belladonna alkaloids/phenobarbital

bell-a-DON-a AL-ka-loyds, fee-noe-BAR-bi-tal

Pharmacologic Class: Antimuscarinic

Uses For belladonna alkaloids/phenobarbital

Belladonna alkaloids and phenobarbital is a combination medicine taken to relieve cramping and spasms of the stomach and intestines. It used also to decrease the amount of acid formed in the stomach.

belladonna alkaloids/phenobarbital is available only with your doctor's prescription.

Before Using belladonna alkaloids/phenobarbital

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 belladonna alkaloids/phenobarbital, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to belladonna alkaloids/phenobarbital 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

Severe side effects may be more likely to occur in infants and children, especially those with spastic paralysis or brain damage. Unusual excitement, nervousness, restlessness, or irritability and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of belladonna alkaloids. Also, when belladonna alkaloids are given to children during hot weather, a rapid increase in body temperature may occur. In addition, the barbiturate in belladonna alkaloids/phenobarbital could cause some children to become hyperactive.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of belladonna alkaloids and barbiturates. Also, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 belladonna alkaloids/phenobarbital, 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 belladonna alkaloids/phenobarbital with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir


• Nifedipine


• Potassium


• Praziquantel


• Ranolazine


• Rilpivirine


• Voriconazole

Using belladonna alkaloids/phenobarbital 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.

• Abiraterone


• Acenocoumarol


• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Anisindione


• Aprobarbital


• Bortezomib


• Bromazepam


• Brotizolam


• Butabarbital


• Butalbital


• Cabazitaxel


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Crizotinib


• Dantrolene


• Dasatinib


• Delavirdine


• Diazepam


• Dicumarol


• Dronedarone


• Erlotinib


• Estazolam


• Ethchlorvynol


• Etravirine


• Everolimus


• Fentanyl


• Flunitrazepam


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Imatinib


• Irinotecan


• Ixabepilone


• Ketazolam


• Ketorolac


• Lapatinib


• Levorphanol


• Linagliptin


• Lopinavir


• Lorazepam


• Lormetazepam


• Maraviroc


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Methoxyflurane


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Naproxen


• Nilotinib


• Nitrazepam


• Nordazepam


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenindione


• Phenobarbital


• Phenprocoumon


• Prazepam


• Primidone


• Propoxyphene


• Quazepam


• Quetiapine


• Remifentanil


• Rivaroxaban


• Roflumilast


• Romidepsin


• Secobarbital


• Sirolimus


• Sodium Oxybate


• Sufentanil


• Sunitinib


• Tacrolimus


• Tapentadol


• Temazepam


• Temsirolimus


• Teniposide


• Thiopental


• Ticagrelor


• Tolvaptan


• Triazolam


• Vandetanib


• Vemurafenib


• Zolpidem

Using belladonna alkaloids/phenobarbital with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine


• Amprenavir


• Betamethasone


• Bexarotene


• Cannabis


• Chlorpromazine


• Clozapine


• Cortisone


• Desogestrel


• Dexamethasone


• Dienogest


• Digitoxin


• Dixyrazine


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethopropazine


• Ethosuximide


• Ethynodiol Diacetate


• Etonogestrel


• Felodipine


• Fluphenazine


• Ginkgo


• Granisetron


• Griseofulvin


• Itraconazole


• Lamotrigine


• Leucovorin


• Levomethadyl


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mesoridazine


• Mestranol


• Methdilazine


• Methotrimeprazine


• Methylprednisolone


• Metoprolol


• Nimodipine


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Oxcarbazepine


• Perazine


• Periciazine


• Perphenazine


• Pipotiazine


• Prednisone


• Prochlorperazine


• Promazine


• Promethazine


• Propiomazine


• Quinidine


• Quinine


• Risperidone


• Ritonavir


• Rufinamide


• Telithromycin


• Theophylline


• Thiethylperazine


• Thioridazine


• Tiagabine


• Tipranavir


• Topiramate


• Trifluoperazine


• Triflupromazine


• Valproic Acid


• Verapamil


• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of belladonna alkaloids/phenobarbital. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, emphysema, or other chronic lung disease or


• Dryness of mouth (severe and continuing) or


• Enlarged prostate or


• Glaucoma or


• Heart disease or


• Hyperactivity (in children) or


• Intestinal blockage or other intestinal problems or


• Urinary tract blockage or difficult urination—Belladonna alkaloids and phenobarbital may make these conditions worse.

• Brain damage (in children) or


• Spastic paralysis (in children)—These conditions may increase the effects of the medicine.

• Down's syndrome (mongolism)—This condition may increase the side effects of the medicine.

• Kidney disease or


• Liver disease—Higher levels of the belladonna alkaloid and barbiturate may result, possibly leading to increased side effects.

Proper Use of belladonna alkaloids/phenobarbital

Take belladonna alkaloids/phenobarbital about ½ to 1 hour before meals, unless otherwise directed by your doctor.

Take belladonna alkaloids/phenobarbital only as directed. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of belladonna alkaloids/phenobarbital 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 belladonna alkaloids/phenobarbital. 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 stomach or intestine problems:
  
  • For oral dosage forms (capsules or tablets):
    
    • Older adults, adults, and teenagers—1 or 2 capsules two to four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (solution):
    
    • Adults and teenagers—The usual dose is 1 to 2 teaspoonfuls (5 to 10 milliliters [mL]) three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 7.5 mL every four to six hours. Your doctor may change the dose if needed.
    
    
  
  
  • For oral dosage form (chewable tablets):
    
    • Older adults, adults, and teenagers—Chew 1 or 2 tablets three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children 2 to 12 years of age—½ to 1 tablet three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children up to 2 years of age—Use is not recommended.
    
    
  
  
  • For long-acting oral dosage form (extended-release tablets):
    
    • Older adults, adults, and teenagers—1 tablet every eight to twelve hours. Your doctor may change the dose if needed.
    
    
    • Children—Use is not recommended
    
    
  
  

Missed Dose

If you miss a dose of belladonna alkaloids/phenobarbital, 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 While Using belladonna alkaloids/phenobarbital

belladonna alkaloids/phenobarbital 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 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 belladonna alkaloids/phenobarbital.

Do not take belladonna alkaloids/phenobarbital within 1 hour of taking antacids or medicine for diarrhea. Taking them too close together will make the belladonna alkaloids less effective.

Belladonna alkaloids will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking belladonna alkaloids/phenobarbital, as overheating could possibly result in heat stroke. This is especially important in children taking belladonna alkaloids.

belladonna alkaloids/phenobarbital may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

belladonna alkaloids/phenobarbital may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to belladonna alkaloids/phenobarbital before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

belladonna alkaloids/phenobarbital may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, 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.

belladonna alkaloids/phenobarbital 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.

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

Rare

• Eye pain


• skin rash or hives


• sore throat and fever


• unusual bleeding or bruising


• yellow eyes or skin

Symptoms of overdose

• Blurred vision (continuing) or changes in near vision


• clumsiness or unsteadiness


• confusion


• convulsions (seizures)


• dizziness (continuing)


• drowsiness (severe)


• dryness of mouth, nose, or throat (severe)


• fast heartbeat


• fever


• hallucinations (seeing, hearing, or feeling things that are not there)


• shortness of breath or troubled breathing


• slurred speech


• unusual excitement, nervousness, restlessness, or irritability


• unusual warmth, dryness, and flushing of 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

• Constipation


• decreased sweating


• dizziness


• dryness of mouth, nose, throat, or skin

Less common or rare

• Bloated feeling


• blurred vision


• decreased flow of breast milk


• difficult urination


• difficulty in swallowing


• headache


• increased sensitivity of eyes to sunlight


• loss of memory


• nausea or vomiting


• unusual tiredness or weakness

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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