Alavert-D 12-Hour

1 What is Alavert-D 12-Hour?

Brand: Alavert-D 12-Hour, Aldex D, AllanVan-S, Allegra-D, BPM Pseudo, Bromfred-PD, Ceron, Deconamine SR, Pediatex 12D, Pediatex-D, Ryneze, Semprex-D, Tannate Pediatric, Tripohist D, Uni-Tann D, Zymine, ZyrTEC-D

Generic: Antihistamine and decongestant

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.

Alavert-D 12-Hour is used to treat nasal congestion, sneezing and runny nose caused by colds and allergies.

Antihistamines work by preventing the effects of histamines, which are produced by the body. Histamines cause itching, sneezing, runny nose and watery eyes.

Antihistamines contained in these combinations are:

  • Acrivastine
  • Azatadine
  • Brompheniramine
  • Carbinoxamine
  • Chlorpheniramine
  • Clemastine
  • Dexbrompheniramine
  • Diphenhydramine
  • Loratidine
  • Pheniramine
  • Phenyltoloxamine
  • Promethazine
  • Pyrilamine
  • Triprolidine.

Decongestants, such as phenylephrine and pseudophedrine, cause blood vessels to narrow. This leads to clearing up nasal congestion, but may cause an increase of blood pressure in patients who have high blood pressure (hypertension).

Some of these combinations are only available with your doctor’s prescription, while others may be available over the counter. You doctor may have special instructions on a proper dose of medication for your condition.

Do not give any over the counter cough and cold medication to any child or infant under 2 years of age. Using these medications in very young children may cause serious or life-threatening side effects.

This product is available in the following forms:

  • Solution
  • Capsule
  • Suspension
  • Tablet, Chewable
  • Tablet, Extended Release
  • Capsule, Extended Release
  • Syrup
  • Tablet
  • Elixir
  • Tablet, Disintegrating
  • Suspension, Extended Release
  • Tablet, Extended Release, 24 HR
  • Liquid
  • Capsule, Extended Release, 24 HR
  • Kit

2 What to Know Before Using

As with all medicines, the risks of using Alavert-D 12-Hour must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

  • AllergiesInform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
  • Pediatric: Very young children are normally more sensitive to the effects of this medication. Increase in blood pressure, nightmares, unusual excitement, nervousness, restlessness or irritability may be more likely to occur in children. Be sure to check the package label very carefully. Some of these medications are too strong for children. If you are not sure whether a specific product can be given to a child, or you have any questions about the amount to give, ask your doctor.Do not give any over the counter cough and cold medicine to child or infant under 2 years of age. Using these medications in very young children may cause serious or life-threatening side effects.
  • Geriatric: Elderly patients are normally more sensitive to the effects of the medication. Confusion, difficult or painful urination, dizziness, drowsiness, dry mouth, unusual excitement, nervousness, restlessness, irritability or convulsions may be more likely to occur in this population.
  • Pregnancy: The occasional use of this medication is unlikely to cause problems in the fetus or newborn baby. However, when used at higher doses or for extended periods of time, the chance of problems may increase. For individual ingredients, the following apply:
    • Alcohol - Some of these medications contain alcohol. Too much alcohol during pregnancy may cause birth defects.
    • Phenylephrine - Studies in birth defects have not been done in either humans or animals.
    • Promethazine - Phenothiazines, such as promethazine, have been shown to cause jaundice and muscle tremors in a few newborn infants whose mothers received phenothiazines during pregnancy. Newborn babies may also have blood clotting problems if promethazine is taken by the mother within 2 weeks before delivery.
    • Pseudoephedrine - Studies on birth defects 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 this medication pass into breast milk. Use is not recommended since the chances are greater that this medication will cause side effects in nursing babies, such as unusual excitement or irritability. Because antihistamines 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 whether loratadine causes these side effects.
  • Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.Using this medication with any of the following is not recommended. Your doctor may decide not to treat you with this medication, or change some of the other medications you take:
    • Alfuzosin
    • Amifampridine
    • Amiodarone
    • Amitriptyline
    • Amprenavir
    • Anagrelide
    • Apomorphine
    • Aripiprazole
    • Arsenic Trioxide
    • Artemether
    • Asenapine
    • Astemizole
    • Atazanavir
    • Azithromycin
    • Bedaquiline
    • Bepridil
    • Buserelin
    • Chloroquine
    • Chlorpromazine
    • Ciprofloxacin
    • Cisapride
    • Citalopram
    • Clarithromycin
    • Clomipramine
    • Clorgyline
    • Clozapine
    • Crizotinib
    • Cyclobenzaprine
    • Dabrafenib
    • Darunavir
    • Degarelix
    • Delamanid
    • Delavirdine
    • Desipramine
    • Deslorelin
    • Dihydroergotamine
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone
    • Donepezil
    • Doxepin
    • Dronedarone
    • Droperidol
    • Ebastine
    • Eribulin
    • Erythromycin
    • Escitalopram
    • Famotidine
    • Felbamate
    • Fingolimod
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Fluvoxamine
    • Formoterol
    • Fosaprepitant
    • Foscarnet
    • Fosphenytoin
    • Furazolidone
    • Galantamine
    • Gatifloxacin
    • Gemifloxacin
    • Gonadorelin
    • Goserelin
    • Granisetron
    • Halofantrine
    • Haloperidol
    • Histrelin
    • Hydroquinidine
    • Hydroxychloroquine
    • Ibutilide
    • Iloperidone
    • Imipramine
    • Indinavir
    • Iproniazid
    • Isocarboxazid
    • Itraconazole
    • Ivabradine
    • Ketoconazole
    • Lapatinib
    • Leuprolide
    • Levofloxacin
    • Levomethadyl
    • Linezolid
    • Lumefantrine
    • Mefloquine
    • Mesoridazine
    • Methadone
    • Methylene Blue
    • Metronidazole
    • Mifepristone
    • Mizolastine
    • Moclobemide
    • Moxifloxacin
    • Nafarelin
    • Nefazodone
    • Nelfinavir
    • Nialamide
    • Nilotinib
    • Norfloxacin
    • Octreotide
    • Ofloxacin
    • Olanzapine
    • Ondansetron
    • Paliperidone
    • Panobinostat
    • Pargyline
    • Paroxetine
    • Pasireotide
    • Pazopanib
    • Pentamidine
    • Perflutren Lipid Microsphere
    • Perphenazine
    • Phenelzine
    • Pimozide
    • Pipamperone
    • Piperaquine
    • Posaconazole
    • Potassium
    • Probucol
    • Procainamide
    • Procarbazine
    • Prochlorperazine
    • Promethazine
    • Propafenone
    • Protriptyline
    • Quetiapine
    • Quinidine
    • Ranolazine
    • Rasagiline
    • Rilpivirine
    • Risperidone
    • Ritonavir
    • Safinamide
    • Saquinavir
    • Selegiline
    • Sertindole
    • Sevoflurane
    • Sibutramine
    • Sodium Phosphate
    • Sodium Phosphate, Dibasic
    • Sodium Phosphate, Monobasic
    • Solifenacin
    • Sorafenib
    • Sotalol
    • Sparfloxacin
    • Sunitinib
    • Tacrolimus
    • Tamoxifen
    • Telaprevir
    • Telavancin
    • Telithromycin
    • Tetrabenazine
    • Thioridazine
    • Tipranavir
    • Tizanidine
    • Toloxatone
    • Tolterodine
    • Toremifene
    • Tranylcypromine
    • Trazodone
    • Trimipramine
    • Triptorelin
    • Vandetanib
    • Vardenafil
    • Vemurafenib
    • Venlafaxine
    • Vilanterol
    • Vinflunine
    • Voriconazole
    • Vorinostat
    • Ziprasidone
    • ZolmitriptanUsing this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:
    • Alefacept
    • Almotriptan
    • Amiodarone
    • Amitriptyline
    • Amoxapine
    • Anagrelide
    • Blinatumomab
    • Bromocriptine
    • Bupropion
    • Carbamazepine
    • Ceritinib
    • Citalopram
    • Clomipramine
    • Clozapine
    • Darunavir
    • Dasatinib
    • Desipramine
    • Desvenlafaxine
    • Dolasetron
    • Donepezil
    • Dothiepin
    • Doxepin
    • Duloxetine
    • Escitalopram
    • Fentanyl
    • Fluoxetine
    • Fluvoxamine
    • Furazolidone
    • Golimumab
    • Granisetron
    • Guanethidine
    • Hydroxytryptophan
    • Idelalisib
    • Imipramine
    • Iobenguane I 123
    • Lanreotide
    • Levomilnacipran
    • Linezolid
    • Lofepramine
    • Lorcaserin
    • Memantine
    • Meperidine
    • Methyldopa
    • Midodrine
    • Milnacipran
    • Mirtazapine
    • Nortriptyline
    • Opipramol
    • Oxymorphone
    • Palonosetron
    • Panobinostat
    • Paroxetine
    • Pirfenidone
    • Protriptyline
    • Quinine
    • Secukinumab
    • Sertraline
    • Sibutramine
    • Siltuximab
    • Tramadol
    • Trazodone
    • Trimipramine
    • Venlafaxine
    • Vilazodone
    • Vortioxetine
    • Ziprasidone
  • Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may change the dose or how often you take your medication, or give you special instructions about the use of food, alcohol or tobacco:
    • Grapefruit juice
  • Other Medical Problems: Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:
    • Type 2 Diabetes Mellitus - The decongestant in this medication may put diabetic patients at greater risk of having heart or blood vessel disease.
    • Enlarged prostate
    • Urinary tract blockage or difficult urination - Some of the affects of antihistamines may make urinary problems worse.
    • Glaucoma - A slight increase in inner eye pressure may occur.
    • Heart or blood vessel disease
    • High blood pressure (hypertension) - The decongestant in this medication may cause blood pressure to increase and may speed up the heart rate.
    • Kidney disease - Higher blood levels of loratadine may result, which may increase the chance of side effects. The dosage of loratadine-containing combination may need to be reduced.
    • Liver disease - Higher blood levels of loratadine may result, which may increase the chance of side effects.
    • Overactive thyroid - If the overactive thyroid causes a fast heart rate, the decongestant in this medication may cause the heart rate so speed up further.
    • Urinary retention - Condition may be worsened with use of pseudoephedrine.

3 Proper Usage

Only take Alavert-D 12-Hour as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

If this medication irritates your stomach, 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:

  • Swallow this medication 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

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

There is a large variety of antihistamine and decongestant combination products. Some products are for use in adults only, while others may be used for children. If you have questions, ask your doctor.

Do not give any over the counter cough and cold medication to a child under 2 years of age. Using these medications in very young children may cause serious or life-threatening side effects.

Missed Dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage

Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze. Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

4 Precautions To Take

Before having any skin tests for allergies, tell your doctor that you are taking Alavert-D 12-Hour. The results of the test may be affected by the antihistamine in this medication.

When taking antihistamines on a regular basis, inform your doctor if you take large amounts of aspirin at the same time. The effects of too much aspirin, such as ringing in the ears (tinnitus), may be covered up by antihistamines.

The antihistamine in this medication will add to the effects of alcohol and other CNS depressants (medications that slow down the nervous system). Some examples of CNS depressants are other antihistamines, medication for allergies or colds, sedatives, tranquilizers, sleeping medication, prescription pain medication, narcotics, barbiturates, medication for seizures, muscle relaxants or anaesthetics. Ask your doctor before taking any of the above medications while on this medication.

The antihistamine in this medication may cause some people to become drowsy, dizzy or less alert than normal. Some antihistamines are more likely to produce these effects than others. Be sure you know how you react to this medication before you drive, operate machinery or other activities that may be dangerous if you are not alert.

The decongestant in this medication may add to the CNS stimulant or other effects of diet aids. Do not use medications for diet or appetite control while taking this medication unless you have talked to your doctor.

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

Antihistamines may cause dryness in the mouth, nose and throat. Some antihistamines are more likely to cause this effect than others. For temporary relief, use sugarless candy or gum, melt ice chips in your mouth or use a saliva substitute. If this effect continues for more than 2 weeks, check with your dentist. Continuous dryness in the mouth may increase the chance of dental disease, including tooth decay, gum disease and fungal infections.

For patients using promethazine-containing medication:

This medication controls nausea and vomiting and, therefore, may cover up the signs of overdose caused by other medications, or symptoms of intestinal blockage. This will make it difficult for your doctor to diagnose these conditions.
Inform your doctor if you are taking this medication if you have other symptoms such as stomach or lower abdominal pain, cramping or soreness. If you think you may have taken an overdose of a medication, inform your doctor that you are taking this medication.

5 Potential Side Effects

Alavert-D 12-Hour may produce unwanted affects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

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

For promethazine only

  • Muscle spasms (especially in the neck or back)
  • Restlessness
  • Shuffling walk
  • Tic-like (jerky) movements of head and face
  • Trembling and shaking of hands

Check with your doctor immediately if you experience any of the following side-effects:

Rare

  • Back, leg or stomach pain
  • Black, tarry stools
  • Bleeding gums
  • Blood, cloudy or dark urine, or sudden decrease in amount of urine
  • Blurred vision
  • Chest pain
  • Confusion
  • Diarrhea
  • Dizziness
  • Faintness, or lightheadedness when getting up from a lying or sitting position
  • Fever or chills
  • Increase in blood pressure
  • 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
  • Trouble breathing
  • Twitching, twisting, or uncontrolled repetitive movements of face
  • Unusual bleeding or bruising
  • Unusual fatigue or weakness
  • Vomiting of blood
  • Weight gain suddenly
  • Yellow or pale eyes or skin

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

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 (palpitations)
  • Ringing or buzzing in ears (tinnitus)
  • Skin rash
  • Stomach upset or pain (more common with pyrilamine)
  • Unusual excitement, nervousness, restlessness, or irritability
  • Unusual sleepiness, weakness or drowsiness, extreme fatigue

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask 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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