Mysoline Oral, Parenteral, Rectal

In the U.S.

• Butisol Sodium
• Mysoline
• Seconal

In Canada

• Nova Rectal

Available Dosage Forms:

• Elixir
• Tablet
• Suppository
• Capsule
• Enema
• Suspension
• Solution

Barbiturates belong to the group of medicines called central nervous system (CNS) depressants (medicines that cause drowsiness). They act on the brain and CNS to produce effects that may be helpful or harmful. This depends on the individual patient's condition and response and the amount of medicine taken.

Some of the barbiturates may be used before surgery to relieve anxiety or tension. In addition, some of the barbiturates are used as anticonvulsants to help control seizures in certain disorders or diseases, such as epilepsy. Barbiturates may also be used for other conditions as determined by your doctor.

The barbiturates have been used to treat insomnia (trouble in sleeping); but if they are used regularly (for example, every day) for insomnia, they are usually not effective for longer than 2 weeks. The barbiturates have also been used to relieve nervousness or restlessness during the daytime. However, the barbiturates have generally been replaced by safer medicines for the treatment of insomnia and daytime nervousness or tension.

If too much of a barbiturate is used, it may become habit-forming.

Barbiturates should not be used for anxiety or tension caused by the stress of everyday life.

These medicines are available only with your doctor's prescription.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Unusual excitement may be more likely to occur in children, who are usually more sensitive than adults to the effects of barbiturates.

Geriatric

Confusion, mental depression, and unusual excitement may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of barbiturates.

Pregnancy

Barbiturates have been shown to increase the chance of birth defects in humans. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this and the following information with your doctor:

• Taking barbiturates regularly during pregnancy may cause bleeding problems in the newborn infant. In addition, taking barbiturates regularly during the last 3 months of pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects in the baby after birth.
• One study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby.
• Barbiturates taken for anesthesia during labor and delivery may reduce the force and frequency of contractions of the uterus; this may prolong labor and delay delivery.
• Use of barbiturates during labor may cause breathing problems in the newborn infant.

Breast Feeding

Barbiturates pass into the breast milk and may cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in babies of nursing mothers taking this medicine.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Artemether
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Dasabuvir
• Delamanid
• Delavirdine
• Elvitegravir
• Isavuconazonium Sulfate
• Lopinavir
• Lumefantrine
• Lurasidone
• Maraviroc
• Nisoldipine
• Ombitasvir
• Paritaprevir
• Ranolazine
• Rilpivirine
• Ritonavir
• Telaprevir
• Tipranavir
• Voriconazole

Using medicines in this class 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
• Afatinib
• Alfentanil
• Alprazolam
• Amobarbital
• Anisindione
• Apixaban
• Apremilast
• Aprobarbital
• Axitinib
• Bedaquiline
• Bosutinib
• Bromazepam
• Bromopride
• Buprenorphine
• Bupropion
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Carbinoxamine
• Carisoprodol
• Carmustine
• Ceritinib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Cobimetinib
• Codeine
• Daclatasvir
• Dantrolene
• Darunavir
• Deferasirox
• Deflazacort
• Delavirdine
• Diazepam
• Dicumarol
• Dihydrocodeine
• Dolutegravir
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxylamine
• Dronedarone
• Elbasvir
• Erlotinib
• Eslicarbazepine Acetate
• Esomeprazole
• Estazolam
• Ethchlorvynol
• Etonogestrel
• Etravirine
• Exemestane
• Fentanyl
• Flibanserin
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fospropofol
• Grazoprevir
• Halazepam
• Hydrocodone
• Hydromorphone
• Idelalisib
• Ifosfamide
• Imatinib
• Ketazolam
• Ledipasvir
• Levorphanol
• Linagliptin
• Lopinavir
• Lorazepam
• Lormetazepam
• Macitentan
• Meclizine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methoxyflurane
• Midazolam
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naloxegol
• Netupitant
• Nifedipine
• Nilotinib
• Nimodipine
• Nintedanib
• Nitrazepam
• Olaparib
• Orlistat
• Oxazepam
• Oxycodone
• Oxymorphone
• Panobinostat
• Pentazocine
• Pentobarbital
• Periciazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Piperaquine
• Pixantrone
• Ponatinib
• Prazepam
• Primidone
• Propofol
• Quazepam
• Remifentanil
• Rivaroxaban
• Romidepsin
• Saquinavir
• Secobarbital
• Simeprevir
• Sirolimus
• Sodium Oxybate
• Sonidegib
• Succinylcholine
• Sufentanil
• Sunitinib
• Tacrolimus
• Tapentadol
• Tasimelteon
• Temazepam
• Teniposide
• Tenofovir Alafenamide
• Thiopental
• Tofacitinib
• Tolvaptan
• Tramadol
• Triazolam
• Ulipristal
• Valproic Acid
• Vandetanib
• Velpatasvir
• Venetoclax
• Vilazodone
• Vortioxetine
• 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on barbiturates may develop.

• Anemia (severe) or
• Asthma (history of), emphysema, or other chronic lung disease or
• Type 2 diabetes mellitus or
• Hyperactivity (in children) or
• Mental depression or
• Overactive thyroid or
• Porphyria (or history of)—Barbiturates may make the condition worse.

• Kidney disease or
• Liver disease—Higher blood levels of barbiturates may result, increasing the chance of side effects.

• Pain—Barbiturates may cause unexpected excitement or mask important symptoms of more serious problems.

• Underactive adrenal gland—Barbiturates may interfere with the effects of other medicines needed for this condition.

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

For patients taking the extended-release capsule or tablet form of this medicine:

• These capsules or tablets are to be swallowed whole. Do not break, crush, or chew before swallowing.

For patients using the rectal suppository form of this medicine:

• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.
• Wash your hands with soap and water.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much is used, it may become habit-forming (causing mental or physical dependence).

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. To do so may increase the chance of your becoming dependent on the medicine. Instead, check with your doctor.

If you are taking this medicine for epilepsy, it must be taken every day in regularly spaced doses as ordered by your doctor in order for it to control your seizures. This is necessary to keep a constant amount of medicine in the blood. To help keep the amount constant, do not miss any doses.

Dosing

The dose medicines in this class 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 these medicines. 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 amobarbital
• For oral dosage form (tablets or capsules):
  • For trouble in sleeping:
    • Adults—65 to 200 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—50 to 300 mg, taken in smaller doses during the day.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight taken three times a day.
  • For sedation before surgery:
    • Adults—200 mg taken one to two hours before surgery.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg.
  • For sedation during labor:
    • Adults—200 to 400 mg every one to three hours if needed. However, the total dose is usually not more than 1000 mg.
• For injection dosage form:
  • For trouble in sleeping:
    • Adults—65 to 200 mg, injected into a muscle or vein.
    • Children up to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle.
    • Children 6 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle, or 65 to 500 mg injected into a vein.
  • For daytime sedation:
    • Adults—30 to 50 mg two or three times a day, injected into a muscle or vein
  • For sedation before surgery:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight or 65 to 500 mg per dose, injected into a vein.
  • For control of seizures:
    • Adults and children 6 years of age and over—65 to 500 mg per dose, injected into a vein.
    • Children up to 6 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein.

For aprobarbital
• For oral dosage form (elixir):
  • For trouble in sleeping:
    • Adults—40 to 160 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—40 mg three times a day.
    • Children—Dose must be determined by your doctor.

For butabarbital
• For oral dosage forms (elixir or tablets):
  • For trouble in sleeping:
    • Adults—50 to 100 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—15 to 30 mg three or four times a day.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
  • For sedation before surgery:
    • Adults—50 to 100 mg sixty to ninety minutes before surgery.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight. However, the dose is usually not more than 100 mg.

For mephobarbital
• For oral dosage form (tablets):
  • For daytime sedation:
    • Adults—32 to 100 milligrams (mg) three or four times a day.
    • Children—16 to 32 mg three or four times a day.
  • For control of seizures:
    • Adults—200 to 600 mg a day, taken in smaller doses during the day.
    • Children 5 years of age and over—32 to 64 mg three or four times a day.
    • Children up to 5 years of age—16 to 32 mg three or four times a day.

For metharbital
• For oral dosage form (tablets):
  • For control of seizures:
    • Adults—At first, 100 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 800 mg a day.
    • Children—50 mg one to three times a day.

For pentobarbital
• For oral dosage forms (elixir or capsules):
  • For trouble in sleeping:
    • Adults—100 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—20 mg three or four times a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (kg) (0.9 to 2.7 mg per pound) of body weight per day.
  • For sedation before surgery:
    • Adults—100 mg before surgery.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg.
• For injection dosage form:
  • For trouble in sleeping:
    • Adults—150 to 200 mg, injected into a muscle. Or, 100 mg injected into a vein, with additional small doses given if needed. However, the dose is usually not more than 500 mg.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. Or, 50 mg injected into a vein, with additional small doses given if needed.
  • For sedation before surgery:
    • Adults—150 to 200 mg, injected into a muscle.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg.
  • For control of seizures:
    • Adults—At first, 100 mg injected into a vein. Additional small doses may be given if needed. However, the dose is usually not more than 500 mg.
    • Children—At first, 50 mg injected into a muscle or vein. Additional small doses may be given if needed.
• For rectal dosage form (suppositories):
  • For trouble in sleeping:
    • Adults—120 to 200 mg inserted into the rectum at bedtime.
    • Children 12 to 14 years of age—60 or 120 mg inserted into the rectum at bedtime.
    • Children 5 to 12 years of age—60 mg inserted into the rectum at bedtime.
    • Children 1 to 4 years of age—30 or 60 mg inserted into the rectum at bedtime.
    • Children 2 months to 1 year of age—30 mg inserted into the rectum at bedtime.
    • Children up to 2 months of age—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—30 mg inserted into the rectum two to four times a day.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kg (0.9 mg per pound) of body weight, inserted into the rectum three times a day.
  • For sedation before surgery:
    • Children 12 to 14 years of age—60 or 120 mg inserted into the rectum.
    • Children 5 to 12 years of age—60 mg inserted into the rectum.
    • Children 1 to 4 years of age—30 or 60 mg inserted into the rectum.
    • Children 2 months to 1 year of age—30 mg inserted into the rectum.
    • Children up to 2 months of age—Dose must be determined by your doctor.

For phenobarbital
• For oral dosage forms (elixir, capsules, or tablets):
  • For trouble in sleeping:
    • Adults—100 to 320 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—30 to 120 mg a day, taken in smaller doses two or three times during the day.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
  • For sedation before surgery:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight.
  • For control of seizures:
    • Adults—60 to 250 mg a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day.
• For injection dosage form:
  • For trouble in sleeping:
    • Adults—100 to 325 mg, injected into a muscle or vein, or under the skin.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—30 to 120 mg a day, injected into a muscle or a vein, or under the skin, in smaller doses two or three times during the day.
    • Children—Dose must be determined by your doctor.
  • For sedation before surgery:
    • Adults—130 to 200 mg, injected into a muscle sixty to ninety minutes before surgery.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight, injected into a muscle or vein sixty to ninety minutes before surgery.
  • For control of seizures:
    • Adults—100 to 320 mg injected into a vein. The dose may be repeated if needed, but is usually not more than 600 mg a day. However, higher doses may be needed for certain types of continuing seizures.
    • Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 20 mg per kg (4.5 to 9 mg per pound) of body weight, injected into a vein. Later, 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day, injected into a vein. Higher doses may be needed for certain types of continuing seizures.

For secobarbital
• For oral dosage form (capsules):
  • For trouble in sleeping:
    • Adults—100 milligrams (mg) at bedtime.
    • Children—Dose must be determined by your doctor.
  • For daytime sedation:
    • Adults—30 to 50 mg three or four times a day.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day.
  • For sedation before surgery:
    • Adults—200 to 300 mg one or two hours before surgery.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight one or two hours before surgery. However, the dose is usually not more than 100 mg.
• For injection dosage form:
  • For trouble in sleeping:
    • Adults—100 to 200 mg injected into a muscle, or 50 to 250 mg injected into a vein.
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg.
  • For sedation before dental procedures:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.1 to 2.2 mg per kg (0.5 to 1 mg per pound) of body weight, injected into a muscle ten to fifteen minutes before the procedure.
    • Children—Dose must be determined by your dentist.
  • For sedation before a nerve block:
    • Adults—100 to 150 mg, injected into a vein.
  • For sedation before surgery:
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 to 5 mg per kg (1.8 to 2.3 mg per pound) of body weight, injected into a muscle.
  • For seizures from tetanus:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 5.5 mg per kg (2.5 mg per pound) of body weight, injected into a muscle or vein. Dose may be repeated every three to four hours if needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein.

For secobarbital and amobarbital combination
• For oral dosage form (capsules):
  • For trouble in sleeping:
    • Adults—1 capsule at bedtime.
    • Children—Dose must be determined by your doctor.
  • For sedation before surgery:
    • Adults—1 capsule taken one hour before surgery.
    • Children—Dose must be determined by your doctor.

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

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.

Store the suppository form of this medicine in the refrigerator.

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:

• Bleeding sores on lips
• chest pain
• fever
• muscle or joint pain
• red, thickened, or scaly skin
• skin rash or hives
• sores, ulcers, or white spots in mouth (painful)
• sore throat and/or fever
• swelling of eyelids, face, or lips
• wheezing or tightness in chest

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

• Confusion
• mental depression
• unusual excitement

• Hallucinations (seeing, hearing, or feeling things that are not there)
• unusual bleeding or bruising
• unusual tiredness or weakness

• Bone pain, tenderness, or aching
• loss of appetite
• muscle weakness
• weight loss (unusual)
• yellow eyes or skin

• Confusion (severe)
• decrease in or loss of reflexes
• drowsiness (severe)
• fever
• irritability (continuing)
• low body temperature
• poor judgment
• shortness of breath or slow or troubled breathing
• slow heartbeat
• slurred speech
• staggering
• trouble in sleeping
• unusual movements of the eyes
• weakness (severe)

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:

• Clumsiness or unsteadiness
• dizziness or lightheadedness
• drowsiness
• "hangover" effect

• Anxiety or nervousness
• constipation
• feeling faint
• headache
• irritability
• nausea or vomiting
• nightmares or trouble in sleeping

Confusion, mental depression, and unusual excitement may be more likely to occur in very ill patients.

After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take up to about 15 days. During this period of time check with your doctor if any of the following side effects occur (usually occur within 8 to 16 hours after medicine is stopped):

• Anxiety or restlessness
• convulsions (seizures)
• dizziness or lightheadedness
• feeling faint
• hallucinations (seeing, hearing, or feeling things that are not there)
• muscle twitching
• nausea or vomiting
• trembling of hands
• trouble in sleeping, increased dreaming, or nightmares
• vision problems
• 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.