LARGACTIL 25 LIQUID

Canada - English - Health Canada

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Active ingredient:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE)
Available from:
SANOFI-AVENTIS CANADA INC
ATC code:
N05AA01
INN (International Name):
CHLORPROMAZINE
Dosage:
25MG
Pharmaceutical form:
LIQUID
Composition:
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) 25MG
Administration route:
ORAL
Units in package:
500ML
Prescription type:
Prescription
Therapeutic area:
PHENOTHIAZINES
Product summary:
Active ingredient group (AIG) number: 0106167001; AHFS: 28:16.08.24
Authorization status:
APPROVED
Authorization number:
01929968
Authorization date:
2006-04-18

PRESCRIBING INFORMATION

LARGACTIL

Chlorpromazine Hydrochloride Drops

40 mg/mL

Chlorpromazine Hydrochloride Suppositories

100 mg

Chlorpromazine Hydrochloride Liquid

25 mg/mL

Neuroleptic

sanofi-aventis Canada Inc.

Revision Date:

2150 St. Elzear Blvd. West

October 13, 2006

Laval, Quebec H7L 4A8

Submission Control No. 107341

s-a version 3.0 dated

Page 2 of 11

NAME OF DRUG

LARGACTIL

Chlorpromazine Hydrochloride Drops

Chlorpromazine Hydrochloride Suppositories

Chlorpromazine Hydrochloride Liquid

THERAPEUTIC CLASSIFICATION

Neuroleptic

ACTION

Chlorpromazine is a phenothiazine of the aminopropyl group. It is a potent antipsychotic

and sedative agent which can control various states of emotional tension, agitation,

hyperactivity and confusion. In addition, it exerts an anti-emetic action and potentiates

the effects of narcotics, barbiturates and analgesics.

INDICATIONS

In psychiatry - schizophrenia, manic depressive psychoses (manic phase), behavioural

disorders, involutional psychoses, senile psychoses and confusional states in the

elderly.

In general medicine - nausea, vomiting; persistent hiccup and organic conditions

associated with emotional stress: acute or chronic alcoholism and for the treatment of

withdrawal symptoms of addicts and alcoholics.

In obstetrics and surgery - as a preoperative medication for the relief of apprehension;

to reduce, by potentiation, narcotic and analgesic requirements; as an antiemetic; to

prevent and treat traumatic or postoperative shock; for use in artificial hibernation and

controlled hypotension.

Page 3 of 11

CONTRAINDICATIONS

Severe CNS depression or comatose states due to alcohol, barbiturates, analgesics or

other CNS depressants. In patients with blood dyscrasias, severe liver disease or a

sensitivity to phenothiazines.

WARNINGS

As with other neuroleptics, very rare cases of QT interval prolongation have been

reported with LARGACTIL. Neuroleptic phenothiazines may potentiate QT interval

prolongation, which increases the risk of onset of serious ventricular arrhythmias of the

torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is

exacerbated, in particular, in the presence of bradycardia, hypokalemia, and congenital

or acquired (i.e., drug induced) QT prolongation. If the clinical situation permits, medical

and laboratory evaluations should be performed to rule out possible risk factors before

initiating treatment with a neuroleptic agent and as deemed necessary during treatment

(See PRECAUTIONS and ADVERSE REACTIONS).

Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in

some patients on long-term therapy or after drug discontinuation. The syndrome is

mainly characterized by rhythmical involuntary movements of the tongue, face, mouth or

jaw. The manifestations may be permanent in some patients. The syndrome may be

masked when treatment is reinstituted, when the dosage is increased or when a switch

is made to a different antipsychotic drug. LARGACTIL should be prescribed in a manner

that is most likely to minimize the risk of tardive dyskinesia. The lowest effective dose

and the shortest duration of treatment should be used, and treatment should be

discontinued at the earliest opportunity, or if a satisfactory response cannot be obtained.

signs

symptoms

tardive

dyskinesia

appear

during

treatment,

discontinuation of LARGACTIL should be considered.

Neuroleptic Malignant Syndrome: Neuroleptic malignant syndrome (NMS) may occur in

patients receiving antipsychotic drugs. NMS is characterized by hyperthermia, muscle

rigidity, altered consciousness, and signs of autonomic instability including irregular

blood pressure, tachycardia, cardiac arrhythmias and diaphoresis. Additional signs may

include elevated serum creatine kinase, myoglobinuria (rhabdomyolysis), acute renal

failure and leukocytosis.

Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be

withdrawn

immediately

appropriate

supportive

therapy

careful

monitoring

instituted.

Page 4 of 11

PRECAUTIONS

LARGACTIL can potentiate the effects of other phenothiazines and CNS depressants.

When treatment is initiated, the usual doses of barbiturates, analgesics, narcotics or

antihistamines

should

reduced

half.

Patients

should

warned

against

consuming alcoholic beverages while on LARGACTIL therapy.

Neuroleptic phenothiazines may potentiate QT interval prolongation. QT prolongation is

exacerbated, in particular, in the presence of bradycardia, hypokalemia, and congenital

or acquired (i.e., drug induced) QT prolongation (See WARNINGS and ADVERSE

REACTIONS).

LARGACTIL should be used cautiously in patients suffering from arteriosclerosis,

cardiovascular disease or other conditions where it is necessary to avoid a sudden drop

in blood pressure. If hypotension does occur and it is necessary to use a hypertensive

agent,

norepinephrine

should

used,

epinephrine,

latter

agent

aggravate hypotension.

Because of its anticholinergic properties, LARGACTIL must be used with caution in

patients with glaucoma or prostatic hypertrophy.

During

protracted

therapy

especially

high

dosages

administered,

recommended that blood counts and liver function tests be performed at regular

intervals.

Drowsiness may occur at the beginning of treatment; patients should therefore be

warned against operating motor vehicles or participating in activities requiring mental

alertness until this effect has subsided.

Phenothiazines

provoke

epileptic

seizures

lowering

seizure

threshold;

therefore, during LARGACTIL therapy, the patient's usual anticonvulsant medication

should be continued at the same dosage.

Because of its antiemetic effect, LARGACTIL can obscure symptoms of intracranial

hypertension or intestinal obstruction.

False positive or negative pregnancy tests have occurred in patients receiving

phenothiazine therapy.

Page 5 of 11

ADVERSE REACTIONS

Drowsiness frequently occurs at the beginning of treatment but gradually disappears or

subsides with a downward adjustment of the dosage - also at the beginning of

treatment, there are rare cases of orthostatic hypotension, particularly when high doses

used

dystonic

extrapyramidal

reactions

appear

during

prolonged

treatment with elevated dosages, but can be eliminated by lowering the doses or

administering an antiparkinsonian agent.

Other side effects which are observed less frequently include: nasal congestion, blurred

vision, xerostomy, sedation, nausea, constipation, changes in libido, gynecomastia,

weight

gain,

skin

corneal

pigmentation,

photosensitivity,

blood

dyscrasias,

leukopenia, eosinophilia and EEG changes.

Very rare cases of QT interval prolongation have been reported. There have been

isolated

reports

sudden

death,

with

possible

causes

cardiac

origin

(see

WARNINGS and PRECAUTIONS), as well as cases of unexplained sudden death, in

patients receiving neuroleptic phenothiazines.

Cholestatic jaundice and liver injury, mainly of cholestatic or mixed type, are rarely

reported in patients treated with LARGACTIL.

Systemic lupus erythematosis has been very rarely reported in patients treated with

LARGACTIL. In some cases, positive anti-nuclear antibodies may be seen without

evidence of clinical disease.

Priapism has been very rarely reported in patients treated with LARGACTIL.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms

Agitation,

hyperactivity,

confusion,

depression

followed

somnolence, coma and circulatory collapse.

Treatment - No specific antidote. Gastric lavage and symptomatic treatment.

hypotension:

glucose

solutions

I.V.

infusion

and,

necessary

norepinephrine added to the infusion liquid.

For respiratory depression: oxygen and artificial respiration

For extrapyramidal reactions: antiparkinsonian drugs

To prevent respiratory infections: wide spectrum antibiotics

Page 6 of 11

Because

antiemetic

action

LARGACTIL,

centrally

acting

emetics

ineffective. Dialysis does not assist in eliminating the drug from the blood.

DOSAGE AND ADMINISTRATION

ADULTS

In general medicine and psychiatry

Oral route: average daily dose of 30 to 75 mg (mild cases) or 75 to 100 mg (more

severe cases) in divided doses. It is occasionally necessary to give a higher

dosage which, when increased gradually, can reach 900 mg or more per day in

some psychiatric patients.

Once the optimum dosage has been reached, it is maintained as long as

necessary for the control of symptoms during the critical phase of the illness.

Eventually, however, it should be gradually reduced so that the patient can be

maintained on the lowest effective dosage.

Rectal route: 100 to 300 mg or 1 to 3 suppositories of 100 mg daily.

In surgery and anesthesia

To potentiate hypnotics, analgesics and anesthetics and as an antiemetic.

Oral route: doses of 25 to 50 mg are administered 2 to 3 hours before anesthesia

and every 4 to 6 hours after surgery.

CHILDREN

Usual single dose: 1/4 mg per pound (1/2 mg/kg) by oral route. This dose can be

repeated every 4 to 6 hours as necessary. The normal daily dose is 40 mg for a

child of 5 years (40 pounds), 75 mg for children of 5 to 12 years (50 to 100

pounds) except in psychiatric patients where dosages can be progressively

elevated above these levels.

In surgery and anesthesia, doses of 1/4 mg per pound, by the same method

recommended for adults.

Page 7 of 11

PHARMACEUTICAL INFORMATION

2-chloro-10 (3-dimethylaminopropyl) phenothiazine or chlorpromazine utilized primarily

as the hydrochloride. Its structural formula may be represented as follows:

Molecular weight: 355.33

Chlorpromazine hydrochloride is a white or off-white crystalline powder which has a

slightly pungent odor. It is very soluble in water, soluble in methanol, ethanol and

chloroform, and insoluble in ether and benzene.

AVAILABILITY OF DOSAGE FORMS

Liquid of 25 mg/5 mL: Each 5 mL of colorless liquid contains: chlorpromazine base 25

mg (as the hydrochloride). Non-medicinal ingredients: alcohol, ascorbic acid, citric acid,

ethyl vanillin, glycerin, peach flavor, purified water, sodium benzoate and sucrose.

Alcohol: 0.5% v/v. Sucrose: 3.9 g/5 mL. Tartrazine-free.

Bottles of 500 mL. Protect from light or discoloration may occur.

Liquid of 100 mg/5 mL: Each 5 mL of yellow liquid contains: chlorpromazine base 100

mg (as the hydrochloride). Non-medicinal ingredients: alcohol, artificial fruit flavor, citric

acid, D&C Yellow No. 10, ethyl vanillin, glycerin, purified water, sodium benzoate and

sucrose. Alcohol: 0.5% v/v. Sucrose: 3.6 g/5 mL. Tartrazine-free. Bottles of 500 mL.

Protect from light or discoloration may occur.

Oral Drops: Each mL of brown solution contains: chlorpromazine base 40 mg (4%) (as

the hydrochloride). Non-medicinal ingredients: alcohol, artificial and natural custard

flavor, caramel, citric acid, glycerin, purified water, sucrose and terpeneless orange oil.

Alcohol: 17.5% v/v. Sucrose: 200 mg. Bottles of 100 mL with calibrated dropper. Protect

from light or discoloration may occur.

Page 8 of 11

Suppositories: Each rectal suppository contains: chlorpromazine base 100 mg (as the

hydrochloride).

Non-medicinal

ingredients:

hydrogenated

vegetable

glycerides.

Tartrazine-free. Boxes of 10 suppositories. Store in a cool place.

PHARMACOLOGY

Chlorpromazine possesses potent sedative and antiemetic effects and potentiates CNS

depressants. It is also a moderately strong adrenolytic agent, but has only weak

anticholinergic activity. The LD

in the mouse is 260 mg/kg P.O. and in the rat, 360

mg/kg P.O. The drug did not interfere with normal reproductive activity nor did it exert

any teratogenic effect on the offspring of the animals studied.

IMPORTANT: PLEASE READ

Page 9 of 11

CONSUMER INFORMATION

Pr

LARGACTIL

®

Chlorpromazine Hydrochloride Drops

Chlorpromazine Hydrochloride Suppositories

Chlorpromazine Hydrochloride Liquid

This leaflet is designed specifically for Consumers. This leaflet

is a summary and will not tell you everything about Largactil

®

.

Contact your doctor or pharmacist if you have any questions

about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Largactil

is used:

To treat symptoms of schizophrenias, psychoses, behavioural

disorders or confusion in the elderly

To control nausea, vomiting or persistent hiccup

Largactil

is also used:

In conditions associated with emotional stress

In the treatment of withdrawal symptoms of addicts and

alcoholics.

Before a surgery to reduce anxiety, to reduce the need for

drugs relieving pain, to control nausea and vomiting or to

prevent and treat shock following the surgery.

Ask your doctor if you have any questions about why Largactil

has been prescribed to you.

What it does:

Largactil

helps to:

reduce and control psychotic symptoms and induce sleep

which can control various states of emotional tension,

agitation, hyperactivity and confusion.

control nausea and vomiting.

intensify the effects of drugs that relieve pain.

When it should not be used:

Do not use Largactil

if you:

Are allergic to Largactil

,

to phenothiazines (a type of

antipsychotic) or to any of the ingredients in the product (see

the section “

What the non-medicinal ingredients are”

Are in an altered state of consciousness or coma, especially if

this is caused by alcohol or drugs

Have a blood disorders

Have liver disease

What the medicinal ingredient is:

chlorpromazine hydrochloride

What the non-medicinal ingredients are:

Liquid of 25 mg/5 mL: alcohol, ascorbic acid, citric acid, ethyl

vanillin, glycerin, peach flavor, purified water, sodium benzoate

and sucrose.

Liquid of 100 mg/5 mL: alcohol, artificial fruit flavor, citric acid,

D&C Yellow No. 10, ethyl vanillin, glycerin, purified water,

sodium benzoate and sucrose.

Oral drops: alcohol, artificial and natural custard flavor, caramel,

citric acid, glycerin, purified water, sucrose and terpeneless

orange oil.

Suppositories: hydrogenated vegetable glycerides.

What dosage forms it comes in:

Liquid 25 mg/5 mL

Liquid 100 mg/5 mL

Oral drops 40 mg/mL

Suppositories 100 mg

WARNINGS AND PRECAUTIONS

At the beginning of treatment, Largactil

may cause some people

to become drowsy or less alert. You should not drive a car,

operate machinery or participate in activities requiring total

alertness until you are sure Largactil

does not affect you.

Tardive dyskinesia, neuroleptic malignant syndrome and cardiac

disorders may occur in some patients taking Largactil

(See the

section

“SIDE EFFECTS AND WHAT TO DO ABOUT

THEM”

Before using Largactil

, tell your doctor if you:

Have heart or blood vessel disease

Have constipation or intestinal blockage

Suffer from an enlarged prostate (Benign prostatic

hypertrophy)

Suffer from an increase pressure within the eyes (glaucoma)

Have or have had seizure disorders (e.g. epilepsy)

Plan to have surgery (or a procedure requiring anaesthetics)

Are or are planning to become pregnant

Are breast-feeding

If you experience severe constipation and you are elderly, please

consult your doctor as soon as possible.

During long-term therapy, liver and blood tests should be done at

regular intervals.

IMPORTANT: PLEASE READ

Page 10 of 11

INTERACTIONS WITH THIS MEDICATION

Largactil

can add to the effects of alcohol. You should avoid

consuming alcoholic beverages while on Largactil

therapy.

Before using any prescription, over-the-counter medicines or

herbal products, check with your doctor or your pharmacist.

Largactil

can add to the effects of other drugs that cause

drowsiness. Some examples of drugs that cause drowsiness are:

Drugs for allergies

Drugs for sleep

Drugs for pain

Drugs for seizure

Drugs for depression

Drugs for mental illness

Largactil

may cause a false pregnancy test result. Please check

with your doctor if this happens.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor has decided the best dose for you based on your

individual situation and needs. It is important to take Largactil

way your doctor told you. Your doctor may increase or decrease

your dose depending on your response.

You may experience side effects if the drug is stopped suddenly.

Contact your physician before stopping your drug.

Adults - In general medicine and psychiatry

Oral route: The average dose is 30 to 75 mg a day (mild cases) or

75 to 100 mg a day (more severe cases). The daily dose is divided

into smaller doses during the day. Your doctor may decrease or

increase your dose if needed.

Rectal route: 1 to 3 suppositories daily.

Adults - In surgery and anesthesia

Oral route: doses of 25 to 50 mg are administered 2 to 3 hours

before anesthesia and every 4 to 6 hours after surgery.

Children

Oral route: Dose is based on body weight.

Overdose:

If you have taken too much Largactil

, immediately see your

doctor or go to your nearest hospital emergency department. Show

the doctor your bottle or box of Largactil

. Do this even if there are

no signs of discomfort or poisoning. The signs if you have taken

too much Largactil

may include agitation, hyperactivity,

confusion, drowsiness and coma.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Largactil

, like any medication, may cause some side effects.

Discuss with your doctor if you do experience side effects.

Side effect include:

Drowsiness frequently occurs at the beginning of treatment

but gradually disappear with time or with a reduction of the

dose. If this effect persists, discuss this with your doctor.

Blurred vision, changes in libido, coloration of the skin or the

cornea (transparent portion of the outer covering of the eyes),

constipation, dryness of the mouth, enlargement of the breast

in male, nasal congestion, nausea, sleepiness, weight gain.

Your skin may be more sensitive to sunlight

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Talk with your

doctor or

pharmacist

Symptom / effect

See text below for more details

Only if

severe

In all

cases

Stop

taking

drug and

call your

doctor or

pharmacist

Common

Hypotension

a)

Uncommon

Allergic Reactions

Blood disorders

b)

Cardiac

disorders

a)

Extrapyramidal

reactions

c)

Liver disorders

b)

Lung disorders

b)

Neuroleptic

malignant

syndrome

d)

Tardive

dyskinesia

e)

a) Cardiac disorders:

At the start of treatment, some people may

have low blood pressure and feel dizzy, especially when getting

up from a lying or sitting position, particularly when high doses

are used. Uncommonly, Largactil

may cause the heartbeat to

IMPORTANT: PLEASE READ

Page 11 of 11

become faster or irregular. Check with your doctor immediately if

you experience any of these side effects.

b) Blood, liver and lung disorders

have been associated with this

class of drug. It is important that you tell your doctor at once about

any unexplained symptom you might experience. Examples of this

are soreness of the mouth, gums or throat or any symptoms of

upper respiratory infection, unexplained fever, itching, flu-like

symptoms, coughing, abdominal pain or jaundice.

c) Extrapyramidal reactions

are rare and usually appear only

after long-term therapy at high doses. The signs and symptoms of

extrapyramidal reactions include tremor, muscle stiffness, body

spasm, impairment of voluntary movement, upward eye rolling,

exaggeration of reflexes or drooling. Tell your doctor immediately

if you experience any of these side effects. Your medication might

have to be reduced.

d) Neuroleptic malignant syndrome

. Another possible serious

unwanted effect is the neuroleptic malignant syndrome. Signs and

symptoms of the neuroleptic malignant syndrome include severe

muscle stiffness, increased sweating, fever, fast or irregular

heartbeat, high or low blood pressure, difficult or fast breathing

and confusion. If any of the above side effects occur, consult your

doctor immediately.

e) Tardive dyskinesia

may occur in some patients on long-term

therapy or after they stop using Largactil

. Signs of tardive

dyskinesia include muscle twitching or uncontrolled movements of

the mouth, tongue, face or jaw. In some patients, this side effect

may not go away after they stop using Largactil

. Tell your doctor

immediately if you experience any muscle twitching or abnormal

body movements.

Other very rare side effects include:

painful erection or systemic lupus erythematosis (an

autoimmune disease: the immune system turns against parts of

the body it is designed to protect. This leads to inflammation

and damage to various body tissues).

This is not a complete list of side effects. For any unexpected

effects while taking Largactil

®

, contact your doctor or pharmacist.

HOW TO STORE IT

Largactil

oral drops, liquid and suppositories should be protected

from exposure to light.

Largactil

suppositories should be stored in a cool place.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on

serious and unexpected effects of drugs. If you suspect you

have had a serious or unexpected reaction to this drug you may

notify Health Canada by:

toll-free telephone:

866-234-2345

toll-free fax

866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness

Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact

your physician or pharmacist.

MORE INFORMATION

Your physician, nurse and pharmacist are always your best source

of information about your condition and treatment. If you have

additional questions or concerns, be sure

to ask them.

This document plus the full product monograph is available upon

request to the sponsor, sanofi-aventis Canada Inc., 2150 St Elzear

Blvd. West, Laval, Quebec H7L 4A8, at:

1-800-265-7927

This leaflet was prepared by sanofi-aventis Canada Inc.

Last revised: October 13, 2006

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