Promethazine Hydrochloride and Codeine Phosphate (Page 4 of 4)

OVERDOSAGE

Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.

Promethazine: Signs and symptoms of overdosage with promethazine HCl 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: The treatment of overdosage with promethazine and codeine 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. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy.

Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

It is important that Promethazine Hydrochloride and Codeine Phosphate Syrup is measured with an accurate measuring device (see PRECAUTIONS- Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.

The average effective dose for adults and children 12 years and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

The average effective dose for children 6 years to under 12 years of age is: ½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

HOW SUPPLIED

Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent. It is supplied as follows:

NDC 12634-909-02 60 mL Bottle

NDC 12634-909-04 120mL Bottle

NDC 12634-909-06 178mL Bottle

NDC 12634-909-08 237 mL Bottle

NDC 12634-909-16 473 mL Bottle

NDC 12634-909-28 3785 mL Bottle

NDC 12634-909-32 946 mL Bottle

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

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

Manufactured by

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 804:08 05/15

Repackged and Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

PRINCIPAL DISPLAY PANEL

label
(click image for full-size original)

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP

6.25 mg/10 mg per 5 mL

Each 5 mL contains:

Promethazine Hydrochloride ……………. 6.25 mg

Codeine Phosphate ………………………….10 mg

Alcohol ………………………………………..7%

Contains FD&C Yellow No. 6

USUAL DOSAGE: See attached insert for full prescribing information.

Keep tightly closed. Store at room temperature between 20° and 25°C (68° and 77°F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container, as defined in the USP.

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
promethazine hydrochloride and codeine phosphate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-909(NDC:50383-804)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 10 mg in 5 mL
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ASCORBIC ACID
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCROSE
Product Characteristics
Color purple (Purple to reddish purple) Score
Shape Size
Flavor BOYSENBERRY (artificial boysenberry flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-909-02 60 mL in 1 BOTTLE None
2 NDC:12634-909-04 120 mL in 1 BOTTLE None
3 NDC:12634-909-06 178 mL in 1 BOTTLE None
4 NDC:12634-909-08 237 mL in 1 BOTTLE None
5 NDC:12634-909-16 473 mL in 1 BOTTLE None
6 NDC:12634-909-28 3785 mL in 1 BOTTLE None
7 NDC:12634-909-32 946 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040151 08/26/1997
Labeler — Apotheca Inc (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca Inc. 051457844 repack (12634-909), relabel (12634-909)

Revised: 03/2017 Apotheca Inc

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