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Methotrimeprazine Full Prescribing Information

Brand Name: Levoprome, Nozinan, Nosinan
Generic Name: Methotrimeprazine

Methotrimeprazine (Levoprome, Nozinan, Nosinan) is an antipsychotic w/ strong sedative properties to treat psychotic disturbances. Uses, dosage, side effects of Methotrimeprazine.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdose
Dosage
Supplied

Description

Methotrimeprazine (Levoprome, Nozinan) possesses strong sedative properties.

Pharmacology

Methotrimeprazine is a neuroleptic that possesses antipsychotic, tranquilizing, anxiolytic, sedative and analgesic properties.

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Indications and Usage

Psychotic disturbances:
Acute and chronic schizophrenias, senile psychoses, manic-depressive syndromes.

Conditions associated with anxiety and tension:
Autonomic disturbances, personality disturbances, emotional troubles secondary to such physical conditions as resistant pruritus, etc.

Methotrimeprazine is also employed:
As an analgesic: In pain due to cancer, zona, trigeminal neuralgia and neurocostal neuralgia and in phantom limb pains and muscular discomforts.

As a sedative:
For the management of insomnia.

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Contraindications

In cases of coma or CNS depression due to alcohol, hypnotics, analgesics or narcotics.

It is also contraindicated in patients with blood dyscrasia, hepatic troubles or a sensitivity to phenothiazines.

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Warnings

Methotrimeprazine can reduce psychomotor activity especially during the first few days of treatment. Patients are cautioned not to participate in activities requiring complete mental alertness, such as driving an automobile or operating machinery.

Usage in Pregnancy & Nursing

The drug should be used with caution in pregnant women, particularly during the first trimester, unless the benefit to the patient outweighs any possible risk to the fetus.

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Precautions

In high oral or parenteral doses, orthostatic hypotension may be encountered at the start of treatment. Patients whose treatment is started by the parenteral route should be kept in bed during the first few days.

Methotrimeprazine therapy should be initiated at low doses in patients with arteriosclerosis or cardiovascular problems.

Methotrimeprazine potentiates the action of other phenothiazines and CNS depressants (barbiturates, analgesics, narcotics and antihistaminics). The usual doses of these agents should be reduced by half if they are to be given concomitantly with methotrimeprazine until the dosage of the latter has been established.

Because of its anticholinergic effects, methotrimeprazine must be administered with caution in patients with glaucoma or prostatic hypertrophy.

During long-term therapy, periodic liver function tests should be performed. In addition, blood counts should be conducted regularly, particularly during the first 2 or 3 months of treatment, and physicians should watch for any signs of blood dyscrasia.

Methotrimeprazine does not alter EEG activity. Nevertheless, since phenothiazines can lower the threshold of cortical excitation, it is advisable to administer an appropriate anticonvulsant medication to epileptic patients receiving Nozinan, Levoprome IM therapy.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking.

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Adverse Reactions

Side-effects include the following:

Drowsiness may appear early in treatment but will gradually disappear during the first weeks or with an adjustment in the dosage.

Weight gain, dryness of the mouth and, in older patients occasional urinary retention, constipation and tachycardia.

Rare instances of agranulocytosis have been reported. Skin reactions due to photosensitivity or allergies are extremely rare.

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Overdose

Signs and Symptoms

Symptoms: simple CNS depression, spasms, tremor or tonic and clonic convulsions, coma accompanied by hypotension and respiratory depression.

There is no specific antidote. After gastric lavage, treatment is symptomatic. Centrally acting emetics are ineffective because of the anti-emetic action of methotrimeprazine.

Any central nervous system stimulant should be used with caution.

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Dosage

Dosage must be adjusted according to the indication and individual needs of the patient. If sedation during the day is too pronounced, lower doses may be given during the day and higher doses at night.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, in a tighly-closed container, away from heat and light.

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.

Adults:
Oral:
Minor conditions in which methotrimeprazine may be given in low doses as a tranquilizer, anxiolytic, analgesic or sedative: begin treatment with 6 to 25 mg/day in 3 divided doses at mealtimes. Increase the dosage until the optimum level has been reached. As a sedative, a single night time dose of 10 to 25 mg is usually sufficient.

Severe conditions:
Such as psychoses or intense pain in which methotrimeprazine is employed at higher doses: begin treatment with 50 to 75 mg/day divided into 2 or 3 daily doses; increase the dosage until the desired effect is obtained. In certain psychotics doses may reach 1 g or more/day. If it is necessary to start therapy with higher doses, i.e., 100 to 200 mg/day, administer the drug in divided daily doses and keep the patient in bed for the first few days.

Parenteral:
IM:

To be used primarily for the initial treatment of psychoses for certain severe pain as a premedication or for the treatment of postoperative pain. In psychoses and pain, doses vary from 75 to 100 mg given as 3 or 4 deep i.m. injections in a large muscle. When given as a premedication or post-operative analgesic, the average dose varies from 10 to 25 mg every 8 hours which is equivalent to 20 to 40 mg given orally. The last dose during premedication, given 1 hour before surgery, can be 25 to 50 mg i.m.

Children:
Oral:

The initial dose has been established at 1/4 mg/kg daily given in 2 or 3 divided doses. This dosage may be increased gradually until an effective level is reached which should not surpass 40 mg/day for a child less than 12 years of age.

Parenteral:
IM:

A dose of 1/16 to 1/8 mg/kg/day in one or divided among several injections. Oral medication should be substituted as soon as possible.

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

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

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How Supplied

Injectable:
Each mL contains: Methotrimeprazine base 25 mg (as the hydrochloride). Also contains sodium sulfite. Ampuls of 1 mL, boxes of 10.

Oral Drops:
Each mL of brown solution contains: Methotrimeprazine base 40 mg (as the hydrochloride). Also contains alcohol 16.5% v/v and sucrose 200 mg. Energy: 7.3 kJ (1.8 kcal)/mL. Tartrazine-free. Bottles of 100 mL.

Liquid:
Each 5 mL of brown liquid contains: Methotrimeprazine base 25 mg (as the hydrochloride). Also contains alcohol 2.0% v/v and sucrose 3.7 g. Energy: 62.3 kJ (14.9 kcal)/5 mL. Tartrazine-free. Bottles of 500 mL.

Tablets:
Each yellow tablet contains: Methotrimeprazine base 2, 5, 25 or 50 mg (as the maleate). Tartrazine-free. Bottles of 100 and 500.

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.

Copyright © 2007 Healthyplace Inc. All rights reserved.

back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

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