Clonazepam (Page 3 of 9)

Neonatal Sedation and Withdrawal Syndrome:

Use of clonazepam orally disintegrating tablets late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS: Pregnancy). Monitor neonates exposed to clonazepam orally disintegrating tablets during pregnancy or labor for signs of sedation and monitor neonates exposed to clonazepam orally disintegrating tablets during pregnancy for signs of withdrawal; manage these neonates accordingly.

PRECAUTIONS

General:

Worsening of Seizures:

When used in patients in whom several different types of seizure disorders coexist, clonazepam orally disintegrating tablets may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and clonazepam orally disintegrating tablets may produce absence status.

Laboratory Testing During Long-Term Therapy:

Periodic blood counts and liver function tests are advisable during long-term therapy with clonazepam orally disintegrating tablets.

Caution in Renally Impaired Patients:

Metabolites of clonazepam orally disintegrating tablets are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.

Hypersalivation:

Clonazepam orally disintegrating tablets may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions.

Respiratory Compromise:

Clonazepam orally disintegrating tablets should be used with caution in patients with compromised respiratory function.

Porphyria:

Clonazepam orally disintegrating tablets may have a porphyrogenic effect and should be used with care in patients with porphyria.

Information for Patients:

A clonazepam orally disintegrating tablets Medication Guide must be given to the patient each time clonazepam orally disintegrating tablets is dispensed, as required by law. Patients should be instructed to take clonazepam orally disintegrating tablets only as prescribed. Physicians are advised to discuss the following issues with patients for whom they prescribe clonazepam orally disintegrating tablets:

Risks from Concomitant Use With Opioids

Inform patients and caregivers that potentially fatal additive effects may occur if clonazepam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider (see WARNINGS: Risks from Concomitant Use With Opioids and PRECAUTIONS: Drug Interactions).

Abuse, Misuse, and Addiction:

Inform patients that the use of clonazepam orally disintegrating tablets, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS: Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE).

Withdrawal Reactions:

Inform patients that the continued use of clonazepam orally disintegrating tablets may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of clonazepam orally disintegrating tablets may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of clonazepam orally disintegrating tablets may require a slow taper (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE).

Interference With Cognitive and Motor Performance :

Because benzodiazepines have the potential to impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that clonazepam orally disintegrating tablets therapy does not affect them adversely.

Suicidal Thinking and Behavior:

Patients, their caregivers, and families should be counseled that AEDs, including clonazepam orally disintegrating tablet, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Pregnancy:

Advise pregnant females that use of clonazepam orally disintegrating tablets late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS: Neonatal Sedation and WithdrawalSyndrome and PRECAUTIONS: Pregnancy). Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant while taking clonazepam orally disintegrating tablets. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. (see PRECAUTIONS: Pregnancy).

Nursing:

Instruct patients to inform their healthcare provider if they are breastfeeding or intend to breastfeed. Instruct breastfeeding patients who take clonazepam orally disintegrating tablets to monitor their infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs (see PRECAUTIONS: Nursing Mothers).

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