Gabapentin - SNRI Uses, MOA, Detail Dose, Drug Drug Interactions, Side effects and ADRs

What is Gabapentin?

Gabapentin is a medicine used to treat partial seizures, nerve pain from shingles and restless leg syndrome. It works on the chemical messengers in your brain and nerves.  Gabapentin is from a group of medicines called anticonvulsants. 

Different brands of gabapentin are not interchangeable and they are FDA approved for different conditions. Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form. 

Neurontin (gabapentin) is used to treat pain you may have from shingles (postherpetic nerve pain). It is also used with other seizure medicines for partial onset seizures in patients 3 years and older.

Gralise (gabapentin) is only used for pain after having shingles (postherpetic nerve pain). It should not be used for any other medical condition.

Horizant (gabapentin enacarbil) is an extended release tablet used to treat restless legs syndrome and for the pain from having shingles (postherpetic nerve pain).

Generic brands of gabapentin capsules, USP are used for postherpetic nerve pain and for add on therapy for partial onset seizures in patients 3 years and older

Warnings

Gabapentin can cause life-threatening breathing problems, especially if you already have a breathing disorder or if you use other medicines that can make you drowsy or slow your breathing. Seek emergency medical attention if you have very slow breathing.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Seizures may increase if you stop using gabapentin suddenly. Ask your doctor before stopping the medicine.

Avoid driving or hazardous activity until you know how gabapentin will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not stop using gabapentin suddenly, even if you feel fine.

Before taking this medicine

You should not take gabapentin if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• breathing problems;

• diabetes;

• depression, a mood disorder, or suicidal thoughts or actions;

• drink alcohol;

• a history of drug addiction;

• a seizure;

• (patients with RLS) if you are a day sleeper or work a night shift; or

• kidney disease (or if you are on dialysis).

some people have thoughts about suicide while taking seizure medicine. Children taking gabapentin may have behavior changes. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

It is not known if gabapentin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not start or stop seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gabapentin on the baby.

Ask a doctor if it is safe to breastfeed while using gabapentin.

How should I take gabapentin?

Take gabapentin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Never take gabapentin in larger amounts, or for longer than prescribed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Both Gralise and Horizant should be taken with food.

Neurontin can be taken with or without food.

If you break a tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days.

Swallow the tablets of Gralise and Horizant whole. Do not crush, break, or dissolve them. Swallow the capsule whole and do not crush, chew, break, or open the capsule.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

You should not stop taking gabapentin suddenly. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using gabapentin.

Your kidney function may need to be checked often and your dose may change based on the results.

Store tablets and capsules at room temperature away from moisture and heat.

Store the liquid medicine in the refrigerator, do not freeze.

Follow all storage instructions provided. Your pharmacist can provide more information about how to store this medicine.

Dosing information

Usual Adult Dose for Epilepsy:

Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
Maintenance dose: 300 to 600 mg orally 3 times a day
Maximum dose: 3600 mg orally daily (in 3 divided doses)
-Maximum time between doses in the 3 times a day schedule should not exceed 12 hours
-The safety and effectiveness of gabapentin available under the trade name Gralise or Horizant in patients with epilepsy has not been studied.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization

Usual Adult Dose for Postherpetic Neuralgia:

-Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
-Titrate up as needed for pain relief
-Maximum dose: 1800 mg per day (600 mg orally 3 times a day)
Gabapentin available under the trade name Gralise:
-Maintenance dose: Gralise should be titrated to 1800 mg orally once daily with the evening meal.
-Recommended titration schedule:
Day 1: 300 mg orally with the evening meal
Day 2: 600 mg orally with the evening meal
Days 3 through 6: 900 mg orally with the evening meal
Days 7 through 10: 1200 mg orally with the evening meal
Days 11 through 14: 1500 mg orally with the evening meal
Day 15: 1800 mg orally with the evening meal
COMMENT:
-Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Gabapentin enacarbil extended release tablets are available under the trade name Horizant:
-The recommended dosage is 600 mg orally 2 times a day. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg 2 times a day (1200 mg/day) on day four.
COMMENT:
Gabapentin enacarbil extended release tablets available under the trade name Horizant and gabapentin are not interchangeable.

Use: Postherpetic neuralgia

Usual Adult Dose for Restless Legs Syndrome:

Gabapentin enacarbil available under the trade name Horizant:
600 mg orally once daily with food at about 5 PM

Use: For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

Usual Pediatric Dose for Epilepsy:

Less than 3 years: Not recommended

Greater than or equal to 3 and less than 12 years:
Starting Dose: Ranges from 10 to 15 mg/kg/day in 3 divided doses
Effective Dose: Reached by upward titration over a period of approximately 3 days; the effective dose in patients 5 years of age and older is 25 to 35 mg/kg/day in divided doses (3 times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (3 times a day). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long term clinical study. The maximum time interval between doses should not exceed 12 hours.

Greater than 12 years:
-Initial dose: 300 mg orally on day one, 300 mg orally 2 times a day on day two, then 300 mg orally 3 times a day on day three
-Maintenance dose: 900 to 1800 mg orally in 3 divided doses; the dose may be increased up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization in patients 3 years of age and older<

What happens if I overdose?

Overdose symptoms may include slow breathing, double vision, tremor, slurred speech, drowsiness, change in your mental state, dizziness, tiredness, or diarrhea.

Gabapentin side effects

Get emergency medical help if you have signs of an allergic reaction to gabapentin: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Gabapentin can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Some side effects are more likely in children taking gabapentin. Call your doctor if the child has any of the following side effects: behavior changes, memory problems, trouble concentrating, or acting restless, hostile, or aggressive.

Gabapentin may cause serious side effects. Call your doctor at once if you have:

• drowsiness, dizziness, weakness;

• problems with balance or muscle movement; or

• increased seizures.

Common gabapentin side effects may include:

• fever, chills, sore throat, body aches, tiredness;

• headache;

• swelling of your legs and feet;

• trouble speaking;

• vision problems, dizziness, drowsiness;

• tremors, problems with balance or muscle movement; or

• nausea, vomiting.

What other drugs will affect gabapentin?

Taking gabapentin with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect gabapentin, especially:

• naproxen;

• opioid medicine - hydrocodone, oxycodone, morphine, buprenorphine;

• zolpidem;

• lorazepam; or

• cimetidine.

Azithromycin - Macrolide Antibiotic Uses, MOA, Dose Information,Side effects, ADRs, Drug Drug Interactions 👨‍⚕️💊⚕️

What is Azithromycin?

Azithromycin is an antibiotic that fights bacteria.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, eye infections, and sexually transmitted diseases.

Warnings

You should not use azithromycin if you have ever had jaundice or liver problems when you have previously taken this medicine.

Before taking this medicine

You should not use azithromycin if you are allergic to it, or if:

• you have ever had jaundice or liver problems caused by taking azithromycin; or

• you are allergic to similar drugs such as clarithromycin, erythromycin, or telithromycin.

To make sure azithromycin is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• myasthenia gravis;

• a heart rhythm disorder;

• low levels of potassium in your blood; or

• long QT syndrome (in you or a family member).

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take azithromycin?

Take azithromycin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The dose and length of treatment may not be the same for every type of infection.

You may take most forms of azithromycin with or without food.

Take Azithromycin extended release liquid (oral suspension) on an empty stomach, at least 1 hour before or 2 hours after a meal.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. To make sure you get the entire dose, add 2 more ounces of water to the same glass, swirl gently and drink right away.

Throw away any mixed Zmax oral suspension (extended release formulation) that has not been used within 12 hours. Throw away any immediate-release suspension that has not been used within 10 days.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use 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 will not treat a viral infection such as the flu or a common cold.

Store at room temperature away from moisture and heat.

What to avoid

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. These antacids can make azithromycin less effective when taken at the same time.

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

Avoid exposure to sunlight or tanning beds. Azithromycin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid other drugs that can cause QT prolongation or irregular heart rhythm.

Azithromycin side effects

Get emergency medical help if you have signs of an allergic reaction to azithromycin: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using azithromycin.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor right away if a baby taking azithromycin becomes irritable or vomits while eating or nursing.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

Common azithromycin side effects may include:

• diarrhea;

• nausea, vomiting, stomach pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Azithromycin side effects

Get emergency medical help if you have signs of an allergic reaction to azithromycin: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using azithromycin.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor right away if a baby taking azithromycin becomes irritable or vomits while eating or nursing.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

Common azithromycin side effects may include:

• diarrhea;

• nausea, vomiting, stomach pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Azithromycin Dosage

Applies to the following strengths: 500 mg; 250 mg; 1 g; 600 mg; 100 mg/5 mL; 200 mg/5 mL; 2 g; 2.5 g

Usual Adult Dose for:

• Legionella Pneumonia
• Mycoplasma Pneumonia
• Pneumonia
• Tonsillitis/Pharyngitis
• Sinusitis
• Skin and Structure Infection
• Bartonellosis
• Gonococcal Infection - Uncomplicated
• Nongonococcal Urethritis
• Chlamydia Infection
• Cervicitis
• Chancroid
• Pelvic Inflammatory Disease
• Bronchitis
• Mycobacterium avium-intracellulare - Prophylaxis
• Mycobacterium avium-intracellulare - Treatment
• Mycobacterium kansasii
• Granuloma Inguinale
• Pertussis Prophylaxis
• Pertussis
• Lyme Disease - Erythema Chronicum Migrans
• Babesiosis
• Bacterial Endocarditis Prophylaxis
• Campylobacter Gastroenteritis
• Shigellosis
• Bacterial Infection
• Syphilis - Early

Usual Pediatric Dose for:

• Otitis Media
• Legionella Pneumonia
• Mycoplasma Pneumonia
• Pneumonia
• Tonsillitis/Pharyngitis
• Sinusitis
• Pelvic Inflammatory Disease
• Skin and Structure Infection
• Bartonellosis
• Gonococcal Infection - Uncomplicated
• Chlamydia Infection
• Mycobacterium avium-intracellulare - Prophylaxis
• Mycobacterium avium-intracellulare - Treatment
• Pertussis Prophylaxis
• Pertussis
• Lyme Disease - Erythema Chronicum Migrans
• Babesiosis
• Bacterial Endocarditis Prophylaxis
• Campylobacter Gastroenteritis
• Shigellosis
• Syphilis - Early

Usual Adult Dose for Legionella Pneumonia

Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Patients appropriate for oral therapy: 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5

Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, significant underlying health problems that may compromise ability to respond to illness (including immunodeficiency or functional asplenia), elderly, debilitated, or require hospitalization.
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.

Uses:

• IV: For the treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

Usual Adult Dose for Mycoplasma Pneumonia

Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Patients appropriate for oral therapy: 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5
Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, significant underlying health problems that may compromise ability to respond to illness (including immunodeficiency or functional asplenia), elderly, debilitated, or require hospitalization.
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.

Uses:

• IV: For the treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

Usual Adult Dose for Pneumonia

Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Patients appropriate for oral therapy: 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5
Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, significant underlying health problems that may compromise ability to respond to illness (including immunodeficiency or functional asplenia), elderly, debilitated, or require hospitalization.
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.

Uses:

• IV: For the treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

Usual Adult Dose for Tonsillitis/Pharyngitis

500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5

Use: For the treatment of mild to moderate pharyngitis/tonsillitis due to S pyogenes as an alternative to first-line therapy in patients who cannot use first-line therapy

Infectious Diseases Society of America (IDSA) Recommendations: 12 mg/kg orally once a day for 5 days

• Maximum dose: 500 mg/dose

Comments:

• Recommended for the treatment of group A streptococcal pharyngitis in patients with penicillin allergy
• Resistance of group A Streptococcus to this drug is well-known and varies geographically and temporally.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Sinusitis

500 mg orally once a day for 3 days

Use: For the treatment of mild to moderate acute bacterial sinusitis due to H influenzae, M catarrhalis, or S pneumoniae

Usual Adult Dose for Skin and Structure Infection

500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5

Use: For the treatment of mild to moderate uncomplicated skin and skin structure infections due to S aureus, S pyogenes, or S agalactiae

IDSA Recommendations:

• Cat scratch disease:
• Weight less than 45 kg: 10 mg/kg orally on day 1, then 5 mg/kg orally once a day for 4 additional days
• Weight at least 45 kg: 500 mg orally on day 1, then 250 mg orally once a day for 4 additional days

The Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV (the Panel) Recommendations:

• Bartonella infections: 500 mg orally once a day for at least 3 months

Comments:

• Recommended for cat scratch disease
• Recommended as an alternative regimen for Bartonella infections (not for endocarditis or CNS infections) in patients with HIV
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Bartonellosis

500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5

Use: For the treatment of mild to moderate uncomplicated skin and skin structure infections due to S aureus, S pyogenes, or S agalactiae

IDSA Recommendations:

• Cat scratch disease:
• Weight less than 45 kg: 10 mg/kg orally on day 1, then 5 mg/kg orally once a day for 4 additional days
• Weight at least 45 kg: 500 mg orally on day 1, then 250 mg orally once a day for 4 additional days

The Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV (the Panel) Recommendations:

• Bartonella infections: 500 mg orally once a day for at least 3 months

Comments:

• Recommended for cat scratch disease
• Recommended as an alternative regimen for Bartonella infections (not for endocarditis or CNS infections) in patients with HIV
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Gonococcal Infection - Uncomplicated

2 g orally as a single dose
Comments:

• No oral formulation (at the recommended dose) should be relied upon to treat syphilis.
• All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing/cultures for gonorrhea at time of diagnosis; if infection is confirmed, appropriate antibacterial therapy and follow-up tests for these diseases should be started.

Use: For the treatment of mild to moderate urethritis and cervicitis due to Neisseria gonorrhoeae

US CDC Recommendations: 2 g orally as a single dose

Comments:

• With gentamicin, recommended as an alternative regimen for uncomplicated gonococcal infections of the cervix, urethra, or rectum if ceftriaxone is not available
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Nongonococcal Urethritis

1 g orally as a single dose
Comments:

• Antibacterial agents used in high doses for short periods of time to treat nongonococcal urethritis may mask or delay symptoms of incubating syphilis or gonorrhea.
• No oral formulation (at the recommended dose) should be relied upon to treat syphilis; in addition, the oral suspension in the single dose packet (1 g) should not be relied upon to treat gonorrhea.
• All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing/cultures for gonorrhea at time of diagnosis; if infection is confirmed, appropriate antibacterial therapy and follow-up tests for these diseases should be started.

Use: For the treatment of mild to moderate urethritis and cervicitis due to Chlamydia trachomatis

US CDC Recommendations:

• Cervicitis and chlamydial infection: 1 g orally as a single dose
• Lymphogranuloma venereum: 1 g orally once a week for 3 weeks
• M genitalium cervicitis or urethritis: 1 g orally as initial dose, followed by 500 mg orally once a day for 3 additional days
• Nongonococcal urethritis: 1 g orally as a single dose OR 500 mg orally as a single dose on the first day, followed by 250 mg orally once a day for 4 days

Comments:

• Recommended as an alternative regimen for cervicitis
• Concurrent therapy for gonococcal infection should be considered if the patient is at risk for gonorrhea or lives in an area with high gonorrhea prevalence.
• Recommended as an alternative regimen for chlamydial infection among adults; recommended regimen for chlamydial infection during pregnancy
• Recommended as an alternative regimen for lymphogranuloma venereum due to C trachomatis
• This regimen has not been validated; a test of cure with C trachomatis nucleic acid amplification test 4 weeks after therapy completion can be considered.
• Recommended regimen after doxycycline if M genitalium resistance testing is available and M genitalium is macrolide sensitive
• Recommended as alternative regimens for nongonococcal urethritis
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Chlamydia Infection

1 g orally as a single dose

Comments:

• Antibacterial agents used in high doses for short periods of time to treat nongonococcal urethritis may mask or delay symptoms of incubating syphilis or gonorrhea.
• No oral formulation (at the recommended dose) should be relied upon to treat syphilis; in addition, the oral suspension in the single dose packet (1 g) should not be relied upon to treat gonorrhea.
• All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing/cultures for gonorrhea at time of diagnosis; if infection is confirmed, appropriate antibacterial therapy and follow-up tests for these diseases should be started.

Use: For the treatment of mild to moderate urethritis and cervicitis due to Chlamydia trachomatis

US CDC Recommendations:

• Cervicitis and chlamydial infection: 1 g orally as a single dose
• Lymphogranuloma venereum: 1 g orally once a week for 3 weeks
• M genitalium cervicitis or urethritis: 1 g orally as initial dose, followed by 500 mg orally once a day for 3 additional days
• Nongonococcal urethritis: 1 g orally as a single dose OR 500 mg orally as a single dose on the first day, followed by 250 mg orally once a day for 4 days

Comments:

• Recommended as an alternative regimen for cervicitis
• Concurrent therapy for gonococcal infection should be considered if the patient is at risk for gonorrhea or lives in an area with high gonorrhea prevalence.
• Recommended as an alternative regimen for chlamydial infection among adults; recommended regimen for chlamydial infection during pregnancy
• Recommended as an alternative regimen for lymphogranuloma venereum due to C trachomatis
• This regimen has not been validated; a test of cure with C trachomatis nucleic acid amplification test 4 weeks after therapy completion can be considered.
• Recommended regimen after doxycycline if M genitalium resistance testing is available and M genitalium is macrolide sensitive
• Recommended as alternative regimens for nongonococcal urethritis
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Cervicitis

1 g orally as a single dose
Comments:

• Antibacterial agents used in high doses for short periods of time to treat nongonococcal urethritis may mask or delay symptoms of incubating syphilis or gonorrhea.
• No oral formulation (at the recommended dose) should be relied upon to treat syphilis; in addition, the oral suspension in the single dose packet (1 g) should not be relied upon to treat gonorrhea.
• All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing/cultures for gonorrhea at time of diagnosis; if infection is confirmed, appropriate antibacterial therapy and follow-up tests for these diseases should be started.

Use: For the treatment of mild to moderate urethritis and cervicitis due to Chlamydia trachomatis

US CDC Recommendations:

• Cervicitis and chlamydial infection: 1 g orally as a single dose
• Lymphogranuloma venereum: 1 g orally once a week for 3 weeks
• M genitalium cervicitis or urethritis: 1 g orally as initial dose, followed by 500 mg orally once a day for 3 additional days
• Nongonococcal urethritis: 1 g orally as a single dose OR 500 mg orally as a single dose on the first day, followed by 250 mg orally once a day for 4 days

Comments:

• Recommended as an alternative regimen for cervicitis
• Concurrent therapy for gonococcal infection should be considered if the patient is at risk for gonorrhea or lives in an area with high gonorrhea prevalence.
• Recommended as an alternative regimen for chlamydial infection among adults; recommended regimen for chlamydial infection during pregnancy
• Recommended as an alternative regimen for lymphogranuloma venereum due to C trachomatis
• This regimen has not been validated; a test of cure with C trachomatis nucleic acid amplification test 4 weeks after therapy completion can be considered.
• Recommended regimen after doxycycline if M genitalium resistance testing is available and M genitalium is macrolide sensitive
• Recommended as alternative regimens for nongonococcal urethritis
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Chancroid

1 g orally as a single dose
Comments:

• Due to the low number of women included in clinical trials, the efficacy of this drug in the treatment of chancroid in female patients has not been established.
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Use: For the treatment of genital ulcer disease in men due to Haemophilus ducreyi (chancroid)

Usual Adult Dose for Pelvic Inflammatory Disease

IV: 500 mg IV once a day for 1 or 2 days
Oral: After IV therapy, 250 mg orally once a day to complete a 7-day course of therapy
Comments:

• Antimicrobial drugs with anaerobic activity should be used concurrently if anaerobic microorganisms are suspected of contributing to the infection.
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.

Use: For the treatment of pelvic inflammatory disease due to C trachomatis, N gonorrhoeae, or M hominis in patients who require initial IV therapy

Usual Adult Dose for Bronchitis

For 3-day regimen: 500 mg orally once a day for 3 days
For 5-day regimen: 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 through 5

Use: For the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to H influenzae, M catarrhalis, or S pneumoniae

Usual Adult Dose for Mycobacterium avium-intracellulare - Prophylaxis

1200 mg orally once a week
Use: Alone or in combination with rifabutin (at its approved dose), for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection

The Panel Recommendations:

• Primary prophylaxis: 1200 mg orally once a week OR 600 mg orally twice a week
• Chronic maintenance therapy: 500 to 600 mg orally once a day

Comments:

• Recommended as preferred regimen for preventing the first episode of disseminated MAC disease (primary prophylaxis) in patients not on fully suppressive antiretroviral therapy (ART) and CD4 count less than 50 cells/mm3 after ruling out disseminated MAC disease based on clinical assessment
• Primary prophylaxis may be discontinued with the initiation of effective ART.
• With ethambutol, recommended as a preferred regimen for chronic maintenance therapy (secondary prophylaxis) of MAC disease when drug interactions/intolerance preclude use of clarithromycin
• Chronic maintenance therapy may be discontinued after completion of at least 12 months of therapy, no signs/symptoms of MAC disease, and CD4 count greater than 100 cells/mm3 sustained (more than 6 months) in response to ART; secondary prophylaxis should be restarted if CD4 drops below 100 cells/mm3.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Mycobacterium avium-intracellulare - Treatment

600 mg orally once a day
Comments:

• Other antimycobacterial drugs with in vitro activity against MAC may be added to this regimen at the health care provider's discretion.

Use: In combination with ethambutol, for the treatment of disseminated MAC infections in patients with advanced HIV infection

American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and IDSA Recommendations:

• MAC:
• Cavitary and refractory: 250 to 500 mg orally once a day
• Nodular-bronchiectatic: 500 mg orally 3 times a week
• M kansasii: 250 to 500 mg orally once a day OR 500 mg orally 3 times a week
• M xenopi and M abscessus: 250 to 500 mg orally once a day

The Panel Recommendations: 500 to 600 mg orally once a day
Comments:

• ATS, ERS, ESCMID, and IDSA: In combination with 2 or more drugs, recommended as part of preferred regimens for MAC, M kansasii, M xenopi, and M abscessus pulmonary disease
• The Panel: With ethambutol, recommended as a preferred regimen to treat disseminated MAC disease when drug interactions/intolerance preclude use of clarithromycin
• Testing of drug susceptibility is recommended.
• At least 2 drugs are recommended as initial therapy to prevent/delay emergence of resistance.
• Chronic suppressive therapy (secondary prophylaxis) is recommended after initial therapy.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Mycobacterium kansasii

600 mg orally once a day

Comments:

• Other antimycobacterial drugs with in vitro activity against MAC may be added to this regimen at the health care provider's discretion.

Use: In combination with ethambutol, for the treatment of disseminated MAC infections in patients with advanced HIV infection

American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and IDSA Recommendations:

• MAC:
• Cavitary and refractory: 250 to 500 mg orally once a day
• Nodular-bronchiectatic: 500 mg orally 3 times a week
• M kansasii: 250 to 500 mg orally once a day OR 500 mg orally 3 times a week
• M xenopi and M abscessus: 250 to 500 mg orally once a day

The Panel Recommendations: 500 to 600 mg orally once a day
Comments:

• ATS, ERS, ESCMID, and IDSA: In combination with 2 or more drugs, recommended as part of preferred regimens for MAC, M kansasii, M xenopi, and M abscessus pulmonary disease
• The Panel: With ethambutol, recommended as a preferred regimen to treat disseminated MAC disease when drug interactions/intolerance preclude use of clarithromycin
• Testing of drug susceptibility is recommended.
• At least 2 drugs are recommended as initial therapy to prevent/delay emergence of resistance.
• Chronic suppressive therapy (secondary prophylaxis) is recommended after initial therapy.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Granuloma Inguinale

US CDC Recommendations: 1 g orally once a week OR 500 mg orally once a day for greater than 3 weeks and until all lesions have completely healed
Comments:

• Recommended regimen for granuloma inguinale (donovanosis) due to Klebsiella granulomatis
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Pertussis Prophylaxis

American Society for Blood and Marrow Transplantation (ASBMT) Recommendations:

• Immunization against pertussis: 250 mg orally once a day
• Postexposure prophylaxis: 500 mg orally for 1 day, then 250 mg orally once a day for 4 days

Comments:

• Recommended as an alternative for immunization against pertussis for hematopoietic cell transplantation (HCT) recipients with an incomplete vaccination series
• Recommended as the first choice for postexposure prophylaxis for HCT recipients, regardless of vaccination status
• Patients should receive the acellular pertussis vaccine after HCT.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Pertussis

American Society for Blood and Marrow Transplantation (ASBMT) Recommendations:

• Immunization against pertussis: 250 mg orally once a day
• Postexposure prophylaxis: 500 mg orally for 1 day, then 250 mg orally once a day for 4 days

Comments:

• Recommended as an alternative for immunization against pertussis for hematopoietic cell transplantation (HCT) recipients with an incomplete vaccination series
• Recommended as the first choice for postexposure prophylaxis for HCT recipients, regardless of vaccination status
• Patients should receive the acellular pertussis vaccine after HCT.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans

IDSA, American Academy of Neurology (AAN), and American College of Rheumatology (ACR) Recommendations: 500 mg orally once a day
Duration of therapy: 7 days (range: 5 to 10 days)
Comments:

• Recommended as an alternative agent for solitary and multiple erythema migrans
• Due to concerns for lower efficacy, macrolide antibiotics (including this drug) are considered second-line agents, and should be reserved for patients in whom other antibiotic classes are contraindicated.
• This drug has not been adequately studied for manifestations of Lyme disease other than erythema migrans.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Babesiosis

IDSA Recommendations:
Ambulatory patients (mild to moderate disease): 500 mg orally on day 1, followed by 250 mg orally every 24 hours
Duration of therapy: 7 to 10 days in immunocompetent patients; often extended in immunocompromised patients

Hospitalized patients:

• Acute severe disease: 500 mg IV every 24 hours until symptoms abate, then should switch to all oral therapy (step-down therapy)
• For immunocompromised patients: 1000 mg orally (with other antibiotics) OR 1000 mg IV once followed by 500 mg IV once a day
• Step-down therapy (switch to oral therapy): 250 to 500 mg orally every 24 hours
• For immunocompromised patients: 500 to 1000 mg orally every 24 hours should be considered

Total duration of therapy (acute disease plus step-down therapy): 7 to 10 days

• For immunocompromised patients: At least 6 consecutive weeks (including 2 final weeks with no parasites detected on peripheral blood smear)

Refractory infections: 500 to 1000 mg orally once a day should be considered
Comments:

• With atovaquone, recommended as preferred treatment regimens for babesiosis patients
• With atovaquone plus clindamycin (with or without quinine), recommended for refractory Babesia infections (limited evidence of efficacy)
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Bacterial Endocarditis Prophylaxis

American Heart Association (AHA) Recommendations: 500 mg orally as a single dose 30 to 60 minutes before procedure
Comments:

• Recommended regimen for a dental procedure in patients allergic to penicillins or ampicillin
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Campylobacter Gastroenteritis

The Panel Recommendations: 500 mg orally once a day for 5 days
Comments:

• Recommended as an alternative regimen (depending on susceptibility results) to treat gastroenteritis due to Shigella infection
• Recommended as a preferred regimen to treat mild to moderate gastroenteritis due to Campylobacter infection
• This drug is not recommended for Shigella or Campylobacter bacteremia.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Shigellosis

The Panel Recommendations: 500 mg orally once a day for 5 days
Comments:

• Recommended as an alternative regimen (depending on susceptibility results) to treat gastroenteritis due to Shigella infection
• Recommended as a preferred regimen to treat mild to moderate gastroenteritis due to Campylobacter infection
• This drug is not recommended for Shigella or Campylobacter bacteremia.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Bacterial Infection

ASBMT Recommendations: 250 mg orally once a day
Comments:

• Recommended as an alternative for prevention of bacterial infections during the first 100 days after HCT for patients with anticipated neutropenic periods of at least 7 days
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Syphilis - Early

The Panel Recommendations: 2 g orally as a single dose
Comments:

• Recommended as an alternative regimen for penicillin-allergic patients for the treatment of early stage syphilis (primary, secondary, and early latent syphilis)
• Chromosomal mutations associated with resistance and treatment failures have been reported with this drug, most commonly in men who have sex with men (MSM); this drug should be used with caution and only when penicillin, doxycycline, or ceftriaxone therapy is not feasible.
• This drug is not recommended for MSM or pregnant patients.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Otitis Media

6 months or older:

• For 1-day regimen: 30 mg/kg orally as a single dose
• Maximum dose: 1500 mg/dose
• For 3-day regimen: 10 mg/kg orally once a day for 3 days
• Maximum dose: 500 mg/dose
• For 5-day regimen: 10 mg/kg orally as a single dose on day 1, followed by 5 mg/kg orally once a day on days 2 through 5
• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 through 5)

Comments:

• The safety of a redosing this drug in a patient who vomits after receiving 30 mg/kg as a single dose has not been established.

Use: For the treatment of mild to moderate acute otitis media due to H influenza, M catarrhalis, or S pneumoniae

Usual Pediatric Dose for Legionella Pneumonia

6 months or older: 10 mg/kg orally as a single dose on day 1, followed by 5 mg/kg orally once a day on days 2 through 5

• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 through 5)

16 years or older:
Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, require hospitalization, elderly, debilitated, or significant underlying health problem that may compromise ability to respond to illness (including immunodeficiency or functional asplenia).
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.
• Efficacy of the 3-day or 1-day oral regimen has not been established in pediatric patients with community-acquired pneumonia.

Uses:

• IV: For the treatment of community-acquired pneumonia due to C pneumoniae, H influenzae, L pneumophila, M catarrhalis, M pneumoniae, S aureus, or S pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

IDSA and Pediatric Infectious Diseases Society (PIDS) Recommendations for Infants and Children Older Than 3 Months:
Inpatient (all ages) and for specific pathogens:

• IV: 10 mg/kg IV on days 1 and 2 of therapy, then should transition to oral therapy if possible
• Oral (step-down therapy or mild infection): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5

Outpatient:

• Younger than 5 years (preschool): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• At least 5 years of age: 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 to 5)

Comments:

• Recommended as preferred therapy for community-acquired pneumonia due to M pneumoniae, C trachomatis, or C pneumoniae
• Recommended as empiric therapy for presumed atypical pneumonia in outpatient and inpatient settings
• Beta-lactam antibiotics may be added for inpatients with presumed atypical pneumonia if diagnosis is in doubt.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Mycoplasma Pneumonia

6 months or older: 10 mg/kg orally as a single dose on day 1, followed by 5 mg/kg orally once a day on days 2 through 5

• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 through 5)

16 years or older:
Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, require hospitalization, elderly, debilitated, or significant underlying health problem that may compromise ability to respond to illness (including immunodeficiency or functional asplenia).
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.
• Efficacy of the 3-day or 1-day oral regimen has not been established in pediatric patients with community-acquired pneumonia.

Uses:

• IV: For the treatment of community-acquired pneumonia due to C pneumoniae, H influenzae, L pneumophila, M catarrhalis, M pneumoniae, S aureus, or S pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

IDSA and Pediatric Infectious Diseases Society (PIDS) Recommendations for Infants and Children Older Than 3 Months:
Inpatient (all ages) and for specific pathogens:

• IV: 10 mg/kg IV on days 1 and 2 of therapy, then should transition to oral therapy if possible
• Oral (step-down therapy or mild infection): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5

Outpatient:

• Younger than 5 years (preschool): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• At least 5 years of age: 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 to 5)

Comments:

• Recommended as preferred therapy for community-acquired pneumonia due to M pneumoniae, C trachomatis, or C pneumoniae
• Recommended as empiric therapy for presumed atypical pneumonia in outpatient and inpatient settings
• Beta-lactam antibiotics may be added for inpatients with presumed atypical pneumonia if diagnosis is in doubt.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pneumonia

6 months or older: 10 mg/kg orally as a single dose on day 1, followed by 5 mg/kg orally once a day on days 2 through 5

• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 through 5)

16 years or older:
Patients who require initial IV therapy:

• IV: 500 mg IV once a day for at least 2 days
• Oral: After IV therapy, 500 mg orally once a day to complete a 7- to 10-day course of therapy

Comments:

• Limitations of Use: Oral formulations of this drug should not be used in patients with pneumonia who are considered inappropriate for oral therapy due to moderate to severe illness or risk factors such as: cystic fibrosis, nosocomial infections, known/suspected bacteremia, require hospitalization, elderly, debilitated, or significant underlying health problem that may compromise ability to respond to illness (including immunodeficiency or functional asplenia).
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.
• Efficacy of the 3-day or 1-day oral regimen has not been established in pediatric patients with community-acquired pneumonia.

Uses:

• IV: For the treatment of community-acquired pneumonia due to C pneumoniae, H influenzae, L pneumophila, M catarrhalis, M pneumoniae, S aureus, or S pneumoniae in patients who require initial IV therapy
• Oral: For the treatment of mild to moderate community-acquired pneumonia due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae in patients appropriate for oral therapy

IDSA and Pediatric Infectious Diseases Society (PIDS) Recommendations for Infants and Children Older Than 3 Months:
Inpatient (all ages) and for specific pathogens:

• IV: 10 mg/kg IV on days 1 and 2 of therapy, then should transition to oral therapy if possible
• Oral (step-down therapy or mild infection): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5

Outpatient:

• Younger than 5 years (preschool): 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• At least 5 years of age: 10 mg/kg orally on day 1, followed by 5 mg/kg orally once a day on days 2 to 5
• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (days 2 to 5)

Comments:

• Recommended as preferred therapy for community-acquired pneumonia due to M pneumoniae, C trachomatis, or C pneumoniae
• Recommended as empiric therapy for presumed atypical pneumonia in outpatient and inpatient settings
• Beta-lactam antibiotics may be added for inpatients with presumed atypical pneumonia if diagnosis is in doubt.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Tonsillitis/Pharyngitis

2 years or older: 12 mg/kg orally once a day for 5 days

• Maximum dose: 500 mg/dose

Use: For the treatment of mild to moderate pharyngitis/tonsillitis due to S pyogenes as an alternative to first-line therapy in patients who cannot use first-line therapy

Usual Pediatric Dose for Sinusitis

6 months or older: 10 mg/kg once a day for 3 days

• Maximum dose: 500 mg/dose

Comments:

• Efficacy of the 1-day or 5-day oral regimen has not been established in pediatric patients with acute bacterial sinusitis.

Use: Treatment of mild to moderate acute bacterial sinusitis due to H influenza, M catarrhalis, or S pneumoniae

Usual Pediatric Dose for Pelvic Inflammatory Disease

16 years or older:

• IV: 500 mg IV once a day for 1 or 2 days
• Oral: After IV therapy, 250 mg orally once a day to complete a 7-day course of therapy

Comments:

• Antimicrobial drugs with anaerobic activity should be used concurrently if anaerobic microorganisms are suspected of contributing to the infection.
• The IV formulation should be followed by the oral formulation as required.
• Patients should be switched from IV to oral therapy at the physician's discretion and according to clinical response.

Use: For the treatment of pelvic inflammatory disease due to C trachomatis, N gonorrhoeae, or M hominis in patients who require initial IV therapy

Usual Pediatric Dose for Skin and Structure Infection

IDSA Recommendations:

• Cat scratch disease:
• Weight less than 45 kg: 10 mg/kg orally on day 1, then 5 mg/kg orally once a day for 4 additional days
• Weight at least 45 kg: 500 mg orally on day 1, then 250 mg orally once a day for 4 additional days

The Panel Recommendations for Adolescents:

• Bartonella infections: 500 mg orally once a day for at least 3 months

Comments:

• Recommended for cat scratch disease
• Recommended as an alternative regimen for Bartonella infections (not for endocarditis or CNS infections) in adolescents with HIV
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bartonellosis

IDSA Recommendations:

• Cat scratch disease:
• Weight less than 45 kg: 10 mg/kg orally on day 1, then 5 mg/kg orally once a day for 4 additional days
• Weight at least 45 kg: 500 mg orally on day 1, then 250 mg orally once a day for 4 additional days

The Panel Recommendations for Adolescents:

• Bartonella infections: 500 mg orally once a day for at least 3 months

Comments:

• Recommended for cat scratch disease
• Recommended as an alternative regimen for Bartonella infections (not for endocarditis or CNS infections) in adolescents with HIV
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Gonococcal Infection - Uncomplicated

US CDC Recommendations for Adolescents: 2 g orally as a single dose
Comments:

• With gentamicin, recommended as an alternative regimen for uncomplicated gonococcal infections of the cervix, urethra, or rectum if ceftriaxone is not available
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Chlamydia Infection

US CDC Recommendations:

• Infants 1 to 3 months:
• Oral suspension: 20 mg/kg orally once a day for 3 days
• Children younger than 8 years weighing at least 45 kg and children 8 years or older: 1 g orally as a single dose
• Adolescents: 1 g orally as a single dose

Comments:

• Recommended as an alternative regimen for chlamydial pneumonia among infants
• Recommended regimen for chlamydial infection among children
• Limited data available regarding efficacy and optimal dose for treating chlamydial infection among infants and children weighing less than 45 kg.
• Recommended as an alternative regimen for chlamydial infection among adolescents
• The patient's sexual partner(s) should also be evaluated/treated.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Prophylaxis

The Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children Recommendations:
Primary prophylaxis:

• First choice: 20 mg/kg orally once a week
• Maximum dose: 1200 mg/dose
• Alternative: 5 mg/kg orally once a day
• Maximum dose: 250 mg/dose

Secondary prophylaxis: 5 mg/kg orally once a day

• Maximum dose: 250 mg/dose

The Panel Recommendations for Adolescents:

• Primary prophylaxis: 1200 mg orally once a week OR 600 mg orally twice a week
• Chronic maintenance therapy: 500 to 600 mg orally once a day

Comments:

• Children: Recommended as a first choice and an alternative regimen for primary prophylaxis of MAC disease in patients with advanced immunosuppression (younger than 1 year with CD4 count less than 750 cells/mm3; 1 to less than 2 years with CD4 count less than 500 cells/mm3; 2 to less than 6 years with CD4 count less than 75 cells/mm3; at least 6 years with CD4 count less than 50 cells/mm3)
• Primary prophylaxis should not be discontinued in children younger than 2 years.
• After at least 6 months of ART, primary prophylaxis may be discontinued if CD4 count is greater than 200 and 100 cells/mm3 for more than 3 consecutive months in children 2 to less than 6 years and children at least 6 years, respectively; if CD4 count drops below 200 and 100 cells/mm3 in the respective age ranges, primary prophylaxis should be restarted.
• Children: With ethambutol, recommended as an alternative regimen for secondary prophylaxis (chronic suppressive therapy) of MAC disease in patients with prior disease
• After at least 6 months of ART, at least 12 months of MAC therapy, and asymptomatic for signs/symptoms of MAC, secondary prophylaxis may be discontinued if CD4 count is greater than 200 and 100 cells/mm3 for at least 6 consecutive months in children 2 to less than 6 years and children at least 6 years, respectively; if CD4 count drops below 200 and 100 cells/mm3 in the respective age ranges, secondary prophylaxis should be restarted.
• Adolescents: Recommended as a preferred regimen for preventing the first episode of disseminated MAC disease (primary prophylaxis) in patients not on fully suppressive ART and CD4 count less than 50 cells/mm3 after ruling out disseminated MAC disease based on clinical assessment
• Primary prophylaxis may be discontinued with the initiation of effective ART.
• Adolescents: With ethambutol, recommended as a preferred regimen for chronic maintenance therapy (secondary prophylaxis) of MAC disease when drug interactions/intolerance preclude use of clarithromycin
• Chronic maintenance therapy may be discontinued after completion of at least 12 months of therapy, no signs/symptoms of MAC disease, and CD4 count greater than 100 cells/mm3 sustained (more than 6 months) in response to ART; secondary prophylaxis should be restarted if CD4 drops below 100 cells/mm3.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Treatment

The Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children Recommendations: 10 to 12 mg/kg orally once a day for at least 12 months

• Maximum dose: 500 mg/dose

The Panel Recommendations for Adolescents: 500 to 600 mg orally once a day
Comments:

• Children: With ethambutol, recommended as an alternative initial regimen for the treatment of MAC disease if intolerant to clarithromycin
• Adolescents: With ethambutol, recommended as a preferred regimen to treat disseminated MAC disease when drug interactions/intolerance preclude use of clarithromycin
• Testing of drug susceptibility is recommended.
• At least 2 drugs are recommended as initial therapy to prevent/delay emergence of resistance.
• Chronic suppressive therapy (secondary prophylaxis) is recommended after initial therapy.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pertussis Prophylaxis

ASBMT Recommendations:

• Immunization against pertussis: 5 mg/kg orally once a day
• Maximum dose: 250 mg/dose
• Postexposure prophylaxis: 10 mg/kg orally as a loading dose, then 5 mg/kg orally once a day for 4 days
• Maximum dose: 500 mg/dose (loading dose); 250 mg/dose (following doses)

Comments:

• Recommended as an alternative for immunization against pertussis for HCT recipients with an incomplete vaccination series
• Recommended as the first choice for postexposure prophylaxis for HCT recipients, regardless of vaccination status
• Patients should receive the acellular pertussis vaccine after HCT.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pertussis

ASBMT Recommendations:

• Immunization against pertussis: 5 mg/kg orally once a day
• Maximum dose: 250 mg/dose
• Postexposure prophylaxis: 10 mg/kg orally as a loading dose, then 5 mg/kg orally once a day for 4 days
• Maximum dose: 500 mg/dose (loading dose); 250 mg/dose (following doses)

Comments:

• Recommended as an alternative for immunization against pertussis for HCT recipients with an incomplete vaccination series
• Recommended as the first choice for postexposure prophylaxis for HCT recipients, regardless of vaccination status
• Patients should receive the acellular pertussis vaccine after HCT.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Lyme Disease - Erythema Chronicum Migrans

IDSA, AAN, and ACR Recommendations for Children: 10 mg/kg orally once a day

• Maximum dose: 500 mg/dose

Duration of therapy: 7 days (range: 5 to 10 days)
Comments:

• Recommended as an alternative agent for solitary and multiple erythema migrans
• Due to concerns for lower efficacy, macrolide antibiotics (including this drug) are considered second-line agents, and should be reserved for patients in whom other antibiotic classes are contraindicated.
• This drug has not been adequately studied for manifestations of Lyme disease other than erythema migrans.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Babesiosis

IDSA Recommendations:
Ambulatory patients (mild to moderate disease): 10 mg/kg orally on day 1, followed by 5 mg/kg orally every 24 hours

• Maximum dose: 500 mg/dose (day 1); 250 mg/dose (the following days)

Duration of therapy: 7 to 10 days in immunocompetent patients; often extended in immunocompromised patients

Hospitalized patients:

• Acute severe disease: 10 mg/kg IV every 24 hours until symptoms abate, then should switch to all oral therapy (step-down therapy)
• Maximum dose: 500 mg/dose
• Step-down therapy (switch to oral therapy): 5 to 10 mg/kg orally every 24 hours
• Maximum dose: 500 mg/dose

Total duration of therapy (acute disease plus step-down therapy): 7 to 10 days
Comments:

• With atovaquone, recommended as preferred treatment regimens for babesiosis patients
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis

AHA Recommendations for Children: 15 mg/kg orally as a single dose 30 to 60 minutes before procedure
Maximum dose: 500 mg/dose
Comments:

• Recommended regimen for a dental procedure in patients allergic to penicillins or ampicillin
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Campylobacter Gastroenteritis

The Panel Recommendations for Adolescents: 500 mg orally once a day for 5 days
Comments:

• Recommended as an alternative regimen (depending on susceptibility results) to treat gastroenteritis due to Shigella infection
• Recommended as a preferred regimen to treat mild to moderate gastroenteritis due to Campylobacter infection
• This drug is not recommended for Shigella or Campylobacter bacteremia.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Shigellosis

The Panel Recommendations for Adolescents: 500 mg orally once a day for 5 days
Comments:

• Recommended as an alternative regimen (depending on susceptibility results) to treat gastroenteritis due to Shigella infection
• Recommended as a preferred regimen to treat mild to moderate gastroenteritis due to Campylobacter infection
• This drug is not recommended for Shigella or Campylobacter bacteremia.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Syphilis - Early

The Panel Recommendations for Adolescents: 2 g orally as a single dose
Comments:

• Recommended as an alternative regimen for penicillin-allergic patients for the treatment of early stage syphilis (primary, secondary, and early latent syphilis)
• Chromosomal mutations associated with resistance and treatment failures have been reported with this drug, most commonly in MSM; this drug should be used with caution and only when penicillin, doxycycline, or ceftriaxone therapy is not feasible.
• This drug is not recommended for MSM or pregnant patients.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available
Comments:

• This drug should be discontinued immediately if signs/symptoms of hepatitis occur.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component, erythromycin, any macrolide, or ketolide drug
• History of cholestatic jaundice/hepatic dysfunction associated with prior use of this drug

IV therapy: Safety and efficacy have not been established in patients younger than 16 years.
Oral therapy:

• Otitis media, acute bacterial sinusitis, and community-acquired pneumonia: Safety and efficacy have not been established in patients younger than 6 months.
• Tonsillitis/pharyngitis: Safety and efficacy have not been established in patients younger than 2 years.
• Prevention or treatment of MAC: Safety and efficacy have not been established in HIV-infected patients younger than 18 years.
• Oral suspension in the single dose packet (1 g): Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Chemically Structure: 

Other Comments

Administration advice:
IV Administration:

• Administer by IV infusion only, over at least 60 minutes; do not administer as an IM injection or an IV bolus.
• The concentration and infusion rate should be 1 mg/mL over 3 hours or 2 mg/mL over 1 hour.
• Other IV substances, additives, or medications should not be added to this product, or infused simultaneously through the same IV line.

Oral Administration:

• The oral suspensions and most tablets: Administer with or without food.
• The 600 mg tablets: For increased tolerability, administer with food.
• Oral suspension in bottle: Shake well before each use; use within 10 days. Discard after full dosing is completed.
• Oral suspension in the single dose packet (1 g): After mixing the entire contents of the packet with water (2 ounces [about 60 mL]), mix thoroughly and drink the entire contents immediately; add an additional 2 ounces of water, mix, and drink to ensure complete consumption of dosage.
• Do not administer this drug concurrently with antacids containing aluminum or magnesium.

Storage requirements:

• IV formulation: Before reconstitution, store vials at or below 30C (86F); when diluted according to the instructions, the solution is stable for 24 hours at or below room temperature 30C (86F), or for 7 days if stored under refrigeration 5C (41F).
• Oral formulations:
• Oral suspension in bottle: Store dry powder below 30C (86F); store constituted suspension between 5C to 30C (41F to 86F) and keep tightly closed. Discard when full dosing is completed.
• Oral suspension in the single dose packet (1 g): Stored below 30C (86F).
• Tablets: Store between 15C to 30C (59F to 86F).

Reconstitution/preparation techniques:

• Injection: After reconstitution, the solution must be further diluted before administration.
• Oral suspensions: These products require constitution before use.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile Water for Injection, Normal Saline (0.9% sodium chloride), 1/2 Normal Saline (0.45% sodium chloride), 5% Dextrose in Water, Lactated Ringer's Solution, 5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride) with 20 mEq potassium chloride, 5% Dextrose in Lactated Ringer's Solution, 5% Dextrose in 1/3 Normal Saline (0.3% sodium chloride), 5% Dextrose in 1/2 Normal Saline (0.45% sodium chloride), Normosol-M in 5% Dextrose, Normosol-R in 5% Dextrose

General:

• The IV formulation is indicted for the treatment of patients with infections due to susceptible strains of the designated microorganisms in the specified conditions; the oral formulations are indicated similarly, but limited to mild to moderate infections.
• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Avoid missing doses and complete the entire course of therapy.
• Discontinue this drug immediately and contact physician if any signs of an allergic reaction occur.
• Contact physician if vomiting and irritability with feeding occur in an infant administered this drug.
• Contact health care provider at once if watery and bloody stools (with or without stomach cramps and fever) develop.