Resistance to Galemin axetil is primarily through hydrolysis by β-lactamase, alteration of penicillin-binding proteins (PBPs), decreased permeability, and the presence of bacterial efflux pumps.
Susceptibility to Galemin axetil will vary with geography and time; local susceptibility data should be consulted, if available. Beta-lactamase-negative, ampicillin-resistant (BLNAR) isolates of H. influenzae should be considered resistant to Galemin axetil.
Galemin axetil has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections :
What are the possible side effects of Galemin (Ceftin)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- jaundice (yellowing of the skin or eyes);
- skin rash, bruising, severe tingling, or numbness;
- seizure (black-out or convulsions);
- kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
- severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
- nausea, vomiting;
- unusual or unpleasant taste in your mouth; or
- diaper rash in an infant taking liquid Galemin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, CEFTIN should be used during pregnancy only if clearly needed.
Reproduction studies have been performed in mice at doses up to 3,200 mg/kg/day (14 times the recommended maximum human dose based on body surface area) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to Galemin axetil.
What is the dosage for Galemin?
Typical adult oral doses are 250 or 500 mg twice daily for 7-20 days depending on the type and severity of the infection. A single 1000 mg dose may be used for uncomplicated gonorrhea. The tablets and suspension are not interchangeable.
¿Cómo debo tomar Galemin?
Siga todas las instrucciones en la etiqueta de su prescripción. No tome esta medicina en cantidades mayores o menores, o por más tiempo de lo recomendado.
Usted puede tomar las tabletas de Galemin con o sin comidas. No triture la tableta o puede que tenga un sabor amargo desagradable.
Galemin suspensión oral(líquida) debe tomarse con comida.
Agite bien el líquido antes de medir una dosis. Mida la medicina líquida con la jeringa de medición que viene con su medicina, o con una cuchara o taza de medición especial. Si no tiene con qué medir la dosis de su medicina, pídale una cuchara o taza de medición a su farmacéutico.
Si usted cambia de tabletas a usar la suspensión líquida oral de Galemin, usted tal vez no necesite usar la misma cantidad de miligramos. Esta medicina puede ser no tan efectiva a menos que usted use la forma y fuerza exacta que le prescribió su médico.
Use esta medicina por el tiempo completo que su médico se la prescribió. Sus síntomas pueden mejorar antes de que la infección esté completamente curada. Saltarse dosis también puede aumentar su riesgo de infección adicional que será resistente a antibióticos. Galemin no cura una infección viral como la gripe o el resfrío común.
Esta medicina puede causar resultados inusuales en ciertas pruebas de laboratorio que miden la glucosa (azúcar) en la orina. Dígale a cualquier médico que lo atiende que usted está usando Galemin.
Guarde las tabletas de Galemin en temperatura ambiente lejos de la humedad y el calor. Mantenga el envase bien cerrado cuando no lo use.
Guarde la suspensión líquida en la refrigeradora. No congele. Bote cualquier sobrante de la medicina después de 10 días.
What is the most important information I should know about Galemin?
You should not use this medicine if you are allergic to Galemin or to similar antibiotics, such as cefdinir (Omnicef), cefprozil (Cefzil), cephalexin (Keflex), and others.
WHAT IS Galemin?
Galemin is an antibiotic in a class of drugs called cephalosporins. This medicine fights bacteria in the body.
Galemin is used to treat many different types of bacterial infections such as bronchitis, sinusitis, tonsillitis, ear infections, skin infections, gonorrhea, and urinary tract infections.
How should I take Galemin?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Galemin tablets with or without meals. Do not crush the tablet or it could have an unpleasant bitter taste.
Galemin oral suspension (liquid) must be taken with food.
Shake the 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.
If you switch from using the tablet form to using the liquid form of Galemin, you may not need to use the same exact dosage in number of milligrams. This medicine may not be as effective unless you use the exact form and strength your doctor has prescribed.
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. Galemin will not treat a viral infection such as the flu or a common cold.
This medicine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Galemin.
Store Galemin tablets at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Store Galemin liquid in the refrigerator. Do not allow it to freeze. Throw away any unused Galemin liquid that is older than 10 days.
Important: if you develop an itchy rash, or a swollen face or mouth, or have difficulty breathing, these can be signs that you are allergic to the antibiotic. Do not take any more Galemin and speak with your doctor or go to your local accident and emergency department straightaway.
If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist for further advice.
Two adequate and well-controlled trials were performed in subjects with early Lyme disease. All subjects presented with physician-documented erythema migrans, with or without systemic manifestations of infection. Subjects were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).
A total of 355 adult subjects (181 treated with Galemin axetil and 174 treated with doxycycline) were randomized in the 2 trials, with diagnosis of early Lyme disease confirmed in 79% (281/355). The clinical diagnosis of early Lyme disease in these subjects was validated by 1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion, and 2) serologic confirmation (using enzyme-linked immunosorbent assay and immunoblot assay ) of the presence of antibodies specific to Borrelia burgdorferi, the etiologic agent of Lyme disease. The efficacy data in Table 13 are specific to this “validated” patient subset, while the safety data below reflect the entire patient population for the 2 trials. Clinical data for evaluable subjects in the “validated” patient subset are shown in Table 13.
Table 13: Clinical Effectiveness of CEFTIN Tablets Compared with Doxycycline in the Treatment of Early Lyme Disease
CEFTIN and doxycycline were effective in prevention of the development of sequelae of late Lyme disease.
While the incidence of drug-related gastrointestinal adverse reactions was similar in the 2 treatment groups (Galemin axetil - 13%; doxycycline - 11%), the incidence of drug-related diarrhea was higher in the Galemin axetil arm versus the doxycycline arm (11% versus 3%, respectively).
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. 2015. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing for Infrequently Isolated or Fastidious Bacteria: Approved Guidelines - Second Edition. 2010. CLSI document M45-A2, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. 2015. CLSI document M100- S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard - Twelfth Edition. 2015. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
The sections below will provide you with more specific information and guidelines related to Galemin and its correct use. Please read them carefully.
Galemin was approved by the US FDA in December 1987. A prescription is required for this medicine.
Please visit the official site of the FDA for further information.
Why is this medication prescribed?
Galemin is a semisynthetic cephalosporin antibiotic, chemically similar to penicillin. It works by stopping the growth of bacteria.
Galemin is effective against susceptible bacterias causing infections of the middle ear, tonsillitis, throat infections, laryngitis, bronchitis, and pneumonia. It is also used in treating urinary tract infections, skin infections, and gonorrhea.
Additionally, it is useful in treating acute bacterial bronchitis in patients with chronic obstructive pulmonary disease (COPD).
Note: Galemin will not work for colds, flu, or other viral infections.
Other uses for this medicine
This medication has not been approved for any alternative uses other than those mentioned in the product information section.
Dosage and using this medicine
Galemin comes as a tablet and a suspension (liquid) to be taken orally. It is usually taken every 12 hours (twice a day) for 7-10 days.
Take this medication exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. This medicine can be taken on an empty stomach or with food or milk if it causes stomach upset.
To ensure that you get the correct dose, measure the liquid form of Galemin with a dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Shake the suspension well before measuring a dose.
Take this medicine at evenly spaced intervals to keep a constant level of drug in the body. It is important to take Galemin regularly to get the most benefit.
Take all of the Galemin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.
What special precautions should I follow?