Phenadoz

Name: Phenadoz

Warnings

Black Box Warnings

IV administration can cause severe tissue injury, including burning, gangrene, or thrombophlebitis, necessitating fasciotomy, skin graft, or amputation

Severe tissue injury can occur from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration

Deep IM injection is preferred method of administration

Intra-arterial and SC administration are contraindicated

25 mg/mL product may be administered by deep IM injection or IV infusion (at rate not to exceed 25 mg/min through flowing IV tubing)

Monitor for signs and symptoms of potential tissue injury including burning or pain at site of injection, phlebitis, swelling, and blistering

Discontinue IV infusion immediately if patient complains of pain during injection

Respiratory fatalities reported with use in children <2 years (use contraindicated); use lowest effective dose in children >2 years; avoid other drugs with respiratory depressant effects

Contraindications

Hypersensitivity

Newborn/premature infants <2 years old (risk of potentially fatal respiratory depression)

SC or intra-arterial administration

Coma

Treatment of lower respiratory tract symptoms, including asthma

Cautions

Use caution in asthma, hepatic impairment, peptic ulcer disease, respiratory impairment, bone marrow suppression, anaphylaxis in susceptible individuals

May impair ability to drive or perform hazardous tasks

May impair core body temperature regulation; caution when taking medications with anticholinergic effects, heat exposure, or strenuous exercise

Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia

May alter cardiac conduction (life-threatening arrhythmias reported)

Antiemetic effect may obscure toxicity of chemotherapeutic drugs

Monitor closely in patients with cardiovascular disease, hepatic impairment, Reye syndrome, or history of sleep apnea

Has anticholinergic effects; use with caution in patients with decreased gastrointestinal motility or obstructions (partial or comlete), urinary retention, urinary obstructions, xerostomia, BPH, or visual problems

May cause extrapyramidal symptoms including pseudoparkinsonism, acute dystonic reactions, tardive dyskinesia, and akathisia

Neuroleptic malignant syndrome reported with use; monitor for fever, muscle rigidity and/or autonomic instability, or mental status changes

May cause orthostatic hypotension; use caution in patients at risk of experiencing hypotensive episodes (cardiovascular disease, cerebrovascular disease, hypovolemia or taking medications that may predispose to bradycardia or hypotension)

May cause photosensitivity

Pyloroduodenal obstruction, stenosing peptic ulcer disease, bladder neck obstruction

Anticholinergic effects of promethazine may exacerbate condition in patients with narrow-angle glaucoma or myasthenia gravis

Phenadoz and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy.  Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Promethazine falls into category C.  Studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women.  This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Phenadoz Usage

Take promethazine exactly as prescribed.

Promethazine comes as a tablet, oral solution (liquid), rectal suppository, or liquid to be injected into the muscle.  
  • For prevention of motion sickness, promethazine is usually taken 30-60 minutes before departure, and then every 12 hours as needed.
  • For treatment of nausea and vomiting, promethazine is usually taken every 4 to 6 hours as needed.
  • For treatment of allergies, promethazine is usually taken once daily at bedtime, or 2 to 3 times daily before meals.
  • For sedation, promethazine is usually taken once daily at bedtime.

Promethazine can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of promethazine at the same time. 

 

Before Using Phenadoz

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of promethazine in the pediatric population. Safety and efficacy have not been established in children below 2 years of age. Caution should be used when this medicine is given to children 2 years of age and older .

Geriatric

Insufficient information is available on the relationship of age to the effects of promethazine in geriatric patients. However, elderly patients may be more sensitive to the side effects of this medicine (such as confusion and severe drowsiness) than in younger adults, and are more likely to have age-related heart or blood vessel disease, liver problems, and kidney disease, which may require adjustment of dosage in patients receiving promethazine .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sodium Oxybate
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Bromazepam
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Butorphanol
  • Carbinoxamine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Codeine
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dihydrocodeine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxylamine
  • Droperidol
  • Efavirenz
  • Erythromycin
  • Escitalopram
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Levorphanol
  • Lithium
  • Lopinavir
  • Lumefantrine
  • Meclizine
  • Mefloquine
  • Meperidine
  • Methadone
  • Metrizamide
  • Metronidazole
  • Mifepristone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nalbuphine
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Periciazine
  • Pimavanserin
  • Pitolisant
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Ribociclib
  • Salmeterol
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sufentanil
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tiotropium
  • Toremifene
  • Tramadol
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zolpidem
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aminolevulinic Acid
  • Belladonna
  • Belladonna Alkaloids
  • Betel Nut
  • Evening Primrose
  • Midodrine
  • Phenylalanine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain disease or injury or
  • Breathing or lung problems (e.g., asthma) or
  • Comatose state (unconscious) or
  • Reye's syndrome or
  • Sleep apnea, history of—Promethazine should NOT be used in patients with any of these conditions .
  • Bone marrow disease or
  • Enlarged prostate or
  • Glaucoma or
  • Heart or blood vessel disease or
  • Intestinal tract obstruction or
  • Jaundice or
  • Liver disease or
  • Neuroleptic malignant syndrome, or history of, or
  • Stomach ulcer or
  • Urinary tract blockage or difficult urination—Use with caution. This medicine may make these conditions worse .
  • Seizure disorders—This medicine may increase the chance of seizures especially in patients who are also using narcotic or anesthetic medicines .

Proper Use of promethazine

This section provides information on the proper use of a number of products that contain promethazine. It may not be specific to Phenadoz. Please read with care.

Never take rectal suppositories by mouth.

Wash your hands with soap and water before and after using this medicine.

To insert suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill the suppository in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For rectal dosage form (suppositories):
    • For allergy symptoms:
      • Adults and teenagers—12.5 milligrams (mg) before meals and at bedtime; or 25 mg at bedtime as needed.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 6.25 to 12.5 mg three times a day; or 25 mg at bedtime as needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For prevention of motion sickness:
      • Adults and teenagers—25 mg twice daily; this initial dose should be taken one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed. On other days of travel, 25 mg may be taken on arising and again before the evening meal.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg one-half to one hour before traveling. The dose may be repeated eight to twelve hours later if needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For nausea and vomiting:
      • Adults and teenagers—25 mg for the first dose, then 12.5 to 25 mg every four to six hours if needed.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg every four to six hours as needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For sedation:
      • Adults and teenagers—25 to 50 mg.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 12.5 to 25 mg.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .
    • For control of pain or anxiety before or after surgery:
      • Adults and teenagers—50 mg the night before surgery; 25 to 50 mg after surgery.
      • Children 2 years of age and older—Your doctor will determine dose based on the weight and/or size of the child. The dose is usually 0.5 mg per pound of body weight (1.1 mg per kg) or 12.5 to 25 mg the night before surgery or after the surgery.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.

Keep out of the reach of children.

Precautions

General

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Phenadoz Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Information for Patients

Phenadoz Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment  (see WARNINGS–CNS Depression  and PRECAUTIONS–Drug Interactions). Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities.

The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. 

Patients should be advised to report any involuntary muscle movements. 

Avoid prolonged exposure to the sun.

Drug Interactions

CNS Depressants – Phenadoz Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Phenadoz Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine – Because of the potential for Phenadoz to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenadoz Suppositories overdose.

Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Phenadoz Suppositories.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl:

Pregnancy Tests

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test

An increase in blood glucose has been reported in patients receiving promethazine HCl.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. 

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of Phenadoz Suppositories in pregnant women. 

Phenadoz Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Phenadoz Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. (See “DOSAGE AND ADMINISTRATION ”). Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine HCl is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Phenadoz Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Phenadoz SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning  and Use in Pediatric Patients).

Phenadoz Suppositories should be used with caution in pediatric patients 2 years of age and older  (see WARNINGS - Use in Pediatric Patients).

Geriatric Use

Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine HCl suppositories and observed closely.

PRINCIPAL DISPLAY PANEL - 12.5 mg Suppository Carton

NDC 0591-2985-39

Phenadoz®
Promethazine HCl Suppositories, USP

12.5 mg            
For Rectal Administration

Watson                    12 Suppositories                    Rx only

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