controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].Incassia Norethindrone Tablets USP, 0.35 mg) The blister packs are available in the following packages:    Carton of 1 Pouch                               NDC 65862-925-87    Carton of 3 Pouches                           NDC 65862-925-88    Carton of 6 Pouches                           NDC 65862-925-92    Carton of 1 Blister Pack                  NDC 65862-925-28    Carton of 3 Blister Packs                 NDC 65862-925-85     Carton of 6 Blister Packs                 NDC 65862-925-86  controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].Incassia Norethindrone Tablets USP, 0.35 mg) The blister packs are available in the following packages:    Carton of 1 Pouch                               NDC 65862-925-87    Carton of 3 Pouches                           NDC 65862-925-88    Carton of 6 Pouches                           NDC 65862-925-92    Carton of 1 Blister Pack                  NDC 65862-925-28    Carton of 3 Blister Packs                 NDC 65862-925-85     Carton of 6 Blister Packs                 NDC 65862-925-86  controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

1. Mode of Action

The food effect on the rate and extent of norethindrone absorption after Incassia administration has not been evaluated. Following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of norethindrone is approximately 4 L/kg. Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20 to 40% of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites.   Plasma clearance rate for norethindrone has been estimated to be approximately 600 L/day. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following single dose administration of Incassia is approximately 8 hours.

Non-Clinical Toxicology
Progestinonly oral contraceptives (POPs) should not be used by women who currently have the following conditions:

Incassia does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestinonly pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. The incidence of ectopic pregnancies for progestinonly oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention. Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. Some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increase the risk. Women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia. Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage. Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

1

. General

Anti-Infective Agents and Anticonvulsants.

Anti-HIV Protease Inhibitors.

Herbal Products.

6. Carcinogenesis

Menstrual irregularity is the most frequently reported side effect.

Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.

Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.

Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

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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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