Senna Plus

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Senna Plus Recall

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Side Effects & Adverse Reactions

Do not use ■ for longer than one week ■ when abdominal pain, nausea or vomiting are present

Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits

that lasts over a period of two weeks

Stop use and ask a doctor if ■ you have rectal bleeding ■ you fail to have a bowel movement

after use of this product, this may indicate a serious condition

If pregnant or breast-feeding, ask a health care professional before use.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

■ for the short term relief of constipation ■ produces bowel movement in 6 to 12 hours

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History

There is currently no drug history available for this drug.

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Other Information

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Sources

Senna Plus Manufacturers

Cardinal Health

Senna Plus | Cardinal Health

■ take preferably at bedtime or as directed by a doctor ■ if you do not have a

comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the

maximum dosage) or decrease dose until you are comfortable

No Recall
Rebel Distributors Corp

Senna Plus | Rebel Distributors Corp

° Take preferably at bedtime or as directed by a doctor ° if you do not have a comfortable bowel movement by the second day, increase dose by one table (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day)

Children 6 to under 12 years: 1 tablet once a day (maximum dosage, 2 tablets twice a day)

Children 2 to under 6 years: 1.2 tablet once a day (maximum dosage, 1 tablet twice a day)

Children under 2 years: do not use

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Senna Plus | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

° Take preferably at bedtime or as directed by a doctor ° if you do not have a comfortable bowel movement by the second day, increase dose by one table (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day)

Children 6 to under 12 years: 1 tablet once a day (maximum dosage, 2 tablets twice a day)

Children 2 to under 6 years: 1.2 tablet once a day (maximum dosage, 1 tablet twice a day)

Children under 2 years: do not use

No Recall
American Health Packaging

Senna Plus | American Health Packaging

Take preferably at bedtime or as directed by a doctor, if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable
age starting dose maximum dose adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor

No Recall
Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy)

Senna Plus | Amerisourcebergen Drug Corporation (good Neighbour Pharmacy)

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or older 2 tablets
once a day 4 tablets
twice a day children 6 to under 12 years 1 tablet
once a day 2 tablets
twice a day children 2 to under 6 years 1/2 tablet
once a day 1 tablet
twice a day children under 2 years ask a doctor ask a doctor

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Senna Plus | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children under 6 years ask a doctor

No Recall
Cardinal Health

Senna Plus | Blenheim Pharmacal, Inc.

2.1 Major Depressive Disorder
Initial Treatment

Adult — Initiate fluoxetine 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon).The maximum fluoxetine dose should not exceed 80 mg/day.

In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [see Clinical Studies ( 14.1)] .

Pediatric (children and adolescents) — Initiate fluoxetine 10 or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies ( 14.1)] .

All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.

Periodically reassess to determine the need for maintenance treatment.

Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [ see Warnings and Precautions (5.2) and Drug Interactions (7.7)].
2.2 Obsessive Compulsive Disorder
Initial Treatment

Adult — Initiate fluoxetine 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.

In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo [see Clinical Studies ( 14.2)] . In one of these studies, no dose-response relationship for effectiveness was demonstrated.

Pediatric (children and adolescents) — In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.

In lower weight children, initiate treatment with a dose of 10 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.

In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies ( 14.2)] .

Periodically reassess to determine the need for treatment.
2.3 Bulimia Nervosa
Initial Treatment — Administer fluoxetine 60 mg/day in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo [see Clinical Studies ( 14.3)] . Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting.

Periodically reassess to determine the need for maintenance treatment.
2.4 Panic Disorder
Initial Treatment — Initiate treatment with fluoxetine 10 mg/day. After one week, increase the dose to 20 mg/day. Consider a dose increase after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies ( 14.4)] . The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.
2.5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I Disorder
When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.

Adult — Administer fluoxetine in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Make dosage adjustments, if indicated, according to efficacy and tolerability within dose ranges of fluoxetine 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.

Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules. However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.

Table 1: Approximate Dose Correspondence Between Symbyax 1 and the Combination of Fluoxetine and Olanzapine

For Symbyax
(mg/day)

Use in Combination

Olanzapine (mg/day)

Fluoxetine (mg/day)

3 mg olanzapine/25 mg fluoxetine

2.5

20

6 mg olanzapine/25 mg fluoxetine

5

20

12 mg olanzapine/25 mg fluoxetine

10 + 2.5

20

6 mg olanzapine/50 mg fluoxetine

5

40 + 10

12 mg olanzapine/50 mg fluoxetine

10 + 2.5

40 + 10

Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
1 Symbyax (olanzapine/fluoxetine HCL) is a fixed-dose combination of fluoxetine and olanzapine. 2.7 Dosing in Specific Populations
Treatment of Pregnant Women — When treating 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)] .

Geriatric — Consider a lower or less frequent dosage for the elderly [ see Use in Specific Populations (8.5)].

Hepatic Impairment — As with many other medications, use a lower or less frequent dosage in patients with hepatic impairment [ see Clinical Pharmacology (12.4) and Use in Specific Populations (8.6)] .

Concomitant Illness — Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments [ see Clinical Pharmacology (12.4) and Warnings and Precautions ( 5.12) ] .

Fluoxetine and Olanzapine in Combination — Use a starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. Fluoxetine and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [ see Warnings and Precautions ( 5.16) and Drug Interactions ( 7.7)].
2.8 Discontinuation of Treatment
Symptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [ see Warnings and Precautions ( 5.15) ] .
2.9 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 fluoxetine. Conversely, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.10 Use of Fluoxetine With Other MAOIs Such as Linezolid or Methylene Blue
Do not start fluoxetine 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 fluoxetine 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, fluoxetine 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 fluoxetine 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 fluoxetine 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)].

No Recall
Geri-care Pharmaceutical Corp

Senna Plus | Geri-care Pharmaceutical Corp

• do not exceed 8 tablets in 24 hours
Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

No Recall
Major Pharmaceuticals

Senna Plus | Major Pharmaceuticals

Take preferably at bedtime or as directed by a doctor if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) age starting dose maximum dose adults and children 12 years & over 2 tablets once daily 4 tablets twice daily children 6 to under 12 years 1 tablet once daily 2 tablets twice daily children 2 to under 6 years 1/2 tablet once daily 1 tablet twice daily children under 2 years ask a doctor ask a doctor

No Recall
Cvs Pharmacy

Senna Plus | Woonsocket Prescription Center,incorporated

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Cardinal Health

Senna Plus | Cardinal Health

• do not exceed 8 tablets in 24 hours
Age
Starting Dose
Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor

No Recall
Cardinal Health

Senna Plus | Cardinal Health

• Take preferably at bedtime or as directed by a doctor • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage)
age

starting dosage

maximum dosage

adults and children 12 years & over

2 tablets once daily

4 tablets twice daily

children 6 to under 12 years

1 tablet once daily

2 tablets twice daily

children 2 to under 6 years

1/2 tablet once daily

1 tablet twice daily

children under 2 years

ask a doctor

ask a doctor

No Recall