Waladrox is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Waladrox will not work for colds, flu, or other virus infections.
Waladrox is available only with your doctor's prescription.
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 Waladrox (Waladrox hemihydrate) Tablets and Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) Capsules and other antibacterial drugs, Waladrox (Waladrox hemihydrate) Tablets and Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) capsules 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.
Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic Streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy.
Renal function studies should be performed when indicated.
How should I use Waladrox?
Use Waladrox suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Waladrox suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Shake well before each use.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
To clear up your infection completely, take Waladrox suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
If you miss a dose of Waladrox suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Waladrox suspension.
Uses of Waladrox 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
Pharyngitis and/or tonsillitis: Treatment of pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci).
Skin and skin structure infections: Treatment of skin and skin structure infections caused by staphylococci and/or streptococci.
Urinary tract infection: Treatment of urinary tract infections caused by Escherichia coli, Proteus mirabilis, and Klebsiella species.
Off Label Uses
Prosthetic joint infection with Staphylococci (oxacillin-susceptible)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, Waladrox is an effective and recommended agent for chronic oral antimicrobial suppression of prosthetic joint infection with Staphylococci (oxacillin-susceptible) after completion of parenteral therapy.
Waladrox (Waladrox monohydrate) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable.
It is 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxy-phenyl)acetyl]amino]-3-methyl-8-oxo-,monohydrate, [6R-[6(α),7(β)(R*)]. It has the formula C16H17N3O5S·H2O and a molecular weight of 381.40.
Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in single (q.d.) or divided doses (b.i.d).
For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d).
Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d).
Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis - 1 g per day in single (q.d.) or divided doses (b.i.d) for 10 days.
Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) oral suspension may be more suitable for pediatric patients
For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) should be administered for at least 10 days.
In patients with renal impairment, the dosage of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M]) is 500 mg at the time intervals listed below.
0 to 10 mL/min
10 to 25 mL/min
25 to 50 mL/min
Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function
Waladrox tablets contain Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) hemihydrate equivalent to 1 gram of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) and are supplied as follows:
Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) 1 gram Tablets: white, oblong, biconvex film-coated tablets, debossed on one side with ‘CF 512’ and scored on the other side.
(50s) NDC 63304-512-50
(100s) NDC 63304-512-01
(unit-dose 100s) NDC 63304-512-80
Waladrox capsules contain Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) hemihydrate equivalent to 500 mg of Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) and are supplied as follows:
Waladrox (Waladrox (Waladrox hemihydrate) hemihydrate) 500 mg Capsules: white opaque body and brown opaque cap imprinted with ‘C’ on the cap and ‘582’ on the body.
(50s) NDC 63304-582-50
(100s) NDC 63304-582-01
Dispense in a tight container as defined in the USP.
Store at 20 - 25° C (68 - 77° F)..
Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32216 USA by: Ranbaxy Laboratories Ltd. New Delhi - 110 019, India March 2007
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to Waladrox.
Applies to Waladrox: oral capsule, oral powder for suspension, oral tablet
In addition to its needed effects, some unwanted effects may be caused by Waladrox (the active ingredient contained in Waladrox). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Waladrox:
Black, tarry stools
blistering, peeling, or loosening of the skin
blood in the urine or stools
cough or hoarseness
difficulty with moving
feeling of discomfort
fever with or without chills
flushing or redness of the skin
general feeling of tiredness or weakness
inflammation of the joints
joint or muscle pain
lower back or side pain
muscle pain or stiffness
painful or difficult urination
pinpoint red spots on the skin
red skin lesions, often with a purple center
red, irritated eyes
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
swollen lymph glands
unusual bleeding or bruising
unusually warm skin
yellow eyes or skin
Incidence not known:
Abdominal or stomach cramps or tenderness
back, leg, or stomach pains
coughing up blood
diarrhea, watery and severe, which may also be bloody
difficulty with breathing or swallowing
general body swelling
increased menstrual flow or vaginal bleeding
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
sudden decrease in the amount of urine
swollen or painful glands
tightness in the chest
unpleasant breath odor
unusual tiredness or weakness
unusual weight loss
vomiting of blood
Minor Side Effects
Some of the side effects that can occur with Waladrox may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Acid or sour stomach
stomach discomfort, upset, or pain
Incidence not known:
Hives or welts
itching of the vagina or genital area
itching or pain of the genital area
pain during sexual intercourse
redness of the skin
thick, white vaginal discharge with no odor or with a mild odor
Do not take this medication if you are allergic to Waladrox, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.
Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.
Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Waladrox 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 has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
DailyMed. "CEFADROXIL/CEFADROXIL HEMIHYDRATE: 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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