Cymbalta (Duloxetine Hcl) Drug Information: Overdosage and Contraindications

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May 27, 2012

Cymbalta

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What are anxiety medications and how do they work?

Anxiety is both a normal and useful response to potentially stressful or dangerous situations. It helps by increasing our awareness of what's going on around us and in other ways. For most people, the anxiety is short lived and normally goes away once the situation has passed. But that is not the case for an estimated 40 million adults in the United States who have some type of anxiety disorder and experience ongoing and unwarranted psychological distress. That distress may also manifest itself in physical symptoms such as muscle tension, headaches, or chest pain.

Anxiety medications include multiple types of drugs that are used to treat the symptoms of anxiety disorders. The three most commonly prescribed types of anxiety medication are antidepressants, anti-anxiety medications -- also known as anxiolytics -- and beta-blockers. The first two types of anxiety medications work primarily by affecting the ba...

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OVERDOSE

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.

Management of Overdose

There is no specific antidote to Cymbalta, 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.

An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. 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.

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 Cmax by an average of one-third, although some subjects had a limited effect of activated charcoal. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial.

In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who are taking or have recently taken Cymbalta and might ingest excessive quantities of a TCA. In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR).

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. These interactions may include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Uncontrolled Narrow-Angle Glaucoma

In clinical trials, Cymbalta use was associated with an increased risk of mydriasis; therefore, its use should be avoided in patients with uncontrolled narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 9/22/2011
This monograph has been modified to include the generic and brand name in many instances.