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Norethindrone
Overview
What is DEBLITANE?
DEBLITANE (Norethindrone tablets, USP). Each yellow, biconvex, round tablet debossed with "K2" on one side contains 0.35 mg norethindrone. Inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch.
Therapeutic class = oral contraceptive.
USP Dissolution Test is Pending
What does DEBLITANE look like?
What are the available doses of DEBLITANE?
Sorry No records found.
What should I talk to my health care provider before I take DEBLITANE?
Sorry No records found
How should I use DEBLITANE?
1. Indications.
2. Efficacy.
To achieve maximum contraceptive effectiveness, norethindrone 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 DEBLITANE?
- Progestin-only oral contraceptives tablets 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 DEBLITANE?
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Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
Norethindrone tablets 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 progestin-only 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.
1. Ectopic Pregnancy
The incidence of ectopic pregnancies for progestin-only 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.
2. Delayed Follicular Atresia/Ovarian Cysts
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.
3. Irregular Genital Bleeding
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.
4. Carcinoma of the Breast and Reproductive Organs
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.
5. Hepatic 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 are the precautions of DEBLITANE?
1. General
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
2. Physical Examination and Follow Up
It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.
3. Carbohydrate and Lipid Metabolism
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is no effect on total cholesterol, HDL, LDL, or VLDL.
4. Drug Interactions
Change in contraceptive effectiveness associated with coadministration of other products:
a. . Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
b. . Several of the anti-HIV protease inhibitors have been studied with coadministration of oral contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of OC products may be affected with the coadministration of anti-HIV protease inhibitors. Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
c. . Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
5. Interactions with Laboratory Tests
- Sex hormone-binding globulin (SHBG) concentrations may be decreased.
- Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).
The following endocrine tests may be affected by progestin-only oral contraceptive use:
6. Carcinogenesis
See section.
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1 to 6% of the levels of maternal plasma. However, isolated post-market cases of decreased milk production have been reported in POPs. Very rarely, adverse effects in the infant/child have been reported, including jaundice.
9. Fertility Following Discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
10. Headache/Migraine
If you have a headache or a worsening migraine headache with a new pattern that is recurrent, persistent, or severe, this requires discontinuation of oral contraceptives and evaluation of the cause.
11. Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
12. Pediatric Use
Safety and efficacy of norethindrone tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
INFORMATION FOR THE PATIENT
- The necessity of taking pills at the same time every day, including throughout all bleeding episodes.
- The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.
- The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.
- The need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.
- The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.
What are the side effects of DEBLITANE?
- 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 DEBLITANE?
Progestin-only oral contraceptives tablets should not be used by women who currently have the following conditions:
What might happen if I take too much DEBLITANE?
There have been no reports of serious ill effects from overdosage, including ingestion by children.
How should I store and handle DEBLITANE?
Unopened vials of Gemcitabine for Injection are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] . DEBLITANE Tablets are available in a compact blister card (NDC 16714-440-01) containing 28 yellow tablets each containing 0.35 mg of the progestational compound, Norethindrone. The round, biconvex, unscored tablets are debossed with “K2” on one side with the other side plain.DEBLITANE Tablets are available in the following configurations: Carton of 1 NDC 16714-440-02 Carton of 3 NDC 16714-440-03 Carton of 6 NDC 16714-440-04STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]DEBLITANE Tablets are available in a compact blister card (NDC 16714-440-01) containing 28 yellow tablets each containing 0.35 mg of the progestational compound, Norethindrone. The round, biconvex, unscored tablets are debossed with “K2” on one side with the other side plain.DEBLITANE Tablets are available in the following configurations: Carton of 1 NDC 16714-440-02 Carton of 3 NDC 16714-440-03 Carton of 6 NDC 16714-440-04STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]DEBLITANE Tablets are available in a compact blister card (NDC 16714-440-01) containing 28 yellow tablets each containing 0.35 mg of the progestational compound, Norethindrone. The round, biconvex, unscored tablets are debossed with “K2” on one side with the other side plain.DEBLITANE Tablets are available in the following configurations: Carton of 1 NDC 16714-440-02 Carton of 3 NDC 16714-440-03 Carton of 6 NDC 16714-440-04STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]DEBLITANE Tablets are available in a compact blister card (NDC 16714-440-01) containing 28 yellow tablets each containing 0.35 mg of the progestational compound, Norethindrone. The round, biconvex, unscored tablets are debossed with “K2” on one side with the other side plain.DEBLITANE Tablets are available in the following configurations: Carton of 1 NDC 16714-440-02 Carton of 3 NDC 16714-440-03 Carton of 6 NDC 16714-440-04STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Norethindrone tablets progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Non-Clinical Toxicology
Progestin-only oral contraceptives tablets should not be used by women who currently have the following conditions:Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.
If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.
Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology).
Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.
Toxicology:
In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.
In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
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.
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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