Histex I / E

Histex I/E is part of the drug class:

• Aminoalkyl ethers

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Because of the risk of death in infants given carbinoxamine-containing drugs, use of carbinoxamine is contraindicated in nursing mothers.

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

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

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

This section provides information on the proper use of a number of products that contain carbinoxamine. It may not be specific to Histex I/E. Please read with care.

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.

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 oral dosage form (extended-release suspension):
  • For treatment of allergies:
    • Adults and children 12 years of age and older—6 to 16 milligrams (mg) 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 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 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 every 12 hours. 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.

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 have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. 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 not able to think well.

This medicine will add to 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 medical 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.

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.