Savella

Savella Recall

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Questions & Answers

Side Effects & Adverse Reactions

For external use only.

When using this product

Avoid contact with the eyes. If contact occurs, rinse eyes thorougly with water.

Stop use and ask a doctor if

If Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

If Condition worsens or does not improve after regular use of this product as directed

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

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

Manufacturer Warnings

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

FDA Labeling Changes

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

Uses

For the relief of the symptoms of dandruff.
Helps Stop recurrence of scalp itching and flaking associated with dandruff.

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Sources

Savella Manufacturers

Cardinal Health

Savella | Prime Enterprises, Inc.

Shake well Wet hair, lather and massage into scalp, rinse hair thoroughly, repeat if desired, For best results use at least twice a week or as directed by a doctor. Children under 6 months of age: ask a doctor.

No Recall
Stat Rx Usa Llc

Savella | Stat Rx Usa Llc

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella (2.4) and Warnings and Precautions (5.7)]
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patient should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications (4.1)].

No Recall
Rebel Distributors Corp

Savella | Rebel Distributors Corp

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella (2.4) and Warnings and Precautions (5.7)]
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patient should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications (4.1)].

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

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

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella (2.4) and Warnings and Precautions (5.7)]
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications (4.1)].

No Recall
Physicians Total Care, Inc.

Savella | Physicians Total Care, Inc.

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella (2.4) and Warnings and Precautions (5.7)]
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications (4.1)].

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Savella | Lake Erie Medical Dba Quality Care Products Llc

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Discontinuing Savella (2.4) and Warnings and Precautions (5.7)]
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications (4.1)].

No Recall
Unit Dose Services

Savella | Unit Dose Services

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
12.5 mg once Day 1:
25 mg/day (12.5 mg twice daily) Days 2-3:
50 mg/day (25 mg twice daily) Days 4-7:
100 mg/day (50 mg twice daily) After Day 7:
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Dosage and Administration ( ) and Warnings and Precautions ( )] 2.45.7
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment. Savella should be used with caution in patients with moderate renal impairment. For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions ( )]. 5.7
2.5 Switching patients to or from a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with Savella. In addition, at least 5 days should be allowed after stopping Savella before starting a MAOI [see Contraindications ( )]. 4.1

No Recall
Forest Laboratories, Inc.

Savella | Forest Laboratories, Inc.

Savella is given orally with or without food.
Taking Savella with food may improve the tolerability of the drug.
2.1 Recommended Dosing
The recommended dose of Savella is 100 mg/day (50 mg twice daily).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).
Doses above 200 mg/day have not been studied.
Savella should be tapered and not abruptly discontinued after extended use [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].
2.2 Patients with Renal Insufficiency
No dosage adjustment is necessary in patients with mild renal impairment.
Savella should be used with caution in patients with moderate renal impairment.
For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).
Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).
Savella is not recommended for patients with end-stage renal disease.
2.3 Patients with Hepatic Insufficiency
No dosage adjustment is necessary for patients with hepatic impairment.
As with any drug, caution should be exercised in patients with severe hepatic impairment.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
2.5 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 a MAOI intended to treat psychiatric disorders and initiation of therapy with Savella. Conversely, at least 5 days should be allowed after stopping Savella before starting a MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Savella with other MAOIs such as Linezolid or Methylene Blue
Do not start Savella in a patient being treated with linezolid or intravenous methylene blue because there is 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 Savella 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, Savella should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Savella 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 Savella 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

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