Ambroxol hydrochloride/roxithromycin/serrapeptase

Each retard capsule contains Ambroxol hydrochloride hydrochloride 75 mg.

Each tablet contains Ambroxol hydrochloride hydrochloride 30 mg.

Each 5 mL of syrup contains Ambroxol hydrochloride hydrochloride 15 or 30 mg.

Each mL of syrup (infant drops) contains Ambroxol hydrochloride hydrochloride 6 mg.

Ambroxol hydrochloride hydrochloride is trans-4-[(2-amino-3,5-dibromo-benzyl)amino] cyclohexanol hydrochloride.

It also contains the following excipients: Retard Capsules: Crospovidone collidon CL, carnauba wax, stearyl alcohol, magnesium stearate.

Tablets: Lactose, maize starch, colloidal silica, magnesium stearate.

Syrup: Purified water, sorbitol liquid, glycerol 85%, woodberry aroma (15 mg only), strawberry aroma (30 mg only), hydroxyethylcellulose, benzoic acid, acesulfame potassium, vanilla aroma.

Infant Drops: Hydroxyethylcellulose, sorbitol solution, glycerol 85%, sodium saccharin, pharma flavors, menthol, benzoic acid, propylene glycol.

Roxithromycin is a semi-synthetic macrolide antibiotic. It is very similar in composition, chemical structure and mechanism of action to erythromycin, azithromycin, or clarithromycin. Roxithromycin prevents bacteria from growing, by interfering with their protein synthesis. Roxithromycin binds to the subunit 50S of the bacterial ribosome, and thus inhibits the translocation of peptides. Roxithromycin has similar antimicrobial spectrum as erythromycin, but is more effective against certain gram-negative bacteria, particularly Legionella pneumophila. It can treat respiratory tract, urinary and soft tissue infections. It is in the United States, but is available in Australia.

Each tablet also contains the following excipients: Titanium dioxide; brilliant blue lake (EC tab 5 mg only), sunset yellow lake (EC tab 10 mg only).

All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma. During acute exacerbations of bronchitis it should be given with the appropriate antibiotic.

Roxithromycin is indicated for the treatment of the following types of mild to

moderately severe infections caused by or likely to be caused by susceptible

micro-organisms: • upper respiratory tract infection - acute pharyngitis, tonsillitis and

sinusitis

• dental infections

• lower respiratory tract infection - acute bronchitis; acute exacerbations

of chronic bronchitis and community acquired pneumonia

• skin and skin structure infections

• non-gonococcal urethritis.

Relief of symptoms related to inflammation eg, edema, swelling, pain, eruption and resolutions of inflammation resulting from areolifis, thrombosis, hematoma, fracture distortion, internal and external hemorrhoids, sinusitis, cystitis, epididymitis, pericoronitis and prolapse, post-operative hemorrhoids.

Ambroxol hydrochloride is a clinically proven systemically active mucolytic agent. When administered orally onset of action occurs after about 30 minutes. The breakdown of acid mucopolysaccharide fibers makes the sputum thinner and less viscous and therefore more easily removed by coughing. Although sputum volume eventually decreases, its viscosity remains low for as long as treatment is maintained.

Erythromycin belongs to the family of medicines called antibiotics. Erythromycin ophthalmic preparations are used to treat infections of the eye. They also may be used to prevent certain eye infections of newborn babies, such as neonatal conjunctivitis and ophthalmia neonatorum. They may be used with other medicines for some eye infections.

Erythromycin is available only with your doctor's prescription.

Sustained-Release Capsule: Adults and Children >12 years: 1 cap once daily after meal with plenty of liquid (sufficient supply of liquid supports the expectorant effect of Ambroxol hydrochloride).

Ambroxol hydrochloride SR capsule is not suitable for children <12 years.

Tablet: Adults and Children >12 years: 1 tab thrice daily for the first 2-3 days and then 1 tab twice daily or ½ tab thrice daily. Children 6-12 years: ½ tab 2-3 times a day.

Syrup: Adults and Children >12 years: 10 mL thrice daily during the first 2-3 days, them 10 mL twice daily or 5 mL thrice daily. Children 6-12 years: 5 mL 2-3 times a day; 2-5 years: 2.5 mL 3 times a day; <2 years: 2.5 mL 2 times a day.

DS Syrup: Adults and Children >12 years: 5 mL thrice daily for 2-3 days then 5 mL twice daily for 2.5 mL thrice daily. Children 6-12 years: 2.5 mL 2-3 times a day.

Infant Drops: Children 13-24 months: 1.25 mL twice a day; 7-12 months: 1 mL twice a day; ≤6 months: 0.5 mL twice a day.

Adults: Recommended Dose: Mild to Moderate Acute Bacterial Exacerbations of COPD, Pneumonia of Mild Severity, Pharyngitis, Tonsillitis and Uncomplicated Skin and Skin Structure Infections: 500 mg as a single dose on the 1st day followed by 250 mg once daily on days 2 through 5.

Genital Ulcer Disease: 1000 mg as single dose.

Urethritis and Cervicitis: 2000 mg as single dose. Capsule should be given at least 1 hr before or 2 hrs after a meal. Azithromycin tablets can be taken with or without food.

Children: Use of azithromycin in children <6 months is not recommended.

Adults: Usually, 1 tablet 3 times daily after meals without chewing.

Dosage may increase according to condition.

See also:
What is the most important information I should know about Ambroxol hydrochloride?

There are no absolute contraindications but in patients with gastric ulceration relative caution should be observed

See also:
What is the most important information I should know about Roxithromycin?

Known allergy to macrolides.

Concomitant administration of roxithromycin with vasoconstrictive ergot (alkaloid) derivatives is contra-indicated since symptoms of ergotism have been described with other macrolides.

Serrapeptase is not contraindicated in patients with severe hepatic or renal disorder.

It is not recommended during pregnancy.

Use Ambroxol hydrochloride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambroxol hydrochloride by mouth with or without food.
• Drink plenty of water while taking Ambroxol hydrochloride.
• If you miss a dose of Ambroxol hydrochloride, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ambroxol hydrochloride.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use erythromycin topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medicine.

Clean and dry the skin area before you apply erythromycin topical. Spread the medicine on lightly, without rubbing it in.

Erythromycin topical is usually applied once or twice daily. Follow your doctor's instructions.

It may take up to 12 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

Store at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use.

The gel form of this medicine is flammable. Do not use near high heat or open flame.

Ambroxol hydrochloride is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.

Roxithromycin is used to treat ear, nose and throat infections, pneumonia (lung infection), skin infections and infections of the genitalia.

See also:
What other drugs will affect Ambroxol hydrochloride?

Amoxicillin may decrease the effectiveness of contraceptives for oral administration.

With the simultaneous use of Max Pidek Pharmaceuticals with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) appears synergies; with bacteriostatic antibiotic (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulphonamide) - antagonism.

Amoxicillin increases the effects of indirect anticoagulants inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.

Amoxicillin reduces the effect of drugs, in the process of metabolism that produce PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of amoxicillin, which can be accompanied by an increase in its concentration in blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides, slow down and reduce, and ascorbic acid increases the absorption of amoxicillin.

With the combined use of amoxicillin and clavulanic acid pharmacokinetics of both components unchanged.

See also:
What other drugs will affect Roxithromycin?

Roxithromycin has a much lower affinity for cytochrome P450 than erythromycin, and consequently has fewer interactions. Interactions may be observed, however, with drugs that bind to alpha-1-acid glycoprotein, e.g. disopyramide. Roxithromycin does not appear to interact with oral contraceptives, prednisolone, carbamazepine, ranitidine or antacids. Theophylline. A study in normal subjects concurrently administered roxithromycin and theophylline has shown some increase in the plasma concentration of the latter. While a change in dosage is usually not required, patients with high levels of theophylline at commencement of treatment should have levels monitored. Ergot alkaloids. Reactions of ergotism with possible peripheral necrosis have been reported after concomitant therapy of macrolides with vasoconstrictive ergot alkaloids, particularly ergotamine and dihydroergotamine. Because a clinical interaction with roxithromycin cannot be excluded, administration of roxithromycin to patients taking ergot alkaloids is contraindicated. Disopyramide. An in vitro study has shown that roxithromycin can displace protein bound disopyramide; such an effect in vivo could result in increased serum levels of disopyramide. Consequently, ECG and, if possible, disopyramide serum levels should be monitored. Terfenadine. Some macrolide antibiotics (e.g. erythromycin) may increase serum levels of terfenadine. This can result in severe cardiovascular adverse events, including QT prolongation, torsades de pointes and other ventricular arrhythmias. Such a reaction has not been documented with roxithromycin, which has a much lower affinity for cytochrome P450 than erythromycin. However, in the absence of a systematic interaction study, concomitant administration of roxithromycin and terfenadine is not recommended. Astemizole, cisapride, pimozide. Other drugs, such as astemizole, cisapride or pimozide, which are metabolised by the hepatic isozyme CYP3A4, have been associated with QT interval prolongation and/or cardiac arrhythmias (typically torsades de pointes) as a result of an increase in their serum level subsequent to interaction with significant inhibitors of this isozyme, including some macrolide antibacterials. Although roxithromycin has no or limited ability to complex CYP3A4 and hence to inhibit the metabolism of other drugs processed by this isozyme, a potential for clinical interaction of roxithromycin with the above mentioned drugs cannot be either ascertained or ruled out in confidence. Thus, concomitant administration of roxithromycin and such drugs is not recommended. Warfarin. While no interaction was observed in volunteer studies, roxithromycin appears to interact with warfarin. Increases in prothrombin time (international normalised ratio (INR)) have been reported in patients treated concomitantly with roxithromycin and warfarin or the related vitamin K antagonist phenprocoumon, and severe bleeding episodes have occurred as a consequence. Digoxin and other cardiac glycosides. A study in healthy volunteers has shown that roxithromycin may increase the absorption of digoxin. This effect, common to other macrolides, may very rarely result in cardiac glycoside toxicity. This may be manifested by symptoms such as nausea, vomiting, diarrhoea, headache or dizziness. Cardiac glycoside toxicity may also elicit heart conduction and/or rhythm disorders. Consequently, in patients treated with roxithromycin and digoxin or another cardiac glycoside, ECG and, if possible, the serum level of the cardiac glycoside should be monitored. This is mandatory if symptoms suggesting cardiac glycoside overdosage have occurred. Midazolam. Roxithromycin, like other macrolides, may increase the area under the midazolam concentration-time curve and the midazolam half-life. Thus, the effects of midazolam may be enhanced and prolonged in patients treated with roxithromycin. There is no conclusive evidence for an interaction between roxithromycin and triazolam. Cyclosporin. A slight increase in plasma concentrations of cyclosporin A has been observed. This does not generally necessitate altering the usual dosage.

Since concomitant use of Serrapeptase with an anticoagulant may intensify the anticoagulant effect, Serrapeptase should be administered cautiously under close observation.

See also:
What are the possible side effects of Ambroxol hydrochloride?

Occasional gastrointestinal side effects may occur but these are normally mild.

See also:
What are the possible side effects of Roxithromycin?

Applies to benzoyl peroxide topical: topical bar, topical cream, topical foam, topical gel/jelly, topical liquid, topical lotion, topical pad, topical soap, topical solution

In addition to its needed effects, some unwanted effects may be caused by benzoyl peroxide topical (the active ingredient contained in Roxithromycin). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking benzoyl peroxide topical:

Less common or rare:

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
• skin rash

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

If any of the following symptoms of overdose occur while taking benzoyl peroxide topical, get emergency help immediately:

Symptoms of overdose:

• Burning, itching, scaling, redness, or swelling of skin (severe)

Minor Side Effects

Some of the side effects that can occur with benzoyl peroxide topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Dryness or peeling of the skin (may occur after a few days)
• feeling of warmth, mild stinging, and redness of the skin

Hypersensitivity: Infrequently hypersensitivity reactions eg, rash and redness may occur.

If such reactions occur, Serrapeptase should be discontinued.

Digestive: Diarrhea may occur. Infrequently, anorexia, gastric discomfort, nausea or vomiting may occur.

Hematologic: Rarely, bleeding tendency eg, epistaxis or bloody sputum may occur.