Mintex PD

Carbinoxamine 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. Carbinoxamine 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 carbinoxamine include sleepiness, dizziness, loss of coordination, stomach irritation, and thickening of mucus. Do not drive or operate heavy machinery until you know how carbinoxamine affects you.

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.

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 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.

Store carbinoxamine 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.

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

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

Breast Feeding

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.

Interactions with Medicines

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
• Sodium Oxybate
• 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
• Bromopride
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Donepezil
• Doxylamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flurazepam
• Fospropofol
• 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
• Periciazine
• Phenobarbital
• Piritramide
• Prazepam
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Ramelteon
• Remifentanil
• Secobarbital
• Sufentanil
• Tapentadol
• Temazepam
• Thioridazine
• Tilidine
• Tiotropium
• Topiramate
• Tramadol
• Triazolam
• Zaleplon
• Zolpidem
• Zopiclone

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain carbinoxamine. It may not be specific to Mintex PD. 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.

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.