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NOZINAN is a brand name for Methotrimeprazine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 09/2022 1 INDICATIONS, 1.2 Geriatrics 09/2022
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 09/2022 7 WARNINGS AND PRECAUTIONS 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics......................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 3 Administration ............................................................................................................. 4 Missed Dose .................................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7
). It is advisable to administer an appropriate anticonvulsant medication to epileptic patients receiving NOZINAN therapy. Careful monitoring of patients with severe renal impairment is recommended, due to the risk of accumulation. NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) Page 6 of 31 Patients should have baseline and periodic monitoring of blood glucose and body weight.
Because of the risk of photosensitization, patients should be advised to avoid exposure to direct sunlight. Patients are strongly advised not to consume alcoholic beverages or to take medicines containing alcohol during treatment with NOZINAN.
Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol. 2 Recommended Dose and Dosage Adjustment 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. Patients should remain lying down for at least one hour after injection, due to the risk of hypotension. M. injection in a large muscle 3 or 4 times per day.
When given as a post-operative analgesic adjunct, the average dose varies from 10 to 25 mg every 8 hours, which is equivalent to 20 to 40 mg given orally. If NOZINAN is administered in conjunction with narcotics, the doses of the latter must be appropriately reduced.
125 mg/kg, given once daily or in divided doses. Oral medication should be substituted as soon as possible. 0625 mg/kg/day in 250 mL of a 5% glucose solution may be administered as a slow infusion (20 to 40 drops per minute). 3 Administration Do not use if solution shows haziness, particulate matter, discolouration, or leakage.
09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics......................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 3 Administration ............................................................................................................. 4 Missed Dose .................................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
09/2022 3 SERIOUS WARNNGS AND PRECAUTIONS BOX 09/2022
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrimeprazine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ampoule opening instructions NOZINAN ampoules are equipped with a weak spot in the glass stem, below the white dot, to facilitate opening the ampoule without excessive force. Hold the bottom part of the ampoule upright with one hand.
If there is liquid in the top or stem of the ampoule, gently tap the top to move it to the bottom of the ampoule. NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) Page 7 of 31 Position the ampoule as indicated in Picture 1, with your thumb at or below the stem, pointing towards the white dot.
Do not exert excessive pressure on the cylinder of the ampoule. With the other hand, grasp the top of the ampoule, positioning the thumb on the white dot at the top of the ampoule as indicated in Picture 2. Correct thumb position will target pressure on the break point (stem) of the ampoule just below the white dot.
Using the thumb on the white dot, gently push the dot away from you (as indicated by the arrow in Picture 2) while applying counter pressure with the index finger of the same hand (pivot). Your two hands: must not move apart (tearing action), must not move closer to each other and must not twist.
4 Missed Dose If a dose is missed, it should be taken promptly, unless it is near the time of the next dose, in which case the missed dose should be skipped. The next dose should be taken at the regular time. Doses should not be doubled.
5 OVERDOSAGE High doses cause depression of the central nervous system, presenting as lethargy, dysarthria, ataxia, stupor, reduction in consciousness into coma, convulsions; mydriasis; cardiovascular symptoms (related to risk of QT interval prolongation), such as hypotension, ventricular tachycardia and arrhythmia; respiratory depression; hypothermia.
These effects may be potentiated by other medicines or by alcohol. Anticholinergic syndrome may occur. Severe parkinsonian syndrome may occur.
Symptoms:
Symptoms of acute intoxication may include: simple CNS depression, spasms, tremor or tonic and clonic convulsions, coma accompanied by hypotension and respiratory depression.
Treatment:
There is no specific antidote. After gastric lavage, treatment is symptomatic. Centrally acting emetics are ineffective because of the anti-emetic action of NOZINAN.
Hypotension:
A 5% glucose solution may be administered. If a hypertensive agent is required, norepinephrine or phenylephrine may be used, but not epinephrine, which can aggravate hypotension.
Respiratory depression:
Oxygen by inhalation or controlled respiration after tracheal intubation. NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) Page 8 of 31 Respiratory infection: Wide spectrum antibiotics.
Extrapyramidal reactions:
An antiparkinsonian agent or chloral hydrate, however the latter must be used with caution because of its depressant effect on respiration. Any CNS stimulant should be used with caution. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging NOZINAN (methotrimeprazine base) 25 mg/mL (as hydrochloride) injectable is available in amber glass ampoules of 1 mL in boxes of 10 ampoules.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Acute withdrawal symptoms, including nausea, vomiting, headache, anxiety, agitation, dyskinesia, dystonia, disturbed temperature regulation, and insomnia, have very rarely been reported following the abrupt cessation of high doses of neuroleptics.
Relapse may also occur, and the emergence of extrapyramidal reactions has been reported. Therefore, gradual withdrawal is advisable. Symptoms of withdrawal can occur following treatment at any dose. Withdrawal of treatment should occur under close medical supervision.
Body Temperature Regulation:
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. […]
1 Special Populations .................................................................................................... 1 Pregnant Women .............................................................................................
2 Breast-feeding .................................................................................................. 4 Geriatrics (> 65 years of age): .......................................................................... 14 NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) Page 3 of 31 8 ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
5 Post-Market Adverse Reactions................................................................................. 16 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions...........................................................................................
2 Drug Interactions Overview ....................................................................................... 3 Drug-Behavioural Interactions ...................................................................................
4 Drug-Drug Interactions .............................................................................................. 5 Drug-Food Interactions ..............................................................................................
6 Drug-Herb Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions.............................................................................
19 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 20 PART II: SCIENTIFIC INFORMATION .....................................................................................
21 13 PHARMACEUTICAL INFORMATION .......................................................................... 21 14 CLINICAL TRIALS ......................................................................................................
22 15 MICROBIOLOGY ...................................................................................................... 22 16 NON-CLINICAL TOXICOLOGY ....................................................................................
22 PATIENT MEDICATION INFORMATION ................................................................................ 23 NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NOZINAN (methotrimeprazine hydrochloride injection) is indicated for: Psychotic disturbances: acute and chronic schizophrenias, senile psychoses, manic-depressive syndromes.
Analgesic: In pain due to cancer, zona, trigeminal neuralgia, neurocostal neuralgia, in phantom limb pains, muscular discomforts and as post-operative analgesic adjunct. Antiemetic: For the treatment of nausea and vomiting of central origin.
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