Antihistamine/decongestant combination (oral route)

Brand Name

US Brand Name

Alavert-D 12-Hour

Aldex D

AllanVan-S

Allegra-D

BPM Pseudo

Bromfed-PD

Ceron

Deconamine SR

Pediatex 12D

Pediatex-D

Robitussin DM

Ryneze

Semprex-D

Tannate Pediatric

Tripohist D

Uni-Tann D

ZyrTEC-D

Canadian Brand Name

Benylin For Allergies

Description

In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products.

Antihistamine and decongestant combinations are used to treat the nasal congestion (stuffy nose), sneezing, and runny nose caused by colds and hay fever.

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Antihistamines contained in these combinations are:

acrivastine, azatadine, brompheniramine, carbinoxamine, chlorpheniramine, clemastine, dexbrompheniramine, diphenhydramine, loratadine, pheniramine, phenyltoloxamine, promethazine, pyrilamine, and triprolidine.

The decongestants, such as phenylephrine, and pseudoephedrine, produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

Some of these combinations are available only with your doctor's prescription. Others are available without a prescription; however, your doctor may have special instructions on the proper dose of the medicine for your medical condition.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 2 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

This product is available in the following dosage forms:

Solution
Tablet, Extended Release
Syrup
Suspension
Elixir
Tablet
Tablet, Chewable
Tablet, Extended Release, 24 HR

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Very young children are usually more sensitive to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children. If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional.

Geriatric

Confusion, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients.

Pregnancy

The occasional use of antihistamine and decongestant combinations is not likely to cause problems in the fetus or in the newborn baby. However, when these medicines are used at higher doses and/or for a long time, the chance that problems might occur may increase. For the individual ingredients of these combinations, the following apply:

Alcohol—Some of these combination medicines contain alcohol. Too much use of alcohol during pregnancy may cause birth defects.
Phenylephrine—Studies on birth defects have not been done in either humans or animals with phenylephrine.
Promethazine—Phenothiazines, such as promethazine (contained in some of these combination medicines [e.g., Phenergan-D]), have been shown to cause jaundice and muscle tremors in a few newborn infants whose mothers received phenothiazines during pregnancy. Also, the newborn baby may have blood clotting problems if promethazine is taken by the mother within 2 weeks before delivery.
Pseudoephedrine—Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when administered in high doses.

Breastfeeding

Small amounts of antihistamines and decongestants pass into the breast milk. Use is not recommended since the chances are greater for this medicine to cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since antihistamines tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients. It is not known yet whether loratadine causes these same side effects.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Amprenavir
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Bepridil
Buprenorphine
Buserelin
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Cisapride
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clorgyline
Clothiapine
Clozapine
Crizotinib
Cyclobenzaprine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Desipramine

Using medicines in this class 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.

Adagrasib
Alefacept
Alfentanil
Almotriptan
Amantadine
Amifampridine
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amoxapine
Amphetamine
Anagrelide
Avacopan
Benzhydrocodone
Benzphetamine
Bromocriptine
Brompheniramine
Buprenorphine
Bupropion
Buspirone
Butorphanol
Carbamazepine
Celecoxib
Chlorpheniramine
Citalopram
Clarithromycin
Clomipramine
Clozapine
Cocaine
Codeine
Cyclobenzaprine
Desipramine
Desvenlafaxine
Dextroamphetamine
Dextromethorphan
Dibenzepin
Difenoxin
Dihydrocodeine
Diphenoxylate

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using medicines in this class 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 your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Proper Use

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

If this medicine irritates your stomach, you may take it with food or a glass of water or milk, to lessen the irritation.

For patients taking the extended-release capsule or tablet form of this medicine:

Swallow it whole.
Do not crush, break, or chew before swallowing.
If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

Dosing

The dose medicines in this class 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 these medicines. 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.

There is a large variety of antihistamine and decongestant combination products on the market. Some products are for use in adults only, while others may be used in children. If you have any questions about this, check with your health care professional.

Follow your doctor's orders if this medicine was prescribed. Or, follow the directions on the box if you are buying this medicine without a prescription

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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.

When taking antihistamines (contained in this combination medicine) on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.

The antihistamine in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are other antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

The antihistamine in this medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Some antihistamines are more likely to cause drowsiness than others (loratadine , for example, rarely produces this effect). Make sure you know how you react before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

The decongestant in this medicine may add to the central nervous system (CNS) stimulant and other effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor

The decongestant in this medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Antihistamines may cause dryness of the mouth, nose, and throat. Some antihistamines are more likely to cause dryness of the mouth than others (loratadine , for example, rarely produces this effect). For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients using promethazine-containing medicine:

This medicine controls nausea and vomiting. For this reason, it may cover up the signs of overdose caused by other medicines or the symptoms of intestinal blockage. This will make it difficult for your doctor to diagnose these conditions. Make sure your doctor knows that you are taking this medicine if you have other symptoms such as stomach or lower abdominal pain, cramping, or soreness. Also, if you think you may have taken an overdose of any medicine, tell your doctor that you are taking this medicine.

Side Effects

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.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

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

For promethazine only

Muscle spasms (especially of neck and back)
restlessness
shuffling walk
tic-like (jerky) movements of head and face
trembling and shaking of hands

Clumsiness or unsteadiness
convulsions (seizures)
drowsiness (severe)
dryness of mouth, nose, or throat (severe)
hallucinations (seeing, hearing, or feeling things that are not there
headache (continuing)
shortness of breath or troubled breathing
slow, fast, or irregular heartbeat
trouble in sleeping

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Back, leg or stomach pain
black, sticky stools
bleeding gums
blood, cloudy or dark urine, or sudden decrease in amount of urine
blood pressure increased
blurred vision
chest pain
confusion
diarrhea
dizziness
faintness, or lightheadedness when getting up from a lying or sitting position
fever or chills
light-colored stools
mood or mental changes
nosebleeds
sore throat and fever
skin rash or hives
stillbirth
swollen mouth, throat, face, fingers, feet, glands or lower legs
sweating suddenly
tightness in chest
troubled breathing
twitching, twisting, or uncontrolled repetitive movements of face
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood
weight gain suddenly
yellow or pale eyes or skin

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

Drowsiness
thickening of the bronchial secretions

Less common

Blurred vision
confusion
difficult or painful urination
dizziness
dryness of mouth, nose, or throat
headache
loss of appetite
nightmares
pounding heartbeat
ringing or buzzing in ears
skin rash
stomach upset or pain (more common with pyrilamine)
unusual excitement, nervousness, restlessness, or irritability
unusual sleepiness, weakness or drowsiness, extreme tiredness

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.

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