Consists of Ambroxol Hcl, Loratadine
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Ambroxol Hcl/Loratadine Uses |
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Consists of Ambroxol Hcl, Loratadine
Treatment of acute respiratory tract diseases with impaired formation of secretions, particularly in acute exacerbations of chronic and asthmatic bronchitis, bronchial asthma and bronchiectasis.
Treatment of respiratory disorders associated with viscid mucus eg, pneumonia, otitis media, sinusitis, nasopharyngitis.
As secretolytic therapy for relieving cough in acute and chronic disorders of the respiratory tract associated with pathologically thickened mucus and impaired mucus transport.
Ambroxol Hcl is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.
Each tablet also contains maize starch, dibasic calcium phosphate, anhydrous microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide as excipients.
Each 5 mL of syrup also contains granulated sucrose, sorbitol 70%, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium benzoate, citric acid monohydrate, propylene glycol, disodium edentate, thiourea, menthol, blackcurrant flavor, soluble ponceu 4R, purified water (15 mg/5 mL pediatric syrup) or deionized water (30 mg/5 mL syrup) as excipients.
Each mL of oral drops also contains granulated sucrose, sorbitol 70%, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium benzoate, citric acid monohydrate, propylene glycol, disodium edentate, thiourea, menthol, blackcurrant flavor, soluble ponceu 4R, purified water as excipients.
Each SR capsule also contains sucrose microgranules, maize starch microgranules, methacrylic acid-methyl methacrylate copolymer 1:1 (Eudragit L100), diethyl phthalate and talc as excipients.
Adult: Tablet: 1 tablet 3 times daily. The tablet should be taken after a meal with adequate fluid.
Syrup: 5 mL of 30 mg/5 mL syrup 3 times daily. The syrup should be taken with food.
Pediatric Syrup: 10 mL of 15 mg/5 mL syrup 2-3 times daily. In severe cases, the dose may be increased up to 20 mL 2 times daily.
SR Capsule: 1 capsule daily. The capsule should be swallowed whole without chewing after a meal with adequate fluid.
Children: Recommended Daily Dose: 1.2-1.6 mg/kg body weight; 6-11 years: Tablet: ½ tablet 3 times daily. Pediatric Syrup: 5 mL 3 times daily; 2-5 years: Pediatric Syrup: 2.5 mL 3 times daily.
Double strength syrup is for initial treatment; the dosage may be halved after 14 days.
Initial Treatment: Syrup: Adult and Children >12 years: 5 mL 3 times daily. Children 6-12 years: 5 mL 2-3 times daily; 2-6 years: 2.5 mL 3 times daily; 1-2 years: 2.5 mL 2 times daily.
Treatment Continuation: Pediatric Syrup: Children 6-12 years: 5 mL 2-3 times daily; 2-6 years: 2.5 mL 3 times daily; 1-2 years: 2.5 mL 2 times daily.
Elderly: There are no relevant data available.
Renal Impairment: In severe renal impairment, Ambroxol Hcl must only be used under medical supervision; maintenance therapy should be reduced or the dosing interval extended. The secretolytic effect of Ambroxol Hcl is supported by adequate fluid intake.
Hepatic Impairment: In severe hepatic impairment, Ambroxol Hcl must only be used under medical supervision.
Antitussives: Concomitant administration of antitussives may impair the expectoration of liquefied bronchial mucus due to inhibition of cough reflex and cause congestion of secretions.
Antibiotics: After using Ambroxol Hcl, the concentrations of the antibiotics amoxicillin, cefuroxime and erythromycin in bronchial secretions and sputum are increased.
Clinical Trial Data: Not relevant for Ambroxol Hcl.
Post-Marketing Data: Adverse reactions are ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune System Disorders : Not Known: Allergic reactions, anaphylactic reactions including anaphylactic shock.
Nervous System Disorders: Common: Dysgeusia* (eg, altered flavors).
Gastrointestinal Disorders: Common: Nausea, oral and pharyngeal hypoesthesia*. Uncommon: Diarrhea, vomiting, dyspepsia, abdominal pain, dry mouth*. Not Known: Dry throat*.
Skin and Subcutaneous Tissue Disorders: Rare: Rash, urticaria. Now Known: Pruritus, angioedema.
*Adverse events have been reported only after syrup use.
Hypersensitivity to Ambroxol Hcl or to bromhexine, or to any of the constituents of Panacough Expectorant Extra.
Should not be taken simultaneously with antitussives (eg, codeine) because phlegm, which has been liquified by Ambroxol Hcl HCl, might not be expectorated.
Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Loratadine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.
Loratadine is also used to treat skin hives and itching in people with chronic skin reactions.
Loratadine may also be used for purposes not listed in this medication guide.
Treatment of seasonal allergic rhinitis, perennial rhinitis, urticaria, allergic dermatologic disorders, angioedema and conjunctivitis. Loratadine is generally considered to be ineffective in asthma.
Acute anaphylaxis should be treated with adrenaline; loratadine and corticosteroids are given to prevent relapse.
Loratadine is also used to control the pruritus associated with skin disorders eg, atopic eczema.
Use Loratadine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Loratadine.
This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives.
Loratadine does not prevent hives or prevent/treat a serious allergic reaction (e.g., anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine.
If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.
Do not use this medication in children younger than 6 years unless directed by the doctor.
If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the instructions on your prescription label. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor or the product package, usually once or twice a day. Remove the tablet from its foil pack immediately before taking and place the tablet on the tongue. It will dissolve quickly. You may swallow the dissolved medication with or without water. Dosage is based on your age, condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.
Tell your doctor if your allergy symptoms do not improve after 3 days of treatment or if your hives last more than 6 weeks. Seek immediate medical attention if your condition worsens or you think you have a serious medical problem (e.g., very serious allergic reaction/anaphylaxis).
Loratadine competes with free histamine for binding at HA-receptor sites. This antagonizes the effects of histamine on HA-receptors, leading to a reduction of the negative symptoms brought on by histamine HA-receptor binding. In addition to the usual allergic symptoms, the drug also treats irritant cough and nausea, vomiting, and vertigo associated with motion sickness. Loratadine's anticholinergic action appears to be due to a central antimuscarinic effect, which also may be responsible for its antiemetic effects, although the exact mechanism is unknown. It also is used commonly to treat drug-induced extrapyramidal symptoms as well as to treat mild cases of Parkinson's disease.
Applies to the following strength(s): 10 mg; 5 mg/5 mL; 5 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
10 mg orally once a day
10 mg orally once a day
2 to 5 years: 5 mg orally once a day (syrup)
6 years or older: 10 mg orally once a day (tablets, capsule, and disintegrating tablets)
2 to 5 years: 5 mg orally once a day (syrup)
6 years or older: 10 mg orally once a day (tablets, capsule, and disintegrating tablets)
CrCl less than 30 mL/min: administer dosage every other day initially
Liver failure: administer dosage every other day initially
Loratadine is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis.
See also:
What other drugs will affect Loratadine?
Loratadine (10 mg once daily) has been coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies in adult volunteers. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n = 24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There were no significant effects on QTc intervals, and no reports of sedation or syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown. These above findings are summarized in TABLE 1.
TABLE 1 Effects on Plasma Concentrations (AUC 0-24 hrs) of Loratadine and Descarboethoxyloratadine After 10 Days of Coadministration (Loratadine 10 mg) in Normal Volunteers | ||
Loratadine | Descarboethoxyloratadine | |
---|---|---|
Erythromycin (500 mg q8h) | + 40% | +46% |
Cimetidine (300 mg qid) | +103% | + 6% |
Ketoconazole (200 mg q12h) | +307% | +73% |
See also:
What are the possible side effects of Loratadine?
Applies to loratadine: oral fixed-combination tablets, oral orally disintegrating tablets, oral solution, oral tablets
Side effects include:
Children 2–5 years of age receiving oral solution: Diarrhea, epistaxis, pharyngitis, flu-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, rash.
Children 6–12 years of age receiving oral solution: Nervousness, wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, upper respiratory tract infection.
Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets: Headache, somnolence, fatigue, dry mouth.
Fixed combination loratadine (the active ingredient contained in Loratadine) pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.
See also:
What is the most important information I should know about Loratadine?
Do NOT use Loratadine if:
you are allergic to any ingredient in Loratadine
Contact your doctor or health care provider right away if any of these apply to you.
Ambroxol Hcl/Loratadine
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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