Regonol

Black Box Warning

Therapy must be administered by trained personnel

Contraindications

Hypersensitivity

Mechanical intestinal or urinary obstruction

Cautions

Caution in epilepsy, asthma, COPD, recent MI, hypertension, vagotonia, hyperthyroidism, dysrhythmia

Keep atropine and epinephrine immediately available to treat hypersensitivity reactions resulting from therapy

Injection unstable in alkaline solutions

If symptoms of excess cholinergic activity occur discontinue therapy

Anticholinesterase sensitivity may develop for brief or prolonged periods

IV Compatibilities

Syringe: glycopyrrolate

Y-site: heparin, hydrocortisone Na-succinate, KCl, vit B/C

Other Information

IV Administration: very slow injection

The side effects of pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis, and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation, and weakness. Muscarinic side effects can usually be counteracted by atropine. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication. Thrombophlebitis has been reported subsequent to intravenous administration.

• Tell all of your health care providers that you take Regonol. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Unsafe effects, including death, may happen.
• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking this medicine outweigh the risks. If your child has been given Regonol, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this medicine to your child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Regonol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

CONTAINS BENZYL ALCOHOL

THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.

THE USE OF A PERIPHERAL NERVE STIMULATOR TO MONITOR RECOVERY OF NEUROMUSCULAR FUNCTION WILL MINIMIZE THE POSSIBILITY OF EXCESS DOSING OR INADEQUATE REVERSAL.

Inadequate reversal of the neuromuscular blockade induced by nondepolarizing (curariform) muscle relaxants is possible. This can be managed by manual or mechanical ventilation until recovery is judged adequate. The administration of additional doses of anticholinesterase reversal agents is not recommended since excessive dosages of such drugs may produce depolarizing block through their own pharmacologic actions.

Pyridostigmine is mainly excreted unchanged by the kidney.2,7,8 Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect.2,7

Drug Interactions

Concomitant administration of Regonol® (pyridostigmine bromide injection USP) and 4-aminopyridine has been reported to delay the onset of action of Regonol®.9

Parenteral administration of high doses of certain antibiotics may intensify or produce neuromuscular block through their own pharmacologic actions. The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. If these or other newly introduced antibiotics are used in conjunction with nondepolarizing neuromuscular blocking drugs during surgery, unexpected prolongation of neuromuscular block or resistance to its reversal should be considered a possibility.

Experience concerning injection of quinidine during recovery from use of nondepolarizing muscle relaxants suggest that recurrent paralysis may occur. This possibility must be considered when administering anticholinesterase agents to antagonize neuromuscular blockade induced by nondepolarizing muscle relaxants.

Electrolyte imbalance and diseases which lead to electrolyte imbalance, such as adrenal cortical insufficiency, have been shown to alter neuromuscular blockade. Depending on the nature of the imbalance, either enhancement or inhibition may be expected. Magnesium salts, administered for the management of toxemia of pregnancy, may enhance the neuromuscular blockade. The possibility that such circumstances may interfere with the restoration of neuromuscular function should be considered when administering Regonol®.

Interactions with Laboratory Tests

None known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

It is not known whether Regonol® (pyridostigmine bromide injection USP) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Regonol® should be given to a pregnant woman only if the administering clinician decides that the benefits outweigh the risks.

Pediatric Use

Safety and efficacy in pediatric patients have not been established.

Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome”, (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.