Axmel

A broad-spectrum semisynthetic antibiotic similar to ampicillin except that its resistance to gastric acid permits higher serum levels with oral administration. Axmel is commonly prescribed with clauvanic acid (a beta lactamase inhibitor) as it is susceptible to beta-lacatamase degradation. [PubChem]

Infections of the Ear, Nose, and Throat

Axmel Capsules, Axmel for oral suspension, Axmel tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Infections of the Genitourinary Tract

Axmel Capsules, Axmel for oral suspension, Axmel tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Infections of the Skin and Skin Structure

Axmel Capsules, Axmel for oral suspension, Axmel tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.

Infections of the Lower Respiratory Tract

Axmel Capsules, Axmel for oral suspension, Axmel tablets (chewable) are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Helicobacter pylori Infection

Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:

Axmel, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual therapy for H. pylori with lansoprazole:

Axmel, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Axmel and other antibacterial drugs, Axmel should be used only to treat infections that are proven or strongly suspected to be caused by 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.

Penicillins are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth.

There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of penicillin usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines (antibiotics). Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.

Penicillins are 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, penicillins are used in certain patients with the following medical conditions:

• Chlamydia infections in pregnant women—Axmel and ampicillin
• Gas gangrene—Penicillin G
• Helicobacter pylori-associated gastritis or peptic ulcer disease—Axmel
• Leptospirosis—Ampicillin and penicillin G
• Lyme disease—Axmel and penicillin V
• Typhoid fever—Axmel and ampicillin

Dosing For Adult And Pediatric Patients > 3 Months Of Age

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Table 1: Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

Dosing In Neonates And Infants Aged ≤ 12 Weeks ( ≤ 3 Months)

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of Axmel in this age group, the recommended upper dose of Axmel is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

Dosing For H. Pylori Infection

Triple therapy

The recommended adult oral dose is 1 gram Axmel, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy

The recommended adult oral dose is 1 gram Axmel and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.

Dosing In Renal Impairment

• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
• Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose.
• Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
• Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
• Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Directions For Mixing

Oral Suspension

Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing

Oral Suspension

After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

How supplied

Dosage Forms And Strengths

Capsules

250 mg, 500 mg. Each capsule of Axmel, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg Axmel as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name Axmel and 250; the cap and body of the 500 mg capsule are imprinted with Axmel and 500.

Tablets

500 mg, 875 mg. Each tablet contains 500 mg or 875 mg Axmel as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with Axmel centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side.

Powder for

Oral Suspension

125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg Axmel as the trihydrate. Each 5 mL of reconstituted bubble-gumflavored suspension contains 200 mg, 250 mg or 400 mg Axmel as the trihydrate.

Storage And Handling

Capsules: Each capsule of Axmel, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg Axmel as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name Axmel and 250; the cap and body of the 500 mg capsule are imprinted with Axmel and 500.

250-mg Capsule

NDC 43598-025-01 Bottles of 100

NDC 43598-025-05 Bottles of 500

500-mg Capsule

NDC 43598-005-01 Bottles of 100

NDC 43598-005-05 Bottles of 500

Tablets: Each tablet contains 500 mg or 875 mg Axmel as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with Axmel centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side.

500-mg Tablet

NDC 43598-024-01 Bottles of 100

NDC 43598-024-05 Bottles of 500

875-mg Tablet

NDC 43598-019-01 Bottles of 100

NDC 43598-019-14 Bottles of 20

Powder for

Oral Suspension:

125 mg/5 mL

NDC 43598-022-80 80-mL bottle

NDC 43598-022-52 100-mL bottle

NDC 43598-022-53 150-mL bottle

200 mg/5 mL

NDC 43598-023-50 50-mL bottle

NDC 43598-023-51 75-mL bottle

NDC 43598-023-52 100-mL bottle

250 mg/5 mL

NDC 43598-009-80 80-mL bottle

NDC 43598-009-52 100-mL bottle

NDC 43598-009-53 150-mL bottle

400 mg/5 mL

NDC 43598-007-50 50-mL bottle

NDC 43598-007-51 75-mL bottle

NDC 43598-007-52 100-mL bottle

Store at or below 20° C (68° F) -250 mg and 500 mg Capsules and 125 mg and 250 mg unreconstituted powder.

Store at or below 25° C (77° F) -500 mg and 875 mg Tablets and 200 mg and 400 mg unreconstituted powder.

Dispense in a tight container.

Manufactured. By: Dr. Reddy's Laboratories Tennessee,LLC. Bristol, TN 37620. Revised: Sep 2015

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

Do not use this medication if you are allergic to Axmel or to any other penicillin antibiotic, such as ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others.

Before using Axmel, tell your doctor if you are allergic to cephalosporins such as Omnicef, Cefzil, Ceftin, Keflex, and others. Also tell your doctor if you have asthma, liver or kidney disease, a bleeding or blood clotting disorder, mononucleosis (also called "mono"), or any type of allergy.

Axmel can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking Axmel.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Axmel will not treat a viral infection such as the common cold or flu.

Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Axmel and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

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

• Take Axmel suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Axmel suspension may be mixed with formula, milk, fruit juice, water, ginger ale, or other cold drinks. If you mix Axmel suspension, take it at once after mixing. Be sure that the entire dose is swallowed.
• To clear up your infection completely, take Axmel suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Axmel suspension, 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 Axmel suspension.

Use: Labeled Indications

Ear, nose, and throat infections (pharyngitis/tonsillitis, otitis media):

Immediate release: Treatment of infections due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Extended release: Treatment of tonsillitis and/or pharyngitis due to Streptococcus pyogenes in adults and pediatric patients ≥12 years of age.

Genitourinary tract infections: Immediate release: Treatment of infections of the genitourinary tract due to beta-lactamase-negative Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Helicobacter pylori eradication: Immediate release: Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence as a component of combination therapy in patients with active or 1-year history of duodenal ulcer disease.

Lower respiratory tract infections (including pneumonia): Immediate release: Treatment of infections of the lower respiratory tract due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Rhinosinusitis, acute bacterial: Immediate release: Treatment of infections due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Skin and skin structure infections: Immediate release: Treatment of infections of the skin and skin structure due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic strains only), Staphylococcus spp., or E. coli.

Off Label Uses

Actinomycosis

Data from a small retrospective study suggest that Axmel may be beneficial for the treatment of actinomycosis.

Prosthetic joint infection

Based on the IDSA guidelines for the management of prosthetic joint infection (PJI), Axmel is an effective and recommended agent for chronic oral antimicrobial suppression of PJI with beta-hemolytic streptococci, Enterococcus spp. (penicillin susceptible), and Cutibacterium spp. after completion of parenteral therapy.

See also:
What other drugs will affect Axmel?

Probenecid

Probenecid decreases the renal tubular secretion of Axmel. Concurrent use of Axmel and probenecid may result in increased and prolonged blood levels of Axmel.

Oral Anticoagulants

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving Axmel and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Allopurinol

The concurrent administration of allopurinol and Axmel increases the incidence of rashes in patients receiving both drugs as compared to patients receiving Axmel alone. It is not known whether this potentiation of Axmel rashes is due to allopurinol or the hyperuricemia present in these patients.

Oral Contraceptives

Axmel may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Other Antibacterials

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Effects on Laboratory Tests

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict' s Solution, or Fehling's Solution. Since this effect may also occur with Axmel, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®) be used.

Following administration of ampicillin or Axmel to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

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

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Gastrointestinal: nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Hypersensitivity Reactions: Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, Axmel should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to Axmel therapy.

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis have been reported.

Renal: Crystalluria has also been reported.

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Combination therapy with clarithromycin and lansoprazole

In clinical trials using combination therapy with Axmel plus clarithromycin and lansoprazole, and Axmel plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Axmel, clarithromycin, or lansoprazole.

Triple therapy: Axmel/clarithromycin/lansoprazole

The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual therapy: Axmel/lansoprazole

The most frequently reported adverse events for patients who received Axmel t.i.d. plus lansoprazole t.i.d. dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with Axmel t.i.d. plus lansoprazole t.i.d. dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.