ASTHALIN DX Syrup (Chlorpheniramine Maleate, Phenylephrine Hydrochloride and Dextromethorphan Syrup)

Table of Content

Cough, cold and flu are among the most commonly experienced conditions in adults and children, leading them to seek medical care.

A cough where no phlegm or mucus is produced (known as non-productive). It often occurs alongside a tickly cough and can be caused by viral infections or allergies. For the management of dry cough, a combination of mainly antitussive/antihistamine is used. Recent guidelines published by the American College of Chest Physicians (ACCP) recommend the use of a first-generation antihistamine in combination with a decongestant for the treatment of chronic cough due to Upper Airway Cough Syndrome (UACS).   The ACCP also recommends the use of antitussive agents in the management of post-infectious cough when the cough adversely affects the patient’s quality of life.

Antitussive agents alone or in combination with antihistamines and/or decongestants may also be used for effective symptomatic relief of dry cough.

Asthalin DX syrup is a multi-ingredient combination product (syrup) recommended for dry cough due to allergy.  Dextromethorphan hydrobromide (anti-tussive): Suppresses the cough reflex by a direct action on the cough centre in the medulla of the brain. Chlorpheniramine maleate (antihistamine): Reduces the symptoms of sneezing, rhinorrhoea and nasal itching by antagonizing the action of the histamine H1 receptors. Phenylephrine (Decongestant): Sympathomimetic effect of phenylephrine produces vasoconstriction, which, in turn, relieves nasal congestion.

Asthalin DX Syrup can be recommended for the relief of cough and upper respiratory symptoms, including nasal congestion associated with allergy or the common cold.

Asthalin DX syrup dosage is as follows:                                                

Adults: 10 ml thrice daily

Children (7–12 years of age): 5 ml thrice daily

Children (4–6 years of age): 2.5 ml thrice daily

For the use of a Registered Medical Practitioner only

Qualitative and Quantitative Composition 

ASTHALIN DX Syrup

Each 5 mL contains:

Chlorpheniramine Maleate, IP............................................. 2 mg

Phenylephrine Hydrochloride, IP…………………………… 5 mg

Dextromethorphan Hydrobromide, IP…………...................15 mg

In a flavoured base………………………………………….q.s.

Colour: Sunset Yellow FCF

Dosage Form(S) and Strength(S)

Oral syrup of 100 mL (each 5 mL contains chlorpheniramine maleate 2 mg, phenylephrine hydrochloride 5 mg and dextromethorphan syrup 15 mg

Clinical Particulars

Therapeutic Indications

ASTHALIN DX Syrup is indicated for the relief of dry cough and upper respiratory symptoms, including nasal congestion associated with allergy or the common cold.

Posology and Method of Administration

Adults

10 mL thrice daily
Paediatric Patients

Aged 7–12 years: 5 mL thrice daily

Aged 4–6 years: 2.5 mL thrice daily

or

As directed by the physician

Contraindications

ASTHALIN DX Syrup is contraindicated in the following:

  • Patients
  • with a hypersensitivity or idiosyncrasy to any of its ingredients.
  • with severe hypertension, severe coronary artery disease, high blood pressure, diabetes mellitus, closed-angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma and patients on monoamine oxidase inhibitor (MAOi) therapy.
  • with narrow-angle glaucoma, urinary retention, peptic ulcer, acute asthma and during an asthma attack.
  • receiving a MAOi or for 2 weeks after stopping the MAOi drug. There is a risk of serotonin syndrome with the concomitant use of dextromethorphan and MAOIs and the concomitant use of these medications may cause a rise in blood pressure and hypertensive crisis.
  • taking selective serotonin-reuptake inhibitors (SSRIs).
  • at risk of developing respiratory failure.
  • Premature infants or neonates because of their increased susceptibility to the antimuscarinic effects.

Special Warnings and Precautions for Use

General

Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions. Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus, and prostatic hypertrophy.

Do not exceed the recommended dosage. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischaemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy. Sympathomimetic amines may produce central nervous system (CNS) stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (aged 60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

Chlorpheniramine maleate should be given with caution to patients with epilepsy, severe cardiovascular disorders, liver disorders, glaucoma, urinary retention, prostatic enlargement, pyloroduodenal obstruction, asthma, bronchitis, bronchiectasis, thyrotoxicosis and severe hypertension.

Special care should be taken when using chlorpheniramine maleate in children and the elderly as they are more prone to developing neurological anticholinergic effects.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drinks.

Although most antihistamines should be avoided by patients with porphyria, chlorpheniramine maleate has been used and is thought to be safe.

Drug Dependence, Tolerance and Potential for Abuse

In all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g. major depression).

Drug Withdrawal Syndrome

The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, and increased respiratory rate or heart rate.

Serotonin Syndrome

Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as SSRIs, drugs which impair metabolism of serotonin (including MAOIs) and CYP2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

If serotonin syndrome is suspected, treatment with this medicine should be discontinued.

This product should not be taken with any other cough and cold medicines.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. While taking this product, patients should be advised to avoid alcoholic drinks and consult a healthcare professional prior to taking with CNS depressants.

Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should, therefore, be exercised in patients who are slow metabolisers of CYP2D6 or use CYP2D6 inhibitors.

This product should be used with caution in atopic children due to histamine release.

Phenylephrine should be used with caution in patients with occlusive vascular disease, including Raynaud's phenomenon.

Other Warnings

A physician should be consulted in situations where the patient has heart disease, high blood pressure, thyroid disease, diabetes mellitus, glaucoma, a breathing problem such as chronic bronchitis, a cough that lasts or is chronic, e.g. the type that occurs with asthma, and a cough that occurs with too much phlegm (mucus).

Drug Interactions

Chlorpheniramine Maleate

Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates,

alcohol and other CNS depressants. MAOIs prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamines. Effects of sympathomimetic are increased with MAOIs and beta-adrenergic blockers.

 Dextromethorphan Hydrobromide

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

Dextromethorphan should not be used concurrently in patients taking MAOIs or within 14days of stopping treatment with MAOIs as there is a risk of serotonin syndrome (pyrexia, hallucinations, gross excitation or coma, hypertension, arrhythmias).

CYP2D6 Inhibitors

Dextromethorphan is metabolised by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome. Potent CYP2D6 enzyme inhibitors include SSRIs such as fluoxetine and paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.

Phenylephrine Hydrochloride

It should not be given to patients being treated with MAOIs or within 14 days of stopping such treatment. It may enhance the effects of anticholinergic drugs such as tricyclic antidepressants. It may increase the possibility of arrhythmias in digitalised patients. It may also enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants).

This medicine should not be taken together with vasodilators, beta-blockers or enzyme inducers such as alcohol.

Use in Special Populations 

Pregnant Women

There are no adequate and well-controlled studies of this combination in pregnant women. Hence, this combination should be administered with caution in pregnancy.

Lactating Women

It is not known whether the drugs in ASTHALIN DX Syrup are excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious side effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the use of these products, taking into account the importance of the drug to the mother.

Patients with Hepatic or Renal Impairment

There have been no specific studies of this product in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

Effects on Ability to Drive and Use Machines

This medicine can impair cognitive function and can affect a patient's ability to drive safely. Drowsiness is possible and, hence, patients should not drive or operate machinery.

Undesirable Effects

Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhoea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria. Gastrointestinal disturbances may occur including abdominal pain, dyspepsia and anorexia.

Paradoxical CNS stimulation may occur especially in children or after high doses. Skin rashes, including exfoliative dermatitis and photosensitivity reactions, and hypersensitivity reactions, including urticaria, may occur. Other side effects include convulsions, sweating, myalgia, paraesthesia, tinnitus, palpitations, tachycardia, arrhythmias, chest pain, haemolytic anaemia and other blood dyscrasias, extrapyramidal effects, tremor, liver dysfunction, including hepatitis and jaundice, sleep disturbances, including nightmares, depression, hypotension, hair loss, thickening of bronchial secretions and confusional psychosis in the elderly.

Dextromethorphan may cause drowsiness, dizziness and gastrointestinal disturbance.

Phenylephrine adverse effects may include tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and, occasionally, urinary retention in males.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com.  You can also report side effects directly via the national Pharmacovigilance Programme of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 1800 267 7779. By reporting side effects, you can help provide more information on the safety of this product.

Overdose

No information is available as to specific results of an overdose of chlorpheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide syrup. The signs, symptoms and treatments described below are those of antihistamine, ephedrine and dextromethorphan overdose.

Symptoms:

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominant symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central system effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhoea and abdominal cramps.

Dextromethorphan Hydrobromide

Symptoms

Symptoms may include agitation, confusional state, hallucinations, mixed, psychotic disorder, ataxia, clumsiness, coma, dizziness, dysarthria, lethargy, nystagmus, seizure, serotonin syndrome, somnolence, tremor, CNS depression, miosis, mydriasis, respiratory depression, nausea, vomiting,

Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability.

In the event of massive overdose, the following symptoms may be observed: coma, respiratory depression, convulsions. 

Management

Treatment should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01 mg/kg body weight).

Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within the preceding hour.

For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome can be used.

Chlorpheniramine Maleate

Overdosage with chlorpheniramine is associated with antimuscarinic, extrapyramidal, gastrointestinal and CNS effects. In infants and children, CNS stimulation predominates over CNS depression, causing ataxia, excitement, tremors, psychosis, hallucinations and convulsions. Hyperpyrexia may also occur. Other symptoms of overdosage in children include dilated pupils, dry mouth, facial flushing. Deepening coma and cardiorespiratory collapse may follow, and even death. In adults CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse, including arrhythmias.

In severe overdosage the stomach should be emptied. Activated charcoal has been given as have saline laxatives. Convulsions may be controlled with diazepam or phenytoin, although it has been suggested that CNS depressants should be avoided. Other treatment is supportive and symptomatic and may include artificial respiration, external cooling for hyperpyrexia and intravenous fluids. Vasopressors such as noradrenaline or phenylephrine may be used to counteract hypotension. Forced diuresis, peritoneal dialysis or haemodialysis appear to be of limited benefit.

Phenylephrine Hydrochloride

Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta-blocker may be required to control cardiac arrhythmias.

Pharmacological Properties

Mechanism of Action

Dextromethorphan hydrobromide is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough centre in the medulla oblongata, raising the threshold for the cough reflex.

Chlorphenamine maleate is a potent antihistamine (H1-antagonist). The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedma and wheal in hypersensitivity reactions such as allergy and anaphylaxis.

The sympathomimetic effect of phenylephrine hydrochloride produces vasoconstriction which in turn relieves nasal congestion.

Pharmacodynamic Properties

Dextromethorphan Hydrobromide

ATC Code: R05DA09 Pharmacotherapeutic Group: Cough Suppressant, Opium alkaloids and derivatives.

Dextromethorphan is the dextrorotatory isomer of 3-methoxy-N-methyl-morphinan. It is a synthetic morphine derivative that, in contrast to its levorotatory isomer, has no significant analgesic, respiratory depressant or physical dependency properties at recommended doses. The onset of antitussive effects is realised within 15 to 30 minutes of oral administration, lasting for approximately 3 to 6 hours.

The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. Dextrorphan also exhibits binding activity at serotonergic receptors and was shown to enhance serotonin activity by inhibiting the reuptake of serotonin. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA)receptors.

Chlorpheniramine Maleate

Chlorpheniramine competitively antagonises the effects of histamine on H1-receptors and has weak antimuscarinic and moderate anti-serotonin and local anaesthetic actions. It penetrates the brain and causes stimulation or sedation in animals. Chlorphenamine also has anticholinergic activity.

Phenylephrine Hydrochloride

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without stimulating effects on the CNS. The sympathomimetic effect of phenylephrine produces vasoconstriction, which, in turn, relieves nasal congestion.

Pharmacokinetic Properties

Chlorpheniramine Maleate

Chlorpheniramine maleate is almost completely absorbed after administration by mouth, with peak plasma concentrations occurring at about 2.5–6 hours. The drug is widely distributed, including into the CNS, with a volume of distribution of between 1 and 10 L/kg. About 70% of chlorpheniramine in the circulation is protein-bound. Chlorpheniramine undergoes some first-pass metabolism and enterohepatic recycling. Chlorpheniramine is extensively metabolised, principally to inactive desmethylated metabolites, which are excreted primarily in the urine, together with about 35% of unchanged drug. Only trace amounts are excreted in the faeces. The mean elimination half-life has been reported to be about 30 hours, with mean values ranging from 2 to 43 hours.

Phenylephrine Hydrochloride

Phenylephrine is readily absorbed after oral administration but is subject to extensive pre-systemic metabolism, much of which occurs in the enterocytes. Therefore, systemic bioavailability is only about 40%. Following oral administration, peak plasma concentrations are achieved in 1–2 hours. The mean plasma half-life is in the range of 2–3 hours. Penetration into the brain appears to be minimal. Following absorption, the drug is extensively metabolised in the liver. Both phenylephrine and its metabolites are excreted in the urine. The volume of distribution is between 200 and 500 litres, but there are no data on the extent of plasma protein-binding.

Dextromethorphan Hydrobromide

Dextromethorphan is well-absorbed from the gastrointestinal tract, metabolised in the liver, and excreted as both unchanged drug and demethylated metabolites.

Absorption

Dextromethorphan is rapidly absorbed from the gastrointestinal tract with peak plasma concentrations reached in approximately 2–2.5 hours. The low plasma levels of dextromethorphan suggest low oral bioavailability secondary to extensive first-pass (pre-systemic metabolism) in the liver. The maximum clinical effects occur 5–6 hours after ingestion of dextromethorphan.

Distribution

Dextromethorphan is widely distributed in the human body. Dextromethorphan and its active metabolite, dextrorphan, a reactively taken up and concentrated in brain tissue. It is not known if dextromethorphan or dextrorphan are excreted in breast milk or cross the placenta.

Metabolism

Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers. It appears that there are distinct phenotypes for this oxidation process, resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan together with the three demethylated morphinan metabolites, dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinan, have been identified as conjugated products in the urine. Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals, metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.

Excretion

Dextromethorphan is primarily excreted via the kidneys as unchanged parent drug and its active metabolite, dextrorphan. Dextrorphan and 3-hydroxy-morphinan are further metabolised by glucuronidation and are eliminated via the kidneys.

The elimination half-life of the parent compound is between 1.4 to 3.9 hours; for dextrorphan, it is between 3.4 to 5.6 hours. The half-life of dextromethorphan in poor metabolisers is extremely prolonged, being in the range of 45 hours.

Non-Clinical Properties

Animal Toxicology or Pharmacology

Dextromethorphan Hydrobromide

General Toxicology

Acute oral toxicity studies conducted with dextromethorphan report the following LD50 values (mg/kg): mouse, 210 and rat, 116. Acute subcutaneous toxicity with dextromethorphan reports the following LD50 value (mg/kg): mouse, 112. Acute intravenous toxicity with dextromethorphan reports the following LD50 value (mg/kg): rat, 16.3.

Repeat dose toxicity studies conducted in rats for 13-weeks’ duration at doses up to 100 mg/kg and 27 weeks at 10 mg/kg, and of 14 weeks in dogs by oral gavage at doses up to 4 mg/kg on 5 days per week. The only effect recorded was of reduced body weight gain in the rat 13-week study at the highest dose.

Genetic Toxicology

Dextromethorphan hydrobromide was negative in the bacterial reverse mutation assay (Ames test). Dextromethorphan 39 mg/kg is reported to be negative in an in vivo mouse micronucleus test and comet assay. Dextromethorphan was reported to be negative in an in vitro chromosome aberration assay tested up to 200 μg/mL.

Carcinogenicity

There are no known reports of animal carcinogenicity studies for dextromethorphan. The overall weight of evidence for dextromethorphan and its structural analogues, support the conclusion that this class of phenanthrene-based chemicals, and dextromethorphan, in particular, are not genotoxic in vitro or in vivo

Teratogenicity

There was no association between dextromethorphan and malformations.

Fertility

Mating, gestation, fertility, littering and lactation were studied in rats at doses up to 50 mg/kg and no adverse effects were found.

Chlorpheniramine Maleate

The antihistaminic potency of chlorpheniramine is confined mainly to its (+)-isomer. The racemate is similarly or slightly more toxic because of the contribution of (-)-isomer. The toxicity may, therefore, be non- specific, perhaps attributable to local anaesthetic action and the toxic effects (excitation/sedation, coma, convulsions and death) resemble those of other classic H1antihistamines. Toxic doses may cause hypotension attributable to myocardial depression, an effect which is clearer with the (-)-isomer.

The experimental data on the carcinogenicity and mutagenicity of chlorpheniramine indicate lack of these adverse effects, but the racemate and the (+)-isomer have shown some embryotoxicity in fertility tests.

Effective antihistaminic concentrations of chlorpheniramine in vitro are about 1–10 μg/L and oral doses of 0.2–1 mg/kg antagonise histamine-induced bronchospasm in guinea pigs.

Description

ASTHALIN DX Syrup is a combination of dextromethorphan hydrobromide, chlorpheniramine maleate and phenylephrine hydrochloride. Dextromethorphan is an antitussive that treats the symptoms of a cough by decreasing chemical activity in the brain that causes coughing. Dextromethorphan combined with chlorpheniramine maleate (an antihistamine) and phenylephrine (a decongestant) helps treat conditions such as allergies, infections, congestion, cold and flu that cause multiple symptoms.

Pharmaceutical Particulars

Incompatibilities

Not applicable.

Shelf-Life

As on the pack

Packaging information

Asthalin DX Syrup: Bottle of 100 mL

Storage and Handling Instructions

Store in a cool place at temperature not exceeding 30oC. Protect from light.

Keep out of the sight and reach of children.

Patient Counselling Information

  • What is ASTHALIN DX Syrup?

ASTHALIN DX Syrup is a combination of dextromethorphan hydrobromide, chlorpheniramine maleate and phenylephrine hydrochloride. Dextromethorphan hydrobromide is an antitussive that treats the symptoms of a cough by decreasing chemical activity in the brain that causes coughing. Dextromethorphan hydrobromide combined with chlorpheniramine maleate (an antihistamine) and phenylephrine hydrochloride (a decongestant) helps treat conditions such as allergies, infections, congestion, cold and flu that cause multiple symptoms.  

  • Do not take ASTHALIN DX Syrup
  • If you have allergy to any of the ingredients in this medicine.
  • If you have heart or circulatory problems.
  • If you have high blood pressure (including that due to a tumour near your kidneys).
  • If you have diabetes, glaucoma or an overactive thyroid.
  • If you are taking monoamine oxidase inhibitors (for depression), or have taken them within the last 14 days.
  • If you are a man with prostate problems.
  • If you are pregnant or breastfeeding.
  • If you are having an asthma attack.
  • If you are taking selective serotonin re-uptake inhibitors (used to treat depression and anxiety such as fluoxetine, paroxetine and sertraline).
  • Before you take ASTHALIN DX Syrup, talk to your healthcare provider (HCP)/doctor about the following:
  • If you have circulation problems such as Raynaud’s phenomenon (a problem that causes cold hands and feet).
  • If you have epilepsy, heart or circulatory disease, liver problems
  • If you have high blood pressure or glaucoma
  • If you have asthma, bronchitis or bronchiectasis emphysema or asthma or have had a cough for a few weeks or a cough with a lot of mucus (phlegm).
  • If you have an overactive thyroid
  • If you are taking any other cough and cold medicines.
  • If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
  • If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
  • If you have difficulty passing urine.
  • If you have an obstruction in their intestine.
  • If you have a rare blood disease called porphyria.
  • If you have been told by your doctor that you are a slow metaboliser of CYP2D6.
  • If you are a man with prostate problems.
  • If you are pregnant or breastfeeding.

 

  • If you are taking medicines such as certain antidepressants or antipsychotics this medicine may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

 

  • If you are taking any other medicines, including the following:
    • Certain drugs for depression such as norepinephrine-dopamine reuptake inhibitors (NDRIs), which include bupropion.
    • Antipsychotics (drugs used to treat mood disorders such as haloperidol, thioridazine, perphenazine).
    • Anti-arrhythmic agents (drugs used to treat irregular heartbeats such as amiodarone, propafenone, quinidine and flecainide).
    • Calcimimetic agents (drugs used to treat secondary hyperparathyroidism, elevated parathyroid hormone levels such as cinacalcet).
    • Antifungals (terbinafine).
    • Opioid analgesics (drugs used to relieve pain, e.g. codeine, tramadol, morphine, methadone).
    • Antihistamines (drugs used to treat the symptoms of allergic reactions).
  • Do not take with any other medicines that contain phenylephrine.
  • If you are taking any other medicines you might be using at the same time, particularly the following:
    • Digoxin (for heart problems)
    • Medicines for high blood pressure
    • Tricyclic antidepressants
    • Other decongestants
    • Other antihistamines
    • Strong painkillers
    • Sleeping tablets
    • Tranquillisers, antidepressants or other medicines for mental problems
    • Phenytoin (for epilepsy)
    • Atropine

 

  • How should I take ASTHALIN DX Syrup?

This medicine is for oral use only.

Take it as prescribed by your doctor/HCP.

Do not take more than the recommended dose.

  • What are the possible side effects of ASTHALIN DX Syrup?

Like all medicines, ASTHALIN DX Syrup may have side effects, but not everybody gets them.

The most common side effect is drowsiness. This drowsiness can be helpful if other symptoms are particularly troublesome at night.

The following side effects may occur. If you get any of the following side effects, stop taking this medicine and see your pharmacist or doctor:

  • Difficulty in breathing, swelling of the face, lips, neck, tongue or throat (severe allergic reactions)
  • Difficulty concentrating, feeling tired, dizziness, headache or blurred vision
  • Loss of appetite, indigestion, feeling or being sick, diarrhoea, tummy pain or dry mouth
  • Low blood pressure (you may feel faint) or changes in heart rhythm
  • Chest tightness or thickening of phlegm
  • Skin peeling, itchy rash and sensitivity to the sun
  • Ringing in the ears
  • Twitching, muscular weakness and abnormal co-ordination
  • Confusion, excitability, irritability, low mood or nightmares
  • Children may become excited.
  • Skin rash
  • Feeling sick, being sick, headache
  • Fast or irregular heartbeat, high blood pressure
  • Occasionally, difficulty in passing urine (in men)

Other effects which may occur but it is not known how often, include the following:

  • Dependence and addiction
  • Dizziness or drowsiness
  • Nausea, vomiting or diarrhoea
  • Upset stomach or stomach pain
  • Difficulty sleeping or feeling agitated, jittery, restless or confused
  • Shallow breathing

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com.  You can also report side effects directly via the national Pharmacovigilance Programme of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 1800 267 7779. By reporting side effects, you can help provide more information on the safety of this product.

  • How should I store ASTHALIN DX Syrup?
  • Store in a cool place at a temperature not exceeding 30oC. Protect from light.
  • Keep out of the sight and reach of children.
  • Do not use this medicine after the expiry (‘EXP’) date shown on the pack.
  • General information about the safe and effective use of this drug

ASTHALIN DX Syrup is a combination of dextromethorphan hydrobromide, chlorpheniramine maleate and phenylephrine hydrochloride.

Dextromethorphan hydrobromide is an antitussive that is used to help relieve dry, irritating coughs. Phenylephrine hydrochloride is a decongestant that acts to relieve a blocked nose. Chlorphenamine maleate is an antihistamine that can help to relieve the symptoms some allergies

  • Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.
  • This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive when taking this medicine if your ability to drive safely is affected.
  • This medicine may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
  • What are the ingredients in ASTHALIN DX Syrup?

ASTHALIN DX Syrup contains dextromethorphan hydrobromide 15 mg, chlorpheniramine maleate 2 mg and phenylephrine hydrochloride 5 mg per 5 mL of syrup.

Details of the Manufacturer/Marketer

Mfd. by:

M/S Ravenbhel Biotech

EPIP, SIDCO, Kartholi

Bari Brahmana, Jammu - 181133

Marketed by:

Cipla Ltd

Regd. Office: Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India

Details of Permission or Licence Number with Date

ML.JK/01/11-12/192

Date of Revision

24/12/2020