Hibiotic … broad spectrum antibiotic

Hibiotic ® is a generic medicine for the brand AUGMENTIN . This medicine produced by Amon pharmaceuticals , and is available in Egypt , Middle East and North Africa countries. This page contains information about Hibiotic supplied by Amon Pharmaceuticals.Hibiotic is (beta-lactam antibacterial penicillin co-formulated with a beta-Iactamase inhibitor).

Price in Egypt

Form

Description

Price in US dollar

Hibiotic 1000 mg tablet

Package 16 tablet

4.1

Hibiotic 625 mg tablet

Package 16 tablet

3.9

Hibiotic 375 mg tablet

Package 20 tablet

3.16

Hibiotic 312 mg /5 ml susp

60 ml bottle

1.5

Hibiotic N 228 mg / 5 ml susp

60 ml bottle

1.5

Hibiotic N 457 mg / 5 ml susp

60 ml bottle

2.3

Hibiotic N 600 mg / 5 ml susp

80 ml bottle

2.6

Presentation

Tablets and suspensions containing different ratios of ( Amoxycillin trihydrate: Potassium clavulanate).

Tablets ( Swallow film-coated)

  • 375 mg (250mg /125 mg).
  • 625 mg (500mg/175 mg).
  • 1 g (875mg/125 mg).

Dry Powder Suspensions

  • Suspension: 200mg /28.5 /5 mL (7:1).
  • Suspension : 400 mg/57 mg/5 ml (7:1).

Inactive ingredients

Hibiotic®1 gm

crospovidoneXL, Aerosil200, purified talc, magnesium stearate, lactose anhydrous, titanium dioxide, opadry purple.

Hibiotic Tablet Suspension - Broad Spectrum Antibiotic
Hibiotic Tablet Suspension – Broad Spectrum Antibiotic

Hibiotic®375 mg              

Crospovidone XL, Aerosil 200, Purified Talc, Magnesium Stearate, Opadry yellow.

Hibiotic®N: 2OO/28.5/5ml

Citric Acid Anhydrous, Tribasic Sodium Citrate, Avicel CL611, Colloidal Silicon Dioxide (aerosol 200), lemon Flavour Powder, Dimethicon 350, Sucrose, Sodium stearyl fumerate.

Hibiotic®N: 400/57/5ml

Citric Acid Anhydrous, Tribasic Sodium Citrate, croscaramellose Sodium, Carboxymethyl cellulose, Aerosil 200, Lemon Flavour Powder, Dimethicon 350, Sucrose, Sodium stearyl fumerate.

What is Hibiotic®?

(beta-lactam antibacterial penicillin co-formulated with a beta-Iactamase inhibitor) is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens’ in general Practice and hospital. The beta-Iactamase inhibitory action of Clavulanate extends the spectrum of amoxycillin to embrace a wider range of organisms, including many resistant to other beta-Iactam antibiotics.

Hibiotic Presentation
Hibiotic Presentation

Indications and Usage

Amoxicillin /clavulanate potassium is indicated in the treatment of infictions caused by susceptible strains of the designated organisms in the conditions listed below :

  • Lower respiratory Tract Infections : caused by B-Iactamase – producing strains of H. influenzae and M. ( Branhamella ) catarrhalis.
  • Otitis media : caused by B-lactamase-producing strains of H influenzae and M. catarrhalis.
  • Sinusitis : caused by B-lactarnase-produong strains of H influenzae and M. catarrhalis.
  • Skin and Skin Structure Infections : caused by B-Iactamase – producing strains of S. aureus, E. coli and klebsiella spp.
  • Urinary Tract Infections : caused by B-Iactamase – producing strains of E. coli, Klebsiella SPP. and Enterobacter spp .

while amoxycillin / clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxycillin/clavulanate potassium due to its amoxycillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and B- lactamase-producing organisms susceptible to amoxicillin/ clavulanate potassium should not require the addition of another antibiotic. Because amoxyocillin  has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxycillin and amoxycillin / clavulanate potassium.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxycillin / clavulanate potassium and other antibacterial drugs amoxycillin /clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to “be caused by susceptible bacteria.

When culture and ,suscepility 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.

Bacteriological studies , to determine the causative organisms and their susceptibility to amoxicillin / clavulanate potassium , should be performed together with any indicated surgical procedures .

Warnings

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxycillin/clavulanate potassium, careful inquiry  should be made concerning previous hypersensitivity reactions to penicillins, Cephalosporins or other allergens. If an allergic reaction occurs, amoxycillin/clavulanate potassium should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management including intubation, should also be administered as indicated.

Pseudomembranous colitis  has been reported with nearly all antibacterial agents, including  amoxicillin /clavulanate potassium, and has ranged in severity from mild to life-threatening. Therefore, it is Important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Hibiotic Indications and Usage
Hibiotic Indications and Usage

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluid and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Amoxycillin / clavulanate potassium should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxycillin/clavulanate potassium is usually reversible . On a rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Concomitant administration of amoxycillin and anticoagulants from the coumarin class, may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary.

Precautions

While amoxycillin / clavulanate potassium possesses the characteristic low toxicity of  the antibiotics,periodic  assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy .

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash . Thus ampicillin – class antibiotics should not be administered to patients with mononucleosis .

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy . If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and or appropriate therapy instituted.

Prescribing amoxicillin / clavulanate potassium in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Hibiotic Dosage and adminstration
Hibiotic Dosage and adminstration

Undesirable effects

Mucocutaneous candidiasis, diarrhoea. nausea and vomiting. have been reported.Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident , they may be reduced by taking Hibiotic at the start of a meal . Uncommenly the following was reported :

  • Indigestion.
  • A moderate rise in AST and / or ALT has been noted in patients treated with beta-Iactam class antibiotics.
  • Skin rash, pruritus and urticaria.
  • There have been rare findings of reversible leucopenia (including neutropenia) and thrombocytopenia.
  • Erythema multiforme and very rarely reversible agranulocytosis and haemolytic anaemia.
  • Prolongation of bleeding time and prothrombin time.
  • Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.
  • Reversible hyperactivity and convulsions. Convulsions may occur in patients with impairment renal function or in those receiving high doses .
  • Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis).
  • Superficial tooth discoloration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discoloration as it can usually be removed by brushing.
  • Hepatitis and cholestatic jaundice.

These events have been noted with other penicillins and cephalosporins

Stevens-Johnson syndrome

toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthemous pustulosis (AGEP). Interstitial nephritis and crystalluria.

Hepatic events

have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.

These events have been very rarely reported in children.

Signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible.

Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications  known to have the potential for hepatic effects.

Hibiotic Precautions
Hibiotic Precautions

Amoxycillin/clavulanate potassium is generally well tolerated

The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.

The following adverse reactions have been reported for ampicillin-class antibiotics:

Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis,glossitis black hairy tongue Mucocutaneous Candidiasis, enterocolitis, and hernorrhagic/pseudomernbranous colitis .

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Hypersensitivity Reactions

 Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported.

These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids, Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin.

Hibiotic overdosage
Hibiotic overdosage

Liver

A moderate rise In AST ( SGOT) and/ or ALT ( SGPT) has been noted in patients treated With ampicillin-class antibiotics, but the significance of these findings is unknown.

Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with amoxycillin/clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic – hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic d function, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Renal

Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported.

Hemic and lymphatic System

Anemia, Including hemolytic anemia, thrombocytopenia, thrormbocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1 of the patients treated with amoxycillin/ clavulanate potassium. There have been reports of increased prothrombin time in patients receiving amoxycillin/clavulanate potassium and anticoagulant therapy concomitantly.

Central. Nervous System

Agitation, anxiety, behavioral changes confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous

Tooth discoloration (brown, yellow, or gray staining) has been rarely reported.

Most reports occurred in pediatric patients discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Dosage and Administration

Pediatric Patients

Based on the amoxycillin component Hibiotic® should be dosed as follows:

Neonates and infants aged less than 12 weeks ( 3 months )

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group , the recommended dose of Hibiotic  is 30 mg / kg / day divided q12h, based on the amoxycillin component, Clavulanate elimination is unaltered in this age group.

Experience with the 200 mg/ 5 ml formulation in this age group is limited and, thus, use of the 125 mg/5 ml oral suspension is recommended.

Patients aged 12 weeks (3 months) and older

INFECTIONS

DOSING REGIMEN

Otitis media, sinusitis, lower

respiratory tract infections, and more sever infections

more se’. ere infections

45 mg/kg/day q12h

Less severe infections

25 mg/kg/day q12h

Duration of therapy for acute otitis media is 10 days .

Pediatric patients weighing 40 kg and more : should be dosed according to the adult recommendations .

Adult

The usual adult dose is one 500/125mg tablets of amoxicillin/ clavulanate potassium every 12 hours .or one 250 mg /62.5 mg tablets every 8 hours.

For more severe infections and infections of the respiratory tract,the dose should be one 875 mg /125 mg amoxicillin /clavulanate potassium every 12 hours Or one 500 mg / 125 mg  tablets of amoxycillin /clavulanate potassium even 8 hours.

Renal Impairment

Dosing adjustments are based on the maximum recommended level of amoxycillin.

Children

Creatinine clearance more than  30ml/min ..No adjustment necessary .

Creatinine clearance from 10 to 30 ml/min.. 15/3.75 mg/kg give as a single daily dose.

In the majority of cases , parenteral therapy , where available , may be preferred.

Adults

Creatinine clearance more than  30ml/min ..No adjustment necessary .

Creatinine clearance from 10 to 30 ml/min .. 1 times  625 mg given b.i.d.; OR1-2 times 375 mg , depending upon severity of infection, given O.D.

 Pregnancy & Lactation

Use in Pregnancy

In a single study in women with preterm, premature rupture of the foetal membrane (pP ROM), it was reported that prophylactic treatment with Hibiotic may be associated with an increased risk of enterocolitis in neonates. As With all medicines use should be avoided in pregnancy, unless considered essential by the physician.

Use in Lactation

Hibiotic may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities m breast milk, there are no known detrimental effects for the breast-fed infant.

Effects on the ability to drive and operate machinery

Adverse effects on the ability to drive or operate machinery have not been observed .

Over dosage

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident, They may be treated symptomatically , with attention to the water / electrolyte balance .

If amoxicillin crystalluria has been observed , Hibiotic  can be removed from the circulation by haemodialysis.

A prospective study of 51 paediatric patients at a poison control centre suggested that over dosages of less than 250 mg/ kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying .

Microbiology

Amoxycillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative micro-organisms . Amoxycillin is , however, susceptible to degradation by beta-lactamases and therefore the spectrum of activity of Amoxycillin alone does not include organisms which produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-Iactamase enzymes commonly found in micro – organisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated beta- lactamases frequently responsible for transferred drug resistance. it is generally less effective against  chromosomally mediated type1 beta-Lactamases, The presence of clavulanic acid in Hibiotic  formulations protects amoxicillin  from degradation by beta-Iactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxyillin and other penicillins and cephalosporins . Thus Hibiotic possesses the distinctive properties of a broad spectrum antibiotic and a beta – lactamase inhibitor . Hibiotiic is bactericidal to a wide range of organisms .

Instructions for use/handling

For administration to children up to 2 years old, Hibiotic® suspensions may be diluted to half-strength usingwater.

Storage Conditions

Store at Temperature not Exceeding 25°C, In dry place.

After reconstitution: Hibiotic N 200/28.5/5ml & Hibiotic N 400/57/5ml: Store at temperature ( 2-8°C) & to be used within 7 days.

Hibiotic Tablet Suspension - Broad Spectrum Antibiotic
Hibiotic Tablet Suspension – Broad Spectrum Antibiotic