Mesoridazine

Brand Name: Mesoridazine Besylate, Serentil

Description

Mesoridazine (Serentil) is a phenothiazine used to treat emotional disorders such as schizophrenia. It may also be used to treat other conditions as determined by your doctor.

Pharmacological studies in laboratory animals have established that mesoridazine has a spectrum of pharmacological activity comparable to thioridazine, except that its effects, other than cataleptic which is weaker, are more pronounced.

Following oral administration, mesoridazine is well absorbed with peak blood levels occurring at 4 hours.

Indications and Usage

Mesoridazine (Serentil) is used in the treatment of both the acute and chronic states of schizophrenia; organic brain syndrome and mental retardation associated with psychotic symptoms or where psychomotor disturbances are predominant; treatment of some patients with symptoms of alcohol withdrawal.

Contraindications

Mesoridazine is contraindicated in patients with known hypersensitivity to the drug.

Severe CNS depression, comatose states, blood dyscrasias, bone marrow depression, liver damage, cross sensitivity to other phenothiazines may occur. Hypertension or hypotensive heart disease of extreme degree.

Warnings

Usage in Pregnancy

Safe use of mesoridazine in human pregnancy has not been established. Therefore, it should not be administered to women of childbearing potential, particularly during the first trimester of pregnancy, unless the expected benefit to the patient outweighs the potential risk to the fetus.

IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. If you are or may be pregnant, check with your doctor for instructions on using this medicine during pregnancy.

Infant breast-feeding is not recommended for women taking this drug because mesoridazine appears to be secreted in low concentrations in human milk.

Precautions

Mesoridazine may produce CNS depression, especially when combined with another CNS depressant such as alcohol.

Mesoridazine increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

Phenothiazines are capable of potentiating CNS depressants (e.g. anesthetics, analgesics, hypnotics, antihistamines, opiates, alcohol, etc.) as well as atropine and phosphorus insecticides. They may also potentiate quinidine's inhibitory effect on cardiac contractility.

Leukopenia, granulocytopenia and/or agranulocytosis have been reported following phenothiazine therapy. The possibility of the occurrence of blood dyscrasia cannot, therefore, be ruled out. Therefore, patients should be observed for any signs or symptoms of blood dyscrasia. It is also advisable to perform regular blood counts, particularly during the first 2 or 3 months of therapy and on the appearance of suspicious clinical signs.

Hypotension may occur especially in the elderly and in alcoholic patients with either dosage form.

Interference with Cognitive or Motor Performance: Since mesoridazine products may produce CNS depression, especially when combined with another CNS depressant (e.g., alcohol), patients should be advised not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.

Drug Interactions

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes guanethidine, and medicines used to treat high blood pressure, heart conditions, depression, and bladder or bowel spasms. Inform your doctor of any other medical conditions including seizure disorders, depression, allergies, pregnancy, or breast-feeding.

Adverse Reactions

CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience changes in vision; changes in breasts; changes in menstrual period; sore throat; inability to move eyes; muscle spasms of face, neck, or back; difficulty swallowing; mask-like face; tremors of hands; restlessness; tension in legs; shuffling walk or stiff arms or legs; puffing of cheeks; lip smacking or puckering; twitching or twisting movements; or weakness of arms or legs. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Other less serious side effects that may go away during treatment include drowsiness, dizziness, nasal congestion, blurred vision, dry mouth, or constipation. If they continue or are bothersome, check with your doctor.

Miscellaneous: Unexpected and sudden deaths have been reported in hospitalized psychotic patients receiving phenothiazines. In some unexpected deaths, myocardial lesions have been observed. Previous brain damage or seizures may also be predisposing factors: High doses should be avoided in known seizure patients. Several patients have shown sudden exacerbations of psychotic behavior patterns shortly before death. Autopsy findings have also revealed acute fulminating pneumonia or pneumonitis and aspiration of gastric contents. The physician should therefore be alerted to the possible development of "silent pneumonias".

Overdose

Symptoms of overdose may include restlessness, muscle spasms, tremors, twitching, deep sleep or loss of consciousness, and seizures.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

There is no specific treatment for phenothiazine poisoning. Treatment should be symptomatic and supportive. Initiate gastric lavage and administer activated charcoal.

Dosage

Do not exceed the recommended dosage.

Do not stop taking this medicine without first checking with your doctor.

Follow the directions for using this medicine provided by your doctor.
Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
If you miss a dose of this medicine, take it as soon as possible. If you are taking 1 dose at bedtime and do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

Adjust to individual needs, using the lowest effective dose. When maximum response is achieved, dosage may be reduced gradually to a maintenance level. Dosage should be increased slowly in elderly patients.

Schizophrenia: 75 to 400 mg daily; usual dose: 150 mg per day in divided doses.

Mental retardation and chronic brain syndrome: 75 to 300 mg daily; usual dose: 100 mg per day in divided doses.

Treatment of Alcohol withdrawl: 50 to 200 mg daily; usual dose: 100 mg per day in divided doses. Maximum symptom reduction can usually be achieved without exceeding 200 mg daily.

IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.

How Supplied

Mesoridazine besylate available in 10 mg, 25 mg, 50 mg tablets.

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