Palgic

Pregnancy Category: C

Lactation: excretion in milk unknown/contraindicated

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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.

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)

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 carbinoxamine, there are no specific foods that you must exclude from your diet when receiving carbinoxamine.

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

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.

Acute Allergic Reactions

Amelioration of allergic reactions to blood or plasma.100 g

Adjunct to epinephrine and other standard measures for management of anaphylaxis after acute symptoms have been controlled.100 g

Allergic and Nonallergic Rhinitis

Symptomatic relief of seasonal (e.g., hay fever) or perennial (nonseasonal) allergic rhinitis or nonallergic (vasomotor) rhinitis.100 g

Allergic Conjunctivitis

Symptomatic relief of allergic conjunctivitis caused by foods or inhaled allergens.100 g

Allergic Skin Disorders

Symptomatic management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.100 g

Treatment of dermatographism.100 g

Regulations Governing Carbinoxamine-containing Preparations

Many unapproved carbinoxamine-containing preparations formerly on the US market contained inappropriate labeling that promoted unapproved uses (including management of congestion†, cough†, or the common cold†, and use in children <2† years of age), which posed serious health risks.101 102 (See Pediatric Use under Cautions and also see Preparations.)

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Carbinoxamine maleate is contraindicated in children younger than 2 years of age.

Carbinoxamine maleate is contraindicated in nursing mothers.

Carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (See Drug Interactions section.)

Palgic (Carbinoxamine Maleate Tablets USP, 4 mg) is supplied as white, round, scored tablets, debossed “PAL” on one side and score “4” on the other side, and are supplied in bottles of 100 tablets, NDC 0525-6748-01 and bottles of 500 tablets, NDC 0525-6748-05.

Palgic (Carbinoxamine Maleate Oral Solution, 4 mg/5 mL) is also supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 4 oz bottles NDC 0525-6752-04 and 16 oz bottles NDC 0525-6752-16.

Store at controlled room temperature, 15°C to 30°C (59°F to 86°F) [See USP].

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium.

 Manufactured for:

Pamlab, L.L.C.

Covington, LA 70433

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Code 838B00

Rev. 09/10

Applies to carbinoxamine: oral capsule extended release, oral liquid, oral solution, oral suspension, oral suspension extended release, oral tablet, oral tablet extended release

Along with its needed effects, carbinoxamine (the active ingredient contained in Palgic) 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 while taking carbinoxamine:

• 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 while taking carbinoxamine:

• 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 of carbinoxamine 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