Ampisid (Powder) Instructions for Use

Marketing Authorization Holder

Mustafa Nevzat Pharmaceutical Industry, A.S. (Turkey)

ATC Code

J01CR04 (Sultamicillin)

Active Substance

Sultamicillin (Rec.INN registered by WHO)

Dosage Form

Ampisid

Powder for preparation of oral suspension 250 mg/5 ml: bottle 70 ml 1 pc.

Dosage Form, Packaging, and Composition

Dark glass bottles with a volume of 70 ml (1) complete with a dosing spoon – cardboard packs.

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor

Pharmacotherapeutic Group

Antibiotic, semi-synthetic penicillin + beta-lactamase inhibitor

Pharmacological Action

Broad-spectrum antibacterial agent. It is a double ester of ampicillin (a semi-synthetic penicillin) and sulbactam (a beta-lactamase inhibitor). It acts bactericidally.

Sultamicillin is active against gram-positive and gram-negative bacteria, including those producing β-lactamases.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to sultamicillin (including gonococci).

Continuation of therapy after a course of treatment with a combination of ampicillin and sulbactam administered parenterally.

ICD codes

Dosage Regimen

For adults and children weighing more than 30 kg, the daily dose is 375-750 mg/day, for children weighing less than 30 kg – 25-50 mg/kg (depending on the severity of the infection).

The frequency of administration is 2 times/day. The course of treatment is 5-14 days.

When treating uncomplicated gonorrhea, Sultamicillin may be prescribed as a single dose of 2.25 g (in combination with probenecid).

Adverse Reactions

From the digestive system: diarrhea; rarely – nausea, vomiting, epigastric pain, colic, enterocolitis and pseudomembranous colitis.

From the CNS: rarely – drowsiness, malaise, headache.

Allergic reactions: itching, rash, skin reactions; in some cases – severe anaphylactic reactions.

Other: development of superinfection (including fungal).

Contraindications

Hypersensitivity to penicillins.

Use in Pregnancy and Lactation

The safety of using sultamicillin during pregnancy and lactation has not been established.

Use in Renal Impairment

In severe renal impairment, the intervals between doses should be increased.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Sultamicillin should not be used in patients with infectious mononucleosis.

If there is a history of allergic reactions to cephalosporins, the possibility of cross-allergy should be considered.

In severe renal impairment, the intervals between doses should be increased.

During long-term treatment with sultamicillin, peripheral blood counts, liver and kidney function should be monitored.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.