5.2 Effect of Grinding on the Stability
Belfix-CV crystallizes with three waters of hydration, which is the most stable crystalline form. The water molecules in the crystal lattice are considered to play a significant role in the chemical stability of Belfix-CV, as the dihydrate and anhydrate forms have been found to be less stable than is the trihydrate form 18]. Kitamura et al. have studied the effect of grinding on the solid-state stability and physicochemical properties of Belfix-CV trihydrate. using x-ray diffraction, scanning electron microscopy, differential scanning calorimetry, and color measurements . It was found that the crystalline trihydrate phase changes to a non-crystalline solid when the trihydrate is milled for four hours in a ball mill, as evidenced by the decrease in x-ray diffraction peak intensities that accompany prolonged grinding times. The dehydration temperature of ground Belfix-CV trihydrate has been found decrease with increasing grinding times.
Before taking Belfix-CV
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Belfix-CV it is important that your doctor knows:
- If you have ever had an allergic reaction to a medicine. It is particularly important that you tell your doctor if you have had a bad reaction to a penicillin or cephalosporin antibiotic.
- If you have any problems with the way your k >
How to take Belfix-CV
- Before you start taking Belfix-CV, read the manufacturer's printed information leaflet from ins >
Before taking Belfix-CV,
- tell your doctor and pharmacist if you are allergic to Belfix-CV; other cephalosporin antibiotic such as cefaclor (Ceclor), cefadroxil cefazolin (Ancef, Kefzol), cefdinir, cefditoren (Spectracef), cefepime (Maxipime), cefotaxime (Claforan), cefotetan, cefoxitin (Mefoxin), cefpodoxime, cefprozil, ceftaroline (Teflaro), ceftazidime (Fortaz, Tazicef, in Avycaz), ceftibuten (Cedax), ceftriaxone (Rocephin), cefuroxime (Zinacef), or cephalexin (Keflex); penicillin antibiotics, or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, or plant to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), and carbamazepine (Carbatrol, Epito, Equetro, Tegretol, Teril). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had gastrointestinal disease (GI; affecting the stomach or intestines), especially colitis (condition that causes swelling in the lining of the colon ), or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Belfix-CV, call your doctor.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that Belfix-CV chewable tablets are sweetened with aspartame that forms phenylalanine.
Interaction of Belfix-CV
Drug interactions may change how your medications work or increase your risk for serious side effects. All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol :
- Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine :
- Amikacin : MODERATE
- Chloramphenicol : MODERATE
- Nifedipine : MAJOR
- Warfarin : MODERATE
- Ethinyl Estradiol : MODERATE
- Cholera Vaccine : SEVERE
- Furosem >MODERATE
- Colitis : MODERATE
- Renal Disease : MODERATE
- Information not available.
- Coombs test : MODERATE
- Urine ketones test : MODERATE
Other uses for this medicine
Belfix-CV is also sometimes used to treat sinus infections in penicillin allergic patients, pneumonia, shigella (an infection that causes severe diarrhea), salmonella (an infection that causes severe diarrhea), and typhoid fever (a serious infection that is common in developing countries). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How to store Belfix-CV
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
- If you have been given liqu >
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines.
If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Storage And Handling
SUPRAX ® is available for oral administration in following dosage forms, strengths and packages listed in the table below:
Dosage Form Strength Description Package Size NDC Code Storage SUPRAX ® (Belfix-CV) tablets USP 400 mg White to off-white, film-coated, capsule shaped tablets with beveled edges and a divided score line on each side, debossed with “SUPRAX” across one side and “LUPIN” across other side, containing 400 mg of Belfix-CV as the trihydrate. Bottles of 10 tablets 27437-201-10 Store at 20 to 25°C (68 to 77°F) . Bottle of 50 tablets 27437-201-08 Bottle of 100 tablets 27437-201-01 SUPRAX ® (Belfix-CV) capsules 400 mg Size “00EL” capsules with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black ink, containing white to yellowish white granular powder containing 400 mg of Belfix-CV as the trihydrate. Bottle of 50 capsules 27437-208-08 Store at 20 to 25°C (68 to 77°F) . Unit Dose Package of 10 (1 blister of 10 capsules) 27437-208-11 SUPRAX ® (Belfix-CV) chewable tablets 100 mg Pink, round tablet, debossed with “SUPRAX 100” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-203-10 Store at 20 to 25°C (68 to 77°F) . Bottle of 50 tablets 27437-203-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-203-11 150 mg Pink, round tablet, debossed with “SUPRAX 150” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-204-10 Bottle of 50 tablets 27437-204-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-204-11 200 mg Pink, round tablet, debossed with “SUPRAX 200” on one side and “LUPIN” on other side. Bottles of 10 tablets 27437-205-10 Bottle of 50 tablets 27437-205-08 Unit Dose Package of 10 (1 blister of 10 tablets) 27437-205-11 SUPRAX ® (Belfix-CV) for oral suspension USP 100 mg/5 mL Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of Belfix-CV as the trihydrate. Bottle of 50 mL 68180-202-03 Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77°F) .
After reconstitution: Store at room temperature or under refrigeration. Keep tightly closed.
Bottle of 75 mL 68180-202-02 Bottle of 100 mL 68180-202-01 200 mg/5 mL Off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 200 mg of Belfix-CV as the trihydrate. Bottle of 25 mL 27437-206-05 Bottle of 37.5 mL 27437-206-06 Bottle of 50 mL 27437-206-03 Bottle of 75 mL 27437-206-02 Bottle of 100 mL 27437-206-01 500 mg/5 mL Off white to cream colored powder forming off-white to pale yellow suspension with characteristic fruity odor on constitution. After reconstituted as directed, each mL of reconstituted suspension contains 100 mg of Belfix-CV as the trihydrate. Bottle of 10 mL 27437-207-02 Bottle of 20 mL 27437-207-03
Manufactured By: Lupin Limited Mandideep 462 046 India. Revised: March 2018.
What is the dosage for Belfix-CV?
The recommended adult dose for otitis media, tonsillitis, pharyngitis, and urinary tract infections is 400 mg once daily or divided and given as 200 mg every 12 hours. Pediatric patients (6 months and older) have a recommended dose of 8 mg/kg/day once daily or in two doses of 4/mg/kg every 12 hours.
Is Belfix-CV safe to take if I'm pregnant or breastfeeding?
Safety in pregnancy has not been established for Belfix-CV. There are no adequate studies in pregnant women; however, studies in animals suggest no important effects on the fetus.
Safety in nursing mothers has not been established. It is not known if Belfix-CV is excreted in breast milk.