Arbinoxa - Carbinoxamine (Oral Route)

    Arbinoxa – Carbinoxamine (Oral Route)

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    Description and Brand Names of Arbinoxa – Carbinoxamine (Oral Route)

    US Brand Name

    1. Arbinoxa
    2. Carbihist
    3. Carboxine
    4. Histex CT
    5. Histex IE
    6. Histex PD
    7. Histuss PD
    8. Karbinal ER
    9. Mintex PD
    10. Palgic
    11. Pediatex
    12. Pediox

    Descriptions

    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 product is available in the following dosage forms:

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

    Before Using Arbinoxa – Carbinoxamine (Oral Route)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Use of carbinoxamine extended-release suspension in children younger than 2 years of age is not recommended. Using this medicine in children younger than 2 years might cause serious or possibly life-threatening side effects.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of carbinoxamine extended-release suspension in the elderly. However, elderly patients are more likely to have dizziness, drowsiness, confusion, lightheadedness, or fainting which may require caution and an adjustment in the dose for patients receiving this medicine.

    Pregnancy

    Breastfeeding

    Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

    • Furazolidone
    • Iproniazid
    • Isocarboxazid
    • Linezolid
    • Methylene Blue
    • Moclobemide
    • Pargyline
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Selegiline
    • Tranylcypromine

    Using this medicine with any of the following medicines is usually not recommended, but may be required 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
    • Amobarbital
    • Anileridine
    • Bromazepam
    • Buprenorphine
    • Buspirone
    • Butabarbital
    • Butorphanol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpromazine
    • Clobazam
    • Clonazepam
    • Clorazepate
    • Codeine
    • Dexmedetomidine
    • Diacetylmorphine
    • Diazepam
    • Difenoxin
    • Dihydrocodeine
    • Diphenhydramine
    • Diphenoxylate
    • Doxylamine
    • Estazolam
    • Eszopiclone
    • Ethchlorvynol
    • Ethylmorphine
    • Fentanyl
    • Flumazenil
    • Flurazepam
    • Halazepam
    • Hydrocodone
    • Hydromorphone
    • Hydroxyzine
    • Ketazolam
    • Ketobemidone
    • Levorphanol
    • Lorazepam
    • Meperidine
    • Meprobamate
    • Methadone
    • Methotrimeprazine
    • Midazolam
    • Morphine
    • Morphine Sulfate Liposome
    • Nalbuphine
    • Nicomorphine
    • Nitrazepam
    • Opium
    • Opium Alkaloids
    • Oxazepam
    • Oxycodone
    • Oxymorphone
    • Papaveretum
    • Paregoric
    • Pentobarbital
    • Phenobarbital
    • Piritramide
    • Prazepam
    • Promethazine
    • Propofol
    • Propoxyphene
    • Quazepam
    • Ramelteon
    • Remifentanil
    • Secobarbital
    • Sufentanil
    • Tapentadol
    • Temazepam
    • Thioridazine
    • Tilidine
    • Topiramate
    • Tramadol
    • Triazolam
    • Zaleplon
    • Zolpidem
    • Zopiclone

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily 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 how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Asthma – This medicine 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 make these conditions worse.

    Proper Use of Arbinoxa – Carbinoxamine (Oral Route)

    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.

    Precautions

    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.

    Side Effects of Arbinoxa – Carbinoxamine (Oral Route)

    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

    1. Blurred vision
    2. chills
    3. confusion
    4. cough
    5. decrease in the frequency of urination
    6. decrease in urine volume
    7. difficult or painful urination
    8. difficulty in passing urine (dribbling)
    9. difficulty with swallowing
    10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    11. fast, irregular, pounding, or racing heartbeat or pulse
    12. hives or welts
    13. itching
    14. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    15. rash
    16. redness of the skin
    17. skin rash
    18. sweating
    19. tightness in the chest
    20. unusual tiredness or weakness

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

    Symptoms of overdose

    1. Agitation
    2. anxiety
    3. bloating
    4. convulsions
    5. diarrhea
    6. difficulty with sleeping
    7. disorientation
    8. dizziness
    9. drowsiness to profound coma
    10. dry mouth
    11. feeling of warmth
    12. fixed and enlarged pupils
    13. gas
    14. headache
    15. lethargy
    16. lightheadedness
    17. loss of appetite
    18. nausea
    19. redness of the face, neck, arms, and occasionally, upper chest
    20. seeing, hearing, or feeling things that are not there
    21. stomach pain
    22. tightness of the chest
    23. trouble breathing
    24. 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

    1. Disturbed coordination
    2. drowsiness
    3. sleepiness

    Incidence not known

    1. Back, leg, or stomach pains
    2. black, tarry stools
    3. bleeding gums
    4. blood in the urine or stools
    5. blurred vision
    6. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    7. chills
    8. confusion
    9. continuing ringing or buzzing or other unexplained noise in the ears
    10. cough or hoarseness
    11. dark urine
    12. difficulty breathing
    13. difficulty having a bowel movement (stool)
    14. dizziness or lightheadedness
    15. double vision
    16. dry mouth, nose, and throat
    17. feeling excited
    18. feeling of constant movement of self or surroundings
    19. fever with or without chills
    20. general body swelling
    21. general feeling of tiredness or weakness
    22. headache
    23. hearing loss
    24. increased sensitivity of the skin to sunlight
    25. itching
    26. loss of appetite
    27. lower back or side pain
    28. nosebleeds
    29. pale skin
    30. pinpoint red spots on the skin
    31. redness or other discoloration of the skin
    32. restlessness
    33. seeing double
    34. seizures
    35. sensation of spinning
    36. severe sunburn
    37. shakiness in the legs, arms, hands, or feet
    38. sore throat
    39. sores, ulcers, or white spots on the lips or in the mouth
    40. trembling or shaking of the hands or feet
    41. trouble sleeping
    42. unusual bleeding or bruising
    43. weight loss
    44. 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.