Warner Chilcott (us), Llc

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered.

Dosage and Administration for 28-Day Dosage Regimen

To achieve maximum contraceptive effectiveness, ESTROSTEP Fe should be taken exactly as directed and at intervals not exceeding 24 hours.

ESTROSTEP Fe provides a continuous administration regimen consisting of 21 white oral contraceptive tablets and seven brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days”.

A. Sunday-Start Regimen: The patient begins taking the first white tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white tablet is taken on the same day. The patient takes one white tablet daily for 21 days. The last white tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 white tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white tablet in the top row. Adhering to this regimen of one white tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one white tablet daily, beginning with the first white tablet in the top row. After the last white tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet dispenser. Following this regimen of 21 white tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.

Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration

Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white tablets, continue medication without interruption.

If the patient forgets to take one or more white tablets, the following is suggested:

One tablet is missed

Two consecutive tablets are missed (Week 1 or Week 2)

Two consecutive tablets are missed (Week 3)Sunday-Start Regimen:

Day-1 Start Regimen:

Three (or more) consecutive tablets are missedSunday-Start Regimen:

Day-1 Start Regimen:

The possibility of ovulation occurring increases with each successive day that scheduled white tablets are missed. While there is little likelihood of ovulation occurring if only one white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white tablets are missed.

If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white tablet was taken.

In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day 1) depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

Use of Oral Contraceptives in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.

2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

Acne

The timing of initiation of dosing with ESTROSTEP Fe for acne should follow the guidelines for use of ESTROSTEP Fe as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section for oral contraceptives.

Erythromycin is well absorbed and may be given without regard to meals. Optimum blood levels are obtained in a fasting state (administration at least one half hour and preferably two hours before or after a meal); however, blood levels obtained upon administration of enteric-coated erythromycin products in the presence of food are still above minimal inhibitory concentrations (MICs) of most organisms for which erythromycin is indicated.

Streptococcal infections: A therapeutic dosage of oral erythromycin should be administered for at least 10 days. For continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the dose is 250 mg twice a day.

Primary syphilis: 30 to 40 grams given in divided doses over a period of 10 to 15 days.

Intestinal amebiasis: 250 mg four times daily for 10 to 14 days for adults; 30 to 50 mg/kg/day in divided doses for 10 to 14 days for children.

Legionnaires’ disease: Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1 to 4 grams daily in divided doses).

Urogenital infections during pregnancy due to Chlamydia trachomatis: Although the optimal dose and duration of therapy have not been established, the suggested treatment is erythromycin 500 mg, by mouth, 4 times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of 250 mg, by mouth, 4 times a day should be used for at least 14 days.

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis in whom tetracyclines are contraindicated or not tolerated: 500 mg, by mouth, 4 times a day for at least 7 days.

Pertussis: Although optimum dosage and duration of therapy have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Nongonococcal urethritis due to Ureaplasma urealyticum: When tetracycline is contraindicated or not tolerated: 500 mg of erythromycin, orally, four times daily for at least 7 days.

Acute pelvic inflammatory disease due to N gonorrhoeae: 500 mg IV of erythromycin lactobionate for injection, USP every 6 hours for 3 days followed by 250 mg of erythromycin, orally every six hours for 7 days.

Comb the hair to remove scaly debris and after suitably parting, apply Dovonex® Scalp Solution, 0.005%, twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Dovonex® Scalp Solution, 0.005%, have been demonstrated in patients treated for eight weeks.

Keep Dovonex®  Scalp Solution, 0.005%, well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.

Apply a thin layer of Dovonex® Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex® Cream have been demonstrated in patients treated for eight weeks.

Apply an adequate layer of Taclonex® Ointment to the affected area(s) once daily for up to 4 weeks. Taclonex® Ointment should be rubbed in gently and completely. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended. Taclonex® Ointment should not be applied to the face, axillae or groin.

2.1 Usual Dosage and Administration

Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. The maximum weekly dose should not exceed 100 g. Patients should shake the bottle prior to using the product. Patients should wash their hands after applying Taclonex Scalp® Topical Suspension.

Taclonex Scalp® Topical Suspension is not for oral, ophthalmic, or intravaginal use.

To achieve maximum contraceptive effectiveness, FEMCON Fe must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FEMCON Fe is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking FEMCON Fe on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on FEMCON Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts FEMCON Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of FEMCON Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin FEMCON Fe the next day. If switching from an implant or injection, the patient should start FEMCON Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if FEMCON Fe is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

FEMCON Fe may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. FEMCON  Fe may be initiated after a first-trimester abortion; if the patient starts FEMCON Fe immediately, additional contraceptive measures are not needed.

For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

To achieve maximum contraceptive effectiveness, Loestrin 24 Fe should be taken exactly as directed and at intervals not exceeding 24 hours. Loestrin 24 Fe tablets may be administered without regard to meals.

Loestrin 24 Fe provides a regimen consisting of 24 white active tablets of Loestrin 24 Fe and 4 brown non-hormonal (placebo) tablets of ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

During the first cycle of use:

The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking Loestrin 24 Fe  on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on Loestrin 24 Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on white tablets—4 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception:

When the patient is switching to Loestrin 24 Fe after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts Loestrin 24 Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching to Loestrin 24 Fe after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of Loestrin 24 Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Loestrin 24 Fe the next day. If switching from an implant or injection, the patient should start Loestrin 24 Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

If spotting or breakthrough bleeding occurs:

The patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if Loestrin 24 Fe is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

For additional patient instructions regarding missed pills:

See the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking the active white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. Therefore, the risk of pregnancy increases with each active (white) tablet missed.

Use after pregnancy, abortion or miscarriage:

Loestrin 24 Fe should be initiated no earlier than 28 days postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered.

Loestrin 24 Fe may be initiated after a first-trimester abortion or miscarriage; if the patient starts Loestrin 24 Fe immediately, additional contraceptive measures are not needed.

For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered.

Dosage and Administration for 28-Day Dosage Regimen

To achieve maximum contraceptive effectiveness, ESTROSTEP Fe should be taken exactly as directed and at intervals not exceeding 24 hours.

ESTROSTEP Fe provides a continuous administration regimen consisting of 21 white oral contraceptive tablets and seven brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days”.

A. Sunday-Start Regimen: The patient begins taking the first white tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white tablet is taken on the same day. The patient takes one white tablet daily for 21 days. The last white tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 white tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white tablet in the top row. Adhering to this regimen of one white tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one white tablet daily, beginning with the first white tablet in the top row. After the last white tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet dispenser. Following this regimen of 21 white tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.

Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration

Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white tablets, continue medication without interruption.

If the patient forgets to take one or more white tablets, the following is suggested:

One tablet is missed

Two consecutive tablets are missed (Week 1 or Week 2)

Two consecutive tablets are missed (Week 3)Sunday-Start Regimen:

Day-1 Start Regimen:

Three (or more) consecutive tablets are missedSunday-Start Regimen:

Day-1 Start Regimen:

The possibility of ovulation occurring increases with each successive day that scheduled white tablets are missed. While there is little likelihood of ovulation occurring if only one white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white tablets are missed.

If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white tablet was taken.

In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day 1) depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

Use of Oral Contraceptives in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.

2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

Acne

The timing of initiation of dosing with ESTROSTEP Fe for acne should follow the guidelines for use of ESTROSTEP Fe as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section for oral contraceptives.

The following is a summary of the instructions given to the patient in the “HOW TO TAKE THE PILL” section of the DETAILED PATIENT LABELING.

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

2.1 How to Take Lo Loestrin Fe

To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling. Lo Loestrin Fe tablets may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Lo Loestrin Fe

Instruct the patient to begin taking Lo Loestrin Fe  on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-Approved Patient Labeling]. One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Loestrin Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Lo Loestrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.

Lo Loestrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Loestrin Fe immediately, additional contraceptive measures are not needed.

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:

      ○ Another pill

      ○ Vaginal ring

      ○ Patch

If the patient is switching from a progestin-only method such as a:

      ○ Progestin-only pill

      ○ Implant

      ○ Intrauterine system

      ○ Injection

2.4 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white pill), she should follow the instructions in the “What to Do if You Miss Pills” section [see FDA-Approved Patient Labeling].

2.1 Treatment of Postmenopausal Osteoporosis

[see Indications and Usage (1.1)]

The recommended regimen is:

2.2 Important Administration Instructions

Instruct patients to do the following:

2.3 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.3)] and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of Atelvia.

2.4 Administration Instructions for Missed Doses

If the once-weekly dose is missed, instruct patients to take one tablet on the morning after they remember and return to taking one tablet once-a-week, as originally scheduled on their chosen day. Patients should not take two tablets on the same day.

2.1 Treatment of Postmenopausal Osteoporosis

[see Indications and Usage (1.1)]

The recommended regimen is:

2.2 Prevention of Postmenopausal Osteoporosis

[see Indications and Usage (1.1)]

The recommended regimen is:

2.3 Treatment to Increase Bone Mass in Men with Osteoporosis

[see Indications and Usage (1.2)]

The recommended regimen is:

2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis

[see Indications and Usage (1.3)]

The recommended regimen is:

2.5 Treatment of Paget’s Disease

[see Indications and Usage (1.4)]

The recommended treatment regimen is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of retreatment.

2.6 Important Administration Instructions

Instruct patients to do the following:

2.7 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of ACTONEL.

2.8 Administration Instructions for Missed Doses

Instruct patients about missing ACTONEL doses as follows:

2.1 Usual Dosage and Administration

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

For pediatric patients above eight years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children over 45 kg, the usual adult dose should be used.

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline-class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6.1)].

If gastric irritation occurs, doxycycline may be given with food or milk [see Clinical Pharmacology (12)].

When used in streptococcal infections, therapy should be continued for 10 days.

Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis: 100 mg by mouth twice a day for 7 days. As an alternate dosing regimen for uncomplicated urethral or endocervical infection caused by Chlamydia trachomatis, administer 200 mg by mouth once-a-day for 7 days.

Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

Nongonococcal urethritis (NGU) caused by U. urealyticum: 100 mg by mouth twice-a-day for 7 days.

Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.

Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.

2.2 For prophylaxis of malaria

For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

2.3 Inhalational anthrax (post-exposure)

ADULTS: 100 mg, of doxycycline, by mouth, twice-a-day for 60 days. CHILDREN: weighing less than 45 kg, 2.2 mg/kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.

2.4 Sprinkling the tablet over applesauce

DORYX Tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release pellets) on a spoonful of applesauce. The delayed-release pellets must not be crushed or damaged when breaking up the tablet. Any loss of pellets in the transfer would prevent using the dose. The applesauce/DORYX mixture should be swallowed immediately without chewing and may be followed by a glass of water if desired. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/DORYX Tablet cannot be taken immediately, the mixture should be discarded and not stored for later use.

2.1 How to Take Minastrin 24 Fe

To achieve maximum contraceptive effectiveness, Minastrin 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the white tablets. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling]. Minastrin 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Minastrin 24 Fe

Instruct the patient to begin taking Minastrin 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Minastrin 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Minastrin 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Minastrin 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Minastrin 24 Fe tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Minastrin 24 Fe is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Minastrin 24 Fe tablet daily for 7 consecutive days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Minastrin 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Minastrin 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Minastrin 24 Fe for 7 consecutive days.

Minastrin 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Minastrin 24 Fe immediately, additional contraceptive measures are not needed.

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:

       ο   Another pill

       ο   Vaginal ring

       ο   Patch

If the patient is switching from a progestin-only method such as a:

       ο   Progestin-only pill

       ο   Implant

       ο   Intrauterine system

       ο   Injection

2.4 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Minastrin 24 Fe tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling].

2.1 Treatment

The recommended dose of SARAFEM for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle). The dosing regimen should be based on individual patient characteristics. In a study comparing continuous dosing of fluoxetine 20 and 60 mg/day to placebo, both doses were proven to be effective, but there was no statistically significant added benefit for the 60 mg/day compared with the 20 mg/day dose. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine dose should not exceed 80 mg/day [see Clinical Studies (14.1)].

Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently [see Clinical Studies (14.1)]. Patients should be periodically re-assessed to determine the need for continued treatment.

2.2 Dosing in Specific Populations

Treatment of Pregnant Women — PMDD does not exist in pregnancy. However, if there is a need to treat pregnant women with fluoxetine, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)].

Hepatic Impairment — A lower or less frequent dosage should be used in patients with hepatic impairment [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)].

Concomitant Illness — Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see Warnings and Precautions (5.11) and Clinical Pharmacology (12.3)].

2.3 Discontinuation of Treatment

Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.14)].

2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with SARAFEM. Conversely, at least 5 weeks should be allowed after stopping SARAFEM before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].

2.5 Use of SARAFEM with Other MAOIs such as Linezolid or Methylene Blue

Do not start SARAFEM in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

In some cases, a patient already receiving SARAFEM therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, SARAFEM should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with SARAFEM may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with SARAFEM is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1       Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

femhrt therapy consists of a single tablet to be taken orally once daily.

2.2       Prevention of Postmenopausal Osteoporosis

femhrt therapy consists of a single tablet taken orally once daily.  

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Patients should be started at the lowest dose for the indication.

1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off).

2. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Treatment is usually initiated with a dose of 1 to 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration.

3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease.

Suggested dosage is 10 mg three times daily for a period of at least three months.

4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.

Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.

5. For prevention of osteoporosis.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.

The lowest effective dose of ESTRACE has not been determined.

2.1 How to Take Lo Minastrin Fe

To achieve maximum contraceptive effectiveness, Lo Minastrin Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The blue tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the blue tablet. The white tablet and the brown tablet are swallowed. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets [see FDA-approved patient labeling]. Lo Minastrin Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Lo Minastrin Fe

Instruct the patient to begin taking Lo Minastrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-approved patient labeling]. One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Minastrin Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Lo Minastrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.

Lo Minastrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Minastrin Fe immediately, additional contraceptive measures are not needed.

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:

•   Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Minastrin Fe.

•   If she previously used a vaginal ring or transdermal patch, she should start using Lo Minastrin Fe on the day she would have resumed the previous product.If the patient is switching from a progestin-only method such as a:

•   She may switch any day from a progestin-only pill; instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill.

•   If switching from an implant or injection, start the first blue tablet on the day her next injection would have been due or on the day of removal of her implant.

•   If switching from an IUD, depending on the timing of removal, back-up contraception may be needed.

2.4 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling].

Use of ESTRACE (estradiol vaginal cream, USP, 0.01%), alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should reevaluate periodically as clinically appropriate (for example, 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For treatment of vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.

Usual Dosage: The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.

The recommended starting dose of Enablex is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.

Enablex should be taken once daily with water. Enablex may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.

For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of Enablex should not exceed 7.5 mg. Enablex is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Warnings & Precautions (5.6), Drug Interactions (7.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.1 How to Take Minastrin 24 Fe

To achieve maximum contraceptive effectiveness, Minastrin 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet should be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling]. Minastrin 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Minastrin 24 Fe

Instruct the patient to begin taking Minastrin 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Minastrin 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Minastrin 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Minastrin 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Minastrin 24 Fe tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Minastrin 24 Fe is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Minastrin 24 Fe tablet daily for 7 consecutive days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Minastrin 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Minastrin 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Minastrin 24 Fe for 7 consecutive days.

Minastrin 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Minastrin 24 Fe immediately, additional contraceptive measures are not needed.

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:

                        − Another pill                             − Vaginal ring                         − Patch

If the patient is switching from a progestin-only method such as a:

                            − Progestin-only pill                             − Implant                             − Intrauterine system                             − Injection

2.4 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Minastrin 24 Fe tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling].

2.1 Important Administration Instructions

2.2 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis

Adults

For adults, the recommended dosage of Asacol is 800 mg (two 400 mg tablets) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks. 

Pediatrics

For pediatric patients 5 years of age and older, the recommended total daily dosage of Asacol is weight-based (up to maximum of 2.4 grams/day) divided into two daily doses for a duration of 6 weeks (see Table 1).

2.3 Dosage for Maintenance of Remission of Mildly to Moderately Active Ulcerative Colitis

For adults the recommended dosage of Asacol is 1.6 grams (four 400 mg tablets) daily in two to four divided doses.

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2 , 5.14)].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response.

 Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

2.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response.

 Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

2.1 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis

Adults For adults, the recommended dosage of DELZICOL is two 400 mg capsules to be taken three times daily (total daily dose of 2.4 grams), for a duration of 6 weeks [see Clinical Studies (14.1)]. 

PediatricsFor pediatric patients 12 years of age and older, the recommended total daily dose of DELZICOL is weight-based (up to maximum of 2.4 grams/day). DELZICOL capsules are to be taken twice daily with or without food for a duration of 6 weeks [see Clinical Studies (14.1)]. ​

 Weight Group (kg)

2.2 Dosage for Maintenance of Remission of Ulcerative Colitis in Adults

For the maintenance of remission of ulcerative colitis, the recommended dose of DELZICOL in adults is 1.6 g daily with or without food in divided doses [see Clinical Studies (14.2)].

2.3 Important Administration Instructions

Do not open, crush, break, or chew the capsules. Swallow whole with water.

Before prescribing DELZICOL capsules, children should be assessed for the ability to swallow capsules.

Two DELZICOL 400 mg capsules should not be substituted with one mesalamine delayed-release 800 mg tablet.

2.4 Testing Prior to DELZICOL Administration

Evaluate renal function prior to initiation of DELZICOL [see Warnings and Precautions (5.1)].

To achieve maximum contraceptive effectiveness, FEMCON Fe must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FEMCON Fe is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking FEMCON Fe on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on FEMCON Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts FEMCON Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of FEMCON Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin FEMCON Fe the next day. If switching from an implant or injection, the patient should start FEMCON Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if FEMCON Fe is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

FEMCON Fe may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. FEMCON  Fe may be initiated after a first-trimester abortion; if the patient starts FEMCON Fe immediately, additional contraceptive measures are not needed.

For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.