Vanadom

Carisoprodol is a prescription medication used to relax muscles and relieve pain due to muscle spasms.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Vanadom is part of the drug class:

• Carbamic acid esters

Before taking carisoprodol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of addictive behavior
• have a history of seizures
• have a history of kidney or liver disease
• are allergic to carisoprodol (Soma) or meprobamate
• 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 pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Carisoprodol falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in carisoprodol is excreted in human breast milk. The effect of carisoprodol on the nursing infant is not known.

If you take too much carisoprodol call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If carisoprodol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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 carisoprodol in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of carisoprodol have not been performed in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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
• Aprobarbital
• Bromazepam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Diazepam
• Dihydrocodeine
• Doxylamine
• Eslicarbazepine Acetate
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Flunitrazepam
• Flurazepam
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Prazepam
• Primidone
• Quazepam
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Tiotropium
• Tramadol
• Triazolam
• Zolpidem

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:

• Drug abuse or dependence, or history of—Use with caution. Dependence on carisoprodol may develop.

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

• Porphyria (an enzyme problem), history of—Should not be used in patients with this condition.

• Seizures—Use with caution. May make this condition worse.

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:

• Black, tarry stools
• chest pain
• chills
• cold sweats
• confusion
• convulsions
• cough
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• loss of bladder control
• muscle spasm or jerking of all extremities
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sudden loss of consciousness
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

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

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision
• change in consciousness
• confusion as to time, place, or person
• difficult or troubled breathing
• false or unusual sense of well-being
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• inability to move the eyes
• increased blinking or spasms of the eyelid
• increased sensitivity of the eyes to light
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• muscle stiffness or tightness
• pale or blue lips, fingernails, or skin
• sticking out of the tongue
• trouble with breathing, speaking, or swallowing
• uncontrolled eye movements
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual excitement, nervousness, or restlessness
• unusual facial expressions
• weakness of the arms and legs

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:

• Drowsiness

• Anxiety
• deep or fast breathing with dizziness
• dry mouth
• face is warm or hot to touch
• fainting feeling of constant movement of self or surroundings
• heartburn
• irritability
• nausea
• nervousness
• numbness of the feet, hands, and around the mouth
• pain or discomfort in the chest, upper stomach, or throat
• redness to face
• restlessness
• sensation of spinning
• shakiness and unsteady walk
• sleeplessness
• trouble sleeping
• unable to sleep
• unsteadiness, trembling, or other problems with muscle control or coordination
• vomiting

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 carisoprodol: compounding powder, oral tablet

General

The most commonly reported adverse reactions have included drowsiness, dizziness, and headache.[Ref]

Nervous system

Very common (10% or more): Drowsiness (17%)
Common (1% to 10%): Dizziness, headache
Postmarketing reports: Ataxia, tremor, seizures[Ref]

Cardiovascular

Postmarketing reports: Tachycardia, postural hypotension, syncope, facial flushing[Ref]

Psychiatric

Postmarketing reports: Agitation, irritability, depressive reactions, insomnia[Ref]

Other

Postmarketing reports: Vertigo, dependence, withdrawal[Ref]

Gastrointestinal

Postmarketing reports: Nausea, vomiting, epigastric discomfort[Ref]

Hematologic

Postmarketing reports: Leukopenia, pancytopenia[Ref]

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