Pediatex

Carbinoxamine is a prescription medication used for the treatment of:

• seasonal and perennial allergic rhinitis (allergies of the nasal airways causing runny, itchy nose and nasal congestion)
• vasomotor rhinitis (runny nose not due to allergy)
• allergic conjunctivitis (inflammation of the membrane covering the white part of the eye) due to inhalant allergens and foods
• hives and swelling under the skin (angioedema) caused by allergic reaction
• dermatographism (skin disorder characterized by the skin becoming raised and inflamed (hive-like) when stroked or rubbed with a dull object)
• treatment of allergic emergencies
• treatment of allergic reactions to blood or plasma

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with carbinoxamine including:

• Pediatric Mortality: Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products; therefore, carbinoxamine is not used in children younger than 2 years of age.
• Concomitant Medical Conditions: Carbinoxamine should be used with caution in patients with:
  • increased intraocular pressure
  • glaucoma
  • hyperthyroidism
  • cardiovascular disease
  • hypertension
  • stenosing (narrowing) peptic ulcer
  • enlargement of the prostate gland
  • bladder neck obstruction, or pyloroduodenal obstruction
• Allergic Reactions due to Sulfites: Carbinoxamine contains a sulfite that may cause allergic-type reactions, including anaphylaxis, life-threatening, or less severe asthmatic episodes in those with an allergy to sulfites/sulfa-containing drugs.

Carbinoxamine can cause drowsiness. Do not drive or operate heavy machinery until you know how carbinoxamine affects you.

Do not give carbinoxamine to the following patients:

• children younger than 2 years of age because deaths have been reported in this age group
• nursing mothers because of the risk of mortality in infants given carbinoxamine-containing products
• patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in carbinoxamine
• who are taking monoamine oxidase inhibitors (MAOI)

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of carbinoxamine, there are no specific foods that you must exclude from your diet when receiving carbinoxamine.

Alcohol may intensify some of the side effects of this medication.

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.

Carbinoxamine falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. Carbinoxamine should be given to a pregnant woman only if clearly needed.

It is not known if carbinoxamine will harm your unborn baby.

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:

• Suspension, Extended Release
• Suspension
• Solution
• Tablet
• Liquid
• Tablet, Extended Release
• Capsule, Extended Release

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Carbinoxamine

Chemical Class: Carbinoxamine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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

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

• Agitation
• anxiety
• bloating
• convulsions
• diarrhea
• difficulty with sleeping
• disorientation
• dizziness
• drowsiness to profound coma
• dry mouth
• feeling of warmth
• fixed and enlarged pupils
• gas
• headache
• lethargy
• lightheadedness
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• stomach pain
• tightness of the chest
• trouble breathing
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Disturbed coordination
• drowsiness
• sleepiness

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• dark urine
• difficulty breathing
• difficulty having a bowel movement (stool)
• dizziness or lightheadedness
• double vision
• dry mouth, nose, and throat
• feeling excited
• feeling of constant movement of self or 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 may report side effects to the FDA at 1-800-FDA-1088.

For all patients taking Pediatex (carbinoxamine liquid):

• If you have an allergy to carbinoxamine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Pediatex within 14 days of those drugs can cause very bad high blood pressure.
• If you have asthma.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

Children:

• If your child is younger than 2 years of age. Do not give Pediatex to a child younger than 2 years of age.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Pediatex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Pediatex for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Avoid drinking alcohol while taking Pediatex.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Pediatex while you are pregnant.

Applies to carbinoxamine: oral capsule extended release, oral liquid, oral solution, oral suspension, oral suspension extended release, oral tablet, oral tablet extended release

Along with its needed effects, carbinoxamine (the active ingredient contained in Pediatex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carbinoxamine:

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

Get emergency help immediately if any of the following symptoms of overdose occur while taking carbinoxamine:

• Agitation
• anxiety
• bloating
• convulsions
• diarrhea
• difficulty with sleeping
• disorientation
• dizziness
• drowsiness to profound coma
• dry mouth
• feeling of warmth
• fixed and enlarged pupils
• gas
• headache
• lethargy
• lightheadedness
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• stomach pain
• tightness of the chest
• trouble breathing
• vomiting

Some side effects of carbinoxamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Disturbed coordination
• drowsiness
• sleepiness

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• dark urine
• difficulty breathing
• difficulty having a bowel movement (stool)
• dizziness or lightheadedness
• double vision
• dry mouth, nose, and throat
• feeling excited
• feeling of constant movement of self or 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