Generic Name

Salbutamol

Brand Name

Salbutrex^®

Dosage Form

Metered-dose inhaler (It’s administrated by the inhaled route which is done from the mouth)

Strength

100 mcg/dose

Indication

Salbutamol is a beta-2 adrenergic receptor agonist used to treat asthma, bronchitis, COPD, as well as prevent exercise induced bronchospasms.

Salbutamol is indicated for (i) the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis, reversible obstructive airway disease, and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor, and/or (ii) the acute prophylaxis against exercise-induced bronchospasm and other stimuli known to induce bronchospasm.

Recommended Dose:

Adults (including elderly) and adolescents (children 12 years and over)

• To relieve asthma: One or two puffs (100 or 200 micrograms).

• To prevent asthma: Two puffs (200 micrograms) 10-15 minutes before exercise or exposure to a recognised allergen.

• Long-term treatment: Up to two puffs (200 micrograms) 4 times a day.

Children under the age of 12 years

• To relieve asthma: One puff (100 micrograms). Your doctor may increase this to two puffs (200 micrograms) if required.

• To prevent asthma: One puff (100 micrograms) 10-15 minutes before exercise or exposure to a recognised allergen. Your doctor may increase this to two puffs if required.

• Long-term treatment: Up to two puffs (200 micrograms) 4 times a day.

An adult should always supervise children when they use Salbutrex Inhaler. Children may need help to use their inhaler. Parents can help by spraying the aerosol when the child begins to breathe in.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Route of Elimination

After oral administration, 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites. A small fraction is excreted in the feces.

Half- life

The elimination half-life of inhaled or oral salbutamol has been recorded as being between 2.7 and 5 hours while the apparent terminal plasma half-life of albuterol has been documented as being approximately 4.6 hours.

Clearance

The renal clearance of salbutamol has been documented as 272 +/- 38 ml/min after oral administration and 291 +/- 70 ml/min after intravenous administration.¹ Furthermore, the renal clearance of the predominant sulfate conjugate metabolite was recorded as 98.5 +/- 23.5 ml/min following oral administration.

Toxicity

The expected signs and symptoms with overdosage of albuterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). In particular, the signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.

Hypokalaemia may occur following overdosage 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.

Pregnancy and Lactation

Salbutamol is categorized as Pregnancy Category C. There are no adequate and well-controlled trials with salbutamolc or albuterol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies No consistent pattern of defects can be discerned, and a relationship between salbutamol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity. Salbutamol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking salbutamol.

Since there exists a potential for beta-agonist interference with uterine contractility, the use of salbutamol during labour should be restricted to those patients in whom the benefits clearly outweigh the risk.

Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of salbutamol are excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of salbutamol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when salbutamol is administered to a nursing woman.

The safety and effectiveness of salbutamol in children younger than 4 years of age has not yet been established.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

· Amineptine

· Amitriptyline

· Amitriptylinoxide

· Amoxapine

· Atomoxetine

· Clomipramine

· Desipramine

· Dibenzepin

· Doxepin

· Imipramine

· Iobenguane

· Levalbuterol

· Lofepramine

· Melitracen

· Methacholine

· Nortriptyline

· Opipramol

· Protriptyline

· Tianeptine

· Trimipramine

· Digoxin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other similar inhaled medicines, such as Isoproterenol, Levalbuterol, Metaproterenol, Pirbuterol, or Terbutaline.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

· Your symptoms do not improve or they become worse after using this medicine.

· Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless your doctor tells you to.

Albuterol may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea, vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

· Fast, irregular, pounding, or racing heartbeat or pulse

· shakiness in the legs, arms, hands, or feet

· trembling or shaking of the hands or feet

Less common:

· Bladder pain

· bloody or cloudy urine

· chest discomfort or pain

· chills

· cough

· cough producing mucus

· diarrhea

· difficult or labored breathing

· difficulty with swallowing

· dizziness

· feeling of warmth

· fever

· frequent urge to urinate

· hives, itching, or skin rash

· hoarseness

· loss of appetite

· lower back or side pain

· nausea

· puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

· redness of the face, neck, arms, and occasionally, upper chest

· runny nose

· sore throat

· stomach pain

· swollen, painful, or tender lymph glands in the neck, armpit, or groin

· tightness in the chest

· unusual tiredness or weakness

Rare:

· Hives or welts

· large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

· noisy breathing

· swelling of the mouth or throat

Contraindications

Salbutamol sulphate is contraindicated in patients with hypersensitivity (allergy) to any of the active substances or the excipients. Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together. Caution is also advised in patients using cardiac glycosides.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.