Pediatex (Oral)

Carbinoxamine is used to relieve symptoms of seasonal (short-term) or perennial (long-term) allergies, including sneezing, runny nose, itching, watery eyes, hives, skin rash, itching, or wheezing. It is also used to help with symptoms of allergic rhinitis, allergic conjunctivitis from inhaled allergens and foods, or allergic skin reactions. This medicine is an antihistamine.

Carbinoxamine is used alongside epinephrine to treat severe allergic reactions (anaphylaxis). It is also used to address allergic reactions to blood or plasma.

This medicine is available only with your doctor's prescription.

If you will be taking this medicine for a long time, it is very important that your doctor check you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you are using an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and unable to think clearly.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

It is not recommended to use carbinoxamine in children younger than 2 years of age. Using this medicine in young children may cause serious or possibly life-threatening side effects.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of carbinoxamine extended-release suspension. However, older adults are more likely to experience dizziness, drowsiness, confusion, lightheadedness, or fainting, or may have age-related issues with their liver, kidneys, or heart. These may require caution and a dose adjustment for patients taking this medicine.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should either stop breastfeeding while using this medicine or ask your doctor to prescribe an alternative.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. If you are taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are significant and not necessarily exhaustive.

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

• Calcium Oxybate
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Magnesium Oxybate
• Methylene Blue
• Moclobemide
• Pargyline
• Phenelzine
• Potassium Citrate
• Potassium Oxybate
• Procarbazine
• Rasagiline
• Selegiline
• Sodium Oxybate
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Alfentanil
• Alprazolam
• Amantadine
• Amifampridine
• Amobarbital
• Anileridine
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Cannabidiol
• Cannabis
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Donepezil
• Doxylamine
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flurazepam
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Loxapine
• Meperidine
• Meprobamate
• Methacholine
• Methadone
• Methotrimeprazine
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Olanzapine
• Opium
• Opium Alkaloids
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentobarbital
• Periciazine
• Phenobarbital
• Piritramide
• Pitolisant
• Prazepam
• Pregabalin
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Secretin Human
• Sufentanil
• Tapentadol
• Temazepam
• Thioridazine
• Tilidine
• Tiotropium
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The interactions below are significant and not necessarily exhaustive.

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If used together, your doctor may adjust the dose or frequency, or give you specific instructions regarding food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical issues may impact the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Allergy to sulfites, history of or
• Asthma—The extended-release oral suspension contains sodium metabisulfite, which may cause allergic reactions in patients with this condition.

• Bladder blockage or
• Bowel blockage or
• Enlarged prostate or
• Glaucoma, narrow-angle or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Peptic ulcer—Use with caution. May worsen these conditions.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

Incidence not known

• Blurred vision
• chills
• confusion
• cough
• decrease in urination frequency
• decrease in urine volume
• painful or difficult urination
• trouble passing urine (dribbling)
• trouble swallowing
• dizziness, faintness, or lightheadedness when standing up suddenly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• hives or welts, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• sweating
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if you notice any of the following overdose symptoms:

Symptoms of overdose

• Agitation
• anxiety
• bloating
• diarrhea
• trouble sleeping
• disorientation
• dizziness
• drowsiness to profound coma
• dry mouth
• feeling warm
• fixed and enlarged pupils
• gas
• headache
• lethargy
• lightheadedness
• loss of appetite
• nausea
• redness of the face, neck, arms, and sometimes, upper chest
• seeing, hearing, or feeling things that are not real
• seizures
• tightness of the chest
• trouble breathing
• vomiting

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your healthcare professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Clumsiness or unsteadiness
• cough with mucus
• drowsiness
• sleepiness

Incidence not known

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• confusion
• continuous ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• dark urine
• difficulty breathing
• trouble having a bowel movement (stool)
• dizziness or lightheadedness
• double vision
• dry mouth, nose, and throat
• feeling excited
• sensation of constant movement of yourself or your surroundings
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• hearing loss
• increased sensitivity of the skin to sunlight
• itching
• loss of appetite
• lower back or side pain
• nosebleeds
• pale skin
• pinpoint red spots on the skin
• redness or other discoloration of the skin
• restlessness
• seeing double
• seizures
• sensation of spinning
• severe sunburn
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• trembling or shaking of the hands or feet
• trouble sleeping
• unusual bleeding or bruising
• weight loss
• yellowing of the eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Arbinoxa
• Carbihist
• Carboxine
• Histex CT
• Histex I/E
• Histex PD
• Histuss PD
• Karbinal ER
• Mintex PD
• Palgic
• Pediatex
• Pediox

Available Dosage Forms:

• Solution
• Tablet
• Suspension, Extended Release

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Carbinoxamine

Chemical Class: Carbinoxamine

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often, unless otherwise directed by your doctor.

Take the tablet and oral syrup on an empty stomach with water.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

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 treatment of allergies: For oral dosage form (extended-release suspension): Adults and children 12 years of age and older—6 to 16 milligrams (mg) or 7.5 to 20 milliliters (mL) every 12 hours. Your doctor may adjust your dose as needed. Children 6 to 11 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 6 to 12 mg or 7.5 to 15 mL every 12 hours. Your doctor may adjust your dose as needed. Children 4 to 5 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 to 8 mg or 3.75 to 10 mL every 12 hours. Your doctor may adjust your dose as needed. Children 2 to 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 to 4 mg or 3.75 to 5 mL every 12 hours. Your doctor may adjust your dose as needed. Children younger than 2 years of age—Use is not recommended. For oral dosage form (solution): Adults and children 12 years of age and older—4 to 8 milligrams (mg) (1 or 2 teaspoonfuls) 3 to 4 times a day. Your doctor may adjust your dose as needed. Children 6 to 11 years of age—2 to 4 mg (½ to 1 teaspoonful) 3 to 4 times a day. Your doctor may adjust your dose as needed. Children 2 to 5 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 to 2 mg (¼ to ½ teaspoonful) 3 to 4 times a day. Your doctor may adjust your dose as needed. Children younger than 2 years of age—Use is not recommended. For oral dosage form (tablets): Adults and children 12 years of age and older—4 to 8 milligrams (mg) (1 or 2 tablets) 3 to 4 times a day. Your doctor may adjust your dose as needed. Children 6 to 11 years of age—2 to 4 mg (½ to 1 tablet) 3 to 4 times a day. Your doctor may adjust your dose as needed. Children younger than 2 years of age—Use is not recommended.

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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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