Phenobarbital

DRUG DESCRIPTION

Phenobarbital is a barbiturate, nonselective central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

Phenobarbital Tablets and Elixir are administered orally and are contained in DEA Schedule IV. Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.

Chemically Designated: 5-Ethyl -5-phenylbarbituric acid
Molecular Formula: C12H12N2O3
Molecular Weight: 232.24

Inactive Ingredients

Oral Tablets - corn starch, lactose (monohydrate), magnesium stearate and sodium starch glycolate
Oral Elixir - ethyl alcohol, glycerin, oil of orange, sucrose, water, FD& C Red #40 and FD& C Blue #1

What are the possible side effects of phenobarbital (Solfoton)?

Phenobarbital may cause a severe allergic reaction. Stop taking phenobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • slow heartbeat, shallow breathing;
  • feeling light-headed, fainting;
  • a fever or a sore throat;
  • sores in...

Read All Potential Side Effects and See Pictures of Phenobarbital

What are the precautions when taking phenobarbital (Phenobarbital)?

Before taking phenobarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as primidone, secobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria), certain vitamin...

Read All Potential Precautions of Phenobarbital


Phenobarbital Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, excitation, headache, tiredness, loss of appetite, nausea, or vomiting may occur as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: staggering walk/clumsiness, double vision.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/shallow breathing, fainting, slow heartbeat, severe tiredness/weakness, pale skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking phenobarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as primidone, secobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin K).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

The liquid form of this product may contain alcohol or sugar. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially drowsiness and dizziness. However, this drug can often cause excitement or confusion instead of drowsiness in older adults.

Children may be more sensitive to the side effects of the drug. This drug can often cause excitement instead of drowsiness in young children.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

This medication may lower your folic acid and vitamin K levels, increasing the risk of spinal cord defects. Therefore, check with your doctor to make sure you are taking enough folic acid and vitamin K. Infants born to mothers who have been using this medication during pregnancy may also have symptoms such as fussiness, shaking, or bleeding. Tell the doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk and may cause excessive sleepiness or feeding problems in the nursing infant. Consult your doctor before breast-feeding.


Phenobarbital Patient Information Including Side Effects

Brand Names: Solfoton

Generic Name: phenobarbital (Pronunciation: fee noe BAR bi tal)

  • What is phenobarbital (Phenobarbital)?
  • What are the possible side effects of phenobarbital (Phenobarbital)?
  • What is the most important information I should know about phenobarbital (Phenobarbital)?
  • What should I discuss with my healthcare provider before taking phenobarbital (Phenobarbital)?
  • How should I take phenobarbital (Phenobarbital)?
  • What happens if I miss a dose (Phenobarbital)?
  • What happens if I overdose (Phenobarbital)?
  • What should I avoid while taking phenobarbital (Phenobarbital)?
  • What other drugs will affect phenobarbital (Phenobarbital)?
  • Where can I get more information?

What is phenobarbital (Phenobarbital)?

Phenobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenobarbital slows the activity of your brain and nervous system.

Phenobarbital is used to treat or prevent seizures. It is also used short-term to treat insomnia, or as a sedative before surgery.

Phenobarbital may also be used for other purposes not listed in this medication guide.

What are the possible side effects of phenobarbital (Phenobarbital)?

Phenobarbital may cause a severe allergic reaction. Stop taking phenobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • slow heartbeat, shallow breathing;
  • feeling light-headed, fainting;
  • a fever or a sore throat;
  • sores in your mouth;
  • easy bruising or bleeding; or
  • broken blood vessels under your skin.

Less serious side effects may include:

  • drowsiness or dizziness;
  • problems with memory or concentration;
  • excitement, irritability, aggression, or confusion (especially in children or older adults);
  • loss of balance or coordination;
  • nausea, constipation;
  • headache; or
  • "hangover" effect (drowsiness the day after a dose).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about phenobarbital (Phenobarbital)?

Phenobarbital may cause a severe allergic reaction. Stop taking phenobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not stop using phenobarbital without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using phenobarbital suddenly. You will need to use less and less before you stop the medication completely.

Take phenobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking phenobarbital and talk with your doctor about another treatment for your sleep disorder.

Do not use phenobarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Phenobarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking phenobarbital.

Phenobarbital may be habit-forming and should be used only by the person it was prescribed for. Phenobarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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