Moxaclav 1.2 IV Injection

Indications of Moxaclav 1.2 IV Injection

Moxaclav 1.2 IV Injection is suitable for the short-term treatment of bacterial infections in the following areas: 

Upper respiratory tract infections (including otorhinolaryngology), such as tonsillitis, sinusitis and otitis media.

Infections of the lower respiratory tract, such as acute and chronic bronchitis, lobular and bronchopneumonia.

Infection of the urogenital tract, such as cystitis, urethritis, pyelonephritis. 
Skin and soft tissue infections.

Infections of bones and joints, such as osteomyelitis.

Other infections, such as septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.

Pharmacology of Moxaclav 1.2 IV Injection

Pharmacodynamic properties: Moxaclav 1.2 IV Injection is an antibacterial combination consisting of the antibiotic amoxicillin and (clavulanic acid 3-lactamase inhibitor). Amoxicillin has broad-spectrum bactericidal activity against many gram-positive and gram-negative microorganisms, but is easily degraded by (3) lactamase, so the spectrum of activity does not include microorganisms that produce these enzymes. Clavulanic acid has the ability to exist The ability to inactivate β-lactamase in microorganisms resistant to penicillin and cephalosporin. Therefore, the clavulanic acid in the preparation protects amoxicillin from degradation by (3-lactamase) and effectively extends the antibiotic spectrum 

Pharmacokinetic properties covering a wide range of microorganisms: The pharmacokinetics of the two components of Moxaclav 1.2 IV Injection are closely related . Peak serum levels of both appeared approximately 1 hour after oral administration. Optimize the absorption of Moxaclav 1.2 IV Injection at the beginning of the meal. Both clavulanate and amoxicillin have low serum binding concentrations; about 70% are free in the serum. Doubling the dose of Moxaclav 1.2 IV Injection roughly doubles the serum level achieved.

Moxaclav 1.2 IV Injection Dosage & Administration

Adults and children over 12 years:

Tablet:

The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.

For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.

Suspension:

Children 6-12 years: 2 teaspoonful every 8 hours.

Children 1-6years: 1 teaspoonful every 8 hours.

Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.

Forte suspension:

The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।

For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).

Children of 2 to 12 years:
Mild to moderate infections:

25/3.6 mg/kg/day (Suspension)

2-6 years (13-21 kg) 2.5 ml suspension b.i.d

7-12years (22-40kg) 5 ml suspension b.i.d

Serious infections:

45/6.4 mg/kg/day (Forte Suspension)

2-6 years (13-21 kg) 5 ml suspension b.i.d

7-12 years (22-40 kg) 10 ml suspension b.i.d

IV Injection

Adults-

Usually, 1.2 gm every 8 hours

Increased in more serious infections to 1.2 gm every 6 hours

For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.

Children-

0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.

3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.

Interaction of Moxaclav 1.2 IV Injection

Some patients treated with Moxaclav 1.2 IV Injection have been reported to have a prolonged bleeding time and prothrombin time. Like other broad-spectrum antibiotics, Moxaclav 1.2 IV Injection may reduce the effectiveness of oral contraceptives, so patients should be warned. Concomitant use of allopurinol during treatment with amoxicillin increases the possibility of allergic skin reactions. There are no data on the simultaneous use of Moxaclav 1.2 IV Injection and allopurinol.

Contraindications

History of allergy to penicillin. Attention should be paid to possible cross-sensitivity with other β-lactam antibiotics. cephalosporins. It is also contraindicated in patients with a history of cholestatic jaundice related to Moxaclav 1.2 IV Injection or penicillin.

Moxaclav 1.2 IV Injection Side Effects

Like amoxicillin, side effects are not common and are mainly mild and short-lived. Diarrhea, pseudomembranous colitis, dyspepsia, nausea, vomiting, and candidiasis have been reported. If oral treatment has gastrointestinal side effects, they can be reduced by taking Moxaclav 1.2 IV Injection before meals. Reports of hepatitis and cholestatic jaundice are rare but are usually reversible. Sometimes hives and erythema can occur. There are few reports of erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis. Like other β-lactam antibiotics, angioedema and allergic reactions have also been reported.

Pregnancy & Lactation

Animal studies of oral and parenteral administration of Moxaclav 1.2 IV Injection have not shown teratogenic effects. The drug has been used orally during human pregnancy in a few cases without adverse effects; however, it is not recommended to use Moxaclav 1.2 IV Injection during pregnancy unless considered essential by the doctor. During lactation, traces of amoxicillin can be detected in breast milk.

Precautions & Warnings

Patients receiving anticoagulant therapy or severe liver dysfunction should use Moxaclav 1.2 IV Injection with caution. For patients with moderate or severe renal impairment, the dose should be adjusted. During the administration of high doses of Moxaclav 1.2 IV Injection, an adequate fluid intake and urine output should be maintained to minimize the possibility of crystalluria.

Therapeutic Class of Moxaclav 1.2 IV Injection

Broad-spectrum penicillins

Storage Conditions

Should be stored below 25°C, protected from light and moisture. After reformulation, the suspension must be stored in the refrigerator (but not frozen) and must be used within 7 days. After reconstitution, the vial must be used within 20 minutes.