Phenadoz

Phenadoz is a neuroleptic drug and antihistamine used for the relief or prevention of symptoms of hay fever, allergic conjunctivitis, and other types of allergy or allergic reactions.

This drug works by preventing the effects of histamine such as:

• Itching
• Sneezing
• Runny nose
• and Watery eyes

This drug can cause bronchoconstriction making breathing difficult. This drug is also used for the prevention and control of motion sickness, nausea, vomiting, and dizziness.

This drug may be used to induce sleep and control their pain or anxiety before or after surgery or other procedures. This drug requires a prescription.

Before using Phenadoz, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of promethazine have not been performed while safety and efficacy have not been established in children below 2 years of age. Caution should be given when using this drug in children 2 years of age and older.

Adjustments in the dose of the elderly may be required since they are more sensitive to the side effects of this drug, and are more likely to have age-related heart or blood vessel disease, liver problems, and kidney disease.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when taking this drug during breastfeeding. Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• CNS depressants
• Anticholinergics
• Epinephrine
• or Monoamine oxidase inhibitors

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

• Brain disease or injury
• Breathing or lung problems
• Comatose state
• Reye's syndrome
• Sleep apnea
• Bone marrow disease
• Enlarged prostate
• Glaucoma
• Cardiovascular disease
• Intestinal tract obstruction
• Jaundice
• Liver disease
• Neuroleptic malignant syndrome
• Stomach ulcer
• Urinary tract blockage
• Difficult urination
• or Seizure disorders

To use Phenadoz properly, you must follow all instructions given by your doctor.

• This drug should not be taken by mouth.
• Your hands must be washed with soap and water before and after using this drug.
• The foil wrapper must be removed and the suppository must be moistened with cold water.
• Lie down on your side and use your finger to push the suppository well up into the rectum.
• Chill the suppository in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper if the suppository is too soft to insert.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults and teenagers with allergy symptoms, motion sickness, or nausea and vomiting are given 12.5 milligrams before meals and at bedtime, or 25 mg at bedtime as needed.

A healthcare professional will determine dose based on the weight and/or size of children 2 years of age and older. The dose is usually 6.25 to 12.5 mg three times a day, or 25 mg at bedtime as needed. Use and dose in children younger than 2 years of age must be determined by your healthcare professional.

The dose in adults and teenagers for control of pain or anxiety before or after surgery is usually 50 mg the night before surgery, 25 to 50 mg after surgery. A healthcare professional will determine dose based on the weight and/or size of children 2 years of age and older.

The dose is usually 0.5 mg per pound of body weight or 12.5 to 25 mg the night before surgery or after the surgery. Use and dose in children younger than 2 years of age must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

Before using Phenadoz, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

Your blood sugar levels may be affected by this drug. Check with your healthcare professional if you notice a change in the results of your blood or urine sugar tests or if you have any questions.

This drug may cause:

• Dizziness
• Lightheadedness
• Drowsiness
• or Reduced alertness

Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous.

This drug will potentiate the effects of alcohol and other CNS depressants such as:

• Antihistamines or drug for hay fever
• Other allergies or colds
• Sedatives
• Tranquilizers
• Antidepressants or sleeping drug
• Prescription pain drug or narcotics
• Barbiturates
• Drug for seizures
• Muscle relaxants or anesthetics
• Including some dental anesthetics

Check with your healthcare professional immediately if you have signs of respiratory depression such as:

• Pale or blue lips, fingernails or skin
• Difficult or troubled breathing
• Irregular, fast, slow or shallow breathing
• or Shortness of breath

Check with your healthcare professional immediately and stop taking your drug if you have symptoms of neuroleptic malignant syndrome such as:

• Muscle stiffness
• Fever
• Difficult or fast breathing
• Seizures
• Fast heartbeat
• Increased sweating
• Loss of bladder control
• Unusually pale skin
• Tiredness or weakness

Notify the healthcare professional in charge that you are taking this drug before having any medical tests, since the results of some tests may be affected by this drug. It is recommended to use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute for relief since this drug may cause dryness of the mouth.

Check with your health care professional or dentist if your mouth continues to feel dry for more than 2 weeks, since continuing mouth dryness may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

This drug may make your skin more sensitive to sunlight. It is recommended to apply sunscreen when you are outdoors. Sunlamps and tanning beds must be avoided.

This drug may cover up some of the signs of overdose caused by other drugs or the symptoms of encephalopathy or Reye's syndrome since this drug controls nausea and vomiting and make it difficult for your healthcare professional to diagnose these conditions. Notify your healthcare professional that you are using this drug.

As with many medications, there are several potential side effects associated with Phenadoz. Side effects may vary for each individual and prompt medical attention should be given if they occur. 

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• Convulsions
• Difficult or unusually fast breathing
• Fast heartbeat or irregular pulse
• High fever
• High or low blood pressure
• Increased sweating
• Loss of bladder control
• Severe muscle stiffness
• Unusually pale skin
• Unusual tiredness or weakness
• Abdominal or stomach pain
• Black, tarry stools
• Bleeding gums
• Blood in urine or stools
• Bloody nose
• Blurred vision
• Chest pain or discomfort
• Chills
• Clay-colored stools
• Confusion as to time, place or person
• A cough or hoarseness
• Dark urine
• Decreased awareness or responsiveness
• Difficulty or troubled breathing
• Double vision
• Fast, pounding or irregular heartbeat or pulse
• Fever with or without chills
• Fixed position of eye
• Headache
• Heavier menstrual periods
• High fever
• Holding false beliefs that cannot be changed by fact
• Hyperexcitability
• Increased or decreased blood pressure
• Increased sweating
• Irregular, fast or slow or shallow breathing
• Itching large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lightheadedness
• Dizziness or fainting
• Loss of appetite
• Loss of bladder control
• Lower back or side pain
• Mimicry of speech or movements
• Mutism
• Nasal stuffiness
• Nausea
• Negativism
• Nightmares
• Noisy breathing
• Not breathing
• Painful or difficult urination
• Pale or blue lips, fingernails or skin
• Peculiar postures or movements
• Mannerisms or grimacing
• Pinpoint red spots on skin
• Seeing double
• Seeing, hearing or feeling things that are not there
• Seizures
• Severe muscle stiffness
• Severe sleepiness
• Shortness of breath
• Skin rash
• Slow or irregular heartbeat
• Sore throat
• Sores, ulcers or white spots on lips or in mouth
• Sticking out of tongue
• Swollen glands
• Tightness in chest
• Tremors
• Uncontrolled twisting movements of neck
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual excitement
• Nervousness or restlessness
• Unusual tiredness or weakness
• Vomiting of blood
• Wheezing
• Yellow eyes or skin
• or Symptoms of overdose such as:
  • Discouragement
  • Dizziness
  • Faintness, or lightheadedness when getting up from a lying or sitting position
  • Suddenly dry mouth
  • Excessive muscle tone
  • Feeling of warmth
  • Feeling sad or empty
  • Irritability
  • Lack of appetite
  • Loss of interest or pleasure
  • Muscle tension or tightness
  • Overactive reflexes
  • Large pupils of eyes and not moving or responding to light
  • Redness of the face, neck, arms and occasionally, upper chest
  • Shakiness and unsteady walk
  • Sudden death
  • Trouble concentrating
  • Trouble sleeping
  • Unconsciousness
  • Unsteadiness
  • Trembling or other problems with muscle control or coordination
  • or Unusual paleness

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.