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  1. NAME OF THE MEDICINAL PRODUCT

Phenobarbital Sodium Injection USP 65mg/1ml Taj Pharma
Phenobarbital Sodium Injection USP 130mg/1ml Taj Pharma
Phenobarbital Sodium Injection USP 200mg/1ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Phenobarbital Sodium Injection USP 65mg/1ml
Each ml of solution contains:
Phenobarbital Sodium                    65mg
Alcohol                                           0.1ml
Propylene glycol                         0.678ml
Benzyl alcohol                            0.015ml
Water for injection                              q.s

b) Phenobarbital Sodium Injection USP 130mg/1ml
Each ml of solution contains:
Phenobarbital Sodium                   130mg
Alcohol                                           0.1ml
Propylene glycol                         0.678ml
Benzyl alcohol                            0.015ml
Water for injection                          q.s

c) Phenobarbital Sodium Injection USP 200mg/1ml
Each ml of solution contains:
Phenobarbital Sodium                   200mg
Alcohol                                           0.1ml
Propylene glycol                         0.678ml
Benzyl alcohol                            0.015ml
Water for injection                          q.s

For the full list of excipients, see section 6.1

  1. PHARMACEUTICAL FORM

Solution for Injection

Clear, colourless, solution practically free from particles

pH = 10.0 – 11.0

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

An anti-convulsant for the treatment all forms of epilepsy except absence seizures.

4.2 Posology and method of administration

Posology

Adults

50 – 200mg as a single dose by intramuscular, subcutaneous or, after dilution 1 in 10 with Water for Injection, by intravenous injection, repeated, if necessary, after 6 hours.

Paediatric population

3 – 5mg per kg body weight as a single dose by intramuscular injection.

Method of administration

Intramuscular, subcutaneous or intravenous injection

4.3 Contraindications

Hypersensitivity to phenobarbital, other barbiturates or to any of the excipients listed in section 6.1

Severe respiratory depression.

Acute intermittent porphyria.

Severe impairment of renal or hepatic function.

4.4 Special warnings and precautions for use

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Phenobarbital Sodium.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

Steven-Johnson syndrome and toxic epidermal necrolysis

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of phenobarbital. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.

If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Phenobarbital treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.

If the patient has developed SJS or TEN with the use of phenobarbital, phenobarbital must not be re-started in this patient at any time.

Phenobarbital should be used with caution in the young, elderly, senile or debilitated patient and those with renal impairment, existing liver disease or respiratory depression, (should be avoided if severe), pregnancy, breastfeeding and porphyria.

Prolonged use may result in dependence of the alcohol-barbiturate type and care must be taken in treating patients with a history of drug abuse or alcoholism.

Intravenous use must be preceded by dilution as described in section 4.2. Subcutaneous injection can cause tissue necrosis.

Sudden withdrawal should be avoided as severe withdrawal syndrome (rebound insomnia, anxiety, tremor, dizziness, nausea, fits and delirium) may be precipitated.

Acute chronic pain – paradoxical excitement may be induced or important symptoms masked.

Herbal preparations containing St John’s wort (Hypericum perforatum) should not be used while taking phenobarbital due to the risk of decreased plasma concentrations and reduced clinical effects of phenobarbital

Excipient warning

The maximum daily dose contains 177.9mg of propylene glycol.

Propylene glycol in high doses may cause central nervous system side-effects, lactic acidosis, kidney and liver toxicity, increase in plasma osmolarity, and haemolytic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Effects on Phenobarbital

  • Alcohol – concurrent administration with alcohol may lead to an additive CNS depressant effect. This is likely with concurrent administration with other CNS depressants.
  • Antidepressants – including MAOIs, SSRIs and tricyclics may antagonise the antiepileptic activity of phenobarbital by lowering the convulsive threshold
  • Antiepileptics – phenobarbital plasma concentrations increased by oxcarbazepine, phenytoin and sodium valproate. Vigabatrin possibly decreases phenobarbital plasma concentrations.
  • Antipsychotics – concurrent use of chlorpromazine and thioridazine with phenobarbital can reduce the serum levels of either drug.
  • Folic acid – if folic acid supplements are given to treat folate deficiency, which can be caused by the use of phenobarbital, the serum phenobarbital levels may fall, leading to decreased seizure control in some patients. (see section 4.6).
  • Memantine – the effect of Phenobarbital is possibly reduced.
  • Methylphenidate – plasma concentration of Phenobarbital is possibly increased.
  • St John’s wort (Hypericum perforatum) – the effect of phenobarbital can be reduced by concomitant use of the herbal remedy St John’s wort.

Effects of phenobarbital on other medicines

Phenobarbital increases the rate of metabolism reducing serum concentrations of the following drugs:

  • Anti-arrhythmics – disopyramide and quinidine loss of arrhythmia control is possible. Plasma levels of antiarrhymics should be monitored, if phenobarbital is added or withdrawn. Changes in dosage may be necessary.
  • Antibacterials – chloramphenicol, doxycycline, metronidazole and rifampicin. Avoid concomitant use of telithromycin during and for 2 weeks after Phenobarbital.
  • Anticoagulants.
  • Antidepressants – paroxetine, mianserin and tricyclic antidepressants.
  • Antiepileptics – carbamazepine, lamotrigine, tiagabine, zonisamide, primidone and possibly ethosuxamide.
  • Antifungals – the antifungal effects of griseofulvin can be reduced or even abolished by concurrent use. Phenobarbital possibly reduces plasma concentrations of itraconazole or posaconazole. Avoid concomitant use of voriconazole.
  • Antipsychotics – phenobarbital possibly reduces concentration of aripiprazole.
  • Antivirals – phenobarbital possibly reduces plasma levels of abacavir, amprenavir, darunavir, lopinavir, indinavir, nelfinavir, saquinavir.
  • Anxiolytics and Hypnotics – clonazepam.
  • Aprepitant – phenobarbital possibly reduces plasma concentration of aprepitant.
  • Beta-blockers – metoprolol, timolol and possibly propranolol.
  • Calcium channel blockers – phenobarbital causes reduced levels of felodipine, isradipine, diltiazem, verapamil, nimodipine and nifedipine and an increase in dosage may be required.
  • Cardiac Glycosides – blood levels of digitoxin can be halved by concurrent use.
  • Ciclosporin or tacrolimus.
  • Corticosteroids.
  • Cytotoxics – phenobarbital possibly reduces the plasma levels of etoposide or irinotecan.
  • Diuretics – concomitant use with eplerenone should be avoided.
  • Haloperidol- serum levels are approximately halved by concurrent used with phenobarbital.
  • Hormone Antagonists – gestrinone and possibly toremifene.
  • Methadone – levels can be reduced by concurrent use of phenobarbital and withdrawal symptoms have been reported in patients maintained on methadone when phenobarbital has been added. Increases in the methadone dosage may be necessary.
  • Montelukast.
  • Oestrogens – reduced contraceptive effect.
  • Progestogens – reduced contraceptive effect.
  • Sodium oxybate – enhanced effects, avoid concomitant use.
  • Theophylline – may require an increase in theophylline dose.
  • Thyroid hormones – Phenobarbital has been shown to accelerate the metabolism of levothyroxine and liothyronine. Prescribers should be alert for changes in thyroid status if barbiturates are added or withdrawn from patients being treated for hypothyroidism.
  • Tibolone
  • Tropisetron
  • Vitamins – barbiturates possibly increase requirements for vitamin D

Phenobarbital may interfere with some laboratory tests including metyrapone test, phentolamine tests and serum bilirubin estimation.

4.6 Fertility, pregnancy and lactation

Pregnancy

Phenobarbital therapy in epileptic pregnant women presents a risk to the foetus in terms of major and minor congenital defects such as congenital craniofacial, digital abnormalities and, less commonly, cleft lip and palate. The risk of teratogenic effects developing appears to be greater if more than one antiepileptic drug is administered. The risk to the mother however is greater if phenobarbital is withheld and seizure control is lost. The risk: benefit balance, in this case, favours continued use of the drug during pregnancy at the lowest possible level to control seizures.

Patients taking phenobarbital should be adequately supplemented with folic acid before conception and during pregnancy (see section 4.5). Folic supplementation during pregnancy can help to counteract the risk of neural tube defects.

Phenobarbital readily crosses the placenta following oral administration and is distributed throughout foetal tissue, the highest concentrations being found in the placenta, foetal liver and brain. Adverse effects on neurobehavioral development have also been reported.

Haemorrhage at birth is also a risk. Prophylactic treatment with vitamin K1 for the mother before delivery (as well as the neonate) is recommended, the neonate should be monitored for signs of bleeding.

Breast-feeding

Phenobarbital is excreted into breast milk and may cause sedation in the infant though the risk is probably small. Breastfeeding is therefore not recommended.

4.7 Effects on ability to drive and use machines

Phenobarbital may impair the mental and/or physical abilities of the patient. If affected patients should not drive or operate machinery.

4.8 Undesirable effects

Antiepileptic hypersensitivity syndrome may occur. Symptoms include fever, rash, lymphadenopathy and hepatitis.

Blood and the lymphatic system disorders: megaloblastic anaemia (due to folate deficiency), agranulocytosis, thrombocytopenia.

Metabolism and nutritional disorders: osteomalacia, rickets.

Psychiatric disorders: paradoxical reaction (unusual excitement), hallucinations, restlessness and confusion in the elderly, mental depression, memory and cognitive impairment, drowsiness, lethargy.

Nervous system disorders: hyperactivity, behavioural disturbances in children, ataxia, nystagmus.

Cardiac disorders: hypotension.

Respiratory disorders: respiratory depression.

Hepato-bilary: hepatitis, cholestasis.

Skin and subcutaneous tissue disorders: allergic skin reactions (maculopapular morbilliform or scarlatiniform rashes), other skin reactions such as exfoliative dermatitis, erythema multiforme. Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4) very rarely.

Musculoskeletal, connective tissue and bone disorders:There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with Phenobarbital. The mechanism by which Phenobarbital affects bone metabolism has not been identified.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms.These include drowsiness, dysarthria, ataxia, nystagmus and disinhibition. There may also be coma, hypotension, hypotonia, hyporeflexia, hypothermia, and respiratory and cardiovascular depression.

The duration and depth of cerebral depression varies with the dose and the tolerance of the patient.

Treatment.Supportive measures alone may be sufficient if symptoms are mild. If an overdose of solution for injection is given,or erroneously taken by mouth, the prime objective of treatment is to maintain vital functions, respiration, cardiovascular and renal functions and the electrolyte balance while the majority of the drug is metabolised by hepatic enzymes. Given normal renal function, forced alkaline diuresis (maintaining the urinary pH at approximately 8 by intravenous infusion) may enhance the excretion of the drug from the kidneys. Charcoal haemoperfusion is the treatment of choice for the majority of patients with severe barbiturate poisoning who fail to improve or who deteriorate despite good supportive care.
  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

(antiepileptics, barbiturates and derivatives).

Phenobarbital is a long-acting barbiturate, which because of its depressant effect on the motor cortex, is used in the treatment of epilepsy. Phenobarbital has a widespread depressant action on cerebral function.

It has selective anticonvulsant activity and, used in hypnotic doses, it alters the stages of sleep in a dose dependent manner.

It has sedative effects and has some protective action against all varieties of human partial and generalised epilepsy, with the exception of absence seizures. Phenobarbital is also effective in preventing seizures in the corresponding experimental animal models of epilepsy.

In different studies phenobarbital appears to have had inconsistent effects in suppressing experimental epileptic foci, and epileptic after-discharges, but it inhibits synaptic transmission, at least in the spinal cord. The drug’s probable biochemical mechanism of action is through prolonging the opening time of Cl– ion channels in postsynaptic neuronal membranes. This effect causes membrane hyperpolarisation and thus impairs nerve impulse propagation. Phenobarbital also decreases intraneuronal Na+ concentrations, and inhibits Ca2+ influx into depolarised synaptosomes. It raises brain serotonin levels, and inhibits noradrenaline (norepinephrine) reuptake into synaptosomes. These additional biochemical actions may contribute towards the anticonvulsant effects of the drug.

5.2 Pharmacokinetic properties

Metabolism

The plasma half-life is about 75 to 120 hours in adults but is greatly prolonged in neonates, and shorter (about 21 to 75 hours) in children. The half-life is increased in the elderly and in neonates and is prolonged by renal and hepatic disorders. There is a considerable interindividual variation in Phenobarbital kinetics. Phenobarbital is only partly metabolised in the liver.

It is about 40% plasma bound.

Elimination

Excretion is mainly in the urine (and is increased in alkaline urine) with about 30% of the drug unchanged. The remainder is inactivated in the liver.

Phenobarbital crosses the placenta and is secreted in the milk of nursing mothers.

5.3 Preclinical safety data

No additional pre-clinical data of relevance to the prescriber is available.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium Edetate, Propylene Glycol and Water for Injection.

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Protect from light.

6.5 Nature and contents of container

Clear type 1 Ph Eur glass ampoules each containing sufficient product to allow removal of 1ml. Sold in cardboard outers of 10 ampoules.

6.6 Special precautions for disposal and other handling

None stated.

 

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Phenobarbital Sodium Injection USP 65mg/1ml Taj Pharma
Phenobarbital Sodium Injection USP 130mg/1ml Taj Pharma
Phenobarbital Sodium Injection USP 200mg/1ml Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Phenobarbital Sodium

(Referred to as Phenobarbital Injection in this leaflet)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Phenobarbital Injection is and what it is used for
2.What you need to know before you are given Phenobarbital Injection
3.How Phenobarbital Injection will be given
4.Possible side effects
5.How to store Phenobarbital Injection
6.Contents of the pack and other information

  1. WHAT PHENOBARBITAL INJECTION IS AND WHAT IT IS USED FOR

Phenobarbital belongs to a group of drugs known as barbiturates. Barbiturates have antiepileptic properties which mean they help prevent some types of epileptic seizures. They also have hypnotic properties which mean they can make you feel sleepy.

Phenobarbital Injection is used in the treatment of most types of epilepsy except absence seizures (petit mal).

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENOBARBITAL INJECTION

You should not be given Phenobarbital Injection if:

  • You are allergic (hypersensitive) to any barbiturates or any of the ingredients of this medicine (see section 6)
  • You suffer from acute intermittent porphyria (a type of blood disorder)
  • You suffer from severe breathing difficulties (respiratory depression)
  • You suffer from liver or kidney problems

If your problem is not severe your doctor may decide to give you the medicine with caution. Talk to your doctor, they will advise you on your particular situation.

If you develop a rash or the following skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine:

  • Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenobarbital Injection appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life- threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
  • If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenobarbital Injection you must not be re-started on Phenobarbital Injection at any time.

Warnings and precautions

Talk to your doctor before you are given Phenobarbital Injection if:

  • You have an alcohol or drug problem
  • You are pregnant, planning to become pregnant or are breast-feeding
  • You are young, elderly or in poor health

A small number of people being treated with anti-epileptics such as Phenobarbital Injection have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Phenobarbital Injection

DO NOT use Phenobarbital in combination with

  • the herbal remedy St John’s Wort (Hypericum perforatum). If you already take St John’s Wort, talk to your doctor before stopping the St John’s Wort preparation

Tell your doctor if you are taking, have recently taken or might take any other medicines including:

  • anticoagulants, such as warfarin (used to stop the blood clotting)
  • digitoxin, eplerenone (used to treat some heart conditions), disopyramide or quinidine (used to treat an abnormal heartbeat)
  • drugs used to treat heart problems such as metoprolol, timolol and propranolol; calcium channel blockers, such as felodipine, isradipine, nicardipine, diltiazem, verapamil, nimodipine or nifedipine
  • medicines used to treat infections, such as chloramphenicol, telithromycin, itraconazole, posaconazole, voriconazole, griseofulvin, doxycycline, metronidazole, rifampicin, indinavir, lopinavir, nelfinavir or saquinavir
  • corticosteroids, such as hydrocortisone, cortisone or prednisolone
  • ciclosporin (an immunosuppressant used following an organ transplant)
  • tropisetron and aprepitant (used to stop you feeling and being sick following chemotherapy), irinotecan (used to treat cancer), toremifene (used to treat breast cancer)
  • tibolone (used to treat osteoporosis), or gestrinone (used to treat endometriosis)
  • liothyronine or levothyroxine (used to treat an under-active thyroid gland)
  • phenytoin, sodium valproate, clonazepam, carbamazepine, vigabatrin tiagabine, ethosuximide, oxcarbazepine or lamotrigine (used to treat epilepsy)
  • theophylline (used to treat asthma, bronchitis and emphysema), montelukast (used to prevent asthma)
  • the non-steroidal anti-inflammatory drug phenylbutazone (used to treat spondylitis)
  • oral contraceptives (the Pill)
  • drugs to treat depression, such as mianserin, paroxetine, amitriptyline, moclobemide or dosulepin • any drugs to treat a mental health problem, such as chlorpromazine, aripiprazole, thioridazine or haloperidol
  • methadone (used as a painkiller); memantine (to treat dementia)
  • methylphenidate to treat attention deficit disorder
  • vitamin D or folic acid, your doctor may advise you to change your daily dose
  • sodium oxybate – used to treat day-time sleepiness

If you are in any doubt please tell your doctor of any medication you are taking.

Phenobarbital Injection and alcohol:

You are advised NOT to drink alcohol with this medicine.

Pregnancy and breast-feeding

This medicine should not be given to you if you are pregnant, trying to become pregnant or are breast-feeding, unless your doctor has specifically recommended it.

Check with your doctor before taking folic acid supplements as they interact with Phenobarbital Injection, your doctor may need to adjust your dose.

This medicine may harm your baby. Ask your doctor for advice if you intend to and before you breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

This medicine may make you feel sleepy. If so, do not drive a car or operate machinery.

Phenobarbital Injection contains propylene glycol

Each dose may contain up to 177.9mg of propylene glycol. This can be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children less than 5 years of age and high-risk groups, such as patients with liver or kidney disease.

  1. HOW PHENOBARBITAL INJECTION WILL BE GIVEN

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you require.

Adults

  • 50 – 200mg as a single dose
  • The injection can be administered into a muscle, under the skin or, into a vein following dilution with water
  • Repeated, if necessary after 6 hours

Use in children

  • Use with caution
  • 3 – 5mg per kg body weight as a single dose into the muscle Your doctor will advise you on the duration of your therapy.

If you are given too much Phenobarbital Injection: If you experience any of the following, tell your doctor immediately:

  • feeling sleepy
  • feeling faint
  • feeling extremely cold
  • your breathing becoming very shallow

If you are at all concerned that you have been given too much of this medicine please tell your doctor.

If you missed a dose of Phenobarbital Injection:

This is not applicable because your doctor will administer this medicine.

If treatment with Phenobarbital Injection is stopped: Stopping treatment with this medicine may result in the return of, and increase in, seizures.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. POSSIBLE SIDE EFFECTS

Like all medicines Phenobarbital Injection can cause side effects, although not everybody gets them.

If the following happens seek urgent medical advice by contacting your doctor immediately or go to the casualty department at your nearest hospital:

  • an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
  • a syndrome called antiepilectic hypersensitivity syndrome. Symptoms of this include fever, rash, yellowing of the eyes and skin (hepatitis), and swollen glands
  • potential life-threatening skin rashes (Stevens- Johnsonsyndrome, toxic epidermal necrolysis) have been reported (see section 2) very rarely.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

Other side effects

The following side effects have been reported:

  • drowsiness, lethargy and depression
  • problems with memory and general perception in the elderly
  • lack of co-ordination and clumsiness
  • involuntary movements of your eyes
  • problems with your breathing, low blood pressure
  • anaemia, a reduction in red blood cells characterised by headaches, weight loss and a sore mouth and tongue
  • restlessness, confusion and excitability
  • hyperactivity and behavioural problems in children
  • hepatitis (inflammation of the liver)
  • jaundice (a yellowing of the skin and whites of the eyes)
  • softening and weakening of the bones
  • a severe skin reaction may occur, which may cause scaly, itchy skin, or red, itchy spots, loss of hair and nails
  • there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

 

If used for extended periods, Phenobarbital can become addictive. If you have any concerns about this, you should discuss them with your doctor.

If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE PHENOBARBITAL INJECTION

Keep out of the sight and reach of children.

Phenobarbital Injection should be kept in the outer carton in order to protect from light. Do not store above 25°C.

Do not use Phenobarbital Injection after the expiry date which is stated on the ampoule label. The expiry date refers to the

last day of that month. The doctor or nurse will check that the product has not passed this date.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect

the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Phenobarbital Injection contains

The active ingredient is Phenobarbital Sodium.

Phenobarbital Injection is a sterile solution.

Each 65mg/ml ampoule contains 65mg of Phenobarbital Sodium

Each 200mg/ml ampoule contains 200mg of Phenobarbital Sodium

The other ingredients are Propylene Glycol, Disodium Edetate and Water for Injections.

What Phenobarbital Injection looks like and contents of the pack:

Each ampoule contains 1ml of Phenobarbital Injection.

The medicine is supplied to your pharmacist or doctor in packs of 10 clear glass ampoules.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com