Azithral A

Each retard capsule contains Ambroxol (Azithral A) hydrochloride 75 mg.

Each tablet contains Ambroxol (Azithral A) hydrochloride 30 mg.

Each 5 mL of syrup contains Ambroxol (Azithral A) hydrochloride 15 or 30 mg.

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

Ambroxol (Azithral A) 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.

Each capsule contains Azithromycin (Azithral A) dihydrate 262.05 mg equivalent to Azithromycin (Azithral A) base 250 mg. It also contains anhydrous lactose, maize starch, magnesium stearate and sodium lauryl sulfate as excipients. The capsule shell contains gelatin, titanium dioxide (E171) and up to 1,000 ppm sulfur dioxide.

Each tablet contains Azithromycin (Azithral A) dihydrate 262.05 mg equivalent to Azithromycin (Azithral A) base 250 mg. It also contains pre-gelatinized starch, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate as excipients. The film-coating contains hydroxypropyl cellulose, triacetin and titanium dioxide (E171).

Each 5 mL of powder for oral suspension contains Azithromycin (Azithral A) dihydrate 209.64 mg equivalent to Azithromycin (Azithral A) base 200 mg. It also contains sucrose (1.94 g/100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients.

Each sachet contains Azithromycin (Azithral A) dihydrate 100.16 mg equivalent to Azithromycin (Azithral A) base 100 mg. It also contains sucrose (1.85 g/Azithromycin (Azithral A) 100-mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients. It also contains a dry powder which yields, when added to water, a white to off-white suspension, cherry/banana with a slight vanilla odor.

Each vial contains Azithromycin (Azithral A) dihydrate 524.1 mg equivalent to Azithromycin (Azithral A) base 500 mg. It also contains anhydrous citric acid and sodium hydroxide as excipients. It is supplied in lyophilized form under a vacuum in a 10-mL vial for IV administration. Upon reconstitution, Azithromycin (Azithral A) powder yields a solution containing the equivalent of Azithromycin (Azithral A) 100 mg/mL.

Azithromycin (Azithral A) is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.

For use Max Pidek Pharmaceuticals as monotherapy and in combination with clavulanic acid: an infectious-inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, infections of the gastrointestinal tract, gynecological infections, infections of the skin and soft tissue, listeria, leptospirosis, gonorrhea.

For use Max Pidek Pharmaceuticals in combination with metronidazole: chronic gastritis in acute, peptic ulcer and duodenal ulcer in acute, associated with Helicobacter Pylori.

Azithromycin (Azithral A) extended-release granules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of designated microorganisms in the specific conditions listed as follows.

Adults: Acute uncomplicated bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Mild to moderate community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis. Azithromycin (Azithral A) is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to Azithromycin (Azithral A), susceptibility tests should be performed when patients are treated with Azithromycin (Azithral A)). Data establishing efficacy of Azithromycin (Azithral A) in subsequent prevention of rheumatic fever are not available.

Pediatrics: Mild to moderate community-acquired pneumonia in pediatric patients 6 months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin (Azithral A) and other antibacterial drugs, Azithromycin (Azithral A) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Azithromycin (Azithral A). Therapy with Azithromycin (Azithral A) may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambroxol (Azithral A) is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant works by loosening mucus and lung secretions in the chest and making coughs more productive.

Azithromycin (Azithral A) injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).

Azithromycin (Azithral A) belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Azithromycin (Azithral A) will not work for colds, flu, or other virus infections. Azithromycin (Azithral A) injection may be used for other problems as determined by your doctor.

Azithromycin (Azithral A) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Azithromycin (Azithral A) is used in certain patients with the following medical condition:

• Trachoma (treatment).

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 (Azithral A)).

Ambroxol (Azithral A) 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.

Azithromycin (Azithral A) for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.

Azithromycin (Azithral A) for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for Azithromycin (Azithral A) (Azithromycin (Azithral A) for oral suspension) 100 mg/5 mL and 200 mg/5 mL bottles.

Directions for administration of Azithromycin (Azithral A) for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of Azithromycin (Azithral A).

Sexually Transmitted Diseases

The recommended dose of Azithromycin (Azithral A) for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1 gram (1000 mg) dose of Azithromycin (Azithral A). This dose can be administered as one single dose packet (1 g).

Mycobacterial Infections

Prevention of Disseminated MAC Infections

The recommended dose of Azithromycin (Azithral A) for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of Azithromycin (Azithral A) may be combined with the approved dosage regimen of rifabutin.

Treatment of Disseminated MAC Infections

Azithromycin (Azithral A) should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of Azithromycin (Azithral A) plus ethambutol at the discretion of the physician or health care provider.

How supplied

Dosage Forms And Strengths

Azithromycin (Azithral A) 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Azithromycin (Azithral A) dihydrate equivalent to 600 mg Azithromycin (Azithral A). These are packaged in bottles of 30 tablets.

Azithromycin (Azithral A) for oral suspension 1000 mg/5 mL is supplied in single-dose packets containing Azithromycin (Azithral A) dihydrate equivalent to 1 gram of Azithromycin (Azithral A).

Storage And Handling

Azithromycin (Azithral A) 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Azithromycin (Azithral A) dihydrate equivalent to 600 mg Azithromycin (Azithral A). These are packaged in bottles of 30 tablets. Azithromycin (Azithral A) tablets are supplied as follows:

Bottles of 30 NDC 0069-3080-30

Tablets should be stored at or below 30°C (86°F).

Azithromycin (Azithral A) for oral suspension is supplied in single-dose packets containing Azithromycin (Azithral A) dihydrate equivalent to 1 gram of Azithromycin (Azithral A) as follows:

Boxes of 10 single-dose packets (1 g) NDC 0069-3051-07

Boxes of 3 single-dose packets (1 g) NDC 0069-3051-75

Store single-dose packets between 5° and 30°C (41° and 86°F).

Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Dec 2015

See also:
What is the most important information I should know about Ambroxol (Azithral A)?

Hypersensitivity to Ambroxol (Azithral A) hydrochloride or to any other excipients of Ambroxol (Azithral A).

In case of rare hereditary conditions that may be incompatible with an excipient of Ambroxol (Azithral A), the use of Ambroxol (Azithral A) is contraindicated.

See also:
What is the most important information I should know about Azithromycin (Azithral A)?

You should not use this medication if you have ever had jaundice or liver problems caused by taking Azithromycin (Azithral A). You should not use Azithromycin (Azithral A) if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with Azithromycin (Azithral A). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Azithromycin (Azithral A) will not treat a viral infection such as the common cold or flu.

Avoid taking an antacid within 2 hours before or after you take Azithromycin (Azithral A). Some antacids can make it harder for your body to absorb Azithromycin (Azithral A).

Use Ambroxol (Azithral A) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambroxol (Azithral A) by mouth with or without food.
• Drink plenty of water while taking Ambroxol (Azithral A).
• If you miss a dose of Ambroxol (Azithral A), 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 (Azithral A).

Use Azithromycin (Azithral A) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Azithromycin (Azithral A). Talk to your pharmacist if you have questions about this information.
• Azithromycin (Azithral A) is for use in the eye only. Do not swallow it.
• Wash your hands immediately before you use Azithromycin (Azithral A).
• To use Azithromycin (Azithral A), turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• If a drop does not come out of the bottle when using your dose, repeat these steps.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Azithromycin (Azithral A). Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• To clear up your infection completely, use Azithromycin (Azithral A) for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Azithromycin (Azithral A), use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azithromycin (Azithral A).

Ambroxol (Azithral A) is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.

Use: Labeled Indications

Oral, IV:

Chancroid: Treatment of genital ulcer disease (in men) due to Haemophilus ducreyi (chancroid)

Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC) in patients with advanced HIV infection; treatment of disseminated MAC (in combination with ethambutol) in patients with advanced HIV infection

Otitis media, acute: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae

Pneumonia, community-acquired: Treatment of community-acquired pneumonia (CAP) due to Chlamydophila pneumoniae, H. influenzae, Legionella pneumophila, M. catarrhalis, Mycoplasma pneumoniae, or S. pneumoniae

Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae

Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis due to S. pyogenes as an alternative to first-line therapy

Urethritis/cervicitis: Treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae

Off Label Uses

Acne vulgaris

Data from controlled trials support the use of Azithromycin (Azithral A) in the treatment of acne vulgaris in adults with moderate to severe acne.

Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, Azithromycin (Azithral A), in combination with topical therapy, may be considered as a treatment option for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. However, its use should be limited to patients who cannot receive a tetracycline (ie, pregnant women). Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, Azithromycin (Azithral A)) and continued for maintenance after the antibiotic course is completed.

Babesiosis

Data from a prospective, nonblinded, randomized trial in patients with non-life-threatening babesiosis, support the use of Azithromycin (Azithral A) (in combination with atovaquone) for the treatment of this condition.

Based on the CDC Yellow Book, the ACG guideline for the diagnosis, treatment, and prevention of acute diarrheal infections in adults, and the IDSA practice guidelines for the diagnosis and management of infectious diarrhea, Azithromycin (Azithral A) is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Azithromycin (Azithral A) may be a recommended first-line treatment, especially in regions with a high prevalence of Campylobacter (eg, Southeast Asia, India) or in geographical areas with suspected fluoroquinolone-resistant pathogens or enterotoxigenic Escherichia coli.

See also:
What other drugs will affect Ambroxol (Azithral A)?

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 Azithromycin (Azithral A)?

Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Azithromycin (Azithral A), no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 24%. In patients receiving both Azithromycin (Azithral A) and antacids, the drugs should not be taken simultaneously. Co-administration of Azithromycin (Azithral A) extended-release granules for oral suspension with a single dose of 20 mL co-magaldrox (aluminum hydroxide and magnesium hydroxide) did not affect the rate and extent of Azithromycin (Azithral A) absorption.

Cetirizine: In healthy volunteers, co-administration of a 5-day regimen of Azithromycin (Azithral A) with 20 mg cetirizine at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.

Didanosine (Dideoxyinosine): Co-administration of 1,200 mg/day Azithromycin (Azithral A) with 400 mg/day didanosine in six HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared to placebo.

Digoxin: Concomitant administration of macrolide antibiotics, including Azithromycin (Azithral A), with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if Azithromycin (Azithral A) and P-glycoprotein substrates such as digoxin are administered concomitantly, the possibility of elevated serum digoxin concentrations should be considered. Clinical monitoring, and possibly serum digoxin levels, during treatment with Azithromycin (Azithral A) and after its discontinuation are necessary.

Ergot: There is a theoretical possibility of interaction between Azithromycin (Azithral A) and ergot derivatives.

Zidovudine: Single 1,000 mg doses and multiple 1,200 mg or 600 mg doses of Azithromycin (Azithral A) had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Azithromycin (Azithral A) increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.

Azithromycin (Azithral A) does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with Azithromycin (Azithral A).

Pharmacokinetic studies have been conducted between Azithromycin (Azithral A) and the following drugs known to undergo significant cytochrome P450-mediated metabolism.

Atorvastatin: Co-administration of atorvastatin (10 mg daily) and Azithromycin (Azithral A) (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). However, post-marketing cases of rhabdomyolysis in patients receiving Azithromycin (Azithral A) with statins have been reported.

Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Azithromycin (Azithral A).

Cimetidine: In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before Azithromycin (Azithral A), on the pharmacokinetics of Azithromycin (Azithral A), no alteration of Azithromycin (Azithral A) pharmacokinetics was seen.

Coumarin-Type

Oral Anticoagulants:

Cyclosporin: In a pharmacokinetic study with healthy volunteers who were administered a 500 mg/day oral dose of Azithromycin (Azithral A) for 3 days and were then administered a single 10 mg/kg oral dose of cyclosporin, the resulting cyclosporin C_max and AUC_0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.

Efavirenz: Co-administration of a single dose of 600 mg Azithromycin (Azithral A) and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole: Co-administration of a single dose of 1,200 mg Azithromycin (Azithral A) did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of Azithromycin (Azithral A) were unchanged by the co-administration of fluconazole; however, a clinically insignificant decrease in C_max (18%) of Azithromycin (Azithral A) was observed.

Indinavir: Co-administration of a single dose of 1,200 mg Azithromycin (Azithral A) had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Azithromycin (Azithral A) had no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam: In healthy volunteers, co-administration of 500 mg/day Azithromycin (Azithral A) for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam.

Nelfinavir: Co-administration of Azithromycin (Azithral A) (1,200 mg) and nelfinavir at steady-state (750 mg three times daily) resulted in increased Azithromycin (Azithral A) concentrations. No clinically significant adverse effects were observed and no dose adjustment was required. Although no dosage adjustment of Azithromycin (Azithral A) is recommended when administered with nelfinavir, close monitoring for known side effects of Azithromycin (Azithral A), such as liver enzyme abnormalities and hearing impairment, is warranted.

Rifabutin: Co-administration of Azithromycin (Azithral A) and rifabutin did not affect the serum concentrations of either drug.

Neutropenia was observed in subjects receiving concomitant treatment of Azithromycin (Azithral A) and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Azithromycin (Azithral A) has not been established.

Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of Azithromycin (Azithral A) (500 mg daily for 3 days) on the AUC and C_max of sildenafil or its major circulating metabolite.

Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Azithromycin (Azithral A) and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred.

Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when Azithromycin (Azithral A) and theophylline are co-administered to healthy volunteers.

Triazolam: In 14 healthy volunteers, co-administration of 500 mg Azithromycin (Azithral A) on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.

Trimethoprim/Sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with 1,200 mg Azithromycin (Azithral A) on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin (Azithral A) serum concentrations were similar to those seen in other studies.

Incompatibilities: Not applicable.

See also:
What are the possible side effects of Ambroxol (Azithral A)?

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution

As well as its needed effects, albuterol (the active ingredient contained in Ambroxol (Azithral A)) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking albuterol, check with your doctor immediately:

More common:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, irregular, pounding, or racing heartbeat or pulse

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Minor Side Effects

Some albuterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

• Sleepiness
• unusual drowsiness

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

See also:
What are the possible side effects of Azithromycin (Azithral A)?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults:

The data described below reflect exposure to Azithromycin (Azithral A) in 728 adult patients. All patients received a single 2 g oral dose of Azithromycin (Azithral A). The population studied had community-acquired pneumonia and acute bacterial sinusitis.

In controlled clinical trials with Azithromycin (Azithral A), the majority of the reported treatment-related adverse reactions were gastrointestinal in nature and mild to moderate in severity.

Overall, the most common treatment-related adverse reactions in adult patients receiving a single 2 g dose of Azithromycin (Azithral A) were diarrhea/loose stools (12%), nausea (4%), abdominal pain (3%), headache (1%), and vomiting (1%). The incidence of treatment-related gastrointestinal adverse reactions was 17% for Azithromycin (Azithral A) and 10% for pooled comparators.

Treatment-related adverse reactions following Azithromycin (Azithral A) treatment that occurred with a frequency of <1% included the following:

Cardiovascular: Palpitations, chest pain

Gastrointestinal: Constipation, dyspepsia, flatulence, gastritis, oral moniliasis

Genitourinary: Vaginitis

Nervous system: Dizziness, vertigo

General: Asthenia

Allergic: Rash, pruritus, urticaria

Special senses: Taste perversion

Pediatric Patients:

The data described below reflect exposure to Azithromycin (Azithral A) in 907 pediatric patients. The population was 3 months to 12 years of age. All patients received a single 60 mg/kg oral dose of Azithromycin (Azithral A).

As in adults, the most common treatment-related adverse reactions in pediatric subjects were gastrointestinal in nature. The pediatric subjects all received a single 60 mg/kg dose (equivalent to 27 mg/lb) of Azithromycin (Azithral A).

In a trial with 450 pediatric subjects (ages 3 months to 48 months), vomiting (11%), diarrhea (10%) loose stools (9%), and abdominal pain (2%) were the most frequently reported treatment-related gastrointestinal adverse reactions. Many treatment related gastrointestinal adverse reactions with an incidence greater than 1% began on the day of dosing in these subjects [43% (68/160)] and most [53% (84/160)] resolved within 48 hr of onset. Treatment-related adverse events that were not gastrointestinal, occurring with a frequency ≥ 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).

In a second trial of 337 pediatric subjects, ages 2 years to 12 years, the most frequently reported treatment-related adverse reactions also included vomiting (14%), diarrhea (7%), loose stools (2%), nausea (4%) and abdominal pain (4%).

A third trial investigated the tolerability of two different concentrations of Azithromycin (Azithral A) oral suspension in 120 pediatric subjects (ages 3 months to 48 months), all of whom were treated with Azithromycin (Azithral A). The study evaluated the hypothesis that a more dilute, less viscous formulation (the recommended 27 mg/mL concentration of Azithromycin (Azithral A)) is less likely to induce vomiting in young children than a more concentrated suspension used in other pediatric studies. The vomiting rate for subjects taking the dilute concentration Azithromycin (Azithral A) was 3% (2/61). The rate was numerically lower but not statistically different from the vomiting for the more concentrated suspension Across both treatment arms, the only treatment-related adverse events with a frequency of ≥ 1% were vomiting (6%, 7/120) and diarrhea (2%, 2/120).

Treatment-related adverse reactions with a frequency of < 1% following Azithromycin (Azithral A) treatment in all 907 pediatric subjects in the Phase 3 studies were:

Body as a whole: Chills, fever, flu syndrome, headache;

Digestive: Abnormal stools, constipation, dyspepsia, flatulence, gastritis, gastrointestinal disorder, hepatitis;

Hematologic and lymphatic: Leukopenia;

Nervous system: Agitation, emotional liability, hostility, hyperkinesia, insomnia, irritability, paresthesia, Somnolence;

Respiratory: Asthma, bronchitis, cough, dyspnea, pharyngitis, rhinitis;

Skin and appendages: Dermatitis, fungal dermatitis, maculopapular rash, pruritus, urticaria;

Special senses: Otitis media, taste perversion;

Urogenital: Dysuria.

Postmarketing Experience with Other Azithromycin (Azithral A) Products

Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Adverse events reported with Azithromycin (Azithral A) immediate release formulations during the postmarketing period for which a causal relationship may not be established include:

Allergic: Arthralgia, edema, urticaria and angioedema

Cardiovascular: Palpitations and arrhythmias including ventricular tachycardia and hypotension

There have been reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration

General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis

Genitourinary: Interstitial nephritis, acute renal failure and vaginitis

Hematopoietic: Thrombocytopenia, mild neutropenia

Liver/biliary: Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with Azithromycin (Azithral A).

Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope

Psychiatric: Aggressive reaction and anxiety

Skin/appendages: Pruritus, rash, photosensitivity, serious skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.

Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss

Laboratory Abnormalities

In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Azithromycin (Azithral A) clinical trials in adults and pediatric patients:

Adults:

Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible.

Pediatric Patients:

Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.