Salbutamol Sulfate BP 2mg/5ml Syrup

  1. Name of the medicinal product

Salbutamol Sulfate Syrup BP 2mg/5ml Taj Pharma

  1. Qualitative and quantitative composition

Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulfate BP).

Excipient with known effect:

Sodium

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Syrup

  1. Clinical particulars

4.1 Therapeutic indications

Salbutamol Sulfate Syrup is indicated in adults, adolescents and children aged 2 to 12 years.

Salbutamol is a selective beta-2 adrenoceptor agonist providing short-acting (4-6 hour) bronchodilation in reversible airways obstruction. Salbutamol Sulfate Syrup can be used in the management of asthma, bronchospasm and/or reversible airways obstruction.

Relief of bronchospasm in bronchial asthma of all types.

Salbutamol Sulfate Syrup is suitable oral therapy for children and adults who are unable to use an inhaler device.

4.2 Posology and method of administration

Posology

Adults

The minimum starting dose is 2mg three times a day given as 5ml syrup. The usual effective dose is 4mg (10ml syrup) three or four times a day, which may be increased to a maximum of 8mg (20ml syrup) three or four times a day if adequate bronchodilation is not obtained.

Elderly

In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose.

Paediatric Population

2 – 6 years: the minimum starting dose is 1mg as 2.5ml of syrup three times daily. This may be increased to 2mg as 5ml of syrup three or four times daily.

6 – 12 years: the minimum starting dose is 2mg as 5ml syrup three times daily. This may be increased to four times daily.

Over 12 years: the minimum starting dose is 2mg three times daily given as 5ml syrup. This may be increased to 4mg as 10ml syrup three or four times daily.

Salbutamol Sulfate Syrup is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose.

For lower doses the syrup may be diluted with freshly prepared purified water BP.

Method of administration

Route of administration: oral

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.4 Special warnings and precautions for use

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in those patients.

Patients should seek medical advice if treatment with Salbutamol Sulfate Syrup becomes less effective.

The dosage or frequency of administration should only be increased on medical advice.

Patients taking Salbutamol Sulfate Syrup may also be receiving short-acting inhaled bronchodilators to relieve symptoms.

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.

Increasing use of bronchodilators in particular short-acting inhaled beta2-agonists to relieve symptoms indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual.

In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (eg. Higher doses of inhaled corticosteroids or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way.

Patients should be warned that if either the usual relief with Salbutamol Sulfate Syrup oral preparations is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.

In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Salbutamol Sulfate Syrup contains 5.6 mg sodium in each 5 ml of syrup. This should be taken into consideration by patients on a controlled sodium diet. Salbutamol Sulfate Syrup is sugar free.

4.5 Interaction with other medicinal products and other forms of interaction

Salbutamol Sulfate Syrup and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.

4.6 Pregnancy and lactation

Pregnancy

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

As with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus at very high dose levels.

Breast-feeding

As salbutamol is probably secreted in breast milk its use in nursing mothers requires careful consideration.

It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3).

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.

Immune system disorders
Very rare:Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders
Rare:Hypokalaemia.
Potentially serious hypokalaemia may result from beta agonist therapy.

Nervous system disorders

Very common:Tremor.
Common:Headache.
Very rare:Hyperactivity.
Cardiac disorders
Common:Tachycardia, palpitations.
Rare:Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles
Unknown:Myocardial ischaemia* (see section 4.4)
Vascular disorders
Rare:Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common:Muscle cramps.
Very rare:Feeling of muscle tension.

* reported spontaneously in post-marketing data therefore frequency regarded as unknown

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

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia (see sections 4.4 and 4.8).

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.

Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists

 

Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle providing short acting (4-6 hours) bronchodilation in reversible airways obstruction.

5.2 Pharmacokinetic properties

Salbutamol administered intravenously has a half life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4′ -O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.

After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine. The bioavailability of orally administered salbutamol is about 50%.

5.3 Preclinical safety data

In common with other potent selective β2-agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of fetuses were found to have cleft palate at 2.5mg/kg dose, 4 times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no significant fetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. Reproductive studies in the rabbit at doses of 50mg/kg/day orally (i.e. much higher than the normal human dose) have shown fetuses with treatment related changes; these included open eyelids (ablepharia), secondary palate clefts (palatoschisis), changes in ossification of the frontal bones of the cranium (cranioschisis) and limb flexure.

In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on fertility, embryofetal development, litter size, birth weight or growth rate..

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium citrate, Citric acid monohydrate, Hydroxypropyl, methylcellulose, Sodium benzoate, Saccharin sodium, Sodium chloride, Orange flavour , Purified water

6.2 Incompatibilities

None known

Salbutamol Sulfate Syrup is sugar free. Dilution of Salbutamol Sulfate Syrup with syrup BP or sorbitol solution is not recommended as this may result in the precipitation of the cellulose thickening agent. If dilution is required freshly prepared Purified Water BP should be used. The diluted mixture must be protected from light and stored below 25°C.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store at a temperature not exceeding 30°C.

Protect from light.

Salbutamol Sulfate Syrup may be diluted with freshly Purified Water BP. The diluted mixture must be protected from light and stored below 25°C. Discard after 28 days.

6.5 Nature and contents of container

Amber glass bottle.

Closure (150ml): plastic tamper evident, child resistant or plastic child resistant or ROPP aluminium (lacquered internally and externally) with either

PVdC faced EPE or LDPE faced PVdC/EPE OR LLDPE/PVdC

PVC/LLDPE/EPE (single or double faced) wad.

Pack size: 150ml.

6.6 Special precautions for disposal and other handling

Salbutamol Sulfate Syrup may be diluted with Purified Water BP (50%v/v). The resulting mixture should be protected from light and used within 28 days.

A 50% v/v dilution of Salbutamol Sulfate Syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.

Admixture of Salbutamol Sulfate Syrup with other liquid preparation is not recommended.

  1. 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

 

Salbutamol Sulfate BP 2mg/5ml Syrup

 

Package Leaflet: Information for the User

Salbutamol Sulfate Syrup BP 2mg/5ml Taj Pharma

salbutamol sulfate

 

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
  • If you have any further questions, ask your doctor, nurse or
  • 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 you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet:

  • What Salbutamol Sulfate Syrup is and what it is used for
  • What you need to know before you take Salbutamol Sulfate Syrup
  • How to take Salbutamol Sulfate Syrup
  • Possible side effects
  • How to store Salbutamol Sulfate Syrup
  • Contents of the pack and other information
  1. What Salbutamol Sulfate Syrup is and what it is used for

Salbutamol Sulfate Syrup contains a medicine called salbutamol. This belongs to a group of medicines called bronchodilators.

  • Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and
  • They help to relieve chest tightness, wheezing and

Salbutamol Sulfate Syrup is used to treat breathing problems in people with asthma and similar conditions. The syrup is used when children and adults cannot use an inhaler device.

  1. What you need to know before you take Salbutamol Sulfate Syrup

Do not take Salbutamol Sulfate Syrup :

  • if you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in Section 6)
  • if you unexpectedly go into early labour (premature labour) or threatened

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Salbutamol Sulfate Syrup if:

  • you have high blood pressure
  • you are diabetic
  • you have an overactive thyroid gland
  • you have a history of heart problems such as an irregular or fast heartbeat or angina
  • you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma
  • you are taking water tablets (diuretics), sometimes used to treat high blood pressure or a heart

Other medicines and Salbutamol Sulfate Syrup

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if you have to go to hospital.

In particular tell your doctor, nurse or pharmacist if you are taking:

  • medicines for an irregular or fast heartbeat
  • other medicines for your

Taking Salbutamol Sulfate Syrup with food and drink

You can take Salbutamol Sulfate Syrup at any time of day, with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Salbutamol Sulfate Syrup is not likely to affect you being able to drive or use any tools or machines.

Salbutamol Sulfate Syrup contains sodium

Salbutamol Sulfate Syrup contains 5.6 mg sodium in each 5 ml of syrup. This should be taken into consideration by patients on a controlled sodium diet. Salbutamol Sulfate Syrup is sugar free.

  1. How to take Salbutamol Sulfate Syrup

Always take this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Taking this medicine

  • use a 5 ml plastic spoon or oral syringe to take the syrup, they are available from your pharmacist
  • shake well before use
  • 5 ml of undiluted syrup provides a dose of 1 mg and 5 ml provides a dose of 2 mg.

 

Children between 2 and 6 years

  • the usual dose is 2.5 ml to 5 ml, three or four times a

Children between 6 and 12 years

  • the usual dose is 5 ml, three or four times a

Children over 12 years

  • the usual dose is 5 ml to 10 ml, three or four times a

Adults (over 18 years)

  • the usual dose is 5 ml to 20 ml, up to four times a

Elderly (over 65 years)

  • the usual dose is 5 ml, up to three times a

If you take more Salbutamol Sulfate Syrup than you should

If you take more than you should, talk to a doctor as soon as possible. The following effects may happen:

  • your heart beating faster than usual
  • you feel shaky
  • hyperactivity
  • acid build up in your body which may cause your breathing to become These effects usually wear off in a few hours.

If you forget to take Salbutamol Sulfate Syrup

  • If you forget a dose, take it as soon as you remember
  • However, if it is time for the next dose, skip the missed
  • Do not take a double dose to make up for a forgotten

If you stop taking Salbutamol Sulfate Syrup

Do not stop taking Salbutamol Sulfate Syrup without talking to your doctor.

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

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Salbutamol Sulfate Syrup and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.

Talk to your doctor as soon as possible if:

  • you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while
  • you may feel your heartbeat is uneven or it gives an extra beat
  • these affect less than 1 in 10

If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.

Tell your doctor if you have any of the following side effects which may also happen with this medicine:

Very common (may affect more than 1 in 10 people)

  • feeling

Common (may affect up to 1 in 10 people)

  • headache
  • muscle

Rare (may affect up to 1 in 1,000 people)

  • Your heart beats too fast, too slow or irregularly (cardiac arrythmia)
  • a low level of potassium in your blood
  • increased blood flow to your extremities (peripheral dilatation).

Very rare (may affect up to 1 in 10,000 people)

  • changes in sleep patterns and changes in behaviour, such as restlessness and excitability
  • muscle

The following side effects can also happen but the frequency of these are not known:

  • chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this occurs. Do not stop using this medicine unless told to do

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.

If you think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your doctor as soon as possible. Your chest problem may be getting worse and you may need a different medicine. Do not take extra Salbutamol Sulfate Syrup unless your doctor tells you to.

  1. How to store Salbutamol Sulfate Syrup
  • Keep this medicine out of the sight and reach of
  • Store undiluted syrup below 30°
  • Protect from
  • If your pharmacist has diluted your syrup (with purified water):
    • store it below 25°C
    • do not use after 28 days
    • follow the instructions on the pharmacist’s
  • Wipe the neck of the bottle after
  • Do not use Salbutamol Sulfate Syrup after the expiry date, which is stated on the bottle label and carton after ‘EXP’. The expiry date refers to the last day of that
  • If you are told to stop taking this medicine return any unused Salbutamol Sulfate Syrup to your pharmacist to be

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 to protect the environment.

  1. Contents of the pack and other information

What Salbutamol Sulfate Syrup contains

  • The active substance is salbutamol
  • The other ingredients are water, sodium citrate, citric acid monohydrate, hydroxypropylmethylcellulose, saccharin sodium, salt (sodium chloride), the preservative sodium benzoate and orange

What Salbutamol Sulfate Syrup looks like and contents of the pack

Salbutamol Sulfate Syrup comes in an amber coloured glass bottle. It is sealed with a child resistant plastic cap.

Each bottle contains 150 ml of syrup.

Each bottle contains 2 mg of salbutamol in each 5 ml of undiluted syrup.

  1. 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