Prochlorperazine Maleate (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Adults

(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.

Elderly Patients

In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

1. To Control Severe Nausea and Vomiting

Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.

Oral Dosage – Tablets

Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.

2. In Adult Psychiatric Disorders

Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or two, longer treatment is usually required before maximal improvement is seen.

Oral Dosage

Non-Psychotic Anxiety – Usual dosage is 5 mg 3 or 4 times daily. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.

Psychotic Disorders including SchizophreniaIn relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily.

In moderate to severe conditions , for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily.

In more severe disturbances , optimum dosage is usually 100 to 150 mg daily.

Children

Do not use in pediatric surgery.

Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises.

Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonia).

1. Severe Nausea and Vomiting In Children

Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.

Oral Dosage

More than 1 day’s therapy is seldom necessary.

Weight Usual Dosage Not to Exceed
under 20 lbs not recommended
20 to 29 lbs 2½ mg 1 or 2 times a day 7.5 mg per day
30 to 39 lbs 2½ mg 2 or 3 times a day 10 mg per day
40 to 85 lbs

2½ mg 3 times a day or

15 mg per day

2. In Children with Schizophrenia

Oral Dosage

For children 2 to 12 years, starting dosage is 2-1/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.

FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.

FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.

HOW SUPPLIED

Prochlorperazine maleate tablets, USP for oral administration are available as:

5 mg: 1 Round, pale-yellow, film coated, unscored tablets, debossed GG 952 on one side and debossed 5 on the reverse side and supplied as follows:

NDC 54868-4721-1NDC 54868-4721-4 Bottles of 15Bottles of 20
NDC 54868-4721-0 Bottles of 30
NDC 54868-4721-2 Bottles of 60
NDC 54868-4721-3 Bottles of 100

10 mg: 2 Round, pale-yellow, film coated, unscored tablets, debossed GG 953 on one side and debossed 10 on the reverse side and supplied as follows:

NDC 54868-1082-1 Bottles of 10
NDC 54868-1082-0 Bottles of 15
NDC 54868-1082-2 Bottles of 20
NDC 54868-1082-4 Bottles of 30
NDC 54868-1082-5 Bottles of 60
NDC 54868-1082-6 Bottles of 90
NDC 54868-1082-3 Bottles of 100

STORAGE

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

REFERENCES

  1. Levophed® is a registered trademark of Abbott Laboratories.
  2. Neo-Synephrine® is a registered trademark of Abbott Laboratories.
  3. Dilantin® is a registered trademark of Parke-Davis.
  4. Amipaque® is a registered trademark of Sanofi Pharmaceuticals.
  5. Benadryl® is a registered trademark of Parke-Davis.

04-2009M

7263

Sandoz Inc.

Princeton, NJ 08540

Relabeling and Repackaging by:

Physicians Total Care, Inc.
Tulsa, OK 74146

5 mg Label

Prochlorperazine

Maleate

Tablets, USP

5 mg*

Rx only

Prochlorperazine Maleate 5 mg Label
(click image for full-size original)

10 mg Label

Prochlorperazine

Maleate

Tablets, USP

10 mg*

Rx only

Prochlorperazine Maleate 10 mg Label
(click image for full-size original)
PROCHLORPERAZINE MALEATE prochlorperazine maleate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4721(NDC:0781-5020)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE) PROCHLORPERAZINE 5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
STEARIC ACID
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color yellow (pale) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GG952;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4721-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4721-1 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4721-2 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4721-3 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-4721-4 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040101 02/10/2003
PROCHLORPERAZINE MALEATE prochlorperazine maleate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1082(NDC:0781-5021)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE) PROCHLORPERAZINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
STEARIC ACID
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color yellow (pale) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code GG953;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1082-0 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-1082-1 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-1082-2 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-1082-3 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-1082-4 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-1082-5 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
7 NDC:54868-1082-6 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040101 01/07/2000
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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