Peritrate con Fenobarbi

Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

Maintenance of Healing of Erosive Esophagitis

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Parenteral

1. 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. Phenobarbital (Peritrate con Fenobarbi) is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital (Peritrate con Fenobarbi) controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates.
2. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.
3. Preanesthetic.
4. Long-term anticonvulsant, (Phenobarbital (Peritrate con Fenobarbi), 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. Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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.
5. Phenobarbital (Peritrate con Fenobarbi) is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.

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

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

Phenobarbital (Peritrate con Fenobarbi) may also be used for purposes not listed in this medication guide.

Suggested doses of Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) and most other anticonvulsants. In children and infants, Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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.

Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi). 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 Phenobarbital (Peritrate con Fenobarbi). 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 Phenobarbital (Peritrate con Fenobarbi). 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 Phenobarbital (Peritrate con Fenobarbi). 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 Phenobarbital (Peritrate con Fenobarbi) 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.

PANTOPRAZOLE is contraindicated in patients with known hypersensitivity to any component of the formulation

See also:
What is the most important information I should know about Phenobarbital (Peritrate con Fenobarbi)?

Do not use Phenobarbital (Peritrate con Fenobarbi) if you are pregnant. It could harm the unborn baby. Phenobarbital (Peritrate con Fenobarbi) may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.

Phenobarbital (Peritrate con Fenobarbi) 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 (Peritrate con Fenobarbi).

Phenobarbital (Peritrate con Fenobarbi) may cause a severe allergic reaction. Stop taking Phenobarbital (Peritrate con Fenobarbi) 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 (Peritrate con Fenobarbi) without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) and talk with your doctor about another treatment for your sleep disorder.

Phenobarbital (Peritrate con Fenobarbi) 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.

Use Phenobarbital (Peritrate con Fenobarbi) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenobarbital (Peritrate con Fenobarbi) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Phenobarbital (Peritrate con Fenobarbi) at home, a health care provider will teach you how to use it. Be sure you understand how to use Phenobarbital (Peritrate con Fenobarbi). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Phenobarbital (Peritrate con Fenobarbi) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Do not suddenly stop using Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi), 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 Phenobarbital (Peritrate con Fenobarbi).

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. Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi)

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, Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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. Phenobarbital (Peritrate con Fenobarbi) 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).

Theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, levonorgestrel/ethinyl estradiol, metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole, or amoxicillin, ketoconazole, ampicillin esters, and iron salts.

See also:
What other drugs will affect Phenobarbital (Peritrate con Fenobarbi)?

Most reports of clinically significant drug interactions occurring with the barbiturates have involved Phenobarbital (Peritrate con Fenobarbi).

1. Anticoagulants: Phenobarbital (Peritrate con Fenobarbi) lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) is added to or withdrawn from their dosage regimen.

2. Corticosteroids: Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) is added to or withdrawn from their dosage regimen.

3. Griseofulvin: Phenobarbital (Peritrate con Fenobarbi) 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: Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.

5. Phenytoin, sodium valproate, valproic acid: The effect of Phenobarbital (Peritrate con Fenobarbi) on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of Phenobarbital (Peritrate con Fenobarbi) on the metabolism of phenytoin is not predictable, phenytoin and Phenobarbital (Peritrate con Fenobarbi) blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease Phenobarbital (Peritrate con Fenobarbi) metabolism; therefore, Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) probably because metabolism of the Phenobarbital (Peritrate con Fenobarbi) is inhibited.

8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of Phenobarbital (Peritrate con Fenobarbi) may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., Phenobarbital (Peritrate con Fenobarbi)) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking Phenobarbital (Peritrate con Fenobarbi).

Headache 6, Diarrhea 4, Flatulence 2, Abdominal pain 1, Rash < 1, Eructation 1, Hyperglycemia 1.

See also:
What are the possible side effects of Phenobarbital (Peritrate con Fenobarbi)?

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 Phenobarbital (Peritrate con Fenobarbi) use.

DRUG ABUSE AND DEPENDENCE

Symptoms of acute intoxication with Phenobarbital (Peritrate con Fenobarbi) include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.

Symptoms of Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Phenobarbital (Peritrate con Fenobarbi). 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 Phenobarbital (Peritrate con Fenobarbi) abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.

Drug dependence on Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Phenobarbital (Peritrate con Fenobarbi) for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Phenobarbital (Peritrate con Fenobarbi) 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 Phenobarbital (Peritrate con Fenobarbi) may be administered IM in addition to the oral dose. After stabilization on Phenobarbital (Peritrate con Fenobarbi), 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 Phenobarbital (Peritrate con Fenobarbi) may be given a lower dose of Phenobarbital (Peritrate con Fenobarbi) at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Phenobarbital (Peritrate con Fenobarbi) should be gradually decreased and completely withdrawn over a 2-week period.

A barbiturate that is metabolized to Phenobarbital (Peritrate con Fenobarbi). It has been used for similar purposes, especially in epilepsy, but there is no evidence mephobarbital offers any advantage over Phenobarbital (Peritrate con Fenobarbi).