Meixam for Injection

MEIXAM FOR INJECTION

Cloxacillin sodium for injection MRAPJ

MRAPJ : Minimum requirement for Antibiotic Product of Japan

Cloxacillin is a synthetic penicillin of the isozalyl group. It shows excellent antibacterial activity against gram-positive bacteria, including multi - drug resistant staphylococci, and gram - negative cocci.

COMPOSITION
One vial of MEIXAM FOR INJECTION contains 250 mg (base), of Cloxacillin sodium JP (Japanese Pharmacopoeia).
One vial of MEIXAM FOR INJECTION contains 500 mg (base), of Cloxacillin sodium JP (Japanese Pharmacopoeia).
One vial of MEIXAM FOR INJECTION contains 1000 mg (base), of Cloxacillin sodium JP (Japanese Pharmacopoeia).

PROPERTIES
Cloxacillin sodium JP is white to pale yellowish white crystals or crystalline powder. It is freely soluble in water, methanol and ethanol, slightly solube in acetone and very slightly soluble in aether and chloroform.
Generic name: Cloxacillin sodium
Molecular formula: C₁₉H₁₇ClN₃NaO₅S.H₂O
Molecular weight: 475.89

INDICATIONS
Infection of:

• The upper respiratory tract, pneumonia, tonsillitis and pharyngitis.
• Otitis media.
• The skin : furuncle, carbuncle, abscess, cellulitis, infections after wound burns.
• Acute and sub acute endocarditis.
• Meningitis cause by Staphylococcus.
• Urinary tract cause by Staphylococcus.
• Cause by penicillinase producing staphylococci, which cannot covered by penicillin.

                     
DOSAGE AND ADMINISTRATION

Dosage for adults
Injection intra muscular	:	250 mg every 6 hours.
Injection drip infussion	:	500 mg every 4 - 6 hours until 2 g a day, depends on the infections.
Intrapleural injection	:	500 mg/day.
Intraarticular injection	:	500 mg/day.
Dosage for children
under 2 years old	:	¼ adult dose.
2-10 years old	:	½ adult dose.

ADMINISTRATION

For intra muscular injection	:	Powder should be diluted in 1,5 ml water for injection.
For intravenous injection	:	Powder should be diluted in 10 - 20 ml water for injection.
For drip infussion	:	Meixam can be diluted in the infussion solution by adding in the bottle drip or injected in the drip pipe for 2 - 3 minutes. Meixam stable in the solution of saline normal for 24 hours, 5 % dextrose, ringer saline dextrose, dextrose 40 % injected in the saline normal and dextran 40 % injected in 5 % dextrose.
For intrapleural injection	:	Powder should be diluted in the 5 - 10 ml water for injection.
For intraarticular injection	:	Powder should be diluted in 2 - 5 ml water for injection, 0,5 % Lignocaine HCl can be used as local anaesthetic if needed.

                                 
PRECAUTIONS
The patients history should be sufficient taken so as to able to predict adverse reactions
such as shock. It is desirable to perform a skin test before starting treatment with the drug.
This drug should be administered under careful clinical observation to :

1. Patients who themselves or when parents or siblings, have a constitution susceptible to allergic reactions.
2. Patients with severely impaired renal function.
3. Probenecid given with penicillin derivate can increase the blood level around 2 - 5 times and maintain for 6 hours. Don't administered Probenecid for the renal failure function

CONTRA INDICATIONS
This drug should not be used in patients with a history of shock due to administration of Cloxacillin sodium.
Babies born from mother who hypersensitive to penicillin.
Don't be injected for sub conjunctival.

DRUG INTERACTION
Mixed injection with other drugs should, as a rule, be avoided. Meixam for intravenous injection should not be combined with protein hydrolysate or another lipid emulsion.

SIDE EFFECTS

1. Shock, rarely shock symptoms may occur, so sufficient observation is needed. If such symptoms as discomfort, a strange feeling in the oral cavity, stridor, vertigo, desire to defecation, tinnitus, etc occurred, administration should be stopped.
2. Hypersensitive, if allergic symptoms such as fever, eruption and urticaria develop, administration should be stopped.
3. Blood, rarely eosinophylia and granulocytopenia may develop.
4. Liver, rarely, increase in the level of SGOT may develop.
5. Digestive tract, rarely, severe colitis with bloody stool such as pseudo membranous colitis may develop. If such symptoms as abdominal pain and frequent diarrhea occur, suitable measures, including discontinuation of the drug, should be taken.

STORAGE AND EXPIRATION DATE
Storage : Store at temperature 15°C - 30°C
Expiration date : Three years. the expiration date is printed on the outer box, and vial label.

HOW SUPPLIED
Meixam for injection 250 mg (base).   Reg. No. DKL 9215301444A1
Meixam for injection 500 mg (base).   Reg. No, DKL 9215301444B1
Meixam for injection 1000 mg (base). Reg. No. DKL 9315301444C1

HARUS DENGAN RESEP DOKTER
PT MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES
Bangil-Pasuruan, Jawa Timur-Indonesia

Licensed by
MEIJI SEIKA KAISHA, LTD.
Tokyo, Japan.

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