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PHILITH

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Overview

What is PHILITH?

PHILITH™ 28-Day (norethindrone and ethinyl estradiol tablets, USP) provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are:

CHO Molecular Weight: 298.42 CHO Molecular Weight: 296.40

The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.



What does PHILITH look like?



What are the available doses of PHILITH?

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

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How should I use PHILITH?

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

The following is a summary of the instructions given to the patient in the “ ” section of the .

The patient is given instructions in five (5) categories:


What interacts with PHILITH?

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What are the warnings of PHILITH?

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What are the precautions of PHILITH?

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What are the side effects of PHILITH?

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What should I look out for while using PHILITH?

Oral contraceptives should not be used in women who currently have the following conditions:

•Thrombophlebitis or thromboembolic disorders

•A past history of deep vein thrombophlebitis or thromboembolic disorders

•Cerebrovascular or coronary artery disease

•Known or suspected carcinoma of the breast

•Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

•Undiagnosed abnormal genital bleeding

•Cholestatic jaundice of pregnancy or jaundice with prior pill use

•Hepatic adenomas or carcinomas

•Known or suspected pregnancy

The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population*. For further information, the reader is referred to a text on epidemiological methods.

*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. 1981; 305: 612-618, 672-677; with author’s permission.


What might happen if I take too much PHILITH?

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.


How should I store and handle PHILITH?

Store at controlled room temperature 15°-30° C (59°-86° F).PHILITH™ 28-Day (norethindrone 0.4 mg and ethinyl estradiol 0.035 mg tablets, USP) are available in a compact blister card (NDC 16714-347-01). Each blister card contains 21 tan, biconvex round tablets debossed with “C35” on one side. Each 7 white, biconvex round tablets debossed with “P” on one side and “N” on the other side.PHILITH™ Tablets are available in the following: Carton of 1 NDC 16714-347-02 Carton of 3 NDC 16714-347-03 Carton of 6 NDC 16714-347-04Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].References are available upon request.PHILITH™ 28-Day (norethindrone 0.4 mg and ethinyl estradiol 0.035 mg tablets, USP) are available in a compact blister card (NDC 16714-347-01). Each blister card contains 21 tan, biconvex round tablets debossed with “C35” on one side. Each 7 white, biconvex round tablets debossed with “P” on one side and “N” on the other side.PHILITH™ Tablets are available in the following: Carton of 1 NDC 16714-347-02 Carton of 3 NDC 16714-347-03 Carton of 6 NDC 16714-347-04Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].References are available upon request.PHILITH™ 28-Day (norethindrone 0.4 mg and ethinyl estradiol 0.035 mg tablets, USP) are available in a compact blister card (NDC 16714-347-01). Each blister card contains 21 tan, biconvex round tablets debossed with “C35” on one side. Each 7 white, biconvex round tablets debossed with “P” on one side and “N” on the other side.PHILITH™ Tablets are available in the following: Carton of 1 NDC 16714-347-02 Carton of 3 NDC 16714-347-03 Carton of 6 NDC 16714-347-04Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].References are available upon request.PHILITH™ 28-Day (norethindrone 0.4 mg and ethinyl estradiol 0.035 mg tablets, USP) are available in a compact blister card (NDC 16714-347-01). Each blister card contains 21 tan, biconvex round tablets debossed with “C35” on one side. Each 7 white, biconvex round tablets debossed with “P” on one side and “N” on the other side.PHILITH™ Tablets are available in the following: Carton of 1 NDC 16714-347-02 Carton of 3 NDC 16714-347-03 Carton of 6 NDC 16714-347-04Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].References are available upon request.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions:

•Thrombophlebitis or thromboembolic disorders

•A past history of deep vein thrombophlebitis or thromboembolic disorders

•Cerebrovascular or coronary artery disease

•Known or suspected carcinoma of the breast

•Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

•Undiagnosed abnormal genital bleeding

•Cholestatic jaundice of pregnancy or jaundice with prior pill use

•Hepatic adenomas or carcinomas

•Known or suspected pregnancy

The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population*. For further information, the reader is referred to a text on epidemiological methods.

*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. 1981; 305: 612-618, 672-677; with author’s permission.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC. Toll-Free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):

•Thrombophlebitis •Cerebral thrombosis •Arterial thromboembolism •Hypertension •Pulmonary embolism •Gallbladder disease •Myocardial infarction •Hepatic adenomas or benign liver tumors

•Cerebral hemorrhage

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

•Mesenteric thrombosis •Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

•Nausea •Change in weight (increase or decrease) •Vomiting •Change in cervical ectropion and secretion •Gastrointestinal symptoms •Possible diminution in lactation when given(such as abdominal cramps and bloating) immediately postpartum •Breakthrough bleeding •Cholestatic jaundice •Spotting •Migraine •Change in menstrual flow •Rash (allergic) •Amenorrhea •Mental depression •Temporary infertility after •Reduced tolerance to carbohydratesdiscontinuation of treatment •Vaginal candidiasis•Edema •Change in corneal curvature (steepening) •Melasma which may persist •Intolerance to contact lenses •Breast changes: tenderness, enlargement, and secretion

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

•Premenstrual syndrome •Erythema nodosum •Cataracts •Hemorrhagic eruption •Changes in appetite •Vaginitis •Cystitis-like syndrome •Porphyria •Headache •Impaired renal function •Nervousness •Hemolytic uremic syndrome •Dizziness •Budd-Chiari syndrome •Hirsutism •Acne •Loss of scalp hair •Changes in libido •Erythema multiforme •Colitis

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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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