Sprinkle Administration Approved for Amrix

The FDA has granted approval for Teva's cyclobenzaprine hydrochloride (Amrix) extended-release capsules to be administered by sprinkling the drug's contents onto a tablespoon of applesauce and swallowing immediately without chewing.

The FDA has granted approval for Teva’s cyclobenzaprine hydrochloride (Amrix) extended-release capsules to be administered by sprinkling the drug’s contents onto a tablespoon of applesauce and swallowing immediately without chewing.

This administration method is only appropriate for patients able to reliably swallow applesauce without chewing. Of note, other foods should not be substituted for applesauce, as they have not been tested for use.

Amrix is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. The drug should only be used for short periods of up to 3 weeks. It is not considered effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

Amrix has the following contraindications:

  • Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors.
  • During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure
  • Hyperthyroidism

Amrix can also have life-threatening interactions with MAO inhibitors and other serotonergic agents. It may enhance the effects of alcohol and barbiturates, as well as seizure risk in those taking tramadol, and it can potentially block the antihypertensive action of guanethidine and similar compounds. It is not recommended for elderly patients or those who have hepatic impairment, and because of its atropine-like action, it should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and those taking anticholinergic medication.

The most common adverse effects of Amrix are dry mouth, dizziness, fatigue, nausea, dyspepsia, and constipation.