Product Description.:
Suppos , clear , torpedo other
Clear to pale yellow
Fully labeled unit dose package is easy to open and contains product description, strength, lot number and expiration date.
COMPRO?
(prochlorperazine) Suppositories, USP 25mg
ANTIEMETIC-TRANQUILIZER
DRUG DESCRIPTION
Prochlorperazine is a clear, pale yellow, viscous liquid. It is sensitive to light, very slightly soluble in water, freely soluble in alcohol, in chloroform, and in ether.
Each suppository, for rectal administration, contains 25mg of prochlorperazine with glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated coconut oil fatty acids and hydrogenated palm kernel oil fatty acids.
INDICATIONS
Prochlorperazine 25mg suppositories are indicated in the control of severe nausea and vomiting in adults.
DOSAGE AND ADMINISTRATION
Adults: Dosage should be increased more gradually in debilitated or emaciated patients. Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.
To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual.Begin with the lowest recommended dosage.
Rectal Dosage: 25mg twice daily.
SIDE EFFECTS
Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur.
Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug.No causal relationship has been established.
Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.
Neuromuscular (Extrapyramidal) Reactions
These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism.
Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice. (Or, injectable diphenhydramine may be useful.) In more severe cases, the administration of an anti-parkinsonism agent, except levodopa (see PDR), usually produces rapid reversal of symptoms.Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed.
Motor Restlessness: Symptoms may include agitation or jitteriness and sometimes insomnia.These symptoms often disappear spontaneously.At times these symptoms may be similar to the original neurotic or psychotic symptoms.Dosage should not be increased until these side effects have subsided.
If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.
Dystonias: Symptoms may include: spasm of the neck muscles, sometimes progressing to torticollis extensor rigidity of back muscles, sometimes progressing to opisthotonos carpopedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue.
These usually subside within a few hours, and almost always within 24 to 48 hours, after the drug has been discontinued.
In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa (see PDR), usually produces rapid reversal of symptoms. In children, reassurance and barbiturates will usually control symptoms. (Or, injectable diphenhydramine may be useful. Note: See diphenhydramine prescribing information for appropriate children's dosage.) If appropriate treatment with anti-parkinsonism agents or diphenhydramine fails to reverse the signs and symptoms, the diagnosis should be reevaluated.
Pseudo-parkinsonism: Symptoms may include: mask-like facies drooling tremors pillrolling motion cogwheel rigidity and shuffling gait. Reassurance and sedation are important. In most cases these symptoms are readily controlled when an anti-parkinsonism agent is
