1.NAME OF THE MEDICINAL PRODUCT
a) Ephedrine Hydrochloride Tablets USP 15mg Taj Pharma.
b) Ephedrine Hydrochloride Tablets USP 30mg Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains:
Ephedrine Hydrochloride USP 15mg
Excipients    q.s.

b) Each tablet contains:
Ephedrine Hydrochloride USP  30mg
Excipients     q.s.
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Tablet
White, circular tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Ephedrine tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma.

4.2  Posology and method of administration

Adults 15 – 60mg three times daily
Children under 1 year

1 – 5 years

6 – 12 years

not recommended

15mg three times daily

30mg three times daily

Elderly Dosage should be substantially reduced. Initial therapy should be 50% of adult dose.


4.3 Contraindications
Ischaemic heart disease

Hypertension

Thyrotoxicosis

Prostatic hypertrophy

Ephedrine has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease.

Ephedrine increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated.

Patients with hyperthyroidism may be susceptible to the effects of ephedrine. Ephedrine may precipitate acute urinary retention in patients with prostatic hypertrophy.

4.4 Special Warnings and precautions for use
Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment.

Ephedrine has potentially life threatening effects in its acute cardiovascular and central stimulant effects.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction
Other adrenoceptor stimulants: Concurrent use of ephedrine with theophylline may result in increased nausea, nervousness, and insomnia.

Anaesthetics: There may be an increased risk of arrhythmias when used with volatile liquid anaesthetics.

Antidepressants: Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors as they may cause hypertensive crisis with marked headache, severe hypertension and subarachnoid haemorrhage. Noradrenaline is displaced by ephedrine with the release of large amounts of catecholamine. The interaction may occur up to two weeks after stopping MAOI therapy. There may be an increased risk of arrhythmias when ephedrine is used with tricyclic antidepressants.

Antihypertensives: Loss of blood pressure control has been detected in hypertensive patients undergoing concurrent therapy with ephedrine and adrenergic neurone blocking drugs and may also occur with other antihypertensives.

Antimigraine drugs: Enhanced vasoconstriction and pressor effects with ergotamine or methysergide; concurrent use of ergotamine not recommended (risk of gangrene).

Cardiac glycosides: Increased risk of arrhythmias in patients receiving ephedrine and cardiac glycosides.

Corticosteroids: Ephedrine has been shown to increase the clearance and prolong the half-life of dexamethasone in asthmatic patients.

Oxytocin: Increased risk of vasoconstrictor or pressor effects in patients receiving oxytocin and ephedrine.

Urinary acidifiers/alkalinisers: Effects of ephedrine may be reduced by acidification and increased by alkalinization of the urine.

4.6 Fertility, Pregnancy and lactation
The use of ephedrine in pregnancy should be avoided as ephedrine crossed the placenta and this has been associated with an increase in foetal heart rate and beat to beat variability. Ephedrine is excreted in breast milk and therefore its use during lactation should be avoided. Irritability and disturbed sleep patterns have been reported in breast fed infants.

4.7 Effects on ability to drive and use machines
Not applicable

4.8 Undesirable Effects
The most common side-effects of ephedrine are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias may occur. Tolerance with dependence has been reported with prolonged administration.

Myocardial infarction has occurred very rarely in patients taking ephedrine or pseudoephedrine.

Ephedrine may act as stimulant in children with nocturnal enuresis and cause sleeplessness. It may have sedative effects in some children.

The elderly are more sensitive to the cardiovascular effects of ephedrine.

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
a) Symptoms
The symptoms of overdose are normally seen as nausea, vomiting, hypertension, fever, palpitations, tachycardia, restlessness, respiratory depression and convulsions. Paranoid psychosis, delusions and hallucinations may also follow ephedrine overdosage.

b) Treatment
In severe overdosage, the stomach should be emptied by emesis and lavage. Management is by supportive symptomatic therapy.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors.

When given by mouth in therapeutic doses, ephedrine constricts the peripheral vessels, thus increasing blood pressure. It also relaxes bronchioles.

5.2 Pharmacokinetic properties
Ephedrine is rapidly and completely absorbed after oral administration and extensively distributed throughout the body with accumulation in the liver, lungs, kidneys, spleen and brain.

Peak plasma concentrations are attained during therapy of 65-120 ug/ml, effective bronchodilator plasma levels are in the range 35-80 ug/ml.

The plasma half-life is reported to be between 3-11 hours, with up to 95% being excreted in the urine.

5.3 Preclinical safety data
Studies in mice have shown that the lethal toxicity of ephedrine is increased by elevation of body temperature.

Ephedrine induces acute locomotor stimulatory activity in rats and mice. The estimated lethal dose in children up to 2 years of age is 200mg and for adults 2g. Fatalities are rare and single doses up to 400mg have been given without serious toxic effects.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Lactose
Maize starch
Acacia spray-dried
Stearic acid
Magnesium stearate

6.2 Incompatibilities
None known.

6.3  Shelf life
Polypropylene and polyethylene containers – Three years.
Blister strips – Two years

6.4 Special precautions for storage
Do not store above 25°C.
Store in the original container in order to protect from light.

6.5 Nature and contents of container
Polypropylene or polyethylene containers with tamper evident closure. Each pack contains 28, 30, 56, 60, 84, 90, 100, 250 or 1000 tablets.
Blister strips of 28, 30, 56, 60, 84, 90 tablets.

6.6 Special precautions for disposal and other handling
Not applicable

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

Ephedrine Hydrochloride Tablets USP 30mg Taj Pharma

Package leaflet: Information for the patient

a) Ephedrine Hydrochloride Tablets USP 15mg Taj Pharma.
b) Ephedrine Hydrochloride Tablets USP 30mg Taj Pharma.

Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Ephedrine Tablets is and what it is used for
2. Before you are given Ephedrine Tablets
3. How you will be given  Ephedrine Tablets
4. Possible side effects
5. How Ephedrine Tablets is stored
6. Further Information

1. What Ephedrine Tablets is and what it is used for
The active ingredient in Ephedrine Tablets is ephedrine hydrochloride, which belongs to a group of medicines called bronchodilators, which open up the airways in your lungs and prevent or relieve wheezing.

Ephedrine Tablets are used to prevent or relieve wheezing associated with asthma.

2. Before you are given Ephedrine Tablets
Do not take Ephedrine Tablets if you:
• are allergic to ephedrine hydrochloride or any of the other ingredients contained in Ephedrine Tablets (see list under heading ‘What Ephedrine Tablets contain’ in section 6)
• have coronary heart disease with narrowing of the blood vessels that supply blood and oxygen to the heart
• suffer from high blood pressure
• have an overactive thyroid gland
• have an enlarged prostate gland
• are being treated for depression with monoamine oxidase inhibitors (MAOIs) or have only recently stopped taking them (within the last two weeks)

If any of the above statements apply to you, you should not take Ephedrine Tablets.

The tablets are not recommended for children under one year of age.

Speak to your doctor before taking Ephedrine Tablets if you:
• suffer from diabetes
• have glaucoma (a disease in which the pressure inside the eyeball is too high)
• have kidney problems.

If any of the above statements apply to you, you should speak to your doctor before taking Ephedrine Tablets.

Taking other medicines
Taking another medicine while you are taking Ephedrine Tablets can affect how it or the other medicine works.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, including those you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following (or any other medication):
• Theophylline, a similar drug used to treat severe asthma and other conditions causing obstruction of the airways in your lungs
• Tricyclic antidepressants, such as amitriptyline or dosulepin, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazid or tranylcypromine, used to treat depression
• Drugs used to treat high blood pressure, such as propranolol or atenolol
• Dexamethasone, a steroid
• Anaesthetics, such as halothane
• Methysergide or ergotamine, used to treat migraine
• Drugs used to treat heart failure or abnormal heart rhythm, such as digoxin
• Oxytocin, used to induce labour and prevent bleeding
• Agents used to make the urine more alkaline (such as potassium citrate or sodium bicarbonate), or more acid (such as ammonium chloride or ascorbic acid).

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

Pregnancy and breast-feeding
You should not take Ephedrine Tablets if you are pregnant or wish to become pregnant. Taking Ephedrine Tablets whilst pregnant can affect your baby’s heartbeat.

Ephedrine can enter breast milk. You should not breast-feed whilst taking Ephedrine Tablets. Irritability and disturbed sleep patterns have been reported in breast-fed infants.

Driving and operating machines
Ephedrine Tablets do not affect the ability to drive or operate machinery.

Important information for patients who have an intolerance to some sugars
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose. You should not take Ephedrine Tablets if you have certain types of intolerance.

3. How you will be given Ephedrine Tablets
Your doctor will decide the dose which is best for you. Always follow your doctor’s instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless instructed differently, take your tablets with a glass of water

Adults
The usual dose for adults is 15-60mg three times daily.

Elderly
Smaller doses are required. For the elderly the starting dose should be half the adult dose.

Children one to five years
For children one to five years old the usual dose is 15mg three times daily.

Children six to 12 years
For children six to 12 years old the dose is usually 30mg three times daily.

The tablets are not recommended for children under one year of age.

If you take more Ephedrine Tablets than you should
If you accidentally take too many tablets contact your doctor, pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist. Symptoms of an overdose include being sick or feeling sick, high blood pressure, fever, rapid heart beat, restlessness, difficulty breathing and convulsions. Hallucinations and delusions may also occur.

If you miss a dose of Ephedrine Tablets
If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

Stopping Ephedrine Tablets
You should continue to take Ephedrine Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

4. Possible Side Effects
Like many medicines Ephedrine Tablets may cause side effects in some patients, although not everybody gets them.

Side effects include:
• feeling sick
• restlessness
• insomnia (difficulty in sleeping)
• anxiety
• dry mouth
• fast or irregular heart beat (these are more likely to occur if you are elderly)
• trembling
• headaches
• high blood pressure
• poor circulation in your fingers and toes
• heart attack (this is a very rare side effect)

Side effects specific to children
In children ephedrine may cause bed-wetting, sleeplessness or drowsiness.

If you take Ephedrine Tablets for a long time
If you have been taking Ephedrine Tablets for a long time you may become dependent on them.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Ephedrine Tablets is stored
Keep out of the reach and sight of children.

Do not take this medicine if the expiry date on the label has passed. The expiry date refers to the last day of that month.
Ephedrine Tablets should not be taken if they show signs of deterioration such as discoloration.
Do not store above 25°C.
Store in the original container or package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Ephedrine Tablets contains
The active ingredient in Ephedrine Tablets is ephedrine hydrochloride.
a) Each tablet contains: Ephedrine Hydrochloride USP     15mg
b) Each tablet contains: Ephedrine Hydrochloride USP          30mg
The other ingredients in Ephedrine Tablets are lactose, maize starch, acacia (spray-dried), stearic acid and magnesium stearate

What Ephedrine Tablets looks like and contents of the pack
Ephedrine Hydrochloride Tablets are white circular tablets.
Ephedrine Hydrochloride Tablets are available in polypropylene (plastic) containers of 28, 56, 100 tablets
Not All Packs May Not Be Marketed.

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