Promethazine Hydrochloride (Page 3 of 3)

OVERDOSAGE

Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine like signs and symptoms – dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms – may occur.

Treatment

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).

Allergy

The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken 3 times daily will usually suffice. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine hydrochloride tablets in 25 mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 mg to 25 mg, twice daily, may be administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients).

The average effective dose of promethazine hydrochloride tablets for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. 12.5 mg to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 mg to 25 mg promethazine hydrochloride tablets by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 mg to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Promethazine hydrochloride tablets in 12.5 mg to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine like drug.

Usual adult dosage is a 50 mg promethazine hydrochloride tablet with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 mg to 25 mg in children and 25 mg to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.

HOW SUPPLIED

Promethazine Hydrochloride Tablets, USP are available containing 12.5 mg, 25 mg or 50 mg of promethazine hydrochloride, USP.

The 12.5 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and PT above the score and 12 below the score on the other side. They are available as follows:

NDC 0378-7028-01
bottles of 100 tablets

NDC 0378-7028-10
bottles of 1000 tablets

The 25 mg tablets are white to off-white, round, scored tablets debossed with M on one side of the tablet and PT above the score and 25 below the score on the other side. They are available as follows:

NDC 0378-7029-01
bottles of 100 tablets

NDC 0378-7029-10
bottles of 1000 tablets

The 50 mg tablets are white to off-white, round tablets debossed with M on one side of the tablet and PT over 50 on the other side. They are available as follows:

NDC 0378-7030-01
bottles of 100 tablets

NDC 0378-7030-10
bottles of 1000 tablets

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

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 JULY 2011
PROM:R2

PRINCIPAL DISPLAY PANEL — 12.5 mg

NDC 0378-7028-01

Promethazine
Hydrochloride
Tablets, USP
12.5 mg

Rx only 100 TABLETS

Each tablet contains:
Promethazine
hydrochloride, USP 12.5 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

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

www.mylan.com

RM7028A1

Promethazine Hydrochloride Tablets 12.5 mg Bottle Labels
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg

NDC 0378-7029-01

Promethazine
Hydrochloride
Tablets, USP
25 mg

Rx only 100 TABLETS

Each tablet contains:
Promethazine
hydrochloride, USP 25 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

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

www.mylan.com

RM7029A1

Promethazine Hydrochloride Tablets 25 mg Bottle Labels
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 0378-7030-01

Promethazine
Hydrochloride
Tablets, USP
50 mg

Rx only 100 TABLETS

Each tablet contains:
Promethazine
hydrochloride, USP 50 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

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

www.mylan.com

RM7030A1

Promethazine Hydrochloride Tablets 50 mg Bottle Labels
(click image for full-size original)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7028
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code M;PT;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7028-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091054 08/30/2011 10/31/2013
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code M;PT;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7029-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-7029-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091054 08/30/2011 02/28/2014
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code M;PT;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7030-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091054 08/30/2011 02/28/2014
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 07/2011 Mylan Pharmaceuticals Inc.

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