drizalma sprinkle

Take DRIZALMA SPRINKLE with or without food (2.1) • DRIZALMA SPRINKLE may be: swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube (2.1) • Take a missed dose as soon as it is remembered. Do not take two doses of DRIZALMA SPRINKLE at the same time (2.1) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) Adults 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.3) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) Adults 30 mg/day 60 mg/day (once daily) 60 mg/day • There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent (2) • Discontinuing DRIZALMA SPRINKLE: Gradually reduce dosage to avoid discontinuation symptoms (2.8, 5.7) 2.1 Important Administration Instructions Administer DRIZALMA SPRINKLE with or without food. Swallow DRIZALMA SPRINKLE whole (do not chew or crush the capsule). For patients unable to…

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)] Serotonin Syndrome [see Warnings and Precautions (5.4)] Increased Risk of Bleeding [see Warnings and Precautions (5.5)] Severe Skin Reactions [see Warnings and Precautions (5.6)] Discontinuation Syndrome [see Warnings and Precautions (5.7)] Activation of Mania/Hypomania [see Warnings and Precautions (5.8)] Angle-Closure Glaucoma [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Increases in Blood Pressure [see Warnings and Precautions (5.11)] Clinically Important Drug Interactions [see Warnings and Precautions (5.12)] Hyponatremia [see Warnings and Precautions (5.13)] Urinary Hesitation and Retention [see Warnings and Precautions (5.15)] Sexual Dysfunction [see Warnings and Precautions (5.16)] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): (6.1) Adults: nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : nausea, diarrhea, decreased weight To report SUSPECTED ADVERSE REACTIONS, contact Sun…

The use of MAOIs intended to treat psychiatric disorders with DRIZALMA SPRINKLE, or within 5 days of stopping treatment with DRIZALMA SPRINKLE, are contraindicated because of an increased risk of serotonin syndrome. The use of DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.10), Warnings and Precautions (5.4), Drug Interactions (7)] . Starting DRIZALMA SPRINKLE in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.4)] . Serotonin Syndrome and MAOIs : Do not use MAOIs intended to treat psychiatric disorders with DRIZALMA SPRINKLE or within 5 days of stopping treatment with DRIZALMA SPRINKLE. Do not use DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start DRIZALMA SPRINKLE in a patient who is being treated with linezolid or intravenous methylene blue (4)

10.1 Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as 1000 mg. Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting. 10.2 Management of Overdose There is no specific antidote to a duloxetine overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Induction of emesis is not recommended. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease AUC and C max by an average of one-third, although some patients had a limited effect of activated charcoal. Due to the large volume of distribution of duloxetine,…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Potent CYP1A2 Inhibitors: Avoid concomitant use (2.6, 7) • CYP2D6 Substrates: Consider dose reduction with concomitant use (7) 7.1 Drugs Having Clinically Important Interactions with DRIZALMA SPRINKLE Table 7: Clinically Important Drug Interactions Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs and SNRIs including duloxetine with MAOIs increases the risk of serotonin syndrome. Intervention •The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated [see Contraindications (4) and Warnings and Precautions (5.4)] .•The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Contraindications (4) and Warnings and Precautions (5.4)] .•Starting duloxetine in a patient who is being treated with MAOIs is also contraindicated [see Dosage and Administration (2.10), Contraindications (4), Warnings and Precautions (5.4)] . Examples Selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, intravenous methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of duloxetine with other serotonergic drugs increases the risk of serotonin syndrome. Intervention •Patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.•Monitor for symptoms of serotonin syndrome when duloxetine is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems.•Treatment with duloxetine delayed-release capsules and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated [see Warnings and Precautions (5.4)] . Examples Other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort Inhibitors of CYP1A2 Clinical Impact Concomitant use of duloxetine with CYP1A2 inhibitors increases AUC, C max , t 1/2 of duloxetine. Intervention Avoid concomitant use of duloxetine delayed-release capsules with potent CYP1A2 inhibitors [see Warnings and Precautions (5.12), Clinical Pharmacology (12.3)]. Examples Fluvoxamine, cimetidine, ciprofloxacin, enoxacin Dual Inhibition of CYP1A2 and CYP2D6 Clinical Impact Concomitant administration of duloxetine with potent CYP1A2 inhibitors to CYP2D6 poor metabolizers results in increased AUC and C max of duloxetine. Intervention Avoid co-administration of duloxetine delayed-release capsules and potent CYP1A2 inhibitors to CYP2D6 poor metabolizers [see Clinical Pharmacology (12.3)] . Examples Fluvoxamine, cimetidine, ciprofloxacin, enoxacin Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of duloxetine with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Intervention Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when duloxetine is initiated or discontinued [Warnings and Precaution (5.5)] . Examples NSAIDs, aspirin, warfarin Inhibitors of CYP2D6 Clinical Impact Concomitant use of duloxetine with CYP2D6 inhibitors increase AUC of duloxetine. Greater degrees of inhibition are expected with higher doses of CYP2D6 inhibitors. Intervention Exercise caution when co-administering duloxetine delayed-release capsules and potent CYP2D6 inhibitors [see Warnings and Precautions (5.12), Clinical Pharmacology (12.3)]. Examples Paroxetine, fluoxetine, quinidine Drugs Metabolized by CYP2D6 Clinical Impact Concomitant use of duloxetine increases AUC of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug. Intervention Monitor plasma concentrations of CYP2D6 substrate and reduce dosage of CYP2D6 substrate drug if necessary [see Warnings and Precautions (5.12), Clinical Pharmacology (12.3)] . Examples TCAs (nortriptyline, amitriptyline, imipramine, desipramine); phenothiazines (thioridazine); Type 1C antiarrhythmics (propafenone, flecainide) Drugs that Affect Gastric Acidity Clinical Impact In patients with conditions that may slow gastric emptying (e.g., some diabetics) and drugs that raise the gastrointestinal pH may lead to earlier the release of duloxetine. Intervention Use with caution [see Clinical Pharmacology (12.3)]. Examples Aluminum-and magnesium-containing antacids, famotidine, proton pump inhibitors Drugs Metabolized by CYP1A2 Clinical Impact Concomitant use of duloxetine with CYP1A2 substrates may increase the AUC of CYP1A2 substrate. Intervention Use with caution [see Clinical Pharmacology (12.3)]. Examples Theophylline, caffeine CNS Drugs Clinical Impact Concomitant use of duloxetine with other centrally acting drugs may increase the CNS effects of duloxetine. Intervention Use with caution [see Warnings and Precautions (5.12)] . Examples Centrally acting CNS drugs Drugs Highly Bound to Plasma Protein Clinical Impact Concomitant use of duloxetine with highly protein bound drugs may cause increased free concentrations of the other drug, potentially resulting in adverse reactions. Intervention Use with caution [see Clinical Pharmacology (12.3)]. Examples Highly plasma protein binding drugs Alcohol Clinical Impact Concomitant use of duloxetine and alcohol may cause liver injury or aggravate pre-existing liver disease. Intervention Avoid use patients with chronic liver disease or heavy alcohol use [see Dosage and Administration (2.7), Warnings and Precautions (5.2, 5.12)] .