What is Phenoral 100 mg?
Phenoral 100 mg is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenoral 100 mg slows the activity of your brain and nervous system.
Phenoral 100 mg is used to treat or prevent seizures. It is also used short-term to treat insomnia, or as a sedative before surgery.
Phenoral 100 mg may also be used for purposes not listed in this medication guide.
Phenoral 100 mg indications
Parenteral
- 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. Phenoral 100 mg is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenoral 100 mg 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.
- Preanesthetic.
- Long-term anticonvulsant, (Phenoral 100 mg, 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. Phenoral 100 mg 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 Phenoral 100 mg 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.
- Phenoral 100 mg is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
How should I use Phenoral 100 mg?
Use Phenoral 100 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Phenoral 100 mg is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Phenoral 100 mg at home, a health care provider will teach you how to use it. Be sure you understand how to use Phenoral 100 mg. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Phenoral 100 mg if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not suddenly stop using Phenoral 100 mg 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 Phenoral 100 mg, 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 Phenoral 100 mg.
Uses of Phenoral 100 mg in details
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. Phenoral 100 mg 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 Phenoral 100 mg
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, Phenoral 100 mg 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 Phenoral 100 mg 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. Phenoral 100 mg 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).
Phenoral 100 mg description
A barbiturate that is metabolized to Phenoral 100 mg. It has been used for similar purposes, especially in epilepsy, but there is no evidence mephobarbital offers any advantage over Phenoral 100 mg.
Phenoral 100 mg dosage
Suggested doses of Phenoral 100 mg for specific indications are as follows:
a. Pediatric
Oral Dosage (as recommended by the American Academy of Pediatrics):
Preoperative: 1 to 3 mg/kg.
b. Adult
Oral
Dosage:
Dosages of Phenoral 100 mg 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 Phenoral 100 mg 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 Phenoral 100 mg and most other anticonvulsants. In children and infants, Phenoral 100 mg 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 Phenoral 100 mg 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.
Phenoral 100 mg 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 Phenoral 100 mg. Dosage should be reduced for patients with impaired renal function or hepatic disease.
How supplied
Oral Tablets
15 mg - Each white round tablet imprinted Þ 026 contains 15 mg of Phenoral 100 mg. 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 Phenoral 100 mg. 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 Phenoral 100 mg. 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).
Oral Elixir
Red, clear elixir contains 20 mg of Phenoral 100 mg 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).
Rx only.
Phenoral 100 mg interactions
See also:
What other drugs will affect Phenoral 100 mg?
Most reports of clinically significant drug interactions occurring with the barbiturates have involved Phenoral 100 mg.
1. Anticoagulants: Phenoral 100 mg lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Phenoral 100 mg 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 Phenoral 100 mg is added to or withdrawn from their dosage regimen.
2. Corticosteroids: Phenoral 100 mg 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 Phenoral 100 mg is added to or withdrawn from their dosage regimen.
3. Griseofulvin: Phenoral 100 mg 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: Phenoral 100 mg 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 Phenoral 100 mg and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.
5. Phenytoin, sodium valproate, valproic acid: The effect of Phenoral 100 mg on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of Phenoral 100 mg on the metabolism of phenytoin is not predictable, phenytoin and Phenoral 100 mg blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease Phenoral 100 mg metabolism; therefore, Phenoral 100 mg 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 Phenoral 100 mg probably because metabolism of the Phenoral 100 mg is inhibited.
8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of Phenoral 100 mg may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., Phenoral 100 mg) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking Phenoral 100 mg.
Phenoral 100 mg side effects
See also:
What are the possible side effects of Phenoral 100 mg?
The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients.
- Nervous system: Somnolence.
- Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.
- Respiratory system: Hypoventilation, apnea.
- Cardiovascular system: Bradycardia, hypotension, syncope.
- Digestive system: Nausea, vomiting, constipation.
- Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic Phenoral 100 mg use.
DRUG ABUSE AND DEPENDENCE
Symptoms of acute intoxication with Phenoral 100 mg include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.
Symptoms of Phenoral 100 mg 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 Phenoral 100 mg withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Phenoral 100 mg. 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 Phenoral 100 mg abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.
Drug dependence on Phenoral 100 mg 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 Phenoral 100 mg 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 Phenoral 100 mg dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Phenoral 100 mg for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Phenoral 100 mg 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 Phenoral 100 mg may be administered IM in addition to the oral dose. After stabilization on Phenoral 100 mg, 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 Phenoral 100 mg may be given a lower dose of Phenoral 100 mg at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Phenoral 100 mg should be gradually decreased and completely withdrawn over a 2-week period.
Phenoral 100 mg contraindications
See also:
What is the most important information I should know about Phenoral 100 mg?
Do not use Phenoral 100 mg if you are pregnant. It could harm the unborn baby. Phenoral 100 mg may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.
Phenoral 100 mg 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 Phenoral 100 mg.
Phenoral 100 mg may cause a severe allergic reaction. Stop taking Phenoral 100 mg 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 Phenoral 100 mg without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using Phenoral 100 mg 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 Phenoral 100 mg and talk with your doctor about another treatment for your sleep disorder.
Phenoral 100 mg 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.
Active ingredient matches for Phenoral 100 mg:
Phenobarbital in Netherlands.
List of Phenoral 100 mg substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Phenoral 50 mg voor honden (Netherlands) | |
Phenoson (Bangladesh) | |
Phenotal (Thailand) | |
Phenotal 20 mg/5 mL x 30 mL (Asian Pharm) | $ 0.18 |
Phenotal 20 mg/5 mL x 60 mL (Asian Pharm) | $ 0.36 |
Phenotal 20 mg/5 mL x 4 L (Asian Pharm) | $ 15.15 |
Phenotal syr 20 mg/5 mL 4 L x 1's (Asian Pharm) | $ 15.15 |
Phenotal syr 20 mg/5 mL 30 mL x 1's (Asian Pharm) | $ 0.18 |
Phenotal syr 20 mg/5 mL 60 mL x 1's (Asian Pharm) | $ 0.36 |
Phenoturic | |
Phenovet (United Kingdom) | |
Liquid; Disinfectant / Food Premises; Disinfectant / Hospital / Healthcare Facilities; Clorophene 11%; O-Phenylphenol 9%; P-Tert-Pentylphenol 2.25% | |
Phental (Indonesia) | |
Phental / amp 100 mg/1 mL x 1's | |
Phenyletten | |
Phenyral | |
Phob | |
PMS-Phenobarbital (Canada) | |
Tablet; Oral; Phenobarbital 100 mg | |
Tablet; Oral; Phenobarbital 15 mg | |
Tablet; Oral; Phenobarbital 30 mg | |
Tablet; Oral; Phenobarbital 60 mg | |
Tablets; Oral; Phenobarbital 100 mg | |
Tablets; Oral; Phenobarbital 15 mg | |
Tablets; Oral; Phenobarbital 30 mg | |
Tablets; Oral; Phenobarbital 60 mg | |
PMS-Phenobarbital Elixir | |
Elixir; Oral; Phenobarbital 5 mg / ml | |
Polcominal | |
Promptonal | |
Rhea Phenobarbital (Philippines) | |
Rhea Phenobarbital 15 mg x 100's (Philusa) | $ 3.19 |
Rhea Phenobarbital 30 mg x 100's (Philusa) | $ 4.06 |
Rhea Phenobarbital 60 mg x 100's (Philusa) | $ 5.59 |
Rhea Phenobarbital 90 mg x 100's (Philusa) | $ 7.35 |
Rhea Phenobarbital tab 15 mg 100's (Philusa) | $ 4.11 |
Rhea Phenobarbital tab 30 mg 100's (Philusa) | $ 4.89 |
Rhea Phenobarbital tab 60 mg 100's (Philusa) | $ 6.78 |
Rhea Phenobarbital tab 90 mg 100's (Philusa) | $ 8.67 |
Rumil (Taiwan) | |
Rumil 30 mg | |
Rumil 30 mg x Blister pk | |
Seda-Tablinen | |
Sedabar | |
Sedabarb | |
Sedicat | |
Sedizorin | |
Sedlyn | |
Sedofen | |
See 775 substitutes for Phenoral 100 mg |
References
- PubChem. "phenobarbital". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "phenobarbital". http://www.drugbank.ca/drugs/DB01174 (accessed September 17, 2018).
- 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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Information checked by Dr. Sachin Kumar, MD Pharmacology