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Risk Factors

Information provided under Risk Factors include Contraindications, Precautions and Risks in Pregnancy and Lactation for the relevant product.

Pregnancy: Risk cannot be ruled out.
Lactation: Contraindicated.
Contraindications: Severe respiratory depression, severe obstructive lung conditions.
Precautions: COPD, raised intracranial pressure, impaired consciousness, head injury, bradyarrhythmia, renal or hepatic impairment. Monitor for signs of respiratory depression. Brain tumour. Risk of tolerance and dependence. Elderly or debilitated patients.

Dosage (Alongwith Indications)

Fast, Quick & Easy Access to Accurate Dosage in Specific Indications

The usual dosage are: Adults: Usually 1 gm daily by deep IM., slow IV inj over at least 2-4 min, or IV infusion. Severe infections, 2-4 gm as a single dose every 24 hrs. Children: Usually 20-50 mg/kg once daily by IM inj., slow IV inj over at least 2-4 min, or IV infusion. Severe infections, up to maximum 80 mg/kg daily. Doses over 50 mg/kg to be given by slow IV infusion over at least 30 minutes. Neonates: IM/IV: Postnatal age ≤ 7 days or > 7 days (body wt ≤ 2 Kg): 50 mg/kg/day given every 24 hrs. Postnatal age > 7 days, body wt > 2 Kg: 50-75 mg/kg/day given every 24 hrs.

Administration

How to prepare and administer e.g. an Injectable
The drug may be administered by IV intermittent infusion over 10-30 min; final concentration for IV administration should not exceed 40 mg/mL. The drug has also been administered by direct IV push over 2-4 min. Inject deep IM into large muscle mass.
IM Injection: 250 mg/500 mg/1000 mg VIAL: To make concentration of 250 mg/mL add Water for Injection 0.9 mL in 250 mg vial; 1.8 mL in 500 mg vial; 3.6 mL in 1000 mg vial.
IV: 250 mg/500 mg/1000 mg VIAL: To make concentration of 100 mg/mL add Water for Injection 2.4 mL in 250 mg vial; 4.8 mL in 500 mg vial; 9.6 mL in 1000 mg vial.
Compatibility: Stable in D5W, D10W, NS, Sodium bicarbonate 5%, bacteriostatic water, SWFI.
Stability: For IV infusion in NS or D5W, solution is stable for 3 days at room temperature or 10 days when refrigerated.

Interactions

Amikacin, Aminoglycosides, Anticoagulants, Gentamicin, Kanamycin, Neomycin, Netilmicin, Streptomycin, Tobramycin, Warfarin.

Adverse Effects

GI upset, skin reactions, blood dyscrasias. Rarely pseudomembranous colitis, raised liver enzymes, glycosuria, oliguria, haematuria, bronchospasm, phlebitis at inj site, urinary and biliary precipitates, pancreatitis.

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