Prescription Drug Information: Haloperidol (Page 3 of 3)

Tardive Dystonia

Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible.

Other CNS Effects

Insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, headache, confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations and catatonic-like behavioral states which may be responsive to drug withdrawal and/or treatment with anticholinergic drugs.

Body as a Whole: Neuroleptic malignant syndrome (NMS), hyperpyrexia and heat stroke have been reported with haloperidol. (See WARNINGS for further information concerning NMS.)

Hematologic Effects: Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis. Agranulocytosis has rarely been reported to have occurred with the use of haloperidol, and then only in association with other medication.

Liver Effects: Impaired liver function and/or jaundice have been reported.

Dermatologic Reactions: Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.

Endocrine Disorders: Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

Gastrointestinal Effects: Anorexia, constipation, diarrhea, hypersalivation, dyspepsia, nausea and vomiting.

Autonomic Reactions: Dry mouth, blurred vision, urinary retention, diaphoresis and priapism.

Respiratory Effects: Laryngospasm, bronchospasm and increased depth of respiration.

Special Senses: Cataracts, retinopathy and visual disturbances.

Post-marketing Events

Hyperammonemia has been reported in a 51⁄2 year old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with haloperidol.

OVERDOSAGE

Manifestations

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction would be manifest by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively. With accidental overdosage, hypertension rather than hypotension occurred in a 2 year old child. The risk of ECG changes associated with Torsades de pointes should be considered. (For further information regarding Torsades de pointes, please refer to ADVERSE REACTIONS.)

Treatment

Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal. Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered. ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate antiarrhythmic measures.

DOSAGE AND ADMINISTRATION

There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.

To determine the initial dosage, consideration should be given to the patient’s age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.

Clinical experience suggests the following recommendations:

Oral Administration

Initial Dosage Range

Adults

Moderate Symptomatology — 0.5 mg to 2 mg b.i.d. or t.i.d.

Severe Symptomatology — 3 mg to 5 mg b.i.d. or t.i.d.

To achieve prompt control, higher doses may be required in some cases.

Geriatric or Debilitated Patients — 0.5 mg to 2 mg b.i.d. or t.i.d.

Chronic or Resistant Patients — 3 mg to 5 mg b.i.d. or t.i.d.

Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently haloperidol has been used in doses above 100 mg for severely resistant patients; however the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Children

The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.)

The total dose may be divided, to be given b.i.d. or t.i.d.

Psychotic Disorders — 0.05 mg/kg/day to 0.15 mg/kg/day

Nonpsychotic Behavior Disorders and Tourette’s Disorder — 0.05 mg/kg/day to 0.075 mg/kg/day

Severely disturbed psychotic children may require higher doses. In severely disturbed, non-psychotic children or in hyperactive children with accompanying conduct disorders, who have failed to respond to psychotherapy or medications other than antipsychotics, it should be noted that since these behaviors may be short lived, short term administration of haloperidol may suffice. There is no evidence establishing a maximum effective dosage. There is little evidence that behavior improvement is further enhanced in dosages beyond 6 mg per day.

Maintenance Dosage

Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.

Switchover Procedure

The oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.

HOW SUPPLIED

Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP.

The 0.5 mg tablets are orange round tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0351-01
bottles of 100 tablets

NDC 0378-0351-10
bottles of 1000 tablets

The 1 mg tablets are orange round tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0257-01
bottles of 100 tablets

NDC 0378-0257-10
bottles of 1000 tablets

The 2 mg tablets are orange round tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0214-01
bottles of 100 tablets

NDC 0378-0214-10
bottles of 1000 tablets

The 5 mg tablets are orange round tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0327-01
bottles of 100 tablets

NDC 0378-0327-10
bottles of 1000 tablets

The 10 mg tablets are light green round tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0334-01
bottles of 100 tablets

The 20 mg tablets are light blue round tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0335-01
bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 11/2016
HALO:R22

DRUG: Haloperidol

GENERIC: haloperidol

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0023-0

COLOR: green

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: MYLAN;334

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • HALOPERIDOL 10mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 1
  • SODIUM LAURYL SULFATE
  • STARCH, CORN
  • MICROCRYSTALLINE CELLULOSE
  • FD&C YELLOW NO. 6
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
Remedy_Label
(click image for full-size original)
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0023(NDC:0378-0334)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color green (light green) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code MYLAN;334
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0023-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070278 11/30/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2020 REMEDYREPACK INC.

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