COMPOSITION

SENOXY-CV 625 mg Tablets 
Each film-coated tablet contains 
Amoxycillin trihydrate IP 
equivalent to Amoxycillin . . . . . 500 mg 
Clavulanic acid......................... 125 mg 
(Present as clavulanate potassium IP) 

SENOXY-CV 228.5 mg Syrup 
Each 5 ml (on reconstitution) contains 
Amoxycillin trihydrate IP 
equivalent to Amoxycillin . . . . . ...200 mg 
Clavulanate Potassium IP 
equivalent to Clavulanic acid ..... 28.5 mg

INDICATIONS

SENOXY-CV is indicated for short-term treatment of bacterial infections at the following sites:

i. Upper Respiratory Tract Infections(including ENT) e.g.recurrent tonsillitis, sinusitis, otitis media 
ii. Lower Respiratory Tract Infections e.g.acute exacerbation of chronic bronchitis, lobar and bronchopneumonia 
iii. Genito-urinary Tract Infections e.g. cystitis, urethritis, pyelonephritis 
iv. Skin and Soft Tissue Infections e.g. boils, abscesses, cellulitis, wound infections, animal bites 
v. Bone and Joint Infections e.g. osteomyelitis 
vi. Other infections e.g. intra-abdominal sepsis, septic abortion, puerperal sepsis 
vii. Dental infections: eg dentoalveolar abscess, severe dental abscess with spreading cellulitis

DOSAGE AND ADMINISTRATION

Oral Administration 
To minimize potential gastrointestinal intolerance, administer at the start of a meal. The absorption of SENOXY-CV is optimized when taken at the start of a meal. Treatment should not be extended beyond 14 days without review.

SENOXY-CV Tablets

Adults and Children over 12 years

Usual dosages for the treatment of infection.

Dentoalveolar abscess one SENOXY-CV 625 mg tablet twice a day for five days.

Renal Impairment

Adults 
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 1g tablet.

Haemodialysis patients should receive 625 mg tablet every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Hepatic Impairment 

Dose with caution; monitor hepatic function at regular intervals.

SENOXY-CV 625mg tablet is not recommended in children of 12 years and under.

Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.

Patients aged 2 years and older:

There is insufficient experience with SENOXY-CV  228.5 mg DT to make dosage recommendations for children under 2 months old.

Infants with immature kidney function 

For infants with immature renal function  SENOXY-CV 228.5 mg DT is not recommended.

Renal impairment 

For children with GFR of > 30 mL/min no adjustment in dosage is required. For children with a GFR of < 30 mL/min          SENOXY-CV 228.5 mg DT is not recommended.

Hepatic impairment 

Dose with caution; monitor hepatic function at regular intervals. There is, as yet, insufficient evidence on which to base a dosage administration.

Disperse the SENOXY-CV 228.5 mg DT in 10 ml of water before administration.

SENOXY-CV Syrup 

Usual dosages for the treatment of infection. 

The table below gives guidance for children.

Children over 2 years:  

Children under 2 years should be dosed according to body weight.  

There is insufficient experience with SENOXY-CV 228.5 mg Syrup to make dosage recommendations for children under 2 months old.

Infants with immature kidney function 
For infants with immature renal function SENOXY-CV 228.5 mg Syrup is not recommended.

Renal impairment 
For children with GFR of > 30 mL/min no adjustment in dosage is required. For children with a GFR of < 30 mL/min  SENOXY-CV  228.5 mg Syrup is not recommended.

Hepatic impairment 
Dose with caution; monitor hepatic function at regular intervals. There is, as yet, insufficient evidence on which to base a dosage administration.

Instructions for use/handling

Direction for preparing the suspension 
At the time of dispensing, the dry powder should be reconstituted to form an oral suspension. First shake the bottle to loosen powder. Twist and open the vial of sterile water given with the pack. Slowly add sterile water into the bottle up to black arrow mark on the label. Put the cap, and shake the bottle vigorously. Adjust the volume upto the black arrow mark by adding more sterile water, if necessary and shake again. Store the reconstituted suspension in the refrigerator. Shake well before each use. Consume the content (reconstituted) of  SENOXY-CV 228.5 mg syrup within 10 days .

CONTRAINDICATIONS

SENOXY-CV is contraindicated in patients with penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics, e.g. cephalosporins. It is also contraindicated in patients with a previous history of SENOXY-CV associated jaundice / hepatic dysfunction.

PACKAGING INFORMATION

SENOXY-CV 625mg tablets ……………........Strip of 6 tablets 
SENOXY-CV 228.5 mg Dry Syrup ..........................Bottle of 30mL