METHADOSE ORAL CONCENTRATE SIDE EFFECTS

SIDE EFFECTS

The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients. In such individuals, lower doses are advisable.

Other adverse reactions include the following: (listed alphabetically under each subsection)

Body as a Whole – asthenia (weakness), edema, headache

Cardiovascular– arrhythmias, bigeminal rhythms, bradycardia, cardiomyopathy, ECG abnormalities, extrasystoles, flushing, heart failure, hypotension, palpitations, phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia, torsade de pointes, ventricular fibrillation, ventricular tachycardia

Central Nervous System – agitation, confusion, disorientation, dysphoria, euphoria, insomnia, hallucinations, seizures, visual disturbances, congenital oculomotor disorders (nystagmus, strabismus)

Digestive – abdominal pain, anorexia, biliary tract spasm, constipation, dry mouth, glossitis

Hematologic and Lymphatic – reversible thrombocytopenia has been described in opioid addicts with chronic hepatitis

Metabolic and Nutritional – hypokalemia, hypomagnesemia, weight gain

Respiratory – pulmonary edema, respiratory depression )

Skin and Appendages – pruritus, urticaria, other skin rashes, and rarely, hemorrhagic urticaria

Special Senses – hallucinations, visual disturbances

Urogenital – amenorrhea, antidiuretic effect, reduced libido and/or potency, urinary retention or hesitancy

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of METHADOSE.

Serotonin Syndrome – Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency – Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis – Anaphylactic reaction has been reported with ingredients contained in METHADOSE.

Androgen Deficiency – Cases of androgen deficiency have occurred with chronic use of opioids.