Chlorpromazine hydrochloride for Injection 25mg/ml Taj Pharma

Chlorpromazine hydrochloride for Injection 25mg/ml Taj Pharma

1. Name of the medicinal product

Chlorpromazine hydrochloride for Injection 25mg/ml Taj Pharma

2. Qualitative and quantitative composition

25mg/ml chlorpromazine hydrochloride.

For full list of excipients see section 6.1

3. Pharmaceutical form

Sterile solution for injection.

A clear, colourless or almost colourless solution.

4. Clinical particulars

4.1 Therapeutic indications

Chlorpromazine hydrochloride injection is a phenothiazine neuroleptic. It is indicated in the following conditions:

– Schizophrenia and other psychoses (especially paranoid) mania and hypomania.

– Anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Chlorpromazine hydrochloride is used as an adjunct in the short-term treatment of these conditions.

– Intractable hiccup.

– Nausea and vomiting of terminal illness (where other drugs have failed or are not available).

– Childhood schizophrenia and autism.

4.2 Posology and method of administration

Route of administration: Deep intramuscular injection.

Oral route administration should be used wherever possible.

Parenteral formulations may be used in emergencies. They may only be administered by deep intramuscular injection. Chlorpromazine hydrochloride is too irritant to give subcutaneously. Repeated injections should be avoided if possible.

ADULTS: A single deep intramuscular injection of 25-50mg followed by oral therapy will suffice in many cases, but the intramuscular dose may be repeated if required at 6 to 8 hour intervals. As soon as possible oral administration should be substituted.

ELDERLY: Should be started on half or even quarter of the adult dosage.

Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety and agitation, childhood schizophrenias and autism:

Hiccup:

Nausea and vomiting of terminal illness:

4.3 Contraindications

• Hypersensitivity to chlorpromazine or to any of the excipients
• Bone marrow depression
• Risk of angle-closure glaucoma
• Risk of urinary retention related to urethroprostatic disorders
• History of agranulocytosis
• Dopaminergic antiparkinsonism agents (see Section 4.5)
• Nursing mothers (see Section 4.6)
• Citalopram, escitalopram

4.4 Special warnings and precautions for use

All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the latter.

As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see Section 4.8) and requires immediate haematological investigation.

Neuroleptic malignant syndrome: treatment must be interrupted in the event of unexplained hyperpyrexia since this can be one of the signs of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity). Signs of autonomic instability, such as hyperhydrosis and irregular blood pressure, can precede the onset of hyperthermia and as such constitute premonitory signs of this syndrome. While this neuroleptic-related effect can be of idiosyncratic origin, certain risk factors such as dehydration and brain damage would seem to indicate a predisposition.

Chlorpromazine hydrochloride should be avoided in patients with, hypothyroidism, phaeochromocytoma, myasthenia gravis and prostate hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma or agranulocytosis.

Acute withdrawal symptoms, including nausea, vomiting 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.

In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time.

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, hypokalaemia, 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 Section 4.8).

Where clinically possible, the absence of any factors favouring the onset of ventricular arrhythmias should be ensured before administration:

• Bradycardia less than 55 beats per minute;
• Hypokalemia;
• Hypocalcaemia;
• Hypomagnesaemia;
• Starvation;
• Alcohol abuse;
• Concomitant therapy with other drugs known to prolong the QT interval;
• Congenital long QT interval;
• Ongoing treatment with any drug which could induce marked bradycardia (<55 beats per minute), hypokalemia, intracardiac conduction depression or QT prolongation (see Section 4.5).

With the exception of emergencies, it is recommended that the initial work up of patients receiving a neuroleptic should include an ECG.

Except under exceptional circumstances, this drug must not be administered to patients with Parkinson’s disease.

The concomitant use of chlorpromazine with lithium, other QT prolonging agents, and dopaminergic antiparkinsonium agents is not recommended (see Section 4.5).

The onset of paralytic ileus, potentially indicated by abdominal bloating and pain, must be treated as an emergency (see Section 4.8).

Cases of venous thromboembolism (VTE), sometimes fatal have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Chlorpromazine hydrochloride and preventative measures undertaken.

Stroke: In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Chlorpromazine hydrochloride should be used with caution in patients with stroke risk factors.

Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotics drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (eg., heart failure, sudden death) or infectious (eg. , pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

As with all antipsychotic drugs, Chlorpromazine hydrochloride should not be used alone where depression is predominant. However, it may be combined with antidepressant therapy to treat those conditions in which depression and psychosis coexist.

Chlorpromazine hydrochloride is not licensed for the treatment of dementia-related behavioural disturbances.

Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight (see Section 4.8).

In those frequently handling preparations of phenothiazines, the greatest care must be taken to avoid contact of the drug with the skin.

Hyperglycaemia or intolerance to glucose has been reported in patients treated with Chlorpromazine hydrochloride. Patients with established diagnosis of diabetes mellitus or with risk factors for the development of diabetes who are started on Chlorpromazine hydrochloride, should get appropriate glycaemic monitoring during treatment (see section 4.8).

The following populations must be closely monitored after administration of chlorpromazine:

o Epileptics, since chlorpromazine may lower the seizure threshold. Treatment must be discontinued if seizures occur.

o Elderly patients presenting with heightened susceptibility to orthostatic hypotension, sedation and extrapyramidal effects; chronic constipation (risk of paralytic ileus), and potentially prostatic hypertrophy. It should be used with caution particularly during very hot or cold weather (risk of hyper-, hypothermia

o Patients presenting with certain forms of cardiovascular disease, since this class of drug has quinidine–like effects can induce tachycardia and hypotension.

o Patients with severe liver and/or renal failure because of the risk of accumulation.

• Patients on long-term treatment should receive regular ophthalmological and haematological examinations.
• Patients are strongly advised not to consume alcohol and alcohol-containing drugs throughout treatment (see Section 4.5)
• Owing to the risk of hypotension, patients should be advised to remain supine for at least half an hour after injection. Tachycardia as well as local pain or nodule formation may occur after intramuscular administration. Blood pressure should be monitored when receiving parenteral chlorpromazine
• Risk of allergic reaction including anaphylactic reactions and bronchospasm owing to the presence of sodium sulfite and disulfite in the formulation.
• Since there is a potential impact on cognitive function, children should undergo a yearly clinical examination to evaluate learning capacity. The dosage should be adjusted regularly as a function of the clinical status of the child.

4.5 Interaction with other medicinal products and other forms of interaction

Adrenaline must not be used in patients overdosed with Chlorpromazine hydrochloride.

Anticholinergic drugs may reduce the antipsychotic effect of Chlorpromazine hydrochloride and the mild anticholinergic effect of Chlorpromazine hydrochloride may be enhanced by other anticholinergic drugs possibly leading to constipation, heat stroke, etc.

The action of some drugs may be opposed by Chlorpromazine hydrochloride; these include amphetamine, levodopa, clonidine, guanethidine and adrenaline.

Increases or decreases in the plasma concentrations of a number of drugs, e.g. propranolol Phenobarbital have been observed but were not of clinical significance.

Simultaneous administration of deferoxamine and prochlorperazine has been observed to induce a transient metabolic encephalopathy characterised by loss of consciousness for 48-72 hours. It is possible this may occur with Chlorpromazine hydrochloride since it shares many of the pharmacological properties of prochlorperazine.

There is an increased risk of agranulocytosis when neuroleptics are used concurrently with drugs with myelosuppressive potential, such as carbamazepine or certain antibiotics and cytotoxics.

Combinations contraindicated

Dopaminergics (quinaglide, cabergoline), not including dopaminergic antiparkinsonism agents, are contraindicated (see Section 4.3); reciprocal antagonism of the dopaminergic agent and neuroleptic.

Citalopram and escitalopram are contraindicated.

Combinations not recommended

Dopaminergic antiparkinsonium agents (amantadine, bromocriptine, cabergoline, levodopa, lisuride, pergolide, piribedil, ropinirole) are not recommended: reciprocal antagonism of the antiparkinsonism agent and neuroleptic (see Section 4.4). Neuroleptic-induced extrapyramidal syndrome should be treated with an anticholinergic rather than a dopaminergic antiparkinsonism agent (dopaminergic receptors blocked by neuroleptics).

Levodopa: reciprocal antagonism of levodopa and the neuroleptic. In Parkinson’s patients, it is recommended to use the minimal doses of each drug.

QT prolonging drugs: There is an increased risk of arrhythmias when neuroleptics are used with concomitant QT prolonging drugs (including certain antiarrhythmics, antidepressants and other antipsychotics including sultopride) and drugs causing electrolyte imbalance.(see Section 4.4)

Alcohol: alcohol potentiates the sedative effect of neuroleptics. Changes in alertness can make it dangerous to drive or operate machinery. Alcoholic beverages and medication containing alcohol should be avoided (see section 4.4)

Lithium (high doses of neuroleptics): concomitant use can cause confusional syndrome, hypertonia and hyper-reflexivity, occasionally with a rapid increase in serum concentrations of lithium (see Section 4.4). There have been rare cases of neurotoxicity Lithium can interfere with the absorption of neuroleptic agents.

Combinations requiring precautions

Anti-diabetic agents: concomitant administration of high chlorpromazine doses (100mg/day) and anti-diabetic agents can lead to an increase in blood sugar levels (decreased insulin release). Forewarn the patient and advise increased self-monitoring of blood and urine levels. If necessary, adjust the anti-diabetic dosage during and after discontinuing neuroleptic treatment.

Topical gastrointestinal agents (magnesium, aluminium and calcium salts, oxides and hydroxides): decreased GI absorption of phenothiazine neuroleptics. Do not administer phenothiazine neuroleptics simultaneously with topical GI agents (administer more than 2 hours apart if possible).

CYP1A2 inhibitors

Administration of chlorpromazine with CYP1A2 inhibitors, in particular strong or moderate inhibitors may lead to an increase of chlorpromazine plasma concentrations. Therefore patients may experience a chlorpromazine dose-dependent adverse drug reaction.

There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates.

Combinations to be taken into consideration

Antihypertensive agents: potentiation of the antihypertensive effect and risk of orthostatic hypotension (additive effects). Guanethidine has adverse clinically significant interactions documented.

Atropine and other atropine derivatives: imipramine, antidepressants, histamine H1-receptor antagonists, anticholinergic antiparkinsonism agents, atropinic antispasmodics, dispyramide: build-up of atropine-associated adverse effects such as urinary retention, constipation and dry mouth, heat stroke etc.

Other CNS depressants: morphine derivatives (analgesics, antitussives and substitution treatments), barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, hypnotics, sedative antidepressants, histamine H1 receptor antagonists, central antihypertensive agents increased central depression. Changes in alertness can make it dangerous to drive or operate machinery.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of the safety of Chlorpromazine hydrochloride in human pregnancy. There is evidence of harmful effects in animals. Like other drugs it should be avoided in pregnancy unless the physician considers it essential. It may occasionally prolong labour and at such a time should be withheld until the cervix is dilated 3-4 cm. Possible adverse effects on the foetus include lethargy or paradoxical hyperexcitability, tremor and low Apgar score.

A large amount of exposure to chlorpromazine during pregnancy did not reveal any teratogenic effect.

It is advised to keep an adequate maternal psychic balance during pregnancy in order to avoid decompensation. If a treatment is necessary to ensure this balance, the treatment should be started or continued at effective dose all through pregnancy.

Neonates exposed to antipsychotics (including Chlorpromazine hydrochloride) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, bradycardia, tachycardia, feeding disorder, meconium ileus, delayed meconium passage, abdominal bloating. Consequently, newborns should be monitored carefully in order to plan appropriate treatment.

Lactation

Chlorpromazine hydrochloride may be excreted in milk, therefore breastfeeding should be suspended during treatment.

Fertility

A decrease in fertility was observed in female animals treated with chlorpromazine. In male animals data are insufficient to assess fertility.

In humans, because of the interaction with dopamine receptors, chlorpromazine may cause hyperprolactinaemia which can be associated with impaired fertility in women (see Section 4.8). In men, data on consequences of hyperprolactinaemia are insufficient with regard to fertility.

4.7 Effects on ability to drive and use machines

Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.

4.8 Undesirable effects

¹may be seen without evidence of clinical disease

²particularly at the start of treatment

³particularly during long term treatment; may occur after the neuroleptic is withdrawn and resolve after reintroduction of treatment or if the dose is increased.

⁴linked to anticholinergic effects

⁵in the anterior segment of the eye caused by accumulation of the drug but generally without any impact on sight

⁶ A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Chlorpromazine jaundice has the biochemical and other characteristics of obstructive (cholestatic) jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon. Liver injury, sometimes fatal, has been reported rarely in patients treated with chlorpromazine. Treatment should be withheld on the development of jaundice (see section 4.4).

⁷ The development of a metallic greyish-mauve coloration of exposed skin has been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (four to eight years).

Risk of allergic reactions including anaphylactic reactions and bronchospasm owing to the presence of sodium sulfite and disulfite in the formulation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Toxicity and treatment of overdosage: Symptoms of chlorpromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmia’s, hypothermia, Parkinsonism, convulsions and coma. Severe extra-pyramidal dyskinesias may occur.

Treatment should be symptomatic with continuous respiratory and cardiac monitoring (risk of prolonged QT interval) until the patients conditions resolves.

If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilation may result in circulatory collapse; raising the patient’s legs may suffice. In severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstriction agents are not generally recommended; avoid the use of adrenaline.

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10mg) or orphenadrine (20-40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.

Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Antipsychotics.

Chlorpromazine hydrochloride is a phenothiazine neuroleptic.

5.2 Pharmacokinetic properties

Chlorpromazine is rapidly absorbed and widely distributed in the body. It is metabolised in the liver and excreted in the urine and bile. Whilst plasma concentration of chlorpromazine itself rapidly declines excretion of chlorpromazine metabolites is very slow. The drug is highly bound to plasma protein. It readily diffuses across the placenta. Small quantities have been detected in milk from treated women. Children require smaller dosages per kg than adults.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium sulphite anhydrous, Sodium citrate

Sodium metabisulphite, Sodium chloride

Water for Injections

6.2 Incompatibilities

Chlorpromazine hydrochloride injection solutions have a pH of 5.0-6.5; they are incompatible with benzylpenicillin potassium, pentobarbital sodium and phenobarbital sodium.

6.3 Shelf life

The shelf life of the Chlorpromazine hydrochloride Injection is 36 months.

6.4 Special precautions for storage

Keep ampoules in outer carton in order to protect from light. Discoloured solution should not be used.

6.5 Nature and contents of container

Chlorpromazine hydrochloride Injection 2.5% w/v is supplied in boxes containing 10 x 1 ml or 10 x 2 ml in glass ampoules.

6.6 Special precautions for disposal and other handling

None.

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Chlorpromazine hydrochloride for Injection 25mg/ml Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorpromazine hydrochloride 25mg/ml Solution for Injection

Chlorpromazine hydrochloride

Read all of this leaflet carefully before you are given this medicine

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse or pharmacist
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist

In this leaflet:

1. What Chlorpromazine hydrochloride is and what it is used for
   2. Before you are given Chlorpromazine hydrochloride
   3. How Chlorpromazine hydrochloride is given
   4. Possible side effects
   5. How to store Chlorpromazine hydrochloride
   6.Further Information
2. What Chlorpromazine hydrochloride is and what it is used for

Chlorpromazine hydrochloride contains a medicine called chlorpromazine. This belongs to a group of medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the brain.

Chlorpromazine hydrochloride can be used for:

• Schizophrenia in adults and children
• Short term treatment of anxiety
• Hiccups
• Feeling or being sick (where other anti-sickness medicines have not worked)
• Autism

2. Before you are given Chlorpromazine hydrochloride

Do not have this medicine and tell your doctor if:

• You are allergic (hypersensitive) to chlorpromazine or any of the other ingredients of Chlorpromazine hydrochloride (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have a low number of blood cells (bone marrow depression).
• You have increased pressure in the eye (glaucoma)
• You are taking a dopaminergic antiparkinsonism drug
• You are breast feeding
• You are taking citalopram or escitalopram
• You have a history of a low white blood cell count
• You have urine retention due to a prostate disorder
  Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Chlorpromazine hydrochloride

Take special care with Chlorpromazine hydrochloride

Check with your doctor or nurse before you have this medicine if:

• You have liver or kidney problems
• You have thyroid problems
• You have heart problems or a family history of heart problems
• You have ever had a stroke
• You have Parkinson’s disease
• You have epilepsy or have had fits (seizures)
• You have depression
• You have ever had alcohol problems
• You have an enlarged prostate gland
• You have had glaucoma (painful eyes with blurred vision)
• You have a tumour on the adrenal gland called ‘phaeochromocytoma’
• You have a form of muscle weakness called ‘myasthenia gravis’
• You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual
• You have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these
• You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
• You are not eating properly
• You are allergic to other phenothiazine medicines such as prochlorperazine
• You are elderly (65 years of age or older)
• You are elderly, particularly during very hot or very cold weather. In these conditions, you could be at risk of hyperthermia or hypothermia
• You have low blood pressure or feel dizzy when you stand up
• You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before being given Chlorpromazine hydrochloride.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Chlorpromazine hydrochloride can affect the way some other medicines work. Also some medicines can affect the way Chlorpromazine hydrochloride works.

In particular, check with your doctor if you are taking any of the following:

• Medicines for indigestion and heartburn (antacids)
• Medicines for diabetes
• Medicines for high blood pressure or prostate problems such as doxazosin and terazosin
• Medicines for Parkinson’s disease such as levodopa
• Medicines for fits (epilepsy) such as carbamazepine or phenobarbital
• Medicines to control your heartbeat such as amiodarone, disopyramide or quinidine
• Medicines to help you sleep (sedatives)
• Medicines for depression
• Other medicines used to calm emotional and mental problems such as olanzapine or prochlorperazine
• Some medicines used for high blood pressure such as guanethidine, clonidine or propranolol
• Some medicines used for infections (antibiotics) such as moxifloxacin
• Some medicines used for cancer (cytotoxics)
• Medicines which can alter electrolytes (salt levels) in your blood
• Amphetamines – used for Attention Deficit Hyperactivity Disorder (ADHD)
• Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence
• Adrenaline – used for life threatening allergic reactions
• Deferoxamine – used when you have too much iron in your blood
• Lithium – used for some types of mental illness
• Medicines that may interact in the metabolism of chlorpromazine; examples include ciprofloxacin, oral contraceptives.

Taking Chlorpromazine hydrochloride with food and drink

Do not drink alcohol while being treated with Chlorpromazine hydrochloride. This is because alcohol can increase the effects of Chlorpromazine hydrochloride and cause serious breathing problems.

Pregnancy and breast-feeding and fertility

Talk to your doctor or nurse before having this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

The following symptoms may occur in newborn babies, of mothers that have used Chlorpromazine hydrochloride in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Do not breast-feed if you are being given Chlorpromazine hydrochloride. This is because small amounts may pass into mothers’ milk. If you are breastfeeding or planning to breast-feed talk to your doctor or nurse before taking this medicine.

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.

Chlorpromazine hydrochloride may make it more difficult for a woman to get pregnant due to it reducing her fertility.

Driving and using machines

You may feel sleepy after having this medicine.

If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Chlorpromazine hydrochloride

• Sodium. This injection contains 4.78mg of sodium in each 50mg dose and is essentially ‘sodium-free’.
• Small amounts of sulphites. These may cause severe allergic reactions (hypersensitivity) and difficulty in breathing (bronchospasm).

This is more likely to happen if you have a history of asthma or allergies. The chances of this happening are rare. Tell a doctor or nurse straight away if you get a rash, swallowing or breathing problems and swelling of your lips, face, throat or tongue.

3. How Chlorpromazine hydrochloride is given

Chlorpromazine hydrochloride is normally given by a doctor or nurse.

This is because it needs to be given as a deep injection into a muscle.

How much Chlorpromazine hydrochloride is given

If you are not sure why you are being given Chlorpromazine hydrochloride or have any questions about how much Chlorpromazine hydrochloride is being given to you, speak to your doctor or nurse.

The usual doses are:

Schizophrenia

Adults: 25-50mg every 6-8 hours

Elderly: 25mg every 8 hours

Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)

Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)

Anxiety

Adults: 25-50mg every 6-8 hours

Elderly: 25mg every 8 hours

Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)

Hiccups

Adults: 25-50mg

Feeling or being sick

Adults: 25-50mg every 3-4 hours

Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)

Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 75mg)

Autism

Children 1-5 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a day is 40mg)

Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours. (Maximum dose in a day is 75mg)

Children under 1 year

Chlorpromazine hydrochloride is not usually given to children under 1 year.

Exposure to sunlight

Chlorpromazine hydrochloride can make your skin more sensitive to sunlight. Keep out of direct sunlight while having this medicine.

Tests

Before and during treatment your doctor may want to carry out some tests. These might include blood tests and an ECG to check your heart is working properly and eye tests.

Your doctor may want to carry out tests every year during your child’s treatment to evaluate your child’s learning capacity.

If you have more Chlorpromazine hydrochloride than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.

Having too much Chlorpromazine hydrochloride may make you feel drowsy or dizzy with increased or rapid heartbeat. You may also feel very cold and restless, with writhing movements, stiffness or shaking. If you start getting any of these symptoms tell your doctor or nurse straight away. If you are away from the hospital, return straight away and speak to your doctor or nurse or go to the casualty department.

If you miss a dose of Chlorpromazine hydrochloride

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.

If you stop having Chlorpromazine hydrochloride

Keep having Chlorpromazine hydrochloride until your doctor tells you to stop. If you stop having Chlorpromazine hydrochloride your illness may come back and you may have other effects such as feeling or being sick and difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.

4. Possible side effects

Like all medicines, Chlorpromazine hydrochloride can cause side effects, although not everybody gets them.

Tell a doctor or nurse or go to a hospital straight away if:

Very common (affects more than 1 in 10 people)

• You have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs
• Trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless

Common (affects 1 to 10 people in a 100 people)

• You have a fit (seizure)
• Alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

Frequency unknown

• You have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swollen eyelids, lips, tongue or throat
• You have a very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain. These could be signs of very serious life threatening heart problems
• You have joint aches and pains, swollen joints, feel tired or weak, with chest pain and shortness of breath. These could be signs of an illness called ‘systemic lupus erythematosus’ (SLE)
• You have yellowing of the skin or eyes (jaundice) and your urine becomes darker in colour. These could be signs of liver damage
• You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’
• You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called ‘neuroleptic malignant syndrome
• You get a bloated feeling and cramping pain in the abdomen (stomach) be sick (vomit) have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the intestine.
• You have pain in your abdomen with vomiting or diarrhoea
• You have a long lasting, painful erection of the penis
• You bruise more easily than usual. This could be because of a blood disorder called ‘thrombocytopenia’
• You have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately

Tell a nurse or doctor as soon as possible if you have any of the following side effects:

Very common (affects more than 1 in 10 people)

• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)

Frequency unknown

• You are breathing more slowly or less deeply than normal
• Changes in skin or eye colour after having Chlorpromazine hydrochloride for a long time
• Problems with eyesight
• Rigid or stiff muscles, trembling or shaking, difficulty moving
• Passing large amounts of urine, excessive thirst and having a dry mouth or skin. You may be more likely to get infections, such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)
• Unusual eye movements (including rolling of the eyes)
• Your neck becomes twisted to one side
• Your jaw is tight and stiff
• You have difficulty in passing water (urine)
• Feeling tired,weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood

Talk to your doctor or nurse if any of the following side effects gets serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

• Dry mouth
• Feeling drowsy or sleepy
• Putting on weight

Common (affects 1 to 10 people in a 100 people)

• Abnormal production of breast milk in men and women
• Loss of menstrual periods
• Feeling anxious

Frequency unknown

• Breast enlargement in men
• Difficulty in getting or keeping an erection (impotence)
• Reduced sexual desire in women
• Difficulty sleeping (insomnia)
• Feeling agitated
• Being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Tiredness, low mood

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Chlorpromazine hydrochloride

This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.

Do not use Chlorpromazine hydrochloride after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Keep the Ampoules in the outer carton in order to protect from light.

Discoloured solution should not be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information

What Chlorpromazine hydrochloride contains

• Each 1ml of solution contains 25mg of the active substance, chlorpromazine hydrochloride
• The other ingredients are: Sodium sulphite, Sodium citrate, Sodium metabisulphite, Sodium chloride, Water for Injection

What Chlorpromazine hydrochloride looks like and contents of the pack

• Chlorpromazine hydrochloride is a clear, colourless solution
• Chlorpromazine hydrochloride is available in boxes containing 10 x 1ml or 10 x 2ml glass ampoules

Not all pack sizes may be marketed

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com