Olycoff A

Uses

• • Acute and chronic diseases of respiratory tracts associated with viscid mucus including acute and chronic bronchitis
• • Productive cough
• • Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus
• • Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus
• • Bronchiectasis
• • Chronic pneumonia.

Guaifenesin is an expectorant commonly found in OTC products for the symptomatic relief from congested chests and coughs associated with cold, bronchitis, and/or other breathing illnesses.

Guaifenesin is an expectorant that is indicated for providing temporary symptomatic relief from congested chests and coughs which may be due to a cold, bronchitis, and/or other breathing illnesses .

Used to open up the airways in people with asthma, bronchitis and other breathing problems.Used to relieve trouble breathing upon exertion.For the prevention and reversal of bronchospasm in patients 12 years of age and older with reversible, obstructive airway disease.Symptomatic management of reversible bronchospasm associated with bronchitis and emphysema.

Olycoff A is also used to associated treatment for these conditions: Airway secretion clearance therapyAllergic Reaction, Asthma, Asthma, Allergic, Bronchial Asthma, Bronchitis, Bronchospasm, Chronic Bronchitis, Chronic Obstructive Respiratory Diseases, Common Cold, Cough, Cough caused by Common Cold, Coughing caused by Allergies, Coughing caused by Flu caused by Influenza, Drug Allergy, Emphysema, Fever, Flu caused by Influenza, Food Allergy, Headache, House dust allergy, Irritative cough, Laryngitis, Nasal Congestion, Nasal Congestion caused by Common Cold, Phlegm, Pollen Allergy, Productive cough, Rash, Rhinorrhoea, Sneezing, Sore Throat, Tracheitis, Urticaria, Whooping Cough, Acute Rhinitis, Chest congestion, Chills occurring with fever, Dry cough, Excess mucus or phlegm, Mild to moderate pain, Minor aches and pains, Airway secretion clearance therapy, ExpectorantAsthma, Bronchospasm, Chronic Cough (CC), Chronic Obstructive Pulmonary Disease (COPD), Cough, Premature Labour, Productive cough, Airway secretion clearance therapy

How Olycoff A works

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Although the exact mechanism of action of guaifenesin may not yet be formally or totally elucidated, it is believed that expectorants like guaifenesin function by increasing mucus secretion . Moreover, it is also further proposed that such expectorants may also act as an irritant to gastric vagal receptors, and recruit efferent parasympathetic reflexes that can elicit glandular exocytosis that is comprised of a less viscous mucus mixture . Subsequently, these actions may provoke coughing that can ultimately flush difficult to access, congealed mucopurulent material from obstructed small airways to facilitate a temporary improvement for the individual .

Consequently, while it is generally proposed that guaifenesin functions as an expectorant by helping to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive, there has also been research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .

Terbutaline is a selective beta-2 adrenergic receptor agonist. Agonism of these receptors in bronchioles activates adenylyl cyclase, increasing intracellular cyclic adenosine monophosphate (cAMP). Increased cAMP decreases intracellular calcium, activating protein kinase A, inactivating myosin light-chain kinase, activating myosin light-chain phosphatase, and finally relaxing smooth muscle in the bronchiole.

Dosage

Olycoff A dosage

Average daily dose (preferably after meal):Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule:

• Adult and children over 12 years old: 1 capsule once daily

Specific application features: Ambroxol may be prescribed to patients suffering from diabetes mellitus.

The recommended adult dose for treating asthma, emphysema or bronchitis is 2.5-5 mg 3 times daily approximately 6 hours apart while awake. The maximum dosage is 15 mg/day. Shake the inhaler several times and uncap the mouthpiece. Breathe out fully. For best results, hold the inhaler 1 to 2 inches in front of your open mouth or attach a spacer to the inhaler and place the spacer in your mouth, above your tongue and past your teeth. Take a deep, slow breath as you push down on the canister. Hold your breath for 10 seconds, then exhale slowly. Use nebulizer machine for better response.

Side Effects

Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

Dry mouth, irritated throat, nausea, dizziness, headache, heartburn, loss of appetite, altered taste sensation, restlessness, anxiety, nervousness, trembling, and sweating may occur but should subside as your body adjusts to the medication.

Toxicity

The most prevalent signs and symptoms associated with an overdose of guaifenesin have been nausea and vomiting .

Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester . An increased occurrence of inguinal hernias was found in the neonates . However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs .

Moreover, guaifenesin is excreted in breast milk in small quantities . Subsequently, caution should be exercised by balancing the potential benefit of treatment against any possible risks .

Additionally, an LD₅₀ value of 1510 mg/kg (rat, oral) has been reported for guaifenesin .

Patients experiencing an overdose may present with abdominal pain, agitation, palpitations, seizures, angina, hypertension, hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, nausea, dizziness, fatigue, malaise, insomnia. Discontinue treatment with terbutaline and initiate symptomatic and supportive therapy.

Precaution

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Before you use this drug, tell your doctor if you have: any allergies, heart disease, high blood pressure, an overactive thyroid gland, seizures, diabetes. Tell your doctor if you ever had a bad reaction to albuterol, bitolterol, ephedrine, epinephrine, isoetharine, isoproterenol, metaproterenol, pseudoephedrine, or pirbuterol or other similar agents. Tell your doctor if you are pregnant before using this medication. Terbutaline is excreted into breast milk. Consult with your doctor before breast-feeding. Terbutaline is not recommended for children under the age of 6. Caution is advised in the elderly.

Interaction

Ambroxol has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Ambroxol should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Ambroxol, might not be expectorated.

Tell your doctor of all nonprescription and prescription medications you take, including: beta-blockers (e.g., propranolol, timolol), all asthma drugs, antidepressants, MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine), diuretics (e.g., hydrochlorothiazide). Many nonprescription medications contain pseudoephedrine or ephedrine, so check the labels carefully. Do not take any of these medications without consulting your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

Volume of Distribution

The geometric mean apparent volume of distribution of guaifenesin determined in healthy adult subjects is 116L (CV=45.7%) .

Terbutaline has a mean volume of distribution of 1.6 L/kg.

Elimination Route

Rapid and almost complete.

Studies have shown that guaifenesin is well absorbed from and along the gastrointestinal tract after oral administration .

A 0.5 mg subcutaneous dose of terbutaline reaches a mean C_max of 9.6 ± ng/mL, with a median T_max of 0.5 hours, and a mean AUC of 29.4 ± 14.2 h*ng/mL. A 5 mg oral terbutaline tablet reaches a mean C_max of 8.3 ± 3.9 ng/mL with a median T_max of 2 hours, and a mean AUC of 54.6 ± 26.8 h*ng/mL. A 5 mg oral terbutaline solution reaches a mean C_max of 8.6 ± 3.6 ng/mL, with a median T_max of 1.5 hours, and a mean AUC of 53.1 ± 23.5 h*ng/mL.

Oral terbutaline has an oral bioavailability of 14-15%.

Half Life

7-12 hours

The half-life in plasma observed for guaifenesin is approximately one hour .

An oral dose of terbutaline has an elimination half life of 3.4 hours, while a subcutaneous dose has an elimination half life of 2.9 hours.

Clearance

The mean clearance recorded for guaifenesin is about 94.8 L/hr (CV=51.4%) .

The average clearance of terbutaline is 3.0 mL/min/kg.

Elimination Route

After administration, guaifenesin is metabolized and then largely excreted in the urine .

An oral dose of terbutaline is 40% eliminated in the urine after 72 hours. The major metabolite in the urine was the sulphate conjugated form of terbutaline. Parenteral doses of terbutaline are 90% eliminated in the urine, with approximately 2/3 as the unchanged parent drug. Less than 1% of a dose of terbutaline is eliminated in the feces.

Pregnancy & Breastfeeding use

Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established.

Although no teratogenic effects have been observed in animals or in patients, Terbutaline should only be administered with caution during the first trimester of pregnancy. Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.

Contraindication

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Do not use Terbutaline if

• You are allergic to any ingredient in Terbutaline or to a sympathomimetic amine (eg, epinephrine, albuterol).
• You need to treat prolonged (more than 48 to 72 hours) premature labor.

Special Warning

Terbutaline is not approved for use by children younger than 6 years of age.

Storage Condition

Store at room temperature between 15 to 30° C. Keep away from moisture and sunlight. Do not puncture. Keep away from the reach of children.

Innovators Monograph

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