COFDOFF TABLET
COMPOSITION:
| Each film coated bilayered tablet contains: | |
| Acebrophylline | 100 mg |
| Acetylcysteine USP | 600 mg |
| Excipients | q.s. |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
- Acebrophylline: A xanthine derivative with bronchodilator and anti-inflammatory properties. It inhibits phosphodiesterase, increases cyclic AMP levels, and modulates inflammatory mediators. It also has mucoregulatory effects that help clear airway secretions.
- N-Acetylcysteine (NAC): A mucolytic agent that breaks disulfide bonds in mucus, reducing its viscosity and improving clearance. It also has antioxidant properties that protect against oxidative stress in chronic respiratory diseases.
Indications
This tablet is indicated for:
- Chronic obstructive pulmonary disease (COPD)
- Bronchial asthma
- Chronic bronchitis
- Cystic fibrosis
- Respiratory tract infections with excessive mucus production
Dosage
Adults: 1 tablet once or twice daily (as directed by a physician).
Children: Not recommended unless prescribed by a doctor.
Precautions
General
- Use with caution in patients with cardiovascular diseases, peptic ulcers, liver disorders, and kidney dysfunction.
- Avoid alcohol, as it may enhance side effects.
Warnings
- Acebrophylline may cause tachycardia and should be used cautiously in patients with arrhythmia.
- N-Acetylcysteine may cause bronchospasm in sensitive individuals.
- Not recommended for patients with active gastrointestinal ulcers.
Contraindications
- Hypersensitivity to Acebrophylline or N-Acetylcysteine.
- Severe cardiac arrhythmias.
- Active peptic ulcer disease.
Drug Interaction
- Theophylline or other xanthines: Increased risk of toxicity.
- Corticosteroids & Diuretics: May enhance hypokalemia when combined with Acebrophylline.
- Antibiotics (e.g., Amoxicillin, Doxycycline): N-Acetylcysteine enhances the bioavailability of some antibiotics.
- Antitussives (e.g., Codeine): May reduce mucus clearance.
Pregnancy
- Category C (Use only if benefits outweigh risks).
- Not recommended during the first trimester unless necessary.
Adverse Effects
- Common: Nausea, vomiting, heartburn, headache, dizziness.
- Rare but serious: Bronchospasm, severe allergic reactions, palpitations.
Overdosage
- Symptoms: Severe nausea, vomiting, tachycardia, hypotension, restlessness, seizures.
- Treatment: Symptomatic and supportive care, gastric lavage if necessary.
Storage
- Store at below 30°C in a dry place.
- Protect from moisture and direct sunlight.
- Keep out of reach of children.
Supply
Alu Alu 10 x 10 Tablets
COFDOFF SYRUP
COMPOSITION:
| Each 5 mL contains: | |
| Acebrophylline | 50 mg |
| Terbutaline Sulphate I.P. | 1.25mg |
| Guaiphenesin I.P. | 50 mg |
| Flavoured syrupy base | q.s. |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
- Acebrophylline: A xanthine derivative with mucoregulating and bronchodilator effects. It inhibits phosphodiesterase, increases cAMP, and modulates inflammation by inhibiting phospholipase A2.
- Terbutaline Sulphate: A β2-adrenergic receptor agonist that relaxes bronchial smooth muscle, reducing airway resistance and improving airflow.
- Guaiphenesin: An expectorant that increases respiratory tract secretions, helping to clear mucus from the airways.
Indications
This syrup is indicated for:
- Acute and chronic bronchitis
- Chronic obstructive pulmonary disease (COPD)
- Bronchial asthma
- Respiratory tract infections with mucus build-up
Dosage
- Adults: 5-10 mL (1-2 teaspoons) 2-3 times daily
- Children: (6-12 years): 5 mL (1 teaspoon) 2-3 times daily
- (2-6 years): 2.5 mL (½ teaspoon) 2-3 times daily (Or as directed by the physician)
Precautions
General
- Use with caution in patients with cardiovascular diseases, hypertension, hyperthyroidism, and diabetes mellitus.
- Avoid alcohol as it may enhance side effects.
Warnings
- Not recommended for patients with severe cardiac arrhythmias or hypersensitivity to any of the components.
- Excessive use may cause tachycardia or tremors.
Contraindications
- Hypersensitivity to Acebrophylline, Terbutaline, or Guaiphenesin
- Severe hypertension
- Uncontrolled cardiac arrhythmias
- Peptic ulcer disease (Acebrophylline may aggravate gastric irritation)
Drug Interaction
- Beta-blockers (e.g., Propranolol): May reduce the bronchodilatory effects of Terbutaline.
- Theophylline & other xanthines: Increased risk of toxicity when combined with Acebrophylline.
- Corticosteroids & Diuretics: May enhance hypokalemia when taken with β2-agonists like Terbutaline.
- Monoamine Oxidase Inhibitors (MAOIs) & Tricyclic Antidepressants: May increase the cardiovascular effects of Terbutaline.
Pregnancy
Category C (Use only if benefits outweigh risks). Terbutaline may cause foetal tachycardia and should be avoided in the first trimester.
Adverse Effects
- Common: Nausea, headache, dizziness, tremors, palpitations, dry mouth
- Serious: Arrhythmia, severe hypotension, hypokalemia, paradoxical bronchospasm (rare)
Overdosage
- Symptoms: Severe palpitations, hypertension, tremors, nausea, vomiting, restlessness, seizures.
- Treatment: Supportive care, beta-blockers (for severe tachycardia), IV fluids, electrolyte correction.
Storage
- Store at below 30°C in a cool, dry place.
- Protect from light and moisture.
- Keep out of reach of children.
Supply
100ml pet bottle
COFDOFF-LS SYRUP
COMPOSITION:
| Each 5 mL contains: | |
| Levosalbutamol Sulphate IP | |
| eq. to Levosalbutamol | 1 mg |
| Ambroxol Hydrochloride IP | 30 mg |
| Guaiphenesin IP | 50 mg |
| Mentholated flavoured syrupy base | q.s. |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
Pharmacodynamics:
This combination syrup is used to relieve cough, bronchospasms, and mucus congestion in respiratory conditions. Each ingredient has a specific role:
- Levosalbutamol (1mg): A β2-adrenergic agonist that relaxes airway muscles, reduces bronchospasms, and improves airflow.
- Ambroxol (30mg): A mucolytic agent that breaks down thick mucus, facilitating its removal from the respiratory tract.
- Guaiphenesin (50mg): An expectorant that loosens and thins mucus, making coughing more productive.
Pharmacokinetics:
- Levosalbutamol: Absorbed within 30 minutes, peak effect at 2 hours, half-life 3–5 hours, excreted via urine.
- Ambroxol: Rapid absorption, onset within 30 minutes, half-life 10 hours, eliminated primarily in urine.
- Guaiphenesin: Rapid absorption, short half-life 1 hour, excreted via urine.
Indications
Cofdoff-LS is used for the symptomatic relief of cough, bronchospasms, and mucus-related respiratory conditions, including:
- Acute and chronic bronchitis
- Asthma-associated cough
- Chronic obstructive pulmonary disease (COPD)
- Pneumonia and lower respiratory infections
- Cough with thick mucus production
Dosage
- Adults: 5–10 mL (1–2 teaspoons) three times daily
- Children (above 12 years): 5–10 mL (1–2 teaspoons) three times daily
- (6 – 12 years): 5 mL (1 teaspoon) three times daily
- (2 – 6 years): 2.5 mL (½ teaspoon) three times daily
- Infants (Below 2 years): Use only under medical supervision. 1.25–2.5 mL two to three times daily (as prescribed by a doctor)
Precautions
General Precautions:
- Use with caution in patients with heart disease, high blood pressure, hyperthyroidism, or diabetes.
- Avoid use in patients with a history of gastric ulcers or GI bleeding, as Ambroxol may cause irritation.
- May cause drowsiness or dizziness; avoid driving or operating heavy machinery.
Warnings:
Cardiovascular Risk: Levosalbutamol may cause increased heart rate, palpitations, and arrhythmias, particularly in heart disease patients.
Gastrointestinal Risk: Ambroxol may cause gastric irritation or ulceration with prolonged use.
Respiratory Risk: Rarely, paradoxical bronchospasm may occur, requiring discontinuation.
Hypersensitivity Risk: Rare cases of Stevens-Johnson syndrome (SJS) and anaphylaxis have been reported with Ambroxol.
Electrolyte Imbalance: Levosalbutamol may cause hypokalemia, particularly in prolonged therapy.
Contraindications:
This syrup should not be used in patients with:
- Hypersensitivity to Levosalbutamol, Ambroxol, or Guaiphenesin.
- Severe heart diseases such as arrhythmias or recent myocardial infarction.
- Peptic ulcer disease or GI bleeding history (due to Ambroxol).
- Uncontrolled hypertension or hyperthyroidism (due to Levosalbutamol).
- Renal or hepatic impairment (use with caution and under medical supervision).
Drug Interactions:
- Beta-blockers (Propranolol, Atenolol) - Antagonizes Levosalbutamol - Reduced bronchodilation
- Diuretics (Furosemide, Thiazides) - Increased risk of hypokalemia - Monitor potassium levels
- CNS Depressants (Alcohol, Sedatives, Antihistamines) - Increased drowsiness - Avoid alcohol
- Antibiotics (Erythromycin, Ciprofloxacin) - Increased Ambroxol absorption - Monitor for side effects
- Cough Suppressants (Codeine, Dextromethorphan) - Opposes Guaiphenesin action - Reduced mucus clearance
Pregnancy
- Pregnancy: Should be used only, if necessary, particularly in the first trimester.
- Lactation: Ambroxol and Levosalbutamol may pass into breast milk, so use with caution.
Adverse Effects
- Gastrointestinal - Nausea, vomiting, diarrhoea - Peptic ulcer, GI bleeding
- Cardiovascular - Palpitations, mild tachycardia - Arrhythmia, severe hypertension
- Respiratory - Throat irritation, dry mouth - Paradoxical bronchospasm
- CNS - Dizziness, headache - Seizures, tremors
- Allergic Reactions - Skin rash, itching - Anaphylaxis, angioedema
Seek immediate medical attention if experiencing severe allergic reactions, irregular heartbeat, or difficulty breathing.
Overdosage
Symptoms of Overdose
- Levosalbutamol Overdose: Severe palpitations, tremors, muscle cramps, hypokalemia.
- Ambroxol Overdose: Excessive nausea, vomiting, diarrhoea.
- Guaiphenesin Overdose: Dizziness, confusion, respiratory depression.
Management:
- Symptomatic and supportive treatment is required.
- Gastric lavage & activated charcoal in early overdose cases.
- Beta-blockers (e.g., propranolol) for severe Levosalbutamol-induced tachycardia.
- IV fluids & electrolyte correction if needed.
Storage
- Store at room temperature (15–30°C).
- Keep in a cool, dry place, away from direct sunlight.
- Do not refrigerate or freeze.
- Keep out of reach of children.
- Use before the expiry date mentioned on the bottle.
Supply
100ml pet bottle
COFDOFF-D SYRUP
COMPOSITION:
| Each 5 mL contains: | |
| Chlorpheniramine Maleate USP | 2 mg |
| Dextromethorphan Hydrobromide USP | 10 mg |
| Phenylephrine Hydrochloride BP | 5 mg |
| In a pleasantly flavoured syrup | q.s. |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
Cough is a protective respiratory reflex by which foreign matter is expelled from the tracheobronchial tree. When cough increases in frequency and severity, it becomes troublesome, disturbs sleep and requires symptomatic treatment. Cough can be caused by disorders of upper and lower respiratory tract. Most coughs associated with acute respiratory infections or allergy or nonproductive or dry and irritating. COFDOFF-D is formulated to provide symptomatic relief of cough and upper respiratory symptoms associated with allergy or common cold, including nasal congestion.
Chlorpheniramine is a potent antiallergic agent which inhibits the vascular response to histamine thereby reducing irritation of cough receptors lining the respiratory mucous membrane. It provides relief from symptoms of allergic upper respiratory catarrh. Chlorpheniramine has moderate sedative and antimuscarinic effects. After absorption, it is widely distributed in body and extensively metabolized; unchanged drug and metabolites are excreted primarily in urine.
Dextromethorphan Hydrobromide is a nonopioid cough suppressant. Dextromethorphan suppresses the cough reflex by a direct action on the medullary cough centre. Dextromethorphan is as effective as codeine in antitussive effect. However, it does not have addictive, sedative or respiratory depressant effect seen with opioid antitussives. The onset of antitussive action is 15-30 minutes after administration and is sustained for upto 6 hours. Dextromethorphan is rapidly absorbed after oral administration. It is metabolized in liver and excreted in urine as unchanged drug and metabolites.
Phenylephrine Hydrochloride is a predominantly indirect acting sympathomimetic agent with a decongestant action on nasal and upper respiratory tract mucosal membranes. Phenylephrine causes far less central nervous system stimulation than ephedrine. The onset of decongestant action is 15-30 minutes, peak activity occurring after approximately one hour. Phenylephrine is readily and completely absorbed after oral administration. It is excreted largely unchanged in urine.
Indications
COFDOFF-D cough formula is indicated for symptomatic relief of nonproductive dry cough and upper respiratory symptoms such as irritation of throat, running nose, nasal congestion and watery eyes associated with allergy or common cold. It may also be useful in coughs associated with upper respiratory tract infection.
Dosage
- Adults: 10ml (2 teaspoonfuls) 3-4 times a day.
- Children: 6-12 years : 5ml (1 teaspoonful) 3-4 times a day.
- 2-6 years : 2.5ml (1/2 teaspoonful) 3-4 times a day or as directed by the physician
Precautions
General :
COFDOFF-D syrup should be used with caution in patients with a history of asthma, narrow angle glaucoma, gastrointestinal obstruction or urinary bladder neck obstruction because of its antihistamine component. COFDOFF-D contains a sympathomimetic and like all such preparations, is should be used with caution in patients with hypertension, heart disease, uncontrolled diabetes or hyperthyroidism.
Warnings:
In infants and small children overdosing of antihistamines can cause excitation, hallucinations and convulsions. Antihistamines can cause reduced mental alertness and patients should be careful about engaging in activities such as driving or operating dangerous machinery.
Contraindications:
Hypersensitivity to any of the ingredients. Do not use in the new-born, in premature infants, in nursing mothers, in patients with severe hypertension or severe coronary artery disease or those receiving monoamine oxidase (MAO) inhibitors. Antihistamines should not be used in treatment of bronchial asthma.
Drug Interactions:
Antihistamines have additive effect with alcohol and other CNS depressants. MAO inhibitors can prolong the anticholinergic effect of antihistamines and may enhance the effect of Phenylephrine. Sympathomimetics may reduce the effect of antihypertensive drugs.
Pregnancy
COFDOFF-D should be given to pregnant women only if clearly needed.
Adverse Effects
COFDOFF-D is well tolerated in most patients and usual side effects are mild and transient. Side effects attributed to Dextromethorphan are uncommon; occasionally nausea, vomiting or gastrointestinal disturbance may occur in some patients. Side effects like sedation, dryness of mouth, nose and throat, thickening of bronchial secretions and dizziness may occur. Insomnia, difficulty in micturition, tightness of chest and cardiovascular side effects are uncommon with usual dosage. Rarely, hypersensitivity reactions may occur.
Overdosage
CNS effects from overdosage of Chlorpheniramine Maleate may vary from depression to stimulation especially in children. Anticholinergic effects may be noted. Toxic doses of Phenylephrine may cause cardiovascular and CNS symptoms. Dextromethorphan in toxic doses can cause drowsiness and other CNS effects. Symptomatic and supportive measures should be instituted.
Storage
Store at a temperature not exceeding 30oC, protected from light.
Supply
100ml pet bottle.
ELYRIA-M BILAYERED TABLET
COMPOSITION:
| Each film coated bilayered tablet contains: | |
| Bilastine IP | 20 mg |
| Montelukast Sodium IP | |
| eq. to Montelukast | 10 mg |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
Bilastine:
A non-sedating H₁ antihistamine that selectively blocks histamine receptors to prevent allergic symptoms. It does not cross the blood-brain barrier significantly, thus causing minimal drowsiness. Rapid onset and long-lasting action (24 hours).
Montelukast:
A leukotriene receptor antagonist that blocks the action of leukotriene D4 in the lungs and airways, reducing inflammation, bronchoconstriction, and mucus production in conditions like asthma and allergic rhinitis.
Bilayered formulation ensures optimal release and absorption kinetics for both drugs.
Indications
Elyria-M is indicated for the treatment of:
- Allergic rhinitis (seasonal and perennial)
- Chronic urticaria
- Asthma (mild to moderate) – as add-on therapy
- Allergy-related respiratory symptoms (nasal congestion, sneezing, rhinorrhoea, wheezing)
Dosage
Adults and children ≥12 years:
1 tablet once daily (preferably in the evening)
Should be taken on an empty stomach (1 hour before or 2 hours after food) for best bilastine absorption.
Precautions
General
- Avoid alcohol and sedatives during treatment
- Montelukast is not meant for acute asthma attacks
- Bilastine has minimal CNS effects but caution in patients with sensitivity to antihistamines
Warnings
- Rare reports of neuropsychiatric events (agitation, anxiety, depression, suicidal thoughts) associated with Montelukast
- Use caution in patients with hepatic impairment
- Do not exceed recommended dosage
Contraindications
- Known hypersensitivity to Bilastine, Montelukast, or any excipients ∙Patients with rare hereditary galactose intolerance (if excipients contain lactose)
Drug Interaction
- Bilastine: Absorption may be reduced with grapefruit juice or other acidic beverages
Montelukast:
- Use with phenobarbital or rifampicin may reduce plasma levels
- No significant interaction with theophylline, warfarin, digoxin, or oral contraceptives
Pregnancy
Pregnancy Category B (Both bilastine and montelukast): No evidence of foetal harm in animal studies, but limited data in humans. Use only if clearly needed.
Adverse Effects
- Common: Headache, Drowsiness (low incidence), Abdominal pain and dry mouth.
- Less common / rare: Behavioural changes (irritability, insomnia, agitation), Skin rash, Elevated liver enzymes (rare) and Anaphylaxis (very rare)
Overdosage
Symptoms: Drowsiness, headache, restlessness and no life-threatening effects observed at high doses in clinical trial.
Management: Supportive care, symptomatic treatment and no specific antidote.
Storage
- Store in a cool, dry place, below 25°C
- Protect from moisture and light
- Keep out of reach of children
Supply
"Alu Alu 10 x 10 tablets"
NASODOFF S SPRAY
COMPOSITION:
| Each mL contains: | |
| Sodium Chloride IP | 0.74% w/v |
| Purified water IP | q.s. |
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Pharmacology
Sodium Chloride (0.74%) in isotonic form mimics the natural salt concentration in body fluids, providing gentle hydration and cleansing to the nasal mucosa.
It works by moisturizing dry nasal passages, loosening mucus, and clearing allergens, dust, and irritants without any pharmacological (drug-like) action.
Helps maintain normal ciliary function and nasal hygiene.
Indications
Nasodoff S Spray is used for:
- Nasal congestion and dryness
- Allergic rhinitis or sinusitis
- Soothing irritated nasal passages (due to pollution, dry air, or infections)
- Daily nasal hygiene
- Post-nasal surgery care
- Assisting in clearing thick mucus in infants, children, and adults
Dosage
Adults & Children: 1–2 sprays per nostril, 2–3 times daily or as needed
Infants: As directed by a paediatrician; usually 1 spray per nostril before feeding or sleeping
Blow or wipe nose gently after use
Precautions
General
- For nasal use only
- Do not share the nozzle with others to avoid contamination
Clean the nozzle after each use
Warnings
- Use under medical advice in infants under 6 months
- Do not use if the solution is cloudy or past expiry date
- In case of persistent symptoms, consult a physician
Contraindications
- Hypersensitivity or known allergy to Sodium Chloride (very rare)
- Do not use in case of severe nasal injury or active bleeding without medical supervision
Drug Interaction
- No known drug interactions ∙Safe to use with other nasal medications (can be used before medicated sprays for better absorption)
Pregnancy
- Safe for use during pregnancy and breastfeeding
- Non-medicated and non-systemic
Adverse Effects
Generally, well tolerated
Rare: Mild nasal irritation or burning sensation during initial use
Overdosage
- Overdose is unlikely due to the non-systemic nature of the product
- Excessive use may cause nasal dryness or irritation
Storage
- Store at room temperature below 25°C
- Keep away from direct sunlight and moisture
- Keep out of reach of children
- Do not use if packaging is damaged
Supply
20 ml pet bottle
