Silgram

AMPICILLIN SODIUM + SULBACTAM SODIUM

250 mg/125 mg
500 mg/230 mg
1 g/500 mg (I.M./I.V.)
Sterile Powder for Injection

ANTIBACTERIAL

Category:

Description

FORMULATION

Each vial contains:

Ampicillin (as sodium) …………………….. 250 mg

Sulbactam (as sodium) …………………… 125 mg

Each vial contains:

Ampicillin (as sodium) …………………….. 500 mg

Sulbactam (as sodium) …………………… 250 mg

Each vial contains:

Ampicillin (as sodium) …………………….. 1 g

Sulbactam (as sodium) …………………… 500 mg

Description

Ampicillin sodium

Ampicillin sodium/Sulbactam sodium (Silgram) is an injectable antibacterial combination consisting of the semisynthetic antibiotic Ampicillin sodium and the beta-lactamase inhibitor Sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived fromt eh penicillin nucleus, 6-aminopenicillinic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-{®-2-amino-2-phenylacetamido}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S.

Sulbactam sodium

Sulbactam sodium is a derivatinve of the basic penicillin nucleus. Chemically, Sulbactam sodium is a sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo–4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22.

CLINICAL PHARMACOLOGY

Immediately after completions of a 15-minute intravenous infusion of Ampicillin sodium/Sulbactam sodium (Silgram), peak serum concentrations of ampicillin and sulbactam are obtained. Ampicillin serum levels are similar to those produced by the administration of equivalent amounts of ampicillin alone. The mean serum half-life of both drug is approximately 1 hour in healthy volunteers. Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration of Ampicillin sodium/Sulbactam sodium (Silgram) to individuals with normal renal function.

INDICATIONS

For the treatment of upper and lower respiratory tract infections, gynaecological infections and as a prophylaxis to reduce the risk of infections following surgery caesarean and birth.

CONTRAINDICATIONS

The use of Ampicillin sodium/Sulbactam sodium (Silgram) is contraindicated individuals with a history of hypersensitivity to any of the penicillins.

DOSAGE AND ADMINISTRATION

Ampicillin sodium/Sulbactam sodium (Silgram) may be administered by either the IV or the IM routes.

For IV administration, the dose can be given slow intravenous injection over at least 10-15 minutes or can also be delivered, in greater dilutions with 50 – 100 mL of a compatible diluent as an intravenous infusion over 15 – 30 minutes.

Ampicillin sodium/Sulbactam sodium (Silgram) may be administered by deep intramuscular injection.

Adult dosage

Ampicillin sodium/Sulbactam sodium (Silgram) is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six (6) hours. This 1.5 to 3 range represents the total of ampicillin content plus the sulbactam content of Ampicillin sodium/Sulbactam sodium (Silgram) and corresponds to a range of 1 g ampicillin/0.5 g sulbactam.

Pediatric dosage

For pediatric patients who weighs 40 kg or more may receive the usual adult dosage.

1 year of age or older- 300 mg/kg daily (200 mg Ampicillin and 100 mg Sulbactam) given by IV infusion in equally divided doses every 6 hours.

1 month or older- 100-150 mg/kg of Ampicillin daily in 4 divided doses for mild to moderate infection.

For the treatment of acute pelvic inflammatory disease, may receive a dosage of 3 g (2 g of Ampicillin plus 1 g of Sulbactam) every 6 hours in conjunction with doxycycline (100 mg every 12 hours administered IV or orally). The parenteral regimen may be discontinued 24 hours after clinical improvement. However, oral doxycycline should be continued to complete 14 days therapy.

DIRECTION FOR USE

For intravenous and Intramuscular administration, the following dilutions may be used:

Strength/Vial Volume of Diluent to be added Withdrawal volume
375 mg 0.8 mL 1.0 mL
750 mg 1.6 mL 2.0 mL
1.5 g 3.2 mL 4.0 mL

Note: Concentrated solution (375 mg/mL), must be administered within one hour after preparation.

For deep intramuscular administration, Silgram may be reconstituted with sterile water for injection or any of the compatible diluents described below. Solution should be allowed to stand after reconstitution to allow any foaming to dissipate in order to permit visual inspection for complete dissolution.

An appropriate volume should then be immediately diluted with a suitable parenteral diluent to yield solutions containing 3 to 45 mg (Silgram) per mL (2 to 30 mg Ampicillin/ 1 to 15 mg Sulbactam per mL).

Maximum Concentration

Diluent (mg/mL) (Ampicillin/Sulbactam) Use Periods
Sterile Water for Injection 45 (30/15)

45 (30/15)

30 (20/10)

8hours at 25°C

48 hours at 4°C

72 hours at 4°C

0.9% Sodium Chloride Injection 45 (30/15)

45 (30/15)

30 (20/10)

8hours at 25°C

8 hours at 4°C

72 hours at 4°C

5% Dextrose Injection 30 (20/10)

30 (20/10)

3 (2/1)

2 hours at 25°C

4 hours at 4°C

4 hours at 25°C

Lactated Ringer’s Injection 45 (30/15)

45 (30/15)

8hours at 25°C

24 hours at 4°C

M/6 Sodium Lactate Injection 45 (30/15)

45 (30/15)

8hours at 25°C

8 hours at 4°C

5%Dextrose in 0.45% Saline 3 (2/1)

15 (10/5)

4 hours at 25°C

4 hours at 4°C

WARNINGS

Serious and occasionally fatal hypersensitivity (anaphylactic), penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. Careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, Ampicillin sodium/Sulbactam sodium (Silgram) should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine, oxygen, intravenous steroids and airway management including intubation should be administered as indicated.

PRECAUTIONS

General

A high percentage of patients with mononucleosis who receive ampicillin develop skin rash. Thus, Ampicillin class antibiotics should not be administered to patients with mononucleosis. In patients treated with Ampicillin sodium/Sulbactam sodium (Silgram) 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.

DRUG INTERACTIONS

Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with Ampicillin sodium/Sulbactam sodium (Silgram) may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent use of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is unknown whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Ampicillin sodium/Sulbactam sodium (Silgram) and allopurinol administered concurrently. Ampicillin sodium/Sulbactam sodium (Silgram) and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of Ampicillin sodium/Sulbactam sodium (Silgram).

ADVERSE EFFECTS

  • Anaphylactic shock
  • Diarrhea or loose bowel, nausea, vomiting, epigastric distress and abdominal cramps
  • Anemia, thrombocytopenia, eosinophilia and leucopenia
  • Transient elevations of ALT (SGPT) and AST (SGOT) transaminases, bilirubinemia, abnormal hepatic function and jaundice
  • Rash, itching and other skin reactions

AVAILABILITY

Silgram 250 mg/125 mg Powder for Injection IM/IV – glass vial

Silgram 500 mg/250 mg Powder for Injection IM/IV – glass vial

Silgram 1 g/500 mg Powder for Injection IM/IV – glass vial

STORAGE

Store at temperatures not exceeding 30°C.

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