Betasef DS

Betasef DS Uses, Dosage, Side Effects, Food Interaction and all others data.

Betasef DS is a first generation cephalosporin antibiotic that works in a similar way to penicillin by inhibiting bacterial cell wall synthesis. It has a broad spectrum bactericidal activity against both gram-positive and gram-negative bacteria. The organisms sensitive to Betasef DS are group A beta hemolytic streptococci, staphylococci including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Escherichia coli, Proteus mirabillis, Klebsiella species and Hemophilus influenzae. Betasef DS is acid stable and is rapidly absorbed after oral administration in the fasting condition. The presence of food in the gastrointestinal tract delays absorption but does not affect the total amount of Betasef DS absorbed. Over 90% of the drug is excreted unchanged in the urine. Betasef DS is minimally (8 to 17%) bound to normal plasma protein and does not cross the blood-brain barrier.

Trade Name Betasef DS
Generic Cefradine
Cefradine Other Names Cefradina, Cefradine, Cefradinum, Cephradin, Cephradine
Weight 250mg/5ml
Type Powder for Suspension
Formula C16H19N3O4S
Weight Average: 349.405
Monoisotopic: 349.109626801
Groups Approved
Therapeutic Class First generation Cephalosporins
Manufacturer Alco Pharma Ltd
Available Country Bangladesh
Last Updated: September 19, 2023 at 7:00 am
Betasef DS
Betasef DS

Uses

(Betasef DS) is used for the treatment of the following infections when caused by susceptible organisms:

The upper and lower respiratory tract infections: pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronic bronchitis, lobar and chronic bronchopneumonia.

Urinary tract infections: cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.

Surgical prophylaxis: Surgical procedures associated with high risk of disastrous consequences of infections. Procef is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection. Protection is best ensured by achieving adequate local tissue concentrations at the time when contaminations are likely to occur. Thus, Procef should be administered immediately prior to surgery and continued during the postoperative period.

Betasef DS is also used to associated treatment for these conditions: Bacterial Sepsis, Bloodstream Infections, Osteomyelitis, Peritonitis, Respiratory Tract Infections (RTI), Septic Arthritis, Skin and Soft Tissue Infections, Urogenital infection bacterial

How Betasef DS works

Betasef DS is a first generation cephalosporin antibiotic with a spectrum of activity similar to Cefalexin. Betasef DS, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that Betasef DS interferes with an autolysin inhibitor.

Dosage

Betasef DS dosage

(Betasef DS) may be given regardless of meal.

Adults

Oral: The usual dose is 1-2 gm daily in 2 to 4 divided doses. In severe and chronic infection, the dose can be increased upto 4 gm daily which should be given in equally divided doses.

In skin and skin structure infections and respiratory tract infections: Usual dose is 250 mg every 6 hours or 500 mg every 12 hours.

In Lobar pneumonia: Usual dose is 500 mg every 6 hours or 1g every 12 hours.

In uncomplicated urinary tract infections: Usual dose is 500 mg every 12 hours. In more serious urinary tract infections including prostatitis, 500 mg every 6 hours or 1 g every 12 hours may be administered.

Injection: The usual dose is 2-4 g daily in four equally divided doses by deep intramuscular or intravenous route. Dose may be increased to 8 gm daily in severe infections e.g. septicaemia and endocarditis.

Surgical prophylaxis: 1-2 gm immediately prior to surgery, by intramuscular or intravenous injection over 3-5 minutes. Subsequent parenteral or oral doses can be administered as appropriate.

Children

Oral: The usual dose is 25-50 mg/kg/day total, given in 2 or 4 equally divided doses. For otitis media daily dose from 75-100 mg/kg body wt. in divided doses every 6 to 12 hours are recommended. Dose may be increased up to 4 g/day depending on the severity of the infection.

Injection: 50-100 mg/kg/day total, given in 4 equally divided doses.

(200-300 mg/kg/day may be required in more severe infections)

 

Elderly

There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic functions.

Dosage in renal impairment

A modified dosage schedule is necessary in patients with decreased renal function. Each patient should be considered individually. The following modified dosage schedule is recommended as a guideline, based on creatinine clearance. In adults, the initial loading dose is 750 mg of Betasef DS and the maintenance dose is 500 mg at the following intervals:

Powder for Suspension: For the suspension, shake the bottle well before adding water. Then add 60 ml of boiled and cooled water (with the help of the provided cup) to thebottle. Then continue shaking the bottle gently until the powder is mixed properly. Shake the bottle well before each use.

Paediatric Drops: Shake the bottle well before adding water. Then add 10 ml (or with the help of provided spoon) of boiled and cooled water. Then continuously shake the bottle well until the powder is mixed properly. Shake the bottle well before each use. 

500 mg Intramuscular Injection: Add 2.0 ml of water for injection to 500 mg vial and shake. 

500 mg Intravenous Injection: Add 5.0 ml of water for injection to 500 mg vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

1 gm Intramuscular Injection: Add 4.0 ml of water for injection to 1 gm vial and shake. 

1 gm Intravenous Injection: Add 10.0 ml of water for injection to 1 gm vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

Side Effects

Rarely Betasef DS may induce a hypersensitivity reaction and gastrointestinal disturbances which include nausea, vomiting, diarrhoea, glossitis, heartburn, dizziness, abdominal pain, candidial overgrowth, vaginitis, skin rashes, urticaria, joint pain and oedema. As with other cephalosporin mild transient eosinophilia, leucopenia, neutropenia and rarely positive direct coombs test and pseudomembraneous colitis have been reported.

Precaution

There is evidence of partial cross-allergenicity between penicillins and cephalosporins. Therefore Betasef DS should be used with caution in patients with known hypersensitivity to penicillins.

Interaction

Increased risk of nephrotoxicity with loop diuretics. Decreased renal clearance with probenecid.

Food Interaction

  • Take with or without food.

Elimination Route

Over 90 percent of the drug is excreted unchanged in the urine within six hours.

Pregnancy & Breastfeeding use

No teratogenicity has been demonstrated in animals, but safety in pregnancy has not been established. Betasef DS is excreted in the breast milk and should be used with caution in lactating mothers.

Contraindication

Patients with known hypersensitivity to the cephalosporin antibiotics.

Special Warning

Directions for reconstitution:

Betasef DS powder for suspension : Add 70 ml (14 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake the bottle well after each addition of water until all the powder is in suspension.

Betasef DS fort powder for suspension :Add 55 ml (with the help of supplied measuring cup) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake the bottle well after each addition of water until all the powder is in suspension.

Betasef DS powder for paediatric drops :Add 10 ml (2 measuring spoonful) of boiled and cooled water to the bottle and shake vigorously.

Note: Shake both the suspension and paediatric drops bottle well before each use. Keep the bottle tightly closed.

Betasef DS 250 IM/IV Injection :

Intramuscular injection : Add 1.2 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 5 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Betasef DS 500 IM/IV Injection:

Intramuscular injection : Add 2 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 5 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Betasef DS  1 gm IM/IV Injection:

Intramuscular injection : Add 4 ml of supplied water for injection BP to the vial and shake.

Intravenous injection : Add 10 ml of supplied water for injection BP to the vial and shake. The solution should be slowly injected directly into a vein over a 3 to 5 minute period.

Pharmaceutical precaution

Betasef DS capsule, powder for suspension, powder for paediatric drops and vial (for injection) should be kept in a cool and dry place, away from light. The reconstituted suspension should be used within 7 days if kept at room temperature or within 14 days if refrigerated. The reconstituted Betasef DS injection solution should be used within 2 hours if kept at room temperature or within 12 hours if kept in refrigerator (2-8°C).

Interaction with other Medicine

The cephalosporins are potentially nephrotoxic (particularly Cefaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as Gentamycin and Tobramycin. One should be cautious about the use of any cephalosporin with Frusemide and Ethacrynic acid.

Storage Condition

Cephradine capsule should be kept below 30° C. Cephradine dry powder for suspension should be kept below 25° C & powder vial for injection should be kept below 25° C.

The reconstituted suspension, forte suspension and paediatric drops should be used within 7 days of preparation if kept at room temperature or within 14 days if kept in a refrigerator.

The Cephradine solution should be protected from bright or direct sunlight. All strengths of reconstituted products should be used immediately.

The reconstituted Cephradine injection solution should be used within 2 hours of preparation if kept at room temperature or within 12 hours when refrigerated at 2° to 8° C.

Innovators Monograph

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FAQ

What is Betasef DS used for?

Betasef DS is a first generation cephalosporin antibiotic used in the treatment of bacterial infections of the respiratory and urinary tracts and of the skin and soft tissues. These include the following: Upper respiratory tract infections - sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media.

How does Betasef DS work?

Betasef DS works by killing bacteria or preventing their growth.

What are the common side effects of Betasef DS?

Common side effects of Betasef DS are include;

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • tightness in your chest;
  • unusual bleeding;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Is Betasef DS safe during pregnancy?

Betasef DS is used to treat bacterial infections such as urinary tract infections, skin infections, chest and throat infections, ear infections and sinusitis. Betasef DS is suitable for adults and older children, and can be taken during pregnancy. Betasef DS showed no negative effects on unborn babies.

Is Betasef DS safe during breastfeeding?

Betasef DS is acceptable to use during breastfeeding. Limited information indicates that maternal doses of oral Betasef DS up to 2 grams daily produce low levels in milk that are not expected to cause adverse effects in breastfed infants.

Can I drink alcohol with Betasef DS?

Yes, you can drink alcohol with Betasef DS.

Can I drive after taking Betasef DS ?

Betasef DS capsules do not usually affect your ability to drive, but if you experience any dizziness do not drive or operate machinery.

When should be taken of Betasef DS?

Betasef DS capsules can be taken either before or after food, although they may start to work a little sooner if they are taken before food.

How long does it take Betasef DS to work?

Betasef DS take to work about 6 hours.

How long does Betasef DS stay in my system?

Measurable serum levels are present six hours after administration. Over 90% of the Betasef DS is excreted unchanged in the urine within 6 hours.

Can I take Betasef DS on an empty stomach?

You may take Betasef DS with or without food. Taking the medicine with food or milk may ease side effects on your stomach.

How long can I take Betasef DS?

Betasef DS is usually given for up to 3 days after lab tests show that the infection has cleared. Very severe infections may need to be treated for several weeks.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose of Betasef DS?

Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include nausea, vomiting, stomach pain, or diarrhea.

Who should not take Betasef DS?

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.

Does Betasef DS make me sleepy?

Betasef DS oral capsule doesn't cause drowsiness. However, it can cause other side effects.

Can Betasef DS cause kidney damage?

The renal injury most commonly associated with the Betasef DS  class of antibiotics is allergic interstitial nephritis, currently available Betasef DS infrequently can cause direct tubular toxicity.

How safe is Betasef DS?

Betasef DS is safe in children at recommended dosages.

What happens if I take too much Betasef DS?

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, and blood in your urine. 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 before using anti-diarrhea medicine.

Can Betasef DS cause anxiety?

Betasef DS can cause anxiety-like symptoms as well as aggravate existing anxiety symptoms, including increasing a sense of nervousness, agitation, danger, and foreboding.

Is Betasef DS safe for liver?

Betasef DS has a good safety profile, it has the propensity to cause severe drug-induced liver injury and, in very rare cases, acute liver failure

*** Taking medicines without doctor's advice can cause long-term problems.
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