Ventolin Rotacaps Salbutamol Sulphate

VENTOLIN™ ROTACAPS™

Salbutamol

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

VENTOLIN ROTACAPS contain a mixture of microfine salbutamol sulphate and larger particle lactose in hard gelatin cartridges.

Each ROTACAP contains 200 micrograms or 400 micrograms of salbutamol (as sulphate).

 

PHARMACEUTICAL FORM

Inhalation powder, hard capsule (ROTACAPS).

 

CLINICAL PARTICULARS

Indications

VENTOLIN is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle, with little or no action in the beta-1 adrenoceptors of the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in mild asthma and for the treatment of acute exacerbations in moderate and severe asthma.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and Peak Expiratory Flow (PEP) values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients mill require high dose inhaled (e.g. greater than 1 mg/day beclomethasone dipropionate) or oral corticosteroid therapy.

With this primary background corticosteroid treatment VENTOLIN provides essential rescue medication for a severe asthmatic in treating acute exacerbations. Failure to respond promptly or fully to such rescue medication, signals a need for urgent medical advice and treatment.

VENTOLIN provides short-acting (four hours) bronchodilation with fast onset (within five minutes) in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. It is suitable for long-term use in the relief and prevention of asthmatic symptoms. VENTOLIN should be used to relieve symptoms when they occur and to present them in those circumstances recognised by the patient to precipitate an asthmatic attack (e.g. before overdose or unavoidable allergen exposure).

VENTOLIN in particularly valuable as rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and axe of regular inhaled corticosteroid therapy.

 

Dosage and Administration

VENTOLIN has a duration of action of 4 to 6 hours in most patients. VENTOLIN inhaled formulations are administered by the inhaled route only, to be breathed in through the mouth.

Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient’s therapy plan maybe required and concomitant glucacorticosteroid therapy should be considered.

As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

VENTOLIN ROTACAPS capsules are for inhalation use only, using a VENTOLIN ROTAHALER inhaler.

 

RELIEF OF ACUTE BRONCHOSPASM

Adults

200 or 400 micrograms.

 

Children

200 micrograms.

 

PREVENTION OF ALLERGEN OR EXERCISE-INDUCED BRONCHOSPASM

Adults

400 micrograms before challenge or exertion.

 

Children

200 micrograms before challenge or exertion.

 

CHRONIC THERAPY

Adults

400 microgramn 3 or 4 times daily.

 

Children

200 micrograms 3 or 4 times daily.

On demand use at VENTOLIN should not exceed four times daily.

Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions).

 

Contraindications

VENTOLIN is contraindicated in patients with a history of hypersensitivity to any of its components (see Excipients). Although i.v. salbutamol and occasionally VENTOLN tablets and VENTOLIN suppositories are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour. Salbutamol presentations should not be used for threatened abortion.

 

Warnings and Precautions

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 short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates deterioration of asthma control. Under these conditions, the patient’s therapy plan should be reassessed.

Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.

VENTOLIN should be administered cautiously to patients with thyrotoxicosis.

Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution in advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations. In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator.

VENTOLIN ROTACAPS should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

 

Interactions

VENTOLIN and non-selective beta-blocking drugs, such as propranolol should not usually be prescribed together. VENTOLIN is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

 

Pregnancy and Lactation

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

During worldwide marketing experience, rare cases of 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. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with salbutamol use cannot be established.

As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.

 

Effects on Ability to Drive and Use Machines

None reported.

 

Adverse Reactions

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including isolated reports.

Very common and common events were generally determined from clinical trial data. Rare and very rare 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-2 agonist therapy.

 

Nervous system disorders

Common: Tremor, headache.

Very rare: Hyperactivity.

 

Cardiac disorders

Common: Tachycardia.

Uncommon: Palpitations.

Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

 

Vascular disorders

Rare: Peripheral vasodilatation.

 

Respiratory, thoracic and mediastinal disorders

Very rare: Paradoxical bronchospasm.

 

Gantrointestinal disorders

Uncommon: Mouth and throat irritation.

 

Musculoskeletal and connective tissue disorders

Uncommon: Muscle cramps.

 

Overdose

The most common signs and symptoms of overdose with VENTOLIN are transient beta agonist pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions). Hypokalaemia may occur following overdosage with VENTOLIN.

Serum potassium levels should be monitored.

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

 

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle, with little or no action on the beta-1 adrenoceptors of cardiac muscle.

 

Pharmacokinetics

Absorption

After administration by the inhaled route, between 10 and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The traction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.

 

Distribution

Salbutamol is bound to plasma proteins to the extent of 10%.

 

Metabolism

On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate. The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.

 

Elimination

Salbutamol administered intravenously has a half-life of 4 to 6 hours and in cleared partly renally and partly by metabolism to the inactive 4’-O-sulphate (phenolic sulphate) 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.

 

Pre-clinical Safety Data

In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, four times the maximum human oral done. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50mg/kg/day, 70 times the maximum human oral dose.

 

PHARMACEUTICAL PARTICULARS

List of Excipients.

Lactose (which contains milk protein).

 

Incompatibilities

None reported.

 

Shelf-life

The expiry date in indicated on the packaging.

 

Special Precautions for Storage

To keep the ROTACAPS in good condition it is important that they are stored in a dry place and where they will not be exposed to extremes of temperature and should be stored below 30oC.

 

Nature and Contents of Container

VENTOLIN inhalation powder is contained in a capsule (ROTACAPS) each containing 200 micrograms or 400 micrograms of salbutamol (as sulphate). An inspiration driven inhaler made of plastic (a ROTAHALER) is used for administration of medication.

 

Instructions for Use/Handling

The ROTACAPS must only be inserted into the ROTAHALER immediately prior to use.

Failure to observe this instruction will affect the delivery of the drug.

 

Instructions for use

Step-by-step guide to using your VENTOLIN ROTAHALER

How to prepare your VENTOLIN ROTAHALER for use

1 Check that your ROTAHALER mouthpiece is clean and dry and free from objects. Hold the white end in one hand and turn the blue end as far as it will go.

2 Insert the clear end of a ROTACAPS capsule into the raised hole at the blue end of your ROTAHALER. Push in firmly until the top of the ROTACAPS capsule is level with the top of the hole.

3 Hold your ROTAHALER horizontally with the moulded line at the top. Turn the blue end back the other way as far as it will go. This opens the capsule. Your ROTAHALER is now ready for use.

 

How to use your VENTOLIN ROTAHALER

4 Sit down in a comfortable position. Hold your ROTAHALER away from your mouth so you don’t blow the powder away. Breathe out fully. Place the mouthpiece (white coloured end) of your ROTAHALER in your mouth between your teeth and lips. Take one quick, deep breath through the mouthpiece. Hold this breath for a few seconds or as long as is comfortable. Remove the ROTAHALER from your mouth and exhale.

5 If your doctor has told you to take two capsules, wait about 30 seconds before you take another capsule by repeating steps 2-4 above. At Step 2, when you press the second capsule into the ROTAHALER, you will push the shell of the tint capsule into the chamber. Pull the 2 halves of the ROTAHALER apart and throw away the previously used shell.

 

How to clean your VENTOLIN ROTAHALER

Your ROTAHALER should be cleaned every 2 weeks.

Follow the instructions below to clean your ROTAHALER.

6 Pull the two halves apart and throw away the empty ROTACAPS shells. If your ROTAHALER needs cleaning: Wash the two halves in warm water and dry thoroughly before reassembling it.

Keep your ROTAHALER away from excessive heat.

Keep your ROTAHALER clean and dry at all times.

Not all presentations are available in every country.

 

Manufactured by

GlaxoSmithKline Australia Pty Ltd.

1061 Mountain Highway

Boronia, Victoria 3155

Australia.

 

VENTOLIN, ROTACAPS and ROTAHALER are trademarks of the GlaxoSmithKline group of companies.

 

© 2012 GlaxoSmithKline group of companies. All rights reserved.

 

Version number: GDS23/IPI05

 

Date of issue: 23 February 2012

Glenmark Ascorex Expectorant Syrup

Ascorex™ Expectorant
(Fixed dose combination of Salbutamol Sulphate, Bromhexine hydrochloride, Guaifenesin and Menthol)

For the use only of a Registered Medical Practitioner or Hospital or a Laboratory.

 

ASCOREX EXPECTORANT

(Fixed dose combination of Salbutamol Sulphate, Bromhexlne hydrochloride, Guaifenesin and Menthol)

 

COMPOSITION

Each 10mI contains:

Salbutamol Sulphate BP equivalent to Salbutamol 2mg

Bromhexine Hydrochloride BP 4mg

Guaifenesin USP 100mg

Menthol BP 1mg

Flavoured Syrup base q.s.

Colour: Sunset Yellow FCF

 

DESCRIPTION

ASCOREX EXPECTORANT contains Salbutamol Sulphate, a selective beta-2 agonist Bromhexine hydrochloride, an expectorant/mucolytic agent; Guaifenesin, an expectorant and Menthol, a soothing agent.

1. Salbutamol Sulphate is a selective beta-2 agonist with bronchodilator property. Chemically it is 2-(hydroxymethyl) 4-[1-hydroxy- 2-(tert-butylamino) ethyl] phenol with a molecular formula of C13H21NO3 and Molecular weight of 239.311.

2. Bromhexine hydrochloride is a mucolytic agent. The drug is a benzylamine derivative and also a derivative of vasicine and adhatodic acid, alkaloids obtained from the plant Adhatoda vasica. Its chemical formula is C14H20Br2N2 and the Molecular weight is 376.13.

3. Guaifenesin is an expectorant that was first approved by the FDA In 1952. Chemically it is 3-(2-methoxyphenoxy) propane-1, 2-diol with a chemical formula of C10H14O4 and Molecular weight of 198.216 g/mol.

4. Menthol is a demulcent/soothing agent with a chemical name of p-Menthan-3-ol; 2-lsopropyl-5 methylcyclohexanol and a molecular formula of C10H20O. It has a molecular weight of 156.3.

 

CLINICAL PHARMACOLOGY

Pharmacodynamics

Salbutamol

Salbutamol is a direct-acting sympathomimetic agent which demonstrates relatively selective action on beta-2 adrenoceptors. The prime action of beta-adrenergic drugs is to stimulate adenyl cylase, the enzyme which catalyzes the formation of cyclic-3, 5-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Salbutamol relaxes the smooth muscle of the bronchi (causing bronchodilation or widening of the airway), uterus, and skeletal muscle vascular bed. Salbutamol is more potent and longer acting beta-2 adrenoceptor agonist as compared to lsoproterenol. Salbutamol may also reduce chemical mediator release from pulmonary mast cells and improve mucociliary transport mechanisms.

Bromhexin

Bromhexine is an expectorant/mucolytic agent. Following oral administration, bromhexine has increased sputum volume and reduced the viscosity of bronchial secretions in chronic bronchitis patients. The drug has been reported to induce hydrolytic depolymerization of mucoprotein fibers and stimulate activity of the ciliated epithelium. An increase in lysosomal activity facilitated by bromhexine has been postulated. Improvements in pulmonary function in bronchitis patients appear secondary to easier expectoration.

Other pharmacological effects of bromhexine have been reported, including enhancement of secretion from exocrine glands (e.g., tear production) and an increase in pulmonary surfactant production. An effect of bromhexine on increasing sputum concentrations of various antibiotics (e.g., oxytetracycilne, erythromycin, ampicillin, amoxicillin) has also been reported. It has been suggested that metabolite of bromhexine, ambroxol (NA-872), may contribute to enhanced secretion from exocrine glands during Bromhexine administration.

Guaifenesin

Guaifenesin is an expectorant which is thought to act by irritating the gastric mucosa and subsequently stimulating respiratory tract secretions. This increase in fluid increases the volume and decreases the viscosity of bronchial secretions. It was first approved by the Food and Drug Administration (FDA) in 1952.

Menthol

Menthol is chiefly used to relieve symptoms of bronchitis, sinusitis, and similar conditions. Menthol exerts soothing and counter-irritant effects on upper respiratory mucosa. It has been suggested that the apparent benefits of menthol in nasal congestion may be due to an effect on calcium channels of sensory nerves.

Pharmacokinetics

Salbutamol

Salbutamol is well absorbed from the gastrointestinal tract with bioavailability of approximately 50% to 85%. Peak plasma concentrations (Cmax) occur 1 to 4 hours (Tmax) after oral administration of salbutamol. Food does not affect the bioavailability of salbutamol. Plasma protein binding for salbutamol is 10% and volume of distribution (Vd) is 156+/-38 liters. Salbutamol is metabolised in the liver to form active metabolite, 4-O-Sulphate ester. Excretion of salbutamol is primarily renal. Approximately 64% to 98% of the dose is recovered in the urine and 1.2% to 7% eliminated in feces. The elimination half-life of salbutamol is 3 to 6.5 hours.

Bromhexine

Bromhexine is well absorbed from the gastrointestinal tract. Peak serum concentrations of bromhexine occur approximately 1 hour following oral administration. Bromhexine is extensively metabolised in the liver to form active metabolite, ambroxol. Bromhexine is excreted primarily in the urine as metabolites. Only small amounts appear as unchanged drug. The elimination half-life of bromhexine is 6.5 hours.

Guaifenesin

Guaifenesin is well absorbed from the gastrointestinal tract. 60% of guaifenesin is hydrolyzed in blood within 7 hours with the formation of Beta-2-methoxyphenoxy-Iactlc acid. Excessive use of guaifenesin may result in urolithiasis; the resultant stones contain the metabolite of guaifenesin, beta-2- methoxyphenoxy-lactic acid. Guaifenesin is excreted in the urine in the form of metabolites. The plasma half-life of guaifenesin is 1 hour.

Menthol

After absorption, menthol is excreted in the urine and bile as a glucuronide.

 

INDICATIONS AND USAGE

ASCOREX EXPECTORANT is indicated for the symptomatic relief in the treatment of productive cough associated with bronchospasm in various respiratory disorders like Pneumonia, COPD, Bronchial asthma, emphysema, acute and chronic bronchitis, etc.

 

DOSAGE AND ADMINISTRATION

• Adults and Children over 12 years: 10 mL (2 teaspoons) three times a day.

• Children from 6 to 12 years: 5 mL (1 teaspoon) three times a day.

• Children from 2 to 5 years: 2.5 mL(1/2 teaspoon) three times a day.

• Not recommended in children below 2 years.

 

USE IN SPECIAL POPULATIONS

Pregnancy

Animal reproduction studies have not been conducted with ASCOREX EXPECTORANT. It is also not known whether ASCOREX EXPECTORANT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ASCOREX EXPECTORANT should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

ASCOREX EXPECTORANT is not recommended in lactating mothers.

Pediatric Use

ASCOREX EXPECTORANT is not recommended in children less than 2 years of age.

 

CONTRAINDICATIONS

Known or suspected hypersensitivity to any of the ingredients.

 

WARNINGS AND PRECAUTIONS

• Salbutamol, as with all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes meliltus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

• Salbutamol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the Qtc interval, and ST segment depression. Therefore, salbutamol should be used with caution in patIents with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

• Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of salbutamol than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti inflammatory treatment; e.g., Corticosteroids.

• Salbutamol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, salbutamol should be discontinued immediately and alternative therapy instituted.

• Immediate hypersensitivity reactions may occur after administration of salbutamol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Rarely, erythema multiforme and Stevens Johnson syndrome have been associated with the administration of oral salbutamol in children.

• Precaution should be taken while using Guaifenesin in treatment of cough accompanied by too much mucus or persistent or chronic cough such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema.

• Bromhexine should be used cautiously in patients with gastric or duodenal ulcer.

 

ADVERSE REACTIONS

ASCOREX EXPECTORANT is generally well tolerated and adverse events are generally mild and transient. The adverse events reported with the individual ingredients are as mentioned below:

Salbutamol

The adverse reactions to salbutamol are similar in nature to reactions to other sympathomimetic agents. The reactions are generally transient in nature. The most frequent adverse reactions to salbutamol are nervousness, tremor, headache, tachycardia, and palpitations. Less frequent adverse reactions are muscle cramps, insomnia, nausea, weakness, dizziness, drowsiness, flushing, restlessness, irritability, chest discomfort, and difficulty in micturition. Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of salbutamol. In addition, salbutamol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.

Bromhexine

Adverse effects of bromhexine include gastrointestinal symptoms (nausea, epigastric pain, vomiting), headache, dizziness, and skin rash; elevations in liver function tests have been reported in a few patients.

Guaifenesin

Adverse effects are primarily minor gastrointestinal complaints. Urolithiasis has been associated with excessive use of guaifenesin.

Menthol

Ingestion of menthol is reported to cause severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma.

 

DRUG INTERACTIONS

Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists.

Beta Blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as salbutamol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta blockers.

Monoamine Oxidase Inhibitors: Hypertensive crises and other adverse effects occur frequently with the concurrent use of indirect-acting sympathomimetics. Direct-acting beta adrenergic agonist drugs should theoretically not interact with monoamine oxidase (MAO) inhibitors. However, two case reports have described adverse effects, including tachycardia and hypomania, attributed to such an interaction.

Digoxin: Decreases of 16% to 22% in serum digoxin levels were seen after single-dose administration of salbutamol to healthy volunteers who had been receiving digoxin for 10 days.

The concomitant use of salbutamol and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects.

 

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Animal or human studies of ASCOREX EXPECTORANT have not been performed to assess the carcinogenic and mutagenic potential, or the effect on fertility.

 

OVERDOSAGE

No overdosage has been reported with ASCOREX EXPECTORANT. Literature mentions reports of overdosage with salbutamol generally describing the features that may be expected such as tachycardia, CNS stimulation, tremor, hypokalaemia, and hyperglycaemia. Symptomatic treatment of the adverse effects has proved successful.

The plasma-potassium concentration and pulse rate have been found to correlate with the plasma concentration of salbutamol. Gastrointestinal discomfort, nausea, and vomiting have occasionally been reported with Guaifenesin, particularly in very large doses. Urinary calculi (Urolithiasis) have been reported in patients consuming large quantities of over-the-counter preparations containing guaifenesin.

 

Storage

Store below 25°C. Protect from light.

Keep all Medicines out of reach of children.

 

Presentation

Bottle of 100 ml.

 

NAFDAC Reg. No. A4-0918

 

MANUFACTURED BY

GLENMARK PHARMACEUTICALS LTD.

PLOT NO. E-37, 39, D-ROAD,

M.I.D.C. INDUSTRIAL AREA,

SATPUR, NASIK -422 007, INDIA.

™Trade Mark

Embassy Dexamethasone Sodium Phosphate Injection

DEXAMETHASONE INJECTION

Dexamethasone Sodium Phosphate Injection

For i.m. / i.v Injection

4 mg/1 ml

 

Composition

Each ampoule of 1mI contains 4mg of dexamethasone-2 1-phosphate in the form of disodium salt.

Dexamethasone is the generic name for 9-alpha-fluoro-16-alpha-methyl-prednisolone.

 

Actions

Dexamethasone exerts a potent anti-allergic and anti-inflammatory action.

 

Indications

Severe allergic reactions (anaphylactic shock, post-transfusion reactions, acute bronchial asthma, medicamentous allergies, asthmatic condition. Stevens-Johnson syndrome, edema of larynx, acute dermatoses), adrenocortical insufficiency, acute exacerbations in patients treated with oral glucocorticoids, viral hepatitis thyroid crisis and acute thyroiditis, croup, differential diagnosis of adrenocortical hyperplasia and rumors, rheumatic diseases of joints and diseases of soft tissues.

 

Contraindications

Absolute active or cured tuberculosis, ophthalmic herpes simplex.

 

Relative

Peptic ulcer, osteoporosis, diabetes, hypertension, fresh intestinal anastomosis, diverticulitis, thrombophiebitis, inelination to psychoses, pregnancy (especially during the first trimester), renal insufficiency. Cushing’s syndrome, healing wounds, myasthenia gravis, acute and chronic infections (varticella, vaccination).

Perforation of tympanic is a contraindication to the use of solution in ear diseases.

 

Precautions

Corticosteroids may conceal symptoms of infections. Due to the risk of adrenocortical insufficiency, the treatment with steroids should not be interrupted suddenly.

Corticosteroids may induce hyperacidity and ponticulus, therefore in prolonged treatment a corresponding diet and application of antiacids are required. In gastric disorders and in prolonged treatment and X-ray control is required. Latent diabetes mellitus occurs faster.

Do not inject into the deltoid muscle because of the danger of tissue atrophy. It should not be injected locally into the infected region or intravertebral space. During pregnancy, the glucocorticoids may be applied exceptionally only, i.e. in extremely severe cases.

Newborns should be controlled carefully.

 

Side effects

Relative adrenocortical insufficiency, increased catabolism of proteins with negative nitrogen balance, disorder of electrolytic balance, disorders in metabolism of glucose with aggravation of diabetes, osteoporosis, spontaneous fractures of bones, aseptic necrosis of the hip, myopathies, activation and aggravation of peptic uncer, aggravation of infection hypertension, moon-shaped face, hirsutism, acne, abdominal striae, convulsions petechiae and purpura amenorrhea, insomnia, mental disorders, increased intraocular pressure, pancreatitis, anglitis, disorders in children’s growth, thrombophlebitis, vertigo, nausea, facial erythema, ulcerous esophagitis, headache, exophthalmos, leukoecytosis, lymphopenia, corneal ulcer oligospermia and systemic fat emboli, abnormal euphoria, increase in appetite and body weight, tissue atrophy hypopigmentation of skin, post-injection swelling, reactions similar to shock.

 

Dosage and Administration

The dosage should be adjusted to individual case. If the drug has been given longer than for a couple of days, the dose should be diminished slowly and the drug should not be discontinued immediately. It may be injected intravenously, intramuscularly, intrasynovial, or by local tissue infiltration.

Initial dose: 1 to 5 or even 20 ampoules daily (i.v. or i.m) followed by a maintenance dose of ½ to 1 ampoule several times daily.

Intrasynovial: ½ to 1 ampoule every 24 hours.

Chronic diseases: Initial treatment at a dose of 0.5 to 1mg daily with a slow increase until clinical effect is observed. Later on the drug is given twice daily.

 

Availability

On physician’s prescription only.

 

Presentation

Boxes 25 ampoules of 1 ml, or boxes 100 ampoules of 1 ml or boxes 10 ampoules of 1 ml.

 

Manufactured by

JIANGSU YIXING FORWARD PHARMAC FACTORY.

CHAN BU. YIXING ECO. DEVPT ZONE. JIANGSU PROVINCE CHINA.

 

Sole Agent

EMBASSY PHARMACEUTICAL & CHEMICALS LTD.

Lagos – Nigeria.