diazepam injection, USP - CARPUJECT Adverse Reactions

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ADVERSE REACTIONS

Side effects most commonly reported were drowsiness, fatigue, and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include:

CNS: Confusion, depression [including respiratory depression. (see WARNINGS; Pediatric Use)], dysarthria, headache, hypoactivity, slurred speech, syncope, tremor, vertigo.

G.I: Constipation, nausea.

G.U.: Incontinence, changes in libido, urinary retention.

Cardiovascular: Bradycardia, cardiovascular collapse, hypotension.

EENT: Blurred vision, diplopia, nystagmus.

Skin: Urticaria, skin rash.

Other: Hiccups, changes in salivation, neutropenia, jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance.

In peroral endoscopic procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm, and pain in throat or chest have been reported.

Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.

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Adverse Reactions

ADVERSE REACTIONS

Side effects most commonly reported were drowsiness, fatigue, and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include:

CNS: Confusion, depression [including respiratory depression. (see WARNINGS; Pediatric Use)], dysarthria, headache, hypoactivity, slurred speech, syncope, tremor, vertigo.

G.I: Constipation, nausea.

G.U.: Incontinence, changes in libido, urinary retention.

Cardiovascular: Bradycardia, cardiovascular collapse, hypotension.

EENT: Blurred vision, diplopia, nystagmus.

Skin: Urticaria, skin rash.

Other: Hiccups, changes in salivation, neutropenia, jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance.

In peroral endoscopic procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm, and pain in throat or chest have been reported.

Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.

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