Colistimethate Sodium Injection IP 1 Million IU

4. Therapeutic Uses

• Management of life-threatening Gram-negative bacterial infections, especially in hospitalized or ICU patients

• Used when pathogens are resistant to other antibiotics or in combination to broaden coverage

5. Safety Profile & Side Effects

Common adverse effects:

• Renal toxicity: increased creatinine, urea nitrogen; decreased urine output

• Neurological symptoms: dizziness, vertigo, slurred speech, tingling or numbness (paresthesia)

• Gastrointestinal upset, fever, general fatigue, rash

• Injection-site reaction or discomfort

Serious risks:

• Respiratory distress or apnea in high-risk patients

• Severe renal injury necessitating dose adjustment or withdrawal

• Neurotoxicity in high doses or vulnerable populations (elderly, renal impairment)

6. Precautions

• Administration only by healthcare professionals self-injection not allowedRenal impairment: Dose adjustment necessary; close monitoring required

• Contraindications / Cautions: Avoid in patients with myasthenia gravis, porphyria, severe kidney disease

• Pregnancy: Use only with medical advice; animal data shows riskconsult physician

• Breastfeeding: Likely safe if prescribed; limited human data

• Alcohol: Safe, though general caution advised; discuss with physician

• Driving/machine use: May impair alertness, vision; avoid if dizziness or drowsiness occursDrug interactions: Caution when co-administered with other nephrotoxic or neurotoxic drugs