Histex I/E (Oral)

Carbinoxamine is used to relieve symptoms of seasonal (short-term) or perennial (long-term) allergies, such as sneezing, runny nose, itching, watery eyes, hives, skin rash, and wheezing. It also helps with 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 manage allergic reactions to blood or plasma.

You can only get this medicine with a prescription from your doctor.

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 help your doctor 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 this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you feel 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 medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of these while using this medicine.

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

In deciding to use a medicine, you need to consider the risks against the benefits. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your healthcare provider 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

Using carbinoxamine in children younger than 2 years is not recommended. It might cause serious or possibly life-threatening side effects in this age group.

Geriatric

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

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. It is especially important that your healthcare provider knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions are selected based on their potential significance and are not all-inclusive.

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

• 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 needed 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
• 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

Some medicines should not be taken at the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions about food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, 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 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:

Incidence not known

• 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, 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 any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• anxiety
• bloating
• 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
• seizures
• 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:

More common

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

Incidence not known

• 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.

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.