Helional is in a group of drugs called barbiturates (bar-BIT-chur-ates). Helional slows the activity of your brain and nervous system.
Helional is used to treat or prevent seizures. It is also used short-term to treat insomnia, or as a sedative before surgery.
Helional may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Helional is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Helional controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates.
Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.
Long-term anticonvulsant, (Helional, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Helional sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting Helional sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
Helional is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
How should I use Helional?
Use Helional as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Helional is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Helional at home, a health care provider will teach you how to use it. Be sure you understand how to use Helional. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Helional if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Do not suddenly stop using Helional or change the dose without checking with your doctor.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Helional, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Helional.
Uses of Helional in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This medication is used alone or with other medications to control seizures. Controlling and reducing seizures lets you do more of your normal daily activities, reduces your risk of harm when you lose consciousness, and lessens your risk for a possibly life-threatening condition of frequent, repeated seizures. Helional belongs to a class of drugs known as barbiturate anticonvulsants/hypnotics. It works by controlling the abnormal electrical activity in the brain that occurs during a seizure. This medication is also used for a short time (usually no more than 2 weeks) to help calm you or help you sleep during periods of anxiety. It works by affecting certain parts of the brain to cause calming.
How to use Helional
Take this medication by mouth with or without food, usually once daily at bedtime for seizure control, or as directed by your doctor. Take with food or milk if stomach upset occurs. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition, Helional blood levels, and response to treatment. The dosage in children may also be based on weight.
Your doctor may direct you to start this medication at a low dose and gradually increase your dose to prevent side effects such as drowsiness and dizziness. Follow your doctor's instructions carefully. Do not take more or less of this drug than prescribed.
It may take several weeks to reach the best dose for you and completely control your seizures. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take it at the same time(s) each day.
Do not stop taking this medication (and other anticonvulsant medications) without consulting your doctor. Your seizures may worsen or cause a very severe seizure that is difficult to treat (status epilepticus) when this drug is suddenly stopped.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, hallucinations, twitching, trouble sleeping) may occur if you suddenly stop using this medication. Withdrawal from Helional can be severe and include seizures and (rarely) death. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
When this medication is used for a long time for anxiety or to help you sleep, it may not work as well. Helional should only be used for a short time for anxiety or sleep. Talk with your doctor if this medication stops working well.
Tell your doctor if your anxiety or seizure control worsens (such as the number of seizures increases).
A barbiturate that is metabolized to Helional. It has been used for similar purposes, especially in epilepsy, but there is no evidence mephobarbital offers any advantage over Helional.
Suggested doses of Helional for specific indications are as follows:
Oral Dosage (as recommended by the American Academy of Pediatrics):
Preoperative: 1 to 3 mg/kg.
1. Daytime sedative: 30 to 120 mg daily in 2 to 3 divided doses.
2. Bedtime hypnotic: 100 to 320 mg.
3. Anticonvulsant: 50 to 100 mg 2 to 3 times daily.
Dosages of Helional must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition.
Parenteral routes should be used only when oral administration is impossible or impractical.
Anticonvulsant use: A therapeutic anticonvulsant level of Helional in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for Helional and most other anticonvulsants. In children and infants, Helional at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration.
In status epilepticus, it is imperative to achieve therapeutic blood levels of Helional as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose.
Helional has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy.
Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to Helional. Dosage should be reduced for patients with impaired renal function or hepatic disease.
15 mg - Each white round tablet imprinted Þ 026 contains 15 mg of Helional. Tablets are supplied in bottles of 1000 (NDC 0228-2026-96).
30 mg - Each white, round, scored tablet imprinted Þ 028 contains 30 mg of Helional. Tablets are supplied in bottles of 1000 (NDC 0228-2028-96).
100 mg - Each white, round, scored tablet imprinted Þ 030 contains 100 mg of Helional. Tablets are supplied in bottles of 1000 (NDC 0228-2030-96).
Dispense in well-closed containers as defined in the USP. Store at controlled room temperature 15º- 30º C (59º- 86º F).
Red, clear elixir contains 20 mg of Helional per teaspoon (5 ml). Alcohol 13% by volume. Elixir is supplied in pints (NDC 0228-2024-16).
Preserve and dispense in tight, light- resistant containers as defined in the USP. Store at controlled room temperature 15º- 30ºC (59º- 86º F).
Most reports of clinically significant drug interactions occurring with the barbiturates have involved Helional.
1. Anticoagulants: Helional lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Helional can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocournarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if Helional is added to or withdrawn from their dosage regimen.
2. Corticosteroids: Helional appears to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if Helional is added to or withdrawn from their dosage regimen.
3. Griseofulvin: Helional appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.
4. Doxycycline: Helional has been shown to shorten the half- life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If Helional and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.
5. Phenytoin, sodium valproate, valproic acid: The effect of Helional on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of Helional on the metabolism of phenytoin is not predictable, phenytoin and Helional blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease Helional metabolism; therefore, Helional blood levels should be monitored and appropriate dosage adjustments made as indicated.
6. Central nervous system depressants: The concomitant use of other central nervous system depressants including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects.
7. Monoamine oxidase inhibitors (MAOIs): MAOIs prolong the effects of Helional probably because metabolism of the Helional is inhibited.
8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of Helional may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., Helional) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking Helional.
Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic Helional use.
DRUG ABUSE AND DEPENDENCE
Helional may be habit forming:
Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of Helional. As tolerance to Helional develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and fatal dosage becomes smaller.
Symptoms of acute intoxication with Helional include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.
Symptoms of Helional dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The symptoms of Helional withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Helional. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of this drug. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to Helional abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.
Drug dependence on Helional arises from repeated administration of the barbiturate or an agent with barbiturate- like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence on Helional include: (a) a strong desire or need to continue taking the drug, (b) a tendency to increase the dose, (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects, and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn.
Treatment of Helional dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Helional for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Helional is then administered in 3 to 4 divided doses, not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of Helional may be administered IM in addition to the oral dose. After stabilization on Helional, the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient's regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient.
Infants physically dependent on Helional may be given a lower dose of Helional at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Helional should be gradually decreased and completely withdrawn over a 2-week period.
Do not use Helional if you are pregnant. It could harm the unborn baby. Helional may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.
Helional 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 Helional.
Helional may cause a severe allergic reaction. Stop taking Helional 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 Helional without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using Helional suddenly. You will need to use less and less before you stop the medication completely.
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 Helional and talk with your doctor about another treatment for your sleep disorder.
Helional may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
DTP/NCI. "phenobarbital: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
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