Janssen Pharmaceutical, Inc.

Janssen Pharmaceutical, Inc. Drugs

• Risperidone
  

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  Risperidone

  

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  Table 1. Recommended Daily Dosage by Indication Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents (2.2) 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg Bipolar mania: adults (2.2) 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg Bipolar mania: children and adolescents (2.2) 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg Irritability in autistic disorder (2.3) 0.25 mgCan increase to0.5 mg by Day 4:(body weight less than 20 kg)0.5 mgCan increase to1 mg by Day 4:(body weight greater than or equal to 20 kg) After Day 4, at intervals of > 2 weeks:0.25 mg(body weight less than 20 kg)0.5 mg(body weight greater than or equal to 20 kg) 0.5 mg:(body weight less than 20 kg)1 mg:(body weight greater than or equal to 20 kg) 0.5 to 3 mg

  Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.

  2.1 Schizophrenia

  Adults

  Usual Initial Dose

  Risperidone can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 mg to 16 mg per day. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg per day has not been evaluated in clinical trials [see Clinical Studies (14.1)].

  Adolescents

  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to a recommended dose of 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

  Maintenance Therapy

  While it is unknown how long a patient with schizophrenia should remain on risperidone, the effectiveness of risperidone 2 mg per day to 8 mg per day at delaying relapse was demonstrated in a controlled trial in adult patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Clinical Studies (14.1)]. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Reinitiation of Treatment in Patients Previously Discontinued

  Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off risperidone, the initial titration schedule should be followed.

  Switching From Other Antipsychotics

  There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to risperidone, or treating patients with concomitant antipsychotics.

  2.2 Bipolar Mania

  Usual Dose

  Adults

  The initial dose range is 2 mg to 3 mg per day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1 mg to 6 mg per day [see Clinical Studies (14.2, 14.3)]. Risperidone doses higher than 6 mg per day were not studied.

  Pediatrics

  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to the recommended target dose of 1 mg to 2.5 mg per day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 mg and 6 mg per day, no additional benefit was observed above 2.5 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

  Maintenance Therapy

  There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with risperidone. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of risperidone in such longer-term treatment (i.e., beyond 3 weeks). The physician who elects to use risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

  2.3 Irritability Associated with Autistic Disorder – Pediatrics (Children and Adolescents)

  The dosage of risperidone should be individualized according to the response and tolerability of the patient. The total daily dose of risperidone can be administered once daily, or half the total daily dose can be administered twice daily.

  For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1.0 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg.

  Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

  Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose.

  2.4 Dosing in Patients with Severe Renal or Hepatic Impairment

  For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10–15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater [see Use in Specific Populations (8.6 and 8.7)].

  2.5 Dose Adjustments for Specific Drug Interactions

  When risperidone is co-administered with enzyme inducers (e.g., carbamazepine), the dose of risperidone should be increased up to double the patient's usual dose. It may be necessary to decrease the risperidone dose when enzyme inducers such as carbamazepine are discontinued [see Drug Interactions (7.1)]. Similar effect may be expected with co-administration of risperidone with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital).

  When fluoxetine or paroxetine is co-administered with risperidone, the dose of risperidone should be reduced. The risperidone dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, risperidone should be titrated slowly. It may be necessary to increase the risperidone dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued [see Drug Interactions (7.1)].

  2.6 Administration of Risperidone Oral Solution

  Risperidone Oral Solution can be administered directly from the calibrated pipette, or can be mixed with a beverage prior to administration. Risperidone Oral Solution is compatible in the following beverages: water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea.

  2.7 Directions for Use of Risperidone Orally Disintegrating Tablets

  Tablet Accessing

  Risperidone Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg

  Risperidone Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are supplied in blister packs of 4 tablets each.

  Do not open the blister until ready to administer. For single tablet removal, separate one of the four blister units by tearing apart at the perforations. Bend the corner where indicated. Peel back foil to expose the tablet. DO NOT push the tablet through the foil because this could damage the tablet.

  Risperidone Orally Disintegrating Tablets 3 mg and 4 mg

  Risperidone Orally Disintegrating Tablets 3 mg and 4 mg are supplied in a child-resistant pouch containing a blister with 1 tablet each.

  The child-resistant pouch should be torn open at the notch to access the blister. Do not open the blister until ready to administer. Peel back foil from the side to expose the tablet. DO NOT push the tablet through the foil, because this could damage the tablet.

  Tablet Administration

  Using dry hands, remove the tablet from the blister unit and immediately place the entire Risperidone Orally Disintegrating Tablet on the tongue. The Risperidone Orally Disintegrating Tablet should be consumed immediately, as the tablet cannot be stored once removed from the blister unit. Risperidone Orally Disintegrating Tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid. Patients should not attempt to split or to chew the tablet.

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• Ortho Evra
  

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  Ortho Evra

  

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  To achieve maximum contraceptive effectiveness, ORTHO EVRA must be used exactly as directed.

  Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.

  2.1 How to Use ORTHO EVRA

  The ORTHO EVRA transdermal system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time.

  Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time.

  Do not cut, damage or alter the ORTHO EVRA patch in any way. If the ORTHO EVRA patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.

  On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a seven-day patch-free interval between dosing cycles.

  2.2 How to Start Using ORTHO EVRA

  The woman has two options for starting the patch and she should choose the option that is right for her:

  First Day Start—The woman should apply her first patch during the first 24 hours of her menstrual period. Sunday Start—The woman should apply her first patch on the first Sunday after her menstrual period begins. With this option, a non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only. If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed. When Switching From the Pill or Vaginal Contraceptive Ring to the Patch—If the woman is switching from the pill or vaginal contraceptive ring to ORTHO EVRA, she should complete her current pill cycle or vaginal ring cycle and apply the first ORTHO EVRA patch on the day she would normally start her next pill or insert her next vaginal ring. If she does not get her period within a week after taking the last active pill or removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ORTHO EVRA for contraception. If the patch is applied more than a week after taking the last active pill or removal of the last vaginal ring, she should use a non-hormonal contraceptive concurrently for the first 7 days of patch use.

  Use after Childbirth

  Start contraceptive therapy with ORTHO EVRA in women who elect not to breastfeed no sooner than 4 weeks after childbirth due to increased risk of thromboembolism. If a woman begins using ORTHO EVRA postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of ORTHO EVRA, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first seven days. [See Warnings and Precautions (5.1) and Pregnancy (8.1).]

  Use after Abortion or Miscarriage

  After an abortion or miscarriage that occurs in the first trimester, ORTHO EVRA may be started immediately. An additional method of contraception is not needed if ORTHO EVRA is started immediately. If use of ORTHO EVRA is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting ORTHO EVRA for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage.

  Start ORTHO EVRA no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. [See Contraindications (4) and Warnings and Precautions (5.1).]

  2.3 How to Apply ORTHO EVRA

  CHOOSING A PLACE ON THE BODY TO PUT THE PATCH

  The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing. The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.

  Before applying the patch:

  The woman should make sure the skin is clean and dry. She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.

  HOW TO APPLY THE PATCH

  The woman should tear open the pouch at the top edge. She should peel open the foil pouch that contains the patch and its clear plastic cover. She should gently remove the patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover. Using a fingernail, the woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers. The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin. The woman should press firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any "wrinkles" around the outer edges of the patch. The woman should check her patch every day to make sure all edges are sticking correctly.

  WHEN TO CHANGE THE ORTHO EVRA PATCH

  The patch works for seven days (one week). The woman should apply a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch. During Week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.) Following Week 4, she repeats the cycle of three weekly applications followed by a patch-free week.

  WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF?

  The patch must stick securely to the skin to work properly. If the ORTHO EVRA patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.

  If a patch edge lifts up:

  The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any "wrinkles" around the edges of the patch. If her patch does not stick completely, she should remove it and apply a replacement patch. She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing.

  If the patch has been off or partially off:

  For less than 1 Day, she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same). For more than 1 Day or if she is not sure for how long, she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom and spermicide or diaphragm and spermicide) for the first week of her new cycle.

  IF THE WOMAN FORGETS TO CHANGE HER PATCH

  at the start of any patch cycle (Week One/Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception, such as a condom and spermicide or diaphragm and spermicide, for the first week of the new cycle. in the middle of the patch cycle (Week Two/Day 8 or Week Three/Day 15), – for one or two days (up to 48 hours), she should apply a new patch immediately. The next patch should be applied on the usual "Patch Change Day." No back-up contraception is needed. – for more than two days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new patch. There is now a new "Patch Change Day" and a new "Day 1." The woman must use back-up contraception for one week. at the end of the patch cycle (Week Four/Day 22), – If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual "Patch Change Day," which is the day after Day 28. No back-up contraception is needed.

  Under no circumstances should there be more than a seven-day patch-free interval between cycles. If there are more than seven patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for seven days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If she has had intercourse during such an extended patch-free interval, consider the possibility of pregnancy.

  Change Day Adjustment

  If the woman wishes to change her Patch Change Day, she should complete her current cycle, removing the third ORTHO EVRA patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new ORTHO EVRA patch on the desired day. In no case should there be more than 7 consecutive patch-free days.

  Breakthrough Bleeding or Spotting

  In the event of unscheduled or breakthrough bleeding or spotting (bleeding that occurs on the days that ORTHO EVRA is worn), treatment should be continued. If unscheduled bleeding persists longer than a few cycles, consider causes other than ORTHO EVRA.

  If the woman does not have scheduled or withdrawal bleeding (bleeding that should occur during the patch-free week), she should resume treatment on the next scheduled Change Day. If ORTHO EVRA has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue ORTHO EVRA if pregnancy is confirmed.

  In Case of Skin Irritation

  If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time.

  Additional Instructions for Dosing

  Unscheduled bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, consider nonfunctional causes. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, take adequate diagnostic measures to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem.

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

  If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue use of ORTHO EVRA if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches. However, if she has adhered to the prescribed regimen, misses one period and has symptoms associated with pregnancy, rule out pregnancy. Discontinue ORTHO EVRA use if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue ORTHO EVRA use if pregnancy is confirmed.

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