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HALDOL®
NAME OF THE MEDICINAL PRODUCT
2 mg/ml and 10 mg/ml oral solution Clear, colourless solution.
5 mg/ml injectable solution Clear, colourless solution, free from visible foreign International Non-Proprietary Name (INN)
QUALITATIVE AND QUANTITATIVE
The tablets contain either 1 mg, 2 mg, 5 mg, 10 mg As a neuroleptic agent in: or 20 mg haloperidol.
- Delusions and hallucinations in: The oral solution contains 2 mg and 10 mg haloperi- • acute and chronic schizophrenia; The injectable solution contains 5 mg haloperidol per • acute confusion, alcoholism (Korsakoff's syn- For excipients, see List of Excipients.
- Hypochondriac delusions.
- Personality disorders: paranoid, schizoid, schizo- type, antisocial, some "borderline" and other per- Oral drops, solution.
As a psychomotor anti-agitation agent in: Solution for injection.
- Mania, dementia, mental retardation, alcoholism.
- Personality disorders: compulsive, paranoid, histri- 1 mg tablets onic and other personalities.
White, circular, biconvex, cross-scored tablet with - Agitation, aggressiveness, and wandering impul- the inscription "JANSSEN" on one side.
sion in the elderly.
- Disorders of behaviour and character in children.
2 mg tablets. Yellow, circular, biconvex, cross-scored table with -Singultus (hiccup).
the inscription "JANSSEN" on one side.
-Tics, stuttering.
5 mg tablets As an adjuvant in the treatment of severe chronic Blue, circular, biconvex, cross-scored tablet with the pain: inscription "JANSSEN" on one side.
On the basis of its limbic activity, Haldol® often 10 mg tablets allows the dosage of the analgesic (usually a mor- Yellow, circular, biconvex, half-scored tablet with the phinomimetic) to be reduced.
inscription "JANSSEN" on one side and "H/10" on As an anti-emetic in: the other side.
Nausea and vomiting of varying origin. Haldol® is the 20 mg tablets drug of preference if the classical medicines for nau- White, circular, flat, half-scored tablet with the sea and vomiting are insufficiently active.
inscription "JANSSEN" on one side and "H/20" on Posology and Method of Administration
the other side.
Haldol® Injection is recommended for IM administra- *Due to regulatory and marketing requirements, the tablet may have a specific The dosages as suggested below are only aver- Contraindications
ages; one should always try to tailor the dose to the Comatose state; CNS depression due to alcohol or patient's response. This often implies an upward titra- other depressant drug; Parkinson's disease; known tion in the acute phase, and a gradual reduction in the hypersensitivity to Haldol®; lesion of the basal ganglia.
maintenance phase, in order to determine the mini- Special Warnings and Special Precautions for
mal effective dose. High doses should only be given Use
to patients responding poorly to lower dosages.
Rare cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, - As a neuroleptic agent including Haldol®.
• Acute phase: acute episodes of schizophre- Elderly patients with dementia-related psychosis nia, delirium tremens, paranoia, acute confu- treated with antipsychotic drugs are at an increased sion, Korsakoff's syndrome, acute paranoia. risk of death. Analyses of seventeen placebo-con- 5-10 mg IM, to be repeated hourly until sufficient trolled trials (modal duration of 10 weeks), largely in symptom control is achieved or up to a maximum patients taking atypical antipsychotic drugs, revealed of 60 mg/day. When given orally, nearly double the a risk of death in drug-treated patients of between above dose may be needed.
1.6 to 1.7 times the risk of death in placebo-treated • Chronic phase: chronic schizophrenia, chronic patients. Over the course of a typical 10 week con- alcoholism, chronic personality disorders. 1-3 mg trolled trial, the rate of death in drug-treated patients orally TID, may be increased to 10-20 mg TID, was about 4.5%, compared to a rate of about 2.6% depending on the response.
in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either - As a psychomotor anti-agitation agent cardiovascular (e.g., heart failure, sudden death) or • Acute phase: mania, dementia, alcoholism, per- infectious (e.g., pneumonia) in nature.
sonality disorders, behaviour and character disor- ders, singultus, choreatic movements, tics, stutter- Observational studies suggest that, similar to atypi- ing: 5-10 mg IM.
cal antipsychotic drugs, treatment with convention- • Chronic phase: al antipsychotic drugs may increase mortality. The 0.5-1 mg TID orally, may be increased to 2-3 mg extent to which the findings of increased mortality in TID, if required, to obtain a response.
observational studies may be attributed to the anti- psychotic drug as opposed to some characteristic(s) - As an adjuvant in chronic pain therapy of the patients is not clear.
0.5-1 mg TID orally, may be adjusted if needed.
- As an anti-emetic Very rare reports of QT prolongation and/or ventricu- • Centrally induced vomiting: 5 mg IM.
lar arrhythmias, in addition to rare reports of sudden • Prophylaxis of postoperative vomiting: 2.5-5 mg IM death, have been reported with haloperidol. They at the end of surgery.
may occur more frequently with high doses and in In elderly patients Treatment should start with half the dosage stated As QT-prolongation has been observed during for adults and adjusted according to the results if Haldol® treatment, caution is advised in patients with QT-prolonging conditions (long QT-syndrome, hypo- In children kalaemia, electrolyte imbalance, drugs known to pro- 0.1 mg/3 kg body weight TID orally; may be adjusted long QT, cardiovascular diseases, family history of QT prolongation), especially if Haldol® is given parenter- ally (see Interactions with Other Medicinal Products may have to be continued after stopping Haldol® if and Other Forms of Interaction). The risk of QT pro- its excretion is faster than that of Haldol® in order longation and/or ventricular arrhythmias may be to avoid the development or aggravation of extra- increased with higher doses (see Undesirable Effects pyramidal symptoms. The physician should keep in and Overdose) or with parenteral use, particularly mind the possible increase in intraocular pressure intravenous administration. Continuous ECG moni- when anticholinergic drugs, including antiparkinson toring should be performed for QT interval prolonga- agents, are administered concomitantly with Haldol®.
tion and for serious cardiac dysrhythmias if Haldol® is Seizure/Convulsions It has been reported that seizures can be triggered by Haldol® Injection is recommended for IM administra- Haldol®. Caution is advised in patients suffering from epilepsy and in conditions predisposing to convul- Tachycardia and hypotension have also been report- sions (e.g., alcohol withdrawal and brain damage).
ed in occasional patients.
Neuroleptic malignant syndrome As Haldol® is metabolized by the liver, caution is In common with other antipsychotic drugs, Haldol® advised in patients with liver disease. Isolated cases has been associated with neuroleptic malignant syn- of liver function abnormalities or hepatitis, most drome: a rare idiosyncratic response characterized by often cholestatic, have been reported.
hyperthermia, generalised muscle rigidity, autonomic Endocrine system concerns instability, altered consciousness. Hyperthermia is Thyroxin may facilitate Haldol® toxicity. Antipsychotic often an early sign of this syndrome.
therapy in patients with hyperthyroidism should be Antipsychotic treatment should be withdrawn imme- used only with great caution and must always be diately and appropriate supportive therapy and care- accompanied by therapy to achieve a euthyroid state.
ful monitoring instituted.
Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause As with all antipsychotic agents, tardive dyskinesia galactorrhoea, gynaecomastia and oligo- or amen- may appear in some patients on long-term therapy orrhoea. Very rare cases of hypoglycaemia and of or after drug discontinuation. The syndrome is main- Syndrome of Inappropriate ADH Secretion have ly characterized by rhythmic involuntary movements been reported.
of the tongue, face, mouth or jaw. The manifesta- Additional considerations tions may be permanent in some patients. The syn- In schizophrenia, the response to antipsychotic drug drome may be masked when treatment is reinstitut- treatment may be delayed.
ed, when the dosage is increased or when a switch Also, if drugs are withdrawn, recurrence of symp- is made to a different antipsychotic drug. Treatment toms may not become apparent for several weeks should be discontinued as soon as possible.
or months. Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely In common with all neuroleptics, extrapyramidal been described after abrupt cessation of high doses symptoms may occur, e.g. tremor, rigidity, hypersali- of antipsychotic drugs. Relapse may also occur and vation, bradykinesia, akathisia, acute dystonia.
gradual withdrawal is advisable.
Antiparkinson drugs of the anticholinergic type may As with all antipsychotic agents, Haldol® should not be be prescribed as required, but should not be pre- used alone where depression is predominant. It may scribed routinely as a preventive measure. If con- be combined with antidepressants to treat those con- comitant antiparkinson medication is required, it ditions in which depression and psychosis coexist.
Interactions with Other Medicinal Products and increase the central nervous system depression
Other Forms of Interaction
produced by other CNS-depressant drugs, includ- As with other antipsychotics, caution is advised ing alcohol, hypnotics, sedatives or strong analge- when prescribing haloperidol with medications sics. An enhanced CNS effect, when combined with known to prolong the QT interval.
methyldopa, has also been reported.
Haloperidol is metabolized by several routes, includ- Haldol® may antagonise the action of adrenaline ing glucuronidation and the cytochrome P450 and other sympathomimetic agents and reverse the enzyme system (particularly CYP 3A4 or CYP 2D6). blood-pressure-lowering effects of adrenergic-block- Inhibition of these routes of metabolism by anoth- ing agents such as guanethidine.
er drug or a decrease in CYP 2D6 enzyme activ- Haldol® may impair the antiparkinson effects of ity may result in increased haloperidol concentrations levodopa.
and an increased risk of adverse events, including Haloperidol is an inhibitor of CYP 2D6. Haldol® QT-prolongation. In pharmacokinetic studies, mild inhibits the metabolization of tricyclic antidepres- to moderately increased haloperidol concentrations sants, thereby increasing plasma levels of these have been reported when haloperidol was given con- drugs.
comitantly with drugs characterized as substrates or Other Forms of Interaction inhibitors of CYP 3A4 or CYP 2D6 isozymes, such In rare cases the following symptoms were report- as, itraconazole, nefazodone, buspirone, venlafaxine, ed during the concomitant use of lithium and halo- alprazolam, fluvoxamine, quinidine, fluoxetine, sertra- peridol: encephalopathy, extrapyramidal symptoms, line, chlorpromazine, and promethazine. A decrease tardive dyskinesia, neuroleptic malignant syndrome, in CYP2D6 enzyme activity may result in increased brain stem disorder, acute brain syndrome and haloperidol concentrations. Increases in QTc have coma. Most of these symptoms were reversible. It been observed when haloperidol was given with a remains unclear whether this represents a distinct combination of the metabolic inhibitors ketoconazole clinical entity.
(400 mg/day) and paroxetine (20 mg/day). It may be Nonetheless, it is advised that in patients, who are necessary to reduce the haloperidol dosage.
treated concomitantly with lithium and Haldol®, ther- Caution is advised when used in combination with apy should be stopped immediately if such symp- drugs known to cause electrolyte imbalance.
Effect of Other Drugs on Haloperidol Antagonism of the effect of the anticoagulant phen- When prolonged treatment with enzyme-inducing indione has been reported.
drugs such as carbamazepine, phenobarbital, rifam- Pregnancy and Lactation
picine is added to Haldol® therapy, this results in a Animal studies have demonstrated a teratogenic significant reduction of haloperidol plasma levels. effect of haloperidol (see Preclinical Safety Data).
Therefore, during combination treatment, the Haldol® Neonates exposed to antipsychotic drugs (including dose or the dosage interval should be adjusted, when haloperidol) during the third trimester of pregnan- necessary. After stopping such drugs, it may be nec- cy are at risk for extrapyramidal and/or withdrawal essary to reduce the dosage of Haldol®.
symptoms that may vary in severity following deliv- Sodium valproate, a drug known to inhibit glucuroni- ery. These symptoms in the neonates may include dation, does not affect haloperidol plasma concen- agitation, hypertonia, hypotonia, tremor, somno- lence, respiratory distress, or feeding disorder Effect of Haloperidol on Other Drugs Haldol® has shown no significant increase in fetal In common with all neuroleptics, Haldol® can anomalies in large population studies. There have been isolated case reports of birth defects following Eye Disorders
fetal exposure to Haldol, mostly in combination with Visual disturbance other drugs. Haldol should be used during pregnan- Constipation cy only if the anticipated benefit justifies the poten- Dry mouth tial risk to the fetus.
Salivary hypersecretion Haldol® is excreted in breast milk. If the use of Haldol® is considered essential, the benefits of breast-feeding Active Comparator-Controlled Data – Adverse
should be balanced against its potential risks.
Drug Reactions Reported at ≥1% Incidence
Extrapyramidal symptoms have been observed in Sixteen double-blind active comparator-controlled tri- breast-fed infants of Haldol® treated women.
als were selected to determine the incidence of ADRs. In these 16 studies, 1295 subjects were treated with Effects on Ability to Drive and Use Machines
Some degree of sedation or impairment of alertness 1-45 mg/day Haldol®, in the treatment of schizophrenia.
may occur, particularly with higher doses and at the ADRs reported by ≥1% of Haldol®-treated subjects start of treatment and may be potentiated by alcohol. noted in the active-comparator controlled clinical tri- Patients should be advised not to drive or operate als are shown in Table 2.
machinery during treatment, until their susceptibility Table 2. Adverse Drug Reactions Reported by ≥1%
of Haldol®-treated Subjects in 16 Double-Blind Active
Comparator Clinical Trials of Haldol®
Clinical Trial Data (n=1295) %
Placebo-Controlled Double-Blind Data – Adverse Nervous System Disorder
Drug Reactions Reported at ≥1% Incidence The safety of Haldol® (2-20 mg/day) was evaluat- Dyskinesia ed in 566 subjects (of which 284 were treated with Hypokinesia Tardive dyskinesia Haldol®, 282 were given placebo) who participated Eye Disorders
in 3 placebo-controlled, double-blind clinical trials, Oculogyric crisis two in the treatment of schizophrenia and the third in Vascular Disorders
the treatment of bipolar disorder.
Orthostatic hypotension Adverse Drug Reactions (ADRs) reported by ≥1% of Reproductive system and breast Disorders
Haldol®-treated subjects in these trials are shown in Erectile dysfunction Table 1. Adverse Drug Reactions Reported by ≥1%
of Haldol®-treated Subjects in 3 Double-Blind Parallel
Placebo-Controlled Clinical Trials of Haldol®
Placebo- and Active Comparator-Controlled Data – Adverse Drug Reactions Reported at <1% Incidence Additional ADRs that occurred in <1% of Haldol®- Nervous System Disorders
treated subjects either of the above 2 clinical datas- Extrapyramidal disorder ets are listed below in Table 3.
Table 3. Adverse Drug Reactions Reported by <1%
of Haldol®-treated Subjects in Either the Placebo- or
Table 3. Adverse Drug Reactions Reported by <1%
In Table 4, ADRs are presented by frequency cate- of Haldol®-treated Subjects in Either the Placebo- or
gory based on spontaneous reporting rates.
Table 4: Adverse Drug Reactions Identified During
Postmarketing Experience with Haloperidol (oral, solution,
or decanoate) by Frequency Category Estimated From
Spontaneous Reporting Rates
Nervous System Disorders
Blood and Lymphatic System Disorders
Motor dysfunction Agranulocytosis, Pancytopenia, Muscle contractions involuntary Thrombocytopenia, Leukopenia, Neutropenia Neuroleptic malignant syndrome Immune System Disorders
Anaphylactic reaction, Hypersensitivity Inappropriate antidiuretic hormone secretion Metabolic and Nutritional Disorders
Psychotic disorder, Agitation, Confusional state, Musculoskeletal and Connective Tissue Disorders
Depression, Insomnia Nervous System Disorders
Convulsion, Headache Torsade de pointes, Ventricular fibrillation, Ventricular tachycardia, Extrasystoles Respiratory, thoracic and mediastinal disorders
Reproductive System and Breast Disorders
Bronchospasm, Laryngospasm, Laryngeal Breast discomfort Acute Hepatic Failure, Hepatitis, Cholestasis, Sexual dysfunction Jaundice, Liver function test abnormal Menstrual disorder Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis, Dermatitis exfolia- General Disorders and Administration Site Conditions
tive, Urticaria, Photosensitivity reaction, Rash, Pruritis, Hyperhidrosis Renal and Urinary Disorders
Urinary retention Pregnancy, Puerperium and Perinatal Conditions
Adverse events first identified as ADRs during post- Very rare Drug withdrawal syndrome neonatal marketing experience with haloperidol are included Reproductive System and Breast Disorders
in Tables 4. The postmarketing review was based Very rare Priapism, Gynaecomastia on review of all cases where there was a use of the General Disorders and Administration Site Conditions
Sudden Death, Face oedema, Oedema, active moiety haloperidol (both haloperidol and halo- peridol decanoate). In the table, the frequencies are Investigations
provided according to the following convention: Electrocardiogram QT prolonged, Weight decreased Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1000 The manifestations are an exaggeration of the known Very rare <1/10,000, including isolated reports pharmacological effects and adverse reactions. The most prominent symptoms are: severe extrapyramidal As a direct consequence of the central dopamine reactions, hypotension, sedation. An extrapyramidal blocking effect, haloperidol has an incisive activity reaction is manifest by muscular rigidity and a gen- on delusions and hallucinations (probably due to an eralised or localised tremor. Hypertension rather than interaction in the mesocortical and limbic tissues) and hypotension is also possible.
an activity on the basal ganglia (nigrostriatal bundles). In extreme cases, the patient would appear comatose Haloperidol causes efficient psychomotor sedation, which explains the favourable effect on mania and with respiratory depression and hypotension that could other agitation syndromes (see "Indications").
be severe enough to produce a shock-like state. The risk of ventricular arrhythmias, possibly associated with On the basis of its limbic activity, haloperidol exerts QT-prolongation, should be considered.
a neuroleptic sedative activity and has been shown to be useful as an adjuvant in the treatment of chronic pain.
There is no specific antidote. Treatment is largely The activity on the basal ganglia probably under- supportive but gastric lavage or induction of emesis lies the extrapyramidal motor side-effects (dystonia, is advised (unless the patient is obtunded, comatose akathisia and parkinsonism).
or convulsing), followed by administration of activat- The more peripheral antidopaminergic effects ed charcoal.
explain the activity against nausea and vomiting (via For comatose patients, a patent airway should be the chemoreceptor-trigger zone), the relaxation of established by use of an oropharyngeal airway or the gastro-intestinal sphincters and the increased endotracheal tube. Respiratory depression may prolactin release (through an inhibition of the activity necessitate artificial respiration.
of the prolactin inhibiting factor, PIF, at the level of ECG and vital signs should be monitored and moni- the adenohypophysis).
toring should continue until the ECG is normal. Pharmacokinetic Properties
Severe arrhythmias should be treated with appropri- Absorption ate anti-arrhythmic measures.
Following oral administration, the bioavailability of the Hypotension and circulatory collapse may be coun- drug is 60 to 70%. Peak plasma levels of haloperidol teracted by use of intravenous fluids, plasma, or con- occur within two to six hours of oral dosing and about centrated albumin and vasopressor agents such as twenty minutes after intramuscular administration.
dopamine or noradrenaline. Adrenaline should not be used, since it might cause profound hypotension in Distribution the presence of Haldol®.
Plasma protein binding is 92%. The volume of distri- bution at steady state (VDss) is large (7.9 ± 2.5 L/kg). In cases of severe extrapyramidal reactions, antipar- Haloperidol crosses the blood-brain barrier easily.
kinson medication (e.g. benztropine mesylate 1 to 2 mg IM or IV) should be administered parenterally.
Haloperidol is metabolized by several routes includ- ing the cytochrome P450 enzyme system (particu- larly CYP 3A4 or CYP 2D6) and glucuronidation.
Haloperidol is a neuroleptic, belonging to the group The mean plasma half-life (terminal elimination) is 24 of the butyrophenones.
hours (range 12 to 38 hours) after oral administration Haloperidol is a potent central dopamine receptor and 21 hours (range 13 to 36 hours) after intramus- antagonist and, therefore, is classified among the cular administration. Excretion occurs with the faeces very incisive neuroleptics. Haloperidol has no anti- (60%) and the urine (40%). About 1% of the ingested histaminergic or anticholinergic activity.
haloperidol is excreted unchanged with the urine.
2 mg/ml oral solution (1 ml = 20 drops): Lactic acid, It has been suggested that a plasma haloperidol methyl parahydroxybenzoate, purified water.
concentration range from 4 μg/L to an upper limit of 10 mg/ml oral solution (1 ml = 20 drops): methyl 20 to 25 μg/L is required for a therapeutic response. parahydroxybenzoate, propyl parahydroxybenzoate, lactic acid, purified water.
Preclinical Safety Data
Nonclinical data reveal no special hazards for 5 mg/ml injectable solution: Lactic acid, water for humans based on conventional studies of repeat injection.
dose toxicity, genotoxicity and carcinogenic- Incompatibilities
ity. In rodents, haloperidol administration showed a None known.
decrease in fertility, limited teratogenicity as well as Shelf Life
Observe expiry date on the outer pack.
Haloperidol has been shown to block the cardiac Special Precautions for Storage
hERG channel in several published studies in vitro. In a number of in vivo studies intravenous admin- Tablets istration of haloperidol in some animal models Store between 15° and 30°C.
has caused significant QTc prolongation, at doses Oral solution around 0.3 mg/kg i.v., giving Cmax plasma levels 3 to Store between 15° and 30°C.
7 times higher than the effective human plasma con- Do not freeze.
centrations of 4 to 20 ng/ml.
These intravenous doses which prolonged QTc did Store between 15° and 30°C.
not cause arrhythmias. In some studies higher intra- Protect from light.
venous doses of 1 to 5 mg/kg haloperidol i.v. caused Keep out of reach of children.
QTc prolongation and/or ventricular arrhythmias at Nature and Contents of Container
Cmax plasma levels 19 to 68 times higher than the Tablets are supplied in PVC/Aluminum foil blister effective human plasma concentrations.
packs or polypropylene bottles with LDPE cap with either 1 mg, 2 mg, 5 mg, 10 mg or 20 mg tablets.
List of Excipients
The 2 mg/ml oral solution is either supplied in a 15 ml dropper bottle (0.1 mg per drop) or in a 100 ml glass 1 mg tablets: Lactose monohydrate, maize starch, bottle with a pipette. The 10 mg/ml oral solution is sucrose, talc, cottonseed oil hydrogenated, purified supplied in a 100 ml amber glass bottle with a pipette.
Injectable solution is supplied in 1 ml amber colored 2 mg tablets: Lactose monohydrate, maize starch, glass ampoules Type I.
sucrose, talc, cottonseed oil hydrogenated, quino- line yellow, purified water.
Instructions for Use and Handling <and
5 mg tablets: Lactose monohydrate, maize starch, Disposal>
talc, cottonseed oil hydrogenated, indigotindisulpho- Oral Drops: nate sodium, purified water.
10 mg tablets: Calcium hydrogen phosphate dihy- drate, maize starch, calcium stearate, quinoline yel- low, purified water.
20 mg tablets: Calcium hydrogen phosphate dihy- drate, maize starch, pregelatinized potato starch, Haldol® is supplied in a 15 ml LDPE dropper bottle calcium stearate, purified water.
with a child-proof cap and is opened as follows: push the plastic screw cap down while turning it Fig. 1: The 100 ml amber glass bottle comes with counter clockwise.
a child-resistant cap, and should be opened as fol- After removal of the screw cap, the required num- lows: ber of drops can be obtained by means of the drop - Push the plastic screw cap down while turning it counter, which is fitted on the bottle.
counter clockwise.
- Remove the unscrewed cap.
Oral solution: (glass pipette) Fig. 2: Insert the pipette into the bottle.
While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millili- ters or milligrams you need to give.
Fig. 3: Holding the bottom ring, remove the entire The 100 ml amber glass bottle comes with a child- pipette from the bottle.
proof cap, that you should replace by the child-proof Empty the pipette into a cup by sliding the upper ring down and drink it immediately.
Close the bottle.
Rinse the pipette with some water for future use.
Ampoules:1. Hold the ampoule between the thumb These two accessories work as follows: and index finger, leaving the tip of the Push the plastic screw cap down, while turning it ampoule free.
counter clockwise.
2. With the other hand, hold the tip of ampoule putting the index finger When using the bottle for the first time: against the neck of ampoule, and the - Fig. 1: Remove the cap from the bottle.
thumb on the coloured point in parallel - Fig. 2: Pull the drop counter out of its case.
to the identification coloured ring(s).
- Now, fit the drop counter on the bottle.
3. Keeping the thumb on the point, sharply break the From then on, whenever you need the medicine, tip of ampoule while holding firmly the other part proceed as below: of the ampoule in the hand.
- Fig. 3: Remove the drop counter from the bottle.
- Take the amount of liquid you need to give. You will find the number of millilitres or milligrams on the drop counter.
- Fit the drop counter back on the bottle after each MANUFACTURED BY
See outer carton.
Oral solution: (plastic pipette) DATE OF REVISION OF THE TEXT

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