Arbinoxa

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• barbiturates such as thiopental (Pentothal), butalbital (Fioricet, Fiorinal), phenobarbital (Luminal)
• benzodiazepines such as diazepam (Valium), alprazolam (Xanax), and lorazepam (Ativan)
• buspirone (Buspar)
• non-benzodiazepines such as zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata)
• CNS depressants such as carisoprodol (Soma) and cyclobenzoprine (Flexeril)
• monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Eldepryl, Emsam), and amitriptyline (Elavil)

This is not a complete list of carbinoxamine drug interactions. 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)

Before taking carbinoxamine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are taking a monoamine oxidase inhibitor (MAOI)
• are prescribed this medication for your child. Children less than 2 years old should not be prescribed this medication.
• have hypertension
• have heart disease
• have a stomach ulcer
• have an enlarged prostate gland
• have trouble with urination
• have hyperthyroidism
• have eye problems, including glaucoma and increased intraocular (eye) pressure
• are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in carbinoxamine
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of carbinoxamine can be fatal, especially to a child.

Overdose symptoms may include extreme drowsiness or restless feeling, dilated pupils, hallucinations, or seizure (convulsions).

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking carbinoxamine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

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.

CArbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).

CArbinoxamine maleate should be taken on an empty stomach with water.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

CArbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.

Clinical experience suggests the following dosage schedules:

Tablets

Usual Adult Dosage:

• 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily

Usual Child's Dosage:

• Six to eleven years1/2 to 1 tablet (2 to 4 mg) 3 or 4 times daily.

Summary of Use during Lactation

Small occasional doses of carbinoxamine are probably acceptable during breastfeeding. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. The nonsedating antihistamines are preferred alternatives.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

There are no reports of infants breastfed during maternal therapy with carbinoxamine. In one telephone follow-up study, mothers reported irritability and colicky symptoms in 10% of infants exposed to various antihistamines and drowsiness was reported in 1.6% of infants. None of the reactions required medical attention.[1]

Effects on Lactation and Breastmilk

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[2][3] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[2] Whether lower oral doses of carbinoxamine have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Desloratadine, Fexofenadine, Loratadine

References

1. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

2. Messinis IE, Souvatzoglou A, Fais N et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143-6. PMID: 3928731

3. Pontiroli AE, De Castro e Silva E, Mazzoleni F et al. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981;52:924-8. PMID: 7228996