Acnelak Gel injection is used to treat bacterial infections in many different parts of the body. It is also used to treat diphtheria, acute pelvic inflammatory disease, and Legionnaire's disease. Acnelak Gel is also used to prevent bacterial endocarditis and rheumatic fever to occur again in patients who have had an allergic reaction to penicillin or sulfa drugs.
Acnelak Gel belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Acnelak Gel will not work for colds, flu, or other virus infections.
Acnelak Gel is to be given only by or under the direct supervision of a doctor.
Acnelak Gel indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Acnelak Gel Base Filmtab tablets and other antibacterial drugs, Acnelak Gel Base Filmtab (Acnelak Gel tablets) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Acnelak Gel Base Filmtab (Acnelak Gel tablets) tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the Acnelak Gel concentrations ordinarily achieved).
Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae.
Listeriosis caused by Listeria monocytogenes.
Respiratory tract infections due to Mycoplasma pneumoniae.
Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).
Pertussis (whooping cough) caused by Bordetella pertussis. Acnelak Gel is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that Acnelak Gel may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma-In the treatment of infections due to Corynebacterium minutissimum.
Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.
Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (Acnelak Gel lactobionate for injection, USP) followed by Acnelak Gel base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving Acnelak Gel as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.
Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, Acnelak Gel is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.
How should I use Acnelak Gel?
Use Acnelak Gel ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
Acnelak Gel ointment may be used around the eye or in the eye. To use Acnelak Gel ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Acnelak Gel ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
Acnelak Gel ointment works best if it is used at the same time each day.
If more than one infant is being treated, use a new tube for each infant.
Do not wear contact lenses while you are using Acnelak Gel ointment. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
To clear up your infection completely, use Acnelak Gel ointment for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Acnelak Gel ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Acnelak Gel ointment.
Uses of Acnelak Gel in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Bacterial infections: Treatment of susceptible bacterial infections, including S. pyogenes, some S. pneumoniae, some S. aureus, M. pneumoniae, Legionella pneumophila, diphtheria, pertussis, Chlamydia, erythrasma, N. gonorrhoeae, E. histolytica, syphilis and nongonococcal urethritis, and Campylobacter gastroenteritis; used in conjunction with neomycin for decontaminating the bowel
Surgical (preoperative) prophylaxis (colorectal): Colorectal decontamination, in conjunction with other agents, prior to surgical intervention
Off Label Uses
Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, oral Acnelak Gel, in combination with topical therapy, may be considered as a treatment option for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. However, its use should be restricted due to an increased risk of bacterial resistance and limited to patients who cannot receive a tetracycline (ie, pregnant women). Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, oral Acnelak Gel) and continued for maintenance after the oral antibiotic course is completed.
Bartonella spp. infections (treatment)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Acnelak Gel may be considered for the treatment of cutaneous bacillary angiomatosis. Guidelines state that therapy has not been systematically examined and Acnelak Gel appears effective based on case reports and small series.
Data from a study with a limited number of patients suggest that Acnelak Gel may be beneficial for the treatment of Bartonella spp infections.
Based on the American College of Gastroenterology (ACG) guidelines for the management of gastroparesis, Acnelak Gel is effective and recommended for the management of gastroparesis.
Granuloma inguinale (donovanosis)
Based on Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Acnelak Gel (base) is effective and recommended for the treatment of granuloma inguinale when azithromycin is not appropriate.
Acnelak Gel description
Acnelak Gel A is a bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Acnelak Gel A A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.
Acnelak Gel dosage
In most patients, PCE tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when either PCE 333 mg or PCE 500 mg tablets are given in the fasting state (at least ½ hour and preferably 2 hours before meals).
The usual dosage of PCE tablets are one 333 mg tablet every 8 hours or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of Acnelak Gel should be administered for at least ten days.
The American Heart Association suggests a dosage of 250 mg of Acnelak Gel orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.
30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae
500 mg Erythrocin Lactobionate-I.V. (Acnelak Gel lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of Acnelak Gel base orally every 12 hours, or 333 mg of Acnelak Gel base orally every 8 hours for 7 days.
500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.
30 to 50 mg/kg/day in divided doses for 10 to 14 days.
Although optimal dosage and duration have not been established, doses of Acnelak Gel utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
PCE tablets (Acnelak Gel particles in tablets) are supplied as unscored, ovaloid tablets in the following strengths and packages.
Acnelak Gel A use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant Acnelak Gel therapy.
Concomitant administration of Acnelak Gel and digoxin has been reported to result in elevated digoxin serum levels. There have been reports of increased anticoagulant effects when Acnelak Gel and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of Acnelak Gel with various oral anticoagulents may be more pronounced in the elderly.
Concurrent use of Acnelak Gel and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
Acnelak Gel A has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of these benzodiazepines.
The use of Acnelak Gel in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of Acnelak Gel with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, cisapride, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, and astemizole. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving Acnelak Gel.
Acnelak Gel A has been reported to significantly alter the metabolism of nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias have been observed. In addition, deaths have been reported rarely with concomitant administration of terfenadine and Acnelak Gel.
There have been postmarketing reports of drug interactions when Acnelak Gel is coadministered with cisapride, resulting in QT prolongation, cardiac arrythmias, ventricular tachycardia, ventricular fibrulation, and torsades de pointes, most like due to inhibition of hepatic metabolism of cisapride by Acnelak Gel. Fatalities have been reported.
Patients receiving concomitant lovastatin and Acnelak Gel should be carefully monitored; cases of rhabdomyolysis have been reported in seriously ill patients.
As well as its needed effects, Acnelak Gel (the active ingredient contained in Acnelak Gel) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Acnelak Gel, check with your doctor immediately:
Blistering, peeling, or loosening of the skin
difficulty with swallowing
hives or welts
joint or muscle pain
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red, irritated eyes
red skin lesions, often with a purple center
redness of the skin
sores, ulcers, or white spots in the mouth or on the lips
tightness in the chest
unusual tiredness or weakness
Incidence not known:
Abdominal or stomach cramps or tenderness
bloody or cloudy urine
chest pain or discomfort
diarrhea, watery and severe, which may also be bloody
general tiredness and weakness
greatly decreased frequency of urination or amount of urine
irregular heartbeat recurrent
irregular or slow heart rate
nausea and vomiting
swelling of the feet or lower legs
unusual weight loss
upper right abdominal or stomach pain
yellow eyes and skin
Minor Side Effects
Some Acnelak Gel side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
You should not take Acnelak Gel if you are allergic to it, or if you are also using cisapride (Propulsid), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), or pimozide (Orap). Acnelak Gel may interact with these medicines and could cause dangerous or life-threatening heart rhythm disorders.
Before you take Acnelak Gel, tell your doctor if you have liver disease, myasthenia gravis, a heart rhythm disorder, a history of Long QT syndrome, or low levels of potassium or magnesium in your blood.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Acnelak Gel will not treat a viral infection such as the common cold or flu.
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 Acnelak Gel and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
DailyMed. "ERYTHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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