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Neo-Synephrine Warnings, Precautions, Pregnancy, Nursing, Abuse - Phenylephrine (Injection)
WARNINGS
If used in conjunction with oxytocic drugs, the pressor effect of sympathomimetic pressor amines is potentiated (see DRUG INTERACTIONS). The obstetrician should be warned that some oxytocic drugs may cause severe persistent hypertension and that even a rupture of a cerebral blood vessel may occur during the postpartum period.
This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS
Phenylephrine hydrochloride should be employed only with extreme caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been done to evaluate the potential of phenylephrine hydrochloride in these areas.
Pregnancy
Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with phenylephrine hydrochloride. It is also not known whether phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
Labor and Delivery
If vasopressor drugs are either used to correct hypotension or added
to the local anesthetic solution, the obstetrician should be cautioned
that some oxytocic drugs may cause severe persistent hypertension and
that a rupture of a cerebral blood vessel may occur during the postpartum
period (see WARNINGS
).
Nursing Mother
It is not known whether this drug is excreted in human milk. Because many are excreted in human milk, caution should be exercised when phenylephrine hydrochloride is administered to a nursing woman.
Pediatric Use
To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds of body weight, administered subcutaneously or intramuscularly, is recommended.
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