mph Bangladesh


Phenobarbital

(fee noe bar' bi tal)

PCI  : Contraindicated in pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
Indication(s) & Dosage

Oral route
Partial seizures
Adult: 60-180 mg daily taken at night. Titrate dose according to patient's needs to achieve adequate control of seizures. Plasma concentrations of 15-40 mcg/ml (65-170 micromol/l) are usually required.
Child: 1 mth-12 yr: Initially, 1-1.5 mg/kg bid. Increase by 2 mg/kg daily, as required, to a maintenance dose of 2.5-4 mg/kg once or bid. 12-18 yr: Initially, 60-180 mg bid. Maintenance: 60-180 mg once daily. 

Generalised tonic-clonic seizures
Adult: 60-180 mg daily taken at night. Titrate dose according to patient's needs to achieve adequate control of seizures. Plasma concentrations of 15-40 mcg/ml (65-170 micromol/l) are usually required.
Child: 1 mth-12 yr: Initially, 1-1.5 mg/kg bid. Increase by 2 mg/kg daily, as required, to a maintenance dose of 2.5-4 mg/kg once or bid. 12-18 yr: Initially, 60-180 mg bid. Maintenance: 60-180 mg once daily.

Sedation
Adult: 30-120 mg/day in 2-3 divided doses.
Child: 6 mg/kg/day or 180 mg/m2/day divided in 3 equal doses.


Hypnotic
Adult: 100-320 mg at bedtime. Do not admin for >2 wk for the treatment ofinsomnia.

Preoperative sedation
Child: 1-3 mg/kg 1-1.5 hr before procedure.

CrCl (ml/min) Dosage Recommendation
<10 Administer every 12-16 hr.

 

Intramuscular route
Emergency management of acute seizures
Adult: As sodium: 200 mg IM repeated after 6 hr if necessary.
Child: As sodium: 15 mg/kg IM as a single dose.

Intravenous route
Status epilepticus
Adult: Doses of 10 mg/kg to a max of 1 g.
Child: As sodium: Neonates and children up to 12 yr: Initially, 20 mg/kg by slow IV inj then 2.5-5 mg/kg once or bid. 12-18 yr: Initially 20 mg/kg (max 1 g) by slow IV inj then 300 mg bid.

Generalised tonic-clonic seizures
Child: As sodium: Neonates: Loading dose is 20 mg/kg by slow IV inj followed by 2.5-5 mg/kg once daily either by slow IV inj or orally.

Partial seizures
Child: As sodium: Neonates: Loading dose is 20 mg/kg by slow IV inj followed by 2.5-5 mg/kg once daily either by slow IV inj or orally.

Intramuscular
Sedation
Adult: As sodium: 30-120 mg/day in 2-3 divided doses.

CrCl (ml/min) Dosage Recommendation
<10 Administer every 12-16 hr.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Parenteral
Hypnotic
Adult: As sodium: 100-320 mg at bedtime via IM/IV/SC inj.
Child: As sodium: 3-5 mg/kg at bedtime via IM/IV/SC inj.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose accordingly.
Intramuscular
Preoperative sedation
Adult: As sodium: 100-200 mg 1-1.5 hr before procedure.
Child: As sodium: 16-100 mg 1-1.5 hr before procedure.
Intravenous
Preoperative sedation
Child: As sodium: 1-3 mg/kg 1-1.5 hr before procedure.

Reconstitution: Inj should be diluted 1 in 10 although 15 mg/ml may be considered in fluid-restricted children. Give dose over 20 min at a rate no >1 mg/kg/min.
Incompatibility: Y-site admin incompatible with amphotericin B cholesteryl sulfate complex, hydromorphone. Do not mix in the same syringe with hydromorphone, pentazocine, ranitidine, sufentanil. Do not admix with chlorpromazine, cimetidine, clindamycin, dimenhydrinate, diphenhydramine, droperidol, ephedrine, hydralazine, hydrocortisone sodium succinate, hydroxyzine, insulin (regular), kanamycin, levorphanol, meperidine, morphine, norepinephrine, pancuronium, penicillin G, pentazocine, phenytoin, procaine, prochlorperazine, promazine, promethazine, streptomycin, succinylcholine, vancomycin.
Overdose Symptoms: Unsteady gait, slurred speech, confusion, jaundice, hypothermia, hypotension, respiratory depression, coma. Management: Charcoal haemoperfusion (in severe cases). Treatment is symptomatic and supportive.
Contraindications Severe renal and hepatic disorders. Severe respiratory depression, dyspnoea or airway obstruction; porphyria. Pregnancy.
Special Precautions Elderly or debilitated patients, children. Withdraw gradually. Impaired renal, hepatic and respiratory function. Patients with acute pain and depressive disorders. May impair ability to drive or operate machinery. Lactation.
Adverse Drug Reaction(s) Bradycardia, hypotension, syncope; drowsiness, lethargy, CNS excitation or depression, impaired judgment, hangover effect, confusion, somnolence, agitation, hyperkinesia, ataxia, nervousness, headache, insomnia, nightmares, hallucinations, anxiety, dizziness; rash, exfoliative dermatitis; nausea, vomiting, constipation; agranulocytosis, thrombocytopenia, megaloblastic anaemia; pain at inj site, thrombophlebitis (IV); oliguria: laryngospasm, respiratory depression, apnoea (especially with rapid IV admin), hypoventilation.
Potentially Fatal: Stevens-Johnson syndrome.
Drug Interactions May enhance the hepatotoxic potential of paracetemaol overdoses. May decrease levels/effects of various CYP isoenzyme substrates e.g. teniposide, methotrexate, antipsychotics, β-blockers, calcium-channel blockers, other anticonvulsants, chloramphenicol, cimetidine, corticosteroids, ciclosporin, doxycycline, oestrogens, felbamate, griseofulvin, tacrolimus, furosemide, methadone, oral contraceptives, theophylline, TCAs, warfarin. May reduce effects of guanfacine. Reduced metabolism and or increased toxicity with chloramphenicol, felbamate, MAOIs, valproic acid. May enhance the nephrotoxic effects of methoxyflurane.
Potentially Fatal: Additive sedation and/or respiratory depression with ethanol, sedatives, antidepressants, opioid analgesics, benzodiazepines and other CNS depressants. May decrease levels/effects of antiarrhythmic drugs e.g. disopyramide, propafenone, quinidine. Please consult detailed drug interactions before prescribing. 
Food Interaction Evening primrose may reduce seizure threshold. Increased CNS depression may occur with valerian, St John's wort, kava kava, gotu kola.
Lab Interference May increase sulfobromophthalein retention and give elevated readings; do not administer within 24 hr preceding the test.
Pregnancy Category (FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Storage Intramuscular: Protect from light. Intravenous: Protect from light. Oral: Protect from light. Parenteral: Protect from light.
Pharmacology Phenobarbitone is a short-acting barbiturate. It depresses the sensory cortex, reduces motor activity, changes cerebellar function, and produces drowsiness, sedation and hypnosis. Its anticonvulsant property is exhibited at high doses.
Onset: Hypnosis: Oral: 20-60 min; IV: Approx 5 min.
Duration: Oral: 6-10 hr; IV: 4-10 hr.
Absorption: Readily absorbed from the GI tract (oral); peak plasma concentrations in about 2 hr (oral), and within 4 hr (IM).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: 45-60%.
Metabolism: Partly hepatic.
Excretion: Via urine (as unchanged drug). Plasma half-life: 75-120 hr (adult), greatly prolonged (neonates), 21-75 hr (children).
ATC Classification N03AA02 - phenobarbital; Belongs to the class of barbiturates and derivatives antiepileptics. Used in the management of epilepsy.

Brand/Product Info


Total Products : 16                
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
Barbit Incepta Pharmaceuticals Limited Phenobarbitone 20 mg/5 ml Elixir Elixir 100ml:MRP 57 Tk
BARBIT 30 Incepta Pharmaceuticals Limited Phenobarbitone 30mg Tablet Tablet 100's: 78 MRP
Barbit 50ml Incepta Pharmaceuticals Limited Phenobarbitone 20 mg/5 ml Elixir Elixir 50ml:MRP 29.06 Tk
BARBIT 60 Incepta Pharmaceuticals Limited Phenobarbitone 60mg Tablet Tablet 100's: 114 MRP
BARBIT Injection Incepta Pharmaceuticals Limited Phenobarbitone Sodium 200 mg/ml Injection Injection 5's: 80.00 MRP
BERDINAL Gaco Pharmaceutical Ltd. Phenobarbital BP 50mg Tablet 100's: 78.00 MRP
BERDINAL Injection Gaco Pharmaceutical Ltd. Phenobarbital Sodium BP 200mg/1ml Injection 1ml amp: 15.99 MRP
EMER Opsonin Pharma Limited Phenobarbital BP 15mg & 30mg & 60mg Tablet 100's each: 57.00 & 78.00 & 114.00 MRP
EMER Elixir Opsonin Pharma Limited Phenobarbital BP 20mg/5ml Syrup 100ml: 56.00 MRP
EMER Injection Opsonin Pharma Limited Phenobarbital Sodium BP 200mg/ml Injection 1ml x5's : 80.00 MRP
EPINAL 30 Square Pharmaceuticals Ltd. Phenobarbital 30mg Tablet 10x10's: 78.00 MRP
EPINAL ELIXIR Square Pharmaceuticals Ltd. Phenobarbital 20mg/5 ml Elixir 100 ml: 56.37 MRP
EPINAL INJ Square Pharmaceuticals Ltd. Phenobarbital 200mg/ml IM/IV Injection 1x5's: 80.25 MRP
PHENO Delta Pharma Limited Phenobarbital BP 30mg & 60mg Tablet 100's each: 78.00 & 114.00 MRP
PHENOBA Biopharma Laboratories Ltd Phenobarbital BP 30mg & 60mg Tablet 100's each: 78.00 & 114.00 MRP
PHENOSON Jayson Pharmaceuticals Ltd. Phenobarbital BP 30mg Tablet 100's: 78.00 MRP

Gen. MedInfo

Why is Phenobarbital prescribed?

Phenobarbital is used to control seizures. Phenobarbital is also used to relieve anxiety. It is also used to prevent withdrawal symptoms in people who are dependent ('addicted'; feel a need to continue taking the medication) on another barbiturate medication and are going to stop taking the medication. Phenobarbital is in a class of medications called barbiturates. It works by slowing activity in the brain.

How should Phenobarbital be used? 

Phenobarbital comes as a tablet and an elixir (liquid) to take by mouth. It is usually taken one to three times a day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take phenobarbital exactly as directed.

If you take phenobarbital for a long time, it may not control your symptoms as well as it did at the beginning of your treatment. Talk to your doctor about how you are feeling during your treatment.

Phenobarbital can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor.

Do not stop taking phenobarbital without talking to your doctor. If you suddenly stop taking phenobarbital, you may experience withdrawal symptoms such as anxiety, muscle twitching, uncontrollable shaking of a part of the body, weakness, dizziness, changes in vision, nausea, vomiting, seizures, confusion,difficulty falling asleep or staying asleep, or dizziness or fainting when getting up from a lying position. Your doctor will probably decrease your dose gradually.

Other uses for Phenobarbital 

Phenobarbital may be prescribed for other uses. Ask your doctor for more information.

What special precautions to follow?    

Before taking phenobarbital, 

  • tell your doctor if you are allergic to phenobarbital; other barbiturates such as amobarbital, butabarbital, pentobarbital, and secobarbital; any other medications, or any of the ingredients in phenobarbital tablets or liquid. Ask your doctor for a list of the ingredients.
  • tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin; disulfiram; doxycycline; griseofulvin; hormone replacement therapy (HRT); monoamine oxidase (MAO) inhibitors such as isocarboxazid, phenelzine, seligiline or tranylcypromine; medications for anxiety, depression, pain, asthma, colds, or allergies; certain medications for seizures such as phenytoin and valproate; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Deltasone);sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
  • tell your doctor if you have or have ever had porphyria (condition in which certain natural substances build up in the body and may cause stomach pain, changes in thinking and behavior, and other symptoms); any condition that causes shortness of breath or difficulty breathing; or liver disease. Your doctor will probably tell you not to take phenobarbital.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol, used street drugs, or overused prescription medications; if you have pain now or have any condition that causes you ongoing pain; if you have ever thought about harming or killing yourself or planned or tried to do so; and if you have or have ever had depression, any condition that affects your adrenal gland (small gland next to the kidney that produces important natural substances), or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking phenobarbital, call your doctor. Phenobarbital may harm the fetus.
  • you should know that phenobarbital may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices). Talk to your doctor about methods of birth control that will work for you while you are taking phenobarbital. Tell your doctor if you have a missed period or think you may be pregnant while you are taking phenobarbital.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking phenobarbital.
  • you should know that Phenobarbital may make you drowsy. Do not drive a car or operate machinery until you know how Phenobarbital affects you.
  • avoid drinking alcohol during your treatment with phenobarbital. Alcohol can make the side effects of phenobarbital worse.

What special dietary instructions to follow? 

Unless your doctor tells you otherwise, continue your normal diet.

What to do if I forget a dose? 

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can Phenobarbital cause?   

Phenobarbital may cause side effects. Call your doctor if any of the following symptoms are severe or do not go away: 

  • drowsiness

  • headache

  • dizziness

  • excitement or increased activity (especially in children)

  • nausea

  • vomiting

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • slowed breathing or difficulty breathing

  • swelling of the eyes, lips, or cheeks

  • rash

  • blistering or peeling skin

  • fever

  • confusion

What to know about storage and disposal of Phenobarbital?

Keep Phenobarbital in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

 

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.     

Symptoms of overdose may include the following:

  • uncontrollable movements of the eyes

  • loss of coordination

  • drowsiness

  • slowed breathing

  • drop in body temperature

  • blisters

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Phenobarbital.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: MedlinePlus, U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

 

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