Karbinal

Karbinal ER is a prescription medication used to treat runny nose, stuffy nose, watery eyes, and itching caused by hay fever, seasonal and perennial allergies, and other allergic conditions. Karbinal ER belongs to a group of drugs called antihistamines, which work by stopping the action of histamines, a substance produced in the body to react to foreign substances.

This medication comes in an extended-release oral suspension (liquid) form to be taken by mouth, once every 12 hours. It may be taken with or without food.

Common side effects of Karbinal ER include sleepiness, dizziness, loss of coordination, stomach irritation, and thickening of mucus. Do not drive or operate heavy machinery until you know how Karbinal ER affects you.

Karbinal ER 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.

• Tris Pharma, Inc.

Serious side effects have been reported with Karbinal ER. See “Drug Precautions” section.

Common side effects of Karbinal ER include:

• sleepiness
• dizziness
• loss of coordination
• stomach irritation
• thickening of mucus.

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

This is not a complete list of Karbinal ER side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 Karbinal ER drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Karbinal ER including:

• Pediatric Mortality: Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products; therefore, Karbinal ER is not used in children younger than 2 years of age.
• Concomitant Medical Conditions: Karbinal ER 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: Karbinal ER 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.

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

Do not give Karbinal ER 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 Karbinal ER or any of the inactive ingredients in Karbinal ER
• 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 Karbinal ER, there are no specific foods that you must exclude from your diet when receiving Karbinal ER.

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

Before taking Karbinal ER, 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 Karbinal ER or any of the inactive ingredients in Karbinal ER
• 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.

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

It is not known if Karbinal ER 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 Karbinal ER is contraindicated in nursing mothers. Do not breastfeed if you are taking Karbinal ER.

• Take Karbinal ER exactly as prescribed.
• The dose of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated. 

• Give Karbinal ER by the orally (by mouth) only. Measure Karbinal ER with an accurate milliliter-measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Karbinal ER at the same time.

Take Karbinal ER exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• Adults and Adolescents 12 years of age and older:
  • 7.5 mL to 20 mL (6 to 16 mg) every 12 hours
• Children 2 to 11 years of age (about 0.2 to 0.4 mg/kg/day):
  • 2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours

  • 4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) every 12 hours

  • 6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours

If you take too much Karbinal ER, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Karbinal ER suspension at room temperature.

Dispense in tight, light-resistant container with child-resistant closure.

Keep this and all medicines out of the reach of children.