Dramamine II

In the U.S.

• Antivert
• Antivert/25
• Antivert/50
• Dramamine II
• Meclicot
• Meni-D
• Motion Sickness Relief
• Simply Motion
• Travel Sickness

Available Dosage Forms:

• Tablet
• Capsule
• Tablet, Chewable

Therapeutic Class: Antiemetic

Pharmacologic Class: Antihistamine

Chemical Class: Piperazine (class)

Meclizine is used to prevent and control nausea, vomiting, and dizziness caused by motion sickness. It is also used for vertigo (dizziness or lightheadedness) caused by ear problems.

Meclizine is an antihistamine. It works to block the signals to the brain that cause nausea, vomiting, and dizziness.

This medicine is available only with your doctor's prescription.

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

Appropriate studies have not been performed on the relationship of age to the effects of meclizine in the pediatric population. Safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

No information is available on the relationship of age to the effects of meclizine in geriatric patients. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving meclizine.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 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
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Clonazepam
• Clorazepate
• Codeine
• Dexmedetomidine
• 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
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Piritramide
• Prazepam
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Ramelteon
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thioridazine
• Tilidine
• Tiotropium
• 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 or
• Enlarged prostate or
• Glaucoma—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain meclizine. It may not be specific to Dramamine II. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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 (tablets):
  • For nausea, vomiting, and dizziness caused by motion sickness:
    • Adults—At first, 25 to 50 milligrams (mg) taken 1 hour before travel. You may take another dose once every 24 hours while traveling.
    • Children 12 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 12 years of age—Use is not recommended.
  • For vertigo:
    • Adults—25 to 100 milligrams (mg) per day, taken in divided doses.
    • Children 12 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 12 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.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, antidepressants, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are taking this medicine.

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:

• Cough
• difficulty swallowing
• dizziness
• drowsiness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness

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:

• Blurred vision

• Dry mouth
• headache

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.

Applies to meclizine: oral capsule, oral tablet, oral tablet chewable

Along with its needed effects, meclizine (the active ingredient contained in Dramamine II) 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 meclizine:

• Cough
• difficulty swallowing
• dizziness
• drowsiness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness

Some side effects of meclizine 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:

• Blurred vision

• Dry mouth
• headache

Applies to meclizine: compounding powder, oral tablet, oral tablet chewable

Nervous system

Frequency not reported: Drowsiness, headache[Ref]

Immunologic

Frequency not reported: Anaphylactoid reaction[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, vomiting[Ref]

Ocular

Rare (less than 0.1%): Blurred vision[Ref]

Other

Frequency not reported: Fatigue[Ref]

Some side effects of Dramamine II may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.